What’s New in the Patient Safety World

June 2015



·         Too Much of a Good Thing? Very Early Mobilization in Stroke

·         Get a Grip on It!

·         More Risks for Parkinson Inpatients

·         Economics and Blood Transfusion




Too Much of a Good Thing? Very Early Mobilization in Stroke



One of the major trends in patient safety in a variety of venues has been a push toward early mobilization of patients. Early mobilization has become part of numerous guidelines for a variety of medical conditions (for example see our December 2010 What’s New in the Patient Safety World column “The ABCDE Bundle”).


Early mobilization in acute stroke patients theoretically makes a lot of sense and several studies have demonstrated positive outcomes from early mobilization in stroke patients. Patients with acute stroke and significant limb weakness are obviously at risk for venous thromboembolism and pressure ulcers among other complications. And the “deconditioning” that occurs with bedrest is likely detrimental to a number of physiologic systems. But the great unknown is how much activity is best and when should it be started. The logical assumption is that the earlier it is started, the better the outcomes are likely to be.


AVERT (A Very Early Rehabilitation Trial for Stroke) was undertaken to answer those questions. AVERT was a randomized (single blinded) controlled trial involving stroke patients (including both ischemic stroke and intracerebral hemorrhages) in 56 acute stroke units in 5 countries (Bernhardt 2015). The very early intervention group began therapy and mobilization within the first 24 hours after stroke (median time to first mobilization 18.5 hours), almost 5 hours on average earlier than those patients in the “usual care” group.


Much to the surprise of the investigators, the primary outcome of the study (a good functional outcome based on a modified Rankin Scale score of 0-2 at three months) was actually worse in the group receiving very early mobilization. And there was no evidence of accelerated walking recovery.


Interestingly, there was no difference in complications between the very early intervention group and the usual care group in AVERT. That includes no difference in the incidence of venous thromboembolism. There was also no statistically significant difference in mortality between the two groups.


Subgroup analysis did not reveal a better outcome in any subgroups in the very early intervention group. But there was some evidence that patients with more severe ischemic strokes and intracerebral hemorrhages might be especially prone to worse outcomes with the very early intervention. The author posit a number of physiologically plausible possible explanations for the worse outcomes in the very early intervention period.


Overall, the outcomes for all patients in the study were relatively good. Complication rates were low in both groups. And the “usual care” group actually was getting mobilization quite early (median time to first mobilization was 22 hours in the “usual care” group).


The investigators plan to further analyze the data to determine whether any dose-response relationship exists.


Will the study results change the approach to early mobilization in stroke patients? Unfortunately, it may be years before more definitively is known about the optimal time to begin and intensity of such mobilization. But the AVERT results would certainly suggest that very early, intensive mobilization may be detrimental in stroke patients.


The study is a reminder that sometimes things that make a lot of sense may not always translate into clinical benefit and may, in fact, have unexpected consequences. The investigators should be commended for undertaking this important study.


One very useful outcome of AVERT is that it demonstrates that randomized controlled trials (RCT’s) can be used to evaluate rehabilitation interventions in a manner similar to how we evaluate medication, surgical or procedural interventions. However, it did take the investigators almost 8 years to accumulate enough patients to have a study powered adequately enough to address the questions asked.






Bernhardt J, Langhorne P, Lindley RI, et al. for the AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015; Published Online April 17, 2015







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Get a Grip on It!



We’ve done many columns on the impact of frailty on surgical outcomes (see list at the end of today’s column). There exist multiple tools for assessing frailty and there has been continued interest in simplifying those tools. A lot of attention in the past several years has been given to gait speed as a parameter easy to assess and highly predictive of outcomes.


Now there has been renewed attention on another component of many frailty indices: grip strength. And it turns out that grip strength not only predicts surgical complications and outcomes but also predicts risk for stroke, MI, cardiovascular and all-cause death.


In an analysis of 351 consecutive patients undergoing major intra-abdominal operations Revenig and colleagues (Revenig 2015) found that “shrinking” and grip strength alone hold the same prognostic information as the full 5-component Fried Frailty Criteria for 30-day morbidity and mortality. When combined with American Society of Anesthesiologists (ASA) score and serum hemoglobin, they form a simple risk classification system with robust prognostic information.


Shortly after that publication, the results of the Prospective Urban-Rural Epidemiology (PURE) study were released (Leong 2015). This was a longitudinal population study done on approximately 140,000 subjects in 17 countries of diverse cultural and socioeconomic settings. Grip strength was measured with a dynamometer. Grip strength was inversely associated with all-cause mortality (16% increase for each 5 kg reduction in grip strength), cardiovascular mortality (17%), non-cardiovascular mortality (17%), myocardial infarction (7%), and stroke (9%). Grip strength was actually a stronger predictor of all-cause and cardiovascular mortality than systolic blood pressure.


So what do you do now with this information? It’s not like we can say “Your cholesterol is elevated and is a risk factor for heart attack and stroke but we can modify that risk with medications.” Unanswered is the question regarding whether improvement in grip strength through physical therapy, for instance, reduces any of the risks. That is unlikely. Much more likely the reduced grip strength is simply a marker for patients having multiple comorbidities that collectively reduce his/her physiologic reserve and make them more vulnerable to adverse outcomes.


But if you were doing a pre-op evaluation on an elderly patient and found poor grip strength you might communicate the increased likelihood of adverse outcomes to that patient and plan for extended resource use during and after the hospitalization. You might also consider using a program like the Hospital Elder Life Program (HELP). A modified HELP intervention, conducted by a trained nurse and not costly, effectively reduced older surgical patients' functional decline and delirium rates by hospital discharge (Chen 2011).



Some of our prior columns on preoperative assessment and frailty:







Revenig LM, Canter DJ, Kim S, et al. Report of a Simplified Frailty Score Predictive of Short-Term Postoperative Morbidity and Mortality. J Am Coll Surg 2015; 220(5): 904-911




Leong DP, Teo KT, Rangarajan S, et al. Prognostic value of grip strength: Findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet 2015; DOI:10.1016/S0140-6736(14)62000-6. Abstract




Chen CC, Lin MT, Tien YW, et al. Modified hospital elder life program: effects on abdominal surgery patients. J Am Coll Surg 2011; 213(2): 245-52







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More Risks for Parkinson Inpatients



We’ve done a couple previous columns highlighting the problems that patients with Parkinson’s Disease run into when they get hospitalized for any reason (see our What’s New in the Patient Safety World columns for August 2011 “Problems Managing Medications in Parkinson’s Disease” and December 2012 “More on Hospitalized Parkinson’s Disease Patients”). Patients with Parkinson’s typically require specific timing of their medications in order to minimize the “on-off” phenomenon and to avoid hyperkinesias. This results in their requiring multiple dosing throughout the day and often at unusual times. Meeting this very precise timing of doses is problematic for most hospitals and hospital units because they are used to their own standardized times for medication dispensing and administration. And most anti-Parkinsonian medications are available only in oral form so it is especially problematic when the patient is NPO or is otherwise unable to swallow. Some anti-Parkinson’s formulations are also of the extended-release variety and should not be crushed. Moreover, drugs that worsen extrapyramidal function are often used in the hospital and these may significantly worsen Parkinsonian features. Patients with Parkinson’s also seem to get temporary declines in function when they get a systemic problem, like an infection.


ISMP has recently done another column on this very problem (ISMP 2015). They provide two case examples that illustrate some of these critical problems. In one case, there was a several hour delay in getting the patient’s medications even though she informed hospital staff immediately about the doses and times. The hospital then scheduled her medication administration for the standard hospital medication administration times. As a result several hours went by in which the patient failed to receive her medications. This led to accentuation of difficulty talking and communicating, increased tremor and difficulty walking. She then became confused and agitated and was given haloperidol, which further worsened her Parkinsonian state.


In the second case, a Parkinson’s patient did not receive his anti-Parkinsonian medications when his wife was not present at the bedside. He, too, was given a contraindicated medication when he developed hallucinations and lost the ability to communicate until his medications were readjusted to the schedule he used at home.


In our December 2012 What’s New in the Patient Safety World column More on Hospitalized Parkinson’s Disease Patients”) we noted a study from The Netherlands (Gerlach 2012) found that 21% of Parkinson patients admitted to a hospital experienced deterioration of motor function and 33% had one or more complications. Moreover, 26% received incorrect anti-Parkinson medications, which was the most significant reason associated with clinical deterioration. And somewhat surprisingly, the researchers found the situation no better in those patients admitted to neurological wards rather than other wards. This simply suggests an overall relative lack of understanding of Parkinson’s disease in healthcare workers who work primarily in inpatient settings. It also reflects some of the rigid medication administration practices we have in most hospitals. Interestingly, in the new ISMP column the first patient scheduled a subsequent elective admission to a hospital where her neurologist worked but she ran into all the same problems even under that arrangement.


ISMP goes on to provide a list of important actions that should be undertaken for inpatients with Parkinson’s Disease:


We encourage you to read the ISMP article for details under each of the above bullet points.


It’s tough enough to manage Parkinson’s Disease as an outpatient. Recognizing these vulnerabilities when patients with Parkinson’s are admitted to hospitals is a first step in preventing complications, minimizing hospital lengths of stay, and avoiding functional deterioration.







ISMP (Institute for Safe Medication Practices). Delayed administration and contraindicated drugs place hospitalized Parkinson’s disease patients at risk. ISMP Medication Safety Alert! Acute Care Edition. March 12, 2015




Gerlach OHH, Broen MPG, van Domburg PHMF, et al. Deterioration of Parkinson's disease during hospitalization: survey of 684 patients. BMC Neurology 2012, 12: 13 (8 March 2012)







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Economics and Blood Transfusion



Over the last decade there has been increasing evidence of the potential harms associated with blood transfusions. Transfusions have been associated with increased risk of infections, SIRS (systemic inflammatory response syndrome), and other complications. While clinical factors need to be considered in any decision about whether to transfuse, use of a hemoglobin (Hb) threshold or trigger is still commonly used. Studies have demonstrated that use of more restrictive Hb triggers (8 g/dL) do not adversely impact patient outcomes and this has been reflected in multiple new guidelines regarding transfusion (see our April 2012 What’s New in the Patient Safety World column “New Transfusion Guidelines from the AABB”).


Now a new study from Johns Hopkins (Ejaz 2015), which has been a leader in improving transfusion practices (see our June 2013 What’s New in the Patient Safety World column “Hopkins Blood Ordering Initiative”), shows that substantial variation in transfusion practices persists, with potentially inappropriate transfusion practices leading to considerable consumption of resources. Ejaz and colleagues looked at PRBC transfusions in patients undergoing major abdominal surgery at Johns Hopkins over almost a 4-year period. They defined “liberal” Hb trigger as transfusion of PRBCs for an intraoperative Hb level of 10 g/dL or greater or a postoperative Hb level of 8 g/dL or greater. Overall, they found that 11.4% of units were transfused using a liberal trigger. They then calculated the estimated costs of such “liberal” transfusions, using an acquisition cost of $220/unit and an activity-based cost of $760/unit (the latter representing the mean cost from another study that calculated the cumulative costs for each step involved in delivering 1 unit of PRBC’s from a donor to a recipient, including technical, administrative, and clinical costs). They estimated that the total overall PRBC transfusion costs may have been reduced by $27,360 to $94,516 per year by adhering to the more restrictive transfusion triggers.


Note that the current study only assessed the acquisition costs of the blood and the estimated costs involved in getting the blood to patients (technical, administrative, and clinical costs). It did not include any additional costs that might have resulted from complications of the transfusion (eg. surgical complications, infection, longer length of stay, etc.). Patients in their study who received transfusions had more perioperative complications and longer lengths of stay even after adjusting for multiple clinical variables. So, given what we know about the potential downsides of unnecessary transfusion, the costs in the current study may be an underestimate of the true total cost of unnecessary transfusion.


The Ejaz study also revealed that the use of “liberal” transfusion varied significantly by type of surgery and by individual surgeon. Significantly, of the 92 participating surgeons the 9 surgeons least compliant with their institutional guidelines accounted for 80% of the total overall estimated excess transfusion costs.


We’ll bet your organization has a similar opportunity to improve both patient outcomes and the financial bottom line by instituting the more restrictive transfusion guidelines and auditing adherence to them.




Prior columns on potential detrimental effects related to red blood cell transfusions:








Ejaz A, Frank SM, Spolverato G, et al. Potential Economic Impact of Using a Restrictive Transfusion Trigger Among Patients Undergoing Major Abdominal Surgery. JAMA Surg 2015; Published online May 06, 2015






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