CiteSeerX — COMMENTS AND RESPONSES Evaluating Open Access: Problems with the Program or the Studies? TO THE EDITOR: I

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Evaluating Open Access: Problems with the Program or the Studies?

TO THE EDITOR:I had the opportunity to read the article by Me- hrotra and colleagues (1). As one of the authors commonly cited in the article’s references section, I feel qualified to comment. Although I applaud the efforts of the practices to make fundamental changes in the way they operate, to make a systematic approach to improve- ments, and to explore change over time, this investigation contains serious and fundamental flaws. First, my co-authors and I have em- phasized that the fundamental dynamic in appointment scheduling is the necessity of balancing or matching patient demand with practice appointment supply or capacity. The first principle in improvement in this field is to fully understand, measure, and achieve a balance between demand and supply. If demand exceeds supply, no system will work. We can develop an understanding of the balance of demand and supply by reviewing 3 critical measures: third-next- available appointment time; daily demand, supply, and activity; and panel size. If the third-next-available appointment measure is stable, this implies a demand–supply balance. If not, it implies a mismatch.

If the daily demand, supply, and activity pattern is favorable, then this implies a balance. Finally, the panel size simply must be man- ageable. The panel capacity limit can be defined by a formula (2, 3).

In Mehrotra and colleagues’ study, although the third-next- available appointment was defined, measured, and monitored over time, the other 2 key measures (daily demand, supply, and activity and panel size) are missing. Without an understanding of the basic demand and supply dynamic and without any accurate measures, it is not surprising that the practices struggled. In addition, most of the studied practices exhibited some early gains, which were derailed by supply loss. If demand continues unabated and supply disappears, then a delay will ensue. The supply loss (illness in 3 of 6 practices, departure in 1 of 6 practices, and maternity leave in 5 of 6 practices) was statistically significant and substantial, often representing a large proportion of the practice full-time equivalents. An aggregate pro- vider “loss” of 9 out of 35.3 total providers is 25%. Second, despite ignoring the most critical of the change strategies that lead to delay reduction, a set of 9 “Elements of Open Access Implementation”

were introduced within a table. I recognize that word limitations restrict an adequate description of how these strategies were utilized.

At the same time, little evidence suggests that backlog (element 1) was ever completely addressed except perhaps temporarily in 1 of the 6 practices, and it is difficult to visualize how “carved out” capacity for same-day appointments (element 4) was avoided when the delays never reached the goal. In addition, my co-authors and I have never advocated the elimination of follow-up appointments (element 5) (4). In fact, we specifically recommend against this strategy. In sum- mary, no evidence suggests that even the incomplete set of elements described in the article was implemented.

The real challenge in this work is how to build systems that resonate with what patients want and reflect the goals and attributes, as outlined in the Institute of Medicine’s report (5). This will require that all of us understand the basic flow dynamic at work here. Every day, all day long, one patient at a time, we are matching customer demand to our capacity. We have no choice about this. We do have

choice about whether to do it well or do it poorly. Doing it well means building systems that function without delay. To accomplish that, we simply must understand the underlying demand and supply.

Although Mehrotra and colleagues’ study was admirable in address- ing vexing problems that we all face, it is inadequate in its understanding of that dynamic.

Mark F. Murray, MD, MPA Mark Murray & Associates Sacramento, CA 95816

Potential Financial Conflicts of Interest:Mark Murray & Associates Healthcare consulting group.

References

1. Mehrotra A, Keehl-Markowitz L, Ayanian JZ. Implementing open-access scheduling of visits in primary care practices: a cautionary tale. Ann Intern Med. 2008;148:915- 22. [PMID: 18559842]

2. Murray M, Davies M, Boushon B. Panel size: how many patients can one doctor manage? Fam Pract Manag. 2007;14:44-51. [PMID: 17458336]

3. Murray M, Davies M, Boushon B. Panel size: answers to physicians’ frequently asked questions. Fam Pract Manag. 2007;14:29-32. [PMID: 18046954]

4. Murray M. Answers to your questions about same-day scheduling. Fam Pract Manag. 2005;12:59-64. [PMID: 15813306]

5. Committee on Quality of Health Care in America, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC:

National Academy Pr; 2001.

TO THE EDITOR:By claiming that their study calls into question the benefits of advanced access, Mehrotra and colleagues (1) have mis- interpreted and misconstrued their findings. What they have in fact demonstrated is simply that if a practice attempts to implement advanced access and fails, it will not realize any of the well-docu- mented benefits of the system. Although reduction in third-next- available appointments for both “short” and “long” appointments is an improvement, it is in no way sufficient to claim that “advanced access” has been achieved. It is therefore no wonder that neither no-show rates nor staff and patient satisfaction improved substan- tially.

Anyone who has attempted to secure a medical appointment and has been offered a next-available appointment weeks or months in the future can immediately appreciate the benefits of advanced access. It is not until the answer for any appointment request is

“How would you like to come in today?” that true advanced access, with all of its benefits, can be achieved. Rather than cast doubt on advanced access, Mehrotra and colleagues’ study should encourage practices interested in transforming their systems to aggressively plan for and manage the challenges that the practices in the study encoun- tered. Only by bringing into balance the supply of and demand for visits will they achieve success.

We have successfully implemented and maintained advanced access in our 7 community health center practice locations in Con- necticut for several years. Although we have faced the same challenges, particularly around maternity leaves, open unfilled positions, and unpredictable demand, we have been able to keep supply and demand roughly in balance through aggressive recruiting, use of lo- cum tenens, and shaping demand in every way possible. Patients and providers have come to know that our commitment to them is that

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all patients in need of an appointment will be offered one at a day and time convenient for them, preferably within 24 hours.

Daren R. Anderson, MD Community Health Center, Inc.

Middletown, CT 06457

Potential Financial Conflicts of Interest:None disclosed.

Reference

TO THE EDITOR:Mehrotra and colleagues (1) describe the difficulties experienced by 6 primary care practices in Boston seeking to implement open-access scheduling. In England, practices have been strongly encouraged to implement advanced access (based on open- access scheduling) after the positive experiences reported by Murray and Berwick (2) in the United States. Practices were given financial incentives to offer people an appointment within 48 hours. A primary care collaborative was established, and “access facilitators” were used in each local area to help practices work together to introduce advanced access.

We did a comprehensive evaluation of this initiative in a before- and-after comparison of 48 practices that did or did not implement advanced access (3, 4). Our evaluation addresses most of the limitations of previous research highlighted by Mehrotra and colleagues because we included a control group and a larger sample of practices and assessed a wide range of outcomes by using both quantitative and qualitative methods.

Advanced access practices provided faster access to care than control practices, with 75% of patients in advanced access practices being seen within the target of 48 hours compared with 57% of patients in control practices (adjusted odds ratio, 2.32 [95% CI, 1.51 to 3.57]; P⬍ 0.001). However, patients in advanced access practices were more likely to report difficulties booking in advance and were no more satisfied overall with the appointment system than patients in control practices (4). The 2 types of practice did not differ in terms of workload, failed appointment rates, or continuity of care (3). Of interest, speed of access was not as important to patients as being able to book an appointment at a convenient time. For some patient groups, particularly the elderly and those with chronic illness, speed was less important than being able to see a particular preferred physician (4).

Early case study reports made dramatic claims for the benefits of advanced access and open-access scheduling, but these claims have not been supported by independent rigorous research once the approach has been rolled out more widely. Several authors (including Murray) have described the difficulties and mixed results that practices have experienced in implementing the model (5, 6). This is typical of organizational innovation, because ideas become adapted, diluted, and often less effective once they spread beyond the early pioneers. If practices in England had limited success in improving access by using open-access scheduling with all the support and incentives available to them, this should raise questions about the effectiveness of the approach.

Chris Salisbury, MD University of Bristol

Bristol, BS8 2AA, United Kingdom

References

2. Murray M, Berwick DM. Advanced access: reducing waiting and delays in primary care. JAMA. 2003;289:1035-40. [PMID: 12597760]

3. Salisbury C, Montgomery AA, Simons L, Sampson F, Edwards S, Baxter H, et al.

Impact of Advanced Access on access, workload, and continuity: controlled before-and- after and simulated-patient study. Br J Gen Pract. 2007;57:608-14. [PMID:

17688754]

4. Salisbury C, Goodall S, Montgomery AA, Pickin DM, Edwards S, Sampson F, et al.

Does Advanced Access improve access to primary health care? Questionnaire survey of patients. Br J Gen Pract. 2007;57:615-21. [PMID: 17688755]

5. Murray M, Bodenheimer T, Rittenhouse D, Grumbach K. Improving timely access to primary care: case studies of the advanced access model. JAMA. 2003;289:1042-6.

[PMID: 12597761]

6. Pope C, Banks J, Salisbury C, Lattimer V. Improving access to primary care: eight case studies of introducing Advanced Access in England. J Health Serv Res Policy.

2008;13:33-9. [PMID: 18325154]

TO THE EDITOR:Kudos to Mehrotra and colleagues (1) for their effort to implement and evaluate open-access scheduling of visits to 6 Boston-area primary care practices. Unfortunately, because the authors didn’t come close to achieving their goal of same-day access, it is difficult to draw meaningful conclusions from their findings. Few patients with an acute problem are likely to consider an 8-day wait for a 15-minute appointment to be a meaningful improvement. But evidently, that was the best these practices could do.

When a patient with a physically uncomfortable or worrisome problem cannot secure an appointment within a reasonable amount of time, one should not be surprised if he or she heads to the nearest emergency department. In fact, emergency department visits by per- sons whose family income is greater than 400% above the poverty level, and those whose usual source of care is a physician’s office, are growing at a much faster rate than emergency department visits by the uninsured (2). Nevertheless, lack of timely access to primary care has not deterred policymakers and third-party payers from labeling many of these visits “inappropriate” or “preventable.”

For far too long, hospital emergency departments have been used to Band-Aid major flaws in our health care system (3). One of the most serious challenges is that tens of millions of U.S. citizens lack timely access to primary care. The paper by Mehrotra and colleagues (1) shows just how tough this will be to fix.

Arthur L. Kellermann, MD, MPH Emory University School of Medicine Atlanta, GA 30322

References

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2. Weber EJ, Showstack JA, Hunt KA, Colby DC, Grimes B, Bacchetti P, et al. Are the uninsured responsible for the increase in emergency department visits in the United States? Ann Emerg Med. 2008;52:108-15. [PMID: 18407374]

3. Institute of Medicine Committee on the Future of Emergency Care in the U. S.

Health System. Hospital Based Emergency Care: At the Breaking Point. Washington D.C. National Academies Pr; 2006.

IN RESPONSE:Dr. Murray and Dr. Anderson question the implementation of open access described in our article and raise concerns about whether supply and demand were adequately assessed. In fact, the participating practices used all 3 measures that Dr. Murray rec- ommends, but panel size, as he has noted, has limited utility in predicting demand (1). On the basis of these 3 measures, the practice leaders judged that supply and demand were in balance at the start of implementation. As detailed in our article, the loss of providers threw off the balance of supply and demand, leading to worsening access and difficulty in convincing providers to reduce the scheduling backlog a second time.

Dr. Murray worries that the model was incompletely or incor- rectly implemented. Open-access experts judged that the practices had implemented the model correctly, including adequately working down the scheduling backlog using extra sessions and “max-pack- ing.” Practices did not force the elimination of follow-up appointments, but a system was created to track follow-up appointments if physicians and patients chose not to prebook appointments months into the future.

Dr. Murray and Dr. Anderson also assert that because the practices did not achieve same-day access, our results are not a fair as- sessment of the impact of open access. However, we have not con- cluded open access cannot work but instead evaluated why it did not achieve the desired results in the 6 practices we studied.

We appreciate Dr. Salisbury’s evaluation of an open-access initiative in England. Although the initiative was implemented within a different health care system, his findings were very similar to those in our report. The practices were able to increase access to care, but this did not result in improved patient satisfaction or reduced no-show rates. Our concern is that evidence supporting open access is mixed;

we hope our study can prompt other rigorous evaluations in the future.

Providing more timely access to primary care is an important goal for many health care systems (2). As Dr. Kellermann notes, emergency departments should not be used as a “Band-Aid” for poor access. Enhancing access is a key component of other proposed reforms to improve primary care, such as the model of the patient- centered medical home (3). We believe all such reforms should not be accepted simply on face validity or anecdotal evidence but rather should be subject to rigorous evaluation to determine how and why they succeed or fail.

Ateev Mehrotra, MD, MPH

University of Pittsburgh School of Medicine Pittsburgh, PA 15213

Lori Keehl-Markowitz, RN, BSN

Crocheted Mountain Rehabilitation Hospital Greenfield, NH 03047

John Z. Ayanian, MD, MPP Harvard Medical School Boston, MA 02115

References

1. Murray M, Berwick DM. Advanced access: reducing waiting and delays in primary care. JAMA. 2003;289:1035-40. [PMID: 12597760]

2. Schoen C, Osborn R, Doty MM, Bishop M, Peugh J, Murukutla N. Toward higher-performance health systems: adults’ health care experiences in seven countries, 2007. Health Aff (Millwood). 2007;26:w717-34. [PMID: 17978360]

3. American Academy of Family Physicians, American Academy of Pediatrics, Ameri- can College of Physicians, American Osteopathic Association. Joint Principles of the Patient-Centered Medical Home. February 2007. Accessed at www.aafp.org/online/etc /medialib/aafp_org/documents/policy/fed/jointprinciplespcmh0207.Par.0001.File .tmp/022107medicalhome.pdf on 4 November 2008.

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Remission of Hepatitis B Virus–Related Cryoglobulinemic Vasculitis with Entecavir

Background: Cryoglobulins are cold-precipitating immuno- globulins that persist in the serum and resolubilize when rewarmed.

Cryoglobulinemic vasculitis is thought to result from the deposition of cryoglobulins on the vessel wall, which activates and mediates this damage. Cryoglobulinemic vasculitis has been well described in chronic hepatitis B and C infection. Entecavir, an analogue of 2'-deoxyguanosine, is converted intracellularly to an active 5'- triphosphate form that inhibits hepatitis B virus (HBV) polymerase (1). Entecavir exhibits potent antiviral activity in patients with chronic HBV infection.

Objective: To describe a case of chronic HBV infection–related cryoglobulinemic vasculitis that responded to entecavir treatment.

Case Report: A 57-year-old Japanese man had chronic HBV infection with a 2-month history of intermittent palpable purpura involving his upper extremities and buttocks. Examination at his first visit revealed palpable purpuric patches and confluent purpuric lesions on his lower extremities. Microscopic examination of skin biopsy specimens demonstrated leukocytoclastic vasculitis in the small vessels of the upper to middle dermis. Direct immunofluores- cence testing revealed perivascular deposits of C3 (Figure). Liver ultrasonography findings were consistent with chronic hepatitis.

Electromyography revealed loss of both motor and sensory function in the peripheral nerves of the legs.

Test results for hepatitis B surface antigen, hepatitis B envelope antibody, and hepatitis B core antibody IgG were positive, and test results for hepatitis B surface antibody and hepatitis B envelope antigen were negative, confirming past exposure. Hepatitis B virus DNA was measured at 6.2 log genome equivalents (LGEs)/mL (normal, 0 to 3.7 LGE/mL) by transcription-mediated amplification.

The level of IgG antiphosphatidylserine–prothrombin complex (anti-PS/PT) antibody was 40 U/mL (normal,⬍12 U/mL) and lupus anticoagulant was positive. To clarify the possible relationship between IgG anti-PS/PT antibody and the cryoglobulins, we measured the anti-PS/PT antibody levels of cryoprecipitates and cryoglobulin- free sera obtained from his serum. His serum was incubated for 48

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hours at 4 °C, and cryoprecipitates were separated by centrifuge for 5 minutes. The cryoprecipitates were washed 3 times with a small volume of ice-cold, phosphate-buffered saline (pH, 7.2). Then the cryoprecipitates were dissolved in warmed (37 °C), phosphate-buffered saline for 2 hours, and the IgG anti-PS/PT antibody level was measured (at 37 °C). We detected that IgG anti-PS/PT antibody level in the cryoprecipitates was higher (120 U/mL) than that in cryoglobulin-free sera (20 U/mL) under the same dilution condi- tions.

The patient was treated with entecavir monotherapy, and within 6 months, HBV DNA levels decreased below the limit of detection; his purpuric rash with paresthesia and numbness disap- peared; and his serum cryoglobulins, anti-PS/PT antibodies, and lupus anticoagulant also became negative.

Discussion: The mechanism of association between hepatitis in- fection and vasculitis is unclear. Phosphatidylserine is a constituent of cell membranes that are exposed during apoptosis or other forms of cell damage, and some reports have suggested that it is initially present in the particles produced by infected hepatocytes during HBV infection (2). Also, prothrombin binds to the surface of apoptotic cells (3). On the basis of our findings of higher anti-PS/PT antibody titers in cryoprecipitates than in cryoglobulin-free sera and of C3 deposition by direct immunofluorescence testing within the cryoglobulinemic vasculitis lesions, we propose that prothrombin in- duced by destroyed hepatocytes binds to phosphatidylserine produced by HBV, triggering production of anti-PS/PT antibody and other cryoglobulins; endothelial cell damage, an inflammatory cyto- kine cascade, and complement activation; and vasculitis. Demonstra- tion of remission of cryoglobulinemic vasculitis by treatment with entecavir suggests that the effect of entecavir against HBV might prevent this cascade of events.

Conclusion: Entecavir treatment seemed to lead to prompt sup- pression of HBV replication and prompt resolution of cryoglobulinemic vasculitis.

Tamihiro Kawakami, MD, PhD Shiho Ooka, MD, PhD Masako Mizoguchi, MD, PhD Yoshinao Soma, MD, PhD

St. Marianna University School of Medicine Kawasaki, Kanagawa 216-8511, Japan

Masahide Yamazaki, MD, PhD

Kanazawa University Graduate School of Medical Science Kanazawa, Ishikawa 920-8640, Japan

References

1. McMahon MA, Jilek BL, Brennan TP, Shen L, Zhou Y, Wind-Rotolo M, et al. The HBV drug entecavir - effects on HIV-1 replication and resistance. N Engl J Med.

2007;356:2614-21. [PMID: 17582071]

2. Vanlandschoot P, Van Houtte F, Roobrouck A, Farhoudi A, Stelter F, Peterson DL, et al. LPS-binding protein and CD14-dependent attachment of hepatitis B surface antigen to monocytes is determined by the phospholipid moiety of the particles. J Gen Virol. 2002;83:2279-89. [PMID: 12185283]

3. D’Agnillo P, Levine JS, Subang R, Rauch J. Prothrombin binds to the surface of apoptotic, but not viable, cells and serves as a target of lupus anticoagulant autoanti- bodies. J Immunol. 2003;170:3408-22. [PMID: 12626602]

Entecavir to Treat Hepatitis B–Associated Cryoglobulinemic Vasculitis

Background: Hepatitis C virus infection is associated with mixed cryoglobulinemia (1). The association of hepatitis B virus (HBV) with cryoglobulinemia is less certain, and treatment is nonspecific.

Objective: To describe a patient with HBV-associated cryo- globulinemic vasculitis that resolved with entecavir.

Case Report: A 57-year-old Taiwanese woman was referred to us because of a purpuric rash on her legs (Figure). Skin biopsy speci- mens showed leukocytoclastic vasculitis in the upper dermis. Her aspartate aminotransferase level was 143 U/L, alanine aminotransferase level was 119 U/L,␥-glutamyltransferase level was 27 U/L, total bilirubin level was 29.1␮mol/L (1.7 mg/dL), albumin level was 3.2 g/dL, creatinine level was 38.13 ␮mol/L (0.50 mg/dL), leukocyte count was 2.6⫻ 10⁹ cells/L, hemoglobin concentration was 10.5 g/dL, and platelet count was 63⫻ 10⁹ cells/L. C-reactive protein and antinuclear and antineutrophil cytoplasmic antibodies were negative. Cryoglobulins were detected by cold precipitation. Test results for antibodies to hepatitis C virus and viral RNA and anti– hepatitis B envelope antigen were negative, and results for hepatitis B surface antigen and hepatitis B envelope antigen were positive. Her HBV DNA level was 6.4 log₁₀copies/mL. The genotype of the HBV was type B. A precore stop codon mutation was found at nucleotide 1896, but no mutations were found at nucleotide 1762 or nucleotide 1764 in the basal core promoter. Abdominal ultrasonography showed no evidence of cirrhosis or hepatocellular carcinoma. A liver biopsy specimen showed moderate inflammation and severe fibrosis.

On the basis of these findings, HBV-associated cryoglobulinemic vasculitis was diagnosed, and entecavir treatment was started at a dose of 0.5 mg/d. The serum HBV DNA level decreased immediately after the start of therapy and became undetectable by polymerase chain reaction testing (⬍2.6 log10copies/mL) by week 6. The aminotransferase activity fell to the normal range by week 12. Cryo- Figure.Direct immunofluorescence revealing perivascular

deposits of C3 within the affected vessels.

Original magnification,⫻60.

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globulins became undetectable by week 20, and skin lesions resolved gradually.

Discussion: Cryoglobulins are abnormal immunoglobulins that undergo reversible precipitation at low temperatures, are deposited in microvessels, and evoke vasculitis. Secondary cryoglobulinemia is best managed by treating the underlying disease. Some cases of chronic hepatitis B complicated by cryoglobulinemic vasculitis have responded to lamivudine or adefovir dipivoxil (2– 4), suggesting an association between HBV infection and cryoglobulinemia. Of particular interest, C¸ akir and colleagues (4) described a patient whose cryoglobulinemic vasculitis responded to lamivudine, recurred owing to the emergence of lamivudine-resistant HBV, and then resolved

after rescue therapy with adefovir. The suppression of HBV by antiviral agents may have resulted in decreased numbers of viral antigens that can form cryoglobulins.

Entecavir is the most potent currently available nucleoside or nucleotide analogue against HBV and has been shown to be superior to lamivudine in randomized, controlled trials (5). In addition, it is associated with the lowest rate of drug resistance. New nucleoside analogues with high antiviral potency and low resistance rates would be useful not only for treating hepatitis, but also for managing extrahepatic manifestations.

Interferon-␣ is an alternative treatment for chronic HBV infection, but it is not preferred to nucleoside or nucleotide analogues for the management of extrahepatic manifestations. One reason is that interferon-␣ produces rapid viral suppression in only some patients.

Another is that interferon-␣ has immunomodulatory activity. The pathogenesis of extrahepatic manifestations is not completely under- stood, but immune-mediated mechanisms are most likely involved.

The use of corticosteroids or immunosuppressive agents alone is not recommended because of possible flare-ups of viral replication.

Conclusion: Entecavir may be a first-line treatment for extra- hepatic manifestations of chronic HBV infection.

Masaru Enomoto, MD

Masamitsu Ishii, MD Akihiro Tamori, MD Norifumi Kawada, MD Osaka City University

Abenoku, Osaka 545-8585, Japan

References

1. Gumber SC, Chopra S. Hepatitis C: a multifaceted disease. Review of extrahepatic manifestations. Ann Intern Med. 1995;123:615-20. [PMID: 7677303]

2. Sawabe T, Uenotsuchi T, Imafuku S, Kohno H, Arima J, Horiuchi T. Remission of hepatitis B virus-related vasculitis with lamivudine [Letter]. Ann Intern Med. 2004;

140:672-3. [PMID: 15096355]

3. Stecevic V, Pevzner MM, Gordon SC. Successful treatment of hepatitis B- associated vasculitis with lamivudine [Letter]. J Clin Gastroenterol. 2003;36:451.

[PMID: 12702993]

4. C¸ akir N, Pamuk ON, Umit H, Midilli K. Successful treatment with adefovir of one patient whose cryoglobulinemic vasculitis relapsed under lamivudine therapy and who was diagnosed to have HBV virologic breakthrough with YMDD mutations. Intern Med. 2006;45:1213-5. [PMID: 17139120]

5. Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, et al. BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006;354:1001-10. [PMID: 16525137]

Figure.Purpuric rash on the patient’s legs.

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Takeshi Nakanishi, MD