Editorials

Writing Evidence-Based Clinical Reviews

JAY SIWEK, M.D.

Georgetown University School of Medicine
Washington, D.C.

See article on page 251.

As mentioned in the August 1, 2001, "Inside AFP," we are strengthening the process for incorporating an evidence-based approach in our clinical review articles. We now ask all authors to rate the level of evidence for key clinical recommendations on diagnosis and treatment. As far as I know, American Family Physician is the first journal to request, where possible, ratings of evidence for all of its articles.

We realize that this is an ambitious undertaking, with several potential pitfalls. First, not all articles are equally suited to evidence ratings. For example, an article on interpreting electrocardiograms or performing certain procedures may not be supported by enough evidence-based resources to warrant the inclusion of ratings.

Second, there are many different rating systems in the medical literature, and these continue to evolve over time. Several are complex, with some including as many as 10 different levels. There are pros and cons to adopting any one system, and challenges in developing a new one. In the interest of simplicity, we have decided to use a three-tier, ABC system, with explicit modifiers. At each rating of evidence, we will tell our readers what the rating means. Consider this a trial period, subject to modification as we and our authors gain experience with this new process. I am hopeful that readers will appreciate a good-better-best approach and get a feel for the strength of the evidence behind important recommendations on therapy.

The third potential pitfall is the subjective nature of applying any rating system to the complex universe of science. Is a fair-quality randomized controlled trial (RCT) "better" than a high-quality retrospective cohort study? What if seven RCTs conclude that a treatment works, but three disagree? And when it comes to expert opinion, whose expertise counts? The literature contains many examples of flawed RCTs, meta-analyses that ultimately prove to be false, and studies with similar objectives but contradictory findings.

We undertake this new process with some humility, knowing that science is inexact; that authors and editors are imperfect; that the process itself is, at best, an attempt to get closer to a standard of best practice, and that this goal may be difficult to achieve. Ultimately, we believe that this process will encourage authors to review the medical literature more critically and provide more informative articles for readers.

For a more detailed description of this process, please see the "Information for Authors" on AFP's Web site, www.aafp.org/afp/authors.html, which refers to a sample article showing how the levels of evidence are to be incorporated in the text and offers additional background information. Please also see the article on page 251 of this issue,¹ which provides guidelines on writing an evidence-based review article.

Jay Siwek, M.D., is professor and chair of the Department of Family Medicine at Georgetown University School of Medicine, Washington, D.C. He is also the editor of American Family Physician.

Address correspondence to Jay Siwek, M.D., Department of Family Medicine, 212 Kober-Cogan Hall, Georgetown University Medical Center, 3800 Reservoir Rd. NW, Washington, D.C. 20007 (e-mail: siwekj@georgetown.edu).

REFERENCE

1. 1. Siwek J, Gourlay ML, Slawson DC, Shaughnessy AF. How to write an evidence-based clinical review article. Am Fam Physician 2002;65:251-8.

I would like to thank Margaret L. Gourlay, M.D., for review of this editorial.

Guideline Implementation: Why Don't We Do It?

LEIF I. SOLBERG, M.D.

HealthPartners Medical Group
Minneapolis, Minnesota

After 10 to 15 years of trying to improve the quality of medical care by developing and disseminating literally tons of clinical guidelines, it is time to admit that we have been doing it wrong. The best evidence for my claim is summarized in the latest report on quality from the Institute of Medicine.¹ Eleven years after publication of the first of its three reports on guidelines,² this report describes not just a gap between what we know and what we do, but a chasm. The report concludes that, if we are to bridge that chasm, a revolution is needed in the way we organize and provide medical care.

The problem is not that we need different physicians or need to get care to people who do not come to see us, it is that we physicians are not consistent and comprehensive in our care for those patients we do see. We just do not provide preventive and chronic care very well, managing everything as acute problems (although there are gaps here, too). Part of the problem is that we are too busy, we are not capable of remembering everything, and we concentrate on responding to the issues that our patients bring to us.³ More fundamentally, however, it is because we have not set up organized support systems in our offices. We appear to believe that we have to do everything ourselves, and we do not understand how to implement guidelines.

A recent article in Family Practice Management highlights the problem.⁴ It describes a group practice in Louisiana that decided to compare their care with the National Institutes of Health (NIH) "General Practice Guidelines for the Diagnosis and Management of Asthma." The practice's chart reviews revealed that their treatment was focused on managing acute exacerbations of asthma, with little prevention, maintenance, or patient education being done. With that knowledge, they designed and conducted two educational sessions on the key recommendations in the NIH guideline and "challenged the physicians and staff to adopt them into regular practice." A repeat audit showed no positive changes. Then they implemented a simple reminder system and found improvements in all four reminder-targeted behaviors. The authors concluded that the extensive randomized trial literature was correct about the failure of continuing education to affect behavior, as well as about the efficacy of reminder systems.

Unfortunately, their report illustrates the problem of quality improvement and guideline implementation in a much larger way than they described. First, it demonstrates that we have not only failed to implement evidence-based guideline care, we have largely failed to even become aware of the extensive evidence base on various approaches to changing clinical behavior. Like the first efforts of these physicians, I still see most well-intentioned efforts to improve practice being based on education, exhortation, feedback of data, and the use of opinion leaders and so-called "academic detailing." There are so many good randomized trials demonstrating the ineffectiveness or marginal benefits from these approaches that there have actually been 47 high-quality systematic reviews of a much larger number of scientific trials evaluating implementation strategies.⁵ There is, indeed, a place for the strategies mentioned above, but only as a foundation for the truly effective approaches of task delegation and office systems.

Secondly, even if there were more widespread understanding of the literature on this topic, the literature itself fails us.⁵ For example, while there is indeed excellent evidence supporting the use of reminders, scientific trials of reminders are usually relatively short-term and do not test the likelihood that, over time, reminders lose much of their effectiveness. Much worse, though, is the failure of the literature to emphasize the systems nature of what does work, or the organizational leadership and change management that is needed to put these systems into place. Only recently are these lessons from other lines of work starting to appear in the medical literature.^6,7

Because the medical groups in our region have been forced to be organized in order to survive, and because many groups have worked collaboratively through the Institute for Clinical Systems Improvement (ICSI) to develop and implement guidelines, they have had an unusually good opportunity to learn these lessons.^8,9 When ICSI began, there was considerable belief that if local physicians became actively engaged in the development of a guideline, they would implement it. After developing 50 primary care guidelines, practices of all sizes learned this belief was untrue. Implementation required work to set up systems, and focusing primarily on changing physician behavior was futile.

Fortunately, we had the resources to conduct small studies of guideline implementation efforts. One of the best studied a systematic effort by one medical group to implement a guideline for management of simple cystitis episodes in women.¹⁰ The implementation approach used was to combine physician and nurse educational efforts with referral of most phone calls to nurses. The nurses used guideline-driven protocols to collect data and to provide three-day antibiotic treatment without cultures to patients who fit the protocol. After implementation of the protocol, these clinics demonstrated a dramatic improvement in adherence to the guideline. However, when the cases managed by nurses were compared with those of similar complexity managed by physicians in these same clinics, it was clear that all of the improvement came from the nurse protocol cases. Physician behavior had not changed at all.

Recently, we conducted in-depth interviews of the people from these medical groups (12 physicians and staff) who had the most successful experience with leading guideline implementation, so-called "insightful implementers."¹¹ Their recommendations emphasized organizational changes and systems and the use of multiple strategies, not single ones. Only two of the top 22 aspects of change management that they recommended related even partly to individual clinicians or to characteristics of the guideline itself.

All of this might suggest that only large clinics could implement guideline-driven systems. Nothing could be further from the truth. The one clinic that consistently did the best job--the real star of the ICSI collaborative--was a four-physician practice in a small town. These physicians understood the value of systems and strongly supported the efforts of their laboratory technician, who was very good at setting up the processes that supported desired guideline actions. My experience in a two-physician practice was similar, and the smoking cessation system that we used helped more than 200 of our regular patients to quit smoking in a four-year period.¹² Our system became the model for the American Academy of Family Physicians' Stop Smoking Kit.

In fact, a solo physician who understands systems principles and who is willing to delegate supporting roles in care to other office staff can actually implement guidelines better than anyone else. Such a physician can establish registries of patients with common chronic conditions, have their charts labeled, and have nursing staff identify and remind or address guideline-recommended care needs for these patients during any of their visits. Staff can also mail or call needed reminders to patients who do not come in to the office.

If your practice group is interested in implementing evidence-based guideline care and in showing the world that there does not need to be a "quality chasm," you can do it. All you have to do is discard outmoded ideas about how to change your practice and build your own office systems. You too can be an "insightful implementer."

Leif I. Solberg, M.D., is the director for Care Improvement Research at HealthPartners Research Foundation, associate medical director for HealthPartners Medical Group, and a part-time practicing family physician, all in Minneapolis, Minn.

Send correspondence to Leif I. Solberg, M.D., Associate Medical Director, HealthPartners Medical Group and Clinics, 8100 34th Ave. South, P.O. Box 1524, Minneapolis, MN 55440 (e-mail: leif.i.solberg@healthpartners.com).

REFERENCES

1. Institute of Medicine (U.S.). Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Committee on Quality Health Care in America, Institute of Medicine. Washington DC: National Academy Press, 2001:33.
2. Field MJ, Lohr KN. Institute of Medicine (U.S.) Committee to Advise the Public Health Service on Clinical Practice Guidelines. United States Dept. of Health and Human Services. Clinical practice guidelines: directions for a new program. Washington, D.C.: National Academy Press, 1990:160.
3. Kottke TE, Brekke ML, Solberg LI. Making "time" for preventive services. Mayo Clin Proc 1993;68: 785-91.
4. Schulte B, O'Hea EL, Darling P. Putting clinical guidelines into practice. Fam Pract Manag 2001; 8:45-6.
5. Solberg LI. Guideline implementation: what the literature doesn't tell us. Jt Comm J Qual Improv 2000;26(9):525-37.
6. NHS Centre for Reviews and Dissemination, University of York. Getting evidence into practice. Eff Health Care 1999;5:1-16.
7. Moss F, Garside P, Dawson S. Organizational change: the key to quality improvement. Qual Health Care 1998;7(suppl):S1-2.
8. Mosser G. Clinical process improvement: engage first, measure later. Qual Manage Health Care 1996;4:11-20.
9. Mosser G. Half a dozen hobbling half-truths about practice guidelines. Group Pract J 1997;46:34-40.
10. O'Connor PJ, Solberg LI, Christianson J, Amundson G, Mosser G. Mechanism of action and impact of a cystitis clinical practice guideline on outcomes and costs of care in an HMO. Jt Comm J Qual Improv 1996;22:673-82.
11. Solberg LI, Brekke ML, Fazio CJ, Fowles J, Jacobsen DN, Kottke TE, et al. Lessons from experienced guideline implementers: attend to many factors and use multiple strategies. Jt Comm J Qual Improv 2000;26:171-88.
12. Solberg LI, Maxwell PL, Kottke TE, Gepner GH, Brekke ML. A systematic primary care office-based smoking cessation program. J Fam Pract 1990; 30:647-54.

Obstructive Sleep Apnea and Essential Hypertension-- Is There a Link?

BENJAMIN W. CHASKA, M.D.

Park Nicollet Health Services
St. Louis Park, Minnesota

See article on page 229.

Obstructive sleep apnea (OSA) occurs in 2 percent of women and 4 percent of men between 30 and 60 years of age.¹ (This compares with an incidence of 4.5 percent for asthma in this age category.)² OSA is infrequently diagnosed. The National Center on Sleep Disorders Research found that in 1989 and 1990, 99 percent of patients with OSA were not diagnosed.³ Data from 1997 suggest that 95 percent of patients with OSA were not diagnosed.⁴ In this issue of American Family Physician, Silverberg and associates⁵ note that the diagnosis of OSA is delayed an average of seven years.

OSA occurs frequently in patients with hypertension. As many as one third of essential hypertension cases may be caused by OSA.^6,7 OSA can cause detrimental effects, including a sevenfold increase in motor vehicle crashes caused by somnolence at the wheel.⁸ Persons with OSA experience a higher incidence of work-related accidents, poor job performance, depression, family discord, and decreased quality of life than do persons without the sleep disorder.⁹

What role do primary care physicians have in the prevention, diagnosis, and treatment of OSA? First, an awareness of the problem is essential. Primary care physicians can approach OSA by identifying risk factors, focusing on prevention, providing anticipatory guidance, treating comorbidities, and mitigating long-term consequences.

Physicians should systematically include sleep evaluations as part of a complete medical history and physical examination. Risk factors for OSA include obesity, family history of the disorder, smoking, large neck size, recessed chin, a narrowed airway, and male gender. Physicians should be aware that some patients with OSA do not have any of these risk factors.

Patients with OSA may present with excessive daytime sleepiness, loud snoring, dry mouth on waking, chronic nasal obstruction, intellectual dysfunction, social dysfunction, irritability, depression, impotence, or morning headaches.^8-10 The Epworth Sleepiness Scale,¹¹ a simple screening tool for sleep disorders, may help identify symptoms.

On physical examination, findings may include truncal obesity, recessed chin, oropharyngeal obstruction or narrowing, large neck size (greater than 17 inches in men and 16 inches in women),¹⁰ hypertension, depression, and cardiovascular disease.

Laboratory full-night polysomnography is the gold standard for diagnosing OSA. Geographic unavailability, patient inconvenience, and high cost limit its usefulness.⁹ At-home overnight oximetry is used as an alternative to full-night polysomnography. Its advantages include wide availability, in-home use, and relative low cost. However, it has poor sensitivity and specificity.¹⁰

The goals for treatment of OSA are to reduce morbidity and mortality and to improve quality of life. These goals can be accomplished by preventing the cardiovascular consequences of sleep apnea and by reducing daytime sleepiness, serious unintended injury, stroke, divorce, and occupational dysfunction.⁹ Treatment of OSA, which is simple and readily available, can dramatically improve patients' quality of life and prevent many cardiovascular complications such as hypertension and congestive heart failure.

Patients with OSA should be counseled about the potential for motor vehicle crashes, job-related hazards, and impaired judgment. They should be encouraged to lose weight, avoid use of alcohol and sedatives, stop smoking, sleep in the lateral position, and get adequate amounts of sleep.⁹

Continuous positive airway pressure during sleep is often required. Medication and oxygen therapy usually are not beneficial. Dental appliances may be helpful in some patients. In severe cases, surgical intervention may be necessary. The overall success rate for surgery including uvulopalatopharyngoplasty and laser-assisted uvulopalatoplasty is about 40 percent. If present, comorbid conditions such as obesity, hypertension, hypothyroidism, and cardiovascular disease also need to be treated.

Family physicians see patients who are impacted by OSA in their offices daily. Most patients with OSA are not aware that they have this disorder, and it often goes undiagnosed. Results from studies show that educating primary care physicians about OSA results in an eightfold increase in the recognition and treatment of OSA.⁴ By educating ourselves and our patients about OSA, we can significantly improve our patients' lives.

For more information, contact the National Center on Sleep Disorders Research at the National Heart, Lung, and Blood Institute Information Center, National Institutes of Health, 6701 Rockledge Dr., MSC 7920, Bethesda, MD 20892-7920, telephone: 301-435-0199 or visit their Web site at http://www.nhlbi.nih.gov/health/prof/sleep/ index.htm; the American Academy of Sleep Medicine, 6301 Bandel Rd. NW, Rochester, MN 55901, telephone: 507-287-6006 or visit their Web site athttp://www.aasmnet.org/; or the American Sleep Apnea Association, 1424 K Street NW, Suite 302, Washington, D.C. 20005, telephone: 202-293-3650 or visit their Web site at http://www.sleepapnea.org.

Benjamin W. Chaska, M.D., is executive vice president and chief medical officer of Park Nicollet Health Services in St. Louis Park, Minn.

Address correspondence to Benjamin W. Chaska, M.D., Park Nicollet Health Services, 6500 Excelsior Blvd., St. Louis Park, MN 55425.

REFERENCES

1. Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 1993;328:1230-5.
2. National Heart, Lung and Blood Institute. Fact book: 1983. Bethesda, Maryland: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, 1984.
3. National Heart, Lung, and Blood Institute. Sleep apnea: is your patient at risk? National Institutes of Health, 1995; NIH publication no. 95-3803.
4. Ball EM, Simon RD Jr, Tall AA, Banks MB, Nino-Murcia G, Dement WC. Diagnosis and treatment of sleep apnea within the community. The Walla Walla Project. Arch Intern Med 1997;157:419-24.
5. Silverberg DS, Oksenberg A. Treating obstructive sleep apnea improves essential hypertension and quality of life. Am Fam Physician 2002;65:229-36.
6. Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med 2000;342:1378-84.
7. Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, et al. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA 2000;283:1829-36.
8. Findley LJ, Fabrizio M, Thommi G, Suratt PM. Severity of sleep apnea and automobile crashes [Letter]. N Engl J Med 1989;320:868-9.
9. Sleep apnea: diagnosis and treatment: a comprehensive teaching curriculum slide set. Retrieved October 2001, from: http://www.aasmnet.org.
10. Davies RJ, Stradling JR. The relationship between neck circumference, radiographic pharyngeal anatomy, and the obstructive sleep apnea syndrome. Eur Respir J 1990;3:509-14.
11. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991;14:540-5.

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