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Dear Reader, Thank you for following the kamagra online without prescription Me&MyDoctor blog. I'm writing to let you know we are moving the public health stories authored by Texas physicians, residents, and medical students, and patients to the Texas Medical Association's social media channels. Be sure to follow us on all kamagra online without prescription our social media accounts (Facebook, Twitter, Instagram) as well as Texas Medicine Today to access these stories and more.

We look forward to seeing you there.Best, Olivia Suarez Me&My Doctor EditorSravya Reddy, MDPediatric Resident at The University of Texas at Austin Dell Medical SchoolMember, Texas Medical AssociationHow does the erectile dysfunction treatment kamagra factor into potentially abusive situations?. To stop the spread of erectile dysfunction treatment, we have isolated ourselves into small family units to avoid catching and transmitting the kamagra. While saving so many from succumbing to a severe illness, socially isolating has unfortunately kamagra online without prescription posed its own problems.

Among those is the increased threat of harm from intimate partner violence, which includes physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse. Potential child abuse is an increased threat as well. The impact of this kamagra happened so kamagra online without prescription rapidly that society did not have time to think about all the consequences of social isolation before implementing it.

Now those consequences are becoming clear.Social isolation due to the kamagra is forcing victims to stay home indefinitely with their abusers. Children and adolescents also have been forced to stay at home since many school districts have made education virtual to keep everyone safe from the kamagra. Caregivers are also home because they are working remotely kamagra online without prescription or because they are unemployed.

With the increase in the number of erectile dysfunction treatment cases, financial strain due to the economic downturn, and concerns of contracting the kamagra and potentially spreading it to family members, these are highly stressful times. Stress leads to an increase in the rate of intimate partner violence. Even those who suffer from it kamagra online without prescription can begin to become abusive to other household members, thus amplifying the abuse in the household.

Some abuse may go unrecognized by the victims themselves. For example, one important and less well-known type of abuse is coercive kamagra online without prescription control. It’s the type of abuse that doesn’t leave a physical mark, but it’s emotional, verbal, and controlling.

Victims often know that something is wrong – but can’t quite identify what it is. Coercive control can still lead to kamagra online without prescription violent physical abuse, and murder. The way in which people report abuse has also been altered by the kamagra.People lacking usual in-person contacts (with teachers, co-workers, or doctors) and the fact that some types of coercive abuse are less recognized lead to fewer people reporting that type of abuse.

Child abuse often is discovered during pediatricians’ well-child visits, but the kamagra has limited those visits. Many teachers, who might kamagra online without prescription also notice signs of abuse, also are not able to see their students on a daily basis. Some abuse victims visit emergency departments (EDs) in normal times, but ED visits are also down due to erectile dysfunction treatment.Local police in China report that intimate partner violence has tripled in the Hubei province.

The United Nations reports it also increased 30% in France as of March 2020 and increased 25% in Argentina. In the kamagra online without prescription U.S. The conversation about increased intimate partner violence during these times has just now started, and we are beginning to gather data.

Preliminary analysis shows police reports of intimate partner violence have increased by 18% to 27% across several U.S. Cities. Individuals affected by addiction have additional stressors and cannot meet with support groups.

Children and adolescents who might otherwise use school as a form of escape from addicted caregivers are no longer able to do so. Financial distress can also play a factor. According to research, the rate of violence among couples with more financial struggles is nearly three and a half times higher than couples with fewer financial concerns.Abuse also can come from siblings.

Any child or adolescent with preexisting behavioral issues is more likely to act out due to seclusion, decreased physical activity, or fewer positive distractions. This could increase risk for others in the household, especially in foster home situations. These other residents might be subject to increased sexual and physical abuse with fewer easy ways to report it.

What can we do about this while abiding by the rules of the kamagra?. How can physicians help?. Patients who are victims of intimate partner violence are encouraged to reach out to their doctor.

A doctor visit may be either in person or virtual due to the safety precautions many doctors’ offices are enforcing due to erectile dysfunction treatment. During telehealth visits, physicians should always ask standard questions to screen for potential abuse. They can offer information to all patients, regardless of whether they suspect abuse.People could receive more support if we were to expand access to virtual addiction counseling, increase abuse counseling, and launch more campaigns against intimate partner violence.

The best solution might involve a multidisciplinary team, including psychiatrists, social workers, child abuse teams and Child Protective Services, and local school boards. Physicians can help in other ways, too. Doctors can focus on assessing mental health during well-child and acute clinic visits and telehealth visits.

A temporary screening tool for behavioral health during the kamagra might be beneficial. Governments could consider allocating resources to telepsychiatry. Many paths can be taken to reduce the burden of mental health issues, and this is an ongoing discussion.

How should physicians approach patients who have or may have experienced intimate partner violence?. Victims of domestic assault can always turn to their physician for guidance on next steps. In response, doctors can:Learn about local resources and have those resources available to your patients;Review safety practices, such as deleting internet browsing history or text messages.

Saving abuse hotline information under other listings, such as a grocery store or pharmacy listing. And creating a new, confidential email account for receiving information about resources or communicating with physicians.If the patient discloses abuse, the clinician and patient can establish signals to identify the presence of an abusive partner during telemedicine appointments.To my fellow physicians, I suggest recognizing and talking about the issue with families.Medical professionals take certain steps if they suspect their patient’s injuries are a result of family violence, or if the patient discloses family violence. Physicians will likely screen a patient, document their conversation with the patient, and offer support and inform the patient of the health risks of staying in an abusive environment, such as severe injuries or even death.

A doctor’s priority is his or her patient’s safety, regardless of why the victim might feel forced to remain in an abusive environment. While physicians only report child and elderly abuse, they should encourage any abused patient to report her or his own case, while also understanding the complexity of the issue. Under no circumstance should any form of abuse be tolerated or suffered.

Any intimate partner violence should be avoided, and reported if possible and safe. My hope is that with more awareness of this rising public health concern, potential victims can better deal with the threat of abuse during this stressful kamagra – and hopefully avoid it..

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The past week has seen an explosion of media commentary about whether kamagra suppliers children in the UK should go back to http://begopa.de/galerie-2/ school. Since ‘lockdown’ (23 March kamagra suppliers 2020) began schools have been open to vulnerable children and young people, and to the children of ‘key workers’. Right from the start there have been differing opinions about the necessity or wisdom of closing schools.

Viner et al1 kamagra suppliers produced a rapid systematic review that concludes that school closures have less impact on rate and mortality than other social distancing measures. Many countries have closed their schools for less time than the UK and have already started to reopen with several protective measures in place.2Concerns about the long-term economic, social and mental impact of lockdown led to the generation of plans to ‘get back to business’. This was conveyed to the population of the UK on 10 May by the UK prime minister, Boris kamagra suppliers Johnson.

He announced a range of measures to gradually reduce the level of lockdown. This is in keeping with modelling undertaken by various groups, including a preprint (not peer-reviewed) modelling exercise by Zhang et al.3Mr kamagra suppliers Johnson announced that there would be a phased return (in England) of some children to school from 1 June. There are no national guidelines as it is recognised that school have differences that require a flexible approach, but there are a broad set of principles relating to social distancing and hygiene.Government ministers and teachers’ unions have opposing views on the safety of reopening schools.

In a joint statement nine unions representing teachers stated that they thought 1 June was too kamagra suppliers early to be safe.4 They recognise that the opening of schools is a vital part of restarting the UK economy, but they have concerns about the safety and welfare of children and others.Meanwhile, the education secretary, Gavin Williamson, spoke at a press conference on 16 May stating that scientific evidence backed their decision. Interestingly, much of his statement was not about the scientific evidence but setting out an emotive argument that school was essential for safe and happy children.There is a consequence to this, the longer that schools are closed the more that children miss out. Teachers know that there are children out there kamagra suppliers that have not spoken or played with another child their own age for the last two months.

They know there are children from difficult or very unhappy homes for whom school is the happiest moment in their week, and it’s also the safest place for them to be. The poorest children will be the ones who fall further behind if we keep kamagra suppliers school gates closed. This phased return is in line with what other European countries are doing.There ensued an at times ill-tempered debate and a flurry of tweets and news articles identifying problems in enacting the government kamagra suppliers plan and the illogical nature of Williamson’s statement.

The Institute for Fiscal Studies has produced a briefing note on children’s experiences of learning during lockdown.5 This is being widely cited as a rationale for reopening schools because children from vulnerable backgrounds are disproportionately affected by not being able to attend school. This has caused concern about the attainment gap, but as Quinn6 points out fewer children from disadvantaged backgrounds are likely to return to school than those from more affluent backgrounds.Government ministers and spokespeople reiterated that scientific evidence and kamagra suppliers observation of other European countries where schools had reopened demonstrated their decision was the correct one. However, there were no links provided to the scientific evidence and unions were quick to seize on this (eg, NASUWT7).The chief scientific advisor to the Department for Education, Osama Rahman, made a statement in a parliamentary science and technology committee meeting on 13 May that:There is a low degree of confidence in evidence that [children] might transmit it less.Carol Monaghan, the Scottish National Party education spokesperson, replied:We’re putting together hundreds of potential vectors that can then go on and transmit.

Is that kamagra suppliers correct?. Osama Rahman responded:Possibly, depending on school sizes.His final statement contains layers of complexity but can be interpreted simply as ‘we don’t know’. This provoked a great deal of disquiet kamagra suppliers.

Rahman had already stated that the Scientific Advisory Group for Emergencies (SAGE) was collecting and considering evidence that was new and emerging, and that confidence was low in the evidence relating to transmission because there was very little evidence.8 However, this normal scientific caution in the evidence base was not discussed, and therefore it was assumed that low or moderate confidence in the evidence means a high-risk strategy is being mooted.There appear to be two major concerns about lifting the lockdown for children. First is the kamagra suppliers risk to children of developing erectile dysfunction disease. The second is the risk to others of children transmitting erectile dysfunction disease, either while being symptomatic or asymptomatic.

Here are some of the available evidence.Morbidity and mortality in children from erectile dysfunction diseaseChildren appear to be less likely to acquire erectile dysfunction disease in various nations.9–11 kamagra suppliers Barton et al12 found that children account for 1.9% of confirmed cases (data collected from government websites and publications). Of these 8113 paediatric cases, 14% required hospital admission. The admission rate kamagra suppliers to critical care was 2.2% of confirmed cases (7.2% of admitted children).

Death was reported in kamagra suppliers 15 cases (0.18%). This adds to other evidence suggesting that children are at a relatively low risk from the kamagra, with other estimates coming in at around 0.01%.13 14 This is likely to be because they appear to have a stronger immune response to the kamagra.15There are concerns that children who have been infected with the kamagra can develop a postviral inflammatory reaction (Kawasaki disease) and this can be severe,16 but the research evidence for this is not well developed yet.Transmission by childrenChildren can be asymptomatic and test positive for erectile dysfunction treatment, and in the absence of effective community testing it will be impossible to know if they are carrying the kamagra. Children also can have normal or abnormal signs (eg, chest imaging) when they have tested positive.17 In short, it is difficult to determine without much more extensive testing if a child can transmit the .Arav et al18 found that the contact route was much more important than the airborne route, which kamagra suppliers they concluded had a negligible contribution.

They suggest protective measures would therefore be good hand hygiene, careful cleaning and avoiding physical contact.Given that there are quite low numbers of symptomatic cases and an unknown quantity of asymptomatic cases, it is very difficult to determine whether children are a significant vector for the disease. Studies cited by kamagra suppliers the Royal College of Paediatrics and Child Health that explored family clusters of suggest that the child was unlikely to be the index case.The riskThis evidence suggests that there is a case for reopening schools to limited numbers of pupils—the risk to pupils and the adults they come into contact with seems to be small, and the potential gains for children may outweigh them. There is a big proviso with this however, and that is that the overall incidence of erectile dysfunction treatment has fallen below specified threshold.

This is quite a contentious issue and depends on us meeting the five key tests for easing lockdown.Making sure the National Health Service can cope.A sustained kamagra suppliers and consistent fall in the daily death rate.Rate of decreasing to manageable levels.Ensuring that personal protective equipment supply can meet demand.Being confident that any adjustments would not risk a second peak.These conditions are open to interpretation, and there appears to be a lack of trust by the public and by professionals from education and health in the information that the government and their scientific advisors are sharing. An example of this is a group of scientists who have come together to challenge the government about their decision-making.19 The concern about whether the evidence and advice that we are given are biased in any way has also been increased by concerns that a government advisor (Dominic Cummings) has attended what were supposed to be politically independent meetings of the SAGE.Scientific evidence continues to emerge, but weighing up the risks and benefits is not easy. Decisions about whether to reopen schools are taken on a national level with a distance from personal concerns kamagra suppliers and fears.

Individuals who are making decisions often rely on media translations of the evidence, and there is a level of mistrust in politicians and the media.20 Individuals are often irrational in their risk perception and management (eg, continuing to smoke or drink alcohol despite strong scientific evidence about the risk).21 22Overall, we are information-poor and opinion-rich. It is kamagra suppliers a difficult path to navigate. The debate about whether the benefits outweigh the risks of returning to school reminds me of the post-Wakefield Measles Mumps and Rubella vaccination situation.

Parents were being asked to believe that MMR was a safe treatment in the face of a massive and emotive campaign that promoted the ‘risk’ of kamagra suppliers having the treatment above all else. This situation is even more complex than that as we have increased access to opinion and difficulty in understanding if or how much that information is kamagra suppliers biased. It is no wonder that decision-making is difficult.

It is likely that evidence will continue to emerge and gradually kamagra suppliers the choice will become easier to make. For now, however, we can understand the difficulties that parents, teachers and councils face.IntroductionWhenever developing training competencies, tools to support clinical practice or a response to a professional issue, seeking the opinion of experts is a common approach. By working kamagra suppliers to identify a consensus position, researchers can report findings on a specific question (or set of questions) that are based on the knowledge and experience of experts in their field.However, there are challenges to this approach.

For example, what should be done when consensus cannot be reached?. How can experts be engaged in kamagra suppliers a way that allows them to consider objectively the views of others and—where appropriate—change their own opinions in response?. One approach that attempts to provide a clear method for gathering expert opinion is the Delphi technique.The Delphi technique was first developed in the 1950s by Norman Dalkey and Olaf Helmer in an attempt to gain reliable expert consensus.

Specifically, they developed an approach—named after the Ancient Greek Oracle of Delphi, who could predict the future—which promoted anonymity and avoided direct confrontation between experts, so that the methods employed “…appear to be more conducive to independent thought on the part of kamagra suppliers the experts and to aid them in the gradual formation of a considered opinion”.1 Though the original Delphi study was linked to the defence industry, the technique has spread to other research areas, including nursing.2Characteristics of Delphi studiesAs with all research methods, the Delphi technique has evolved since it was first reported on in the 1960s. However, many of the fundamental characteristics of the approach still remain from Dalkey and Helmer’s original outline. First, the overarching approach kamagra suppliers is based on a series of ‘rounds’, where a set of experts are asked their opinions on a particular issue.

The questions for each round are based in part of the findings of the previous one, allowing the study to evolve over time in response to earlier findings.Second, participants are able to see the results of previous rounds—including their own responses—allowing them to reflect on the views of others and reposition their own opinions accordingly.2 This also gives them the opportunity to consider and feedback on what they perceive to be the strengths and weaknesses of other’s responses. Finally, the kamagra suppliers findings of each round are always shared with the broader group anonymously. This avoids any bias that might result from participants being concerned about their own views being viewed negatively or from their own opinions kamagra suppliers being biased by personal factors.

This framework of expert opinion rounds, with each round built on previous findings and each allowing for responses to be reconsidered by participants, is designed to allow the development of a consensus view that answers the research question.Within this broad approach, there can be variation in areas such as how many rounds there are, how the questions are delivered and responses collected, and how ‘consensus’ is judged. For example, a study of human factors kamagra suppliers that contributed to nursing errors used only two rounds. The first took the form of an online survey asking 25 experts to list all the ‘human’ causes of nursing errors that they could.

Analysis of responses resulted in a list of 28 potential reasons—this list was sent back to the same group of experts for the second round, asking them kamagra suppliers to score each one for importance. Analysis of this scoring then allowed for consensus conclusions on the top 10 human factors that contributed to nursing errors (with fatigue, heavy workload and communication problems the top three).3In another example, nurse practitioners (NPs) were recruited to participate in a Delphi study to achieve consensus related to NP advance care planning competencies. In round 1, draft competencies were developed from the findings of a survey kamagra suppliers of NP beliefs, knowledge and level of implementation of advance care planning.

Round 2 included engagement with 29 NPs who evaluated the draft competencies and their components. Revisions were made based on the original feedback, and a third round was conducted where 15 of the original NP participants confirmed their kamagra suppliers consensus with the final document. The final document includes four competencies, each with several elements.

Clinical Practice, Consultation and Communication, Advocacy and Therapeutic Management.4Strengths and weaknesses kamagra suppliers of Delphi studiesThe Delphi technique offers a flexible approach to gathering the views of experts on an area of interest. The ability for participants to reconsider their views in light of the contribution of others allows for an element of reflection that is missing from studies based on single interviews or focus groups. The anonymity among the expert groups kamagra suppliers that underpins Delphi studies promotes honesty among participants and reduces the risk of the ‘halo effect’ where views from dominant or high-profile members of the group are given extra credence.5However, Delphi studies can—by their very nature—be complex and time consuming.

The need for participants to complete multiple rounds can lead to high drop-out rates which impacts kamagra suppliers on validity of the study. The ability of participants to amend or alter their views at each round is also something of a double-edged sword. It provides those taking part with the opportunity to reflect and reconsider their position kamagra suppliers in response to additional information, which is an important part of nursing practice.

Conversely though, there is a danger that this flexibility introduces bias, with participants altering their response to comply with what they view to be the majority view (sometime called the ‘bandwagon effect’).5Delphi studies can be criticised due to a lack of clarity on what is meant by ‘consensus’. Even with the level kamagra suppliers of flexibility and reflexivity present in Delphi studies, it is still unlikely that a group of experts will demonstrate 100% agreement on issues. However, because consensus is a requirement of a Delphi study, there does need to be a judgement on when this point is reached.

This is where there is inconsistency across studies and authors, with the suggested level of consensus ranging from 51% to 100%.2 In addition, it has been identified that in some areas, consensus is not predefined as part of the study method kamagra suppliers. For example, a review of Delphi studies in nurse education found that fewer than half of the papers appraised included a predefined level at which consensus was judged to have been achieved.6 In addition, the identification of an objective level consensus is only possible when gathering quantifiable data—the judgement on consensus being reached in some qualitative Delphi studies will always be rather more subjective on the part of the researcher, and therefore potentially open to bias.By their nature, Delphi studies often rely purely on expert opinion to generate findings. A further kamagra suppliers limitation is therefore related to the quality of evidence, with expert opinion viewed as providing a poor basis for making judgements on healthcare interventions.7 This does not mean that the findings of Delphi studies are intrinsically unreliable or invalid.

It does mean that researchers should consider whether their research question is one that can be answered through expert consensus or whether other approaches (such as a systematic review of research evidence) are more appropriate.ConclusionThe Delphi technique is a well-established approach to answering a research question through the identification of a consensus view across subject experts. It allows for reflection among participants, who are able kamagra suppliers to nuance and reconsider their opinion based on the anonymised opinions of others. However, researchers must take steps to enhance robustness of the studies.

It is important to try and prevent participants from simply resorting to agreeing kamagra suppliers with the majority view. Studies must also predefine what is meant by ‘consensus’ and how it will be established.With careful and clear design though, Delphi studies can make a valuable contribution to the nursing evidence base by tapping into the profession’s most precious resource—the knowledge and expertise of its practitioners..

The past week has seen an explosion of media commentary about whether children in the UK should http://www.egarciajr.com/?p=244 go back to kamagra online without prescription school. Since ‘lockdown’ (23 March 2020) kamagra online without prescription began schools have been open to vulnerable children and young people, and to the children of ‘key workers’. Right from the start there have been differing opinions about the necessity or wisdom of closing schools. Viner et kamagra online without prescription al1 produced a rapid systematic review that concludes that school closures have less impact on rate and mortality than other social distancing measures. Many countries have closed their schools for less time than the UK and have already started to reopen with several protective measures in place.2Concerns about the long-term economic, social and mental impact of lockdown led to the generation of plans to ‘get back to business’.

This was conveyed to the population of the UK on 10 May by the UK prime minister, Boris Johnson kamagra online without prescription. He announced a range of measures to gradually reduce the level of lockdown. This is in keeping with modelling undertaken by various groups, including a preprint (not peer-reviewed) modelling exercise by Zhang et al.3Mr kamagra online without prescription Johnson announced that there would be a phased return (in England) of some children to school from 1 June. There are no national guidelines as it is recognised that school have differences that require a flexible approach, but there are a broad set of principles relating to social distancing and hygiene.Government ministers and teachers’ unions have opposing views on the safety of reopening schools. In a joint statement nine unions representing teachers stated that they thought 1 June was too early to be safe.4 They recognise that the opening of schools kamagra online without prescription is a vital part of restarting the UK economy, but they have concerns about the safety and welfare of children and others.Meanwhile, the education secretary, Gavin Williamson, spoke at a press conference on 16 May stating that scientific evidence backed their decision.

Interestingly, much of his statement was not about the scientific evidence but setting out an emotive argument that school was essential for safe and happy children.There is a consequence to this, the longer that schools are closed the more that children miss out. Teachers know that there are children out there that have not spoken or played with another child their own age for the last two months kamagra online without prescription. They know there are children from difficult or very unhappy homes for whom school is the happiest moment in their week, and it’s also the safest place for them to be. The poorest children will be kamagra online without prescription the ones who fall further behind if we keep school gates closed. This phased return is in line with what other European countries are doing.There ensued an at times ill-tempered debate and a flurry of tweets and news articles identifying kamagra online without prescription problems in enacting the government plan and the illogical nature of Williamson’s statement.

The Institute for Fiscal Studies has produced a briefing note on children’s experiences of learning during lockdown.5 This is being widely cited as a rationale for reopening schools because children from vulnerable backgrounds are disproportionately affected by not being able to attend school. This has caused concern about the attainment gap, but as Quinn6 points out fewer children from disadvantaged backgrounds are likely to return to school than those from more affluent backgrounds.Government ministers and spokespeople kamagra online without prescription reiterated that scientific evidence and observation of other European countries where schools had reopened demonstrated their decision was the correct one. However, there were no links provided to the scientific evidence and unions were quick to seize on this (eg, NASUWT7).The chief scientific advisor to the Department for Education, Osama Rahman, made a statement in a parliamentary science and technology committee meeting on 13 May that:There is a low degree of confidence in evidence that [children] might transmit it less.Carol Monaghan, the Scottish National Party education spokesperson, replied:We’re putting together hundreds of potential vectors that can then go on and transmit. Is that correct? kamagra online without prescription. Osama Rahman responded:Possibly, depending on school sizes.His final statement contains layers of complexity but can be interpreted simply as ‘we don’t know’.

This provoked a great deal of disquiet kamagra online without prescription. Rahman had already stated that the Scientific Advisory Group for Emergencies (SAGE) was collecting and considering evidence that was new and emerging, and that confidence was low in the evidence relating to transmission because there was very little evidence.8 However, this normal scientific caution in the evidence base was not discussed, and therefore it was assumed that low or moderate confidence in the evidence means a high-risk strategy is being mooted.There appear to be two major concerns about lifting the lockdown for children. First is the risk to children of developing kamagra online without prescription erectile dysfunction disease. The second is the risk to others of children transmitting erectile dysfunction disease, either while being symptomatic or asymptomatic. Here are some of the available evidence.Morbidity and mortality in children from erectile dysfunction diseaseChildren appear to be less likely to kamagra online without prescription acquire erectile dysfunction disease in various nations.9–11 Barton et al12 found that children account for 1.9% of confirmed cases (data collected from government websites and publications).

Of these 8113 paediatric cases, 14% required hospital admission. The admission rate to critical care was 2.2% of confirmed kamagra online without prescription cases (7.2% of admitted children). Death was reported in kamagra online without prescription 15 cases (0.18%). This adds to other evidence suggesting that children are at a relatively low risk from the kamagra, with other estimates coming in at around 0.01%.13 14 This is likely to be because they appear to have a stronger immune response to the kamagra.15There are concerns that children who have been infected with the kamagra can develop a postviral inflammatory reaction (Kawasaki disease) and this can be severe,16 but the research evidence for this is not well developed yet.Transmission by childrenChildren can be asymptomatic and test positive for erectile dysfunction treatment, and in the absence of effective community testing it will be impossible to know if they are carrying the kamagra. Children also can have normal or abnormal signs (eg, chest imaging) when they have tested positive.17 In short, it is difficult to determine without much more extensive testing if a child can transmit the .Arav et al18 found that the contact route was much kamagra online without prescription more important than the airborne route, which they concluded had a negligible contribution.

They suggest protective measures would therefore be good hand hygiene, careful cleaning and avoiding physical contact.Given that there are quite low numbers of symptomatic cases and an unknown quantity of asymptomatic cases, it is very difficult to determine whether children are a significant vector for the disease. Studies cited by the Royal College kamagra online without prescription of Paediatrics and Child Health that explored family clusters of suggest that the child was unlikely to be the index case.The riskThis evidence suggests that there is a case for reopening schools to limited numbers of pupils—the risk to pupils and the adults they come into contact with seems to be small, and the potential gains for children may outweigh them. There is a big proviso with this however, and that is that the overall incidence of erectile dysfunction treatment has fallen below specified threshold. This is quite a contentious issue and depends on us meeting the five key tests for easing lockdown.Making sure the National Health Service can cope.A sustained and consistent fall in the daily death rate.Rate of decreasing to manageable levels.Ensuring that personal protective equipment supply can meet demand.Being confident that any adjustments kamagra online without prescription would not risk a second peak.These conditions are open to interpretation, and there appears to be a lack of trust by the public and by professionals from education and health in the information that the government and their scientific advisors are sharing. An example of this is a group of scientists who have come together to challenge the government about their decision-making.19 The concern about whether the evidence and advice that we are given are biased in any way has also been increased by concerns that a government advisor (Dominic Cummings) has attended what were supposed to be politically independent meetings of the SAGE.Scientific evidence continues to emerge, but weighing up the risks and benefits is not easy.

Decisions about whether to reopen schools kamagra online without prescription are taken on a national level with a distance from personal concerns and fears. Individuals who are making decisions often rely on media translations of the evidence, and there is a level of mistrust in politicians and the media.20 Individuals are often irrational in their risk perception and management (eg, continuing to smoke or drink alcohol despite strong scientific evidence about the risk).21 22Overall, we are information-poor and opinion-rich. It is a difficult kamagra online without prescription path to navigate. The debate about whether the benefits outweigh the risks of returning to school reminds me of the post-Wakefield Measles Mumps and Rubella vaccination situation. Parents were being asked to believe that MMR was a safe treatment kamagra online without prescription in the face of a massive and emotive campaign that promoted the ‘risk’ of having the treatment above all else.

This situation is even more complex than that as http://www.ec-internationale-schuman-strasbourg.ac-strasbourg.fr/wp/?page_id=11 we have increased access to opinion and difficulty in understanding if or how much that kamagra online without prescription information is biased. It is no wonder that decision-making is difficult. It is likely that evidence kamagra online without prescription will continue to emerge and gradually the choice will become easier to make. For now, however, we can understand the difficulties that parents, teachers and councils face.IntroductionWhenever developing training competencies, tools to support clinical practice or a response to a professional issue, seeking the opinion of experts is a common approach. By working to identify a consensus position, researchers can report findings on a specific question (or set of questions) that are based on the knowledge and experience of experts in their field.However, there kamagra online without prescription are challenges to this approach.

For example, what should be done when consensus cannot be reached?. How can experts be engaged in a way that allows them to consider objectively the views of others and—where kamagra online without prescription appropriate—change their own opinions in response?. One approach that attempts to provide a clear method for gathering expert opinion is the Delphi technique.The Delphi technique was first developed in the 1950s by Norman Dalkey and Olaf Helmer in an attempt to gain reliable expert consensus. Specifically, they developed an approach—named after the Ancient Greek Oracle of Delphi, who could predict the future—which promoted anonymity and avoided direct confrontation between experts, so that the methods employed “…appear to be more conducive to independent thought on the part of the experts and to aid them in the gradual formation of a considered opinion”.1 Though the original Delphi study was linked to the defence industry, the technique has spread to kamagra online without prescription other research areas, including nursing.2Characteristics of Delphi studiesAs with all research methods, the Delphi technique has evolved since it was first reported on in the 1960s. However, many of the fundamental characteristics of the approach still remain from Dalkey and Helmer’s original outline.

First, the overarching approach is based on a series of ‘rounds’, where a set of experts are asked their opinions on a kamagra online without prescription particular issue. The questions for each round are based in part of the findings of the previous one, allowing the study to evolve over time in response to earlier findings.Second, participants are able to see the results of previous rounds—including their own responses—allowing them to reflect on the views of others and reposition their own opinions accordingly.2 This also gives them the opportunity to consider and feedback on what they perceive to be the strengths and weaknesses of other’s responses. Finally, the findings of each round are always shared with the broader group anonymously kamagra online without prescription. This avoids any bias that might result from participants being concerned about their own views being viewed negatively or from their own kamagra online without prescription opinions being biased by personal factors. This framework of expert opinion rounds, with each round built on previous findings and each allowing for responses to be reconsidered by participants, is designed to allow the development of a consensus view that answers the research question.Within this broad approach, there can be variation in areas such as how many rounds there are, how the questions are delivered and responses collected, and how ‘consensus’ is judged.

For example, a study of human kamagra online without prescription factors that contributed to nursing errors used only two rounds. The first took the form of an online survey asking 25 experts to list all the ‘human’ causes of nursing errors that they could. Analysis of responses resulted in a list of 28 potential reasons—this list was sent back to the kamagra online without prescription same group of experts for the second round, asking them to score each one for importance. Analysis of this scoring then allowed for consensus conclusions on the top 10 human factors that contributed to nursing errors (with fatigue, heavy workload and communication problems the top three).3In another example, nurse practitioners (NPs) were recruited to participate in a Delphi study to achieve consensus related to NP advance care planning competencies. In round 1, draft competencies were developed from the findings of a survey of NP beliefs, knowledge and level kamagra online without prescription of implementation of advance care planning.

Round 2 included engagement with 29 NPs who evaluated the draft competencies and their components. Revisions were made based on the original feedback, and a third round was conducted where 15 of the original NP participants confirmed their consensus with kamagra online without prescription the final document. The final document includes four competencies, each with several elements. Clinical Practice, Consultation and Communication, Advocacy and Therapeutic Management.4Strengths and weaknesses of Delphi studiesThe Delphi technique offers a flexible approach kamagra online without prescription to gathering the views of experts on an area of interest. The ability for participants to reconsider their views in light of the contribution of others allows for an element of reflection that is missing from studies based on single interviews or focus groups.

The anonymity among the expert groups that underpins Delphi studies promotes honesty among participants and reduces the risk of the ‘halo effect’ where views from dominant or high-profile members of the kamagra online without prescription group are given extra credence.5However, Delphi studies can—by their very nature—be complex and time consuming. The need for participants to complete kamagra online without prescription multiple rounds can lead to high drop-out rates which impacts on validity of the study. The ability of participants to amend or alter their views at each round is also something of a double-edged sword. It provides those taking part with the opportunity to reflect and reconsider their position in response to kamagra online without prescription additional information, which is an important part of nursing practice. Conversely though, there is a danger that this flexibility introduces bias, with participants altering their response to comply with what they view to be the majority view (sometime called the ‘bandwagon effect’).5Delphi studies can be criticised due to a lack of clarity on what is meant by ‘consensus’.

Even with the level of flexibility and reflexivity present in Delphi studies, it is still unlikely that a group of experts will demonstrate 100% agreement kamagra online without prescription on issues. However, because consensus is a requirement of a Delphi study, there does need to be a judgement on when this point is reached. This is where there is inconsistency across studies and authors, with the suggested level of consensus ranging from 51% to 100%.2 In addition, it has been identified that in some areas, consensus is not predefined as part of kamagra online without prescription the study method. For example, a review of Delphi studies in nurse education found that fewer than half of the papers appraised included a predefined level at which consensus was judged to have been achieved.6 In addition, the identification of an objective level consensus is only possible when gathering quantifiable data—the judgement on consensus being reached in some qualitative Delphi studies will always be rather more subjective on the part of the researcher, and therefore potentially open to bias.By their nature, Delphi studies often rely purely on expert opinion to generate findings. A further limitation is therefore related to the quality of kamagra online without prescription evidence, with expert opinion viewed as providing a poor basis for making judgements on healthcare interventions.7 This does not mean that the findings of Delphi studies are intrinsically unreliable or invalid.

It does mean that researchers should consider whether their research question is one that can be answered through expert consensus or whether other approaches (such as a systematic review of research evidence) are more appropriate.ConclusionThe Delphi technique is a well-established approach to answering a research question through the identification of a consensus view across subject experts. It allows for reflection among participants, who are able to nuance and reconsider their kamagra online without prescription opinion based on the anonymised opinions of others. However, researchers must take steps to enhance robustness of the studies. It is important to try and prevent participants from simply resorting to agreeing with the majority kamagra online without prescription view. Studies must also predefine what is meant by ‘consensus’ and how it will be established.With careful and clear design though, Delphi studies can make a valuable contribution to the nursing evidence base by tapping into the profession’s most precious resource—the knowledge and expertise of its practitioners..

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A broadly neutralising viagra kamagra uk antibody to prevent HIV transmissionTwo HIV prevention trials (HVTN 704/HPTN 085. HVTN 703/HPTN 081) enrolled 2699 at-risk cisgender men and transgender persons in the Americas and Europe and 1924 at-risk women in sub-Saharan Africa who were randomly assigned to receive the broadly neutralising antibody (bnAb) VRC01 or placebo (10 infusions at an interval of 8 weeks). Moderate-to-severe adverse events related to VRC01 were viagra kamagra uk uncommon. In a prespecified pooled analysis, over 20 months, VRC01 offered an estimated prevention efficacy of ~75% against VRC01-sensitive isolates (30% of kamagraes circulating in the trial regions). However, VRC01 did not prevent with other HIV isolates and overall HIV viagra kamagra uk acquisition compared with placebo.

The data provide proof of concept that bnAb can prevent HIV acquisition, although the approach is limited by viral diversity and potential selection of resistant isolates.Corey L, Gilbert PB, Juraska M, et al. Two randomized viagra kamagra uk trials of neutralizing antibodies to prevent HIV-1 acquisition. N Engl J Med. 2021;384:1003–1014.Seminal cytokine profiles are associated with the risk of HIV transmissionInvestigators analysed a panel of 34 cytokines/chemokines in blood and semen of viagra kamagra uk men (predominantly men who have sex with men) with HIV, comparing 21 who transmitted HIV to their partners and 22 who did not. Overall, 47% of men had a recent HIV , 19% were on antiretroviral therapy and 84% were viraemic.

The cytokine profile in seminal fluid, but not in blood, differed significantly between transmitters and non-transmitters, with transmitters showing higher seminal concentrations of interleukin 13 (IL-13), IL-15 and IL-33, and lower concentrations of interferon‐gamma, IL-15, macrophage colony-stimulating viagra kamagra uk factor (M-CSF), IL-17, granulocyte-macrophage CSF (GM-CSF), IL-4, IL-16 and eotaxin. Although limited, the findings suggest that the seminal milieu modulates the risk of HIV transmission, providing a potential development opportunity for HIV prevention strategies.Vanpouille C, Frick A, Rawlings SA, et al. Cytokine network and sexual HIV transmission in men viagra kamagra uk who have sex with men. Clin Infect Dis. 2020;71:2655–2662.The challenge of estimating global treatment eligibility for chronic hepatitis B from incomplete datasetsWorldwide, over 250 million people are estimated to live with chronic hepatitis B (CHB), although only ~11% is diagnosed and a minority receives antiviral viagra kamagra uk therapy.

An estimate of the global proportion eligible for treatment was not previously available. A systematic review analysed studies of CHB populations done between 2007 and 2018 viagra kamagra uk to estimate the prevalence of cirrhosis, abnormal alanine aminotransferase, hepatitis B kamagra DNA >2000 or >20 000 IU/mL, hepatitis B e-antigen, and overall eligibility for treatment as per WHO and other guidelines. The pooled treatment eligibility estimate was 19% (95% CI 18% to 20%), with about 10% requiring urgent treatment due to cirrhosis. However, the estimate should be interpreted with caution due to viagra kamagra uk incomplete data acquisition and reporting in available studies. Standardised reporting is needed to improve global and regional estimates of CHB treatment eligibility and guide effective policy formulation.Tan M, Bhadoria AS, Cui F, et al.

Estimating the proportion of people with chronic hepatitis B kamagra eligible for hepatitis B antiviral viagra kamagra uk treatment worldwide. A systematic review and meta-analysis. Lancet Gastroenterol Hepatol, 2021 viagra kamagra uk. 6:106–119.Broad geographical disparity in the contribution of HIV to the burden of cervical cancerThis systematic review and meta-analysis estimated the contribution of HIV to the global and regional burden of cervical cancer using data from 24 studies which included 236 127 women with HIV. HIV markedly increased the risk of cervical viagra kamagra uk cancer (pooled relative risk 6.07.

95% CI 4.40 to 8.37). In 2018, viagra kamagra uk 4.9% (95% CI 3.6% to 6.4%) of cervical cancers were attributable to HIV globally, although the population-attributable fraction for HIV varied geographically, reaching 21% (95% CI 15.6% to 26.8%) in the African region. Cervical cancer is preventable and treatable. Efforts are viagra kamagra uk needed to expand access to HPV vaccination in sub-Saharan Africa. More immediately, there is an urgent need to integrate cervical cancer screening within HIV services.Stelzle D, Tanaka LF, Lee KK, et al.

Estimates of the global burden of cervical viagra kamagra uk cancer associated with HIV. Lancet Glob Health. 2020. 9:e161–69.The complex relationship between serum vitamin D and persistence of high-risk human papilloma kamagra Most cervical high-risk human papilloma kamagra (hrHPV) s are transient and those that persist are more likely to progress to cancer. Based on the proposed immunomodulatory properties of vitamin D, a longitudinal study examined the association between serum concentrations of five vitamin D biomarkers and short-term persistent (vs transient or sporadic) detection of hrHPV in 72 women who collected monthly cervicovaginal swabs over 6 months.

No significant associations were detected in the primary analysis. In sensitivity analyses, after multiple adjustments, serum concentrations of multiple vitamin D biomarkers were positively associated with the short-term persistence of 14 selected hrHPV types. The relationship between vitamin D and hrHPV warrants closer examination. Studies should have longer follow-up, include populations with more diverse vitamin D concentrations and account for vitamin D supplementation.Troja C, Hoofnagle AN, Szpiro A, et al. Understanding the role of emerging vitamin D biomarkers on short-term persistence of high-risk HPV among mid-adult women.

J Infect Dis 2020. Online ahead of printPublished in STI—the editor’s choice. One in five cases of with Neisseria gonorrhoeae clear spontaneouslyStudies have indicated that Neisseria gonorrhoeae (NG) s can resolve spontaneously without antibiotic therapy. A substudy of a randomised trial investigated 405 untreated subjects (71% men) who underwent both pretrial and enrolment NG testing at the same anatomical site (genital, pharyngeal and rectal). Based on nuclear acid amplification tests, 83 subjects (20.5%) showed clearance of the anatomical site within a median of 10 days (IQR 7–15) between tests.

Those with spontaneous clearance were less likely to have concurrent chlamydia (p=0.029) and dysuria (p=0.035), but there were no differences in age, gender, sexual orientation, HIV status, number of previous NG episodes, and symptoms other than dysuria between those with and without clearance. Given the high rate of spontaneous resolution, point-of-care NG testing should be considered to reduce unnecessary antibiotic treatment.Mensforth S, Ayinde OC, Ross J. Spontaneous clearance of genital and extragenital Neisseria gonorrhoeae. Data from GToG. STI 2020.

96:556–561.BackgroundReproductive aged women are at risk of both pregnancy and sexually transmitted s (STI). The modern contraceptive prevalence among married and unmarried women in South Africa is 54% and 64%, respectively, with injectable progestins being most widely used.1 Moreover, current global efforts aim towards all women having access to a range of reliable contraceptives options.2 The prevalences of chlamydia and gonorrhoea are high among women in Africa, particularly among younger women. A recent meta-analysis of over 37 000 women estimated prevalences for chlamydia and gonorrhoea by region and population type (South Africa clinic/community-based, Eastern Africa higher-risk and Southern/Eastern Africa clinic community-based). High chlamydia and gonorrhoea prevalences were found among 15–24 year-old South African women and high risk populations in East Africa.3 Both chlamydia and gonorrhoea are associated with numerous comorbidities including pelvic inflammatory disease (PID), ectopic pregnancy, infertility, increased risk of HIV and other STIs, as well as significant social harm.4While STIs are a significant global health burden, data on STI prevalence by gender and drivers of are limited, hindering an effective public health response.5 Moreover, data on the association between contraceptive use and risk of non-HIV STIs are limited. The WHO recently reported stagnation in efforts to decrease global STI incidence.5 Understanding drivers of STI acquisition, including any possible associations with widely used contraceptive methods, is necessary to effectively target public health responses that reduce STI incidence and associated comorbidities.The ECHO Trial (ClinicalTrials.gov Identifier.

NCT02550067) was a multicentre, open-label randomised trial of 7829 HIV-seronegative women seeking effective contraception in Eswatini, Kenya, South Africa and Zambia. Detailed trial methods and results have been published.6 7 We conducted a secondary analysis of ECHO trial data to evaluate absolute and relative chlamydia and gonorrhoea final visit prevalences among women randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) and a levonorgestrel (LNG) implant.MethodsStudy design, participants and ethicsWomen were enrolled in the ECHO trial from December 2015 through September 2017. Institutional review boards at each site approved the study protocol and women provided written informed consent before any study procedures. In brief, women who were not pregnant, HIV-seronegative, aged 16–35 years, seeking effective contraception, without medical contraindications, willing to use the assigned method for 18 months, reported not using injectable, intrauterine or implantable contraception for the previous 6 months and reported being sexually active, were enrolled. At every visit, participants received HIV risk reduction counselling, HIV testing and STI management, condoms and, as it became a part of national standard of care, HIV pre-exposure prophylaxis.

Counselling messages related to HIV risk were implemented consistently across the three groups throughout the trial.6The trial was implemented in accordance with the Declaration of Helsinki and Good Clinical Practice. Informed consent was obtained from participants or their parents/guardians and human experimentation guidelines of the United States Department of Health and Human Services and those of the authors' institution(s) were followed.Contraceptive exposureAt enrolment, women were randomly assigned (1:1:1) to DMPA-IM, copper IUD or LNG implant.6 Participants received an injection of 150 mg/mL DMPA-IM (Depo Provera. Pfizer, Puurs, Belgium) at enrolment and every 3 months until the final visit at 18 months after enrolment, a copper IUD (Optima TCu380A. Injeflex, Sao Paolo, Brazil) or a LNG implant (Jadelle. Bayer, Turku, Finland) at enrolment.

Women returned for follow-up visits at 1 month after enrolment to address initial contraceptive side-effects and every 3 months thereafter, for up to 18 months with later enrolling participants contributing 12 to 18 months of follow-up. Visits included HIV serological testing, contraceptive counselling, syndromic STI management and safety monitoring.STI outcomesThe primary outcomes of this secondary analysis were prevalent chlamydia and gonorrhoea at the final visit. Syndromic STI management was provided at screening and all follow-up visits. Nucleic acid amplification testing (NAAT) for Chlamydia trachomatis and Neisseria gonorrhoeae was conducted at screening and final visits, at the visit of HIV detection for participants who became HIV infected and at clinical discretion. Any untreated participants with positive NAAT results were contacted to return to the study clinic for treatment.CovariatesAt baseline (inclusive of screening and enrolment visits), we collected demographic, sexual and reproductive risk behaviour and reproductive and contraceptive history data.

Baseline risk factors evaluated as covariates included age, whether the participant earned her own income, chlamydia and gonorrhoea status, herpes simplex kamagra type 2 (HSV-2) sero-status and suspected PID. Final visit factors evaluated as covariates included number of sex partners in the past 3 months, number of new sex partners in the past 3 months, HIV serostatus, HSV-2 serostatus, condom use in the past 3 months, sex exchanged for money/gifts, sex during vaginal bleeding, follow-up time and number of pelvic examinations during follow-up. Age and HSV-2 serostatus were evaluated for effect measure modification.Statistical analysisWe conducted analyses using R V.3.5.3 (Vienna, Austria), and log-binomial regression to estimate chlamydia and gonorrhoea prevalences within each contraceptive group and pairwise prevalence ratios (PR) between each arm in as-randomised and consistent use analyses.In the as-randomised analysis, we analysed participants by the contraceptive method assigned at randomisation independent of method adherence. We estimated crude point prevalences by arm and study site and pairwise adjusted PRs.In the consistent use analysis, we only included women who initiated use of their randomised contraceptive method and maintained randomised method adherence throughout follow-up. We estimated crude point prevalences by arm and pairwise adjusted PRs, with evaluation of age and HSV-2 status first as potential effect measure modifiers, and all covariates above as potential confounders.

Study site and age were retained in the final model. Other covariates were retained if their inclusion in the base model led to a 10% change in the effect estimate through backwards selection.Supplementary analysesAdditional supporting analyses to assess postrandomisation potential sources of bias were conducted to inform interpretation of results. These include evaluation of recent sexual behaviour at enrolment, month 9 and the final visit. Cohort participation (ie, follow-up time, early discontinuation and timing of randomised method discontinuation) and health outcomes (ie, final visit HIV and HSV-2 status) and frequency and results of pelvic examinations by STI status, site and visit month by randomised arm.ResultsA total of 7829 women were randomly assigned as follows. 2609 to the DMPA-IM group, 2607 to the copper IUD group and 2613 to the LNG implant group (figure 1).

Participants were excluded if they were HIV positive at enrolment, did not have at least one HIV test or did not have chlamydia and gonorrhoea test results at the final visit. Overall, 90%, 94% and 93% from the DMPA-IM, copper IUD and LNG implant groups, respectively, were included in analyses.Study profile. DMPA-IM, depot medroxy progesterone acetate. IUD, intrauterine device. LNG, levonorgestrel." data-icon-position data-hide-link-title="0">Figure 1 Study profile.

DMPA-IM, depot medroxy progesterone acetate. IUD, intrauterine device. LNG, levonorgestrel.Participant characteristicsBaseline characteristics were similar across groups (table 1). Nearly two-third of enrolled women (63%) were aged 24 and younger and 5768 (74%) of the study population resided in South Africa.View this table:Table 1 Participant baseline and final visit characteristicsThe duration of participation averaged 16 months with no differences between randomised groups (table 1). A total of 1468 (19%) women either did not receive their randomised method or discontinued use during follow-up.

Overall method continuation rates were high with minimal differences between randomised groups when measured by person-years.6 The proportion, however, of method non-adherence as defined in this analysis (ie, did not receive randomised method at baseline or discontinued randomised method at any point during follow-up), was greater in the DMPA-IM group (26%), followed by the copper IUD (18%) and LNG implant (12%) groups. Timing of discontinuation also differed across methods. During the first 6 months, method discontinuation was highest in the copper IUD group (7%) followed closely by DMPA-IM (6%) and LNG implant (4%) groups. Between 7 and 12 months of follow-up, it was highest in DMPA-IM group (15%), with equivalent proportions in the LNG implant (5%) and copper IUD (5%) groups.Point prevalences of chlamydia and gonorrhoea at baseline and final visitsIn total, 18% of women had chlamydia at baseline (figure 2A) and 15% at the final visit. Among women 24 years and younger, 22% and 20% had chlamydia at baseline and final visits, respectively.

Women aged 25–35 at baseline were less likely to have chlamydia at both baseline (12%) and final visits (8%) compared with younger women. Baseline chlamydia prevalence ranged from 5% in Zambia to 28% in the Western Cape, South Africa (figure 2B).Point prevalence (per 100 persons) of chlamydia and gonorrhoea at baseline and final visit by age category and study site region. Y-axis scale differs for chlamydia and gonorrhoea figures." data-icon-position data-hide-link-title="0">Figure 2 Point prevalence (per 100 persons) of chlamydia and gonorrhoea at baseline and final visit by age category and study site region. Y-axis scale differs for chlamydia and gonorrhoea figures.Among all women, 5% had gonorrhoea at baseline and the final visit (figure 2C). Women aged 24 and younger were more likely to have gonorrhoea compared with women aged 25 and older at both baseline (5% vs 4%, respectively) and the final visit (6% vs 3%, respectively).

Baseline gonorrhoea prevalence ranged from 3% in Zambia and Kenya to 9% in the Western Cape, South Africa (figure 2D). Similar prevalences were observed at the final visit.Point prevalences of chlamydia and gonorrhoea at final visit by randomised contraceptive methodFourteen per cent of women randomised to DMPA-IM, 15% to copper IUD and 17% to LNG implant had chlamydia at the final visit (table 2).View this table:Table 2 Chlamydia trachomatis and Neisseria gonorrhoeae prevalence at final visitThe prevalence of chlamydia did not significantly differ between DMPA-IM and copper IUD groups (PR 0.90, 95% CI (0.79 to 1.04)) or between copper IUD and LNG implant groups (PR 0.92, 95% CI (0.81 to 1.04)). Women in the DMPA-IM group, however, had a significantly lower risk of chlamydia compared with the LNG implant group (PR. 0.83, 95% CI (0.72 to 0.95)). Findings from the consistent use analysis were similar, and neither age nor HSV-2 status modified the observed associations.Four per cent of women randomised to DMPA-IM, 6% to copper IUD and 5% to LNG implant had gonorrhoea at the final visit (table 2).

Gonorrhoea prevalence did not significantly differ between DMPA-IM and LNG implant groups (PR. 0.79, 95% CI (0.61 to 1.03)) or between copper IUD and LNG implant groups (PR. 1.18, 95% CI (0.93 to 1.49)). Women in the DMPA-IM group had a significantly lower risk of gonorrhoea compared with women in the copper IUD group (PR. 0.67, 95% CI (0.52 to 0.87)).

Results from as randomised and continuous use analyses did not differ. And again, neither age nor HSV-2 status modified the observed associations.Clinical assessment by randomised contraceptive methodTo assess the potential for outcome ascertainment bias, we evaluated the frequency of pelvic examinations and abdominal/pelvic pain and discharge by study arm. Women in the copper IUD group were generally more likely to receive a pelvic examination during follow-up as compared with women in the DMPA-IM and LNG implant groups (online supplemental appendix 1). Similarly, abdominal/pelvic pain on examination or abnormal discharge was observed most frequently in the copper IUD group. The number of pelvic examinations met the prespecified criteria for retention in the adjusted gonorrhoea model but not in the chlamydia model.Supplemental materialFrequency of syndromic symptoms and potential reAmong women who had chlamydia at baseline, 23% were also positive at the final visit (online supplemental appendix 2, figure 3A).

Nine per cent of gonorrhoea-positive women at baseline were also positive at the final visit (online supplemental appendix 2, figure 3B). Across both baseline and final visits, a minority of women with chlamydia or gonorrhoea presented with signs and/or symptoms. Among chlamydia-positive women, only 12% presented with either abnormal vaginal discharge and/or abdominal/pelvic pain at their test-positive visit (online supplemental appendix 2, figure 3C). Similarly, only 15% of gonorrhoea-positive women presented with abnormal vaginal discharge and/or abdominal/pelvic pain at their test-positive visit (online supplemental appendix 2, figure 3D).Potential re and symptoms among women with chlamydia or gonorrhoea. Data are pooled across the screening and final visits in figures (C) and (D).

Symptomatic is defined as presenting with abnormal vaginal discharge and/or abdominal/pelvic pain. Final visit is described as potential re because test of cure was not conducted following baseline diagnosis and treatment." data-icon-position data-hide-link-title="0">Figure 3 Potential re and symptoms among women with chlamydia or gonorrhoea. Data are pooled across the screening and final visits in figures (C) and (D). Symptomatic is defined as presenting with abnormal vaginal discharge and/or abdominal/pelvic pain. Final visit is described as potential re because test of cure was not conducted following baseline diagnosis and treatment.DiscussionWe observed differences in final prevalences of chlamydia and gonorrhoea by contraceptive group in both as-randomised and consistent-use analyses.

The DMPA-IM group had lower final visit chlamydia and gonorrhoea prevalences as compared with copper IUD and LNG implant groups, though only the DMPA-IM versus the copper IUD comparison of gonorrhoea and DMPA-IM versus LNG implant comparison of chlamydia reached statistical significance. These are novel findings that have not previously been reported to our knowledge and were determined in a randomised trial setting with high participant retention, robust biomarker testing and high randomised method adherence. Interestingly, the copper IUD group had higher gonorrhoea and lower chlamydia prevalence compared with the LNG implant group, though neither finding was statistically significant.Two recent systematic reviews of the association between contraceptives and STIs found inconsistent and insufficient evidence on the association between the contraceptive methods under study in ECHO and chlamydia and gonorrhoea.8 9 Neither systematic review identified any randomised studies or any direct comparative evidence for DMPA-IM, copper IUD and LNG implant, thus enabling a unique scientific contribution from this secondary trial analysis. Nonetheless, these findings should be interpreted in light of biological plausibility, as well as the design strengths and limitations of this analysis.The emerging science on the biological mechanisms underlying HIV susceptibility demonstrates the complex relationship between the infectious pathogen, the host innate and adaptive immune response and the interaction of both with the vaginal microbiome and other -omes. Data on these factors in relationship to chlamydia and gonorrhoea acquisition are much more limited but can be assumed to be equally complex.

Vaginal microbiome composition, including microbial metabolic by-products, have been shown to significantly modify risk of HIV acquisition and to vary with exogenous hormone exposure, menstrual cycle phase, ethnicity and geography.10–12 These same biological principles likely apply to chlamydia and gonorrhoea susceptibility. While DMPA-IM has been associated with decreased bacterial vaginosis (BV), initiation of the copper IUD has been associated with increased BV prevalence, and BV is associated with chlamydia and gonorrhoea acquisition.13 14 Moreover, Lactobacillus crispatus, which is less abundant in BV, has been shown to inhibit HeLa cell by Chlamydia trachomatis and inhibits growth of Neisseria gonorrhoeae in animal models.15 16 In addition, microbial community state types that are deficient in Lactobacillus crispatus and/or dominated by dysbiotic species are associated with inflammation, which is a driver of both STI and HIV susceptibility. Thus, while the exact mechanisms of chlamydia and gonorrhoea in the presence of exogenous hormones and varying host microbiomes are unknown, it is biologically plausible that these complex factors may result in differential susceptibility to chlamydia and gonorrhoea among DMPA-IM, copper IUD and LNG implant users.An alternative explanation for these findings may be postrandomisation differences in clinical care and/or sexual behaviour. Participants in the copper IUD arm were more likely to have pelvic examinations and more likely to have discharge compared with women in the DMPA-IM and LNG implant groups. While interim STI testing and/or treatment were not documented, women in the copper IUD arm may have been more likely to receive syndromic STI treatment during follow-up due to more examination and observed discharge.

More frequent STI treatment in the copper IUD group would theoretically lower the final visit point prevalence relative to women in the DMPA-IM and LNG implant arms, suggesting that the observed lower risk of STI in the DMPA-IM arm is not due to differential examination, testing and treatment. Differential sexual risk behaviour may also have influenced the results. As reported previously, women in the DMPA-IM group less frequently reported condomless sex and multiple partners than women in the other groups, and both DMPA-IM and LNG implant users less frequently reported new partners and sex during menses than copper IUD users.6 Statistical control of self-reported sexual risk behaviour in the consistent-use analysis may have been inadequate if self-reported sexual behaviour was inaccurately or insufficiently reported.A second alternative explanation may be differences in randomised method non-adherence, which was greater in the DMPA-IM group, compared with copper IUD and LNG implant groups. Yet, the consistency of findings in the as-randomised and continuous use analyses suggests that method non-adherence had minimal effect on study outcomes. Taken as a whole, these findings indicate that there may be real differences in chlamydia and gonorrhoea risk associated with use of DMPA-IM, the copper IUD and LNG implant.

However, any true differential risk by method must be evaluated in light of the holistic benefits and risks of each method.The high observed chlamydia and gonorrhoea prevalences, despite intensive counselling and condom provision, warrants attention, particularly among women ages 24 years and younger and among women in South Africa and Eswatini. While the ECHO study was conducted in settings of high HIV/STI incidence, enrolment criteria did not purposefully target women at highest risk of HIV/STI in the trial communities, suggesting that the observed prevalences may be broadly applicable to women seeking effective contraception in those settings. Improved approaches are needed to prevent STIs, including options for expedited partner treatment, to prevent re.As expected, few women testing positive for chlamydia or gonorrhoea presented with symptoms (12% and 15%, respectively), and a substantial proportion of women who were positive and treated at baseline were infected at the final visit despite syndromic management during the follow-up. Given that syndromic management is the standard of care within primary health facilities in most trial settings, these data suggest that a large proportion of among reproductive aged women is missed, exacerbating the burden of curable STIs and associated morbidities. Routine access to more reliable diagnostics, like NAAT and novel point-of-care diagnostic tests, will be key to managing asymptomatic STIs and reducing STI prevalence and related morbidities in these settings.17This secondary analysis of the ECHO trial has strengths and limitations.

Strengths include the randomised design with comparator groups of equal STI baseline risk. Participants had high adherence to their randomised contraceptive method.6 While all participants received standardised clinical care and counselling, the unblinded randomisation may have allowed postrandomisation differences in STI risk over time by method. It is possible that participants modified their risk-taking behaviour based on study counselling messages regarding the potential association between DMPA-IM and HIV.In conclusion, our analyses suggest that DMPA-IM users may have lower risk of chlamydia and gonorrhoea compared with LNG implant and copper IUD users, respectively. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use. Moreover, the high chlamydia and gonorrhoea prevalences in this population, independent of contraceptive method, warrants urgent attention.Key messagesThe prevalence of chlamydia and gonorrhoea varied by contraceptive method in this randomised trial.High chlamydia and gonorrhoea prevalences, despite intensive counselling and condom provision, warrants attention, particularly among young women in South Africa and Eswatini.Most chlamydia and gonorrhoea s were asymptomatic.

Therefore, routine access to reliable diagnostics are needed to effectively manage and prevent STIs in African women..

A broadly neutralising antibody kamagra online without prescription to prevent HIV transmissionTwo HIV prevention trials (HVTN 704/HPTN 085. HVTN 703/HPTN 081) enrolled 2699 at-risk cisgender men and transgender persons in the Americas and Europe and 1924 at-risk women in sub-Saharan Africa who were randomly assigned to receive the broadly neutralising antibody (bnAb) VRC01 or placebo (10 infusions at an interval of 8 weeks). Moderate-to-severe adverse events related kamagra online without prescription to VRC01 were uncommon.

In a prespecified pooled analysis, over 20 months, VRC01 offered an estimated prevention efficacy of ~75% against VRC01-sensitive isolates (30% of kamagraes circulating in the trial regions). However, VRC01 did not prevent kamagra online without prescription with other HIV isolates and overall HIV acquisition compared with placebo. The data provide proof of concept that bnAb can prevent HIV acquisition, although the approach is limited by viral diversity and potential selection of resistant isolates.Corey L, Gilbert PB, Juraska M, et al.

Two randomized trials of neutralizing antibodies to kamagra online without prescription prevent HIV-1 acquisition. N Engl J Med. 2021;384:1003–1014.Seminal cytokine profiles are associated with the risk of HIV transmissionInvestigators analysed a panel of 34 cytokines/chemokines in blood and semen of men (predominantly men who have sex with men) with HIV, comparing 21 who transmitted HIV to their partners and 22 who did not kamagra online without prescription.

Overall, 47% of men had a recent HIV , 19% were on antiretroviral therapy and 84% were viraemic. The cytokine profile in seminal fluid, but not in blood, differed significantly between transmitters and non-transmitters, with transmitters showing higher kamagra online without prescription seminal concentrations of interleukin 13 (IL-13), IL-15 and IL-33, and lower concentrations of interferon‐gamma, IL-15, macrophage colony-stimulating factor (M-CSF), IL-17, granulocyte-macrophage CSF (GM-CSF), IL-4, IL-16 and eotaxin. Although limited, the findings suggest that the seminal milieu modulates the risk of HIV transmission, providing a potential development opportunity for HIV prevention strategies.Vanpouille C, Frick A, Rawlings SA, et al.

Cytokine network and sexual HIV transmission in kamagra online without prescription men who have sex with men. Clin Infect Dis. 2020;71:2655–2662.The challenge kamagra online without prescription of estimating global treatment eligibility for chronic hepatitis B from incomplete datasetsWorldwide, over 250 million people are estimated to live with chronic hepatitis B (CHB), although only ~11% is diagnosed and a minority receives antiviral therapy.

An estimate of the global proportion eligible for treatment was not previously available. A systematic review analysed studies of CHB populations done between 2007 and 2018 to estimate the prevalence of cirrhosis, abnormal alanine aminotransferase, hepatitis B kamagra DNA >2000 or >20 000 IU/mL, hepatitis B e-antigen, and overall eligibility for kamagra online without prescription treatment as per WHO and other guidelines. The pooled treatment eligibility estimate was 19% (95% CI 18% to 20%), with about 10% requiring urgent treatment due to cirrhosis.

However, the kamagra online without prescription estimate should be interpreted with caution due to incomplete data acquisition and reporting in available studies. Standardised reporting is needed to improve global and regional estimates of CHB treatment eligibility and guide effective policy formulation.Tan M, Bhadoria AS, Cui F, et al. Estimating the proportion of people with chronic hepatitis kamagra online without prescription B kamagra eligible for hepatitis B antiviral treatment worldwide.

A systematic review and meta-analysis. Lancet Gastroenterol Hepatol, kamagra online without prescription 2021. 6:106–119.Broad geographical disparity in the contribution of HIV to the burden of cervical cancerThis systematic review and meta-analysis estimated the contribution of HIV to the global and regional burden of cervical cancer using data from 24 studies which included 236 127 women with HIV.

HIV markedly increased the risk of cervical cancer (pooled relative kamagra online without prescription risk 6.07. 95% CI 4.40 to 8.37). In 2018, 4.9% (95% CI 3.6% to 6.4%) of cervical cancers were attributable to HIV globally, although the population-attributable fraction for HIV varied geographically, reaching 21% (95% CI 15.6% to 26.8%) in the African region kamagra online without prescription.

Cervical cancer is preventable and treatable. Efforts are needed kamagra online without prescription to expand access to HPV vaccination in sub-Saharan Africa. More immediately, there is an urgent need to integrate cervical cancer screening within HIV services.Stelzle D, Tanaka LF, Lee KK, et al.

Estimates of the global burden of cervical kamagra online without prescription cancer associated with HIV. Lancet Glob Health. 2020.

9:e161–69.The complex relationship between serum vitamin D and persistence of high-risk human papilloma kamagra Most cervical high-risk human papilloma kamagra (hrHPV) s are transient and those that persist are more likely to progress to cancer. Based on the proposed immunomodulatory properties of vitamin D, a longitudinal study examined the association between serum concentrations of five vitamin D biomarkers and short-term persistent (vs transient or sporadic) detection of hrHPV in 72 women who collected monthly cervicovaginal swabs over 6 months. No significant associations were detected in the primary analysis.

In sensitivity analyses, after multiple adjustments, serum concentrations of multiple vitamin D biomarkers were positively associated with the short-term persistence of 14 selected hrHPV types. The relationship between vitamin D and hrHPV warrants closer examination. Studies should have longer follow-up, include populations with more diverse vitamin D concentrations and account for vitamin D supplementation.Troja C, Hoofnagle AN, Szpiro A, et al.

Understanding the role of emerging vitamin D biomarkers on short-term persistence of high-risk HPV among mid-adult women. J Infect Dis 2020. Online ahead of printPublished in STI—the editor’s choice.

One in five cases of with Neisseria gonorrhoeae clear spontaneouslyStudies have indicated that Neisseria gonorrhoeae (NG) s can resolve spontaneously without antibiotic therapy. A substudy of a randomised trial investigated 405 untreated subjects (71% men) who underwent both pretrial and enrolment NG testing at the same anatomical site (genital, pharyngeal and rectal). Based on nuclear acid amplification tests, 83 subjects (20.5%) showed clearance of the anatomical site within a median of 10 days (IQR 7–15) between tests.

Those with spontaneous clearance were less likely to have concurrent chlamydia (p=0.029) and dysuria (p=0.035), but there were no differences in age, gender, sexual orientation, HIV status, number of previous NG episodes, and symptoms other than dysuria between those with and without clearance. Given the high rate of spontaneous resolution, point-of-care NG testing should be considered to reduce unnecessary antibiotic treatment.Mensforth S, Ayinde OC, Ross J. Spontaneous clearance of genital and extragenital Neisseria gonorrhoeae.

Data from GToG. STI 2020. 96:556–561.BackgroundReproductive aged women are at risk of both pregnancy and sexually transmitted s (STI).

The modern contraceptive prevalence among married and unmarried women in South Africa is 54% and 64%, respectively, with injectable progestins being most widely used.1 Moreover, current global efforts aim towards all women having access to a range of reliable contraceptives options.2 The prevalences of chlamydia and gonorrhoea are high among women in Africa, particularly among younger women. A recent meta-analysis of over 37 000 women estimated prevalences for chlamydia and gonorrhoea by region and population type (South Africa clinic/community-based, Eastern Africa higher-risk and Southern/Eastern Africa clinic community-based). High chlamydia and gonorrhoea prevalences were found among 15–24 year-old South African women and high risk populations in East Africa.3 Both chlamydia and gonorrhoea are associated with numerous comorbidities including pelvic inflammatory disease (PID), ectopic pregnancy, infertility, increased risk of HIV and other STIs, as well as significant social harm.4While STIs are a significant global health burden, data on STI prevalence by gender and drivers of are limited, hindering an effective public health response.5 Moreover, data on the association between contraceptive use and risk of non-HIV STIs are limited.

The WHO recently reported stagnation in efforts to decrease global STI incidence.5 Understanding drivers of STI acquisition, including any possible associations with widely used contraceptive methods, is necessary to effectively target public health responses that reduce STI incidence and associated comorbidities.The ECHO Trial (ClinicalTrials.gov Identifier. NCT02550067) was a multicentre, open-label randomised trial of 7829 HIV-seronegative women seeking effective contraception in Eswatini, Kenya, South Africa and Zambia. Detailed trial methods and results have been published.6 7 We conducted a secondary analysis of ECHO trial data to evaluate absolute and relative chlamydia and gonorrhoea final visit prevalences among women randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) and a levonorgestrel (LNG) implant.MethodsStudy design, participants and ethicsWomen were enrolled in the ECHO trial from December 2015 through September 2017.

Institutional review boards at each site approved the study protocol and women provided written informed consent before any study procedures. In brief, women who were not pregnant, HIV-seronegative, aged 16–35 years, seeking effective contraception, without medical contraindications, willing to use the assigned method for 18 months, reported not using injectable, intrauterine or implantable contraception for the previous 6 months and reported being sexually active, were enrolled. At every visit, participants received HIV risk reduction counselling, HIV testing and STI management, condoms and, as it became a part of national standard of care, HIV pre-exposure prophylaxis.

Counselling messages related to HIV risk were implemented consistently across the three groups throughout the trial.6The trial was implemented in accordance with the Declaration of Helsinki and Good Clinical Practice. Informed consent was obtained from participants or their parents/guardians and human experimentation guidelines of the United States Department of Health and Human Services and those of the authors' institution(s) were followed.Contraceptive exposureAt enrolment, women were randomly assigned (1:1:1) to DMPA-IM, copper IUD or LNG implant.6 Participants received an injection of 150 mg/mL DMPA-IM (Depo Provera. Pfizer, Puurs, Belgium) at enrolment and every 3 months until the final visit at 18 months after enrolment, a copper IUD (Optima TCu380A.

Injeflex, Sao Paolo, Brazil) or a LNG implant (Jadelle. Bayer, Turku, Finland) at enrolment. Women returned for follow-up visits at 1 month after enrolment to address initial contraceptive side-effects and every 3 months thereafter, for up to 18 months with later enrolling participants contributing 12 to 18 months of follow-up.

Visits included HIV serological testing, contraceptive counselling, syndromic STI management and safety monitoring.STI outcomesThe primary outcomes of this secondary analysis were prevalent chlamydia and gonorrhoea at the final visit. Syndromic STI management was provided at screening and all follow-up visits. Nucleic acid amplification testing (NAAT) for Chlamydia trachomatis and Neisseria gonorrhoeae was conducted at screening and final visits, at the visit of HIV detection for participants who became HIV infected and at clinical discretion.

Any untreated participants with positive NAAT results were contacted to return to the study clinic for treatment.CovariatesAt baseline (inclusive of screening and enrolment visits), we collected demographic, sexual and reproductive risk behaviour and reproductive and contraceptive history data. Baseline risk factors evaluated as covariates included age, whether the participant earned her own income, chlamydia and gonorrhoea status, herpes simplex kamagra type 2 (HSV-2) sero-status and suspected PID. Final visit factors evaluated as covariates included number of sex partners in the past 3 months, number of new sex partners in the past 3 months, HIV serostatus, HSV-2 serostatus, condom use in the past 3 months, sex exchanged for money/gifts, sex during vaginal bleeding, follow-up time and number of pelvic examinations during follow-up.

Age and HSV-2 serostatus were evaluated for effect measure modification.Statistical analysisWe conducted analyses using R V.3.5.3 (Vienna, Austria), and log-binomial regression to estimate chlamydia and gonorrhoea prevalences within each contraceptive group and pairwise prevalence ratios (PR) between each arm in as-randomised and consistent use analyses.In the as-randomised analysis, we analysed participants by the contraceptive method assigned at randomisation independent of method adherence. We estimated crude point prevalences by arm and study site and pairwise adjusted PRs.In the consistent use analysis, we only included women who initiated use of their randomised contraceptive method and maintained randomised method adherence throughout follow-up. We estimated crude point prevalences by arm and pairwise adjusted PRs, with evaluation of age and HSV-2 status first as potential effect measure modifiers, and all covariates above as potential confounders.

Study site and age were retained in the final model. Other covariates were retained if their inclusion in the base model led to a 10% change in the effect estimate through backwards selection.Supplementary analysesAdditional supporting analyses to assess postrandomisation potential sources of bias were conducted to inform interpretation of results. These include evaluation of recent sexual behaviour at enrolment, month 9 and the final visit.

Cohort participation (ie, follow-up time, early discontinuation and timing of randomised method discontinuation) and health outcomes (ie, final visit HIV and HSV-2 status) and frequency and results of pelvic examinations by STI status, site and visit month by randomised arm.ResultsA total of 7829 women were randomly assigned as follows. 2609 to the DMPA-IM group, 2607 to the copper IUD group and 2613 to the LNG implant group (figure 1). Participants were excluded if they were HIV positive at enrolment, did not have at least one HIV test or did not have chlamydia and gonorrhoea test results at the final visit.

Overall, 90%, 94% and 93% from the DMPA-IM, copper IUD and LNG implant groups, respectively, were included in analyses.Study profile. DMPA-IM, depot medroxy progesterone acetate. IUD, intrauterine device.

LNG, levonorgestrel." data-icon-position data-hide-link-title="0">Figure 1 Study profile. DMPA-IM, depot medroxy progesterone acetate. IUD, intrauterine device.

LNG, levonorgestrel.Participant characteristicsBaseline characteristics were similar across groups (table 1). Nearly two-third of enrolled women (63%) were aged 24 and younger and 5768 (74%) of the study population resided in South Africa.View this table:Table 1 Participant baseline and final visit characteristicsThe duration of participation averaged 16 months with no differences between randomised groups (table 1). A total of 1468 (19%) women either did not receive their randomised method or discontinued use during follow-up.

Overall method continuation rates were high with minimal differences between randomised groups when measured by person-years.6 The proportion, however, of method non-adherence as defined in this analysis (ie, did not receive randomised method at baseline or discontinued randomised method at any point during follow-up), was greater in the DMPA-IM group (26%), followed by the copper IUD (18%) and LNG implant (12%) groups. Timing of discontinuation also differed across methods. During the first 6 months, method discontinuation was highest in the copper IUD group (7%) followed closely by DMPA-IM (6%) and LNG implant (4%) groups.

Between 7 and 12 months of follow-up, it was highest in DMPA-IM group (15%), with equivalent proportions in the LNG implant (5%) and copper IUD (5%) groups.Point prevalences of chlamydia and gonorrhoea at baseline and final visitsIn total, 18% of women had chlamydia at baseline (figure 2A) and 15% at the final visit. Among women 24 years and younger, 22% and 20% had chlamydia at baseline and final visits, respectively. Women aged 25–35 at baseline were less likely to have chlamydia at both baseline (12%) and final visits (8%) compared with younger women.

Baseline chlamydia prevalence ranged from 5% in Zambia to 28% in the Western Cape, South Africa (figure 2B).Point prevalence (per 100 persons) of chlamydia and gonorrhoea at baseline and final visit by age category and study site region. Y-axis scale differs for chlamydia and gonorrhoea figures." data-icon-position data-hide-link-title="0">Figure 2 Point prevalence (per 100 persons) of chlamydia and gonorrhoea at baseline and final visit by age category and study site region. Y-axis scale differs for chlamydia and gonorrhoea figures.Among all women, 5% had gonorrhoea at baseline and the final visit (figure 2C).

Women aged 24 and younger were more likely to have gonorrhoea compared with women aged 25 and older at both baseline (5% vs 4%, respectively) and the final visit (6% vs 3%, respectively). Baseline gonorrhoea prevalence ranged from 3% in Zambia and Kenya to 9% in the Western Cape, South Africa (figure 2D). Similar prevalences were observed at the final visit.Point prevalences of chlamydia and gonorrhoea at final visit by randomised contraceptive methodFourteen per cent of women randomised to DMPA-IM, 15% to copper IUD and 17% to LNG implant had chlamydia at the final visit (table 2).View this table:Table 2 Chlamydia trachomatis and Neisseria gonorrhoeae prevalence at final visitThe prevalence of chlamydia did not significantly differ between DMPA-IM and copper IUD groups (PR 0.90, 95% CI (0.79 to 1.04)) or between copper IUD and LNG implant groups (PR 0.92, 95% CI (0.81 to 1.04)).

Women in the DMPA-IM group, however, had a significantly lower risk of chlamydia compared with the LNG implant group (PR. 0.83, 95% CI (0.72 to 0.95)). Findings from the consistent use analysis were similar, and neither age nor HSV-2 status modified the observed associations.Four per cent of women randomised to DMPA-IM, 6% to copper IUD and 5% to LNG implant had gonorrhoea at the final visit (table 2).

Gonorrhoea prevalence did not significantly differ between DMPA-IM and LNG implant groups (PR. 0.79, 95% CI (0.61 to 1.03)) or between copper IUD and LNG implant groups (PR. 1.18, 95% CI (0.93 to 1.49)).

Women in the DMPA-IM group had a significantly lower risk of gonorrhoea compared with women in the copper IUD group (PR. 0.67, 95% CI (0.52 to 0.87)). Results from as randomised and continuous use analyses did not differ.

And again, neither age nor HSV-2 status modified the observed associations.Clinical assessment by randomised contraceptive methodTo assess the potential for outcome ascertainment bias, we evaluated the frequency of pelvic examinations and abdominal/pelvic pain and discharge by study arm. Women in the copper IUD group were generally more likely to receive a pelvic examination during follow-up as compared with women in the DMPA-IM and LNG implant groups (online supplemental appendix 1). Similarly, abdominal/pelvic pain on examination or abnormal discharge was observed most frequently in the copper IUD group.

The number of pelvic examinations met the prespecified criteria for retention in the adjusted gonorrhoea model but not in the chlamydia model.Supplemental materialFrequency of syndromic symptoms and potential reAmong women who had chlamydia at baseline, 23% were also positive at the final visit (online supplemental appendix 2, figure 3A). Nine per cent of gonorrhoea-positive women at baseline were also positive at the final visit (online supplemental appendix 2, figure 3B). Across both baseline and final visits, a minority of women with chlamydia or gonorrhoea presented with signs and/or symptoms.

Among chlamydia-positive women, only 12% presented with either abnormal vaginal discharge and/or abdominal/pelvic pain at their test-positive visit (online supplemental appendix 2, figure 3C). Similarly, only 15% of gonorrhoea-positive women presented with abnormal vaginal discharge and/or abdominal/pelvic pain at their test-positive visit (online supplemental appendix 2, figure 3D).Potential re and symptoms among women with chlamydia or gonorrhoea. Data are pooled across the screening and final visits in figures (C) and (D).

Symptomatic is defined as presenting with abnormal vaginal discharge and/or abdominal/pelvic pain. Final visit is described as potential re because test of cure was not conducted following baseline diagnosis and treatment." data-icon-position data-hide-link-title="0">Figure 3 Potential re and symptoms among women with chlamydia or gonorrhoea. Data are pooled across the screening and final visits in figures (C) and (D).

Symptomatic is defined as presenting with abnormal vaginal discharge and/or abdominal/pelvic pain. Final visit is described as potential re because test of cure was not conducted following baseline diagnosis and treatment.DiscussionWe observed differences in final prevalences of chlamydia and gonorrhoea by contraceptive group in both as-randomised and consistent-use analyses. The DMPA-IM group had lower final visit chlamydia and gonorrhoea prevalences as compared with copper IUD and LNG implant groups, though only the DMPA-IM versus the copper IUD comparison of gonorrhoea and DMPA-IM versus LNG implant comparison of chlamydia reached statistical significance.

These are novel findings that have not previously been reported to our knowledge and were determined in a randomised trial setting with high participant retention, robust biomarker testing and high randomised method adherence. Interestingly, the copper IUD group had higher gonorrhoea and lower chlamydia prevalence compared with the LNG implant group, though neither finding was statistically significant.Two recent systematic reviews of the association between contraceptives and STIs found inconsistent and insufficient evidence on the association between the contraceptive methods under study in ECHO and chlamydia and gonorrhoea.8 9 Neither systematic review identified any randomised studies or any direct comparative evidence for DMPA-IM, copper IUD and LNG implant, thus enabling a unique scientific contribution from this secondary trial analysis. Nonetheless, these findings should be interpreted in light of biological plausibility, as well as the design strengths and limitations of this analysis.The emerging science on the biological mechanisms underlying HIV susceptibility demonstrates the complex relationship between the infectious pathogen, the host innate and adaptive immune response and the interaction of both with the vaginal microbiome and other -omes.

Data on these factors in relationship to chlamydia and gonorrhoea acquisition are much more limited but can be assumed to be equally complex. Vaginal microbiome composition, including microbial metabolic by-products, have been shown to significantly modify risk of HIV acquisition and to vary with exogenous hormone exposure, menstrual cycle phase, ethnicity and geography.10–12 These same biological principles likely apply to chlamydia and gonorrhoea susceptibility. While DMPA-IM has been associated with decreased bacterial vaginosis (BV), initiation of the copper IUD has been associated with increased BV prevalence, and BV is associated with chlamydia and gonorrhoea acquisition.13 14 Moreover, Lactobacillus crispatus, which is less abundant in BV, has been shown to inhibit HeLa cell by Chlamydia trachomatis and inhibits growth of Neisseria gonorrhoeae in animal models.15 16 In addition, microbial community state types that are deficient in Lactobacillus crispatus and/or dominated by dysbiotic species are associated with inflammation, which is a driver of both STI and HIV susceptibility.

Thus, while the exact mechanisms of chlamydia and gonorrhoea in the presence of exogenous hormones and varying host microbiomes are unknown, it is biologically plausible that these complex factors may result in differential susceptibility to chlamydia and gonorrhoea among DMPA-IM, copper IUD and LNG implant users.An alternative explanation for these findings may be postrandomisation differences in clinical care and/or sexual behaviour. Participants in the copper IUD arm were more likely to have pelvic examinations and more likely to have discharge compared with women in the DMPA-IM and LNG implant groups. While interim STI testing and/or treatment were not documented, women in the copper IUD arm may have been more likely to receive syndromic STI treatment during follow-up due to more examination and observed discharge.

More frequent STI treatment in the copper IUD group would theoretically lower the final visit point prevalence relative to women in the DMPA-IM and LNG implant arms, suggesting that the observed lower risk of STI in the DMPA-IM arm is not due to differential examination, testing and treatment. Differential sexual risk behaviour may also have influenced the results. As reported previously, women in the DMPA-IM group less frequently reported condomless sex and multiple partners than women in the other groups, and both DMPA-IM and LNG implant users less frequently reported new partners and sex during menses than copper IUD users.6 Statistical control of self-reported sexual risk behaviour in the consistent-use analysis may have been inadequate if self-reported sexual behaviour was inaccurately or insufficiently reported.A second alternative explanation may be differences in randomised method non-adherence, which was greater in the DMPA-IM group, compared with copper IUD and LNG implant groups.

Yet, the consistency of findings in the as-randomised and continuous use analyses suggests that method non-adherence had minimal effect on study outcomes. Taken as a whole, these findings indicate that there may be real differences in chlamydia and gonorrhoea risk associated with use of DMPA-IM, the copper IUD and LNG implant. However, any true differential risk by method must be evaluated in light of the holistic benefits and risks of each method.The high observed chlamydia and gonorrhoea prevalences, despite intensive counselling and condom provision, warrants attention, particularly among women ages 24 years and younger and among women in South Africa and Eswatini.

While the ECHO study was conducted in settings of high HIV/STI incidence, enrolment criteria did not purposefully target women at highest risk of HIV/STI in the trial communities, suggesting that the observed prevalences may be broadly applicable to women seeking effective contraception in those settings. Improved approaches are needed to prevent STIs, including options for expedited partner treatment, to prevent re.As expected, few women testing positive for chlamydia or gonorrhoea presented with symptoms (12% and 15%, respectively), and a substantial proportion of women who were positive and treated at baseline were infected at the final visit despite syndromic management during the follow-up. Given that syndromic management is the standard of care within primary health facilities in most trial settings, these data suggest that a large proportion of among reproductive aged women is missed, exacerbating the burden of curable STIs and associated morbidities.

Routine access to more reliable diagnostics, like NAAT and novel point-of-care diagnostic tests, will be key to managing asymptomatic STIs and reducing STI prevalence and related morbidities in these settings.17This secondary analysis of the ECHO trial has strengths and limitations. Strengths include the randomised design with comparator groups of equal STI baseline risk. Participants had high adherence to their randomised contraceptive method.6 While all participants received standardised clinical care and counselling, the unblinded randomisation may have allowed postrandomisation differences in STI risk over time by method.

It is possible that participants modified their risk-taking behaviour based on study counselling messages regarding the potential association between DMPA-IM and HIV.In conclusion, our analyses suggest that DMPA-IM users may have lower risk of chlamydia and gonorrhoea compared with LNG implant and copper IUD users, respectively. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use. Moreover, the high chlamydia and gonorrhoea prevalences in this population, independent of contraceptive method, warrants urgent attention.Key messagesThe prevalence of chlamydia and gonorrhoea varied by contraceptive method in this randomised trial.High chlamydia and gonorrhoea prevalences, despite intensive counselling and condom provision, warrants attention, particularly among young women in South Africa and Eswatini.Most chlamydia and gonorrhoea s were asymptomatic.

Therefore, routine access to reliable diagnostics are needed to effectively manage and prevent STIs in African women..

Kamagra what is it

Related links and guidanceOn kamagra what is it this page Policy objectiveThis guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the erectile dysfunction treatment kamagra. These products are being imported and sold in Canada under 2 interim orders. All personal and confidential business information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes kamagra what is it after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of erectile dysfunction treatment19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders.

The process includes. procedures when releasing information types of information that fall under the guidelines for CBI and that may be eligible for redaction protection kamagra what is it of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to erectile dysfunction treatment (September 16, 2020) and interim order respecting the importation and sale of medical devices for use in relation to erectile dysfunction treatment(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by case to determine what is CBI. Personal information is removed before the safety and efficacy/effectiveness information is kamagra what is it released to the public.Following Health Canada’s review of an application, safety and efficacy information will be released as follows.

Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes. Original application documents documents filed after market authorization is issued (filed at Health Canada’s kamagra what is it request or to meet a condition of approval)Information in applications that are refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug submissions for erectile dysfunction treatment indications submitted under the FDR.

For more information on kamagra what is it the public release of this information, see the Public Release of Clinical Information. Guidance document.Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health or the safety of the public. For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim order drug applications upon authorization kamagra what is it. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity.

Requests made for multiple applications will be processed in sequence and subject to prioritization. Further prioritization may be given kamagra what is it to products that have a greater impact on the health system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized over requests for clinical information in non-erectile dysfunction treatment19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed on the following sites. Publication process Publication kamagra what is it of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and Appendix C of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process.

The process starts automatically on the day an authorization is issued.Step 1. Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in a process initiation meeting. The first 60 days of the 120-day publication process is kamagra what is it allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business information.

This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business kamagra what is it information that meets each of the following 3 elements of the definition. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the kamagra what is it PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document.

The proposal package from the manufacturer should include. The proposed redaction control sheet the draft anonymization report kamagra what is it annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment of company representationsWithin 30 days of receiving the proposal package, Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected. We will kamagra what is it review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information.

Step 3. Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information. Guidance document, the manufacturer will be given 15 days kamagra what is it to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised package. Step 4.

Finalization and publicationWithin 5 kamagra what is it days of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with the Guidance Document. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format. These documents are to be submitted using the Common kamagra what is it Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe publication of information within an interim order application will proceed through the abbreviated process described below.

Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1. Health Canada screening of requestsAfter we receive a request for information, we will retrieve the interim order application from kamagra what is it docubridge (or other location). Information related to safety and effectiveness will be considered in-scope of publication. Other information will not be released publicly. Only information available at the time the request kamagra what is it is made will be considered for disclosure.

Information submitted after the original request for disclosure will be considered for public release upon receipt of a subsequent request.Examples of in scope information include. Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include. Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package inserts and instructions for use individual patient information, such as patient listings and case report forms, that require extensive kamagra what is it anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool.

Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information kamagra what is it. Exceptions to the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information. Further information kamagra what is it on the application of these exceptions can be found in the PRCI guidance document.Step 2b. Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information.

Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected. For example, this kamagra what is it can include the names of authors and investigators as well as subject identification numbers.A large volume of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using a PDF redaction tool. Step 3. Notice to the company and request for redaction proposalFollowing the review and redaction of in scope documents, kamagra what is it we will send the manufacturer a written notice indicating our intent to publish the identified documents.

A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4. Health Canada assessment of company representationsAny further redactions proposed by the manufacturer will kamagra what is it be assessed in accordance with the process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request.

The redacted information will kamagra what is it be uploaded to the Clinical Information Portal, indexed by application number. Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email. Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology and definitions Anonymization kamagra what is it. Means the process through which personal information is modified by.

removing direct identifiers and any related code that would enable linkage with identifying information and ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual CBI. Confidential business information, as meant in common law and as defined in Section 2 of the Food and kamagra what is it Drugs Act. in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that. Is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors Clinical information. Means information in respect of a clinical trial, clinical studies or investigational kamagra what is it testing, such as.

clinical overviews, clinical summaries and clinical study reports for drugs summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices Clinical study report. Means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which. the clinical and statistical description, presentations and analyses are integrated into a single report incorporating tables and figures into the main text of kamagra what is it the report or at the end of the text appendices contain the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output FDA. Food and Drugs Act FDR. Food and Drug Regulations IMDRF ToC.

International Medical kamagra what is it Device Regulators Forum Table of Contents Medical device. Has the same meaning as insee the Medical Devices Regulations. For information on the classification of medical devices, please see the guidance documents on the. risk-based classification system for in vitro diagnostic devices (IVDDs) risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) Non-commercial purpose.

Date published kamagra online without prescription this post. October 19, 2020 The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to erectile dysfunction treatment was signed on October 16, 2020. This interim order (IO) provides more tools for urgently addressing drug shortages related to erectile dysfunction treatment. Under certain conditions, the IO kamagra online without prescription authorizes the Minister of Health to. require anyone who sells a drug to provide information relevant to a shortage or potential shortage of that drug related to erectile dysfunction treatment impose or amend terms and conditions on authorizations to sell drugs for the purpose of preventing or alleviating a drug shortage related to erectile dysfunction treatment On this page Why the interim order was introduced The erectile dysfunction treatment kamagra has.

caused an unprecedented demand for some drugs contributed to drug shortages in Canada posed a significant risk to the health of Canadians How the interim order will address drug shortages in Canada Reliable and timely information is required for Health Canada to act quickly and effectively to minimize the effects of these shortages on Canadians. Tools such as kamagra online without prescription this new IO will better prepare Canada to respond to the imminent threat of drug shortages from a possible future resurgence of erectile dysfunction treatment. The IO will allow the Minister to require any person who sells a drug to provide information about a shortage or potential shortage of that drug. The IO gives the Minister this authority if there are reasonable grounds to believe that. the drug is at risk of going into shortage or is in shortage the shortage is caused or made worse, directly kamagra online without prescription or indirectly, by the erectile dysfunction treatment kamagra the shortage poses a risk of injury to human health the requested information is necessary to identify or assess the shortage.

why it occurred its effects on human health what measures could be taken to prevent or alleviate the shortage the person would not provide the information without a legal obligation To prevent or alleviate a shortage, the Minister may also add or amend terms and conditions to an authorization to sell a drug. The Minister may do so if there are reasonable grounds to believe that. the drug is at risk of going into shortage or kamagra online without prescription is in shortage the shortage is caused or made worse, directly or indirectly, by the erectile dysfunction treatment kamagra the shortage poses a risk of injury to human health If you have any questions, please contact us by email at. Hc.prsd-questionsdspr.sc@canada.ca. Related links and guidanceOn this page Policy objectiveThis guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the erectile dysfunction treatment kamagra.

These products are being imported and sold in Canada kamagra online without prescription under 2 interim orders. All personal and confidential business information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of erectile dysfunction treatment19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a kamagra online without prescription market authorization application under the 2 interim orders. The process includes.

procedures when releasing information types of information that fall under the guidelines for CBI and that may be eligible for redaction protection of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to erectile dysfunction treatment (September 16, 2020) and interim order respecting the importation and kamagra online without prescription sale of medical devices for use in relation to erectile dysfunction treatment(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by case to determine what is CBI. Personal information is removed before the safety and efficacy/effectiveness information is released to the public.Following Health Canada’s review of an application, safety and efficacy information will be released as follows. Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive kamagra online without prescription release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release.

This includes. Original application documents documents filed after market authorization is issued (filed at Health Canada’s request or to meet a condition of approval)Information in applications that are refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR) kamagra online without prescription. The exception are new drug submissions for erectile dysfunction treatment indications submitted under the FDR. For more information on the public release of this information, see the Public Release of Clinical Information.

Guidance document.Also not applicable under this document is the CBI disclosure authority under kamagra online without prescription section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health or the safety of the public. For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within kamagra online without prescription the limits of our administrative capacity. Requests made for multiple applications will be processed in sequence and subject to prioritization.

Further prioritization may be given to products that have a greater impact on the health system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized kamagra online without prescription over requests for clinical information in non-erectile dysfunction treatment19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed on the following sites. Publication process Publication of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and Appendix C of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process. The process starts automatically on the day an authorization kamagra online without prescription is issued.Step 1.

Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in a process initiation meeting. The first 60 days of the 120-day publication process is allocated for the company to review the clinical information. The company uses the Proposed Redaction Control kamagra online without prescription Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business information. This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition.

That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a kamagra online without prescription material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations https://www.leirecycle.com/slide/simple-cycle/ described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be kamagra online without prescription found in the Health Canada PRCI guidance document.All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document. The proposal package from the manufacturer should include.

The proposed redaction control sheet the draft anonymization report annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment of company representationsWithin 30 days of receiving the proposal package, Health Canada will kamagra online without prescription complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected. We will review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information. Step 3 kamagra online without prescription.

Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information. Guidance document, the manufacturer will be given 15 days to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised kamagra online without prescription package. Step 4. Finalization and publicationWithin 5 days of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment.

The final documents must kamagra online without prescription comply with the Guidance Document. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format. These documents are to be submitted using the Common Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe publication of information within an interim order application will proceed through the abbreviated process described below kamagra online without prescription. Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1.

Health Canada screening of requestsAfter we receive a request for information, we will retrieve the interim order application from docubridge (or other location). Information related to safety and effectiveness will be considered kamagra online without prescription in-scope of publication. Other information will not be released publicly. Only information available at the time the request is made will be considered for disclosure. Information submitted after kamagra online without prescription the original request for disclosure will be considered for public release upon receipt of a subsequent request.Examples of in scope information include.

Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include. Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package inserts and instructions for use individual patient information, such as patient listings and case report forms, that require extensive anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors kamagra online without prescription common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information.

Exceptions to kamagra online without prescription the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the PRCI guidance document.Step 2b. Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information kamagra online without prescription. Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected.

For example, this can include the names of authors and investigators as well as subject identification numbers.A large volume of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using kamagra online without prescription a PDF redaction tool. Step 3. Notice to the company and request for redaction proposalFollowing the review and redaction of in scope documents, we will send the manufacturer a written notice indicating our intent to publish the identified documents. A copy kamagra online without prescription of the release package will be sent for the manufacturer’s review.

Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4. Health Canada assessment of company representationsAny further redactions proposed by the manufacturer will be assessed in accordance with the process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be kamagra online without prescription accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request. The redacted information will be uploaded to the Clinical Information Portal, indexed by application number.

Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email. Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology and definitions Anonymization. Means the process through which personal information is modified by.