MMMC Cochrane

Cochrane Clinical Answers
Question:
How do other emergency contraception pills compare with traditional Yuzpe (estradiol‐levonorgestrel combination)?
Christopher Bunt
| 24 May 2018
Clinical Answer:
Both levonorgestrel alone (0.75 mg × 2, over 24 hours) and mifepristone (all doses) emergency contraception regimens reduced rates of observed pregnancy and led to fewer adverse effects when compared with the Yuzpe method (estradiol 100 mcg plus levonorgestrel 500 mcg, two doses given 12 hours apart).

High‐quality evidence demonstrates fewer observed pregnancies for levonorgestrel compared with Yuzpe in all women (on average, 17 vs 29 per 1000), as well as in women at high risk (on average, 20 vs 53 per 1000) and those taking emergency contraception 25 to 48 hours after unprotected in*******se (on average, 17 vs 41 per 1000). “High risk” was defined as additional acts of unprotected sexual in*******se during the same cycle in which emergency contraception was utilized.

High‐quality evidence shows fewer observed pregnancies for mifepristone (all doses) than for Yuzpe among all women (on average, 3 vs 25 per 1000).

Levonorgestrel and mifepristone were associated with fewer overall adverse effects than Yuzpe (including nausea, vomiting, headache, dizziness, fatigue, abdominal pain, hot flushes and spotting/bleeding).

Comparisons of high‐dose estrogens and danazol versus the Yuzpe method were underpowered to detect a clinically important difference between groups, if present.

Cochrane Library

What is an audit?
Auditing is a vital part of clinical practice. An audit is an assessment of local practice and performance against an established standard. Essentially, clinical audit is a quality assurance and improvement process. It can be considered an exploration of what IS being done vs what SHOULD be done.

NICE definition of clinical audit:

“A quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against specific criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.”
Principles of Best Practice in Clinical Audit (2002, NICE/CHI).

How does it differ from research?
In short, research looks to acquire new knowledge whereas auditing does not.

Research looks into an explicit hypothesis and uses defined methods to generate results, with the aim to answer that question. In other words, ‘what is best practice?’. From research, a new drug may be developed, or perhaps a new service or a new way of managing a condition. As research deals with patients, it is necessary that it complies with the Declaration of Helsinki and gains ethical approval from a relevant Research Ethics Committee (REC). This comes under the practice of research governance, ensuring research is ethical, protecting both participants and researchers. On the other hand, audit looks to assess how well local practice is complying with best practice. Whilst audits should be carried out ethically, formal ethical approval from an REC is not required.

Research and audits serve very different, but necessary purposes. Smith summarises this nicely with the following quote from a 1990’s BMJ article:

“…research is concerned with discovering the right thing to do whereas audit is intended to make sure that the thing is done right.”
Smith R. Audit & Research. BMJ 1992; 305: 905-6 (1)

History
Florence Nightingale was thought to be one of the first auditors in healthcare in the 1850’s. At that time, she documented the particularly dirty conditions in the barracks during the Crimean War, noting that both morbidity and mortality was a significant burden. Following an increase in cleanliness and nursing care, she was able to reduce mortality by 38%, a pivotal finding that greatly supported Nightingale’s theories of promoting proper hygiene practices in patient care.

Why Audit?
There are many reasons to carry out clinical audits. Firstly, it is a necessary part of your duty as a clinician in the NHS. This is encompassed by the practice of clinical governance. Clinical governance is a range of activities that health professionals undertake to maintain and develop patient care standards (2). Other areas of clinical governance include Clinical effectiveness, Risk management, Education and training, Staffing, Patient and public involvement and Information Technology. Further discussions regarding clinical governance are beyond the scope of this article.

Auditing is also necessary to truly execute evidence-based medicine. The high quality research used to formulate guidelines is utilised effectively by ensuring that local practice conforms with best-practice ideals. This ultimately results in improvements in patient care and safety.

Local audits also allow national standards to be improved. The National Clinical Audit and Patient Outcomes Programme (NCAPOP) consists of over 30 national audits run by the Healthcare Quality Improvement Partnership (HQIP) for NHS England. They feature the most common conditions that are present in clinical practice across the UK. Local data collection at various Trusts across England feed into the national audits to provide an overview of standards of care in these areas. These regular audits provide the local Trusts with individualised reports on their current practice and compliance with the chosen audited guidelines, allowing areas of improvement to be clearly identified.

The Audit Cycle
The audit cycle is summarised in the diagram below:

Identify topic
The topic must be an important issue as it underpins the entire audit. Examples of important issues include those that are high-risk for patients, high costs for the trust, areas of patient concern (which could have been collected from a survey) or areas of high volume workload. It is also necessary to register the proposed audit with the Local Clinical Audit Team and have it approved by the relevant Audit Lead.

Select the standards
Select an established guideline (national or international) that is considered best-practice. Often the Royal College websites for different specialities have existing audit templates that are very useful. Extract the necessary targets from these guidelines (e.g. 100% of patients should be offered smoking cessation).

Data collection
This can be retrospective or prospective. It may be beneficial to do this retrospectively to prevent performance bias from staff members that are aware of any prospective audit. Additionally, data can be collected from physical or computer records.

Data analysis
Analyse the collected data and assess whether local practice meets guideline standards. Explore how well the standards were met and discuss any reasons for low compliance.

Implement change
Present the results at local departmental meetings and possibly at local or regional conferences. Develop an action plan outlining what needs to be done and then create these changes!

Allow time for changes to take place
It is important to allow sufficient time to pass for the uptake of new changes. Auditing too soon may underestimate the impact of new interventions, as they have not had time to take full effect.

Re-audit
Conduct the audit again to assess whether practice has improved in light of changes from the previous audit.



How can I get involved in the audit process?
Get involved with your local hospital team – Identify areas of improvement through observation but also by liaising with the permanent staff – these doctors and nurses will be very familiar of areas that could be audited.

Register the audit with the Local Clinical Audit Team – this may be an online registration form, but it’s worth going in person to speak with the team. It’s useful to meet the Audit Lead to discuss the feasibility of the audit and whether they are happy to accept it.

Plan the audit rigorously – This includes thinking about what standards you will compare against, how you will collect the data and where the data will be disseminated.

There are many useful resources across the internet but in addition, local audit teams and healthcare professionals will have audit experience and should be happy for anyone to get involved.



References
Smith, R. (1992). Audit and research. BMJ, 305(6859), pp.905-906.
Scally, G and Donaldson, L. (1998). Looking forward: Clinical governance and the drive for quality improvement in the new NHS in England. BMJ, 317(7150), pp.61-65.

Tips for attending a Cochrane Colloquium – a student perspective
Posted on April 11, 2019 by Sarah Tanveer

News

In September 2018, I attended the Cochrane Colloquium in Edinburgh, Scotland. Here are my tips on making the most of your first Cochrane meeting!

Before you go
Submit an abstract – One of the best ways to get your work noticed is by presenting at conferences like Cochrane. If you are working on a research project that is within the scope of the meetings purview, I would encourage you to submit an abstract to this year’s Cochrane Colloquium. The abstract deadline is April 12, 2019.

*Tip: The EQUATOR Network has reporting guidelines for conference abstracts (i.e., PRISMA for Abstracts). The Cochrane website also has a recorded webinar that contains tips for writing a great abstract for Cochrane reviews.

Apply for funding – This can be through scholarships, travel grants, or your own university departmental funding. Students are generally eligible for reduced conference rates and may also be apply to apply for a Cochrane stipend to attend the meeting.

Create some goals – Write down your reasons for attending the conference and make goals around those reasons. For example, if you are attending the meeting to network with other students and researchers, make a concrete goal to meet with at least 5 new people, exchange contact information, and follow up after the meeting.

Plan out your sessions and get organized- Once the conference website has posted the meeting schedule, plan out your sessions. To get organized, you can use the conference app or go to Google Calendar to schedule your sessions with details such as location, topic and presenter. This will save you some time from having to reference the booklet that is provided once you get to the meeting.Calendar screenshot showing sessions attended at the conference

During the meeting
Utilize the Cochrane Buddies! – Buddies can help assist attendees in answering questions, providing information, or advising on which sessions to attend.

Take Notes – You should take notes on any interesting points, important concepts, or questions that arose during the talk to help retain information about what you learned.

Attend workshop sessions – I highly recommend attending workshop sessions. They are typically interactive and set up so that you work in groups with other attendees. I would suggest getting to these sessions early as they tend to fill up quickly.

photo of a slide saying "Welcome to Edinburgh"

Learn about the host city – One of the great things about the Cochrane Colloquium is that it is hosted in a different city every year. Take advantage and explore the surrounding area if you have time. The meeting organizers typically offer a social activity for attendees. In Edinburgh, I took part in a walking tour led by a Blue Badge guide and got to learn a lot about Scottish heritage and culture!

Picture of Princes Street Garden, Edinburgh
Above is a picture of Princes Street Garden which we visited during a walking tour

After the meeting
Reflect on what you learned – Be sure to compile your notes and summarize your main takeaway points so that you can reference them at a later point. It can also be helpful to share what you learned with other students in your lab/department during department meetings. The Cochrane abstracts are also published online so that you can view and share them after the meeting.

Follow up with contacts made during the meeting – Send a quick follow-up email to new contacts and colleagues made during the meeting!

Cochrane in the Workplace - High School
Cochrane in the Workplace

Cochrane does not make clinical recommendations, instead it provides unbiased and high-quality health evidence so that health decisions, policies, and clinical guidelines can be informed by the best available evidence. ‘Cochrane in the workplace’ series collects stories about how Cochrane evidence is being 'put to work' in non-clinical settings - by teachers, by guideline makers, and by policy makers.

High School teacher, Ray Gowlett's story of using Cochrane evidence:

Ray Gowlett
Physical Education High School Teacher
Central Algoma Secondary School
Algoma District School Board


"I'm a physical education teacher at a high school outside of my small hometown of Richards Landing, Ontario, Canada. When teaching about nutrition, many students would make claims of ‘research says this’, and ‘research says that’. I had to teach my students how to analyze the primary research that lead to the recommendations in the first place. My students had to be taught to think critically and evaluate evidence for themselves. They needed to learn the concepts and terminology required to provide an accurate rationale for ignoring click bait editors who misinterpret results and sensationalize headlines.

In order to learn about how to read and understand evidence, I had to go outside of the world of education. As luck would have it, I ran into a retired emergency medicine doctor, Dr. Roedde, who had taught evidence based medicine using the principles of Cochrane. We quickly hit it off, and he committed to helping me through this process which is now going into year three. Since then, it has been an absolute whirlwind of reading, analyzing, presenting, and defending what I have come to understand about the Cochrane principles.

I was amazed that in a relatively short period of time students had gone from reading “Buzzfeed” articles for advice, to formulating clinical questions addressing outcomes of interest, finding systematic reviews of randomized control trials, differentiating between statistical significance and real world relevance, and were forming reasonable conclusions. I would leave classes exhausted, but impressed.

After my experiences of using the principles of Cochrane to improve my own subject specific knowledge and pedagogical practices, I believe that it is my professional obligation to become as proficient as I can with this skillset and to teach it to as many of my colleagues who would like to do the same. I believe it is my responsibility to teach the principles of Cochrane to students, so they too, will have the ability to ‘Debunk Anything That I Teach Them’."

Read Ray's full story, including details about his in-class exercise and the material that he used.

Cochrane in the Workplace - High School Hear from school teachers globally who are using Cochrane evidence.

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Colloids or crystalloids for fluid replacement in critically people
Background

Critically ill people may lose large amounts of blood (because of trauma or burns), or have serious conditions or infections (e.g. sepsis); they require additional fluids urgently to prevent dehydration or kidney failure. Colloids and crystalloids are types of fluids that are used for fluid replacement, often intravenously (via a tube straight into the blood).

Crystalloids are low-cost salt solutions (e.g. saline) with small molecules, which can move around easily when injected into the body.

Colloids can be man-made (e.g. starches, dextrans, or gelatins), or naturally occurring (e.g. albumin or fresh frozen plasma (FFP)), and have bigger molecules, so stay in the blood for longer before passing to other parts of the body. Colloids are more expensive than crystalloids. We are uncertain whether they are better than crystalloids at reducing death, need for blood transfusion or need for renal replacement therapy (filtering the blood, with or without dialysis machines, if kidneys fail) when given to critically ill people who need fluid replacement.

Study characteristics

The evidence is current to February 2018. We searched the medical literature and identified 69 relevant studies with 30,020 critically ill participants who were given fluid replacement in hospital or in an emergency out-of-hospital setting. Studies compared colloids (starches; dextrans; gelatins; or albumin or FFP) with crystalloids.

Key results

We found moderate-certainty evidence that using colloids (starches; dextrans; or albumin or FFP) compared to crystalloids for fluid replacement probably makes little or no difference to the number of critically ill people who die within 30 or 90 days, or by the end of study follow-up. We also found low-certainty evidence that using gelatins or crystalloids may make little or no difference to the number of deaths within each of these time points.

We found moderate-certainty evidence that using starches probably slightly increases the need for blood transfusion. However, we are uncertain whether using other types of colloids, compared to crystalloids, makes a difference to whether people need a blood transfusion because the certainty of the evidence is very low.

We found moderate-certainty evidence that using starches for fluid replacement probably slightly increases the need for renal replacement therapy. Using albumin or FFP compared to crystalloids may make little or no difference to the need for renal replacement therapy. One study comparing gelatins did not report results for renal replacement therapy according to the type of fluid given, and no studies comparing dextrans assessed renal replacement therapy.

Few studies reported adverse events (specifically, allergic reactions, itching, or rashes), so we are uncertain whether either fluid type causes fewer adverse events (very low-certainty evidence). We found little or no difference between starches or crystalloids in allergic reactions, but fewer participants given crystalloids reported itching or rashes. We found little or no difference in allergic reactions for the use of dextrans (four studies), gelatins (one study), and albumin or FFP (one study).

Certainty of the evidence

Some study authors did not report study methods clearly and many did not register their studies before they started, so we could not be certain whether the study outcomes were decided before or after they saw the results. Also, we found that some people who were given crystalloids may also have had colloids, which might have affected the results. For some outcomes, we had very few studies, which reduced our confidence in the evidence.

Conclusions

Using colloids (starches; dextrans; or albumin or FFP) compared to crystalloids for fluid replacement probably makes little or no difference to the number of critically ill people who die. It may make little or no difference to the number of people who die if gelatins or crystalloids are used for fluid replacement.

Starches probably increase the need for blood transfusion and renal replacement therapy slightly. Using albumin or FFP may make little or no difference to the need for renal replacement therapy. We are uncertain whether using dextrans, albumin or FFP, or crystalloids affects the need for blood transfusion. Similarly, we are uncertain if colloids or crystalloids increase the number of adverse events. Results from ongoing studies may increase our confidence in the evidence in future.

Authors' conclusions:
Using starches, dextrans, albumin or FFP (moderate-certainty evidence), or gelatins (low-certainty evidence), versus crystalloids probably makes little or no difference to mortality. Starches probably slightly increase the need for blood transfusion and RRT (moderate-certainty evidence), and albumin or FFP may make little or no difference to the need for renal replacement therapy (low-certainty evidence). Evidence for blood transfusions for dextrans, and albumin or FFP, is uncertain. Similarly, evidence for adverse events is uncertain. Certainty of evidence may improve with inclusion of three ongoing studies and seven studies awaiting classification, in future updates.

Review: Compression stockings for preventing deep vein thrombosis in airline passengers
Year published: 2016
Review Group: Cochrane Vascular
Conclusions: High‐quality evidence shows that airline passengers similar to those in the trials in this review can expect a substantial reduction in their risk of a symptomless deep vein thrombosis (DVT) if they wear compression stockings. Wearing stockings might reduce the incidence of this outcome from a few tens per thousand passengers, to two or three per thousand. There is moderate‐quality evidence that superficial vein thrombosis may be reduced if passengers wear compression stockings. Low‐quality evidence shows that passengers who wear stockings will also experience less oedema in their legs. However, this review is unable to identify whether these effects of wearing stockings translate into effects on outcomes such as death, pulmonary embolism and symptomatic DVT.
Plain language summary: available in English, Deutsch, Hrvatski, Polski, Português, and Русский
Note worthy mentions: Wikipedia entry on compression socks

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Cochrane Database of Systematic Reviews
Omega‐3 fatty acid addition during pregnancy

Authors' conclusions
In the overall analysis, preterm birth < 37 weeks and early preterm birth < 34 weeks were reduced in women receiving omega‐3 LCPUFA compared with no omega‐3. There was a possibly reduced risk of perinatal death and of neonatal care admission, a reduced risk of LBW babies; and possibly a small increased risk of LGA babies with omega‐3 LCPUFA.

For our GRADE quality assessments, we assessed most of the important perinatal outcomes as high‐quality (e.g. preterm birth) or moderate‐quality evidence (e.g. perinatal death). For the other outcome domains (maternal, child/adult and health service outcomes) GRADE ratings ranged from moderate to very low, with over half rated as low. Reasons for downgrading across the domain were mostly due to design limitations and imprecision.

Omega‐3 LCPUFA supplementation during pregnancy is an effective strategy for reducing the incidence of preterm birth, although it probably increases the incidence of post‐term pregnancies. More studies comparing omega‐3 LCPUFA and placebo (to establish causality in relation to preterm birth) are not needed at this stage. A further 23 ongoing trials are still to report on over 5000 women, so no more RCTs are needed that compare omega‐3 LCPUFA against placebo or no intervention. However, further follow‐up of completed trials is needed to assess longer‐term outcomes for mother and child, to improve understanding of metabolic, growth and neurodevelopment pathways in particular, and to establish if, and how, outcomes vary by different types of omega‐3 LCPUFA, timing and doses; or by characteristics of women.

Further reading refer to :

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INTRODUCTION TO WRITING COCHRANE REVIEW
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COURSE OUTLINE
The three-day workshop consists of developing a protocol for a review, searching and managing references, extracting and using data and using Revman. Implementation is by presentations, interactive sessions with hands on practical work at computer stations and group work.

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The workshop is planned for people who are interested in writing Cochrane style review.

PARTICIPANTS FOR THE WORKSHOP
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COURSE OUTLINE
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