Buy generic zithromax onlineAdvertisementContinue reading the main storySupported byContinue reading the main storyPhys EdHow Weight Training May Help With Weight ControlPeople who regularly do muscle-strengthening exercises are about 20 to 30 buy generic zithromax online percent less likely to become obese over time than people who do not.Credit...Neil Hall/EPA, via ShutterstockJuly 7, 2021Lifting weights a few times a week might help us stave off obesity, according to an interesting new study of resistance exercise and body fat. It shows that people who regularly complete muscle-strengthening exercises of any kind are about 20 to 30 percent less likely to become obese over time than people who do not, whether they also work out aerobically or not.The findings indicate that weight training could be more consequential buy generic zithromax online for weight control than many of us might expect, and a little lifting now may keep us lighter, later.The incidence of obesity in America is rising, with about 40 percent of adults currently meeting the standard criteria for obesity. That number is expected to increase to more than 50 percent by the end of this decade.Unfortunately, few of us will drop any added pounds, long term, once we gain them. Most people who buy generic zithromax online shed more than about 5 percent of their body weight regain it within five years.The most effective way to deal with obesity, then, is probably to prevent it. And regular exercise can help in that regard. Many studies show that people who often walk, jog, cycle, swim or otherwise work out aerobically tend to gain less weight with age than sedentary people and are at lower risk of buy generic zithromax online becoming obese.But far less has been known about whether weight training likewise influences weight. Some past research hints that resistance training helps people retain muscle mass while people are trying to lose weight buy generic zithromax online. But whether it might also check long-term weight gain and avert obesity has not been clear.So, for the new study, which was published in June in PLOS Medicine, researchers at Iowa State University in Ames, Iowa, and other institutions, decided to look into the relationship, if any, between weights and waistlines. They began by turning to the large and useful database compiled for the Aerobics Center Longitudinal Study, a famous undertaking that had tracked the medical, health and fitness status of tens of thousands of patients who buy generic zithromax online visited the Cooper Clinic in Dallas between 1987 and 2005. The men and women had gone through extensive testing during repeated visits to the clinic over the years.Now, the Iowa researchers pulled the records for almost 12,000 of the participants, most of them middle-aged. None of them were obese, based on their B.M.I., when they first joined the Aerobics Center buy generic zithromax online study. (B.M.I., or body mass index, indirectly estimates body fat, based on your height buy generic zithromax online and weight. You can check yours online here.)These particular men and women had completed the typical array of health and fitness measurements during their visits to the clinic and also filled out an exercise questionnaire that asked, among other issues, about weight training. Did they ever engage in âÂÂmuscle-strengthening exercises,â it inquired, and if so, how often and for how buy generic zithromax online many minutes each week?. The researchers then began crosschecking, comparing peopleâÂÂs weights and other measurements from one clinic visit to the next. Based on B.M.I., about 7 percent of the men and women had become obese within about six years buy generic zithromax online of their first visit to the clinic.But B.M.I. Is a loose approximation of body composition and not always an accurate measure of obesity. So the researchers also checked buy generic zithromax online changes to peopleâÂÂs waist circumferences and their body-fat percentage to determine if they had become obese. By the yardsticks of a waist circumference greater than 40 inches for men and 35 for women, or a body-fat percentage above 25 percent for men and 30 percent buy generic zithromax online for women, as many as 19 percent of participants developed obesity over the years.Weight lifting, however, changed those outcomes, the researchers found, substantially lowering the risk that someone would become obese, by any measure. Men and women who reported strengthening their muscles a few times a week, for a weekly total of one to two hours, were about 20 percent less likely to become obese over the years, based on B.M.I., and about 30 percent less likely, based on waist circumference or body-fat percentage.The benefits remained when the researchers controlled for age, sex, smoking, general health and aerobic exercise. People who worked out aerobically and lifted weights were buy generic zithromax online much less likely to become obese. But so were those who lifted almost exclusively and reported little, if any, aerobic exercise.The results suggest that âÂÂyou can get a lot of benefit from even a littleâ weight training, says Angelique Brellenthin, a professor of kinesiology at Iowa State, who led the new study.Of course, the study was observational and does not prove that resistance training prevents weight gain, only that they are linked. It also did not consider peopleâÂÂs diets, genetics or health attitudes, any of which could affect obesity risk.Perhaps most important, it buy generic zithromax online does not tell us how muscle strengthening influences weight, although it is likely that resistance training builds and maintains muscle mass, Dr. Brellenthin says buy generic zithromax online. A metabolically active tissue, muscle burns calories and slightly increases our metabolic rate. Interestingly, the buy generic zithromax online desirable effect of adding muscle mass may also explain why fewer lifters avoided obesity when the researchers used B.M.I. As a measure. B.M.I. Does not differentiate muscle from fat, Dr. Brellenthin points out. If you add muscle with weight training, your B.M.I. Can rise.Still, the primary message of the study is that some weight training likely helps, over time, with weight control. ÃÂÂSo, my advice would be to fit in a few body weight exercises before or after your usual daily walk,â Dr. Brellenthin suggests. Or join a gym or an online class. Or try one of WellâÂÂs easy, at-home resistance-training routines, like the 7-Minute Standing Workout.AdvertisementContinue reading the main storyAdvertisementContinue reading the main storySupported byContinue reading the main storyWhat to Look for in a Physical TherapistNot all P.T.s are created equal. Find a professional who values evidence over anecdote.In some instances, exercise during physical therapy is even as effective as surgery.Credit...Getty ImagesJuly 6, 2021ThereâÂÂs been a quiet revolution taking place in the field of physical therapy. In the early 2000s, you could go to five different physical therapists for an injury and receive five different treatment plans. Some would have advised targeted exercises to strengthen muscles or classic treatments, like heat and cold packs.Others might have relied on âÂÂvoodoo treatmentsâ like uasound, lasers and electrotherapy, despite the fact that experts werenâÂÂt really sure how â or even if â they worked. Today, many of those techniques have been set aside as the science has slowly accumulated that they donâÂÂt accelerate healing. You may still find them in some offices, however, as the field has struggled with a lack of uniformity and a lingering reputation for pseudoscience, leaving patients unsure whom to trust.Take uasound, for instance. The technique has been used in physical therapy since the 1950s to treat everything from back pain to ankle sprains using high-frequency sound waves to speed the healing process. As early as the 1990s, uasoundâÂÂs efficacy started to be debunked, with few studies showing any clinical benefit, but itâÂÂs taken over 20 years for the technique to finally fall out of favor with practitioners.âÂÂThereâÂÂs very little, if any, evidence that uasound does anything at all,â said Bruce Greenfield, a professor in the department of rehabilitation medicine at Emory University. ÃÂÂBut P.T.s are using it, and theyâÂÂre charging for it, and theyâÂÂre getting reimbursed for it â basically for a technique thatâÂÂs not effective. Is that fraud?. I donâÂÂt know.âÂÂOver the last 15 years, leaders in the physical therapy field have worked to shed this reputation, improving standards and consistency. TheyâÂÂve developed systems to diagnose and classify injuries and turned to scientific research to create evidence-backed treatment guidelines. ÃÂÂThatâÂÂs how you change the face of the profession,â said David Wert, an associate professor of physical therapy at the University of Pittsburgh. ÃÂÂUsing evidence and applying interventions for folks that are meaningful.âÂÂA Shift From Passive to Active TreatmentOriginally, physical therapy was largely based on the use of treatments like heat and ice to ease peopleâÂÂs pain and aid healing. Practitioners have also been quick to adopt technologies like laser therapy, which purportedly travels through skin and cells to increase energy production in mitochondria (the powerhouse of the cell) to accelerate recovery. But a treatmentâÂÂs effect on a cell in a petri dish doesnâÂÂt necessarily translate to a patient in the clinic. The most recent â and some say most definitive â study on the technique shows no benefit over a placebo.Over the past two decades, studies and meta-analyses (like the one conducted on uasound) have revealed that these types of passive treatments, where patients lie down on a table and have a therapy performed on them, actually do very little. And in some cases, they can even slow down recovery.For example, ice has long been used to reduce swelling after an injury by constricting blood vessels in the area, which prevents blood and inflammatory cells from reaching the damaged tissue. But those blood and inflammatory cells are also a necessary part of the healing process, and restricting them with a cold pack or ice bath can delay or even prevent recovery.When compared head-to-head, active exercise-based therapies are both less expensive and more effective than passive ones. In some instances, exercise is even as effective as surgery. In one study of 350 patients who had meniscal tears, there was no difference after six months between the patients whoâÂÂd had surgery and those whoâÂÂd used active physical therapy. Other research is currently exploring whether the same might be true for partial rotator cuff tears.Instead, whatâÂÂs emerged from decades of research as a clear winner â whether itâÂÂs used to treat low back pain or frozen shoulder or knee ligament injuries â is good old-fashioned exercise.âÂÂWe have gotten quite a bit more evidence for the effectiveness of exercise in both facilitating recovery and also protecting people from different kinds of injuries or diseases,â said James Gordon, chair of the division of biokinesiology and physical therapy at the University of Southern California. Marilyn Moffat, a professor of physical therapy at New York University, agreed, saying that for every type of patient seen by physical therapists, âÂÂwhether itâÂÂs patients with cardiovascular disease, whether itâÂÂs patients with diabetes, whether itâÂÂs patients with orthopedic problems or fibromyalgia or neuromuscular disorders or falls or frailty or obesity, the literature out there in terms of exercise interventions is so strong for every single one.âÂÂChanging the Field, SlowlyThese days, most physical therapists recognize that treatments should consist of exercises that improve strength and flexibility, as well as ergonomic adjustments to peopleâÂÂs work or workout routines to prevent future injuries. However, some practitioners argue that passive treatments still have their place and they are still taught in physical therapy doctorate programs.James Irrgang, chair of the physical therapy department at the University of Pittsburgh, said he wasnâÂÂt surprised there is still a gap between what evidence shows is effective and what some clinical practices do. Across medicine, it traditionally takes 17 years for research to make its way to the clinic. As a result, Dr. Irrgang said that much of the emphasis in physical therapy now is on implementation. ÃÂÂHow do we get the clinicians to adhere to the best available evidence?. ÃÂÂHe hopes the answer is through education. In 2006, Dr. Irrgang â who at the time was the president of the Academy of Orthopaedic Physical Therapy â helped develop guidelines in the form of a report card for diagnostic and treatment techniques commonly used by physical therapists, based on the best scientific evidence.Some techniques, like doing exercises to increase quadriceps strength after an A.C.L. Tear, get an A. Others, like using electrotherapy to improve heel pain for plantar fasciitis, get a D.What to Look for in a Physical TherapistSo how can you tell if your P.T. Is relying on the best science?. During your first visit, the physical therapist will evaluate your symptoms, level of pain, how you move and your limitations for range of motion, strength and balance. That will become the basis of a diagnosis. This is not a medical diagnosis. The physical therapist wants to know what is limiting the function of, say, your knee, via muscle weakness or joint stiffness.Dr. Moffat said that this initial appointment is a good time to decide whether you want to work with the physical therapist. ÃÂÂThe most important thing is what the therapist does with their initial exam,â she said. ÃÂÂDo they really take the time initially to examine whatâÂÂs going on and then determine whatâÂÂs most appropriate for that patient?. ÃÂÂAfter the evaluation, the treatment they recommend should be evidence-based, drawing from the clinical practice guidelines, but it should also be tailored to your individual limitations and goals. It should also be active, incorporating strengthening and stretching exercises.ItâÂÂs important for the physical therapist to be empathetic and honest about what your course of treatment will entail, because the process can be painful. Whether or not you like your practitioner can also make a big difference in how you see the outcome. According to one meta-analysis, patients consistently rated their physical therapists based on how much they liked them as people, not on whether or not they got better.And if you find yourself in a clinic where passive therapies like heat packs or uasound seem to be the main approach to treatment, âÂÂFind another place to go,â Dr. Gordon said. Those treatments may be useful for temporarily reducing pain or inflammation, âÂÂbut they are not therapeutic in and of themselves. They are adjuncts to treatment.âÂÂThis approach to physical therapy may not use lasers or cryocompression pants or whatever the hot new toy is, and it requires work on the patientâÂÂs part, but it does work.âÂÂI think we are improving what we do, but I think itâÂÂs an evolution,â said Dr. Gordon, whoâÂÂs been practicing physical therapy for over 40 years. Incremental, evidence-based advances are âÂÂhaving an impact, but itâÂÂs not sexy. ItâÂÂs not a new robotic thing. ItâÂÂs hard to put it on the seven oâÂÂclock news. But it is truly a revolution in health care.âÂÂDana Smith is a health and science writer based in Durham, N.C. Her work has appeared in The Atlantic, The Guardian, Scientific American, STAT and more.AdvertisementContinue reading the main story. Where can i buy zithromax online
In this issue of BMJ Quality and Safety, Jorro-Barón and colleagues1 report the findings of a stepped-wedge where can i buy zithromax online 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 site web May 2019. According to the authors, prior to the intervention there were complaints that handovers were âÂÂâ¦lengthy, disorganized, â¦participants experienced problems with interruptions, distractions, and ⦠senior professionals had problems accepting dissentâÂÂ.Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument where can i buy zithromax online. 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 (37.5âÂÂ97.4) vs intervention 60.4 (33.2âÂÂ109.9), where can i buy zithromax online p=0.998, risk ratio. 1.0 (0.74âÂÂ1.34)). Regarding balancing where can i buy zithromax online measures, there was no observed difference in the âÂÂfull-shiftâ handover duration (control 35.7 min (29.6âÂÂ41.8). Intervention 34.7 min (26.5âÂÂ42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77âÂÂ8.81). Control 5.96 where can i buy zithromax online min (4.69âÂÂ7.23). 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 23âÂÂ658 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 patientâÂÂs 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 âÂÂcross-coveringâÂÂ, âÂÂfloatâ or âÂÂmoonlightingâ 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.8âÂÂ11 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 ICUs12âÂÂ16. Admissions to a surgery unit17. Management of trauma patients18âÂÂ20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23âÂÂ28. And end-of-rotation resident transitions.29âÂÂ31Given 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 internationally34âÂÂ40. And extensive training materials are available to assist programmes in implementation.39 41âÂÂ45 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 handoverâÂÂillness 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 elementsâÂÂsituational awareness/contingency planning and synthesisâÂÂhave 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 ChildrenâÂÂs 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 âÂÂâ¦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 scaleâÂÂ, while also noting limitations including its uncontrolled, âÂÂbefore and afterâ 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 10âÂÂ740 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 2.5âÂÂmin. 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 47âÂÂ50 In a mentored implementation study conducted in 2015âÂÂ2016 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 ChildrenâÂÂs 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 patientâÂÂs 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 âÂÂnon-standardizedâ 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). ÃÂÂLast-minuteâÂÂ, early morning order writing decreased, and handover duration increased but not significantly (+5.5âÂÂmin. 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 click this over here now 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.52âÂÂ57 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.53âÂÂ57 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.52âÂÂ56Regarding 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 toolâÂÂI-PASSâÂÂhas 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 âÂÂThe Science of ImprovementâÂÂ, 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 childrenâÂÂs 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 interventionâÂÂessentially 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 urgentâÂÂall 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.1âÂÂ3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or âÂÂtriggersâÂÂ), including a projected survival of less than 1âÂÂyear,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.7âÂÂ12 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 clinicianâÂÂmachine collaboration may even outperform both.13 Second, algorithm-based âÂÂnudgesâ 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%âÂÂrisk 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 âÂÂsituational challengesâ 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 alâÂÂs work adds to our understanding of critical perceptions regarding end usersâ 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 cliniciansâ 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 alâÂÂs 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 cliniciansâ 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 patientâÂÂs prognosis.9 21 The brevity of the interviews in Saunders et alâÂÂs study (mean. 12âÂÂmin) 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 âÂÂfocus on the presentâÂÂ, 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 cliniciansâ 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 patientâÂÂs 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 patientâÂÂprovider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et alâÂÂs findings cannot be extrapolated to outpatient care. This is particularly relevant as many âÂÂoff-the-shelfâ 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 alâÂÂs 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 âÂÂopt-outâ 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 effectivenessâÂÂimplementation 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 effectivenessâÂÂimplementation 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 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 paediatric intensive care units (PICUs) buy generic zithromax online at five Argentinian hospitals between July 2018 and https://schwihag-produktion.de/waermebehandlung/ May 2019. According to the authors, prior to the intervention there were complaints that handovers were âÂÂâ¦lengthy, buy generic zithromax online disorganized, â¦participants experienced problems with interruptions, distractions, and ⦠senior professionals had problems accepting dissentâÂÂ.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 primary outcome there buy generic zithromax online were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5âÂÂ97.4) vs intervention 60.4 (33.2âÂÂ109.9), p=0.998, risk ratio. 1.0 (0.74âÂÂ1.34)). Regarding balancing measures, buy generic zithromax online there was no observed difference in the âÂÂfull-shiftâ handover duration (control 35.7 min (29.6âÂÂ41.8). Intervention 34.7 min (26.5âÂÂ42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77âÂÂ8.81). Control 5.96 buy generic zithromax online min (4.69âÂÂ7.23). 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 23âÂÂ658 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 patientâÂÂs 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 âÂÂcross-coveringâÂÂ, âÂÂfloatâ or âÂÂmoonlightingâ 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.8âÂÂ11 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 ICUs12âÂÂ16. Admissions to a surgery unit17. Management of trauma patients18âÂÂ20. ICU to general ward transfers21 22. Night and weekend coverage of large services, many of whose patients are unfamiliar to the physician receiving the handover23âÂÂ28. And end-of-rotation resident transitions.29âÂÂ31Given 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 internationally34âÂÂ40. And extensive training materials are available to assist programmes in implementation.39 41âÂÂ45 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 handoverâÂÂillness 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 elementsâÂÂsituational awareness/contingency planning and synthesisâÂÂhave 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 ChildrenâÂÂs 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 âÂÂâ¦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 scaleâÂÂ, while also noting limitations including its uncontrolled, âÂÂbefore and afterâ 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 10âÂÂ740 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 2.5âÂÂmin. 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 47âÂÂ50 In a mentored implementation study conducted in 2015âÂÂ2016 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 ChildrenâÂÂs 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 patientâÂÂs 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 âÂÂnon-standardizedâ 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). ÃÂÂLast-minuteâÂÂ, early morning order writing decreased, and handover duration increased but not significantly (+5.5âÂÂmin. 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.52âÂÂ57 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.53âÂÂ57 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.52âÂÂ56Regarding 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 toolâÂÂI-PASSâÂÂhas 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 âÂÂThe Science of ImprovementâÂÂ, 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 childrenâÂÂs 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 interventionâÂÂessentially 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 urgentâÂÂall 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.1âÂÂ3 The Centre to Advance Palliative Care has established a set of recommended clinical criteria (or âÂÂtriggersâÂÂ), including a projected survival of less than 1âÂÂyear,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.7âÂÂ12 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 clinicianâÂÂmachine collaboration may even outperform both.13 Second, algorithm-based âÂÂnudgesâ 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%âÂÂrisk 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 âÂÂsituational challengesâ 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 alâÂÂs work adds to our understanding of critical perceptions regarding end usersâ 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 cliniciansâ 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 alâÂÂs 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 cliniciansâ 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 patientâÂÂs prognosis.9 21 The brevity of the interviews in Saunders et alâÂÂs study (mean. 12âÂÂmin) 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 âÂÂfocus on the presentâÂÂ, 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 cliniciansâ 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 patientâÂÂs 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 patientâÂÂprovider relationships are markedly different between the inpatient and outpatient settings, suggesting Saunders et alâÂÂs findings cannot be extrapolated to outpatient care. This is particularly relevant as many âÂÂoff-the-shelfâ 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 alâÂÂs 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 âÂÂopt-outâ 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 effectivenessâÂÂimplementation 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 effectivenessâÂÂimplementation 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.. What side effects may I notice from Zithromax?Side effects that you should report to your prescriber or health care professional as soon as possible:
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Zithromax while pregnantEver since medicine adopted a race-based zithromax while pregnant formula to assess kidney health in the mid-2000s, some experts have spoken out against it. The fight to remove a âÂÂBlack or not Blackâ dichotomy from the kidney test equation, known as the estimated glomerular fiation rate (eGFR), has picked up steam in recent years, culminating in a recommendation from zithromax while pregnant the National Kidney Foundation and the American Society of Nephrology to remove the race variable.But for countless people living with kidney disease, the recommendation comes too late. People like Glenda Roberts, who long self-identified as Black, and who has lived with kidney disease for most of her adult life. The âÂÂBlack correctionâ in the eGFR made it look like her kidneys were doing better than they zithromax while pregnant actually were, which delayed her being worked up for a kidney transplant. This delay zithromax while pregnant led Roberts into an unplanned âÂÂcrash into dialysisâ before her transplant workup was complete. A few years after the transplant, a genetic test Roberts had done by Ancestry.com indicated that she had only 48% African ancestry. Had she known that earlier, identifying as not Black would have helped her get on the kidney transplant list sooner.advertisement On this zithromax while pregnant weekâÂÂs âÂÂFirst Opinion Podcast,â Roberts and kidney specialist Vanessa Grubbs, a longtime critic of using race in the eGFR, spoke about the impact this equation has had on patientsâ lives and whether the profession has truly reckoned with it.âÂÂNephrology is a is a field of equations â thereâÂÂs an equation to calculate everything to two and three decimal places. But when it comes to race, if you think youâÂÂre Black, thatâÂÂs Black enough,â Grubbs said.advertisement The conversation stems from Robertsâ First Opinion essay, âÂÂHad I done Ancestry.com sooner, I could have gotten a kidney transplant two years earlier.âÂÂBe sure to sign up for the weekly âÂÂFirst Opinion Podcastâ on Apple Podcasts, Stitcher, Google Play, or wherever you get your podcasts.And if you have any feedback for us â First Opinion authors to feature on the podcast, vocal mannerisms the host needs to jettison, kudos or darts â email us at [email protected] and please put âÂÂpodcastâ in the subject line.. Ever since medicine adopted a race-based formula to assess kidney health in the mid-2000s, some experts buy zithromax for chlamydia online have spoken out buy generic zithromax online against it. The fight to remove a âÂÂBlack or not Blackâ dichotomy from the kidney test equation, known as the estimated glomerular fiation rate (eGFR), has picked up steam in recent years, culminating in a recommendation from the National Kidney Foundation and the American Society of Nephrology to remove the race variable.But for countless people living with kidney disease, the recommendation buy generic zithromax online comes too late. People like Glenda Roberts, who long self-identified as Black, and who has lived with kidney disease for most of her adult life. The âÂÂBlack correctionâ in the eGFR made it look like buy generic zithromax online her kidneys were doing better than they actually were, which delayed her being worked up for a kidney transplant. This delay led Roberts buy generic zithromax online into an unplanned âÂÂcrash into dialysisâ before her transplant workup was complete. A few years after the transplant, a genetic test Roberts had done by Ancestry.com indicated that she had only 48% African ancestry. Had she known that earlier, identifying as not Black would have helped her get on the kidney transplant list sooner.advertisement On this weekâÂÂs âÂÂFirst Opinion Podcast,â buy generic zithromax online Roberts and kidney specialist Vanessa Grubbs, a longtime critic of using race in the eGFR, spoke about the impact this equation has had on patientsâ lives and whether the profession has truly reckoned with it.âÂÂNephrology is a is a field of equations â thereâÂÂs an equation to calculate everything to two and three decimal places. But when it comes to race, if you think youâÂÂre Black, thatâÂÂs Black enough,â Grubbs said.advertisement The conversation stems from Robertsâ First Opinion essay, âÂÂHad I done Ancestry.com sooner, I could have gotten a kidney transplant two years earlier.âÂÂBe sure to sign up for the weekly âÂÂFirst Opinion Podcastâ on Apple Podcasts, Stitcher, Google Play, or wherever you get your podcasts.And if you have any feedback for us â First Opinion authors to feature on the podcast, vocal mannerisms the host needs to jettison, kudos or darts â email us at [email protected] and please put âÂÂpodcastâ in the subject line.. How to buy zithromax onlineA big change is coming to patient access to Best online viagra electronic how to buy zithromax online health record information. Starting Monday, Nov. 16, UC Davis Health will begin sharing almost all notes how to buy zithromax online with patients. Beginning Nov. 16, patients will have easier access how to buy zithromax online to most of their health information.Patients have always had the right to access their medical records. This change simply makes the information easier for patients to view. In this case, patients will see the clinical information how to buy zithromax online via the MyUCDavisHealth (formerly MyChart) portal. Most test results ö lab, radiology, and procedures ö will also be shared with patients when finalized.One significant benefit of more accessible and open notes is better patient engagement through a deeper understanding of their condition and care.âÂÂMany organizations have already started sharing notes with patients,â said Scott MacDonald, an internist who serves as medical director for UC Davis HealthâÂÂs electronic health records system and has helped lead the open notes initiative for the health system. ÃÂÂWeâÂÂve tested the change in patient access with how to buy zithromax online several departments and itâÂÂs been a favorable process so far. About 10 to 15% of patients have read their notes, and while requests to change notes happen, it appears to have minimal impact on clinician workloads.âÂÂThe change, which is being implemented by health providers throughout the nation, stems from a federal law that was passed several years ago called the 21st Century Cures Act. Among its rules, health care providers are prohibited from doing anything that interferes with the access, exchange, or use of electronic health information.There are some exceptions how to buy zithromax online to immediate patient access to results. Biopsies showing cancer, HIV and hepatitis, as well as clinical research. ÃÂÂState law does mandate that providers discuss with their patients possibly life-changing results like cancer diagnoses before the results are automatically posted online,â said MacDonald.The federal law also allows note authors (physicians, how to buy zithromax online nurses, allied health care professionals) to NOT share a note under certain strict conditions, such as when the information might lead to a violation of someoneâÂÂs privacy or could lead to physical harm. UC Davis Health is only releasing provider notes going forward from Nov. 16. Older notes will still be available through the Health Information Management (HIM) request process.Over time, the complete health record will be available to patients. Patients also will be able to share their health information through third-party apps such as Apple Health. To help explain some of the details, a UC Davis Health team from clinical, HIM, Legal, Compliance and IT departments, has put together this Frequently Asked Questions document about the changes in patient access to their health information.Saturday, October 24 is the Drug Enforcement AgencyâÂÂs National Prescription Drug Take Back Day. This is an opportunity to clean out your medicine cabinet and dispose of unwanted, unused and expired medications. Medication drop-off bins are accessible year-round.According to the 2018 National Survey on Drug Use and Health, 9.9 million Americans misused controlled prescription drugs and many of these drugs were obtained from the medicine cabinets of family and friends.In response to this vital public safety public health issue, UC Davis Health began offering consumers a safe option for disposing unwanted or expired medication. Last year, drug take-back bins were installed in the main lobby of the hospital, near the pharmacy in the Lawrence J. Ellison Ambulatory Care Center, in the Comprehensive Cancer Center Pharmacy and at the UC Davis Health Davis Clinic Pharmacy. Please note that these bins are available and accessible every day of the year.All prescription medications, including Schedule II-V controlled substances, creams, over-the-counter medications and pet medications are accepted. Please consider dropping off your unwanted prescriptions and help prevent diversion, misuse and abuse.. A big change is coming to patient access to electronic health record information buy generic zithromax online. Starting Monday, Nov. 16, UC Davis Health buy generic zithromax online will begin sharing almost all notes with patients. Beginning Nov. 16, patients buy generic zithromax online will have easier access to most of their health information.Patients have always had the right to access their medical records. This change simply makes the information easier for patients to view. In this case, patients will see the clinical information buy generic zithromax online via the MyUCDavisHealth (formerly MyChart) portal. Most test results ö lab, radiology, and procedures ö will also be shared with patients when finalized.One significant benefit of more accessible and open notes is better patient engagement through a deeper understanding of their condition and care.âÂÂMany organizations have already started sharing notes with patients,â said Scott MacDonald, an internist who serves as medical director for UC Davis HealthâÂÂs electronic health records system and has helped lead the open notes initiative for the health system. ÃÂÂWeâÂÂve tested the buy generic zithromax online change in patient access with several departments and itâÂÂs been a favorable process so far. About 10 to 15% of patients have read their notes, and while requests to change notes happen, it appears to have minimal impact on clinician workloads.âÂÂThe change, which is being implemented by health providers throughout the nation, stems from a federal law that was passed several years ago called the 21st Century Cures Act. Among its rules, health care providers are prohibited from doing anything that interferes with the access, buy generic zithromax online exchange, or use of electronic health information.There are some exceptions to immediate patient access to results. Biopsies showing cancer, HIV and hepatitis, as well as clinical research. ÃÂÂState law does mandate that providers buy generic zithromax online discuss with their patients possibly life-changing results like cancer diagnoses before the results are automatically posted online,â said MacDonald.The federal law also allows note authors (physicians, nurses, allied health care professionals) to NOT share a note under certain strict conditions, such as when the information might lead to a violation of someoneâÂÂs privacy or could lead to physical harm. UC Davis Health is only releasing provider notes going forward from Nov. 16. Older notes will still be available through the Health Information Management (HIM) request process.Over time, the complete health record will be available to patients. Patients also will be able to share their health information through third-party apps such as Apple Health. To help explain some of the details, a UC Davis Health team from clinical, HIM, Legal, Compliance and IT departments, has put together this Frequently Asked Questions document about the changes in patient access to their health information.Saturday, October 24 is the Drug Enforcement AgencyâÂÂs National Prescription Drug Take Back Day. This is an opportunity to clean out your medicine cabinet and dispose of unwanted, unused and expired medications. Medication drop-off bins are accessible year-round.According to the 2018 National Survey on Drug Use and Health, 9.9 million Americans misused controlled prescription drugs and many of these drugs were obtained from the medicine cabinets of family and friends.In response to this vital public safety public health issue, UC Davis Health began offering consumers a safe option for disposing unwanted or expired medication. Last year, drug take-back bins were installed in the main lobby of the hospital, near the pharmacy in the Lawrence J. Ellison Ambulatory Care Center, in the Comprehensive Cancer Center Pharmacy and at the UC Davis Health Davis Clinic Pharmacy. Please note that these bins are available and accessible every day of the year.All prescription medications, including Schedule II-V controlled substances, creams, over-the-counter medications and pet medications are accepted. Please consider dropping off your unwanted prescriptions and help prevent diversion, misuse and abuse.. |
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