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High efficacy of high dose intravenous ceftriaxone against extragenital gonorrhoeaCeftriaxone monotherapy is well established for treating Neisseria gonorrhoeae where can you buy propecia (NG) urethritis, but data are limited for pharyngeal and rectal s. This prospective single-centre study was conducted in Japan in 2017–2020 among HIV-negative men who have where can you buy propecia sex with men (MSM) who underwent routine STI screening, including nucleic acid amplification tests (NAATs) for rectal and pharyngeal NG every 3 months.1 Among 320 cases of extragenital gonorrhoea (all asymptomatic), 208 received only ceftriaxone (single 1 g intravenous dose) and 112 received additional treatment with doxycycline (100 mg two times a day for 7 days) or azithromycin (single 1 g dose) for concomitant STIs (predominantly, Chlamydia trachomatis (CT)). There was no difference in NG cure rates between the two groups (98.1% vs 95.5%) or by site. Data are needed for where can you buy propecia other ceftriaxone dosing strategies and in areas where ceftriaxone resistance is a major concern.Published in STI—The Editor’s Choice. Neisseria gonorrhoeae where can you buy propecia is associated with poor pregnancy and birth outcomesThis systematic review and meta-analysis compiled data from 30 studies that reported NG testing during pregnancy and compared pregnancy and birth outcomes between women with and without NG.2 Results indicated that NG s during pregnancy nearly doubled the risk of preterm birth (summary adjusted OR 1.90.

95% CI 1.14 to 3.19). The effect was more pronounced in low-income and middle-income countries than in high-income where can you buy propecia countries. Additionally, results suggested that NG may be associated with premature rupture of membranes, perinatal mortality, low birth weight and ophthalmia neonatorum, although estimates in most studies where can you buy propecia did not sufficiently control for confounders. The findings identify NG s as risk factor for poor pregnancy outcomes.Inadvertent HPV vaccination during or peripregnancy is not associated with adverse outcomesHuman papillomapropecia (HPV) vaccination is not recommended in pregnancy due to lack of safety data. However, a where can you buy propecia pregnancy test is not required prior to vaccination.

This multisite cohort study collated data from 445 women who received the nonavalent HPV treatment during pregnancy and 496 that received the treatment peripregnancy (within 42 days before last menstrual period (LMP)).3 Pregnancy and neonatal outcomes in these groups were compared with those of 552 distal (16–22 weeks pre-LMP) exposures to the quadrivalent or nonavalent HPV treatment. Compared with distal-exposures, during-pregnancy or peripregnancy, exposures were not associated with spontaneous abortion, where can you buy propecia preterm birth or small-for-gestational-age births. Birth defects were rare in where can you buy propecia all groups. The findings inform counselling for women who inadvertently receive the nonavalent (and possibly quadrivalent) HPV treatment during pregnancy. Data are needed for the bivalent HPV treatment.Has the time come where can you buy propecia for point-of-care STI testing?.

Point-of-care (POC) STI where can you buy propecia testing has been proposed as a strategy to both improve treatment rates and optimise antibiotic stewardship. This study investigated the performance of the Visby Medical Sexual Health Test, a POC PCR-based NAAT for rapid (30 m) detection of CT, NG and Trichomonas vaginalis (TV).4 The analysis used self-collected vaginal samples from 1535 women who attended 10 clinics in seven US states over an 11-month period. Results were where can you buy propecia compared with those of clinician-collected samples tested using gold-standard laboratory-based NAATs. Specificity and sensitivity of the POC test were 98.3% and 97.4% for CT, 97.4% and 99.4% for NG and 99.2% and 96.9% for TV. These results highlight the potential utility of easy-to-use POC NAATs in clinical practice.Point of care HIV-1 RNA where can you buy propecia testing facilitates the same-day confirmation of HIV and leads to rapid viral suppression when followed by immediate antiretroviral treatmentMSM with primary HIV (PHI) and those with established but undiagnosed can be an important source of onward transmission.

This study from where can you buy propecia Amsterdam evaluated a strategy comprising. (i) an online media campaign to increase awareness about PHI among MSM and promote self-referral for testing, (ii) qualitative POC HIV-1 RNA testing for same-day confirmation of and delivery of results and (iii) immediate referral of newly diagnosed men to a treatment centre to initiate antiretroviral therapy (ART within 24 hours.5 Time to viral suppression was only 55 days for MSM who benefitted from the strategy and shorter than previous strategies that deferred ART initiation and/or did not employ HIV-1 RNA POC testing. The approach proved feasible in Amsterdam and should be investigated in other settings.Pre-exposure prophylaxis, HIV incidence and risk behaviour among MSM in West AfricaThis prospective cohort study investigated the use of pre-exposure prophylaxis (PrEP) among MSM in Côte D’Ivoire, Mali, Togo and Burkina Faso as an extension of CohMSM, a prevention study that did not include PrEP.6 Participants were free where can you buy propecia to choose between daily or event-driven PrEP, change between the two and stop and restart PrEP. Among 598 MSM followed for 743.6 person years, HIV incidence was 2.3 per 100 person-years (95% CI 1.3 to where can you buy propecia 3.7) and lower than in CohMSM (adjusted incidence rate ratio 0.21. 95% CI 0.12 to 0.36).

There was no evidence of an increase in risk behaviour since reports of condomless anal sex and prevalence of STIs remained stable, whereas the number of male sexual partners and of sex acts with casual male partners where can you buy propecia decreased. PrEP is an effective prevention tool for MSM in West Africa.Ethics statementsPatient consent for publicationNot required..

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Credit http://pacificanaturopathic.com/2014/02/happy-winter-2014/ baldness drug propecia. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black women and is the most common form of permanent alopecia baldness drug propecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb. Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University baldness drug propecia School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries.

During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those with fibroids was compared in patients with and baldness drug propecia without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition. In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls baldness drug propecia.

Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of the link between the two conditions remains baldness drug propecia unclear,” she says. However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be screened not baldness drug propecia only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition.

The other authors on this paper baldness drug propecia were Ginette A. Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This baldness drug propecia study clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint baldness drug propecia inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New baldness drug propecia England Journal of Medicine, could be used to guide future clinical trials for these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells. As a result, the drugs cause the immune system to fight cancer in how can i get propecia the same way that it would fight an .

These medicines baldness drug propecia have had remarkable success in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others baldness drug propecia to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief medical oncology fellow. Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an effect the mutational burden has baldness drug propecia on outcomes to immune checkpoint inhibitors across many different cancer types was unclear.

To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden baldness drug propecia of thousands of tumor samples from patients with different tumor types. Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half baldness drug propecia of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer.

€œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive. It’s one of those things that doesn’t sound right when you hear it,” says Hopkins baldness drug propecia. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and baldness drug propecia highly aggressive skin cancer, tends to have a moderate number of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a propecia, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

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Yarchoan receives funding from the baldness drug propecia Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

Credit official site where can you buy propecia. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects where can you buy propecia black women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb.

Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a where can you buy propecia higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries. During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those where can you buy propecia with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition.

In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings where can you buy propecia translate to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls. Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. €œThe cause of where can you buy propecia the link between the two conditions remains unclear,” she says.

However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring where can you buy propecia alopecia should be screened not only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition. The other authors on where can you buy propecia this paper were Ginette A.

Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study where can you buy propecia clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumor’s DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The “mutational burden,” or the number of mutations present in a tumor’s DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint where can you buy propecia inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New England Journal of Medicine, could be used to guide future clinical trials for where can you buy propecia these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells.

As a result, the drugs cause the immune system to fight cancer in the same way that it would fight an . These medicines have had remarkable success where can you buy propecia in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than where can you buy propecia others to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief medical oncology fellow.

Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an effect the mutational burden has on outcomes to immune checkpoint where can you buy propecia inhibitors across many different cancer types was unclear. To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden of thousands of tumor samples from patients with different tumor where can you buy propecia types.

Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer type’s mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer where can you buy propecia. €œThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive.

It’s one of those things where can you buy propecia that doesn’t sound right when you hear it,” says Hopkins. €œBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.” Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number where can you buy propecia of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a propecia, which seems to encourage a strong immune response despite the cancer’s lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which where can you buy propecia these drugs haven’t yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by investigating whether mutational burden might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy where can you buy propecia drugs.

€œThe end goal is precision medicine—moving beyond what’s true for big groups of patients to see whether we can use this information to help any given patient,” he says. Yarchoan receives funding from where can you buy propecia the Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

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Start Preamble Centers for Medicare alternatives to rogaine and propecia &. Medicaid Services (CMS), HHS. Notice of alternatives to rogaine and propecia meeting.

This notice announces a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for Calendar Year 2021. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers alternatives to rogaine and propecia for Medicare &. Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.

The advice provided by the Panel will be considered as we prepare the annual updates for the hospital alternatives to rogaine and propecia outpatient prospective payment system. Meeting date. The virtual meeting of alternatives to rogaine and propecia the Panel is scheduled for Monday, August 23, 2021, from 9:30 a.m.

To 5:00 p.m. Eastern Daylight alternatives to rogaine and propecia Time (EDT). The times listed in this notice are EDT and are approximate times.

Consequently, the meetings may last longer or be shorter than the times listed in this notice, but would not begin before the posted time. Deadline for alternatives to rogaine and propecia presentations and comment letters. Presentations or Start Printed Page 39026comment letters, and form CMS-20017 (located at https://www.cms.gov/​Medicare/​CMS-Forms/​CMS-Forms/​downloads/​cms20017.pdf), must be received by 5:00 p.m.

EDT, Friday, alternatives to rogaine and propecia August 6, 2021. We note that form CMS-20017 must accompany each presentation or comment letter submission. Presentations and alternatives to rogaine and propecia comment letters that are not received by the due date and time, or that do not include a completed form CMS-20017 are considered late or incomplete, and cannot be included on the agenda.

In commenting, refer to file code CMS-1764-N. Meeting Registration alternatives to rogaine and propecia Timeframe. All presentation or comment letter speakers, including any alternates, with items on the agenda must register electronically to our Panel mailbox, APCPanel@cms.hhs.gov no later than 5:00 p.m.

EDT, Friday, August 6, alternatives to rogaine and propecia 2021. The subject of the email may state “Agenda Speaker Registration for HOP Panel Meeting.” Meeting location and webinar. The meeting will be held virtually.

The public may participate in this alternatives to rogaine and propecia meeting by webinar, or listen-only via teleconference. Closed captioning will be available on the webinar. Teleconference dial-in and webinar information will alternatives to rogaine and propecia appear on the final meeting agenda, which will be posted on our website when available at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. News alternatives to rogaine and propecia media. Press inquiries are handled through the CMS Press Office at (202) 690-6145.

Advisory committees alternatives to rogaine and propecia information line. The telephone number for the Advisory Panel on Hospital Outpatient Payment Committee Hotline is (410) 786-3985. Websites alternatives to rogaine and propecia.

For additional information on the Panel, including the Panel charter, and updates to the Panel's activities, we refer readers to view our website at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. Information about the Panel and its membership in the Federal Advisory Committee Act (FACA) database are also located at alternatives to rogaine and propecia.

Https://www.facadatabase.gov. Start Further Info alternatives to rogaine and propecia Elise Barringer, Designated Federal Official (DFO) (410) 786-9222, email at. APCPanel@cms.hhs.gov.

End Further Info End Preamble Start Supplemental Information I alternatives to rogaine and propecia. Background The Secretary of the Department of Health and Human Services (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) and is allowed by section 222 of the Public Health Service Act (PHA) to consult with an expert outside Panel, such as the Advisory Panel on Hospital Outpatient Payment (the Panel), regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights. The Panel is governed by the provisions of alternatives to rogaine and propecia the Federal Advisory Committee Act (Pub.

L. 92-463), as amended (5 alternatives to rogaine and propecia U.S.C. Appendix 2), to set forth standards for the formation and use of advisory Panels.

We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the Hospital Outpatient Prospective Payment System (OPPS) for the following calendar year (CY). II. Annual Advisory Panel Meeting A.

Meeting Agenda The agenda for the August 23, 2021 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter. Addressing whether procedures within an APC group are similar both clinically and in terms of resource use. Reconfiguring APCs.

Evaluating APC group weights. Reviewing packaging the cost of items and services, including drugs and devices, into procedures and services, including the methodology for packaging and the impact of packaging the cost of those items and services on APC group structure and payment. Removing procedures from the inpatient only list for payment under the OPPS.

Using claims and cost report data for Centers for Medicare &. Medicaid Services (CMS) determination of APC group costs. Addressing other technical issues concerning APC group structure.

Evaluating the required level of supervision for hospital outpatient services. OPPS APC rates for covered Ambulatory Surgical Center (ASC) procedures. The Agenda will be posted on our website at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups approximately 1 week before the meeting. B. Meeting Information Updates The actual meeting hours and days will be posted in the agenda.

As information and updates regarding this webinar and listen-only teleconference, including the agenda, become available, they will be posted to our website at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. C.

Presentations and Comment Letters The subject matter of any presentation and comment letter must be within the scope of the Panel as designated in the Charter. Any presentations or comments outside of the scope of the Panel will be returned or requested for amendment. Unrelated topics include, but are not limited to.

The conversion factor, charge compression, revisions to the cost report, pass-through payments, correct coding, new technology applications (including supporting information/documentation), provider payment adjustments, supervision of hospital outpatient diagnostic services, and the types of practitioners that are permitted to supervise hospital outpatient services. The Panel may not recommend that services be designated as nonsurgical extended duration therapeutic services. Presentations or Comment Letters that address OPPS APC rates as they relate to covered ASC procedures are within the scope of the Panel's charter.

However, ASC payment rates, ASC payment indicators, the ASC covered procedures list, or other ASC payment system matters will be considered out of scope. The Panel may use data collected or developed by entities and organizations other than Department of Health and Human Services and CMS in conducting its review. We recommend organizations submit data for CMS staff and the Panel's review.

All presentations are limited to 5 minutes, regardless of the number of individuals or organizations represented by a single presentation. Presenters may use their 5 minutes to present either one or more agenda items. In the email, all of the following information must be submitted when registering.

Speaker's name. Speaker's organization or company name. Company or organization that the speaker is representing that submitted a presentation or comment letter that is on the agenda.

Email addresses to which materials regarding meeting registration and instructions on connecting to the meeting may be sent.Start Printed Page 39027 Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by August 06, 2021. In addition, registration information must reflect individual-level content and not reflect an organization entry.

Also, each individual may only register one person at a time (that is, one individual may not register multiple individuals at the same time). A confirmation email will be sent upon receipt of the registration. The email will provide information to the speaker in preparation for the meeting.

Registration is only required for agenda speakers and alternates and must be submitted by the deadline specified above. We note that no registration is required for participants who plan to view the Panel meeting by webinar or listen teleconference. Section 508 Compliance For this meeting, we are aiming to have all presentations and comment letters available on our website.

Materials on our website must be Section 508 compliant to ensure access to federal employees and members of the public with and without disabilities. We encourage presenters and commenters to reference the guidance on making documents section 508 compliant as they draft their submissions, and, whenever possible, to submit their presentations and comment letters in a 508 compliant form. Such guidance is available at.

Https://www.cms.gov/​research-statistics-data-and-systems/​cms-information-technology/​section508. We will review presentations and comment letters for 508 compliance and place compliant materials on our website. As resources permit, we will also convert non-compliant submissions to 508 compliant forms, and offer assistance to submitters who are making their submissions 508 compliant.

All 508 compliant presentations and comment letters will be made available on the CMS website. If difficulties are encountered accessing the materials, contact the Designated Federal Official (DFO) (the DFO's address, email, and phone number are provided in the FOR FURTHER INFORMATION CONTACT section of this notice). In order to consider presentations and/or comment letters, we will need to receive the following.

1. An email copy of the presentation or comment letters sent to the DFO mailbox. APCPanel@cms.hhs.gov.

2. Form CMS-20017, with complete contact information that includes the names, addresses, phone numbers, and email addresses for all presenters. Comment letters.

And a contact person who can answer any questions and provide revisions that are requested for the presentation or comment letter. Presenters and commenter letters must clearly explain the actions that they are requesting CMS take in the appropriate section of the form. A presenter or commenter's relationship with the organization that they represent must also be clearly listed.

D. Formal Presentations In addition to formal presentations (limited to 5 minutes total per presentation), there will be an opportunity during the meeting for public comments as time permits (limited to 1 minute for each individual and a total of 3 minutes per organization). E.

Panel Recommendations and Discussions The Panel's recommendations at any Panel meeting generally are not final until they have been reviewed and approved by the Panel on the last day of the meeting, before the final adjournment. These recommendations will be posted to our website after the meeting. F.

Membership Appointments to the Advisory Panel on Hospital Outpatient Payment The Panel Charter provides that the Panel may meet up to 3 times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the following calendar year. The Panel may consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS.

The Panel may also include a representative of the provider with ASC expertise, who may advise CMS only on OPPS APC rates, as appropriate, impacting ASC covered procedures within the context and purview of the Panel's scope. The Secretary or a designee selects the Panel membership based upon either self-nominations or nominations submitted by Medicare providers and other interested organizations of candidates determined to have the required expertise. For supervision deliberations, the Panel may include members that represent the interests of Critical Access Hospitals, who advise CMS only regarding the level of supervision for hospital outpatient therapeutic services.

New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. The Secretary rechartered the Panel in 2020 for a 2-year period effective through November 20, 2022. The current charter is available on the CMS website at.

Https://www.cms.gov/​files/​document/​2020-hop-panel-charter.pdf. The Panel presently consists of members and a Chair named below. E.L.

Hambrick, M.D., J.D., CMS Chairperson Terry Bohlke, C.P.A., C.M.A, M.H.A., C.A.S.C Carmen Cooper-Oguz, P.T., D.P.T, M.B.A, C.W.S, W.C.C Paul Courtney, M.D. Peter Duffy, M.D. Lisa Gangarosa, M.D.

Michael Kuettel, M.D., M.B.A, Ph.D. Scott Manaker, M.D., Ph.D. Brian Nester, D.O., M.B.A.

Bo Gately, M.B.A. Matthew Wheatley, M.D., F.A.C.E.P. III.

Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Start Signature Dated.

July 20, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services.

End Signature End Supplemental Information [FR Doc. 2021-15727 Filed 7-22-21. 8:45 am]BILLING CODE 4120-01-P.

Start Preamble Centers for Buy lasix canada Medicare where can you buy propecia &. Medicaid Services (CMS), HHS. Notice of where can you buy propecia meeting. This notice announces a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for Calendar Year 2021.

The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the where can you buy propecia Centers for Medicare &. Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the where can you buy propecia annual updates for the hospital outpatient prospective payment system. Meeting date.

The virtual meeting of where can you buy propecia the Panel is scheduled for Monday, August 23, 2021, from 9:30 a.m. To 5:00 p.m. Eastern Daylight Time where can you buy propecia (EDT). The times listed in this notice are EDT and are approximate times.

Consequently, the meetings may last longer or be shorter than the times listed in this notice, but would not begin before the posted time. Deadline for presentations and comment where can you buy propecia letters. Presentations or Start Printed Page 39026comment letters, and form CMS-20017 (located at https://www.cms.gov/​Medicare/​CMS-Forms/​CMS-Forms/​downloads/​cms20017.pdf), must be received by 5:00 p.m. EDT, Friday, August 6, 2021 where can you buy propecia.

We note that form CMS-20017 must accompany each presentation or comment letter submission. Presentations and comment letters that are not received by the due date and time, or where can you buy propecia that do not include a completed form CMS-20017 are considered late or incomplete, and cannot be included on the agenda. In commenting, refer to file code CMS-1764-N. Meeting Registration Timeframe where can you buy propecia.

All presentation or comment letter speakers, including any alternates, with items on the agenda must register electronically to our Panel mailbox, APCPanel@cms.hhs.gov no later than 5:00 p.m. EDT, Friday, August 6, where can you buy propecia 2021. The subject of the email may state “Agenda Speaker Registration for HOP Panel Meeting.” Meeting location and webinar. The meeting will be held virtually.

The public may participate in this where can you buy propecia meeting by webinar, or listen-only via teleconference. Closed captioning will be available on the webinar. Teleconference dial-in and webinar information will appear on the final meeting agenda, where can you buy propecia which will be posted on our website when available at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups.

News where can you buy propecia media. Press inquiries are handled through the CMS Press Office at (202) 690-6145. Advisory where can you buy propecia committees information line. The telephone number for the Advisory Panel on Hospital Outpatient Payment Committee Hotline is (410) 786-3985.

Websites where can you buy propecia. For additional information on the Panel, including the Panel charter, and updates to the Panel's activities, we refer readers to view our website at. Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. Information about the Panel and its where can you buy propecia membership in the Federal Advisory Committee Act (FACA) database are also located at.

Https://www.facadatabase.gov. Start where can you buy propecia Further Info Elise Barringer, Designated Federal Official (DFO) (410) 786-9222, email at. APCPanel@cms.hhs.gov. End Further Info End Preamble Start where can you buy propecia Supplemental Information I.

Background The Secretary of the Department of Health and Human Services (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) and is allowed by section 222 of the Public Health Service Act (PHA) to consult with an expert outside Panel, such as the Advisory Panel on Hospital Outpatient Payment (the Panel), regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights. The Panel is governed by the where can you buy propecia provisions of the Federal Advisory Committee Act (Pub. L. 92-463), as amended (5 U.S.C where can you buy propecia.

Appendix 2), to set forth standards for the formation and use of advisory Panels. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the Hospital Outpatient Prospective Payment System (OPPS) for the following calendar year (CY). II. Annual Advisory Panel Meeting A.

Meeting Agenda The agenda for the August 23, 2021 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter. Addressing whether procedures within an APC group are similar both clinically and in terms of resource use. Reconfiguring APCs. Evaluating APC group weights.

Reviewing packaging the cost of items and services, including drugs and devices, into procedures and services, including the methodology for packaging and the impact of packaging the cost of those items and services on APC group structure and payment. Removing procedures from the inpatient only list for payment under the OPPS. Using claims and cost report data for Centers for Medicare &. Medicaid Services (CMS) determination of APC group costs.

Addressing other technical issues concerning APC group structure. Evaluating the required level of supervision for hospital outpatient services. OPPS APC rates for covered Ambulatory Surgical Center (ASC) procedures. The Agenda will be posted on our website at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups approximately 1 week before the meeting. B. Meeting Information Updates The actual meeting hours and days will be posted in the agenda. As information and updates regarding this webinar and listen-only teleconference, including the agenda, become available, they will be posted to our website at.

Https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​FACA/​AdvisoryPanelonAmbulatoryPaymentClassificationGroups. C. Presentations and Comment Letters The subject matter of any presentation and comment letter must be within the scope of the Panel as designated in the Charter. Any presentations or comments outside of the scope of the Panel will be returned or requested for amendment.

Unrelated topics include, but are not limited to. The conversion factor, charge compression, revisions to the cost report, pass-through payments, correct coding, new technology applications (including supporting information/documentation), provider payment adjustments, supervision of hospital outpatient diagnostic services, and the types of practitioners that are permitted to supervise hospital outpatient services. The Panel may not recommend that services be designated as nonsurgical extended duration therapeutic services. Presentations or Comment Letters that address OPPS APC rates as they relate to covered ASC procedures are within the scope of the Panel's charter.

However, ASC payment rates, ASC payment indicators, the ASC covered procedures list, or other ASC payment system matters will be considered out of scope. The Panel may use data collected or developed by entities and organizations other than Department of Health and Human Services and CMS in conducting its review. We recommend organizations submit data for CMS staff and the Panel's review. All presentations are limited to 5 minutes, regardless of the number of individuals or organizations represented by a single presentation.

Presenters may use their 5 minutes to present either one or more agenda items. In the email, all of the following information must be submitted when registering. Speaker's name. Speaker's organization or company name.

Company or organization that the speaker is representing that submitted a presentation or comment letter that is on the agenda. Email addresses to which materials regarding meeting registration and instructions on connecting to the meeting may be sent.Start Printed Page 39027 Registration details may not be revised once they are submitted. If registration details require changes, a new registration entry must be submitted by August 06, 2021. In addition, registration information must reflect individual-level content and not reflect an organization entry.

Also, each individual may only register one person at a time (that is, one individual may not register multiple individuals at the same time). A confirmation email will be sent upon receipt of the registration. The email will provide information to the speaker in preparation for the meeting. Registration is only required for agenda speakers and alternates and must be submitted by the deadline specified above.

We note that no registration is required for participants who plan to view the Panel meeting by webinar or listen teleconference. Section 508 Compliance For this meeting, we are aiming to have all presentations and comment letters available on our website. Materials on our website must be Section 508 compliant to ensure access to federal employees and members of the public with and without disabilities. We encourage presenters and commenters to reference the guidance on making documents section 508 compliant as they draft their submissions, and, whenever possible, to submit their presentations and comment letters in a 508 compliant form.

Such guidance is available at. Https://www.cms.gov/​research-statistics-data-and-systems/​cms-information-technology/​section508. We will review presentations and comment letters for 508 compliance and place compliant materials on our website. As resources permit, we will also convert non-compliant submissions to 508 compliant forms, and offer assistance to submitters who are making their submissions 508 compliant.

All 508 compliant presentations and comment letters will be made available on the CMS website. If difficulties are encountered accessing the materials, contact the Designated Federal Official (DFO) (the DFO's address, email, and phone number are provided in the FOR FURTHER INFORMATION CONTACT section of this notice). In order to consider presentations and/or comment letters, we will need to receive the following. 1.

An email copy of the presentation or comment letters sent to the DFO mailbox. APCPanel@cms.hhs.gov. 2. Form CMS-20017, with complete contact information that includes the names, addresses, phone numbers, and email addresses for all presenters.

Comment letters. And a contact person who can answer any questions and provide revisions that are requested for the presentation or comment letter. Presenters and commenter letters must clearly explain the actions that they are requesting CMS take in the appropriate section of the form. A presenter or commenter's relationship with the organization that they represent must also be clearly listed.

D. Formal Presentations In addition to formal presentations (limited to 5 minutes total per presentation), there will be an opportunity during the meeting for public comments as time permits (limited to 1 minute for each individual and a total of 3 minutes per organization). E. Panel Recommendations and Discussions The Panel's recommendations at any Panel meeting generally are not final until they have been reviewed and approved by the Panel on the last day of the meeting, before the final adjournment.

These recommendations will be posted to our website after the meeting. F. Membership Appointments to the Advisory Panel on Hospital Outpatient Payment The Panel Charter provides that the Panel may meet up to 3 times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the following calendar year.

The Panel may consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS. The Panel may also include a representative of the provider with ASC expertise, who may advise CMS only on OPPS APC rates, as appropriate, impacting ASC covered procedures within the context and purview of the Panel's scope. The Secretary or a designee selects the Panel membership based upon either self-nominations or nominations submitted by Medicare providers and other interested organizations of candidates determined to have the required expertise. For supervision deliberations, the Panel may include members that represent the interests of Critical Access Hospitals, who advise CMS only regarding the level of supervision for hospital outpatient therapeutic services.

New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. The Secretary rechartered the Panel in 2020 for a 2-year period effective through November 20, 2022. The current charter is available on the CMS website at. Https://www.cms.gov/​files/​document/​2020-hop-panel-charter.pdf.

The Panel presently consists of members and a Chair named below. E.L. Hambrick, M.D., J.D., CMS Chairperson Terry Bohlke, C.P.A., C.M.A, M.H.A., C.A.S.C Carmen Cooper-Oguz, P.T., D.P.T, M.B.A, C.W.S, W.C.C Paul Courtney, M.D. Peter Duffy, M.D.

Lisa Gangarosa, M.D. Michael Kuettel, M.D., M.B.A, Ph.D. Scott Manaker, M.D., Ph.D. Brian Nester, D.O., M.B.A.

Bo Gately, M.B.A. Matthew Wheatley, M.D., F.A.C.E.P. III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements.

Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The Administrator of the Centers for Medicare &. Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register.

Start Signature Dated. July 20, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare &. Medicaid Services.

End Signature End Supplemental Information [FR Doc. 2021-15727 Filed 7-22-21. 8:45 am]BILLING CODE 4120-01-P.

Propecia fertility side effects

A key consideration in timing of aortic valve replacement (AVR) for patients with aortic stenosis (AS) is whether there is an More about increased risk of sudden cardiac death (SCD) that might propecia fertility side effects be reduced by relief of outflow obstruction. Minners and colleagues1 addressed this issue in a retrospective analysis of outcomes in 1840 patients with mild to moderate propecia fertility side effects AS (aortic maximum velocity 2.5–4.0 m/s) in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Overall the annualised rate of SCD was 0.39% per year with 27 events in asymptomatic patients. The most recent propecia fertility side effects echocardiogram prior to SCD showed mild–moderate AS in most (80%) of these patients with no difference in SCD event rates in those who progressed to severe AS compared to those who did not develop severe valve obstruction. On Cox regression analysis, the only independent risk factors for SCD were age (HR 1.06, 95% CI 1.01 to 1.11 per year, p=0.02), increased left ventricular mass index (HR 1.20, 95% CI 1.10 to 1.32 per 10 g/m2, p<0.001) and lower body mass index (HR 0.87, 95% CI 0.79 to 0.97 per propecia fertility side effects kg/m2, p=0.01) but not the severity of valve obstruction (figure 1).Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study.

The number of events for each variable is reflected by the dark, horizontal bars with separation at the median for continuous variables. A forest plot visualisation of HRs for propecia fertility side effects SCD is provided on the right. LVED, left ventricular enddiastolic diameter. LVES, left ventricular propecia fertility side effects endsystolic diameter. LVM, left propecia fertility side effects ventricular mass.

SCD, sudden cardiac death." data-icon-position data-hide-link-title="0">Figure 1 Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number of events for each variable is reflected propecia fertility side effects by the dark, horizontal bars with separation at the median for continuous variables. A forest plot visualisation of HRs for SCD is provided on the right. LVED, left ventricular propecia fertility side effects enddiastolic diameter. LVES, left propecia fertility side effects ventricular endsystolic diameter.

LVM, left ventricular mass. SCD, sudden cardiac death.The lack of association between AS severity and the risk of SCD in the SEAS study is thought-provoking and challenges the conventional wisdom that early AVR would prevent SCD in asymptomatic patients propecia fertility side effects with AS.2 In the past, syncope and SCD in patients with AS were thought to be due to mechanisms such as left ventricle (LV) baroreceptor malfunction, hypotension secondary to peripheral vasodilation in the face of fixed valve obstruction, or a shortened diastolic filling interval at high heart rates leading to a reduced stroke volume. However, it is doubtful that any of these mechanisms would account for SCD when AS is only mild to propecia fertility side effects moderate in severity. €˜It is increasingly recognised that that AS is not simply a mechanical problem of the valve leaflets not opening fully. Instead, AS compromises a complex interplay between the valve, ventricle and vasculature with abnormal function of all three components of the propecia fertility side effects disease process.’ As I conclude in an editorial, ‘It is unlikely that early AVR will reduce the risk of sudden death when severe valve obstruction is not present.

Perhaps it is time to turn our attention to mitigating the non-valvular disease processes in adults with calcific valve disease.’In another interesting paper in this issue of Heart, Williams and Brown3 hypothesised that the apparent benefit of fractional flow reserve (FFR) guidance of percutaneous coronary intervention (PCI) in patients with chronic coronary syndromes (CCS) might simply be due to utilisation of fewer stents rather than to knowledge about the physiological severity of the coronary lesions. In a Monte Carlo simulation using data from the PCI strata of the Bypass Angioplasty Revascularization Investigation 2 Diabetes study, random deferral of PCI progressively reduced the risk of death and myocardial infarction at 1 year, suggesting that FFR-guided deferral of PCI improves outcomes simply because fewer stents are placed.In an editorial, Weintraub and Boden4 put this data into the context propecia fertility side effects of 30 years of clinical trials comparing PCI with optimal medical therapy from CCS and conclude ‘In contrast to patients with acute coronary syndrome, there remains no convincing evidence that PCI will prevent events in patients with stable angina and chronic ischaemic heart disease. We know that, if needed, PCI will ameliorate severe angina, but we also know that this may not be a durable propecia fertility side effects effect. By contrast, for the great majority of patients who are not disabled by angina, PCI can be safely deferred in both diabetic and non-diabetic patients, with revascularisation reserved only for those with unacceptable angina or who develop an acute coronary syndrome during follow-up. The role of FFR remains uncertain at best and need not be propecia fertility side effects performed routinely in all patients with CCS, though it may be useful where the visual estimation of angiographical severity is uncertain.’Cardiac involvement in patients with sepsis contributes to adverse outcomes with most previous studies focusing on left ventricular dysfunction.

In order to assess the impact of right ventricular involvement on outcomes in sepsis Kim and colleagues5 performed a retrospective cohort study of 778 patients with septic shock with echocardiographic imaging. Sepsis-induced cardiac dysfunction propecia fertility side effects was present in 34.7% of the entire cohort, affecting the LV in 67.3% and the right ventricle (RV) in 40.7% of these patients. Any type of sepsis-induced cardiac dysfunction was associated with a significantly propecia fertility side effects higher 28-day mortality (35.9 vs 26.8%. P<0.01), longer intensive care unit length of stay and longer duration of mechanical ventilator, compared with those without cardiac dysfunction. Isolated RV dysfunction was rare (24/270, 8.9%) propecia fertility side effects but was associated with a higher risk of 28-day mortality (adjusted OR 2.77, 95% CI 1.20 to 6.40, p=0.02) (figure 2).Comparisons of survival curves between each type of dysfunction.

LV, left ventricle. RV, right ventricle." propecia fertility side effects data-icon-position data-hide-link-title="0">Figure 2 Comparisons of survival curves between each type of dysfunction. LV, left propecia fertility side effects ventricle. RV, right ventricle.The mechanisms of cardiac dysfunction in patients with sepsis are summarised in an editorial by Dugar and Vallabhajosyula6 (figure 3). They also point out the challenges in understanding cardiac involvement in patients with propecia fertility side effects sepsis including the effect of timing of imaging on detection, difficulties in measuring RV systolic performance, and differing definitions of RV dysfunction.

They conclude propecia fertility side effects. €˜there is a crucial need to understand the how to identify RV dysfunction in sepsis and the causative mechanisms associated with higher mortality in this population, which will significantly influence how we prevent and manage this disease process.’Mechanism of RV dysfunction associated organ failure and mortality in sepsis. RV, right propecia fertility side effects ventricular." data-icon-position data-hide-link-title="0">Figure 3 Mechanism of RV dysfunction associated organ failure and mortality in sepsis. RV, right ventricular.The Education-in-Heart article in this issue by Steiner and Kirkpatrick7 focuses on palliative care in management of pateints with cardiovascular disease. Palliative care now encompasses propecia fertility side effects much more than end-of-life comfort measures.

Instead, ‘Palliative care is a specialised type of medical care that propecia fertility side effects focuses on improving communication about goals of care, maximising quality of life and reducing symptoms’ and thus applies to many of our patients at many time points in their disease course. Each of you will want to read the entire article yourself which includes several useful tools, such as the one shown in figure 4, to improve conversations with patients about treatment options, goals of care and planning for adverse outcomes.Ask-Tell-Ask tool to guide difficult conversations." data-icon-position data-hide-link-title="0">Figure 4 Ask-Tell-Ask tool to guide difficult conversations.Be sure to try the two Image Challenge questions in this issue.8 9 Over 150 board-review format multiple choice questions based on all types of cardiac images can be found in our online archive on the Heart homepage (https://heart.bmj.com/pages/collections/image_challenges/).In symptomatic patients with severe aortic stenosis (AS), there is no question that aortic valve replacement (AVR) relieves symptoms and prolongs life. In asymptomatic patients, clinical decision making is propecia fertility side effects less clear because of the need to balance the risks of intervention and a prosthetic valve against the risks of continued watchful waiting. On the other hand, symptom onset is inevitable in patients with severe AS—the decision is not whether but rather when to replace the valve.The primary rationale for deferring AVR until a later date is the lack of evidence that AVR before symptom onset would improve longevity. In addition, the risks, discomfort and disability associated with propecia fertility side effects a surgical or transcatheter procedure are postponed until a later date.

Furthermore, if a mechanical AVR is chosen, delaying intervention reduces the length of time the patient is exposed propecia fertility side effects to the risks and inconvenience of warfarin anticoagulation. If a bioprosthetic AVR is chosen, implantation later in life increases the likelihood that the valve will not deteriorate to the point of reintervention during the patient’s lifetime. Unfortunately, patients with AS do not have the option of propecia fertility side effects a normal aortic valve. Instead the diseased native valve is replaced with an imperfect prosthetic valve.On the other hand, accumulating evidence from advanced imaging studies shows that aortic valve obstruction is associated with adverse changes in left ventricular (LV) structure and function, even in the absence of symptoms, which may not resolve after AVR.1 In addition, observational studies suggest that there may be an increased risk of sudden cardiac death in apparently asymptomatic patients with severe AS, although the magnitude and predictors of risk remain unclear.In order to provide clarity about the risk of sudden death in asymptomatic adults with AS, Minners and colleagues examined the data from the Simvastatin and Ezetimibe in Aortic ….

A key consideration in timing of aortic valve replacement (AVR) for patients where can you buy propecia with aortic stenosis (AS) is whether there is an increased risk of sudden cardiac death (SCD) that might be reduced by relief of outflow obstruction. Minners and colleagues1 addressed this issue in a retrospective where can you buy propecia analysis of outcomes in 1840 patients with mild to moderate AS (aortic maximum velocity 2.5–4.0 m/s) in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Overall the annualised rate of SCD was 0.39% per year with 27 events in asymptomatic patients.

The most recent echocardiogram prior to SCD showed mild–moderate AS in most (80%) where can you buy propecia of these patients with no difference in SCD event rates in those who progressed to severe AS compared to those who did not develop severe valve obstruction. On Cox regression analysis, the only independent risk factors for SCD were age (HR 1.06, 95% CI 1.01 to 1.11 per year, p=0.02), increased left ventricular mass index (HR 1.20, 95% CI 1.10 to 1.32 per 10 g/m2, p<0.001) and lower body mass index (HR where can you buy propecia 0.87, 95% CI 0.79 to 0.97 per kg/m2, p=0.01) but not the severity of valve obstruction (figure 1).Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number of events for each variable is reflected by the dark, horizontal bars with separation at the median for continuous variables.

A forest plot visualisation where can you buy propecia of HRs for SCD is provided on the right. LVED, left ventricular enddiastolic diameter. LVES, left ventricular endsystolic diameter where can you buy propecia.

LVM, left where can you buy propecia ventricular mass. SCD, sudden cardiac death." data-icon-position data-hide-link-title="0">Figure 1 Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number of events for each variable is reflected by the dark, horizontal where can you buy propecia bars with separation at the median for continuous variables.

A forest plot visualisation of HRs for SCD is provided on the right. LVED, left ventricular enddiastolic where can you buy propecia diameter. LVES, left ventricular where can you buy propecia endsystolic diameter.

LVM, left ventricular mass. SCD, sudden cardiac death.The lack of association between AS severity and the risk of SCD in the SEAS study is thought-provoking and challenges the conventional wisdom that early AVR would prevent SCD in asymptomatic patients with AS.2 In the past, syncope and SCD in patients with AS were thought to be due to mechanisms such as left ventricle (LV) baroreceptor malfunction, hypotension where can you buy propecia secondary to peripheral vasodilation in the face of fixed valve obstruction, or a shortened diastolic filling interval at high heart rates leading to a reduced stroke volume. However, it is doubtful that any of where can you buy propecia these mechanisms would account for SCD when AS is only mild to moderate in severity.

€˜It is increasingly recognised that that AS is not simply a mechanical problem of the valve leaflets not opening fully. Instead, AS compromises a complex interplay between the valve, ventricle and vasculature with abnormal function of all three components of the disease process.’ As where can you buy propecia I conclude in an editorial, ‘It is unlikely that early AVR will reduce the risk of sudden death when severe valve obstruction is not present. Perhaps it is time to turn our attention to mitigating the non-valvular disease processes in adults with calcific valve disease.’In another interesting paper in this issue of Heart, Williams and Brown3 hypothesised that the apparent benefit of fractional flow reserve (FFR) guidance of percutaneous coronary intervention (PCI) in patients with chronic coronary syndromes (CCS) might simply be due to utilisation of fewer stents rather than to knowledge about the physiological severity of the coronary lesions.

In a Monte Carlo simulation using where can you buy propecia data from the PCI strata of the Bypass Angioplasty Revascularization Investigation 2 Diabetes study, random deferral of PCI progressively reduced the risk of death and myocardial infarction at 1 year, suggesting that FFR-guided deferral of PCI improves outcomes simply because fewer stents are placed.In an editorial, Weintraub and Boden4 put this data into the context of 30 years of clinical trials comparing PCI with optimal medical therapy from CCS and conclude ‘In contrast to patients with acute coronary syndrome, there remains no convincing evidence that PCI will prevent events in patients with stable angina and chronic ischaemic heart disease. We know that, if needed, PCI where can you buy propecia will ameliorate severe angina, but we also know that this may not be a durable effect. By contrast, for the great majority of patients who are not disabled by angina, PCI can be safely deferred in both diabetic and non-diabetic patients, with revascularisation reserved only for those with unacceptable angina or who develop an acute coronary syndrome during follow-up.

The role of FFR remains uncertain at best and where can you buy propecia need not be performed routinely in all patients with CCS, though it may be useful where the visual estimation of angiographical severity is uncertain.’Cardiac involvement in patients with sepsis contributes to adverse outcomes with most previous studies focusing on left ventricular dysfunction. In order to assess the impact of right ventricular involvement on outcomes in sepsis Kim and colleagues5 performed a retrospective cohort study of 778 patients with septic shock with echocardiographic imaging. Sepsis-induced cardiac dysfunction was present in 34.7% of the entire cohort, affecting the where can you buy propecia LV in 67.3% and the right ventricle (RV) in 40.7% of these patients.

Any type of sepsis-induced cardiac dysfunction was associated with a where can you buy propecia significantly higher 28-day mortality (35.9 vs 26.8%. P<0.01), longer intensive care unit length of stay and longer duration of mechanical ventilator, compared with those without cardiac dysfunction. Isolated RV dysfunction was rare (24/270, 8.9%) but was associated where can you buy propecia with a higher risk of 28-day mortality (adjusted OR 2.77, 95% CI 1.20 to 6.40, p=0.02) (figure 2).Comparisons of survival curves between each type of dysfunction.

LV, left ventricle. RV, right ventricle." data-icon-position data-hide-link-title="0">Figure 2 Comparisons where can you buy propecia of survival curves between each type of dysfunction. LV, left ventricle where can you buy propecia.

RV, right ventricle.The mechanisms of cardiac dysfunction in patients with sepsis are summarised in an editorial by Dugar and Vallabhajosyula6 (figure 3). They also point out the challenges in understanding cardiac involvement in patients with sepsis including the effect of timing of imaging where can you buy propecia on detection, difficulties in measuring RV systolic performance, and differing definitions of RV dysfunction. They conclude where can you buy propecia.

€˜there is a crucial need to understand the how to identify RV dysfunction in sepsis and the causative mechanisms associated with higher mortality in this population, which will significantly influence how we prevent and manage this disease process.’Mechanism of RV dysfunction associated organ failure and mortality in sepsis. RV, right ventricular." data-icon-position data-hide-link-title="0">Figure 3 Mechanism of RV dysfunction associated organ where can you buy propecia failure and mortality in sepsis. RV, right ventricular.The Education-in-Heart article in this issue by Steiner and Kirkpatrick7 focuses on palliative care in management of pateints with cardiovascular disease.

Palliative care where can you buy propecia now encompasses much more than end-of-life comfort measures. Instead, ‘Palliative care is a specialised type of medical care that focuses on improving communication about goals of care, maximising quality of life and reducing symptoms’ and thus applies to many of our where can you buy propecia patients at many time points in their disease course. Each of you will want to read the entire article yourself which includes several useful tools, such as the one shown in figure 4, to improve conversations with patients about treatment options, goals of care and planning for adverse outcomes.Ask-Tell-Ask tool to guide difficult conversations." data-icon-position data-hide-link-title="0">Figure 4 Ask-Tell-Ask tool to guide difficult conversations.Be sure to try the two Image Challenge questions in this issue.8 9 Over 150 board-review format multiple choice questions based on all types of cardiac images can be found in our online archive on the Heart homepage (https://heart.bmj.com/pages/collections/image_challenges/).In symptomatic patients with severe aortic stenosis (AS), there is no question that aortic valve replacement (AVR) relieves symptoms and prolongs life.

In asymptomatic where can you buy propecia patients, clinical decision making is less clear because of the need to balance the risks of intervention and a prosthetic valve against the risks of continued watchful waiting. On the other hand, symptom onset is inevitable in patients with severe AS—the decision is not whether but rather when to replace the valve.The primary rationale for deferring AVR until a later date is the lack of evidence that AVR before symptom onset would improve longevity. In addition, the risks, discomfort and disability associated with a surgical or transcatheter procedure are postponed until a later date where can you buy propecia.

Furthermore, if a mechanical AVR is chosen, delaying intervention reduces the length of time the patient is exposed to the risks where can you buy propecia and inconvenience of warfarin anticoagulation. If a bioprosthetic AVR is chosen, implantation later in life increases the likelihood that the valve will not deteriorate to the point of reintervention during the patient’s lifetime. Unfortunately, patients with AS do where can you buy propecia not have the option of a normal aortic valve.

Instead the diseased native valve is replaced with an imperfect prosthetic valve.On the other hand, accumulating evidence from advanced imaging studies shows that aortic valve obstruction is associated with adverse changes in left ventricular (LV) structure and function, even in the absence of symptoms, which may not resolve after AVR.1 In addition, observational studies suggest that there may be an increased risk of sudden cardiac death in apparently asymptomatic patients with severe AS, although the magnitude and predictors of risk remain unclear.In order to provide clarity about the risk of sudden death in asymptomatic adults with AS, Minners and colleagues examined the data from the Simvastatin and Ezetimibe in Aortic ….

Dosage of propecia for hair loss

Imagine being infected with a deadly dosage of propecia for hair loss cheap propecia pills propecia that makes you impervious to pain. By the time you realize you dosage of propecia for hair loss are infected, it’s already too late. You have spread it far and wide.

Recent findings in my lab suggest that this scenario may be one reason that people infected with hair loss, the propecia causing hair loss treatment, may be spreading the disease without knowing it.Most accounts to date have focused on how the propecia invades cells via the ACE2 protein on the surface of dosage of propecia for hair loss many cells. But recent studies, which have not yet been peer-reviewed, suggest there is another route to infecting the cell that enables it to infect the nervous system. This led my research group to uncover a link between a particular cellular protein and pain – an interaction that is dosage of propecia for hair loss disrupted by the hair loss.

Our research has now been peer-reviewed and will be published in the journal PAIN.I am a scientist who studies how proteins on cells trigger pain signals that are transmitted through the body to the brain. When these proteins are active, the nerve cells are talking to each dosage of propecia for hair loss other. This conversation occurs at deafening levels in chronic pain.

So by studying what causes the excitability of nerve cells to change, we dosage of propecia for hair loss can begin to unravel how chronic pain becomes established. This also allows us to design ways to mute this conversation to blunt or stop chronic pain.My laboratory has a longstanding interest in designing nonopioid-based alternatives for pain management.Linking hair loss and painYou might be wondering how my lab began to probe the connection between hair loss and pain. We were inspired by two preliminary reports that appeared on the dosage of propecia for hair loss preprint server BioRxiv that showed that the infamous spike proteins on the surface of the hair loss propecia bound to a protein called neuropilin-1.

This means that the propecia can also use this protein to invade nerve cells as well as through the ACE2 protein.For the past year, some six months before the propecia took hold, my colleagues and I had been studying the role of neuropilin-1 in the context of pain perception. Because neuropilin-1, like the ACE2 receptor, allowed spike to enter the cells, we wondered if this alternate gateway could also be related to pain.Under normal circumstances, the neuropilin-1 protein controls the growth of blood vessels, and as well as the growth and survival of neurons.However, when neuropilin-1 binds to a naturally occurring dosage of propecia for hair loss protein called called Vascular endothelial growth factor A (VEGF-A), this triggers pain signals. This signal is transmitted via the spinal cord into higher brain centers to cause the sensation we all know as pain.Staring at this jigsaw puzzle – neuropilin-1 and VEGF-A and neuropilin and spike – we wondered if there was a link between spike and pain.Previous research has shown a link between VEGF-A and pain.

For people with osteoarthritis, for instance, studies have shown that increased activity of the VEGF gene in fluids lubricating joints, like the knee, is associated with higher pain scores.Although activity of the neuropilin-1 gene is higher in biological samples from hair loss treatment patients compared to healthy controls and activity of the neuropilin-1 gene is increased in pain-sensing neurons in an animal model of chronic pain, the role of neuropilin-1 in pain has never been explored until now.In in vitro studies done in my lab using nerve cells, we showed that when spike dosage of propecia for hair loss binds to neuropilin-1 it decreases pain signaling, which suggests that in a living animal it would also have a pain-dulling effect.When the spike protein binds to the neuropilin-1 protein, it blocks the VEGF-A protein from binding and thus hijack’s a cell’s pain circuitry. This binding suppresses the excitability of pain neurons, leading to lower sensitivity to pain.Crystal structure of neuropilin-1 b1 domain (white surface with binding site in red) showing binding of VEGF-A (left), spike protein (middle), and the neuropilin-1 inhibitor EG00229 (right). (Credit.

Dr. Samantha Perez-Miller, CC BY-SA)From the hair loss treatment fog a new pain target emergesIf our finding that the new hair loss is attacking cells through a protein associated with pain and disabling the protein can be confirmed in humans, it may provide a new pathway for drug development to treat hair loss treatment.A small molecule, called EG00229, targeting neuropilin-1 had been reported in a 2018 study. This molecule binds to the same region of the neuropilin-1 protein as the viral spike protein and VEGF-A.

So I and my colleagues asked if this molecule was able to block pain. It did, during pain simulations in rats. Our data reaffirmed the notion of neuropilin-1 as a new player in pain signaling.There is precedence for targeting the neuropilin-1 protein for cancer treatment.

For example, a Phase 1a clinical trial of an antibody called MNRP1685A (known under the product name Vesencumab) that recognizes and binds to neuropilin-1 and blocks VEGF-binding. This was mostly well tolerated in cancer patients, but it caused pain rather than blocking it.Our studies identify a different approach because we targeted blocking the pain-triggering VEGF-A protein, which then resulted in pain relief. So our preclinical work described here provides a rationale for targeting the VEGF-A/NRP-1 pro-pain signaling system in future clinical trials.Analysis of the structure of the neuropilin-1 receptor protein may allow design of drugs targeting this critical site which also controls axon growth, cell survival – in addition to pain relief.For instance, these neuropilin-1 receptor targeted drugs could potentially block viral .

The testing of several candidate compounds, some of them on the FDA’s generally regarded as safe list, is currently underway by my group.Sneaky propecia, fooling people into believing that they do not have hair loss treatment. But, ironically, it may be gifting us with the knowledge of a new protein, critical for pain. Two roads emerge in the forest ahead.

(1) block neuropilin-1 to limit hair loss entry, and (2) block neuropilin-1 to block pain.Rajesh Khanna is a Professor of Pharmacology, University of Arizona. This article originally appeared on The Conversation under a Creative Commons license. Read the original here..

Imagine being where can you buy propecia low cost propecia infected with a deadly propecia that makes you impervious to pain. By the time you realize you are infected, it’s already too late where can you buy propecia. You have spread it far and wide.

Recent findings in my lab suggest that this scenario may be one reason that people infected with hair loss, the where can you buy propecia propecia causing hair loss treatment, may be spreading the disease without knowing it.Most accounts to date have focused on how the propecia invades cells via the ACE2 protein on the surface of many cells. But recent studies, which have not yet been peer-reviewed, suggest there is another route to infecting the cell that enables it to infect the nervous system. This led my research group to uncover where can you buy propecia a link between a particular cellular protein and pain – an interaction that is disrupted by the hair loss.

Our research has now been peer-reviewed and will be published in the journal PAIN.I am a scientist who studies how proteins on cells trigger pain signals that are transmitted through the body to the brain. When these proteins where can you buy propecia are active, the nerve cells are talking to each other. This conversation occurs at deafening levels in chronic pain.

So by studying what causes the excitability where can you buy propecia of nerve cells to change, we can begin to unravel how chronic pain becomes established. This also allows us to design ways to mute this conversation to blunt or stop chronic pain.My laboratory has a longstanding interest in designing nonopioid-based alternatives for pain management.Linking hair loss and painYou might be wondering how my lab began to probe the connection between hair loss and pain. We were inspired by two preliminary reports that appeared on the preprint server BioRxiv that showed that the infamous spike proteins on where can you buy propecia the surface of the hair loss propecia bound to a protein called neuropilin-1.

This means that the propecia can also use this protein to invade nerve cells as well as through the ACE2 protein.For the past year, some six months before the propecia took hold, my colleagues and I had been studying the role of neuropilin-1 in the context of pain perception. Because neuropilin-1, like the ACE2 receptor, allowed spike to enter the cells, we wondered if this alternate gateway could also be related to pain.Under normal circumstances, the neuropilin-1 protein controls the growth where can you buy propecia of blood vessels, and as well as the growth and survival of neurons.However, when neuropilin-1 binds to a naturally occurring protein called called Vascular endothelial growth factor A (VEGF-A), this triggers pain signals. This signal is transmitted via the spinal cord into higher brain centers to cause the sensation we all know as pain.Staring at this jigsaw puzzle – neuropilin-1 and VEGF-A and neuropilin and spike – we wondered if there was a link between spike and pain.Previous research has shown a link between VEGF-A and pain.

For people with osteoarthritis, for instance, studies have shown that increased activity of the VEGF gene in fluids lubricating joints, like the knee, is associated with higher pain scores.Although activity of the neuropilin-1 gene is higher in biological samples from hair loss treatment patients compared to healthy controls and activity of the neuropilin-1 gene is increased in pain-sensing neurons in an animal model of chronic pain, the role of neuropilin-1 in pain has never where can you buy propecia been explored until now.In in vitro studies done in my lab using nerve cells, we showed that when spike binds to neuropilin-1 it decreases pain signaling, which suggests that in a living animal it would also have a pain-dulling effect.When the spike protein binds to the neuropilin-1 protein, it blocks the VEGF-A protein from binding and thus hijack’s a cell’s pain circuitry. This binding suppresses the excitability of pain neurons, leading to lower sensitivity to pain.Crystal structure of neuropilin-1 b1 domain (white surface with binding site in red) showing binding of VEGF-A (left), spike protein (middle), and the neuropilin-1 inhibitor EG00229 (right). (Credit.

Dr. Samantha Perez-Miller, CC BY-SA)From the hair loss treatment fog a new pain target emergesIf our finding that the new hair loss is attacking cells through a protein associated with pain and disabling the protein can be confirmed in humans, it may provide a new pathway for drug development to treat hair loss treatment.A small molecule, called EG00229, targeting neuropilin-1 had been reported in a 2018 study. This molecule binds to the same region of the neuropilin-1 protein as the viral spike protein and VEGF-A.

So I and my colleagues asked if this molecule was able to block pain. It did, during pain simulations in rats. Our data reaffirmed the notion of neuropilin-1 as a new player in pain signaling.There is precedence for targeting the neuropilin-1 protein for cancer treatment.

For example, a Phase 1a clinical trial of an antibody called MNRP1685A (known under the product name Vesencumab) that recognizes and binds to neuropilin-1 and blocks VEGF-binding. This was mostly well tolerated in cancer patients, but it caused pain rather than blocking it.Our studies identify a different approach because we targeted blocking the pain-triggering VEGF-A protein, which then resulted in pain relief. So our preclinical work described here provides a rationale for targeting the VEGF-A/NRP-1 pro-pain signaling system in future clinical trials.Analysis of the structure of the neuropilin-1 receptor protein may allow design of drugs targeting this critical site which also controls axon growth, cell survival – in addition to pain relief.For instance, these neuropilin-1 receptor targeted drugs could potentially block viral .

The testing of several candidate compounds, some of them on the FDA’s generally regarded as safe list, is currently underway by my group.Sneaky propecia, fooling people into believing that they do not have hair loss treatment. But, ironically, it may be gifting us with the knowledge of a new protein, critical for pain. Two roads emerge in the forest ahead.

(1) block neuropilin-1 to limit hair loss entry, and (2) block neuropilin-1 to block pain.Rajesh Khanna is a Professor of Pharmacology, University of Arizona. This article originally appeared on The Conversation under a Creative Commons license. Read the original here..

Propecia alternative 2020

In this issue of BMJ Quality and Safety, Jorro-Barón and colleagues1 propecia alternative 2020 report Buy viagra with prescription the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six paediatric intensive care units (PICUs) at five Argentinian hospitals between July 2018 and May 2019. According to the authors, prior to the intervention there propecia alternative 2020 were complaints that handovers were ‘…lengthy, disorganized, …participants experienced problems with interruptions, distractions, and … senior professionals had problems accepting dissent’.Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the propecia alternative 2020 primary outcome there were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.998, risk ratio.

1.0 (0.74–1.34)). Regarding balancing measures, there propecia alternative 2020 was no observed difference in the ‘full-shift’ handover duration (control 35.7 min (29.6–41.8). Intervention 34.7 min (26.5–42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77–8.81). Control 5.96 propecia alternative 2020 min (4.69–7.23).

P=0.001). From the provider perspective, preintervention and postintervention Agency for Healthcare Research and Quality (AHRQ) safety culture surveys did not show significant differences in their responses to communication-focused questions before and after the intervention.Thus, consistent with all previous studies, I-PASS was implemented successfully and handover quality improved. However, is the lack of association of I-PASS implementation with clinical outcomes and adverse events in this study a concern?. To answer this question, it is necessary to review the origins of I-PASS more than a decade ago and its continually expanding evidence base.Healthcare has a handover problemHandovers are among the most vulnerable reoccurring processes in healthcare.

In the AHRQ safety culture survey,3 the handovers and transitions of care domain is consistently among the lowest scoring, and handover and communication issues are among the most common cause of Joint Commission Sentinel Events and the subject of Joint Commission Sentinel Event Alert Issue 58.4 A study by CRICO Strategies found that communication issues were a factor in 30% of 23 658 malpractice claims filed from 2009 to 2013, accounting for $1.7 billion in incurred losses.5 The importance of handovers and care transitions for trainees is specifically discussed in a Clinical Learning Environment Review Issue Brief published by the Accreditation Council for Graduate Medical Education (ACGME),6 and Section VI.E.3 (Transitions of Care) of the ACGME Common Program Requirements (Residency) addresses the requirement for residents to be taught and to use structured handovers.7Both the numbers of handovers and handover-related problems have increased in contemporary practice because of greater patient complexity and the expanding number and types of providers involved in a typical patient’s care. Further, in teaching institutions, resident work-hour restrictions have resulted in the need for complex coverage schemes. Off-hours care is often provided by ‘cross-covering’, ‘float’ or ‘moonlighting’ practitioners who are responsible for numerous unfamiliar patients during their shifts, thus imposing an even greater need for effective handovers. The net effect of all these changes may be inconsistent, fragmented care resulting from suboptimal handovers from one provider, service or hospital to another, with resulting medical errors (often of omission) and adverse events.Structured, standardised handoversThese serious vulnerabilities have led to pleas for more consistent, structured and standardised handovers.8–11 In addition to their use in routine shift-to-shift provider sign-off, these may be of particular value in the high-risk transfers of critically ill patients, such as from operating rooms to postoperative care units and ICUs12–16.

Admissions to a surgery unit17. Management of trauma patients18–20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23–28.

And end-of-rotation resident transitions.29–31Given these considerations, standardised handovers, often involving mnemonic devices, have been widely advocated and studied in the past several decades, though many lack rigorous evaluation and few if any showed demonstrable associations with outcomes.32 33 Further, although some individual hospitals, units and services have implemented their own idiosyncratic handover systems, this does not solve the issue of handover inconsistency between different care delivery sites. A basic, common framework that could be customised to individual use cases would clearly be preferable.The I-PASS systemResponding to these concerns, the I-PASS Study Group was initiated in 2009 and the I-PASS Institute in 2016. Although numerous other systems are available, since its pilot studies a decade ago,34 35 I-PASS has emerged as the dominant system in healthcare for structured, standardised handovers. This system is specifically designed for healthcare applications.

It is based on adult educational principles and simple to use. It has been extensively validated in the peer-reviewed literature encompassing studies at multiple institutions in the USA and internationally34–40. And extensive training materials are available to assist programmes in implementation.39 41–45 Ideally, this system is implemented hospital-wide, which addresses the issue of cross-unit and cross-service transfers.I-PASS includes five major elements regarded as important for every handover—illness severity, patient summary, action list, situation awareness/contingency planning and synthesis by receiver. The first three of these elements are often included in non-structured handovers, although not necessarily in a specific sequence or format.

The last two I-PASS elements—situational awareness/contingency planning and synthesis—have not historically been included in typical handover practice. The former assures that any anticipated problems are conveyed from the handover giver to the incoming provider and that appropriate responses to these issues are discussed. Synthesis is closed-loop communication, with brief read-back of the handover information by the receiver to assure their accurate comprehension, followed by an opportunity for questions and discussion. This read-back of mission-critical communications is standard operating practice in other high-reliability settings such as aviation, the military and nuclear power.

It is essential to establishing a shared mental model of the current state and any potential concerns. However, other than in I-PASS, it is quite uncommon in healthcare, with the potential exception of confirming verbal or telephonic orders.I-PASS validationIn an initial study of I-PASS handover implementation by residents on two general inpatient paediatric units at Boston Children’s Hospital,34 written handovers were more comprehensive and had fewer omissions of key data, and mean time spent on verbal handover sessions did not change significantly (32.3 min vs 33.2 min). Medical errors and adverse events were ascertained prospectively by research nurse reviewers and independent physician investigators. Following I-PASS implementation, preventable adverse events decreased from 3.3 (95% CI 1.7 to 4.8) to 1.5 (95% CI 0.51 to 2.4) per 100 admissions (p=0.04), and medical error rates decreased significantly from 33.8 per 100 admissions (95% CI 27.3 to 40.3) to 18.3 per 100 admissions (95% CI 14.7 to 21.9.

P<0.001). A commentary by Horwitz46 noted that this was ‘…by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale’, while also noting limitations including its uncontrolled, ‘before and after’ design, confounding by secular changes, Hawthorne effects and inability to blind the nurses collecting adverse event data.The more expansive, landmark I-PASS study was conducted by Starmer and colleagues37 among nine paediatric hospitals and 10 740 patient admissions between January 2011 and May 2013. Handover quality was evaluated, and medical errors and adverse events were ascertained by active surveillance, including on-site nurse review of medical records, orders, formal incident reports, nursing reports and daily medical error reports from residents. Independent physician investigators classified occurrences as adverse events, near misses or exclusions, and they subclassified adverse events as preventable or non-preventable.

Results revealed a 23% reduction in medical errors from the preintervention to the postintervention period (24.5 vs 18.8 per 100 admissions, p<0.001) and a 30% reduction in preventable adverse events (4.7 vs 3.3 events per 100 admissions, p<0.001). Inclusion of prespecified elements in written and verbal handovers increased significantly, and there was no significant change in handover time per patient (2.4 vs 2.5 min. P=0.55).Subsequent investigations in other institutions have replicated many of the findings of the original I-PASS studies, with higher postintervention inclusion rates of critical handover elements. Fewer mistakes or omissions.

Greater provider satisfaction with handover organisation and information conveyed. Unchanged or shorter handoff times. And decreased handover interruptions (probably reflecting greater attention to the importance of the handover process).36 40 47–50 In a mentored implementation study conducted in 2015–2016 among 16 hospitals (five community hospitals, 11 academic centres and multiple specialties), handover quality improved, and there was a provider-reported 27% reduction in adverse events.38 Among nurses at Boston Children’s Hospital, I-PASS implementation was associated with significant decreases in handover-related care failures.40In recognition of its achievements in improving healthcare quality, the I-PASS Study Group was awarded the 2016 John M Eisenberg Award for Patient Safety and Quality by the National Quality Forum and the Joint Commission.The challenge of linking handovers to clinical outcomes and eventsAlthough investigations from many centres, including the report of Jorro-Barrón and colleagues,1 have now confirmed that I-PASS can be readily assimilated and used by clinicians, most of these have either not rigorously assessed adverse events, medical errors and other clinical outcomes (Kirkpatrick Level 4 evaluation) or have failed to demonstrate significant postintervention improvements in these clinical outcomes. Why is this, and should current or potential I-PASS users be concerned?.

With regard to the first question, there are practical considerations that complicate the rigorous study of clinical outcome improvements associated with I-PASS (or any other handover system). Notwithstanding the importance of effective communications, these are only one of many provider processes and hospital systems, not to mention the overall hospital quality and safety culture, that impact a patient’s clinical outcome. In most hospitals, a diverse portfolio of quality and safety improvement initiatives are always being conducted. Disentangling and isolating the effects of any one specific intervention, such as I-PASS handovers, is challenging if not impossible.

At a minimum, it requires real-time, prospective monitoring by trained nurse or physician reviewers as in the original I-PASS studies, a research design which realistically is unlikely to be reproduced. Ideally, the study design would also include blinding of the study period (control or intervention) and blinding of observers, the former of which is virtually impossible for this type of intervention.Further, if other provider processes and hospital systems are functioning at a high level, they may partially offset the impact of suboptimal communications and make it even more challenging to demonstrate significant improvements. The current study of Jorro-Barón and colleagues,1 which uses PICUs as the unit of analysis, illustrates this concept. PICUs are typically among the most compulsive, detail-oriented units in any hospital, even if they may have nominally ‘non-standardized’ handovers.Study design.

The SW-CRTIn an attempt to address the limitations of some previous studies, Parent and colleagues51 studied eight medical and surgical ICUs across two academic tertiary teaching hospitals using an SW-CRT design. Clinician self-assessment of having been inadequately prepared for their shift because of a poor-quality handoff decreased from 35 of 343 handoffs (10.2%) in the control arm to 53 of 740 handoffs (7.2%) postintervention (OR 0.19. 95% CI 0.03 to 0.74. P=0.03).

€˜Last-minute’, early morning order writing decreased, and handover duration increased but not significantly (+5.5 min. 95% CI 0.34 to 9.39. P=0.30). As in the current study of Jorro-Barón and colleagues,1 who also employed an SW-CRT, there were no associated changes in clinical outcomes such as ICU length of stay, duration of mechanical ventilation or necessity for reintubation.

The authors comment that given high baseline quality of care in these ICUs, it was not surprising that there were no changes in outcomes.An SW-CRT is generally considered a rigorous study design as it includes cluster randomisation. However, though novel and increasingly popular, this approach is complex and may sometimes add confusion rather than clarity.52–57 Its major appeal is that all clusters will at some point, in a random and sequential fashion, transition from control to intervention condition. For an intervention that is perceived by participants as having more potential for good than harm, this may enhance cluster recruitment. It may also make it possible to conduct a randomised study in scenarios where pragmatic considerations, such as the inability to conduct interventions simultaneously across numerous clusters, may make a parallel randomised study (or any study) infeasible.However, as acknowledged even by its proponents, the added practical and statistical complexity of SW-CRTs often makes them more challenging to properly implement, and compared with traditional parallel cluster randomised trials they may be more prone to biases.53–57 A Consolidated Standards of Reporting Trials extension has been specifically developed in response to these concerns.55 Unique design and analytical considerations include the number of clusters, sequences and periods.

Clusters per sequence. And cluster-period sizes.55 56 Concerns include recruitment and selection biases. Proper accounting for secular trends in outcomes (ie, because of the sequential rather than simultaneous nature of the SW-CRT design, observations from the intervention condition occur on average at a later calendar time, so that the intervention effect may be confounded by an underlying time trend). Accounting for repeated measures on participants and clusters in sample size calculations and analyses (ie, data are not independent).

Possible time-varying treatment effects. And the potential for within-cluster contamination of observations obtained under the control or intervention condition.52–56Regarding contamination, a secular trend may be responsible if, for example, institutional activities focused on improving patient outcomes include a general emphasis on communications. There might also be more direct contamination of the intervention among clusters waiting to be crossed over, as described in the context of the Matching Michigan programme.58 Participating in a trial and awareness of being observed may change the behaviour of participants. For example, in the handover intervention of Jorro-Barón and colleagues,1 some providers in a control condition cluster may, because they are aware of the interest in handovers, begin to implement more standardised practices before the formal shift to the intervention condition.

This potentially dilutes any subsequent impact of the intervention by virtue of what could be considered either a Hawthorne effect or a local secular trend, in either case leading to generally better handovers in the preintervention period. Some SW-CRTs include a transition period without any observations to allow for sufficient time to implement the intervention,53 59 thereby creating more contrast. Finally, because of sometimes prolonged PICU length of stay and regularly scheduled resident rotations on and off a unit or service, some patients and providers might overlap the transition from control to intervention state and contribute observations to both, while others will be limited to one or the other. This possibility is not clearly defined by the authors of the current study, but seems unlikely to have had a major statistical effect.Do we need more evidence?.

From an implementation science perspective, handovers are a deeply flawed healthcare process with the demonstrated potential to harm patients. A new tool—I-PASS—has been developed which can be easily and economically taught and subsequently applied by virtually any provider, and many resources are available to assist in implementation.45 It has few, if any, unintended negative consequences to patients or providers and has been associated in at least two extensive and well-conducted (although non-randomised) trials with dramatic reductions in medical errors and adverse events. Notably, these were conducted at a time when there was much less emphasis on and awareness of handover systems, including I-PASS. Thus, there was much greater separation between control and intervention states than would be possible today.Returning to the question posed at the beginning of this commentary, is the inability to demonstrate a favourable impact on clinical outcomes in studies other than those of the developers34 35 a reason to question the value of I-PASS?.

For the reasons discussed above, I think not. In his classic 2008 article,60 ‘The Science of Improvement’, Dr Don Berwick recounts the transformational development of sophisticated statistical analyses in healthcare, of which the randomised clinical trial is the paradigm. While in many instances randomised controlled trials have been invaluable in scientifically affirming or rejecting the utility of specific treatments or interventions, their limitations are more obvious in interventions involving complex social and behavioural change. Berwick illustrates this challenge with the example of hospital rapid response teams, whose benefit was challenged by the results of a large cluster randomised trial.

His comments regarding that conflict are equally applicable to the current challenge of demonstrating the impact of standardised handovers on clinical outcomes:These critics refused to accept as evidence the large, positive, accumulating experience of many hospitals that were adapting rapid response for their own use, such as children’s hospitals. How can accumulating local reports of effectiveness of improvement interventions, such as rapid response systems, be reconciled with contrary findings from formal trials with their own varying imperfections?. The reasons for this apparent gap between science and experience lie deep in epistemology. The introduction of rapid response systems in hospitals is a complex, multicomponent intervention—essentially a process of social change.

The effectiveness of these systems is sensitive to an array of influences. Leadership, changing environments, details of implementation, organizational history, and much more. In such complex terrain, the RCT is an impoverished way to learn. Critics who use it as a truth standard in this context are incorrect.Having personally observed the value of I-PASS, as well as the devastating consequences of inadequate handovers, I vote with Dr Berwick.

The evidence for effectiveness is overwhelming and the need for action is urgent—all that is lacking is the will to implement.Ethics statementsPatient consent for publicationNot required.Palliative care is associated with improved patient-centred and caregiver-centred outcomes, higher-quality end-of-life care, and decreased healthcare use among patients with serious illness.1–3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or ‘triggers’), including a projected survival of less than 1 year,4 to help clinicians identify patients likely to benefit from palliative care. Nevertheless, referrals often occur within the last 3 months of life5 due in part to clinician overestimation of prognosis.6 A growing number of automated predictive models leverage vast data in the electronic medical record (EMR) to accurately predict short-term mortality risk in real time and can be paired with systems to prompt clinicians to refer to palliative care.7–12 These models hold great promise to overcome the many clinician-level and system-level barriers to improving access to timely palliative care. First, mortality risk prediction algorithms have been shown to outperform clinician prognostic assessment, and clinician–machine collaboration may even outperform both.13 Second, algorithm-based ‘nudges’ that systematically provide prognostic information could address many cognitive biases, including status quo bias and optimism bias,14 15 that make clinicians less apt to identify patients who may benefit from palliative care. Indeed, such models have been shown to improve the frequency of palliative care delivery and patient outcomes in the hospital and clinic settings.9 16 17 With that said, successful implementation of automated prognostic models into routine clinical care at scale requires clinician and patient engagement and support.In this issue of BMJ Quality &.

Safety, Saunders and colleagues report on the acceptability of using the EMR-based Modified Hospitalised-Patient One-Year Mortality Risk (mHOMR) score to alert clinicians to individual patients with a >21% risk of dying within 12 months. The goal of the clinician notification of an elevated risk score was to prompt clinicians to consider palliative care referral.18 In a previously reported feasibility study among 400 hospitalised patients, use of the mHOMR alert was associated with increased rates of goals of care discussions and palliative care consultation in comparison to the preimplementation baseline (34% vs 18%, respectively).19 In the present study, the authors conducted qualitative interviews pre-mHOMR and post-mHOMR implementation among 64 stakeholders, including patients identified at high risk by the mHOMR algorithm, their caregivers, staff and physicians. Thirty-five (55%) participants agreed that the mHOMR tool was acceptable. 14 (22%) were unsure or did not agree.

And 15 (23%) did not respond. Participants identified many potential benefits of the programme, citing the advantages of an automated approach to facilitate and justify clinical decision making. Participants also acknowledged possible barriers, particularly ‘situational challenges’ such as the content, timing and mechanism of provider notification. Additional logistical concerns included alert fatigue, potential redundancy, uncertainty regarding next steps and a worry that certain therapeutic options could be withheld from flagged patients.

The authors concluded that clinicians and patients found the automated prognostic trigger to be an acceptable addition to usual clinical care.Saunders et al’s work adds to our understanding of critical perceptions regarding end users’ acceptability of automated prognostic triggers in routine clinical care. The findings from this study align with prior evidence suggesting that clinicians recognise the value of automated, algorithm-based approaches to improve serious illness care. For example, in a qualitative study of clinicians by Hallen et al, prognostic models confirmed clinicians’ gestalt and served as a tool to help communicate prognosis to patients.20 Clinicians described prognostic models as a tool to facilitate interclinician disagreements, mitigate medicolegal risk, and overcome the tendency to ignore or overestimate prognosis.20 Clinicians also reported that EMR-generated lists of high-risk patients improved their ability to identify potential palliative care beneficiaries in a mixed-methods study by Mason et al.21 In a single-centre pilot study, we similarly found that most clinicians believed that using an EMR-based prognostic model to encourage inpatient palliative care consultation was acceptable.9 However, in the Saunders et al study, as in prior similar work, clinicians highlighted the importance of delivering notifications without causing excess provider workload, redundancy or alert fatigue.16 18 21 Clinicians also raised concerns regarding the accuracy of the prognostic information and the potential for negative effects on patients due to common misperceptions about palliative care being equivalent to hospice.18 20 21 Ultimately, Saunders et al’s work complements and builds on existing literature, demonstrating a general perception that integration of automated prognostic models into routine clinical care could be beneficial and acceptable.Important gaps remain in this literature which were not addressed by the Saunders et al study. For example, there is a need to capture more diverse clinician and patient perspectives, and there was no information provided about the sociodemographic or clinical characteristics of the study participants.

Additionally, important themes found in prior studies were not identified in this study. For example, two prior studies of clinicians’ perspectives on automated prognostic triggers for palliative care revealed concerns that prognosis alone may not be a sufficient surrogate indicator of actual palliative care need, or may inadvertently engender clinician overconfidence in an individual patient’s prognosis.9 21 The brevity of the interviews in Saunders et al’s study (mean. 12 min) could suggest all relevant themes may not have emerged in the data analysis. Additionally, while the inclusion of patient and caregiver perceptions is an important addition, limited information is provided about their perspectives and whether certain themes differed among the stakeholders.

In the study from Mason et al, themes unique to patients and caregivers were identified, such as hesitancy due to a lack of understanding of palliative care, a preference to ‘focus on the present’, and a worry that a clinician would not have the time to adequately address advanced care planning or palliative care during their visit.21 Healthcare systems should therefore be prepared to consider their unique workflows, patients and staff prior to implementing one of these programmes.Achieving stakeholder acceptability prior to widespread implementation is essential. An intervention should ideally undergo multiple cycles of optimisation with ongoing appraisal of patient and clinician perspectives prior to wide-scale implementation.22 23 Additionally, it is unclear whether clinicians’ acceptability of the intervention in one setting will generalise to other inpatient health settings. For instance, Saunders et al found that some providers were leery about the use of mHOMR due the need to balance the patient’s acute needs that brought them to the hospital with their long-term priorities that may be better served in the outpatient setting.18 Clinical workflows, patient acuity and patient–provider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et al’s findings cannot be extrapolated to outpatient care. This is particularly relevant as many ‘off-the-shelf’ prognostic algorithms are now commercially available that, while accurate, may not be as familiar or acceptable to clinicians as a homegrown model.

Therefore, while Saunders et al’s work is a great addition to the field, additional assessments are needed across different healthcare environments and varying clinical and demographic cohorts to demonstrate that this approach is acceptable in other health settings. It is likely that multiple implementation strategies will be needed to successfully adapt automated prognostic models across a range of clinical settings.Thoughtful consideration of the many forces that alter clinical decision making will also be critical for downstream success of these interventions. Suboptimal clinical decision making is often a result of systemic biases, such as status quo and optimism bias, which result in clinician resistance to change current practice and a belief that their patients are less prone to negative outcomes.14 15 Intentional application of targeted behavioural economics principles will help ensure that the use of prognostic triggers to improve palliative care effectively changes clinical behaviour.24 For example, using an ‘opt-out’ approach for palliative care referral may make the optimal choice the path of least resistance, increasing uptake among clinicians.16 These approaches will need to be balanced against rising clinician alert fatigue25 and resource constraints.Given the implementation challenges that accompany an intervention using prognostic triggers, hybrid effectiveness trials that test both clinical effectiveness and implementation outcomes offer one strategy to advance the integration of automated prognostic models.26 Implementation outcomes are typically based on a framework which provides a systematic way to develop, manage and evaluate interventions. For example, Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) is a framework that measures the impact of a programme based on five factors.

Reach, effectiveness, adoption, implementation and maintenance.27 Due to their pragmatic approach, hybrid trials frequently include heterogenous samples and clinical settings that optimise external validity and generalisability.26 28 They can be designed to primarily test the effects of a clinical interventions while observing and gathering information on implementation outcomes (type I), for equal evaluation of both the clinical intervention and implementation strategies (type II), or to primarily assess implementation outcomes while collecting effectiveness data (type III).26 29 For example, Beidas et al used a type I hybrid effectiveness–implementation trial design to test the effectiveness of an exercise intervention for breast cancer. This study not only evaluated the effectiveness of the intervention but also identified multiple significant implementation barriers such as cost, referral logistics and patient selection challenges which informed their subsequent dissemination efforts.30 Prospective, randomised, hybrid effectiveness–implementation designs focusing on other key implementation outcomes are a logical and necessary next step in advancing the field. In total, the work by Saunders et al demonstrates the potential acceptability of an automated prognostic model to improve the timeliness of palliative care, setting the stage for further work to optimise and implement these programmes into real-world clinical care.Ethics statementsPatient consent for publicationNot required..

In this issue of BMJ Quality and http://nijumakeup.com/buy-viagra-with-prescription/ Safety, Jorro-Barón and colleagues1 report the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six where can you buy propecia paediatric intensive care units (PICUs) at five Argentinian hospitals between July 2018 and May 2019. According to the authors, prior to the intervention there were complaints that handovers were ‘…lengthy, disorganized, …participants experienced problems with interruptions, distractions, and … senior professionals had problems accepting dissent’.Adverse events were assessed by two independent reviewers using where can you buy propecia the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the primary outcome there were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) where can you buy propecia vs intervention 60.4 (33.2–109.9), p=0.998, risk ratio.

1.0 (0.74–1.34)). Regarding balancing measures, there was no observed difference where can you buy propecia in the ‘full-shift’ handover duration (control 35.7 min (29.6–41.8). Intervention 34.7 min (26.5–42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77–8.81). Control 5.96 where can you buy propecia min (4.69–7.23).

P=0.001). From the provider perspective, preintervention and postintervention Agency for Healthcare Research and Quality (AHRQ) safety culture surveys did not show significant differences in their responses to communication-focused questions before and after the intervention.Thus, consistent with all previous studies, I-PASS was implemented successfully and handover quality improved. However, is the lack of association of I-PASS implementation with clinical outcomes and adverse events in this study a concern?. To answer this question, it is necessary to review the origins of I-PASS more than a decade ago and its continually expanding evidence base.Healthcare has a handover problemHandovers are among the most vulnerable reoccurring processes in healthcare.

In the AHRQ safety culture survey,3 the handovers and transitions of care domain is consistently among the lowest scoring, and handover and communication issues are among the most common cause of Joint Commission Sentinel Events and the subject of Joint Commission Sentinel Event Alert Issue 58.4 A study by CRICO Strategies found that communication issues were a factor in 30% of 23 658 malpractice claims filed from 2009 to 2013, accounting for $1.7 billion in incurred losses.5 The importance of handovers and care transitions for trainees is specifically discussed in a Clinical Learning Environment Review Issue Brief published by the Accreditation Council for Graduate Medical Education (ACGME),6 and Section VI.E.3 (Transitions of Care) of the ACGME Common Program Requirements (Residency) addresses the requirement for residents to be taught and to use structured handovers.7Both the numbers of handovers and handover-related problems have increased in contemporary practice because of greater patient complexity and the expanding number and types of providers involved in a typical patient’s care. Further, in teaching institutions, resident work-hour restrictions have resulted in the need for complex coverage schemes. Off-hours care is often provided by ‘cross-covering’, ‘float’ or ‘moonlighting’ practitioners who are responsible for numerous unfamiliar patients during their shifts, thus imposing an even greater need for effective handovers. The net effect of all these changes may be inconsistent, fragmented care resulting from suboptimal handovers from one provider, service or hospital to another, with resulting medical errors (often of omission) and adverse events.Structured, standardised handoversThese serious vulnerabilities have led to pleas for more consistent, structured and standardised handovers.8–11 In addition to their use in routine shift-to-shift provider sign-off, these may be of particular value in the high-risk transfers of critically ill patients, such as from operating rooms to postoperative care units and ICUs12–16.

Admissions to a surgery unit17. Management of trauma patients18–20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23–28.

And end-of-rotation resident transitions.29–31Given these considerations, standardised handovers, often involving mnemonic devices, have been widely advocated and studied in the past several decades, though many lack rigorous evaluation and few if any showed demonstrable associations with outcomes.32 33 Further, although some individual hospitals, units and services have implemented their own idiosyncratic handover systems, this does not solve the issue of handover inconsistency between different care delivery sites. A basic, common framework that could be customised to individual use cases would clearly be preferable.The I-PASS systemResponding to these concerns, the I-PASS Study Group was initiated in 2009 and the I-PASS Institute in 2016. Although numerous other systems are available, since its pilot studies a decade ago,34 35 I-PASS has emerged as the dominant system in healthcare for structured, standardised handovers. This system is specifically designed for healthcare applications.

It is based on adult educational principles and simple to use. It has been extensively validated in the peer-reviewed literature encompassing studies at multiple institutions in the USA and internationally34–40. And extensive training materials are available to assist programmes in implementation.39 41–45 Ideally, this system is implemented hospital-wide, which addresses the issue of cross-unit and cross-service transfers.I-PASS includes five major elements regarded as important for every handover—illness severity, patient summary, action list, situation awareness/contingency planning and synthesis by receiver. The first three of these elements are often included in non-structured handovers, although not necessarily in a specific sequence or format.

The last two I-PASS elements—situational awareness/contingency planning and synthesis—have not historically been included in typical handover practice. The former assures that any anticipated problems are conveyed from the handover giver to the incoming provider and that appropriate responses to these issues are discussed. Synthesis is closed-loop communication, with brief read-back of the handover information by the receiver to assure their accurate comprehension, followed by an opportunity for questions and discussion. This read-back of mission-critical communications is standard operating practice in other high-reliability settings such as aviation, the military and nuclear power.

It is essential to establishing a shared mental model of the current state and any potential concerns. However, other than in I-PASS, it is quite uncommon in healthcare, with the potential exception of confirming verbal or telephonic orders.I-PASS validationIn an initial study of I-PASS handover implementation by residents on two general inpatient paediatric units at Boston Children’s Hospital,34 written handovers were more comprehensive and had fewer omissions of key data, and mean time spent on verbal handover sessions did not change significantly (32.3 min vs 33.2 min). Medical errors and adverse events were ascertained prospectively by research nurse reviewers and independent physician investigators. Following I-PASS implementation, preventable adverse events decreased from 3.3 (95% CI 1.7 to 4.8) to 1.5 (95% CI 0.51 to 2.4) per 100 admissions (p=0.04), and medical error rates decreased significantly from 33.8 per 100 admissions (95% CI 27.3 to 40.3) to 18.3 per 100 admissions (95% CI 14.7 to 21.9.

P<0.001). A commentary by Horwitz46 noted that this was ‘…by far the most comprehensive study of the direct effects of handoff interventions on outcomes within the context of existing work-hour regulations and is the first to demonstrate an associated significant decrease in medical errors on a large scale’, while also noting limitations including its uncontrolled, ‘before and after’ design, confounding by secular changes, Hawthorne effects and inability to blind the nurses collecting adverse event data.The more expansive, landmark I-PASS study was conducted by Starmer and colleagues37 among nine paediatric hospitals and 10 740 patient admissions between January 2011 and May 2013. Handover quality was evaluated, and medical errors and adverse events were ascertained by active surveillance, including on-site nurse review of medical records, orders, formal incident reports, nursing reports and daily medical error reports from residents. Independent physician investigators classified occurrences as adverse events, near misses or exclusions, and they subclassified adverse events as preventable or non-preventable.

Results revealed a 23% reduction in medical errors from the preintervention to the postintervention period (24.5 vs 18.8 per 100 admissions, p<0.001) and a 30% reduction in preventable adverse events (4.7 vs 3.3 events per 100 admissions, p<0.001). Inclusion of prespecified elements in written and verbal handovers increased significantly, and there was no significant change in handover time per patient (2.4 vs 2.5 min. P=0.55).Subsequent investigations in other institutions have replicated many of the findings of the original I-PASS studies, with higher postintervention inclusion rates of critical handover elements. Fewer mistakes or omissions.

Greater provider satisfaction with handover organisation and information conveyed. Unchanged or shorter handoff times. And decreased handover interruptions (probably reflecting greater attention to the importance of the handover process).36 40 47–50 In a mentored implementation study conducted in 2015–2016 among 16 hospitals (five community hospitals, 11 academic centres and multiple specialties), handover quality improved, and there was a provider-reported 27% reduction in adverse events.38 Among nurses at Boston Children’s Hospital, I-PASS implementation was associated with significant decreases in handover-related care failures.40In recognition of its achievements in improving healthcare quality, the I-PASS Study Group was awarded the 2016 John M Eisenberg Award for Patient Safety and Quality by the National Quality Forum and the Joint Commission.The challenge of linking handovers to clinical outcomes and eventsAlthough investigations from many centres, including the report of Jorro-Barrón and colleagues,1 have now confirmed that I-PASS can be readily assimilated and used by clinicians, most of these have either not rigorously assessed adverse events, medical errors and other clinical outcomes (Kirkpatrick Level 4 evaluation) or have failed to demonstrate significant postintervention improvements in these clinical outcomes. Why is this, and should current or potential I-PASS users be concerned?.

With regard to the first question, there are practical considerations that complicate the rigorous study of clinical outcome improvements associated with I-PASS (or any other handover system). Notwithstanding the importance of effective communications, these are only one of many provider processes and hospital systems, not to mention the overall hospital quality and safety culture, that impact a patient’s clinical outcome. In most hospitals, a diverse portfolio of quality and safety improvement initiatives are always being conducted. Disentangling and isolating the effects of any one specific intervention, such as I-PASS handovers, is challenging if not impossible.

At a minimum, it requires real-time, prospective monitoring by trained nurse or physician reviewers as in the original I-PASS studies, a research design which realistically is unlikely to be reproduced. Ideally, the study design would also include blinding of the study period (control or intervention) and blinding of observers, the former of which is virtually impossible for this type of intervention.Further, if other provider processes and hospital systems are functioning at a high level, they may partially offset the impact of suboptimal communications and make it even more challenging to demonstrate significant improvements. The current study of Jorro-Barón and colleagues,1 which uses PICUs as the unit of analysis, illustrates this concept. PICUs are typically among the most compulsive, detail-oriented units in any hospital, even if they may have nominally ‘non-standardized’ handovers.Study design.

The SW-CRTIn an attempt to address the limitations of some previous studies, Parent and colleagues51 studied eight medical and surgical ICUs across two academic tertiary teaching hospitals using an SW-CRT design. Clinician self-assessment of having been inadequately prepared for their shift because of a poor-quality handoff decreased from 35 of 343 handoffs (10.2%) in the control arm to 53 of 740 handoffs (7.2%) postintervention (OR 0.19. 95% CI 0.03 to 0.74. P=0.03).

€˜Last-minute’, early morning order writing decreased, and handover duration increased but not significantly (+5.5 min. 95% CI 0.34 to 9.39. P=0.30). As in the current study of Jorro-Barón and colleagues,1 who also employed an SW-CRT, there were no associated changes in clinical outcomes such as ICU length of stay, duration of mechanical ventilation or necessity for reintubation.

The authors comment that given high baseline quality of care in these ICUs, it was not surprising that there were no changes in outcomes.An SW-CRT is generally considered a rigorous study design as it includes cluster randomisation. However, though novel and increasingly popular, this approach is complex and may sometimes add confusion rather than clarity.52–57 Its major appeal is that all clusters will at some point, in a random and sequential fashion, transition from control to intervention condition. For an intervention that is perceived by participants as having more potential for good than harm, this may enhance cluster recruitment. It may also make it possible to conduct a randomised study in scenarios where pragmatic considerations, such as the inability to conduct interventions simultaneously across numerous clusters, may make a parallel randomised study (or any study) infeasible.However, as acknowledged even by its proponents, the added practical and statistical complexity of SW-CRTs often makes them more challenging to properly implement, and compared with traditional parallel cluster randomised trials they may be more prone to biases.53–57 A Consolidated Standards of Reporting Trials extension has been specifically developed in response to these concerns.55 Unique design and analytical considerations include the number of clusters, sequences and periods.

Clusters per sequence. And cluster-period sizes.55 56 Concerns include recruitment and selection biases. Proper accounting for secular trends in outcomes (ie, because of the sequential rather than simultaneous nature of the SW-CRT design, observations from the intervention condition occur on average at a later calendar time, so that the intervention effect may be confounded by an underlying time trend). Accounting for repeated measures on participants and clusters in sample size calculations and analyses (ie, data are not independent).

Possible time-varying treatment effects. And the potential for within-cluster contamination of observations obtained under the control or intervention condition.52–56Regarding contamination, a secular trend may be responsible if, for example, institutional activities focused on improving patient outcomes include a general emphasis on communications. There might also be more direct contamination of the intervention among clusters waiting to be crossed over, as described in the context of the Matching Michigan programme.58 Participating in a trial and awareness of being observed may change the behaviour of participants. For example, in the handover intervention of Jorro-Barón and colleagues,1 some providers in a control condition cluster may, because they are aware of the interest in handovers, begin to implement more standardised practices before the formal shift to the intervention condition.

This potentially dilutes any subsequent impact of the intervention by virtue of what could be considered either a Hawthorne effect or a local secular trend, in either case leading to generally better handovers in the preintervention period. Some SW-CRTs include a transition period without any observations to allow for sufficient time to implement the intervention,53 59 thereby creating more contrast. Finally, because of sometimes prolonged PICU length of stay and regularly scheduled resident rotations on and off a unit or service, some patients and providers might overlap the transition from control to intervention state and contribute observations to both, while others will be limited to one or the other. This possibility is not clearly defined by the authors of the current study, but seems unlikely to have had a major statistical effect.Do we need more evidence?.

From an implementation science perspective, handovers are a deeply flawed healthcare process with the demonstrated potential to harm patients. A new tool—I-PASS—has been developed which can be easily and economically taught and subsequently applied by virtually any provider, and many resources are available to assist in implementation.45 It has few, if any, unintended negative consequences to patients or providers and has been associated in at least two extensive and well-conducted (although non-randomised) trials with dramatic reductions in medical errors and adverse events. Notably, these were conducted at a time when there was much less emphasis on and awareness of handover systems, including I-PASS. Thus, there was much greater separation between control and intervention states than would be possible today.Returning to the question posed at the beginning of this commentary, is the inability to demonstrate a favourable impact on clinical outcomes in studies other than those of the developers34 35 a reason to question the value of I-PASS?.

For the reasons discussed above, I think not. In his classic 2008 article,60 ‘The Science of Improvement’, Dr Don Berwick recounts the transformational development of sophisticated statistical analyses in healthcare, of which the randomised clinical trial is the paradigm. While in many instances randomised controlled trials have been invaluable in scientifically affirming or rejecting the utility of specific treatments or interventions, their limitations are more obvious in interventions involving complex social and behavioural change. Berwick illustrates this challenge with the example of hospital rapid response teams, whose benefit was challenged by the results of a large cluster randomised trial.

His comments regarding that conflict are equally applicable to the current challenge of demonstrating the impact of standardised handovers on clinical outcomes:These critics refused to accept as evidence the large, positive, accumulating experience of many hospitals that were adapting rapid response for their own use, such as children’s hospitals. How can accumulating local reports of effectiveness of improvement interventions, such as rapid response systems, be reconciled with contrary findings from formal trials with their own varying imperfections?. The reasons for this apparent gap between science and experience lie deep in epistemology. The introduction of rapid response systems in hospitals is a complex, multicomponent intervention—essentially a process of social change.

The effectiveness of these systems is sensitive to an array of influences. Leadership, changing environments, details of implementation, organizational history, and much more. In such complex terrain, the RCT is an impoverished way to learn. Critics who use it as a truth standard in this context are incorrect.Having personally observed the value of I-PASS, as well as the devastating consequences of inadequate handovers, I vote with Dr Berwick.

The evidence for effectiveness is overwhelming and the need for action is urgent—all that is lacking is the will to implement.Ethics statementsPatient consent for publicationNot required.Palliative care is associated with improved patient-centred and caregiver-centred outcomes, higher-quality end-of-life care, and decreased healthcare use among patients with serious illness.1–3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or ‘triggers’), including a projected survival of less than 1 year,4 to help clinicians identify patients likely to benefit from palliative care. Nevertheless, referrals often occur within the last 3 months of life5 due in part to clinician overestimation of prognosis.6 A growing number of automated predictive models leverage vast data in the electronic medical record (EMR) to accurately predict short-term mortality risk in real time and can be paired with systems to prompt clinicians to refer to palliative care.7–12 These models hold great promise to overcome the many clinician-level and system-level barriers to improving access to timely palliative care. First, mortality risk prediction algorithms have been shown to outperform clinician prognostic assessment, and clinician–machine collaboration may even outperform both.13 Second, algorithm-based ‘nudges’ that systematically provide prognostic information could address many cognitive biases, including status quo bias and optimism bias,14 15 that make clinicians less apt to identify patients who may benefit from palliative care. Indeed, such models have been shown to improve the frequency of palliative care delivery and patient outcomes in the hospital and clinic settings.9 16 17 With that said, successful implementation of automated prognostic models into routine clinical care at scale requires clinician and patient engagement and support.In this issue of BMJ Quality &.

Safety, Saunders and colleagues report on the acceptability of using the EMR-based Modified Hospitalised-Patient One-Year Mortality Risk (mHOMR) score to alert clinicians to individual patients with a >21% risk of dying within 12 months. The goal of the clinician notification of an elevated risk score was to prompt clinicians to consider palliative care referral.18 In a previously reported feasibility study among 400 hospitalised patients, use of the mHOMR alert was associated with increased rates of goals of care discussions and palliative care consultation in comparison to the preimplementation baseline (34% vs 18%, respectively).19 In the present study, the authors conducted qualitative interviews pre-mHOMR and post-mHOMR implementation among 64 stakeholders, including patients identified at high risk by the mHOMR algorithm, their caregivers, staff and physicians. Thirty-five (55%) participants agreed that the mHOMR tool was acceptable. 14 (22%) were unsure or did not agree.

And 15 (23%) did not respond. Participants identified many potential benefits of the programme, citing the advantages of an automated approach to facilitate and justify clinical decision making. Participants also acknowledged possible barriers, particularly ‘situational challenges’ such as the content, timing and mechanism of provider notification. Additional logistical concerns included alert fatigue, potential redundancy, uncertainty regarding next steps and a worry that certain therapeutic options could be withheld from flagged patients.

The authors concluded that clinicians and patients found the automated prognostic trigger to be an acceptable addition to usual clinical care.Saunders et al’s work adds to our understanding of critical perceptions regarding end users’ acceptability of automated prognostic triggers in routine clinical care. The findings from this study align with prior evidence suggesting that clinicians recognise the value of automated, algorithm-based approaches to improve serious illness care. For example, in a qualitative study of clinicians by Hallen et al, prognostic models confirmed clinicians’ gestalt and served as a tool to help communicate prognosis to patients.20 Clinicians described prognostic models as a tool to facilitate interclinician disagreements, mitigate medicolegal risk, and overcome the tendency to ignore or overestimate prognosis.20 Clinicians also reported that EMR-generated lists of high-risk patients improved their ability to identify potential palliative care beneficiaries in a mixed-methods study by Mason et al.21 In a single-centre pilot study, we similarly found that most clinicians believed that using an EMR-based prognostic model to encourage inpatient palliative care consultation was acceptable.9 However, in the Saunders et al study, as in prior similar work, clinicians highlighted the importance of delivering notifications without causing excess provider workload, redundancy or alert fatigue.16 18 21 Clinicians also raised concerns regarding the accuracy of the prognostic information and the potential for negative effects on patients due to common misperceptions about palliative care being equivalent to hospice.18 20 21 Ultimately, Saunders et al’s work complements and builds on existing literature, demonstrating a general perception that integration of automated prognostic models into routine clinical care could be beneficial and acceptable.Important gaps remain in this literature which were not addressed by the Saunders et al study. For example, there is a need to capture more diverse clinician and patient perspectives, and there was no information provided about the sociodemographic or clinical characteristics of the study participants.

Additionally, important themes found in prior studies were not identified in this study. For example, two prior studies of clinicians’ perspectives on automated prognostic triggers for palliative care revealed concerns that prognosis alone may not be a sufficient surrogate indicator of actual palliative care need, or may inadvertently engender clinician overconfidence in an individual patient’s prognosis.9 21 The brevity of the interviews in Saunders et al’s study (mean. 12 min) could suggest all relevant themes may not have emerged in the data analysis. Additionally, while the inclusion of patient and caregiver perceptions is an important addition, limited information is provided about their perspectives and whether certain themes differed among the stakeholders.

In the study from Mason et al, themes unique to patients and caregivers were identified, such as hesitancy due to a lack of understanding of palliative care, a preference to ‘focus on the present’, and a worry that a clinician would not have the time to adequately address advanced care planning or palliative care during their visit.21 Healthcare systems should therefore be prepared to consider their unique workflows, patients and staff prior to implementing one of these programmes.Achieving stakeholder acceptability prior to widespread implementation is essential. An intervention should ideally undergo multiple cycles of optimisation with ongoing appraisal of patient and clinician perspectives prior to wide-scale implementation.22 23 Additionally, it is unclear whether clinicians’ acceptability of the intervention in one setting will generalise to other inpatient health settings. For instance, Saunders et al found that some providers were leery about the use of mHOMR due the need to balance the patient’s acute needs that brought them to the hospital with their long-term priorities that may be better served in the outpatient setting.18 Clinical workflows, patient acuity and patient–provider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et al’s findings cannot be extrapolated to outpatient care. This is particularly relevant as many ‘off-the-shelf’ prognostic algorithms are now commercially available that, while accurate, may not be as familiar or acceptable to clinicians as a homegrown model.

Therefore, while Saunders et al’s work is a great addition to the field, additional assessments are needed across different healthcare environments and varying clinical and demographic cohorts to demonstrate that this approach is acceptable in other health settings. It is likely that multiple implementation strategies will be needed to successfully adapt automated prognostic models across a range of clinical settings.Thoughtful consideration of the many forces that alter clinical decision making will also be critical for downstream success of these interventions. Suboptimal clinical decision making is often a result of systemic biases, such as status quo and optimism bias, which result in clinician resistance to change current practice and a belief that their patients are less prone to negative outcomes.14 15 Intentional application of targeted behavioural economics principles will help ensure that the use of prognostic triggers to improve palliative care effectively changes clinical behaviour.24 For example, using an ‘opt-out’ approach for palliative care referral may make the optimal choice the path of least resistance, increasing uptake among clinicians.16 These approaches will need to be balanced against rising clinician alert fatigue25 and resource constraints.Given the implementation challenges that accompany an intervention using prognostic triggers, hybrid effectiveness trials that test both clinical effectiveness and implementation outcomes offer one strategy to advance the integration of automated prognostic models.26 Implementation outcomes are typically based on a framework which provides a systematic way to develop, manage and evaluate interventions. For example, Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) is a framework that measures the impact of a programme based on five factors.

Reach, effectiveness, adoption, implementation and maintenance.27 Due to their pragmatic approach, hybrid trials frequently include heterogenous samples and clinical settings that optimise external validity and generalisability.26 28 They can be designed to primarily test the effects of a clinical interventions while observing and gathering information on implementation outcomes (type I), for equal evaluation of both the clinical intervention and implementation strategies (type II), or to primarily assess implementation outcomes while collecting effectiveness data (type III).26 29 For example, Beidas et al used a type I hybrid effectiveness–implementation trial design to test the effectiveness of an exercise intervention for breast cancer. This study not only evaluated the effectiveness of the intervention but also identified multiple significant implementation barriers such as cost, referral logistics and patient selection challenges which informed their subsequent dissemination efforts.30 Prospective, randomised, hybrid effectiveness–implementation designs focusing on other key implementation outcomes are a logical and necessary next step in advancing the field. In total, the work by Saunders et al demonstrates the potential acceptability of an automated prognostic model to improve the timeliness of palliative care, setting the stage for further work to optimise and implement these programmes into real-world clinical care.Ethics statementsPatient consent for publicationNot required..

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Baldness drug propecia

Ibi bikorwa byatangarijwe mu nama iba rimwe mu mwaka igahuza  Inama y’Igihugu y’Abantu bafite Ubumuga n’abafatanyabikorwa bayo ku wa 15/…

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Baldness drug propecia

Ubu ni ubutumwa bwatanzwe n’Umunyamabanga Nshingwabikorwa w’Inama y’Igihugu y’Abantu bafite Ubumuga Bwana Emmanuel NDAYISABA ubwo hizihizwaga…

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Baldness drug propecia

Ubwo yafungura Inteko y’Inama rusange ya NCPD Umunyamabanga wa Leta UShinzwe Imibereho myiza y’Abaturage Madamu Alvera Mukabaramba  yavuze ko …

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Baldness drug propecia

This workshop took place in Muhanga District at Hotel Saint Andre de Kabgayi. The participants came in the different institutions like: Handicap…

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Baldness drug propecia

Ku wa 02 Kamena 2017, mu Murenge wa Jari ho mu Karere ka Gasabo hafunguwe ku mugaragara ikigo “JYAMUBANDI MWANA‘’.  Iki kigo cyatashywe uyu…

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Baldness drug propecia

On 30-31th June 2017, at sports View Hotel held Disability Coordination Forum which is the meeting joins NCPD and their Stakeholders. The meeting is…

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Baldness drug propecia

“Dufite icyizere cyo kubaho tutitaye ku bumuga dufite “Ubu ni bumwe mu butumwa bwatanzwe n’abana barerwa mu kigo cya HVP/Gatagara, Ku wa 26…

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Baldness drug propecia

Ku wa 19 Gicurasi 2017, Inama  y’Igihugu y’Abantu bafite Ubumuga ( NCPD ) hamwe n’abakozi b’ Urugaga rw’Imiryango y’Abantu bafite Ubumuga…

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Baldness drug propecia

Nyuma   y’uko Dr NDAHIRO  James wari   Depute uhagarariye  Abafite Ubumuga   mu Nteko y’Afurika  y’Iburasirazuba(EALA)  arangije  manda ze…

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