Study protocol for Women of Color and Asthma Control: A randomized controlled trial of an asthma-management intervention for African American women.

0.21 MB·English

by  Janevic, Mary R

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STUDY PROTOCOL Open Access
Women of Color and Asthma
Study protocol for
Control:
A randomized controlled trial of an
asthma-management intervention for African
American women
Mary R Janevic1*, Georgiana M Sanders2, Lara J Thomas1, Darla M Williams1, Belinda Nelson1, Emma Gilchrist1,
Timothy RB Johnson3 and Noreen M Clark1
Abstract
Background: Among adults in the United States, asthma prevalence is disproportionately high among African
American women; this group also experiences the highest levels of asthma-linked mortality and asthma-related
health care utilization. Factors linked to biological sex (e.g., hormonal fluctuations), gender roles (e.g., exposure to
certain triggers) and race (e.g., inadequate access to care) all contribute to the excess asthma burden in this group,
and also shape the context within which African American women manage their condition. No prior interventions
for improving asthma self-management have specifically targeted this vulnerable group of asthma patients. The
current study aims to evaluate the efficacy of a culturally- and gender-relevant asthma-management intervention
among African American women.
Methods/Design: A randomized controlled trial will be used to compare a five-session asthma-management
intervention with usual care. This intervention is delivered over the telephone by a trained health educator.
Intervention content is informed by the principles of self-regulation for disease management, and all program
activities and materials are designed to be responsive to the specific needs of African American women. We will
recruit 420 female participants who self-identify as African American, and who have seen a clinician for persistent
asthma in the last year. Half of these will receive the intervention. The primary outcomes, upon which the target
sample size is based, are number of asthma-related emergency department visits and overnight hospitalizations in
the last 12 months. We will also assess the effect of the intervention on asthma symptoms and asthma-related
quality of life. Data will be collected via telephone survey and medical record review at baseline, and 12 and
24 months from baseline.
Discussion: We seek to decrease asthma-related health care utilization and improve asthma-related quality of life
in African American women with asthma, by offering them a culturally- and gender-relevant program to enhance
asthma management. The results of this study will provide important information about the feasibility and value of
this program in helping to address persistent racial and gender disparities in asthma outcomes.
Trial Registration: ClinicalTrials.gov: NCT01117805
Keywords: Asthma, randomized controlled trials, women, African Americans, chronic disease management, self-
regulation, behavioral interventions
*Correspondence:[email protected]
1CenterforManagingChronicDisease,UniversityofMichigan,1415
WashingtonHeights,AnnArbor,Michigan,USA
Fulllistofauthorinformationisavailableattheendofthearticle
©2012Janevicetal;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommons
AttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,andreproductionin
anymedium,providedtheoriginalworkisproperlycited.
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Background and gender-role issues in asthma management. This
Asthma and asthma-management among African- intervention was efficacious in reducing health care utili-
American women zation while improving asthma-related quality of life and
AsthmaprevalenceintheUnitedStatescontinuestobeat clinical status [15,16]. However, unpublished analyses
a worrying high level across the population, and both examining the subgroup of African American women in
womenandAfricanAmericanscontinuetobedispropor- this trial (n = 89) suggest that this group failed to
tionatelyaffectedbythisillness.Amongadults,prevalence achieve the same magnitude of positive outcomes as the
among women is nearly double that among men (9.7 vs. overall study population, although statistical power was
5.5%), representing a shift from childhoodwhereasthma limited. These findings suggest the possibility that an
predominates among boys, and is higher among non- intervention that better meets the specific asthma-edu-
Hispanic Blacks compared to non-Hispanic Whites (8.7 cation and support needs of African American women
vs.8.1%)[1].Genderandracedisparitiesarealsopresent may achieve more positive results. There are few exam-
inmeasuresofasthmamorbidity,emergencydepartment ples in the literature of asthma-management programs
use/hospitalization,andmortality[2-4]. relevant to the needs of African American patients (see
The greater asthma incidence, prevalence and severity [17] for review), and none that are specific to women.
observed among women compared to men has been TheWomenBreatheFreeprogramwasadaptedtomeet
relatedtomultipleissues;forexample,hormonally-linked the needs and preferences of African American women
biological differences [5] and greater effects of smoking using a process that consisted of two primary phases:
andobesity[5,6].Certainriskfactorsforpoorasthmaout- focusgroups and expert review. In the first phase, forty-
comessuchasdepressionandmedicationnon-adherence fourAfricanAmericanwomenwithasthmawhohadcom-
may also be more commonamong women[6]. Similarly, pleted the Women Breathe Free study were recruited to
multiple factors, many of which are associated with low take part in focus group discussions. Open-ended ques-
socioeconomicstatus(SES),likelyplayaroleinthegreater tions were posed about asthma-management concerns,
asthma burden among African Americans; e.g., lack of andalsothesocial,cultural,clinical,andpracticalaspects
access to optimal medical care, greater prevalence of of an intervention that would help them better manage
indoor and outdoor environmental triggers commonly their asthma. Major themes that emerged from these
foundinlow-incomeareas,lackofasthmaeducationand groups included: difficulties associated with being over-
support,racialdiscrimination,andlessuseofanti-inflam- weight; extensive family care responsibilities; costs asso-
matorymedicines[7-10]. ciated with asthma care and medicines as a barrier to
With excess risk conferred by both gender and race, management;theinfluenceofsocialnetworkmemberson
AfricanAmericanwomencompriseaparticularlyvulner- asthma management; and the importance of social sup-
ablegroupofasthmapatients,andarethusalogicalfocus port.Desiredcharacteristicsofanasthma-educationpro-
of programsto improveasthmaoutcomes. Thedesignof gram included: a personalized program that addresses
theseprogramsshouldconsiderfactorslinkedtobothsex/ asthma-management challenges in the context of eco-
genderandracethatmayaffectasthmamanagement.For nomicconstraints;counselorswhosharethewomen’scul-
example, many women experience menstruation-linked turalbackgroundanddemonstraterespectfortheirsocial
fluctuation in asthma symptoms and have greater expo- and cultural experience, values, and beliefs; counselors
surethanmentocommonasthmatriggerssuchashouse- whoareknowledgeable,patient,andabletomotivateand
hold cleaning products [11]. Compared to other ethnic offer‘handholding’whenneeded;deliveredbytelephone,
groups, African American women have a higher average a mode whichthe women foundmore flexible, personal,
body mass index (BMI), which has been linked to more andprivatethangroupmeetings;andmaterialsthatmake
severeasthmasymptoms[12].Inaddition,amongwomen useofchecklistsandgraphicsinplaceofextensivetext.
screenedforparticipationinabirthcohortstudy,African Aftermaterialsrelatedtointerventioncontentandpro-
AmericanwomenhadhigherlevelsoftotalIgE,withspe- cesswereinitiallydevelopedbasedonfocusgroupresults,
cificsensitivitytomoreaeroallergens,thantheirCaucasian thesecondphaseofadaptation,expertreview,tookplace.
counterparts [13]. They may also have a greater reliance A panel was convened consisting of three doctoral-level
onover-the-counterorhomeremediesandbemorelikely expertsinasthmaandculturalappropriateness(anepide-
todelaycare-seeking[14]. miologist/healtheducator,aculturalanthropologist,anda
socialworker).AllpanelmemberswerethemselvesAfrican
Adapting Women Breathe Free for an African American Americanwomenwhohadextensiveexperience working
population inthe fieldof asthma educationintheAfrican American
A telephone-based asthma education intervention for community. This group reviewed all materials and made
women age 18 and over, Women Breathe Free, was the suggestionsformodificationsasneeded.Asummaryofthe
first published trial of an intervention addressing sex ways in which the new program, called Women of Color
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andAsthmaControl(WCAC),isdesignedtoberelevantto e.g. asthma symptoms and QOL, the intervention effect
anAfricanAmericanpopulationcanbefoundinTable1. occurredduringthefirst12monthsandthepowercalcu-
lations for these were performed at 12 months, which is
Methods/Design thesameormoreconservativethan24months.
This study uses a randomized controlled design (inter- TherelativelyrareoccurrenceofEDvistsandhospitali-
vention vs. usual care) to test the efficacy of Women of zations for asthma requires a large sample size to detect
Color and Asthma Control, a telephone-based asthma clinical improvementover time. Inpreviousworkby the
management intervention for African American women. authorsbasedon364participantswithasthma,belonging
All study procedures have been reviewed and approved to the intervention group was associated with a 75%
by the Institutional Review Board at the University of reductionforhospitalizationand53%forEDvisitswithat
Michigan (IRB Study HUM00033784). least80%power(alpha=5%)at24-monthfollow-up.We
conservatively estimate a smaller reduction for the same
Study hypotheses twooutcomeswithasimilarsamplesizeandthesamesta-
Compared to women in the usual care group, women in tistical power. An initial total sample of 420 and a final
theinterventiongroupwill:1)useemergencydepartment availablesampleof286willhavesufficientpowertodetect
(ED) services for asthma less frequently and be hospita- a32%improvementintheproportionofparticipantshav-
lized for asthma less frequently; 2) need urgent care in a ingat least1EDvisit(42% inmeanEDvisits)anda41%
physician’sofficelessoften;3)experiencefewersymptoms improvementintheproportionhavingatleastonehospi-
of asthma; and 4) have higher levels of asthma-related talization(46%inmeanhospitalizations).Notethatthese
qualityoflife.Weexpecttoseebetween-groupdifferences powercalculations also ensureour ability to assessother
atboth12and24monthsfrombaseline. important outcomes such as asthma symptoms and
asthmaqualityoflife.
Sample size determination
The sample size of 420 at baseline (210 women in each Participant recruitment
treatment condition) was determined by power calcula- Wearerecruitingatotalof420participantsforthisstudy
tions using the primary study outcomes of ED visits and overanapproximatelytwo-yearperiod.Tobeeligible,par-
hospitalizationsinthelast12months,takingintoaccount ticipantsmust:1)beawoman18yearsofageorolderand
30%attritionrateover24monthsandalossof5women self-identifyasAfricanAmerican,2)haveaccesstoaland-
per group due to pregnancy. In previous work we line or mobile telephone, 3) not be pregnant, and 4) not
observedthatforEDvisitsandhospitalizationsthetreat- resideinaninstitution.
menttakesatleast12monthstoreachfulleffect;thus,the Primary recruitment is through the University of
sample size calculations for these outcomes were per- Michigan Health System (UMHS), with eligibility
formed at 24 months. However, for the other outcomes, requirements for participants including: 1) have at least
Table 1Examplesofculturally-relevant aspects ofthe WomenofColor andAsthma Control intervention
Programelement Relevance
Programstaff InterventioncounselorsareAfrican-Americanwomen,toenhancerapportwithparticipants.Non-counselingstaffaretrained
inissuesrelatedtoculturalsensitivity.
Participantvisuals PhotographsinworkbookrepresentadiversityofAfricanAmericanwomenandfamilies.Photosoftelephonecounselors
includedinworkbook.
Workbookcontent Useofculturally-relevantactivitieswhendiscussingpotentialtriggers(e.g.,nailsalons,churchandfamilygatherings).Useof
culturally-relevantexamplesinlistofpotentialasthma-managementproblems(e.g.,asthmamedicineisexpensivesoIonly
buyitwhenmysymptomsarebad,myfamilythinksprayerisallIneedtotakecareofmyasthma).
Telephonesession Culturally-linkedfactorsaddressedbytelephonecounselorsduringprogramsessions,whererelevant:
content –Potentialperceptionthatasthmaislife-threateningandthatfears,ifnotmanaged,canblockeffectiveaction.
–Therolethatbeingoverweightmayplayinworseningasthmasymptoms.
–Impactoftimeandfamilyresponsibilities,includingextendedfamily.
–Economicconstraintsinmanagingasthma.
–Theimportanceofcommunitylifeandthepotentialinfluenceonasthmamanagementofthebeliefsofotherwomenin
theirsocialcircles.
–Potentialuseofalternativetherapies.
–Possibilityoffrequentasthmasymptoms.
–Possibilityofuseofurgentandemergencyservicesforasthmaasaregularfeatureofcare.
–Possibilityofnotusinganti-inflammatorymedicine.
–Generationofapotentialallergyprofiletohelpinformulatingstrategiesrelatedtoenvironmentalcontrol,potential
seasonsofincreasedrisk,andtherelationshipbetweenasthmaandrhinitis.
-Effectivecommunicationwithhealthcareteamandothersourcesofsupport.
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one outpatient visit at the University of Michigan Health block, there will be an equal number of intervention
System (UMHS) in the past year; and 2) be listed on the and control participants. This process ensures that over
UMHS Asthma Patient Registry, a validated all-payer the course of the study, 210 women will be assigned to
registry of patients with persistent asthma cared for each of the two study conditions. It also reduces poten-
within UMHS. Lists of potential participants from the tial confounding effects (e.g., seasonal variation) which
UMHS Asthma Registry are periodically generated and might occur due to the rolling recruitment process.
reviewed by a research nurse. Eligible patients are then
mailed a packet including consent forms, a study over- Theory and content of intervention
view page and a letter from the project director inviting WCAC is based on the Center for Managing Chronic
them to enroll. The letter is followed by a recruitment Diseasemodelofself-regulationfordiseasemanagement,
phone call, which includes information about the study’s a framework that has been informed by social cognitive
purpose, randomization, and data collection. Upon theory [18]. Participants are introduced to a self-regula-
returning a signed consent form, participants are tory problem-solving process, which is designed to help
enrolled in the study and randomized after baseline data them engage more effectively in their asthma manage-
collection. ment.Thisprocess,whichreflectsthekeycomponentsof
Secondaryrecruitmentmethodsincludepostingonthe the self-regulationmodel,includethe followingsteps:1)
University of Michigan’s clinical trial research database, Identifying a problem in asthma management (partici-
http://UMClinicalStudies.org; partnering with the Blue pants are offered a list of potential asthma-management
Cross Blue Shield of Michigan (BCBSM) to identify problems,includingthoseassociatedwiththeirsex,gen-
members in the area who meet study criteria; and insti- der roles, culture and other relevant challenges; recom-
tutingacommunityrecruitmentplanthatincludespost- mendations from the participant’s physician are also
ingflyersinlocalhealthcenters,hairsalons,community reviewedatthisstage);2)Observingoneself,one’senvir-
organizations, and churches. All patients recruited out- onment, and one’s pattern of symptoms so as to under-
side of the Registry will have patient records in the stand both the influences on the problem and the way
UMHS or BCBSM systems that can be used for analysis those influences might be ameliorated; 3) Setting an
ofoutcomesrelatedtohealthcareutilization.Anypoten- asthma-management goal; 4)Developing a plan or
tialparticipantcontactingstudystaffafterlearningabout strategy to achieve the goal; and 5)Tracking progress,
the study through one of these secondary recruitment reacting appropriately, and establishing suitable
methods will be screened for eligibility and then mailed rewardsforsuccess.Participantsareguidedbythecoun-
thestudypacketasdescribedabove. selor through a period of self-observation using a peak-
To enhance recruitmentandretentionof participants, flow meterandsymptomdiary,alongwithachecklistof
a number of strategies are employed. Strategies include: physicalactivity,environmentalfactors,andotherpoten-
1) providing a $20 gift card upon completion of each tial precipitants to asthma exacerbations. This observa-
data-collection interview; 2) mailing periodic greeting tion period enables them to see the barriers and
cards to establish a personal connection; 3) providing facilitators to achieving desired management practices
eachintervention-group participantwithhercounselor’s and outcomes. Telephone sessions last 45 minutes to 1
photograph and a personalized letter; 4) utilizing as hour and take place approximately every two weeks.
recruiters, interviewers, and counselors individuals who Table2providesan overview ofthe content ofeachses-
share a cultural understanding and who have worked sion. Importantly, the content of the intervention also
with and in the African American population; and 5) reinforcestheprioritymessagesputforthbytheNational
attemptingcontactsovera periodofseveralweekssince AsthmaEducationand PreventionProgram’sGuidelines
disconnected phone lines are sometimes reconnected Implementation Panel [19]: appropriate use of inhaled
afteraperiodoftime. corticosteroids, reviewing asthma control, having an
asthma action plan, periodic follow-up visits with clini-
Randomization cian as appropriate, and allergen and irritant exposure
After the baseline interview, participants are assigned to control.
either treatment or control groups using a restricted
randomization scheme. This scheme achieves balance Control condition
between the two groups at all points during the study The control condition will consist of usual care from the
period. Prior to the beginning of the study, a permuted UMHS or a BCBSM provider. At the UMHS, this care
block randomization schedule for 420 subjects was cre- consists of evidence-based clinical practice and adher-
ated using the RANTBL and RANUNI functions in SAS ence to National Asthma Education and Prevention Pro-
to generate blocks with varying sizes of 8, 10, or 12 and gram (NAEPP) guidelines for asthma diagnosis and
random numbers for group assignment. After every treatment, and development of asthma action plans.
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Table 2WomenofColor andAsthma Control intervention: Overview ofprogramsessioncontent
Session Examplesoftopics,andself-regulationphases Goalsforparticipant Othercontent
addressed:
1 Useofpeakflowmeter(PFM);trackingsymptoms, Self-observeusingasthmadiary(mail
medicationsandtriggers;allergies. copyofdiarydatabacktohealth
educator).
2 ReviewPFMandsymptomdiary. Usereviewtoidentifysymptom
patternsandtriggers.Continueself-
observation.
3 ReviewPFMandsymptomdiary;review Developaplanforaddressingthe Discussionsofsex-,gender-andculture-
therapeuticplanprovidedbyphysician.Identifya problemareaandreachinggoal.Carry relatedinfluencesonasthmaandasthma
managementgoalanddevelopplantoachieve outstepsofthemanagementplan. managementareintegratedintoeach
goal. session.
4 Reviewprogresstowardgoalandadjustplanas Assessprogress,fine-tuneplan,and
needed. continuetowardproblemresolution.
5 Reviewprogresstowardgoalandconsidernext Achievegoalasappropriate,apply
steps(e.g.,refineplan,choosenewproblem,etc.). problemsolvingprocesstonew/
Discussrewardandbenchmarksofprogress. differentmanagementproblems.
Emphasis is also placed on patient education about dis- nighttime asthma symptoms, rescue medication use, and
ease processes, importance of trigger avoidance, and the overall self-rated asthma control over the last 4 weeks.
development of a partnership for asthma care. Standar- Mini Asthma Quality of Life Questionnaire [21]
dized asthma education kits are available in all UMHS This validated 15-item scale addresses the following four
clinic sites, and clinic personnel have been trained in domains specific to adult asthma patients: 1) activity
their use by a certified asthma educator. Of note, sex- limitations; 2) symptoms; 3) emotional function; and 4)
specific, gender-role, or culturally-related issues are not environmental stimuli.
systematically or routinely addressed during the clinical Absenteeism activity days
encounter or in educational materials. All WCAC parti- In the previous 12 months, 1) total days when physical
cipants are sent basic asthma education materials ("Con- activity was limited because of asthma; 2) total days of
trolling Your Asthma” booklet from the American missed work or school because of asthma.
College of Chest Physicians) upon completion of the Other health care utilization
baseline interview. In the previous 12 months, unscheduled clinic visits for
urgent asthma treatment and scheduled clinic visits for
Outcomes and measures asthma care.
Data is collected from participants via telephone inter- Asthma self-regulation skills and self-efficacy
viewswithtrainedresearchassistants.Dataiscollectedon A scale was developed by the authors that measures the
paper and then entered twice into Qualtrics, a secure frequency with which participants engage in the self-reg-
onlinesurveyprogram,toensureaccuracy.Withtheparti- ulatory behaviors of observations, judgments, and reac-
cipants’permission,anaudiorecordingoftheinterviewis tions as applied to asthma management; and also
also made to verify data accuracy and completion. Data measures self-efficacy for each of these behaviors.
collectiontakesplaceatthreetimepoints:baseline(before Sex/gender-specific management problems
randomization),12months,and24months. This scale, used in previous work by the authors [15],
Theprimarystudyoutcomesarethenumberofasthma- measures the frequency of problems of asthma manage-
relatedEmergencyDepartment(ED)visitsandthenumber ment related to hormonal cycles, sexual activity, urinary
ofovernighthospitalizations inthelast 12months.These incontinence, and triggers associated with gender roles.
willbecollectedviaself-reportontelephoneinterviews,as African-American-specific management problems
wellasfrommedicalandbillingrecords. This scale, developed by the authors, measures the fre-
Other outcomes of interest include the following: quency with which participants experience asthma-man-
Frequency of daytime and nighttime asthma symptoms agement challenges that may be common among
(coughing, wheezing, shortness of breath, and chest African American women (e.g., having numerous family
tightness), over the past month, seasonally, and in the responsibilities, physician communication, money con-
last 12 months. cerns or worries).
Asthma Control Test [20] Data is also collected on a wide array of demographic,
This validated, five-item questionnaire assesses the effect health and psychosocial characteristics at all three time
of asthma on daily functioning, shortness of breath, points.
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Analysis will also provide important information about the recep-
Statistical testing will evaluate changes in the primary tiveness of participants to an intervention relevant in
andsecondaryoutcomes,andotheroutcomesofinterest, this manner. If shown to be efficacious, the WCAC pro-
over the course of the study, and assess differences in gram will represent one means of addressing persistent
these changesasa function ofparticipation inthe inter- racial disparities in asthma outcomes.
vention. Descriptive statistics will be computed for all
outcomes, aswell associodemographicandhealthchar-
Listofabbreviationsused
acteristics, overall and for each study group (treatment
ED:EmergencyDepartment;WCAC:WomenofColorandAsthmaControl;
andcontrol).Thiswillhelpdeterminewhetherthetreat- PFM:peakflowmeter;QOL:qualityoflife;SES:socioeconomicstatus;BMI:
mentandusual-caregroupsareequivalentpriortointer- bodymassindex;UMHS:UniversityofMichiganHealthSystem;BCBSM:Blue
CrossBlueShieldofMichigan.
vention,andhowthesegroupsdifferatspecificfollow-up
points (12 and 24 months after baseline). We will use Acknowledgements
mixed-effectsmodelsfortheanalysisofcontinuousout- ThistrialisfundedbyGrantR18HL094272-01fromtheLungDivisionofthe
NationalHeart,Lung,andBloodInstitute.MRJissupportedbyan
come variables and generalized estimating equations
administrativesupplementtothisgrantforRe-entryinBiomedicaland
(GEEs) for analyzing discrete outcomes. Pre-planned BehavioralResearchCareers.Wewouldalsoliketothankallthewomen
contrasts will examine the nature of change over time, participatinginthistrial.
includingthetimingandlongevityofinterventioneffects.
Authordetails
SAS Version 9.2 and IVEware (to multiply impute miss- 1CenterforManagingChronicDisease,UniversityofMichigan,1415
ingdata)willbeusedforanalysis[22,23]. WashingtonHeights,AnnArbor,Michigan,USA.2UniversityofMichigan
MedicalSchoolandDepartmentsofInternalMedicineandPediatrics,1500E.
MedicalCenterDrive,AnnArbor,Michigan,USA.3UniversityofMichigan
Process evaluation MedicalSchoolandDepartmentofObstetricsandGynecology,1500E.
Data will also be collected regarding key aspects of the MedicalCenterDrive,AnnArbor,Michigan,USA.
intervention process. First, participants will be asked to
Authors’contributions
complete a brief online or mail survey regarding their NMCisthePrincipalInvestigatorofthestudy,andGMSandTRBJareCo-
experience with the WCAC program (e.g., satisfaction investigators;MRJisaResearchAssociatewiththestudy.LJT,DMW,BN,and
EGareinvolvedinprojectmanagementand/orinterventiondelivery.All
with counselor, perceived improvement in asthma-man-
authorsparticipatedinthedesignofthetrial,intervention,and/ormeasures.
agement skills) when they have completed the series of MRJandNMCdraftedthemanuscript;allauthorsreviewed,edited,and
telephone counseling sessions. This survey also includes approvedthefinalmanuscript.
itemsdesignedtoassessparticipants’satisfactionwiththe
Competinginterests
culturally-relevant elements of the program (e.g.,“If you Theauthorsdeclarethattheyhavenocompetinginterests.
weretoparticipate ina programlike thisone again,how
Received:3January2012 Accepted:24January2012
importantwoulditbetoyouthatyourhealtheducatorbe
Published:24January2012
African American?”). Second, telephone counselors will
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Pre-publicationhistory
Thepre-publicationhistoryforthispapercanbeaccessedhere:
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doi:10.1186/1471-2458-12-76
Citethisarticleas:Janevicetal.:StudyprotocolforWomenofColorand
AsthmaControl:Arandomizedcontrolledtrialofanasthma-
managementinterventionforAfricanAmericanwomen.BMCPublic
Health201212:76.
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