American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News
for the Week of 6-10-08

Highlights

  • ADVANCE trial finds no link between tight glucose control and mortality in diabetics
  • No difference in PCI outcomes between men and women, study finds
  • Uninsured numbers halved one year after Massachusetts' health insurance mandate

Health Care Disparities

  • Quality of health care affected by race and geography, report finds
  • Studies explore racial, ethnic disparities among kidney disease patients
  • Academy for Health Equity to take aim at disparities

Oncology

  • Desensitization protocol helps allergic patients tolerate chemotherapy

Ethics

  • Student organization rates med schools on pharma interactions

FDA actions

  • Doctors should tell patients to switch to HFA-propelled albuterol inhalers

CMS update

  • Senator acts to avert cuts to Medicare physician payments
  • New provisions mean physicians may still begin participation in PQRI
  • New competitive bidding program for durable medical equipment to begin July 1

From ACP Hospitalist

From ACP online

  • What they’re saying on the blogs and in our newsgroups

Cartoon caption contest


Highlights

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ADVANCE trial finds no link between tight glucose control and mortality in diabetics

Intensive control of glucose reduced the incidence of nephropathy in patients with type 2 diabetes but showed no significant effect on other vascular outcomes, according to new results from the ADVANCE trial.

In the randomized study, 11,140 type 2 diabetes patients underwent either standard therapy or intensive glucose control, which involved the use of gliclazide (modified release) plus other drugs to achieve a glycated hemoglobin of 6.5% or less. The patients were followed for a median of five years, and endpoints were death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, and new or worsening nephropathy or retinopathy.

Patients in the intensive group achieved an average glycated hemoglobin of 6.5%, compared with 7.3% in the standard group. They also had a 21% relative reduction in new or worsening nephropathy (4.1% vs. 5.2%). However, there were no significant differences between the groups in major macrovascular events or mortality. The intensive group did have a higher rate of severe hypoglycemia (2.7% vs. 1.5%). The results were presented at the scientific session of the American Diabetes Association and will appear in the June 12 New England Journal of Medicine.

The results of this study significantly differ from the finding of excess mortality that caused the premature termination of ACCORD, another recent large, randomized trial of intensive glucose control. Study authors noted that no subgroup of ADVANCE participants showed adverse vascular outcomes as a result of intensive control, even those who had an initial glycated hemoglobin value similar to that of ACCORD study subjects.

In fact, the authors speculated that further analyses of ADVANCE combined with other studies may find that intensive control does reduce the risk of macrovascular events because the study was inadequately powered to reliably detect such an effect. The ADVANCE trial did find a reduction in macrovascular outcomes that, although insignificant, was potentially proportional to the decrease in glycated hemoglobin that study participants achieved.

The study was released early online.

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No difference in PCI outcomes between men and women, study finds

The gender gap in outcomes after percutaneous coronary intervention (PCI) has disappeared, with women faring as well as men in both the short- and long-term, a new study found.

Earlier studies have shown that PCI was riskier in women than men, in part because women have smaller arteries. PCI has improved over the last decade, however, with new techniques, stents and medications.

To test the effects of the recent advances, researchers analyzed data from 18,885 patients who underwent PCI at the Mayo Clinic in Rochester, Minn. between 1979 and 2004. Patients were divided into two groups: those treated between 1979 and 1995 (“early group”) and those treated between 1996 and 2004 (“recent group”). Women were older than men at the time of PCI by an average of about five years, and were more likely to have severe or unstable chest pain, diabetes and high blood cholesterol levels. The study is published in the June 10 online issue of the Journal of American College of Cardiology.

The immediate success rate for PCI was 89% in women and 90% in men. Among women, 30-day mortality fell from 4.4% in the early group to 2.9% in the recent group (P= 0.002). Among men, 30-day mortality fell from 2.8% to 2.2% in the same time period (P= 0.04). When researchers adjusted for the greater age and health problems of women at time of PCI, there were no significant mortality differences between men and women either at 30 days or one year after PCI.

The study should reassure many physicians who, research has shown, are more reluctant to refer women for invasive procedures like PCI, said lead author Mandeep Singh, ACP Member, in a release. “Raising awareness among physicians will help us overcome this referral bias. The decision to refer a patient for PCI should not be influenced by gender,” Dr. Singh said.

The Journal of the American College of Cardiology is online.

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Uninsured numbers halved one year after Massachusetts' health insurance mandate

One year after Massachusetts implemented mandatory health insurance, the uninsured rate among adults in the state dropped by almost half, from 13% to 7.1%, according to a new study.

Access to care for low-income Massachusetts adults has increased, and the share of adults with high out-of-pocket health care costs and problems paying medical bills has dropped, the study said. Researchers found no evidence that the state’s expansion of publicly subsidized coverage crowded out employer-sponsored coverage.

The findings were based on two rounds of telephone interviews with randomly selected adults ages 18-64, in fall 2006 and fall 2007. Reforms enacted in April 2006 did the following:

  • expanded the state's Medicaid program,
  • created income-related state subsidies to buy health insurance,
  • created a new purchasing arrangement for private health insurance,
  • created an individual mandate requiring that state residents purchase health insurance,
  • required employers with more than 10 workers either to contribute to their employees’ coverage or pay into a state fund, and
  • consolidated individual and small-group private insurance markets.

Among low-income adults—those in families with incomes less than 300% of the federal poverty level, the group eligible for subsidized coverage under the reforms—23.8% reported being uninsured in fall 2006, while only 12.9% said they lacked coverage in fall 2007, the study reported. Among adults with incomes below 100% of poverty level, who were eligible for fully subsidized coverage, the uninsurance rate dropped by nearly two-thirds, down to 10% in fall 2007.

Other key findings:

  • Increased access to care. In fall 2007, 83.1% of low-income adults said they had a usual source of medical care, compared with 79.5% in fall 2006. In fall 2007, low-income adults were also more likely to report a visit to a dentist and physician for preventive care within the past 12 months than in fall 2006.
  • No crowd-out of employer coverage. The share of working adults using employer-sponsored health coverage remained stable between fall 2006 and fall 2007. Employer coverage among low-income adults increased by 5% between fall 2006 and fall 2007.
  • Fewer financial barriers to care. In fall 2007, 16.9% of low-income adults said that they had not received needed care in the past 12 months because of cost, compared with 27.3% in fall 2006. The proportion of low-income adults with more than $500 in out-of-pocket spending dropped from 48.2% in fall 2006 to 37.4% in fall 2007.

Three major challenges remain. First, costs have exceeded expectations, in part because the number of uninsured adults exceeded initial state projections. Second, between fall 2006 and fall 2007, the percentage of low-income adults who did not receive care because of difficulty finding a health care provider rose from 4.1% to 6.9%. Third, reaching the remaining uninsured adults in Massachusetts—typically young, low-income males in good to excellent health—may be difficult.

The study, conducted by the Urban Institute and published in the June 3 issue of Health Affairs, was supported by the Blue Cross Blue Shield of Massachusetts Foundation, The Commonwealth Fund and the Robert Wood Johnson Foundation.

The article and a companion piece charting challenges and reforms still to be addressed are online.

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Health care disparities

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Quality of health care affected by race and geography, report finds

Getting mammograms and other basic recommended health care varies significantly by race and geographic region, according to a new report on Medicare beneficiaries released last week by the Robert Wood Johnson Foundation.

Researchers at the Dartmouth Atlas Project at the Dartmouth Institute for Health Policy and Clinical Practice analyzed Medicare claims on five quality measures and found that overall, blacks were less likely than whites to get recommended care and that quality varied across regions. One in three women did not get mammograms in 2004-05, the study reported. Blacks were less likely than whites to undergo the screening (57% vs. 64%, respectively) while Maine fared best (74%) and Mississippi worst (57%) in regional comparisons.

The most striking racial disparity was for leg amputations due to complications from peripheral vascular disease and diabetes, the report said. African Americans were five times as likely to lose a leg as were whites (4.17 per 1,000 beneficiaries vs. 0.88 per 1,000, respectively), with the highest rate of amputations in Louisiana (1.66 per 1,000 patients).

Researchers also reported that one in seven patients with diabetes were not getting important blood tests, with 85% of white patients with diabetes getting a hemoglobin A1C test between 2003-05 compared with 79% of blacks. There was a 20-point gap between the state with the highest percentage of diabetics getting the blood tests (Vermont) and the state with the lowest percentage (Alaska).

In conjunction with the report's release, the Robert Wood Johnson Foundation announced a $300 million initiative called Aligning Forces for Quality aimed at improving care in 14 communities across the U.S., according to a June 5 foundation news release. The effort is aimed at improving overall health care quality, reducing racial and ethnic disparities and providing models for national reform.

The Robert Wood Johnson news release and full report[PDF] are online.

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Studies explore racial, ethnic disparities among kidney disease patients

Two studies in the June issue of the Journal of the American Society of Nephrology (JASN) examine the reasons for racial and ethnic disparities in outcomes for chronic kidney disease and propose potential solutions.

The two studies are based on recent government research showing that black and Hispanic patients are more likely than whites to develop end-stage renal disease (ESRD). Health United States 2007, for example, reported that black patients with ESRD make up 33% of all patients on the kidney transplant waitlist but only 13% of the general population, according to a June 4 American Society of Nephrology news release. Similarly, the 2007 National Health Care Disparities Report found that while blacks and whites are equally as likely to receive dialysis, the percentage of blacks on the kidney transplant waitlist is significantly lower than the proportion of whites.

In one of the JASN studies, researchers attribute the disparities to several factors: lack of trust by patients, cultural and communication barriers, and residential segregation that groups minorities in communities with lower quality care. They also point to systemic issues such as lower rates of insurance among minorities and under-representation of minorities in clinical trials. A second article notes that other factors might impact racial disparities in kidney transplantation, such as waitlist registration practices and attitudes and beliefs about organ donation.

Individual physicians can help reduce these disparities, researchers said, by striving to communicate with patients, advocating for improved health systems and conducting relevant medical research, such as why black and Hispanic patients are more likely to progress to ESRD.

An American Society of Nephrology news release is online[PDF].

The JASN articles are online.

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Academy for Health Equity to take aim at disparities

"Building capacity to eliminate health disparities," the founding meeting of the Academy for Health Equity, will be held June 26-27 in Denver.

The nonprofit Academy for Health Equity is a multidisciplinary group dedicated to eliminating health disparities through research, advocacy, education and policy development. The inaugural meeting is expected to establish a forum for experts to share knowledge and practical applications aimed at eliminated racial and ethic disparities.

The conference is aimed at increasing participants' ability to address health systems change, delivery of services, new models of medical care, policies that facilitate access to care and new methods of measurement for preventable diseases in underserved, poorly served and never-served populations. Other goals include:

  • promote evidence-based findings of disease prevention and health promotion,
  • identify gaps in knowledge of the causal factors of health disparities,
  • explore trans-disciplinary approaches to address disparities, and
  • apply the latest theories and practices to improving health literacy, cultural competency and communications programs.

More information about the conference and how to register is online.

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Oncology

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Desensitization protocol helps allergic patients tolerate chemotherapy

A 12-step rapid desensitization protocol may help cancer patients who are allergic to chemotherapy tolerate the drugs, a new study found.

Previous studies have shown that up to 27% of patients who receive more than seven cycles of common chemotherapy drugs develop allergic sensitivity to the medication.

The new study examined 98 patients who had hypersensitivity reactions to carboplatin, cisplatin, oxaliplatin, paclitaxel, liposomal doxorubicin, doxorubicin, or rituximab. The patients, most of whom had breast, ovarian or other gynecologic cancers, received rapid desensitization to the drugs, either intravenously or intraperitoneally, via a standardized protocol that took four to eight hours and involved administering the targeted dose in incremental steps. The study was published in the May 27 online Journal of Allergy and Clinical Immunology.

Of the 413 desensitizations done, 94% induced mild or no reactions. All patients received their full target dose, and no life-threatening reactions or deaths occurred during the procedure. When there were reactions, most occurred during the infusion of the third solution, and during the last step of the protocol. With multiple desensitizations, most reactions were seen in the first two desensitizations. The means by which the drugs were delivered didn’t make a difference in terms of tolerance.

Because the study was biased toward female patients with certain types of cancer, it is uncertain if the results can be generalized to male patients, to those with other types of malignancies, or to patients who are allergic to other kinds of medicine. Still, “the protocol was effective for drugs with different chemical structures and that presumably cause hypersensitivity through different mechanisms,” the study’s authors said. Brigham Women’s Hospital has already adopted the standardized rapid desensitization, a press release said.

The May 27 Journal of Allergy and Clinical Immunology is online.

The American Academy of Allergy Asthma and Immunology release is online.

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Ethics

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Student organization rates med schools on pharma interactions

Many U.S. medical schools still have work to do on their efforts to restrict conflicts of interest caused by pharmaceutical marketing, according to the American Medical Student Association (AMSA).

Last week, AMSA released its PharmFree Scorecard which rated the country’s 150 medical schools on their conflict-of-interest policies. The scorecard evaluated the schools’ regulations on gifts, paid speaking for products, acceptance of samples, interaction with sales representatives and industry-funded education, among other criteria.

Only seven schools received an A, and 14 scored a B. The A-rated schools were: Mount Sinai School of Medicine, the University of Pittsburgh Medical Center, the Uniformed Services University of the Health Sciences, the University of California Los Angeles David Geffen School of Medicine, the University of Pennsylvania School of Medicine, the University of California, Davis School of Medicine, and the University of California, San Francisco School of Medicine.

Of the remaining schools, four received a C, 19 received a D and 60 received an F. Schools that declined to submit policies or did not respond to requests for their policies received an automatic F. An additional 28 respondents received a grade of “in process” because their policies are currently under review or revision.

AMSA collaborated with the Prescription Project, an industry watchdog group, to develop the methodology of the scorecard and an interactive Web site that offers a school-by-school look at policies regarding industry interaction with medical school faculty and trainees.

The scorecard is online.

The May ACP Hospitalist cover story, which looked at changes to conflict-of-interest policies, is online.

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FDA actions

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Doctors should tell patients to switch to HFA-propelled albuterol inhalers

Physicians should talk to their asthma and COPD patients now about switching to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the U.S. after this year, the FDA said.

CFC inhalers are being phased out by Dec. 31, 2008 because they contribute to the depletion of the Earth’s ozone layer. Three HFA inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol is available as Xopenex HFA Inhalation Aerosol.

Manufacturers have been increasing production of HFA albuterol inhalers so an adequate supply is currently available, the FDA said. HFA inhalers may taste and feel different than the CFC inhalers. Patients must also prime and clean HFA-propelled inhalers to prevent buildup of the drug in the inhalation device, which can block the medicine from reaching the lungs. Each HFA inhaler has different priming, cleaning, and drying instructions, which patients should be told to read before using the inhaler.

The FDA release is online.

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CMS update

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Senator acts to avert cuts to Medicare physician payments

Senator Max Baucus (D-MT), chairman of the Senate Finance Committee, introduced legislation last Friday that would avert the physician payment cuts scheduled for the end of June. Currently, physician payments under Medicare are scheduled to be cut by 10.6% on July 1, and by another 5% on January 1, 2009. The bill from Senator Baucus, The Medicare Improvements for Patients and Providers Act of 2008 (S. 3101), would replace the scheduled cuts with 18 months of positive updates to the Physician Fee Schedule.

In addition to averting the payment cuts, the legislation, which is co-sponsored by Senators Olympia Snowe (R-ME), Gordon Smith (R-OR) and Jay Rockefeller (D-WV), provides other significant benefits for internists. It includes a provision to change Medicare budget rules to increase payments for office visits by changing the Medicare relative value units (RVUs). Beginning in 2011, Medicare would also be required to increase payments for office visits to primary care physicians in designated Physician Scarcity Areas. This change would lay the groundwork for Congress, in the future, to expand the increased payments to primary care physicians nationwide. The legislation also includes increased funding for the Medicare medical home demonstration project, a project that would pay physicians a monthly fee for coordinating care of Medicare patients, in addition to their usual fee-for-service payments.

Later in the week Jeffrey P. Harris, MD, FACP, president of ACP, will be emailing College members to let you know how you can help gain support for this legislation. A summary of the legislation can be found online[PDF].

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New provisions mean physicians may still begin participation in PQRI

Physicians can still collect a bonus payment from the Physician Quality Reporting Initiative (PQRI), even if they have not yet begun reporting. The PQRI was introduced by CMS in July of 2007. The program awards a bonus payment of 1.5% of allowed charges for Medicare patients to physicians who submit quality measure codes.

To participate in the 2007 PQRI program, physicians selected three quality measures that applied to their practice. To qualify for the bonus payment, they had to report on 80% of the claims that applied to each of those measures over the course of the year. This threshold made it difficult for physicians to begin participation late in the year.

However, at the end of 2007, Congress passed a law that modified the PQRI so that physicians would not have to meet the 80% threshold if they reported quality measures organized in specific measure groups. Under CMS implementation of the new legislation, physicians choose to report on one of four groups of measures: diabetes, end-stage renal disease, chronic kidney disease, and preventive care. Physicians would then need to report the measures on claims for 15 consecutive eligible Medicare patients to receive a bonus payment of 1.5% of their total allowed Medicare charges for July 1-Dec. 31, 2008.

Full details about participation in PQRI are online.

Additionally, CMS announced last week that the 2007 PQRI Final Feedback Reports will be available through the agency’s Web site in mid-July. The reports will be available by practice, using the Taxpayer Identification Number, and will include information on reporting rates, clinical performance, incentives earned by individual physicians and summary information for the practice. CMS will issue a check to the practice for the amount of the bonus earned by each physician who successfully participated in mid-July 2008.

Practices need to register on the Individuals Authorized Access to CMS Computer Services – Provider Community (IACS-PC) Web site to access their information. Because the process of verifying registration for this secure Web site may take some time, CMS recommends that most practices set up their accounts now so that they can access the reports as soon as they are available. CMS recommends that only group practices or solo practices with a staff member who will access the PQRI reports start to register at this time. If you are in solo practice and will access the website personally, as opposed to having a staff person register and be the access point person, CMS asks that you hold off on registering until it unveils the simpler and less time-consuming process aimed at your practice situation. More information about the IACS and registration is online[PDF].

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New competitive bidding program for durable medical equipment to begin July 1

A new program will change the way that fee-for-service Medicare pays for durable medical equipment under Part B. The Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding will be phased in starting in July.

Spending on DMEPOS has grown, with annual growth rates as high as 20% during the past decade. CMS attributes some of this growth in spending to Medicare’s current DMEPOS payment system. The old system is based on historical Medicare payments, which led to CMS, at times, paying far more than the retail price for many items of DMEPOS. Under the new program suppliers must compete by submitting bids to furnish certain medical equipment and supplies. Medicare uses these bids to set a single payment amount for those items within a particular competitive bidding area.

Under the new program, physicians still will be allowed to furnish to their patients certain types of competitively bid items without having to be a Medicare contract supplier. The items are limited to crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors and infusion pumps. Physicians will be paid using the single payment amount established for the area through the competitive bidding process.

On July 1, the new payment amounts will be effective in 10 of the largest Metropolitan Statistical Areas. In 2009 the program will be expanded into 70 additional Metropolitan Statistical Areas, and into other locations thereafter.

More information about the DMEPOS competitive bidding program can be found on the CMS Web site.

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From ACP Hospitalist

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Recommend your colleagues as Hospitalists of the Year

ACP Hospitalist is seeking candidates for its first annual Hospitalists of the Year issue. To recommend a colleague who made notable contributions to the field in 2008, whether through cost savings, improved work flow, patient safety, leadership, mentorship or quality improvement, readers can fill out the online form. All recommendations must be received by July 14. Hospitalists of the Year will be profiled in our November 2008 issue.

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From ACP online

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What they’re saying on the blogs and in our newsgroups

Join your colleagues on ACP's blogs and online newsgroups, which let our member internists talk directly to one another about what's on their minds. Clinical issues, politics, practice management issues and even some humor are part of the mix.

In the past week alone, ACP Internist's blog has updated clinicians on breaking medical advances, highlighted two useful resources for keep abreast of guidelines and drug alerts, and continued its feature on "Medical News of the Obvious," new every Monday.

Updates happen daily, so keep checking back.

ACP’s discussion boards let internists reach one another about clinical and practice management issues. The newsgroups have been active for years and have a core of members who post items ranging from curbside consultation on patients to passionate political debate.

In the Clinical Practice newsgroup, one participant wrote: “The speaker [at Internal Medicine 2008] indicated that he told his medical students and residents that to him this drug was more than just equal to placebo, it was a drug that seemed to work 40% of the time and he reminded the students that in real life practice placebo is not an option.”

A respondent replied: “In oncology, we'll reject a therapy that isn't significantly better than placebo. Not only must the benefit (as defined prior to the trial)—be it progression free interval, response rate, etc. must be statistically better than placebo; but the result must be clinically meaningful. A treatment that improves survival by one week isn't worthless, even if the p value is <0.00001.”

Join discussions at http://www.acponline.org/auth-cgi/readnews.pl.

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Cartoon caption contest

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Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner.

Put words in our mouth

E-mail acpinternist@acponline.org all entries by June 13. ACP staff will choose three finalists and post them in the June 17 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the June 24 issue.

Pen the winning caption and win a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.

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About ACP InternistWeekly

ACP InternistWeekly is a weekly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.

To add your e-mail address to your member record and to begin receiving ACP InternistWeekly, please click here.

Copyright 2008 by the American College of Physicians.

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