Featured review: Low-dose misoprostol given by mouth for induction of labour
First author of this new Cochrane Review, 'Low‐dose oral misoprostol for induction of labour', Robert Kerr explains, “Our review found that Misoprostol given orally outperforms the ‘gold-standard’ drug which is much more expensive, and used in preference in many countries. This review has the potential to impact millions of women and babies who have inductions of labour through its comparison of oral misoprostol with other commonly used induction techniques."
Labour inductions are common around the world. Induction rates vary worldwide, but for example in the UK, 1 in 3 women will have labour induced. Induction of labour may be a life-saving intervention and identifying effective and safe methods will help achieve greater positive birth experiences for mothers and their babies.
In this recently published Cochrane review, authors explored the evidence from randomised controlled trials to see if low-dose misoprostol given by mouth is effective in starting labour in women in their third trimester with a live baby. They compared misoprostol with other commonly used methods of inducing labour.
What is the issue?
Artificially starting labour, or induction, is common in pregnancy. Reasons include the mother having high blood pressure in pregnancy or the baby being past the due date. Misoprostol is a type of prostaglandin that can be taken in low doses by mouth to induce labour. Prostaglandins are hormone-like compounds that are made by the body for various functions (including the natural onset of labour). Unlike other prostaglandins such as vaginal dinoprostone, misoprostol does not need to be stored in the refrigerator. Taking a tablet is convenient to mothers and the low-dose tablet sizes are now available (25 µg).
Why is this important?
A good induction method achieves a safe birth for mother and baby. It is effective, results in a relatively low number of caesarean sections, has few side effects, and is highly acceptable to mothers. Some methods of inducing labour may cause more caesarean sections by being ineffective at bringing on labour, other methods may lead to more caesareans as they cause too many contractions (hyperstimulation) that result in the baby becoming distressed (foetal heart rate changes).
What evidence did we find?
We searched for evidence on 14 February 2021 and identified 61 trials involving 20,026 women for inclusion in this review. Not all trials were high quality.
Starting with oral misoprostol immediately may have a similar effect on rates of caesarean section (4 trials, 594 women; low-certainty evidence) to giving no treatment for 12 to 24 hours then starting oxytocin, while the effects of misoprostol on uterine hyperstimulation with foetal heart rate changes are unclear (3 trials, 495 women; very low-quality evidence). All women in theses trials had ruptured membranes.
Oral misoprostol was compared to vaginal dinoprostone in 13 trials (9676 women). Misoprostol use probably decreased the risk of caesarean section (moderate-certainty evidence). When studies were divided by their initial dose of misoprostol, there was evidence that use of 10 µg to 25 µg may be effective in reducing the risk of a caesarean section (9 trials, 8652 women), while the higher 50 µg dose might not reduce the risk (4 trials, 1024 women). There may be very small or no differences between misoprostol and dinoprostone in rates of vaginal births within 24 hours (10 trials, 8983 women; low-certainty evidence) but may be fewer cases of hyperstimulation with foetal heart rate changes with oral misoprostol (11 trials, 9084 women; low-certainty evidence).
Oral misoprostol was compared with vaginal misoprostol in 33 trials (6110 women). Oral use may have resulted in fewer vaginal births within 24 hours (16 trials, 3451 women; low-certainty evidence). Oral use may have caused less hyperstimulation with foetal heart rate changes (25 trials, 4857 women; low-certainty evidence), especially with a dose of 10 µg to 25 µg. There was no clear difference in the number of caesarean sections overall (32 trials, 5914 women; low-certainty evidence) but oral use likely resulted in fewer caesareans being performed because of concerns of the baby being in distress (24 trials, 4775 women).
When oral misoprostol was compared to oxytocin for induction, misoprostol use probably resulted in fewer caesarean sections (6 trials, 737 women). We found no clear difference in vaginal birth within 24 hours (3 trials, 466 women; moderate-certainty evidence) or hyperstimulation with foetal heart rate changes (3 trials, 331 women; very low-certainty evidence).
Oral misoprostol was compared to a balloon catheter inserted in the cervix to mechanically induce labour. The number of vaginal births within 24 hours may have increased with misoprostol (4 trials, 1044 women; low-certainty evidence). Misoprostol probably reduced the risk of caesarean section (6 trials, 2993 women; moderate-certainty evidence) with no difference in risk of hyperstimulation with foetal heart rate changes (4 trials, 1044 women; low-certainty evidence).
Different doses and timings of giving oral misoprostol were explored in three small trials. The certainty of the findings from these trials was either low or very low so we cannot draw any meaningful conclusions from this data.
What does this mean?
Using low-dose (50 µg or less) oral misoprostol to induce labour likely leads to fewer caesarean sections and so more vaginal births than vaginal dinoprostone, oxytocin, and a transcervical Foley catheter. Rates of hyperstimulation with foetal heart rate changes were comparable with these methods. Misoprostol taken by mouth causes less hyperstimulation with foetal heart changes compared to when taken vaginally.
More trials are needed to establish the most effective misoprostol regimen for labour induction, but for now the findings of this review support oral rather than vaginal use, and suggest that commencing oral misoprostol at a dose of 25 µg or less may be safe and effective.
Low-dose oral misoprostol is probably associated with fewer caesarean sections (and therefore more vaginal births) than vaginal dinoprostone, and lower rates of hyperstimulation with foetal heart rate changes. However, time to birth may be increased, as seen by a reduced number of vaginal births within 24 hours.
Compared to transcervical Foley catheter, low-dose oral misoprostol is associated with fewer caesarean sections, but equivalent rates of hyperstimulation.
Low-dose misoprostol given orally rather than vaginally is probably associated with similar rates of vaginal birth, although rates may be lower within the first 24 hours. However, there is likely less hyperstimulation with foetal heart changes, and fewer caesarean sections performed due to foetal distress.
The best available evidence suggests that low-dose oral misoprostol probably has many benefits over other methods for labour induction. This review supports the use of low-dose oral misoprostol for induction of labour, and demonstrates the lower risks of hyperstimulation than when misoprostol is given vaginally. More trials are needed to establish the optimum oral misoprostol regimen, but these findings suggest that a starting dose of 25 µg may offer a good balance of efficacy and safety.
Featured review: Low‐dose oral misoprostol for induction of labour
EME, the Portuguese-language Students 4 Best Evidence blog, launches today
We are delighted to announce the creation of "Estudantes para Melhores Evidências", a Portuguese-language blog for all students that aims to be a source for sharing and disseminating evidence-based information, as well as a centerpiece platform to encourage networking among Portuguese-speaking healthcare workers interested in evidence-based healthcare. The initiative, inspired by the English and Spanish-language counterparts (S4BE and ExME), was conceived by Cochrane Brasil Rio de Janeiro (an Affiliate of the Cochrane Brazil Network) and is supported by Cochrane and Cochrane Brazil.
Beyond bringing together recent reviews, EME will provide tools for evidence-based training (like one of their series of posts on "Key Concepts"), interact with the community via social media, and encourage interaction among members.
"We truly believe that the success of evidence-based practice in the future goes through the engagement and training of generations of healthcare students to the philosophy of using the best evidence available to support clinical decision making, as well as understanding and helping to overcome evidence production and dissemination challenges we face currently," states Prof. Luis Eduardo Fontes, director of Cochrane Brasil Rio de Janeiro Affiliate.
"We are a community for students, by students. Our goal is to gather resources on evidence-based healthcare in an interactive space. We believe we will be able to inspire students from multiple backgrounds to learn and disseminate evidence-based healthcare, which is in much needed, especially today," says the Organizing Committee, initially composed by students from the Centro Universitário Arthur Sá Earp(UNIFASE) - host of Cochrane Brasil Rio de Janeiro- and Universidade Federal de São Paulo (UNIFESP), the two academic institutions leading this initiative.
From undergraduate to graduate students, EME is open for new contributors interested in learning more or producing new blog posts on evidence-based healthcare. If you would like to become an EME contributor, feel free to contact them at firstname.lastname@example.org.
" É com grande entusiasmo e alegria que hoje lançamos o ESTUDANTES PARA MELHORES EVIDÊNCIAS (EME), iniciativa organizada pelo Centro Afiliado Cochrane Brasil Rio de Janeiro, Cochrane Brasil e pela Cochrane. Trata-se de um blog em lingua portuguesa feito por estudantes para estudantes que têm interesse em Saúde Baseada em Evidências. Um ambiente virtual para compartilhar e disseminar informações , assim como uma plataforma central para encorajar o networking entre os profissionais de saúde que falam ou compreendem português interessados em Saúde Baseada em Evidências.
" Nós realmente acreditamos que o sucesso da prática clínica baseada em evidências no futuro passa pelo engajamento e treinamento de gerações de estudantes da área da saúde na filosofia de usar as melhores evidências disponíveis para apoiar a tomada de decisões clínicas, assim como entender e ajudar a superar os desafios de produção e disseminação de evidências que enfrentamos atualmente" afirma o Prof. Luis Eduardo Fontes, diretor do Centro Afiliado Cochrane Brasil Rio de Janeiro.
"Somos uma comunidade para estudantes, por estudantes. Nosso objetivo é reunir recursos em Saúde Baseada em Evidências em um espaço interativo e acreditamos que seremos capazes de inspirar estudantes de países de lingua portuguesa de todo mundo a aprender e disseminar a prática clínica baseada em evidências" acredita o Comitê Organizador, inicialmente composto por estudantes do Centro Universitário Arthur Sá Earp (UNIFASE) - instituição sede do Centro Afiliado Cochrane Brasil Rio de Janeiro - e da Universidade Federal de São Paulo (UNIFESP), as duas instituições acadêmicas que lideram esta iniciativa.
Da escola aos estudantes de pós-graduação, o EME está aberta a novos colaboradores interessados em aprender mais ou produzir novos posts no blog (se você gostaria de se tornar um colaborador da EME, entre em contato com email@example.com)
Watch the video: Cochrane Sweden host webinar on clinical trial transparency
Cochrane Sweden recently held a webinar on registration and reporting of clinical trials in collaboration with their host institution, Lund University.
Clinical trial transparency is a key advocacy topic for Cochrane, and the webinar was a continuation of Cochrane Sweden’s efforts to promote this issue. At the end of 2020, they launched a joint report with TranspariMED which highlighted shortcomings in clinical trial reporting in Sweden – finding that over 70% of verifiably due clinical trial results are missing.
Emma Thompson, Cochrane’s Advocacy and Partnership Officer, moderated alongside Heiko Herwald, Vice-Dean at the Lund University Faculty of Medicine.
Mixing both regional and national perspectives, the webinar aimed to be relevant both within and outside of the context of Sweden. Presentations covered topics including current trial transparency regulations and best practices for improving reporting at universities. Examples were also shared from Karolinska Institutet and Clinical Studies Sweden, who have both taken steps to improve the reporting of their trials. Participants then had the opportunity to ask panellists their questions in an extended Q&A session.
7:32 We have come a long way: Data Transparency and Pharmaceutical Regulation Europe (Slides)
Shai Mulinari, Dept Sociology, Lund University
26:48 Getting all clinical trial results reported - lessons learnt from successful universities (Slides and QUEST manual for clinical trial reporting)
Till Bruckner, author of a clinical trial reporting manual for universities. He is a Research Fellow at the BIH QUEST Center and the founder of the TranspariMED campaign
47:10 Centralizing the Clinical Trial Registration and Results Reporting Process in Academic Institutions (Slides)
Tony Durkee, Lead Coordinator for Clinical Trials at the Compliance and Data Office (CDO) at Karolinska Institutet
1:06:09 Clinical Trial Registering and Reporting (Slides)
Maria Skoog, Clinical trial manager, Clinical Studies Sweden - Forum South
1:16:03 Panel Discussion and Q&A
- If you are interested in learning more about this work and how you can support it, please contact Emma Thompson.
Founder of Cochrane Skin, Professor Hywel Williams, awarded the Order of the British Empire
Professor Hywel Williams has been awarded an Order of the British Empire (OBE). He has received the award for services to the national Covid-19 research response and his lifelong research into skin diseases.
Professor Williams was a founding member of the Cochrane Skin group in 1997 and was the Co-ordinating Editor for 21 years. He is a Professor of Dermato-Epidemiology and Co-Director of the Centre of Evidence-Based Dermatology in the School of Medicine at the University of Nottingham, where Cochrane Skin is based.
In his role as Director of the NIHR Health Technology Assessment Programme Director and more recently as NIHR Scientific and Coordinating Centre Programmes Contracts Advisor, Professor Williams worked tirelessly to galvanise a joined-up research response to the pandemic. He was, and still is, a key advisor to a number of funding and oversight groups set up to help manage the Covid-19 research response, and to ensure that effective treatments reach NHS patients in record time.
Within dermatology, Professor Williams contributed to national guidance on shielding for patients taking immunosuppressive medications at the request of the Chief Medical Officer. He co-ordinated efforts to ensure consistent advice to people with eczema on how to handwash during the pandemic; producing a training video which has been used worldwide.
Karla Soares-Weiser, Editor in Chief of the Cochrane Library said, “The impact of Hywel’s work in the field is massive. He is one of the most cited dermatologists in the world. His impact at Cochrane has been just as important. He established the Cochrane Skin group and worked tirelessly to champion patient and public involvement in research and the evidence-based approach for treatment for people with skin problems.”
Dr Bob Boyle and Professor Robert Dellavalle, Joint Co-Ordinating Editors, said, “Cochrane Skin extends their warmest congratulations to Hywel on this well-deserved recognition. Words cannot describe the importance of the contributions Dr. Williams has made to the field of dermatology.”
- Visit the Cochrane Skin website
- Learn more about the history of Cochrane Skin
- Listen to a podcast with Professor Williams discusses his involvement in Cochrane and his belief in the importance of patient involvement in research.
- Check out the COVID-19 Resources for Dermatology
News item adapted from University of Nottingham’s ‘Double birthday honours for University of Nottingham medics’.Wednesday, June 16, 2021
Remembering Dr. Murray Enkin
Dr. Murrary Enkin, whos work contributed to the creation of Cochrane, passed away on 6 June 2021.
An obstetrics pioneer and prominent influencer in the early days of the formation of Cochrane, Dr. Murray Enkin was instrumental in developing evidence-based perinatal clinical trials and systematic reviews, challenging many common interventions not supported by research evidence. He, along with his latewife, Eleanor, also strongly advocated for family-centred maternity care such as the presence of fathers during childbirth and non-labour room deliveries.
Dr. Enkin, who passed away on 6 June 2021, graduated from medical school at the University of Toronto, Canada, in 1947 and received specialist training on obstetrics and gynecology at Long Island College Hospital in Brooklyn, United States, a few years later. The mainstay of his medical practice was in Hamilton, Canada, becoming departmental chief of Obstetrics and Gynaecology at St. Joseph’s Hospital and among inaugural faculty for the opening of the McMaster University Medical School. As Professor Emeritus, he retired in 1988.
Dr. Enkin was recognized with the Order of Canada in 2013 for his contributions to maternal care and development of midwifery as a recognized profession in Canada. From 1999-2017, McMaster hosted the annual Murray and Eleanor Enkin Lectureship, to focus on the key role that humanitarian values should take in clinical research and science in general.
Iain Chalmers, the first Director of Cochrane UK, said, “My friend and colleague Murray Enkin has died a few days after his 97th birthday. He had every reason to be pleased with the contributions he made during his long life, and I am indebted to him for many of these. My friendship and collaboration with Murray began in the late 1970s when we had met at a meeting entitled ‘Maternity Care in Ferment’ organised by the Maternity Center Association (MCA) in New York. Prompted by discussions at the MCA meeting, Murray and his wife Eleanor decided to spend a sabbatical year with me and my colleagues at the National Perinatal Epidemiology Unit in Oxford. The most tangible result of our work together there was a book we co-edited entitled ‘Effectiveness and Satisfaction in Antenatal Care’ (Enkin and Chalmers 1982). The less tangible result of our work was the mutual learning that resulted from our different backgrounds in care during pregnancy and childbirth: Murray provided the wisdom that had come from decades of challenging some aspects of obstetric orthodoxy; I had come to challenge orthodoxy by raising questions about the effects of components of maternity care, reviewing existing evidence from research, and doing additional research to address important uncertainties. Our recruitment of Marc Keirse (who brought expertise in reproductive physiology) as a third editor led to the creation of an international team of over 100 people who worked together throughout the 1980s to create the 2- volume book ‘Effective Care in Pregnancy and Childbirth” (Chalmers et al. 1989). Murray was also primarily responsible for creating a paperback summary of the larger book for women using the maternity services entitled ‘A Guide to Effective Care in Pregnancy and Childbirth’ (Enkin et al. 1989). To correct the systematic reviews in the books and keep them up to date, the reviews were also published electronically as the updatable ‘Oxford Database of Perinatal Trials’ (Chalmers ed. 1988).”
James Neilson, Editor with Cochrane Pregnancy and Childbirth shares, “The Pregnancy & Childbirth Group was the first review group to establish with the start of the Cochrane Collaboration in 1992. Murray was its Co-ordinating Editor. He and Eleanor spent large periods of time in Oxford, and Murray developed the template of what it was to be a Cochrane Co-ordinating Editor and what a Cochrane review group would look like. More than anyone, he was the practical bridge between ‘The Oxford Database of Perinatal Trials’ and The Cochrane Database of Systematic Reviews. He stepped down as Co-ordinating Editor in 1995 when the editorial base moved to Liverpool but continued to contribute as Editor and review author. Murray Enkin was not only a systematic reviewer of high methodological standing, but he was also a beautiful writer. He was very much the lead author of ‘Guide to Effective Care in Pregnancy and Childbirth’, which ran to three editions. It started life as a paperback guide to the mammoth ‘Effective Care in Pregnancy & Childbirth,’ but took on a life of its own, combining evidence from Cochrane systematic reviews with a beautifully composed linking narrative. It was wildly popular, the third edition selling > 35,000 copies. Popular with consumers, obstetricians and midwives, its success was testament to Murray Enkin’s rare ability to communicate clearly and succinctly”.
Karla Soares-Weiser, Editor in Chief of the Cochrane Library said, "Murray Enkin will be deeply missed. We are proud of the contribution he made to the work that inspired the Cochrane Collaboration. Together, the ‘Effective Care in Pregnancy and Childbirth’, its paperback summary of contents ‘A Guide to Effective Care in Pregnancy and Childbirth’, and ‘Oxford Database of Perinatal Trials’ provided the model that led to the development of the Cochrane Collaboration in the early 1990s.”
Cochrane COVID-19 Study Register evaluation study
Research evaluation of the Cochrane COVID-19 Study Register finds high comprehensiveness for interventional studies and added value to review authors for containing additional references for eligible studies.
The Cochrane COVID-19 Study Register (CCSR) is a freely available collection of study references on COVID-19. The CCSR links different references for the same studies, making all references easier for systematic reviewers to find. The aim of the CCSR is to support rapid and living evidence synthesis, including the CEOsys evidence ecosystem for COVID-19 research. CEOsys is a consortium of 21 German university medical centers providing researchers and guideline developers with a comprehensive, up-to-date source of curated evidence from clinical and public health studies.
As part of CEOsys project, an evaluation study was conducted in November 2020 to measure the CCSR's performance and to identify areas for improvement. The study found high comprehensiveness (sensitivity) for trial registry records (100%) and journal articles (86.5%), interventional studies (94%) and clinical management topics (87%). The evaluation also found high accuracy of the CCSR's study descriptions (e.g., interventional or observational) (93-98%) and rapid publishing times for trial registry records (0.5 day) and journal article records (2 days). Areas for improvement were identified as coverage and publishing times for preprints.
An exciting evaluation finding was that the CCSR contained 112 additional (uncited) references for 286 eligible studies from a sample of COVID-19 systematic reviews from journals with a high impact factor. Of these extra 112 references contained in the CCSR, 70 (62.5%) could have been retrieved at the time the systematic reviews in the sample conducted their searches. This means that systematic reviewers searching the CCSR will find higher coverage of all available references and data for their eligible studies.
The CEOsys evaluation study showed that the CCSR is performing well as a COVID-19 evidence source and provided insights to improve its coverage and publishing times. Further, the evaluation showed the value of study registers to provide a complete evidence-base for the production of systematic reviews. The CEOsys consortium concluded that the CCSR is a time-saving resource for retrieving COVID-19 evidence to support evidence synthesis.
For more information, please see Maria-Inti Metzendorf's and Robin Featherstone's publication in Research Synthesis Methods:
How Cochrane is responding to COVID-19 in 2021
In 2020, Cochrane’s editorial response to COVID-19 pandemic brought together collaborations across our global organization to publish reviews addressing stakeholder needs as they emerged. Large, highly organized review teams worked together to produce evidence addressing priorities in treatment, prevention, and diagnostics. In 2021, Cochrane continues to produce new and updated reviews in response to the pandemic.
In this interview with Deputy Editor in Chief Toby Lasserson and Executive Editor of Cochrane's Central Editorial Service Helen Wakeford, we ask them about Cochrane’s editorial approach to COVID-19 in 2021. The interview supports their paper, which sets out how Cochrane will respond to COVID-19 going forward and the priorities which inform this response.
What have you set out to explain in this paper?
Helen: "The scope of reviews that Cochrane could potentially publish on COVID-19 is enormous. In addition, most review questions have a rapidly evolving evidence base that demands frequent updating of the review in order for it to remain useful to readers. So we needed to prioritise key topics on which to focus our resources. This paper sets out those priorities, and the rationale for why we have identified them as such. In 2021 and beyond, we will consider future submissions against these priorities. We will also be able to identify evidence synthesis gaps within our priority areas and actively commission reviews.
We are aware that the COVID-19 pandemic is a rapidly evolving situation and we want to retain flexibility to respond to emerging priorities. In the report, we have explained that will stay tuned into organisations such as COVID-END who ‘horizon scan’ for emerging areas of need. We will also track the production of other high quality evidence syntheses to make sure that we are avoiding research waste."
What was 2020 like in terms of pace and coverage?
Helen: "2020 – at least, from March onwards - was extremely fast-paced! Authors from Cochrane Centres, CRGs and those who were new to Cochrane, worked around the clock to address urgent evidence synthesis questions. We considered producing preprints of these reviews, but instead developed an ultra-rapid editorial process of between 7-21 days in order to retain both speed and editorial rigour, and stay true to Cochrane’s reputation for ‘trusted evidence’. This meant close collaboration between the Central Editorial Service team and many colleagues across Cochrane, involving long days and late nights at work.
Cochrane’s coverage of COVID-19 reviews in 2020 was broad and responded to the needs of guideline developers. Our reviews examined the effectiveness of public health measures such as quarantine, PPE, ash for hand washing, universal screening, travel control measures and digital contact tracing in controlling COVID-19. We also published a qualitative review of barriers and facilitators of healthcare workers’ adherence to infection and prevention control, and scoping reviews looking at school measures to control COVID-19 and ICU care bundles for improving patient outcomes.
Reviews of diagnostic test accuracy were another major feature of our COVID-19 response, examining the diagnostic accuracy of antibody tests, signs and symptoms, thoracic imaging, routine laboratory tests and rapid, point of care tests.
As high-quality data from trials of COVID-19-specific therapeutics were slower to emerge, so were reviews of these interventions. We published reviews of convalescent plasma and hyperimmune immunoglobulin, and anticoagulants. The mental health of particularly impacted populations was also addressed by our reviews Interventions to support the resilience and mental health of frontline health and social care professionals during a disease outbreak, epidemic or pandemic and following de-escalation and Video calls for reducing social isolation and loneliness in older people.
Several of these reviews were updated multiple times during the course of the year (e.g. quarantine, convalescent plasma, thoracic imaging).
The above reviews were managed centrally, but others were published via Cochrane Review Groups, including a suite of reviews on mouth washes and sprays for preventing COVID infection, oxygen targets during ventilation and an update of a review of physical interventions to reduce the spread of respiratory viruses.
We were very much, and quite rightly in my view, in ‘response mode’ in 2020, attempting to address the urgent needs of our stakeholders. But now we can take stock, look at our emerging priorities and plan for the future."
What key priorities are set out in the paper?
Toby: "We identified important public health intervention and diagnostic accuracy reviews last year, so keeping those up to date is important. We are also looking to expand coverage in three areas relating to vaccination and immunity, generic medicines, and mental health consequences of the pandemic.
We would also do well to look back as well as forward. In the years after the influenza pandemic of 1918, there was an increase in neurological conditions thought to be related to the influenza virus. In a similar vein we can expect long term health consequences of COVID 19 to emerge years from now. Priorities will continue to shift but the need for evidence is fixed. To ensure that the evidence we can provide is relevant, we need to be flexible and move with what we know is happening.
Varied as these topic areas are, they each serve to highlight how misinformation and inequity have exacerbated and lengthened the course of the global pandemic. Addressing them will require no shortage of effort or evidence. To be relevant to the challenges ahead, our response to COVID 19 is not just about what we cover, but how we cover it. Where possible we want to see our reviews adopt an equity perspective to ensure that we can inform health and policy decisions."
How will these priority areas shape what Cochrane publishes?
Toby: "They will keep us on track to ensure our output is focused and relevant to what we know are the most important considerations for health systems globally. Since the start of 2020 I think we’ve got a better sense of what we need to stay on top of, but we’ve also seen how quickly gaps in coverage can emerge as new interventions and diagnostic tests are promoted and used. The need for effective treatments and tests has stressed efforts to evaluate these things properly, so balancing speed and rigour has become ever more important for us.
The collaborative work between all parts of Cochrane in response to COVID 19 needs to continue for us to continue to meet the information needs of our users. Working closely with CRGs as we have done in responding to COVID 19 so far shows how effective we are as a team in Cochrane. For the collaboration to truly pay off, we also need to reduce unnecessary duplication of effort, and so we recommended surveillance of what other review producers are doing."
If you look back in five-years-time, what will you most proud and pleased to have achieved in response to the pandemic?
Toby: "I think seeing the reviews coming through to publication having worked with Helen to put together an editorial team and process so quickly. Something profound was happening as so many people from across the community found a connection with us and with each other through this process. To know that all of this was happening against a backdrop of great turmoil and isolation from colleagues, friends and family was humbling."
Helen: "I feel proud of the number of reviews published and the speed at which this was achieved, despite such stressful circumstances. The Central Editorial Team have managed the editorial process for 29 COVID-19 reviews and updates to date, and this shows no sign of slowing down. Seeing the number of times these reviews have been shared and cited makes me feel that we may have made a real contribution to evidence-based decision making during the pandemic.
What makes me most pleased is that when we could have felt at our most isolated, we came together as a global team and supported one another. I feel much closer to my colleagues after the past year and consider them friends."
Over a 12-week period from March to August 2020, we drew together reflections about what external stakeholders thought about Cochrane’s initial response to COVID-19 - you can read the External Stakeholder Evaluation of Cochrane's COVID-19 response here. If you would like more information on the findings, please contact Jo Anthony firstname.lastname@example.org or Karen Head Khead@cochrane.org from Cochrane's Knowledge Translation Department.
Cochrane launches Cochrane Kenya to promote evidence-informed decision making in healthcare in the country
Cochrane is pleased to announce that on June 8, Cochrane Kenya launched at the 11th KASH (Kenya Medical Research Institute Annual Scientific and Health) Conference.
Cochrane Kenya is a geographical affiliate of the global Cochrane collaboration. It is also part of Cochrane Africa, a regional, independent Cochrane network of researchers, professionals, patients, carers, and people interested in health in Africa. Cochrane Kenya will promote evidence-informed decision making in health care in Kenya by supporting and training new authors of Cochrane Reviews, as well as working with clinicians, professional associations, policy makers, patients, and the media to encourage the dissemination and use of synthesized or summarized evidence.
Judith Brodie, Cochrane’s Interim Chief Executive Officer, said of the launch: “I am delighted we are announcing the launch of Cochrane Kenya, which I’m confident will deepen and expand the reach and impact of Cochrane activities, extending access to the best evidence for health and healthcare decision-making in East Africa, and therefore improving lives for citizens in Kenya and this region.”
The launch was well-received at the Conference, with Charles Wiysonge, Director of Cochrane South Africa, saying, "Cochrane Kenya will make an impact in Kenya, in Africa and globally. It could not have been born at a better time."
"COVID-19 highlights the hunger for rapid evidence to inform decision making. Cochrane Kenya will actively advocate for evidence-informed healthcare in Kenya & the East African region," said Eleanor Ochodo, from the Kenya Medical Research Institute and Centre for Evidence Based Health Care at the launch.
Cochrane Kenya is part of Cochrane, a global independent network of researchers, professionals, patients, carers and people interested in health. Cochrane produces reviews which study all of the best available evidence generated through research and make it easier to inform decisions about health. Cochrane is a not-for profit organization working to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest. Cochrane’s work is recognized as representing an international gold standard for high quality, trusted information.
Illustrating Cochrane evidence in a more gentle way: Interview with Jen Ma
We chatted with Jen Ma of Gentle Facts about how art can help in communicating science and health evidence, the challenges involved, and her work to address these.
Can you tell us a bit about yourself and background?
My name is Jennifer Ma (I go by Jen). I am a researcher by training and did my PhD in the Stem Cell Bioengineering lab at the University of Toronto. I originally planned to stay in research and contribute to innovations in healthcare, but gradually discovered the crucial role of science communication to bring the existing body of knowledge to the public. Examples were all around me: friends were choosing alternative medicine over evidence-based treatments; unproven and dangerous “stem cell therapies” were masquerading as Regenerative Medicine and thriving; the anti-vax movement was gaining more followers by the day. I wanted to use my education, combined with my passion in visual arts, to fight misinformation and promote engagement with science. I also hope to reach an audience that might have been missed by traditional science media and connect with them at a human level. After finishing grad school, I am now focusing mostly on my science communication project Gentle Facts and loving every minute of it!
And how did Gentle Facts get started? Can you explain the focus?
I was finishing up my PhD thesis during the pandemic. It was a very stressful time so, to stay sane, I shielded myself from all other stressors from the outside world, including the constant bombardment of information about COVID-19 and the polarization of opinions online. However, being uninformed prevented me from doing my part as a citizen and a researcher/science advocate to fight the pandemic and other social issues, leaving me with feelings of guilt and powerlessness.
I saw that many others had similar sentiments: struggling to find a balance between staying in these important conversations and protecting our mental health. Gentle Facts is my attempt to be the solution, where we curate concise, actionable, evidence-based information and present them in an accessible way without drama. We hope that our mindful approach will lessen the mental toll and empower people to take informed actions more confidently.
What’s your goal for Gentle Facts?
Our main goal is to create social change through compassionate science communication. The current infodemic and increasingly hostile environment online means people are often talking over each other and nobody is actually listening. We believe an empathy-driven approach is necessary to facilitate constructive conversations and inspire positive actions. Gentle Facts creates a space where our audience’s emotions, especially those who feel drained and overwhelmed, are validated and cared for. We address their concerns through concise, evidence-based, and actionable information and empower them to create change together as a community.
You use art to communicate health evidence and science. What do you think about this intersection?
Appealing visuals really help catch people’s attention. But art can be so much more than just a “pretty face” for science content. Art is an amazing medium for expressing and evoking emotions. There is plenty of evidence that scientific facts and emotions both play an important part in our decision making process. Art and Science, therefore, work well together to connect, inform, and motivate towards common goals—what we aim to achieve at Gentle Facts. By relating evidence and emotions through art and compassion-driven communication, we hope to reach and connect with audiences who do support science but are usually disengaged.
What do you see as a challenge for evidence-based information on social media?
Social media is an interesting place where both good and bad are exponentially amplified. It can bring some people together while dividing others, provide high quality resources and spread misinformation on the same platform. Therefore, one critical piece of the puzzle is to boost the positive signals. Create evidence-based content that is engaging and sharable. Promote scientific and media literacy through education. Help people connect with each other by facilitating conversations and building communities. I believe with the right training, everyone can practice compassionate science communication, and we need all hands on deck to beat the infodemic.
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Recently you illustrated the Cochrane review on walking for hypertension. Why did you pick this review and what did you want to get across?
I picked this review because it aligns very well with Gentle Facts’ principles: compassionate, factual, and actionable. It acknowledges and addresses the issue that exercising can be difficult for some people physically or mentally. The evidence collected is high in quality and includes participants with diverse backgrounds. It provides an easy-to-implement solution that most people can do. It is a great example of how evidence can empower people to take better care of themselves and contribute to public health.
If you would like to learn more about Jen and Gentle Facts:
If you would like to learn more about knowledge translation and disseminating evidence at Cochrane:
Featured review: Training healthcare providers to respond to intimate partner violence against women
Cochrane US talks about overabundance of information and how Cochrane is responding to the "infodemic"
The World Health Organization defines an infodemic as “overabundance of information – some accurate and some not – that occurs during an epidemic. It can lead to confusion and ultimately mistrust in governments and public health response”. This has been a particular challenge during the COVID-19 pandemic.
Cochrane US Senior Officer, Tiffany Duque, explains the current 'Infodemic', how to manage it, and how Cochrane is responding in this short video. This is an adaption of presentation given at the monthly CU Anschutz Medical Campus Rocky Mountain Cochrane Series (view the longer live webinar).
Cochrane is committed to supporting evidence-informed decision making through the production of high-quality, relevant, and up-to-date research syntheses.
Appointment of new Interim Chief Executive Officer for Cochrane
Cochrane’s Governing Board is pleased to announce, with effect from 1 June 2021, the appointment of Judith Brodie as our new interim Chief Executive Officer. Judith will lead Cochrane as the organisation undergoes its search for a permanent CEO and ensure a smooth transition.
Governing Board Co-Chairs, Tracey Howe and Catherine Marshall welcomed Judith’s appointment: "Judith is a seasoned, well-respected and proven interim Chief Executive with an exceptional record in non-profit organisations and brings expertise in finance, fundraising, public and patient involvement in healthcare and marketing. Judith is a great fit for Cochrane and is well qualified to lead Cochrane as we drive a programme of change at this crucial time of global health and economic challenge."
On her appointment, Judith, said: "I am delighted to be joining Cochrane and being part of this global collaboration. The work of Cochrane has surely never been more important. I am looking forward to meeting and working with many of Cochrane’s Group staff and contributors and the wider network over the coming months."
The Co-Chairs added, "We would also like to record our appreciation to our Editor-in-Chief, Karla Soares-Weiser, for taking on the additional role of Acting CEO, as well as to Toby Lasserson who has been Acting Editor-in-Chief and Chris Champion who took on additional responsibilities for governance and finance."
On behalf of Cochrane’s Governing Board, we warmly welcome Judith to this important leadership role, she will work alongside the Governing Board and the Senior Management Team and we look forward to her joining us for our forthcoming Governance Meetings on 22nd and 24th June.
Judith will also introduce herself at the Editor in Chief monthly webinars on June 3rd, register here to take part.
Read more about Judith Brodie here
Tracey Howe and Catherine Marshall
Governing Board Co-Chairs
Cochrane's statement to the 74th World Health Assembly
Cochrane has submitted a statement to the 74th World Health Assembly, which is taking place virtually this week (24 May to 1 June).
The World Health Assembly (WHA) is the decision-making body of the World Health Organization (WHO) and is attended by representatives of all Member States.
Our statement emphasises the importance of clinical trial transparency within the context of global health crises, since it is not possible to make truly evidence-informed decisions without access to data from all clinical trials.
Read the full statement below:
Cochrane supports the Independent Panel’s report which identifies, alongside other strategies, evidence-informed decision-making as a clear route to ending the COVID-19 pandemic.
However, one barrier to evidence-informed decision making is a lack of access to clinical trial data. Despite this being an ethical, and often legal, requirement, an unacceptable number of trials still go unpublished within the required timeframe, making it impossible to get a full picture of the evidence. Such delays are even more crucial in a global health emergency.
Cochrane backs the joint statement made by WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) earlier this month highlighting this issue. We call on Member States to actively enforce these standards, and for clinical trial sponsors to take their obligations seriously. Requirements for transparent registration and reporting of clinical trials during health emergencies should also be considered within the pandemic treaty.
Cochrane is a strong advocate for clinical trial transparency. See below for recent updates in this area:
- Cochrane shows support for WHO-ICMRA statement on transparency and data integrity
- Cochrane signs letter asking medicines regulators in Europe to address unpublished clinical trials
- US FDA begins enforcement of clinical trial transparency regulation
- Cochrane Belgium partners on clinical trial transparency report
- Cochrane Austria launches joint trial transparency report
- Cochrane Sweden highlights under-reporting of Swedish clinical trials
- Read the Evidently Cochrane blog post 'Retention to clinical trials: how can we keep participants involved?'
- Read the Cochrane Review 'Strategies to improve retention in randomised trials'
- Free Webinar co-hosted by Cochrane Sweden: 'Clinical trial reporting and registration' on 16 June
Tuesday, June 1, 2021
Featured review: Is vitamin D an effective and safe treatment for COVID‐19?
Cochrane Belgium partners on clinical trial transparency report
Cochrane Belgium, together with TranspariMED, Test Aankoop and Kom op tegen Kanker, recently released a report detailing the status of clinical trial transparency in Belgium.
The report used data collected on the EU Trials Tracker, which monitors the status of clinical trials recorded in the EU Clinical Trials Register. According to EU legislation, clinical trial sponsors must post summary results to the register within one year of a study ending (or six months for paediatric trials).
Several clinical trial sponsors in Belgium with overdue results were reminded last year to update the registry. While some then took significant steps to upload missing data, others have made little progress.
22% of verifiably due trials were found to have not yet posted results on the registry. However, it is likely that far more trials are still missing results, since only 292 of 1,098 registered trials are marked as complete – including several which started over 10 years ago and are likely not still ongoing. Results from trials sponsored by universities and hospitals were also found to be missing more often than trials with commercial sponsors.
The paper also calls upon the Belgian medicines regulator, AFMPS, to ensure that information on trials is kept up to date and recommends that research funders in Belgium monitor trial reporting.
A follow-up report is planned in six months to track further progress on this issue.
Cochrane supports clinical trial transparency. We rely on the availability of results from clinical trials to produce high quality and relevant systematic reviews. When trial results are not published, it is not possible to make truly evidence-informed decisions about healthcare, and people can be put at risk of harm.
Interested in learning more on this issue? Free webinar on 16 June
Cochrane Sweden and Lund University are hosting a webinar on clinical trial registration and reporting on 16 June at 13:30-15:30 (CEST).
The session will be an opportunity to learn more about the ethical and legal requirements around trial transparency.
Blog - Retention to clinical trials: how can we keep participants involved?
This Evidently Cochrane blog (originally posted here) is for all those involved in clinical trials. Katie Gillies and Derek Stewart, from the Trials Methodology Research Partnership and the Health Research Board Trials Methodology Research Network, highlight the need for focussed research on trial retention to help fill the evidence gaps identified in a national research agenda on retention to clinical trials developed and prioritised by all relevant stakeholders.
What do we know about the best ways to keep people involved in clinical trials? Frankly, not a lot.
Clinical trials can provide evidence about which treatments work. Clinical trials are research studies that involve people and compare different groups of people receiving different treatments and look at which treatments improve outcomes (like pain) the most. During the design of a trial, calculations are made about how many people need to join the trial and complete all of the data collection requirements (which might be, for example, a questionnaire or a clinic appointment). These calculations allow the researchers to be confident in the results at the end of the trial.
If there are problems with keeping people involved in a clinical trial this can often result in a delay in completing the trial or problems in using the results to make informed decisions about clinical care. Identifying ways to keep people involved in trials, i.e. they provide all of the data or measurements that the trial needs, has been identified as one of the top priorities for research into the design and delivery of clinical trials.What is already known about retention to clinical trials?
So, we don’t know a lot about how to keep people in trials but we do know a little. What we do know focuses on how to get trial participants to return postal questionnaires. Evidence from a recent Cochrane Review Strategies to improve retention in randomised trials (March 2021) suggests that some approaches may improve return rates of postal questionnaires. However, we we are not able to say with confidence that any of the results we found is a true effect and not caused by other factors, such as flaws with the design of the studies. As such, the effect of ways to encourage people to stay involved in trials is still not clear and more research is needed to see if these retention methods really do work. Of the 70 relevant articles we identified only two of those investigated how best to encourage people to attend clinical visits as part of the trial follow up. Of the studies included in the Cochrane Review on strategies to improve retention to RCTs only a handful included patients as partners in their design – this needs to change. We should be involving trial participants in decision-making about how best to improve retention.Where should research teams focus efforts?
The Cochrane review did, however, identify key strategies that research teams should focus on. The first set of priorities requires replication of evaluations of existing interventions using high quality evaluations of to provide evidence as to whether such strategies are effective or not. These four strategies all focus on are:
- Monetary incentives: specifically, does giving a £5 gift voucher at same time as sending the questionnaire improve response to postal questionnaires.
- Return postage: several return postage strategies have been evaluated to improve response of postal questionnaire e.g. reply paid compared to second class stamps, business post etc. Ensuring participants are not out of pocket is key, but which strategy to evaluate could be decided by the patient partners involved in the trial.
- Pens: A number of studies have evaluated the inclusion of a pen with a postal questionnaire to improve response. It looks promising but further studies, specifically in trials that include younger populations with participants who are men are required.
- Electronic reminders: emails or text messages reminding people (so sent in advance of the questionnaire) may also have an effect on postal questionnaire return. High quality replications are required.
These evaluations will help to provide evidence for trial teams as to what works to improve responses to postal questionnaires. They will begin to answer some of the questions identified as the top priorities for trials methodology retention research from a priority setting partnership (PSP) designed and delivered in association with the James Lind Alliance (JLA), the PRioRiTY II project. These prioritisation exercises help researchers and funders to focus on what matters most to all of those involved and ultimately contributes to global efforts to minimise waste in research by focussing activities. Future efforts to improve retention in trials should aim to target at least one of these stakeholder agreed priorities.
The past year has shone a bright light on the importance of clinical trials to provide evidence to inform health care decision making, But trials are only valuable if they recruit and retain enough people so that meaningful conclusions can be drawn from the results. Focussing efforts on keeping people in trials is effort well spent and will result in more valid and reliable result son which to base decisions for all.
- Join in the conversation on Twitter with @GilliesKatie @DerekCStewart @CochraneUK
- Leave a comment on the Evidently Cochrane blog post
- Read the Cochrane Review 'Strategies to improve retention in randomised trials'
- References [PDF]
Bringing together scientists, artists, and storytellers - Interview with Lifeology
Lifeology’s tagline is ‘The place where science and art converge’. They offer a platform that brings together scientists, artists, and storytellers to help people better understand and engage with science and health information and research. One of the main ways they meet their objectives is through beautifully illustrated, science-backed, bite-sized ‘flashcard’ courses about science and health-related topics aimed at the general public and students. We spoke to Paige Jarreau, VP of Science Communication at LifeOmic and co-founder of Lifeology more about their work.
Can you tell us a bit more about yourself?
My name is Paige Jarreau and I am VP of Science Communication at LifeOmic, a health software company. I am the co-founder of Lifeology (a LifeOmic product) along with Doryan Algarra, the VP of Design at LifeOmic.
I am a scientist turned storyteller and science communication scholar. When I was a child, the first thing I ever wanted to be when I grew up was a poet (or a science fiction writer!). As I got older I settled on a more “practical” career path as a doctor or a biomedical engineer - I imagined creating artificial organs and implants. But many years later I was enrolled in a PhD program in biomedical engineering when I realized that writing and creative expression needed to become my priority again, for my own mental health and fulfillment. From there, I never looked back. I started science blogging and ultimately got my PhD in Mass Communication studying science communication in new media environments.
Over the past decade, my interest in creative science communication has slowly morphed from primarily written to visual methods and formats. For example, I became interested in how scientists’ “selfies” on Instagram could help people see them as more human and trustworthy! I became interested in how art could make science more relatable to people. Meeting and collaborating with Doryan at LifeOmic was a turning point in my change in perspective of what good science communication looks like. We founded Lifeology on the idea that art is a critical, foundational aspect of engaging and accessible science communication - but that scientists struggle to create this art on their own.
How did Lifeology get started?
Lifeology, a platform that combines science and art, was the brainchild of my friend and coworker Doryan Algarra, VP of Design at LifeOmic. Over the course of his time at LifeOmic, Doryan has worked on the design of all kinds of products that facilitate precision medicine and wellness. In this work, he has realized that science and health information is often presented in overly complex and technical ways, or in outdated ways such as doctors’ office brochures that are not accessible and inclusive, much less interesting and beautiful to look at. Before developing the idea of Lifeology, Doryan had also been inspired by a book he was reading on epigenetics, of all things. Doryan generally felt that the book was complex and hard to follow. But he remembers one particular chapter to this day that helped the concept of epigenetics finally “click” for him. The chapter started with a question and then told a story about how some bees become queens and the rest become workers - based on different diets that affect the expression of their DNA! This got Doryan thinking about how even small storytelling devices and metaphors could help him understand and remember science that he thought was too difficult and niche for him to understand, let alone enjoy! As a designer, he quickly began imagining how these metaphors, and the “invisible” factors of epigenetics, could be made visual for even more impact.
Fast forward a few months, and Doryan had designed a prototype of what we know as Lifeology “flashcard” courses today. By giving art and science the same “real estate” on each “flashard” and making these courses easy to access and fun to interactively navigate on a phone, he hoped to make science and health information less intimidating and more inviting. He hoped to make science and health information more accessible to all people, including people who might be distrustful of or put off by science.
When Doryan showed me his Lifeology prototype, I was in awe. Like Doryan, I saw in these flashcard courses an innovative and fun way of delivering science information to broad audiences. But in talking through how courses would be created, we also began to see an opportunity to bring scientists and artists together to create the content as a team. Working together (a designer with a science communicator!) we became convinced that sci-art collaboration had to be a core feature of Lifeology courses. Today, we and the rest of the Lifeology team are baking collaboration tools and community into our platform to allow scientists, storytellers and artists to easily work together in the creation of Lifeology courses for broader audiences. We do this through cloud-based software collaboration tools but also processes and educational materials that help scientists and artists successfully collaborate to create better science communication.
What does Lifeology do?
Lifeology is a platform and communication tool that engages broader audiences in science, health and research in a fun, accessible way. We do this by bringing together science and art in our bite-sized digital “flashcard” courses. We designed these courses and their creation process to engage populations underserved by many science communication efforts - people with low literacy for example, and populations who tend to mistrust healthcare, science and government. Self-paced learning, empathetic storytelling and inclusive visuals are some of our key elements.
But we also believe that science communication in any format, including our flashcard courses, is far better when it is the product of collaboration between scientists and professional creatives like storytellers and artists. That is why we embedded within the Lifeology platform a growing community of storytellers, translators and artists from all over the world who want to collaborate with scientists. We have over 800 members in this community today! Our Lifeology platform guides scientists and other experts through successful collaborations with storytellers and artists as they create Lifeology courses together.
Teaching people the skillset to communicate science seems important to Lifeology. Can you tell us more?
Absolutely. While there are many tools out there that try to make it easier for scientists to create visual content to communicate their work, no tool can replace the need for collaboration and empathetic storytelling. To help scientists be successful in creating engaging, accessible and inclusive Lifeology courses (or other other science communication products!), we try to teach them key science communication skills, from knowing their audience, to how to tell a story, to how to be inclusive, to how to work with artists. One way we are doing this is through our Lifeology University SciComm Program, a free series of Lifeology courses and activities that help scientists become better communicators!
What advice do you have for researchers who want to communicate their review findings out?
Our most important piece of advice is to collaborate! Collaborate with members of the communities you are trying to reach with communication of your findings. Get to know your audience and involve them in the creation of culturally relevant content. Collaborate with community leaders. Collaborate with storytellers and artists who excel at creating content that connects with people on an emotional as well as a cognitive level.
The World Health Organization has said that in addition to dealing with a global COVID-19 Pandemic we are also dealing with a Pandemic with all the misinformation being spread. What do you think about this?
Misinformation around COVID-19 has certainly become its own pandemic or “infodemic.” The uncertainty, anxiety and fear that have surrounded the spread of COVID-19 have only accelerated this spread of misinformation. Uncertainty, anxiety and fear drove people to seek their own answers to questions that science didn’t have clear answers to yet.
In my mind, the only way to deal with this, from a science communication perspective, is through transparency, empathy and storytelling that is driven by data but also by local knowledge systems. It takes two-way communication and not making people feel bad for falling for misinformation, while also clearly and accessible presenting what we know now and solutions that people can actually put into practice locally.
There is also plenty that each of us can do to double-check what we read online and to prevent spreading misinformation.
Plans are in the works for some future collaborations between Cochrane and Lifeology. What are your thoughts on this?
We are so excited to collaborate! We hope to produce beautifully illustrated and accessible educational content around the topic of infodemics and what we can all do to prevent the appearance and spread of misinformation.
If you would like to learn more about Lifeology:
If you would like to learn more about knowledge translation and disseminating evidence at Cochrane: