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February 18, 2015 ACFAS.org | FootHealthFacts.org | JFAS | Contact Us

News From ACFAS


What Super Bowl? ACFAS 2015 Takes Over Phoenix
ACFAS 2015 is here and the excitement is palpable! Attendees are arriving at the Phoenix Convention Center, the pre-conference workshops are in full swing and preparations are well underway for tomorrow morning’s opening general session with physician-researcher and noted author David H. Newman, MD.

The buzz today is all about tomorrow’s instructional courses, educational programs and workshops that officially kick off ACFAS 2015. Attendees will be inspired by thought-provoking sessions where they can find the limitless opportunities that lie ahead of them, including:
  • Surgical IQ: Ego, Humility, Maturity and Renewed Perspectives
  • Minimally Invasive Surgery: Pendulum Swinging Back?
  • Charcot Ex-Fix Sawbones Workshop
ACFAS 2015 runs until Feb. 22, and plans are already in place for next year’s conference in Austin, Texas. Mark your calendars now for ACFAS’ 74th Annual Scientific Conference scheduled for Feb. 11–14, 2016 at the Austin Convention Center.
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Follow #ACFAS2015 on Social Media
ACFAS’ Twitter and Facebook feeds are already buzzing about the 2015 Annual Scientific Conference in Phoenix! Stay in the loop no matter where you are—just follow #ACFAS2015 on Twitter and Facebook. ACFAS 2015 is on target to be the biggest conference yet—don’t miss out on the action!
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Going Mobile at ACFAS 2015!
ACFAS has officially landed in Phoenix—keep track of all the conference action by downloading the free ACFAS 2015 Mobile App. Even if you’re not in Phoenix, you can still follow all the happenings in sessions and events, locate vendors and read up-to-the-minute action on our Twitter and Facebook feeds—right in the app!

Download the app today via:
1. Your mobile phone's Web browser at http://m.core-apps.com/acfas2015.
2. Your app store by searching ACFAS 2015.
3. Visiting acfas.org/phoenix for a link.

Once you’ve downloaded your app, you can populate it with your personal schedule and contact information by entering your Attendee ID located on the back of your badge or in an email you received from the College.

Our mobile app keeps ACFAS 2015 right at your fingertips and keeps you on the move—download today!
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ACFAS Regional Division Elects New Officer
Congratulations to Adam E. Fleischer, DPM, MPH, FACFAS of Division 6: Midwest, on being elected the new Treasurer/Secretary for the Division.

Dr. Fleischer’s term will commence at the 2015 Annual Scientific Conference in Phoenix.

Many thanks to all local officer candidates for becoming involved in their ACFAS Division and to all ACFAS Division members who voted in their local election.
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Foot and Ankle Surgery


Comparison of SPECT/CT and MRI in Diagnosing Symptomatic Lesions in Ankle and Foot Pain Patients: Diagnostic Performance and Relation to Lesion Type
Researchers compared the diagnostic performance of single-photon emission computed tomography (SPECT) plus computed tomography (CT) and magnetic resonance imagery (MRI) in patients with ankle and foot pain, in terms of lesion types. The study enrolled 50 consecutive patients who received 99mTc-MDP SPECT/CT and MRI. Determination of symptomatic lesions was based on clinical examination and response to treatment. Detected lesions were classified on MRI and SPECT/CT as bone, ligament/tendon and joint lesions. Uptake on SPECT/CT was evaluated with a 4-grade system. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of SPECT/CT and MRI were assessed in all detected lesions and each lesion type. Analysis of diagnostic value of uptake grade was performed using receiver-operating characteristics (ROC) curve analysis. Diagnostic performance was compared via Chi-square or McNemar tests. The respective sensitivity, PPV and NPV of SPECT/CT for symptomatic lesions overall were 93 percent, 56 percent and 91 percent, and 98 percent, 48 percent and 95 percent for MRI. No significant difference between SPECT/CT and MRI was observed, but the specificity of SPECT/CT was significantly higher than that of MRI. Uptake grade on SPECT/CT was substantially higher in symptomatic lesions, and its area under curve on ROC analysis was 0.787. Lesion type analysis demonstrated poor specificity of SPECT/CT versus MRI, while MRI showed lower specificity than SPECT/CT in bone lesions and ligament/tendon lesions.

From the article of the same title
PLoS ONE (02/15) Ha, Seunggyun; Hong, Sung Hwan; Paeng, Jin Chul; et al.
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Underlying Reasons Associated with Hospital Readmission Following Surgery in the United States
A study was held to define reasons, timing and factors associated with unplanned post-surgical hospital readmissions, focusing on patients undergoing surgery at one of 346 continuously enrolled U.S. hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program between Jan. 1, 2012, and Dec. 31, 2012. Readmission rates and reasons were evaluated for all surgical procedures and for six representative operations: bariatric procedures, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair and lower extremity vascular bypass.

The unplanned readmission rate for the 498,875 operations was 5.7 percent. For individual procedures, the readmission rate ranged from 3.8 percent for hysterectomy to 14.9 percent for lower extremity vascular bypass. Overall, and after colectomy or proctectomy, ventral hernia repair, hysterectomy, arthroplasty and lower extremity vascular bypass, the most frequently cited reason for unplanned readmission was surgical site infection (SSI). The second most common reason for readmission overall, and after colectomy or proctectomy, ventral hernia repair and hysterectomy, and the most common reason for readmission after bariatric surgery, was obstruction or ileum.

Just 2.3 percent of patients were readmitted for the same complication they had experienced during their index hospitalization, and only 3.3 percent of patients readmitted for SSIs had sustained an SSI during index hospitalization. No time pattern for readmission was observed, and early and late readmissions related to the same three most common reasons: SSI, ileus or obstruction and bleeding. A higher risk of readmission was associated with patient comorbidities, index surgical admission complications, non-home discharge, teaching hospital status and higher surgical volume.

From the article of the same title
Journal of the American Medical Association (02/03/15) Vol. 303, No. 5, P. 483 Merkow, Ryan P.; Ju, Mila H.; Chung, Jeanette W.; et al.
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Practice Management


The Key Factors When Explaining Treatment Risk
When explaining treatment risk, physicians must weigh various factors, with some being less aggressive in describing risks if they think the treatment would be of benefit to the patient. However, experts say full disclosure of risks is critical to ensuring patient autonomy. How physicians describe risk, both verbally and nonverbally, is important. One expert advises when having an informed consent discussion, a physician must look the patient in the eye, rather than analyze a body part or stare at a computer screen, and respond empathically to patients' responses. Also recommended is physicians assuming an "ask, tell, ask" approach to the dialogue, in which patients are asked to describe what they know about a treatment before educating them about it as part of the consent process. It also is suggested physicians ask patients to reiterate what they have heard to make sure they understand. Physicians also should try to make patients feel less vulnerable. Another expert urges physicians to have a "PABRC" conversation with patients to protect their autonomy and ensure they have sufficient information to act in their own best interest. A PABRC conversation is one in which the medical provider outlines the procedure, alternatives, benefits, risks and complications. Also advised is careful and thorough documentation of the risk conversation and informed consent process, especially from a legal perspective. Physicians need to strictly concentrate on explaining the material risks of treatment, namely those that occur most often and have a higher severity. An expert recommends patients be asked to report what they understand about the risks, benefits and alternatives of the treatment and to continue the conversation until the patient fully understands.

From the article of the same title
Medscape (02/04/15) Reese, Shelly
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Three Strategies to Help Your Practice Embrace ICD-10
Three strategies can help physician practices adopt ICD-10, starting with overcoming the fear many people feel toward the system. "There's absolutely nothing here that doctors aren't already aware of; it's just about making sure you communicate the patient's story more fully," says the American Academy of Family Physicians' Barbie Hays. Although some legitimate concern exists about cash-flow difficulties in the last quarter of the year, when the new codes are enacted, Hays notes this is easily addressed by setting aside some money to tide the practice over. Ensuring the entire team is invested in the plan to embrace ICD-10 also is vital. "Try to get everyone in the practice involved in planning for the transition," recommends American Academy of Professional Coders (AAPC)-certified coder/trainer Asia Blunt. "Ask for input at staff meetings. Ask for suggestions about how to make training more fun and effective. If everyone has a say in the process, they will feel more a part of things and less likely to resent the change." Finally, promoting ICD-10 as a long overdue improvement in medical documentation may be the biggest driver of practice buy-in. "Healthcare providers get into this field because they want to take care of patients," stresses AAPC's Jackie Stack. "ICD-10 will enable them to provide better patient care."

From the article of the same title
Physicians Practice (02/04/15) Hurt, Avery
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Health Policy and Reimbursement


GAO Gives CMS ICD-10 Readiness Thumbs Up
A new report from the Government Accountability Office (GAO) found that the Centers for Medicare and Medicaid Services' (CMS') efforts to prepare providers, clearinghouses and health plans for the upcoming ICD-10 deadline on Oct. 1 are on track, and that CMS is prepared to process claims using the new codes. GAO says that CMS has developed appropriate educational materials and has carried out appropriate outreach and monitoring of covered entities and vendors. CMS has also modified its Medicare systems and policies to be in line with the impending shift to ICD-10, and the agency has provided technical assistance to Medicaid agencies and has ensured they are prepared for ICD-10.

From the article of the same title
Health Data Management (02/15) Slabodkin, Greg
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Medicare Getting Stricter on Covering High-Priced Therapies
A new study from Tufts University examines the Centers for Medicare and Medicaid Services' (CMS') decisions to cover or not cover new "big-ticket" treatments during the last decade and a half. The researchers examined CMS' evidence base for national coverage determination to see how the agency's coverage decisions have changed between February 1999 and August 2012. They found that of the 213 coverage decisions made during that period, 126 were positive decisions, 74 were noncoverage decisions and 13 were coverage with evidence development policies. They found that coverage approvals were 20 times more likely in the first three and a half years of the studied period than in the last three and half years. Another trend the researchers noticed was that in the last five years, CMS has rarely issued noncoverage decisions, preferring instead to approve a treatment only for specific patient populations.

From the article of the same title
MedPage Today (02/06/15) Firth, Shannon
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Survey Reveals ICD-10 Costs for Small Physician Practices Significantly Lower
The Professional Association of Health Care Office Management (PAHCOM) has presented the results of a survey of small physician practices about the costs of ICD-10 at a congressional briefing in Washington, DC. The survey of 276 physician offices with six or fewer providers found that ICD-10 expenditures were dramatically lower than initially feared. The survey found that ICD-10 expenditures across an entire practice averaged $8,167, with average per-provider expenditures of between $3,430 for a single-provider practice and $1,838 for a six-provider practice.

From the article of the same title
HIT Consultant (02/10/15) Pennic, Fred
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Medicine, Drugs and Devices


Denosumab Effective Over Two Years in Men With Low Bone Density
Treatment with the antiresorptive denosumab appears to be safe and effective over a two-year period in men with low bone mineral density, according to a study published in the Journal of Clinical Endocrinology & Metabolism. During the second year of treatment, bone mineral density continued to increase at all sites assessed and bone resorption decreased, according to the results of the Phase 3 ADAMO study. The study included a double-blind, placebo-controlled phase and was funded by Amgen, which markets denosumab.

From the article of the same title
Reuters Health (01/30/15)
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Determination of Loads Carried by Polypropylene Ankle-Foot Orthoses: A Preliminary Study
A study was conducted to establish a method enabling quantification of the contribution of ankle-foot orthoses (AFOs) to the control of the ankle joint during gait, with emphasis on measuring strain on the AFO during walking by the use of strain gauges. In the wake of successful experimentation with the use of strain gauges to measure polypropylene tensile specimens, an AFO was instrumented by affixing strain gauges to it so as to allow the movement generated on the AFO in the sagittal plane about the ankle to be quantified. Walking trials using this AFO on an able-bodied subject exhibited good step-to-step repeatability. Utilization of an instrumented AFO coupled with kinematic and kinetic data acquisition would enable determination of the contribution of the AFO and the residual anatomical loads. The benefit of such a procedure over previously used procedures is that the orthosis is actually being worn by patients, thereby allowing tests to be performed under real-life situations. It is thought such analysis of the load actions of an orthosis, which may in the future be carried out in three dimensions, would enable better understanding of leg-orthosis interaction.

From the article of the same title
Journal of Engineering in Medicine (01/15) Vol. 229, No. 1, P. 40 Papi, Enrica; Maclean, John; Bowers, Roy J.; et al.
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FDA Makes Official Its Hands-Off Approach to Regulating Health Apps and Medical Software
The U.S. Food and Drug Administration (FDA) has issued final guidance on the regulation of health apps and other software confirming that it will take a hands-off approach to most medical device data systems (MDDS), software that conveys data to and from medical devices. In a statement about the new guidance, FDA said, "This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store or display data from medical devices." The agency updated its Mobile Medical Device Apps guidance to conform with the MDDS guidance, stating that they will not regulate apps that do not pose a real health threat to the user if they do not malfunction.

From the article of the same title
VentureBeat (02/06/15) Sullivan, Mark
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FDA Wants Consumer-Friendly Drug Ads
In a new draft guidance, the U.S. Food and Drug Administration (FDA) suggests that drug makers offer "consumer-friendly" summaries in print ads and promotional materials, instead of lengthy fine print describing risks and caveats. The summaries would still include information about serious risks, such as adverse events and interactions with other drugs, but would not need to include every specific side effect or so-called contraindication. "Many consumers lack the technical background to understand some of the information as described" in what is known as the package insert, the detailed risk information that accompanies a prescription and is duplicated in ads, FDA writes in its draft guidance. Moreover, some of the information, such as clinical pharmacology, "may be of limited use to consumers. The agency recommends the brief summary "focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers." In explaining its decision to alter policy, FDA cites research showing that few consumers read half or more of a brief summary that was presented in the traditional format.

From the article of the same title
Wall Street Journal (02/06/15) Silverman, Ed
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Generic Drug Industry Gets More Time to Comment on New FDA Regulatory Policies
The U.S. Food and Drug Administration (FDA) has posted a notice on its website that it is extending the public comment period on a number of aspects of the Generic Drug User Fee Act (GDUFA). Like other user fee programs, GDUFA would set up user fees that would be levied on generic drug makers for applications and inspections. In exchange, FDA has said that it will hire more staff to speed up the generic drug review process and make improvements to its regulatory review system. Since the passage of GDUFA, FDA has released a number of guidance documents outlining means of making it easier for generic manufactures to submit Abbreviated New Drug Applications. In its notice, FDA says that it is extending for an extra 30 days the public comment period on five of the guidance documents as well as a proposal for 180-day first-to-file exclusivity determinations. However, FDA said that it was no longer seeking public comment on the issue of first generic review prioritization, which is being worked on separately.

From the article of the same title
Regulatory Affairs Professionals Society (02/06/2015) Gaffney, Alexander
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This Week @ ACFAS
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This Week @ ACFAS is a weekly executive summary of noteworthy articles distributed to ACFAS members. Portions of "This Week" are derived from a wide variety of news sources. Unless specifically stated otherwise, the content does not necessarily reflect the views of ACFAS, and does not imply endorsement of any view, product or service by ACFAS.

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