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ANNALS OF EMERGENCY MEDICINE JOURNAL CLUB Frequent Fliers, Internal and External Validity, and Problems With Making Continuous Variables Binary Answers to the May 2009 Journal Club Questions Sanjay Arora, MD David L. Schriger, MD, MPH From the Department of Emergency Medicine, Keck School of Medicine/University of Southern California, Los Angeles, CA (Arora); and the University of California, Los Angeles, CA (Schriger). 0196-0644/$-see front matter Copyright © 2009 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2009.04.013 Editor’s Note: You are reading answers to the ninth installment of Annals of Emergency Medicine Journal Club. The questions and the article they are about (Aisiku et al. Ann Emerg Med. 2009;53:587-593.) were published in the May 2009 issue. Information about journal club can be found at http://www.annemergmed.com/content/journalclub. Readers should recognize that these are suggested answers. We hope they are accurate; we know that they are not comprehensive. There are many other points that could be made about these questions or about the article in general. Questions are rated “novice,” ( ) “intermediate,” ( ) and “advanced” ( ) so that individuals planning a journal club can assign the right question to the right student. The “novice” rating does not imply that a novice should be able to spontaneously answer the question. “Novice” means we expect that someone with little background should be able to do a bit of reading, formulate an answer, and teach the material to others. Intermediate and advanced questions also will likely require some reading and research, and that reading will be sufficiently difficult that some background in clinical epidemiology will be helpful in understanding the reading and concepts. We are interested in receiving feedback about this feature. Please e-mail [email protected] with your comments. DISCUSSION POINTS 1. As stated in its title, this study 1 seeks to compare patients with sickle cell disease who are frequent and infrequent users of the emergency department (ED). The authors recruited patients from “established [sickle cell disease] clinics, health fairs, referrals, and targeted mailings.” A. Contrast this study design to one in which all patients were recruited from ED logs. Draw a Venn diagram comparing the patients likely to be included in these 2 designs. How do the populations differ? B. Describe the pros and cons of each approach focusing on internal and external validity. C. What techniques might be used to overcome the limitations of each approach? D. What ethical issues arise in each study design? E. Read the abstract’s conclusions. How might you modify them? How might you modify the limitations section? 2. Patients were asked to keep a daily diary for 6 months, though investigators included patients who completed as few as 30 of the 188 study days. Each subject’s data were extrapolated to create 1-year values. Examine the paper’s figure. A. What pattern do you see on the far left of the figure about the number of ED visits by infrequent users? How do you explain this pattern? Does this figure represent the true frequencies or an artifact of the study methods? How could a patient have 1 ED visit per year, given the way data were handled in this study? B. These authors defined frequent users as patients who had at least 3 ED visits per year. According to your clinical experience, are there alternate definitions that might be used? Considering Figure 1, do you think that other definitions might be warranted? 3. The authors write, “[Al]though the data were not statistically significant, high ED utilizers trended toward a higher incidence of anxiety, higher incidence of avascular necrosis and higher WBC count.” Write a sentence that starts, “Although data were not statistically significant, low ED utilizers trended toward . . .” Discuss the meaning of their and your sentence. What are some problems with this approach? How else might the authors have conveyed this information? 4. The authors suggest that the “frequent flier” designation that some emergency physicians give to patients who visit often for sickle cell pain is unjustified because, on average, these patients were sicker than infrequent users. A. Honestly examine your own feelings about the “frequent flier” designation. Do you use the term? How do you feel when others use it? Do you view patients who come in often differently? Do you manage their treatment differently? Do you worry that you may miss a change in their chronic condition? How do you balance pragmatic and moral concerns related to this issue? 628 Annals of Emergency Medicine Volume , . : October

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Page 1: Frequent Fliers, Internal and External Validity, and Problems With Making Continuous Variables Binary: Answers to the May 2009 Journal Club Questions

ANNALS OF EMERGENCY MEDICINE JOURNAL CLUB

Frequent Fliers, Internal and External Validity, and Problems WithMaking Continuous Variables Binary

Answers to the May 2009 Journal Club Questions

Sanjay Arora, MDDavid L. Schriger, MD, MPH

From the Department of Emergency Medicine, Keck School of Medicine/University of SouthernCalifornia, Los Angeles, CA (Arora); and the University of California, Los Angeles, CA (Schriger).

0196-0644/$-see front matterCopyright © 2009 by the American College of Emergency Physicians.doi:10.1016/j.annemergmed.2009.04.013

Editor’s Note: You are reading answers to the ninthinstallment of Annals of Emergency Medicine Journal Club.The questions and the article they are about (Aisiku et al. AnnEmerg Med. 2009;53:587-593.) were published in the May2009 issue.

Information about journal club can be found athttp://www.annemergmed.com/content/journalclub.

Readers should recognize that these are suggestedanswers. We hope they are accurate; we know that they arenot comprehensive. There are many other points that could bemade about these questions or about the article in general.Questions are rated “novice,” ( ) “intermediate,” ( )and “advanced” ( ) so that individuals planning a journalclub can assign the right question to the right student. The“novice” rating does not imply that a novice should be able tospontaneously answer the question. “Novice” means weexpect that someone with little background should be able todo a bit of reading, formulate an answer, and teach thematerial to others. Intermediate and advanced questions alsowill likely require some reading and research, and that readingwill be sufficiently difficult that some background in clinicalepidemiology will be helpful in understanding the reading andconcepts.

We are interested in receiving feedback about this feature.Please e-mail [email protected] with your comments.

DISCUSSION POINTS

1. As stated in its title, this study1 seeks to compare patientswith sickle cell disease who are frequent and infrequentusers of the emergency department (ED). The authorsrecruited patients from “established [sickle cell disease]clinics, health fairs, referrals, and targeted mailings.”A. Contrast this study design to one in which all patientswere recruited from ED logs. Draw a Venn diagramcomparing the patients likely to be included in these 2designs. How do the populations differ?B. Describe the pros and cons of each approach focusingon internal and external validity.C. What techniques might be used to overcome thelimitations of each approach?

D. What ethical issues arise in each study design?

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E. Read the abstract’s conclusions. How might you modifythem? How might you modify the limitations section?

2. Patients were asked to keep a daily diary for 6 months,though investigators included patients who completed asfew as 30 of the 188 study days. Each subject’s data wereextrapolated to create 1-year values. Examine the paper’sfigure.A. What pattern do you see on the far left of the figureabout the number of ED visits by infrequent users? Howdo you explain this pattern? Does this figure represent thetrue frequencies or an artifact of the study methods? Howcould a patient have 1 ED visit per year, given the waydata were handled in this study?B. These authors defined frequent users as patients whohad at least 3 ED visits per year. According to your clinicalexperience, are there alternate definitions that might beused? Considering Figure 1, do you think that otherdefinitions might be warranted?

3. The authors write, “[Al]though the data were notstatistically significant, high ED utilizers trended toward ahigher incidence of anxiety, higher incidence of avascularnecrosis and higher WBC count.” Write a sentence thatstarts, “Although data were not statistically significant, lowED utilizers trended toward . . .” Discuss the meaning oftheir and your sentence. What are some problems withthis approach? How else might the authors have conveyedthis information?

4. The authors suggest that the “frequent flier” designationthat some emergency physicians give to patients who visitoften for sickle cell pain is unjustified because, on average,these patients were sicker than infrequent users.A. Honestly examine your own feelings about the“frequent flier” designation. Do you use the term? How doyou feel when others use it? Do you view patients whocome in often differently? Do you manage their treatmentdifferently? Do you worry that you may miss a change intheir chronic condition? How do you balance pragmatic

and moral concerns related to this issue?

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B. Similarly, what is your approach to pain managementin patients who frequently come to the ED complaining ofchronic or acute-on-chronic pain? How does yourbehavior compare with that of your peers? Whatarguments do you invoke to justify your approach?

ANSWER 1Q1. As stated in its title, this study seeks to compare patients

with sickle cell disease who are frequent and infrequent users of theemergency department (ED). The authors recruited patients from“established [sickle cell disease] clinics, health fairs, referrals, andtargeted mailings.”

Q1.a Contrast this study design to one in which all patients wererecruited from ED logs. Draw a Venn diagram comparing thepatients likely to be included in these 2 designs. How do thepopulations differ?

Figure 1, the Venn diagram we had in mind, illustrates 2seemingly contradictory conclusions that could both be true: (a)the study is valid and, in the patients recruited for this study,frequent users are a minority and the frequency of visits isassociated with disease severity and little else; (b) there exists alarge group of patients who use the ED frequently and whosevisit frequency is unrelated to disease severity.

This paradox highlights the importance of being very clearabout the relationship of the study design to the researchquestion. The Aisuku et al1 study examines the ED usebehaviors of a group of patients who attend sickle cell clinics,health fairs, etc, and were willing to participate in the study. Itdoes not study the behavior of patients with sickle cell diseasewho do not participate in the activities targeted for recruitment.It also does not capture the behavior of patients who wereidentified for recruitment but refused to participate in the study.

The sample in the Aisuku et al1 study and the sample thatwould result from combing ED logs likely differ in many of thecharacteristics that determine the utilization of health care.2 Weare not surprised that patients who are engaged with the health

Figure 1. Distribution of frequent ED users amonghypothetical populations of study subjects.

care system—as many of the patients in the Aisuku et al1 sample

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were—used the ED infrequently. It is also wholly conceivablethat the kinds of patients who were not recruited for this studymay use the ED frequently. An alternative study design thatrecruited patients from the ED would be a better proxy forpatients with sickle cell disease who use the ED for some part oftheir care, assuming that that study was successful in recruitingand retaining subjects.

The important point is that the 2 approaches arecomplementary and answer different questions. A study of EDusers might document an abundance of frequent users whosefrequency of use had little correlation with other proxies forseverity of illness but would fail to capture the patients whomanage their disease with few or no trips to the ED. Thecurrent study may have missed the patients who use the ED astheir primary source of care regardless of their frequency of useand may underestimate the frequent user problem.

Q1.b Describe the pros and cons of each approach focusing oninternal and external validity.

There are many textbooks that nicely define external andinternal validity, and readers are directed to these for detailedstudy3,4 or, for those who want to study the opposite of validity,to an article that describes 53 distinct forms of bias, each ofwhich can compromise the validity of a study.5 In brief, by“internal validity” we mean the extent to which a study providesan unbiased estimate of the true value, with bias defined as “anyprocess at any stage of inference which tends to produce resultsor conclusions that differ systematically from the truth.”5 Aninternally valid study, if repeatedly executed, will produce valuesthat approach, on average, the truth for that population. If onemeasured the weight of a random sample of female USnewborns with a scale that was out of calibration, one wouldhave a study that lacked internal validity because the averageweight of the children reported in the study would not approachthe average weight of the children in the population. Similarly,because the study by Aisuku et al1 is based on patient diaries, ifthe subjects systematically over- or underreported their EDvisits, then the study would lack internal validity. Forrandomized trials, the expectation is that if all study limbs weregiven the same treatment (exposure), then, apart from randomerror, all would have the same outcome. If this is not the case,then the study lacks internal validity.

A study has external validity if the results apply to thepopulation identified in the study question. In the exampleabove, if the baby scale were recalibrated to perfection, the studywould have excellent internal validity and external validity aslong as the question were, what is the weight of newbornfemales? However, if the study question were, “what is theweight of newborn infants?”, then the study might have poorexternal validity if female and male infants differ in weight.External validity issues typically predominate in large, well-conducted, randomized trials because these trials may have greatinternal validity but may have patient selection issues thatrender the study population a poor homologue for the

population defined in the study question.

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The internal validity of the study by Aisuku et al1 could beincreased by actually measuring events (ie, ED visits), ratherthan relying on self-report. This is true regardless of how thepopulation was recruited. Alternatively, the magnitude ofmeasurement bias could be estimated by reviewing the medicalrecords of a sample of enrolled patients to compare actual EDvisits with patient diaries. Our assessment of the externalvalidity of the study depends on our understanding of the studyquestion. The authors write “. . . we sought to bettercharacterize sickle cell disease patients who frequently utilize theED.” If we assume this is the study question, the study’s samplemay be a poor proxy for the target population and the studymay lack external validity.

The “pro” of the authors’ approach is that they recruitedpatients who were generally willing to complete the diaries (seebelow). This made the study feasible. We suspect that thepatients missed by the study’s recruitment procedures would beunlikely to participate in the study or complete the diary shouldthey consent to participate. The “con” is that the study mayhave missed the patients who were most likely to be frequentusers of ED services.

The considerable pro of the alternate approach is that itwould identify the patients most likely to be frequent users. Thecons are that it is wholly unclear whether these patients wouldbe willing to consent and participate and that there may beethical issues about how these patients are identified andapproached (see Q1.e below).

Q1.c What techniques might be used to overcome the limitationsof each approach?

As discussed above, the major threat to the external validityof the study by Aisuku et al1 is that it missed the patients mostlikely to be frequent users The authors could have examined thispossibility by stratifying their data on the recruitment method.One might hypothesize that the patients most connected to thehealth care system (ie, those recruited from dedicated sickle cellclinics) would be least likely to be frequent users, whereas thosewith weaker ties (eg, those identified at a health fair who had noregular physician) would be more likely. If heterogeneity werefound among strata, one would have a better sense of howdifferent the ED-use behavior of those not captured in the studymight be. The absence of heterogeneity would suggest that themissed patients may not be that different from those captured.

The major limitations of recruitment through the ED arelogistics and ethics (see Q1.d), selection bias, and compliance. Ifpatients most likely to use the ED are unwilling to participate orfail to complete the diaries, then the study would be infeasible.Alternate means of outcome measurement (eg, gettingpermission from patients to use insurance billing data or EDlogs to directly measure their utilization) might prove a betterstrategy for measuring utilization in this group.

Q1.d What ethical issues arise in each study design?We begin by reviewing some facts about HIPAA, the Health

Insurance Portability and Accountability Act of 1996. HIPAA

was created in anticipation of the proliferation of electronic

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medical record systems and the concern that patient recordsproduced by such systems could be accessed by unauthorizedusers. Congress recognized that additional safeguards wereneeded to keep personal health information private, so theyadded provisions for further layers of protection. The HIPAAPrivacy Rule (Standards for Privacy of Individually IdentifiableHealth Information) had a mandatory compliance date of April14, 2003.

HIPAA specifies what information is “protected healthinformation”—information of any form (oral, written,electronic) that identifies an individual—and when and withwhom such information may be shared.

In the design by Aisuku et al,1 there are no obvious HIPAAor ethical issues because the patients keep their own diaries, donot have to tell their treating physicians that they are part of aresearch study, and are deidentified when the data are presented.There are, however, aspects of the recruitment phase of thestudy that, if improperly conducted, could be in violation ofHIPAA. First, the authors indicate that some patients wererecruited by “referral.” It is not explicitly stated where thesereferrals came from, but if they came from the patient’sphysician without the patient’s knowledge, that would be aHIPAA violation. Similarly, it is unclear how recipient lists forthe targeted mailings were created.

In the alternative strategy, there are several ways in whichpatients could be identified from the ED. Research assistantscould be summoned to the ED to approach patients with sicklecell disease in real time. However, unless an ED has full-timeresearch assistant coverage, this strategy could be costly andinfeasible. An alternate approach would be to review billingrecords for recent visits with International Classification ofDiseases, Ninth Revision code 282.6 (sickle cell anemia) and thencontact these patients after the fact. Such contact would violateHIPAA (45 CFR 164.514) unless investigators first obtain “apartial waiver of consent/HIPAA” for screening and recruitmentpurposes from their institutional review board. Severalrequirements must be met to obtain this waiver: (1) there mustbe no more than minimal risk to the subjects; (2) theenrollment could not be effectively and practically carried outwithout obtaining a waiver; (3) waiving consent will notadversely affect the subject’s rights and welfare (ie, they have theright to refuse to participate, they will be provided theopportunity to fully consent to participation, and those who sayno will immediately have their recorded identifying informationdestroyed). Federal regulations further require that if a waiver isgranted that researchers obtain only the minimal personal healthinformation that is necessary for recruitment. In this case, thatwould be name, telephone number, and possibly address. Afterpatients are identified, they should be approached with astandardized letter or verbal script that is institutional reviewboard approved and designed to eliminate intrusive questionsand coercion and allows the subject to easily say no. Although

somewhat cumbersome, this is a commonly used recruitment

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strategy in prospective trials and could have been used toidentify ED users in this trial.

Q1.e Read the abstract’s conclusions. How might you modifythem?

The abstract’s conclusion reads “[a] substantial minority ofsickle cell disease patients are high ED utilizers. However, highED utilizers with sickle cell disease are more severely ill asmeasured by laboratory variables, have more pain, more distress,and have a lower quality of life.” Given the discussion in Q1.ato Q1.d, the truth would be better served if the words “includedin this study” were inserted after “patients.”

Abstracts are short (Annals has a 250-word limit), and manydetails conveyed in an article are necessarily omitted from theabstract. Unfortunately, important caveats and qualifiers areoften among the omitted details. As a result, those who readonly the abstract may get a false sense of the meaning orapplicability of an article’s conclusions.

How might you modify the limitations section?The article’s limitations section considers how self-reported

ED use may differ from actual use but fails to consider the mostimportant limitation of the study, the recruitment strategy. Asdiscussed above, the patients in the study may be poorlyrepresentative of the patients who actually visit the ED. Thisthreat to external validity should have been considered either inthe methods and results, where the analysis suggested in Q1.cwould be reported, or in the limitations section. The limitationssection also failed to discuss how the treatment of a continuousoutcome variable (number of visits) as a binary one (high versuslow use) and the choice of cut point (greater than 2 visits) mightaffect study results. Authors also failed to address the myriadproblems that can arise when extrapolating as little as 1 month’sworth of data to 12 months.

Finally, the authors argue that if there is bias in the self-reports of ED use, the bias is toward underreporting. We don’tsee why this is necessarily so because those patients who missedmany of the diary days (they could miss up to 157 of the 188days and still be in the study) may be more likely to completethe diary on days when they were in pain or days when theyconsulted a provider. This could lead to an overestimation ofthe number of ED visits and to a spuriously enhancedcorrelation between severity of illness and ED visit frequency. Ifthere is a body of literature that supports their claim, theauthors should have referenced it to strengthen their argument.

ANSWER 2Q2. Patients were asked to keep a daily diary for 6 months,

though investigators included patients who completed as few as 30of the 188 study days. Each subject’s data were extrapolated tocreate 1-year values. Examine the article’s figure.

Q2.a What pattern do you see on the far left of the figure aboutthe number of ED visits by infrequent users?

A magnified version of the far left of the article’s figure isshown in Figure 2. We note that most patients had an even

number of annual visits (0, 2, 4), whereas few had an odd

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number (1, 3, 5). We also note that more than 50% of subjectsin this study of ED users actually had no ED visits.

How do you explain this pattern?This pattern can be explained by looking closely at the

method by which annual visit rates were calculated. The authorscollected at most 6 months and as little as 1 month of data oneach patient. Annual rates were calculated by multiplying thenumber of reported visits by the fraction: 365/number of dailydiaries completed. For example, if a patient reported 2 ED visitsin 3 months of completed diaries, his or her annual total wouldbe 8 visits (2�365/91�2�4�8). The Table shows the possibleannual rates achieved by this method and reveals the cause ofthe undulating pattern.

Is it representative of the true frequencies or an artifact of thestudy methods?

As explained above, this is an artifact of the multiplier effect.For patients who have no events, we have little idea whetherthey kept 30, 60, or 188 daily diaries. Similarly, a patient with 1visit in 1 month of recorded diary would be listed as having 12visits, but this is a very imprecise estimate of the actual visit rate.

How could a patient have 1 ED visit per year, given the waydata were handled in this study?

According to the multiplier method described and the 6-

Figure 2. Highly magnified view of left side of the Figure inAisiku et al.1

month maximum for data collection, it is not possible for a

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patient to have just 1 ED visit per year. As shown in the Tableabove, the minimum multiplier value is 2; hence, the minimumnumber of annual visits for a patient with at least 1 visit is 2.We do not know how a patient was given a value of 1, but theexistence of this data point reminds us that the scientificliterature is imperfect and both authors and peer reviewers canmiss what should be easily detectable errors. (Editor’s note: Wequeried the authors and they explained that rather thanrounding, they simply took the integer part of any decimalnumbers. Hence 1.96 [a patient with 1 visit in a full 188 days ofdiaries) was rounded to 1, not 2]. They did not provide ajustification for this practice.)

Q2.b These authors defined frequent users as patients who hadat least 3 ED visits per year. According to your clinical experience,are there alternate definitions that might be used? ConsideringFigure 1, do you think that other definitions might be warranted?

The definition of “frequent user” is certainly in the eye of thebeholder. An emergency physician who had a medical conditionthat required 3 ED visits each year might consider himself afrequent user, but that same physician, told by the nurse thatthis was a patient’s third visit in 12 months, would not makemuch of it. Here lies a paradox of this article.

The authors based their cut point on the Multicenter Studyof Hydroxyurea, which considered patients with 3 or more visitsper year sick enough to warrant this treatment. This choice ofcut point is somewhat tautologic. Their goal is to show thatfrequent ED users are sicker than infrequent users, and they usea cut point that has already been shown to define a sicker groupof patients by virtue of their frequency of ED use.

We can think of many other ways to define frequent users:patients who are treated at least once each month, patientstreated several times each week, patients who are known to theED staff on a first-name basis, patients who have a protocol inplace for treatment to be administered when they arrive,patients who self-report that they come to the ED “all thetime,” or patients who visit multiple EDs in a given area in a

Table. Method for calculating visits/year.

Months Completed No. of Visits Multiplier Annual Total

1, 2, 3, 4, 5, or 6 0 12, 6, 4, 3, 2.4, 2 01 1 12 122 1 6 63 1 4 44 1 3 35 1 2.4 �26 1 2 21 2 12 242 2 6 123 2 4 84 2 3 65 2 2.4 �56 2 2 4

Most multipliers are even, and consequently, most rates (annual totals) areeven.

short period.

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The authors’ results might be very different had they selecteda cut point of 12 or 24. A way out of this problem is to resistthe temptation to take a continuous variable, the annual visitrate, and make it binary (high versus low).6 An analysisconducted using 4 groups (no use, 1 to 6 visits per year, 7 to 19visits per year, and �20 visits per year) would provide richerinformation that might illuminate important patterns that cannotbe seen with this binary treatment. An alternative methodwould be to use graphics to show each patient’s disease severityversus ED use so that readers could see patterns in the data.

Another strategy for making a continuous variable categoricalis to look at the data before making the grouping. Although it isgenerally advisable to let theory guide the creation of categories,pragmatic considerations related to sample size are sometimesimportant. Consider a study of children. According to theory,one might argue that meaningful groupings would be ageyounger than 6 months, 6 months to 2 years, 3 to 12 years, and13 to 17 years. Age quartiles (created by making 4 equally sizedgroups) might be 0 to 4 months, 4 months to 3 years, 3 to 15years, and 16 to 17 years. The quartiles create equal-sizedgroups but groups that may make little sense (eg, 3 to 15 years),depending on the clinical question. Investigators need tobalance sample size considerations and theoretic considerations,with the latter given emphasis in questionable situations.

In this case (see the figure in Aisuku et al1), the first 2quartiles would include 53% of the patients (because of ties), allof whom had no ED visits. The third quartile (22%) wouldinclude patients with 1 to 5 visits, and the fourth quartile (25%)would be greater than or equal to 6 visits. One would have towrestle with the cut points suggested by theory (such as thosementioned 2 paragraphs above) and the need to have anadequate N in each group. In this case, we would let theoryprevail and accept that the high-use groups will havesubstantially less precision (because of smaller Ns) than the low-use groups.

ANSWER 3Q3. The authors write “[Al]though the data were not

statistically significant, high ED utilizers trended toward a higherincidence of anxiety, higher incidence of avascular necrosis andhigher WBC count.”

Write a sentence that starts, “Although data were not statisticallysignificant, low ED utilizers trended toward.. . .”

Although data were not statistically significant, infrequentED utilizers trended toward being wealthier (33% versus 49%earned �$10,000), older (53% �35 years of age versus 39%),and receiving care at a specialty center (53% versus 43%).(Editor’s note: There are other possible sentences but this oneserves to make our general point.)

Discuss the meaning of their and your sentence.If this were a randomized trial with no bias and no

measurement error, then, in a classic statistics framework, theabsence of statistical significance would be taken to mean thatwe have insufficient evidence to reject the null hypotheses about

the factors mentioned in these sentences. This failure could

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represent a good decision (a true negative) because there existsno true difference in these factors in low and high ED users, andthe observed differences are solely due to random error. It couldalso represent a type II (false negative), or �, error. Thelikelihood of this being a type II � error depends on the powerof the study (the sample size relative to the variance of themeasure in question). For example, if the investigators of thishypothetical randomized trial had powered their study to have a� of .1 (power of .9), then there is only a 10% chance that thefailure to find statistical significance would be a type II error,and the more reasonable interpretation is that the observeddifferences represent random variation.

This is not, however, a large randomized trial. This is anobservational study of self-reported ED use, subject to anynumber of systematic biases and systematic and random formsof measurement error. In this case, the interpretation ofobserved differences is far more complicated than in arandomized controlled trial because differences could be real(approximating the truth except for random error), due to bias,due to measurement error, due to random error, or due to anycombination of the above. Furthermore, because the authorsprovide no description of why their study is this particular size(no sample size or power calculation), the failure to achievestatistical significance could be due to the absence of animportant effect (true negative) or to a lack of power (type IIerror).

We are therefore left in a bit of a quandary about how tointerpret these nonsignificant results and, for that matter, thesignificant ones. We lack access to highly stratified data thatmight help us decide whether results represent truths, randomerror, or bias. (Editor’s note: We suspect that some of ourreaders had questions about the use of the Bonferroni methodto reduce � to account for multiple testing. We promise tocover this in detail in a future journal club article but hereacknowledge that this may not be the best way to handle thisproblem.7)

What are some problems with this approach?The main problem with the authors’ sentence is that it tells

only half the story. If authors highlight the “nonsignificant”results that support their argument, should they not, in thename of balance, also mention results that are contrary? Whatscientific basis is there for including their sentence but not ours?

How else might the authors have conveyed this information?Our preferred alternative is to say nothing. The data tables

(particularly Tables 2 and 3 that provide between-group differenceswith their confidence intervals) give readers a sense for themagnitude of each variable in each group and how they differ.Readers can interpret the meaning of these differences as they wish.Readers might be aided by more detailed tables and figures thatshow further stratification of the results but are unlikely to behelped by sentences that cherry pick selected results.

ANSWER 4Q4. The authors suggest that the “frequent flier” designation

that some emergency physicians give to patients who visit often for

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sickle cell pain is unjustified because, on average, these patients weresicker than infrequent users.

Q4.a Honestly examine your own feelings about the “frequentflier” designation.

Meditation cushions are available for this purpose at http://annemergmed.com. Just kidding.

Do you use the term?We will not attempt to answer these questions in any

comprehensive way or attempt to say which opinions are“correct.” We posed these questions to stimulate journal clubparticipants to have a candid discussion about these difficultissues. In the name of complete disclosure, we do our best toanswer the questions honestly. We make no claim that ouranswers are more important than anyone else’s answers. Thefollowing is simply a summary of our opinions, which can beused as a conversation starter.

We both admit to using the term at times and that it wasdifficult to write these answers without resorting to it. We chosenot to because “frequent flier” means different things todifferent people. The literal slang meaning is that someone usesa service often, be it popping into Starbucks daily at 7:05 AM fora java fix or appearing frequently at a neighborhood ED. Thewords have no inherent judgmental quality. The negativeconnotation is instilled by context—how it is used and who isusing it. In our experience, the term is occasionally usednonjudgmentally, (for certain nonsmelly, undemanding, non–drug-seeking, anxious [but not too anxious] little old ladies wholike to check in periodically) but more frequently is loaded withjudgments about the appropriateness and motivations of thepatient’s visit.

How do you feel when others use it?Although we both use the term on occasion, it worries us

when undergraduate research assistants, medical students, andjunior residents use it. Neither of us has a degree in semiotics,but we believe that changes in language often precede culturalchange and worry that the use of this language by those whoseattitudes are still being shaped may foster the development of amore callous attitude toward all kinds of needy patients. Asmuch as we hate to admit it, we think we can all agree that mostof the time when we call a patient a “frequent flier,” we do notmean it as a compliment. This logic leads us to question ourown use of the term and whether, as teachers, we should beavoiding language that could foster undesirable attitudes in ourstudents.

Do you view patients who come in often differently? Do youtreat their disease differently? Do you worry that you may miss achange in their chronic condition?

We strive to avoid prejudging patients, but for selectindividuals, we have strong opinions before entering the room.We hope that our self-awareness of our tendency to do thishelps us avoid errors that can occur when one assumes that thepatient is here “for the same old thing” or when one fails to hearthe patient saying that “something is different.” Neither of us

feels that we systematically manage frequent users differently

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Journal Club

from infrequent users and believe that our knowledge of apatient’s frequent-user status affects our treatment more thanour assessment.

How do you balance pragmatic and moral issues related to thisissue?

We struggle to define what constitutes an appropriatebalance of “pragmatic and moral issues” and leave you to workout your own comfort zone with respect to these issues.

Q4.b Similarly, what is your approach to pain management inpatients who frequently come to the ED complaining of chronic oracute-on-chronic pain?

Patients are generally assumed to have legitimate painconcerns that warrant treatment unless there is a specific historyto suggest otherwise.

How does your behavior compare with that of your peers?The behaviors exhibited by emergency physicians are as wide

as the day is long. Some of our peers regularly give patientswhatever they want (within a “3 shots and be admitted ordischarged” policy). These faculty members believe that even ifthey question the patient’s authenticity, it is better to treat thepatient than risk failing to treat a patient in need or create aconfrontation. The other group believes that there are a smallnumber of patients who resist all attempts to be shepherded intoappropriate continuing care. These attending physicians, aftergiving patients ample warning that they will not be givennarcotics unless they establish a demonstrable relationship witha continuing care provider, will not give narcotics to patientswho fail to do so. We fall in the latter group.

What arguments do you invoke to justify your approach?Being an emergency physician for a frequent user who is

seeking narcotics but refuses to establish a relationship with aprimary care provider is a bit like being the parent of a toddleror teenager. In the short term, saying yes is the easiest path; itmakes all parties happy and eliminates all of the conflict anddrama. But one has cause to worry about the children of parentswho consistently use this strategy. Saying no is harder in themoment but may lead to better long-term outcomes. Many

emergency physicians for whom we have great respect argue that

634 Annals of Emergency Medicine

they would rather have many false-positive results (givingnarcotics to someone who is merely drug seeking) than 1 false-negative result (denying someone in pain adequate analgesia).8

They also argue that there is little harm in giving a narcoticsaddict narcotics. However, we find these arguments a bitshortsighted because they fail to consider the negative long-termconsequences of these strategies. We believe that manyexperienced emergency physicians will learn to trust their gut,rather than always erring on the side of giving narcotics. Each ofus knows patients whom we refuse to treat with narcotics. Inour experience, when these patients arrive in the ED and learnthat one of us is the attending physician on duty, they leave. Weare each satisfied with this arrangement.

Section editors: Tyler W. Barrett, MD; David L. Schriger, MD,MPH

REFERENCES1. Aisiku IP, Smith WR, McClish DK, et al. Comparisons of high

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2. Aday LA, Andersen R. A framework for the study of access tomedical care. Health Serv Res. 1974;9:208-220.

3. Rothman KJ, Greenland S, Lash TL. Validity in epidemiologicstudies. In: Rothman KJ, Greenland S, Lash TL, eds. ModernEpidemiology. 3rd ed. Philadelphia, PA: Lippincott; 2008:128-129.

4. Altman D. Clinical trials. In: Practical Statistics for MedicalResearch. London: Chapman & Hall; 1991.

5. Sackett DL. Bias in analytic research. J Chronic Dis. 1979;32:51-63.

6. Altman DG, Royston P. The cost of dichotomizing continuousvariables. BMJ. 2006;332:1080.

7. Rothman KJ, Greenland S. Fundamentals of epidemiologic dataanalysis. In: Rothman KJ, Greenland S, Lash TL, eds. ModernEpidemiology. 3rd ed. Philadelphia, PA: Lippincott; 2008:236-237.

8. Henry G. What’s your pain care philosophy? Emergency PhysiciansMonthly Web site. Available at: http://www.epmonthly.com/index.php?option�com_content&task�view&id�453&Itemid�91.Accessed April 13, 2009. (Archived by WebCite at http://www.

webcitation.org/5g0KuiMcP).

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