Quality of life in patients with allergic rhinitis

Review articleSupported by an unrestricted from AstraZeneca Pharmaceuticals

Quality of life in patients with allergic rhinitisAnn K Thompson, MBA, BSN; Elizabeth Juniper, MCSP, MSc; and Eli O Meltzer, MD‡

Learning objectives: Reading this article will familiarize the practitioner withongoing efforts to measure the effects of allergic rhinitis symptoms and its treat-ments on the health-related quality of life (HRQOL) of patients. The reader willlearn about instruments used to collect HRQOL data, results of studies showing theburden of illness and the effects of treatments on HRQOL, and efforts to interpretthe clinical relevance of changes in HRQOL status.Data sources: Information was gleaned from articles listed in MEDLINE re-

garding HRQOL in allergic rhinitis between 1966 and 2000 (English languageonly), and from the personal experiences of the authors.Study selection: Questionnaire validation studies and representative controlled

trials employing measures to assess the effects of allergic rhinitis symptoms and itstreatments on HRQOL are described.Results from this Review: Allergic rhinitis symptoms can have detrimental

effects on the physical, psychologic, and social aspects of patients’ lives. Clinicaltrial data suggest a variety of pharmacologic therapies can significantly improveHRQOL in patients with allergic rhinitis. Validated questionnaires are now avail-able that can easily be used in clinical practice to measure the effects of interven-tions on HRQOL for individual patients.Conclusions: Evaluating the effects of interventions on HRQOL may be partic-

ularly important in a non-life-threatening condition such as rhinitis. Health-relatedquality of life measures can be used to indicate the risk/benefit and the cost/benefitratios of competing treatment options. Clinicians and policy makers are alreadyusing HRQOL data to evaluate results of medical interventions to guide patientmanagement and reimbursement decisions.

Ann Allergy Asthma Immunol 2000;85:338–348.

INTRODUCTIONThe prevalence of allergic rhinitis inthe United States is reported to be be-tween 15% and 20%.1 Although rhini-tis symptoms are not life-threatening,they can have detrimental effects onthe physical, psychologic, and socialaspects of patients’ lives, and can sig-nificantly decrease quality of life.2,3

“Quality of life” has been defined asthe subjective value a person placesupon satisfaction with his or her life.Within the last 10 to 15 years, therehas been a move toward greater appre-ciation of quality of life as it relates tohealth status. Health-related quality oflife (HRQOL) has been described bySchipper et al as “the functional effectsof an illness and its consequent therapyupon a patient, as perceived by thepatient.”2 It is becoming increasinglyaccepted that to obtain a completemeasure of the health status of patientswith allergic rhinitis, HRQOL assess-ments should be made in addition toclinical measurements.4 Indeed, thecorrelation between clinical measures

of allergic rhinitis (eg, symptom sever-ity) and patient quality of life appearsto be only weak to moderate.3,5Health-related quality of life is a

relatively new area of investigation;nevertheless, the use of HRQOL mea-sures in the assessment of therapeuticinterventions appears to be increasing.Rigorous practical questionnaires (in-struments) applicable to allergic rhini-tis have been developed and validatedfor use in clinical research trials. Meth-ods of correlating changes in HRQOLscores in clinical trials with clinicallymeaningful outcomes for individualpatients have been proposed and con-tinue to be a subject of investigation.The ease of use of many HRQOL in-struments suggests they may have util-ity in clinical practice to document thechanges in a patient’s current and fu-ture health due to therapeutic deci-sions.6–10This review describes the types of

tools used in allergy-specific HRQOLresearch, the effects of allergic rhinitison HRQOL, examples of assessmentsof allergy-related therapeutic interven-tions on HRQOL, and efforts to trans-late research data into useful informa-tion to guide therapeutic interventionsfor individual patients.

HRQOL INSTRUMENTSTypes of InstrumentsThe quality of HRQOL data is highlydependent on the instrument withwhich they are gathered. Two types ofinstruments, generic and disease-spe-cific, are used to assess HRQOL. Ge-neric instruments are general measuresof health status that can be used toevaluate different disease states, treat-ment interventions, and populations.Examples include the Sickness Impact

* Aventis Pharmaceuticals, Inc., Kansas City,Missouri.† McMaster University, Hamilton, Ontario,

Canada.‡ Allergy and Asthma Medical Group and

Research Center, San Diego, California.Received for publication March 25, 2000.Accepted for publication in revised form May

30, 2000.

338 ANNALS OF ALLERGY, ASTHMA, & IMMUNOLOGY

Profile (SIP), and the generic instru-ment used most often in allergic rhini-tis studies, the Medical OutcomesStudy 36-Item Short Form Health Sur-vey (SF-36).11,12 The SF-36 is a psy-chometric questionnaire with 36 ques-tions in 9 domains (Table 1).Generic instruments play an impor-

tant role in the overall assessment ofHRQOL. The breadth of coverage ofthese instruments may reveal impor-tant but unexpected effects onHRQOL.13,14 Another advantage isthey allow comparison of the burden ofillness among different diseases. TheSF-36 is not disease or treatment re-stricted.11 Generic instruments alsohave disadvantages. Because they areso all-encompassing and comprehen-sive, they may not focus adequately onproblems specific to a particular con-dition. Further, they may not be re-sponsive enough to detect small butclinically meaningful changes inHRQOL in a given disease state.14To surmount the shortcomings of

generic instruments, disease-specificHRQOL questionnaires have been de-veloped (Table 2). The disease-spe-cific instrument used most frequentlyin allergic rhinitis is the Rhinoconjunc-tivitis Quality of Life Questionnaire(RQLQ).15 The RQLQ measures theeffect of rhinoconjunctivitis symptomson seven disease-related domains (Ta-ble 3). Disease-specific instrumentsare more responsive than generic in-struments and they can be targeted to aspecific population, disease, or func-tion. Disease-specific instruments do

not allow comparisons between differ-ent medical conditions.Generic instruments may be modi-

fied to measure disease-specificHRQOL. An instrument gaining pop-ularity in allergic rhinitis treatment tri-als is the Work Productivity and Ac-tivity Impairment (WPAI) instrument.The WPAI is a generic instrument thathas been validated for use in allergicrhinitis; it measures impairment ofphysical and occupational functioningdue to allergy symptoms at work, inthe classroom, and during normal dailyactivities.16,17

Developing and ValidatingInstrumentsTo evaluate changes in HRQOL overtime in clinical trials or in clinicalpractice, HRQOL instruments must beresponsive and valid. The RQLQ isone of the first disease-specific instru-ments validated to measure HRQOL inrhinitis. When developing the RQLQ,Juniper and Guyatt were guided bycriteria they considered essential to areliable instrument. Specifically, thequestionnaire should (1) measure bothphysical and emotional function; (2)reflect areas of function important topatients with rhinoconjunctivitis; (3)provide summary scores amenable tostatistical analysis; (4) provide repro-ducible scores when the clinical state isstable; (5) be responsive to clinicallyimportant changes, even small ones;(6) be valid (ie, actually measure sub-jective aspects of health status); and(7) be relatively short to optimize costand efficiency.15All instruments used to evaluate

HRQOL in allergic rhinitis compriseone or more of four broad domains:physical and occupational function,psychologic state, social interaction,and somatic sensation (ie, problemspatients experience as a result of dis-ease symptoms).2 Selecting relevanthealth-related questions to be includedin an instrument is a methodical pro-cess. To create the RQLQ, the investi-gators drew on their personal experi-ences, reviewed other HRQOLinstruments, and interviewed allergicpatients to construct a broad list of 91

health-related items in areas of impor-tance to patients. Rhinitis patientsranked items on the list in order ofimportance and the RQLQ was re-duced to 28 items in 7 health-relateddomains. The instrument was thentested for reproducibility, responsive-ness, and validity in a large clinicaltrial that evaluated different therapeu-tic regimens in patients with rhinocon-junctivitis. Reproducibility was estab-lished by administering the test on twooccasions, 2 weeks apart, during a pe-riod of clinical stability. Responsive-ness was proved by correlating themagnitude of changes in RQLQ scoreswith patient-reported symptom sever-ity over the course of the trial. Validitywas supported by correlations in dete-riorating patient functionality reflectedin RQLQ scores as pollen counts rose(and vice versa); as well as by corre-lations between changes in RQLQ di-mension scores and recordings in nasaland eye symptoms diaries.15Disease-specific instruments can

(and should) be adapted to a particularpopulation. Juniper and colleagues de-veloped and validated versions of theRQLQ for adolescents aged 12 to 17years (Adol-RQLQ) and for childrenaged 6 to 12 years (PRQLQ).18,19 Ad-olescents with rhinoconjunctivitis ex-perience problems similar to thoseidentified by adults, except they havefewer sleep problems and more diffi-culty with concentration, particularlywith schoolwork. Younger children(aged 6 to 12 years) are troubled bypractical problems (eg, carrying tissuesor taking medication) but do not reportthe interference with daily activities orthe emotional distress experienced byadults and adolescents. This may bedue the younger child’s difficulty indifferentiating a healthy versus a dis-eased state and/or his or her inability toarticulate the problem.The RQLQ has also been shortened

(the Mini-RQLQ) for use in large clin-ical trials, surveys, and practice moni-toring, where high efficiency is impor-tant.20 Additionally, the RQLQ hasbeen adapted to measure only rhinitis(Rhinitis Quality of Life Question-

Table 1. Health-Related Quality of LifeDomains in the SF-36

Domains Questions

Physical functioning 10Role limitations due to

physical problems4

Bodily pain 2General health 5Vitality 4Social functioning 2Role limitations due to

emotional problems3

Mental health 5Health transition 1

VOLUME 85, NOVEMBER, 2000 339

naire) by removing questions pertain-ing to eye symptoms.10An instrument must retain the exact

wording and the validated administra-tion technique must be used to avoidbiases. Modes of administering HRQOLinstruments vary; they include personalinterview, telephone interview, patientself-reporting, and use of surrogate re-sponders.14 Each mode has advantagesand disadvantages. Interviewing the pa-tient face-to-face improves accuracyand minimizes missing information,but is resource intensive. Telephoneinterview removes the necessity of anoffice visit; however, the patient mustbe given a list of the appropriate re-sponses before the interview and thereis no guarantee that the interviewee is,in fact, the patient. Patient self-report-ing requires fewer resources but thereis a higher risk that the questionnairemay be incomplete. Use of surrogateresponders is appealing with certainpopulations (eg, children), however,accuracy may be compromised.14 Inaddition to the mode of administration,the increasing use of computers hasintroduced a new variable to HRQOLassessment: the mode of data collec-tion. Until recently, data were col-lected only in paper form. Preliminary

findings of a recent study suggest datacollected electronically do not differsignificantly from information col-lected on paper.21New rhinitis-specific instruments con-

tinue to be developed. For example, aninstrument to assess patient comfort andsatisfaction with nasal sprays has beendeveloped, the Nasal Comfort Index(NCI) although this instrument has yet tobe validated in a clinical trial.22

EFFECTS OF ALLERGICRHINITIS ON HRQOLAllergic rhinitis symptoms may seeminnocuous enough to the nonsufferer.People with allergic rhinitis, however,report that not only are symptoms ofrhinorrhea, nasal congestion, sneezing,itching, and associated eye problemsdisturbing, but also their emotionalwell-being, social functioning, andquality of life are diminished. Bous-quet et al used the SF-36 to assessHRQOL in subjects with perennial al-lergic rhinitis.8 These subjects reportedsignificantly poorer HRQOL than non-allergic control subjects in 8 of 9SF-36 domains. Similarly, using boththe SF-36 and the RQLQ, Meltzer et alfound that subjects with allergic rhini-tis experienced decreases in a majority

of domains of the SF-36 and in alldomains of the RQLQ (higher scoresindicate more severe symptoms) com-pared with non-allergic controls (Figs1 and 2).6 Rhinitis quality of life ques-tionnaire responses in another largestudy of subjects with moderate-to-se-vere allergic rhinitis symptoms indi-cated more than 90% of untreated pa-tients believed their ability to performdaily activities and work productivitywere impaired by rhinitis symptoms(Fig 3).23 Finally, in a recent study byMeltzer et al untreated patients withmoderate-to-severe allergic rhinitis re-ported high levels of activity, work,and classroom impairment (Fig 4).24In addition to psychosocial effects,

allergic rhinitis has detrimental effects

Table 2. HRQOL Instruments Used in Allergic Rhinitis

Instrument Questions (N) Patient Reference

Rhinoconjunctivitis Quality of LifeQuestionnaire (RQLQ)

28 Adults 15

Standardized Rhinoconjunctivitis Quality ofLife Questionnaire*

28 Adults 39

Mini Rhinoconjunctivitis Quality of LifeQuestionnaire

14 Adults 20

Pediatric Rhinoconjunctivitis Quality of LifeQuestionnaire

23 6–12 years 19

Adolescent Rhinoconjunctivitis Quality ofLife Questionnaire

25 12–17 years 18

Rhinitis Quality of Life Questionnaire 24 Adults 10Nasal Comfort Index In development Adults 22Nocturnal Rhinitis Quality of Life

QuestionnaireIn development �12 years †

Work Productivity and Activity ImpairmentInstrument‡

9 Adults 16, 17

MOS SF-36‡ 36 Adults 11, 12

* Same as the original RQLQ except activities are standardized rather than specified by thepatient.† Beginning validation process [personal communication (AT, EM, EJ)].‡ Generic instrument validated for use in allergic rhinitis.

Table 3. List of Functional ImpairmentsMost Important to Adults withRhinoconjunctivitis

Practical problemsNeed to blow nose repeatedlyNeed to rub nose/eyesInconvenience of having to carry tissues

Nasal symptomsStuffy/blockedSneezingRunnyItchy

Eye symptomsItchyWaterySwollenSore

SleepLack of sleepWake during nightDifficulty getting to sleep

Non-hay-fever symptomsTirednessFatigueWorn outPoor concentrationThirstReduced productivity

Activity limitationsPhysicalSocialOccupational

Emotional functionIrritableFrustratedEmbarrassed by nose or eye symptomsImpatientRestless


on mood and cognitive function. Usingthe non-allergy-specific Positive Af-fect Negative Affect Scales (PANAS),Marshall and Colon showed atopic in-dividuals experienced significant de-clines in positive affect scores duringallergy seasons compared with non-allergy seasons.25 Allergic subjectsalso consistently exhibit significantimpairment in cognitive processing,psychomotor speed, verbal learning,and memory during allergy seasoncompared with nonallergic controlsubjects.26 Further, Vuurman and col-leagues used a computer-simulated di-dactic simulation model to comparelearning capacity of allergic childrentreated with an antihistamine or pla-cebo with that of healthy controls.27Allergic children exhibited learningdeficits compared with healthy chil-dren, regardless of prior treatment.Nevertheless, although treatment

may not completely eliminate the ad-verse effects of allergic inflammation,clinical trial data suggests a variety ofpharmacologic therapies can signifi-cantly improve HRQOL.

EFFECTS OF ALLERGICRHINITIS TREATMENTS ONHRQOLIt has been proposed that there arethree reasons to treat patients: to pre-vent mortality, reduce probability offuture morbidity, and improve well-being.3 Until recently, the goal of treat-ment has been to meet the first twoobjectives, with improved well-beingassumed to be a natural consequenceof reduced symptom severity. Increas-ing data indicate, however, there isonly a modest correlation betweenclinical measures and how patients feeland function.3,5 It is now apparent thattreatments for allergic rhinitis must notonly relieve symptoms but must alsodemonstrate the ability to improvedaily functioning and maximize well-being. In fact, some national regulatoryagencies are beginning to require out-comes evidence of patient benefit be-fore approving new product submis-sions.3Health-related quality of life data

can be used to identify optimal thera-

peutic regimens and suggest practiceguidelines for allergic disorders. The-oretically, HRQOL evaluations willprovide rational comparisons of treat-ment alternatives and indicate the cost/benefit ratios of competing treatmentoptions. Comparing HRQOL datafrom separate trials can be problem-atic; the case-mix of patients understudy must be controlled since severityof disease will affect results, and pa-tients may have comorbidities, whichalso must be considered. Social andfinancial conditions of the patient caninfluence outcomes as well.28

The most common treatments for al-lergic rhinitis are antihistamines, decon-gestants, nasal steroids, and immuno-therapy. Low-sedating and nonsedatingantihistamines have been shown to im-prove HRQOL in subjects with moder-ate-to-severe allergic rhinitis comparedwith placebo.8,23,24 In a large health out-comes study, 60 mg BID fexofenadineHCl significantly improved HRQOL asindicated by the RQLQ and perfor-mance at work and in daily activities asindicated by the WPAI in patients withmoderate to severe SAR symptoms.23Use of these instruments in another

Fig. 1. Effects of allergic rhinitis on quality of life as measured with the Medical Outcomes Study36-Item Short Form Health Survey (SF-36). f � Allergic rhinitis and e � control. *P � .01 and† P � .05.

Fig. 2. Effects of allergic rhinitis on quality of life as measured with the Rhinoconjunctivitis Qualityof Life Questionnaire (RQLQ). f � allergic rhinitis and e � control. *P � .01.


study showed once-daily fexofenadine(120 mg and 180 mg QD) also im-proved patient-reported HRQOL anddecreased work and activity impair-ment compared with placebo.24 Nasalsteroids, including fluticasone propi-onate, budesonide, and beclometha-sone dipropionate have also beenshown to improve HRQOL in subjectswith allergic rhinitis compared withplacebo.9,10,29 Finally, Kumar and col-

leagues used the RQLQ to evaluatechanges in HRQOL related to allergenimmunotherapy in patients with aller-gic rhinitis 1 year prior to beginningimmunotherapy and during the courseof 3 years of treatment.30 Health-re-lated quality of life was significantlyimproved after 1 year compared withpretreatment and at year 2 comparedwith year 1 (year 3 data not yet avail-able).

Comparative HRQOL data formembers of the same drug class (eg,antihistamines) and between drugclasses (eg, nasal steroid versus anti-histamine) are now becoming avail-able. Results of a large multinationaltrial comparing the effects of fexofe-nadine and loratadine in SAR patientsshowed fexofenadine 120 mg QD sig-nificantly improved overall RQLQscores compared with placebo (P �0.01) and loratadine 10 mg QD (P �0.05).31 Similarly, a comparison of flu-ticasone propionate and loratadine us-ing the RQLQ in patients with SARindicated significantly more favorableoutcomes were obtained with the nasalsteroid (Fig 5).32Many studies suggest various aller-

gic rhinitis interventions are associatedwith statistically significant improve-ments in HRQOL compared with pla-cebo. Clinical efficacy trials typicallyuse statistical significance to indicatemeaningful change; however statisticalsignificance is not necessarily a reli-able indicator in HRQOL studies.Even when HRQOL changes are sta-tistically significant compared withplacebo, perhaps the difference is sosmall that it has no clinical relevance.Another concern is that when a changeis not statistically significant, perhapsthe study has not been adequately pow-ered to detect a meaningful change.33A variety of efforts have been (andcontinue to be) made to interpretchanges in HRQOL status in terms oftheir clinical relevance.

INTERPRETING HRQOL DATAIt has been proposed that any change inan HRQOL measure is clinically sig-nificant because it represents a pa-tient’s perception of their state ofhealth.34 Because HRQOL assessmentsare perceptual and not physiologic,they have been viewed as less mean-ingful than physiologic measures (de-spite the fact that subjective assess-ments of symptom severity areroutinely used to evaluate treatmentoptions in allergic rhinitis). Cliniciansmay require more experience with theHRQOL measures to trust their clinicalrelevance to the degree they have come

Fig. 3. Percent of patients who report impairment due to allergies as measured by the WorkProductivity and Activity Impairment (WPAI) questionnaire. *Percent of patients reporting any work orclassroom time missed, or any impairment in daily activities at work, or in the classroom, secondary toallergies (WPAI-AS).

Fig. 4. Reported levels of impairment at work, in the classroom, and in daily activities due to allergicrhinitis symptoms as measured by the WPAI. *Mean impairment levels reported by patients withseasonal allergic rhinitis (n � 845) before treatment as measured by the Work Productivity and ActivityImpairment Questionnaire (WPAI).


to rely on changes in rhinitis symptomscores.33 For this reason, an estimate ofthe difference in score on disease-spe-cific HRQOL questionnaires that canbe considered clinically meaningfulhas been a matter of investigation. Jae-schke and colleagues developed theconcept of a minimally important dif-ference (MID), which they defined as“the smallest change in score that pa-tients themselves perceive as importantand that would justify a change in thepatient’s treatment in the absence of un-due side effects or excessive cost.”35,36Several approaches have been suggestedfor determining the MID needed to sig-nal clinical improvement (or decrement)due to therapy. A “distribution based”approach is based on the statistical dis-tribution of the results, the most com-monly used statistic being “effect size,”which is derived from the magnitude ofchange and the variability in stable sub-jects.3 The problem with this approach isit does not indicate whether the magni-tude of change is of importance to thepatient. Another approach is referred toas “anchor based” and involves compar-ing or “anchoring” changes in HRQOLmeasures to other patient-perceived clin-ically meaningful outcomes. Juniper andcolleagues determined that a change inscore of 0.5 on the RQLQ is the MID byanchoring RQLQ responses against pa-tient responses on global rating ofchange questionnaires.3 Recent evidencesuggests using only MID to interpret re-search data is not necessarily reliable.Comparing mean differences betweentreatment groups using only MID valuesmay lead to erroneous conclusions. Ifonly the mean value for the group isconsidered, valuable information is lost.Patients are heterogenous in their re-sponses to an intervention. Looking onlyat the mean ignores the distributionabout the mean. For example, though amean change in RQLQ score of 0.4 isless than the MID, analysis of individualscores may show more patients experi-enced a clinically meaningful improve-ment from an intervention than thosewhose condition worsened.37Using a calculation (reported else-

where)36 comparing the proportion ofsubjects benefiting from a treatment

versus those not benefitting allows de-termination of the number needed totreat (NNT). The NNT is the numberof patients who would have to betreated for one patient to experience aclinically meaningful improvement inquality of life over and above thatwhich he or she would have experi-enced without the treatment (eg, withplacebo) or with a different interven-tion. The NNT can be used either forsummarizing the results of a therapeu-tic trial or for medical decision makingabout an individual patient.38 Prelimi-nary data suggest the NNT for someallergy and asthma treatments may berelatively low, in the single digits.37Single-digit NNT values strongly sup-port the clinical relevance of an inter-vention. Consider, for example, thatthe NNTs used to justify the use ofstatin drugs in stroke patients are in thetriple digits.

MAKING HRQOLASSESSMENTS IN CLINICALPRACTICEGeneric and disease-specific instru-ments commonly used in research havebeen validated in clinical trials; how-

ever, more study is needed to confirmtheir usefulness in individual patients.Nevertheless, a growing number of cli-nicians are measuring HRQOL duringroutine patient assessments.2 Health-related quality of life instruments areeasy to use and may provide an accept-able means of obtaining a formalizedand quantitative patient history. Theo-retically, the patient can complete thequestionnaire in the waiting room anda quick scan of responses by the clini-cian might reduce consultation timeand allow the clinician to quickly focuson areas of interest to the patient. Fur-ther, questionnaires may reveal prob-lems not spontaneously volunteered bypatients, particularly children.2 An-swers to questionnaires at multiple vis-its may indicate the effectiveness ofinterventions not only to the clinician,but also to the patient. Visible docu-mentation of benefit (improvements inscores) could help to reinforce persis-tence with a therapeutic regimen. Eval-uating the effectiveness of treatmentsin the “real world,” and not just inhighly controlled clinical studies, mayalso help to establish realistic practiceguidelines.

Fig. 5. Treatment comparisons made with the Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ). *FP ANS � fluticasone propionate aqueous nasal spray. †P � .05 versus placebo. ‡P � .05versus loratadine. Adapted with permission from Ratner et al. J Fam Pract 1998; 47:118–125.


SUMMARYAllergic rhinitis symptoms cause sig-nificant impairment of HRQOL. Con-ventional clinical indices of symptomseverity do not necessarily correlatewith patients’ feelings and functioning.Health-related quality of life can bemeasured directly using generic or dis-ease-specific instruments that havebeen shown to be reproducible, re-sponsive, and valid in controlled trials,and which may be easily incorporatedinto clinical practice. Experience withan instrument will make determiningthe clinical significance of HRQOLscores easier; however, in the mean-time, methods of evaluating clinicalrelevance of quality of life assessmentsare now available.Health-related quality of life mea-

sures can be used to indicate the risk/benefit and the cost/benefit ratios ofcompeting treatment options. Clini-cians and policy makers are alreadyusing HRQOL data to evaluate resultsof medical interventions to guide pa-tient management and reimbursementdecisions.2,11

ACKNOWLEDGMENTThe authors thank Sheila Owens forassistance in the preparation of thismanuscript.

REFERENCES1. Nathan RA, Meltzer EO, Seiner JC,Storms W. Prevalence of allergic rhi-nitis in the United States. J AllergyClin Immunol 1997;99:S808–S814.

2. Juniper EF. Rhinitis management: thepatient’s perspective. Clin Exp Allergy1998;28(suppl 6):34–38.

3. Juniper EF. Impact of upper respira-tory allergic diseases on quality of life.J Allergy Clin Immunol 1998;101(2 pt2):S386–S391.

4. Meltzer EO, Tyrell RJ, Rich D, WoodCC. A pharmacologic continuum inthe treatment of rhinorrhea: the clini-cian as economist. J Allergy Clin Im-munol 1995;95(5 pt 2):1147–1152.

5. De Graff-in ’t Veld T, Koenders S,Gerrelds IM, Gerth van Wijk R. Therelationships between nasal hyperreac-tivity, quality of life, and nasal symp-toms in patients with perennial allergicrhinitis. J Allergy Clin Immunol 1996;

98(3):508–513.6. Meltzer EO, Nathan RA, Selner JC,Storms W. Quality of life and rhiniticsymptoms: Results of a nationwidesurvey with the SF-36 and RQLQquestionnaires. J Allergy Clin Immu-nol 1997;99:S815–S819.

7. Blaiss MS. Quality of life in allergicrhinitis. Ann Allergy Asthma Immunol1999;83:449–454.

8. Bousquet J, Duchateau J, Pignot JC, etal. Improvement of quality of life bytreatment with cetirizine in patientswith perennial allergic rhinitis as de-termined by a French version of theSF-36 questionnaire. J Allergy ClinImmunol 1996;98:309–316.

9. Goodwin B, Bowers B, Hampel F. Su-perior improvement in disease-specificquality of life for SAR patients receiv-ing intranasal fluticasone vs loratadinetablets. J Allergy Clin Immunol 1997;99:S27D.

10. Juniper EF, Guyatt GH, Andersson B,Ferrie PJ. Comparison of powder andaerosolized budesonide in perennialrhinitis: validation of rhinitis quality oflife questionnaire. Ann Allergy 1993;70:225–230.

11. Ware JE, Sherbourne CD. The MOS36-item short-form health survey (SF-36). Med Care 1992;30:473–483.

12. How to score the MOS 36-item short-form health survey (SF-36). SF-36scoring rules (version 1.1). Interna-tional Resource Center (IRC) forHealth Care Assessment, New En-gland Medical Center Hospitals. Copy-right 1992 MOS Trust, Inc.

13. Ellis AK, Day JH, Lundie MJ. Impactof quality of life during an allergenchallenge research trial. Ann AllergyAsthma Immunol 1999;83:33–39.

14. Guyatt GH, Feeny DH, Patrick DL.Measuring health-related quality oflife. Ann Intern Med 1993;118:622–629.

15. Juniper EF, Guyatt GH. Developmentand testing of a new measure of healthstatus for clinical trials in rhinocon-junctivitis. Clin Exp Allergy 1991;21:77–83.

16. Reilly MC, Zbrozek AS, Dukes EM.The validity and reproducibility of awork productivity and activity impair-ment instrument. PharmacoEconomics1993;4(5):353–365.

17. Reilly MC, Tanner A, Meltzer EO.Work, classroom, and activity impair-ment instruments. Clin Drug Invest1996;11(5):278–288.

18. Juniper EF, Guyatt GH, Dolovich J. As-sessment of quality of life in adolescentswith allergic rhinoconjunctivitis: devel-opment and testing of a questionnaire forclinical trials. J Allergy Clin Immunol1994;93(2):413–423.

19. Juniper EF, Howland WC, RobertsNB, et al. Measuring quality of life inchildren with rhinoconjunctivitis. J Al-lergy Clin Immunol 1998;101(2 pt 1):163–170.

20. Juniper EF, Thompson AK, Ferrie PJ,Roberts JN. Development and valida-tion of the mini rhinoconjunctivitisquality of life questionnaire. Clin ExpAllergy 2000;30(1):132–140.

21. Caro JJ, Caro I, Caro J, et al. Elec-tronic implementation of quality of lifemeasures in asthma [Abstract]. Am JRespir Crit Care Med 1999;159(3):693.

22. Keresteci MA, Ungar W, Ryan N, etal. Development of a nasal comfortindex for nasal sprays in adults withseasonal allergic rhinitis [Abstract].Value Health 1999;2(3):181.

23. Tanner LA, Reilly M, Meltzer EO, etal. Effect of fexofenadine on quality oflife and work, classroom, and dailyactivity impairment in patients withseasonal allergic rhinitis. Am J ManCare 1999;5(suppl):S235–S247.

24. Meltzer EO, Casale TB, Nathan RA,Thompson AK. Once-daily fexofena-dine HCl improves quality of life andreduces work and activity impairmentin patients with seasonal allergic rhini-tis. Ann Allergy Asthma Immunol1999;83:311–317.

25. Marshall PS, Colon EA. Effects of al-lergy season on mood and cognitivefunction. Ann Allergy 1993;71:251–258.

26. Simons FER. Learning impairmentand allergic rhinitis. Allergy AsthmaProc 1996;17:185–189.

27. Vuurman EF, van Veggel LM, Uiter-wijk MM, et al. Seasonal allergic rhi-nitis and antihistamine effects on chil-dren’s learning. Ann Allergy 1993;71(2):121–126.

28. Blaiss MS. Why outcomes? [editorial].Ann Allergy Asthma Immunol 1995;74(5):359–361.

29. Milgrom H, Biondi R, Georgitis JW, etal. Comparison of ipratropium bro-mide 0.03% with beclomethasonedipropionate in the treatment of peren-nial rhinitis in children. Ann AllergyAsthma Immunol 1999;83:105–111.

30. Kumar P, Kamboj S, Rao P, et al. The


cost of care and quality of life in pa-tients with allergic rhinitis on allergenimmunotherapy. Allergy Clin Immu-nol Int 1997;9:133–135.

31. Van Cauwenberge P, Juniper EF,Meltzer E, Star Study InvestigatingGroup. Comparison of the efficacy,safety, and quality of life providedby fexofenadine hydrochloride 120mg, loratadine 10 mg, and placeboadministered once daily for the treat-ment of seasonal allergic rhinitis.Clin Exp Allergy 2000;30:891–899.

32. Ratner PH, van Bavel JH, martin BG,et al. A comparison of the efficacy offluticasone propionate aqueous nasalspray and loratadine alone and in com-bination, for the treatment of seasonalallergic rhinitis. J Fam Pract 1998;47:

118–125.33. Juniper EF. Quality of life

questionnaires: does statistically sig-nificant equal clinically important?Editorial. J Allergy Clin Immunol1998;102(1):16–17.

34. Lydick E, Epstein RS. Interpretation ofquality of life changes. Quality LifeRes 1993;2:221–226.

35. Jaeschke R, Singer J, Guyatt GH. Mea-surement of health status. ControlledClin Trials 1989;10:407–415.

36. Juniper EF, Guyatt GH, Willan A,Griffith LE. Determining a minimalimportant change in a disease-specificquality of life questionnaire. J ClinEpidemiol 1994;47:81–87.

37. Juniper EF. Interpreting of Quality ofLife Data. Quality of Life Newsletter,

September–December 1999;2:3.38. Chatellier G, Zapletal E, Lemaitre D,

et al. The number needed to treat: aclinically useful nomogram in itsproper context. Br Med J 1996;312:426–429.

39. Juniper EF, Thompson AK, Ferrie PJ,Roberts JN. Validation of the standard-ized version of the RhinoconjunctivitisQuality of Life Questionnaire. J Al-lergy Clin Immunol 1999;104(2 pt 1):364–369.

CME ExaminationNo 2000-011Questions 1–20. Thompson AK. Ann Allergy Asthma Immunol 2000;85:338–348CME Test Questions

1. “Health-Related Quality of life”has been defined as:a. Patient satisfaction with his orher physician

b. Patient satisfaction with drugtherapy

c. Patient’s perception of thefunctional effects of an illnessand its treatment

d. Improvement in health due totreatment

e. Physician’s perception of thepatient’s functional status

2. HRQOL data may be beneficialfora. Comparing treatment optionsb. Guiding patient managementc. Informing reimbursement deci-sions

d. Indicating risk/benefit ratiose. All of the above

3. An example of a generic HRQOLinstrument that is commonly usedin used in allergic rhinitis is thea. RQLQb. SF-36c. WPAId. A and Be. B and C

4. Which of the following is not afeature of generic HRQOL instru-ments:a. Can be used to evaluateHRQOL in different diseasestates

b. Are responsive enough to de-tect small but clinically mean-ingful changes in HRQOL

c. Can be used to assess HRQOLin various populations

d. May reveal important but un-expected effects of interven-tions on HRQOL

e. Can compare the burden of ill-ness between different diseasestates

5. Which of the following are advan-tages of disease-specific HRQOLinstruments:a. Because it is targeted to a sin-gle disease, it is more respon-sive than generic instruments

b. Does not require validation oradaptation to different popula-tions

c. Allow comparisons betweendifferent medical conditions

d. A and Be. All of the above

6. Which of the following instru-ments best measures the effects ofallergic rhinitis on productivity?a. Rhinoconjunctivitis Quality ofLife Questionnaire (RQLQ)

b. Work Productivity and Activ-ity Impairment questionnaire(WPAI)

c. Medical Outcomes Study 36-Item Short Form Health Survey(SF-36)

d. Nasal Comfort Index (NCI)e. Mini RQLQ

7. Which of the following is not adomain of the RQLQa. Sleepb. Eye symptomsc. Practical Problemsd. Emotional functione. Psychomotor performance

8. Criteria essential for a reliableHRQOL instrument includea. Measure physical and emo-tional function

b. Reflect areas of function im-portant to the patient

c. Provide measurements amena-ble to statistical analysis

d. Provide reproducible scoreswhen health status is stable

e. All of the above

Request reprint should be addressed to:Ann K Thompson, MBA, BSNUS Medical AffairsAventis Pharmaceuticals10236 Marion Park DrKansas City, MO 64137


9. The validity of an HRQOL instru-ment is a measure of its ability toa. Reflect areas of function im-portant to the patient

b. Be responsive to small but im-portant changes

c. Actually measure subjectiveaspects of health status by cor-relating with symptom scores

d. Be administered quicklye. Reflect the outcomes of thera-peutic interventions

10. Which of the following domains isnot assessed in an HRQOL instru-ment:a. Physical and occupationalfunction

b. Psychological statec. Body mass indexd. Social interactione. Somatic sensation

11. When administering and HRQOLinstrument it is important toa. Use the exact working of thevalidated instrument

b. Allow family/friends to assistpatient in completing the ques-tionnaire

c. Encourage patient to completethe entire questionnaire

d. A and Be. A and C

12. The most reliable (and most re-source intensive) mode of adminis-tration of an HRQOL instrument isa. Direct patient interviewb. Computer surveyc. Telephone interviewd. Surrogate responderse. Patient self-reporting

13. Compared with their nonallergicpeers, during allergy season, sub-jects with allergic rhinitis exhibitimpaired:a. Social functioningb. Productivity at work and/orschool

c. Learning abilityd. Psychomotor performancee. All of the above

14. The correlation between clinicalmeasures of health and patients’feelings of well-being isa. Nonexistentb. Weak to moderatec. Strongd. Inversely proportionale. None of the above

15. Which of the following treatmentsfor allergic rhinitis have beenshown to improve HRQOL com-pared with placebo in controlledtrials:a. Antihistaminesb. Nasal steroidsc. Immunotherapyd. All of the abovee. None of the above

16. Methods of defining the clinicalrelevance of health-related qualityof life (HRQOL) outcomes in-clude:a. Minimally important differ-ences

b. Number needed to treatc. Effect sized. All of the abovee. None of the above

17. The minimally important differ-ence (MID) has been defined as:a. A reduction in symptom sever-ity of 50%

b. The smallest change the patientwould perceive as importantand that would justify a changeof treatment, barring unduecosts or side effects

c. A difference in RQLQ score of0.5

d. A statistical difference of p �0.05

e. None of the above18. The number needed to treat (NNT)

has been defined asa. The number of patients whowould have to be treated forone patients to have a clinicallymeaningful improvement inHRQOL compared with no (ora different) treatment

b. The number of patients neededin a clinical trial to provide suf-ficient statistical power

c. The mean number of doses of atherapeutic intervention neededto relieve rhinitis symptoms

d. The number of patients whoexperience a clinically mean-ingful change in HRQOL dueto an intervention

e. None of the above19. Advantages of using HRQOL as-

sessments in clinical practice in-clude:a. Identifying areas of interest tothe patient regarding his or herhealth status

b. Assessing results of therapeuticinterventions

c. Identifying problems not spon-taneously volunteered by thepatient

d. Establishing patient historye. All of the above

20. When developing a HRQOL in-strument, items (questions) aregenerated by:a. Drawing on personal experi-ences

b. Reviewing scientific literatureand existing instruments

c. Interviewing patientsd. Ranking items in order of im-portance

e. A, B, and C


Documents

Quality of life in patients with allergic rhinitis