The impact of asthma self-management education programs on the health outcomes: A meta-analysis (systemic review) of randomized controlled trials

Transcription

1 Calforna State Unversty, San Bernardno CSUSB ScholarWorks Theses Dgtzaton Project John M. Pfau Lbrary 2003 The mpact of asthma self-management educaton programs on the health outcomes: A meta-analyss (systemc revew) of randomzed controlled trals Surender Gaddam Follow ths and addtonal works at: Part of the Health Servces Admnstraton Commons Recommended Ctaton Gaddam, Surender, "The mpact of asthma self-management educaton programs on the health outcomes: A meta-analyss (systemc revew) of randomzed controlled trals" (2003). Theses Dgtzaton Project Ths Thess s brought to you for free and open access by the John M. Pfau Lbrary at CSUSB ScholarWorks. t has been accepted for ncluson n Theses Dgtzaton Project by an authorzed admnstrator of CSUSB ScholarWorks. For more nformaton, please contact scholarworks@csusb.edu.

2 THE MPACT OF ASTHMA SELF-MANAGEMENT EDUCATON PROGRAMS ON THE HEALTH OUTCOMES: A META-ANALYSS (SYSTEMC REVEW) OF RANDOMZED CONTROLLED TRALS A Thess Presented,to the Faculty of Calforna State Unversty San Berntrdno n Partal Fulfllment of the Requrements for the Degree Master of Scence n ; Health Servces Admnstraton by Surender Gaddam June 2003

3 THE MPACT OF ASTHMA SELF-MANAGEMENT EDUCATON PROGRAMS ON THE HEALTH OUTCOMES: A META-ANALYSS (SYSTEMC REVEW) OF RANDOMZED CONTROLLED TRALS A Thess Presented to the Faculty of Calforna State Unversty San Bernardno Surender (Saddam June 2()03 Approved by: Jbsepa Lovett,* Ph.D., Health Scence and Human Ecology

4 ABSTRACT Background: Asthma self-management educatonal programs form the backbone for the management of the both pedatrc and adult asthma. Several studes n many countres have revealed ths fact and the evdence-based t practtoners have been usng the evdence n the routne practce., Objectves: Ths study was'desgned to examne the mpact of asthma self-management educatonal programs on the health outcomes n pedatrc and adult subjects of ' Unted States. Further an attempt has been made to fnd the dfference n mpact n chldren and adults, group and ndvdual educaton, and other, sub-groups. Methodology: All the trals ncluded n the metaanalyss (systemc revew) were J retreved from MEDLNE, CNAHL,, Cochrane Controlled Trals Regster, and by hand searchng after they satsfed the ncluson crtera. The qualty of the studes was assessed by valdated qualty scale. Followng ths the trals were, crtcally apprased and evdence tables created wta the key nformaton n the studes. The pooled effect sze was calculated usng nverse varance weght method., j -, : ;!

5 Results: The lterature search had retreved 60 clncal trals but only 7 were ncluded n the study. Ten of the '7 studes were of 'poor qualty'. On poolng the effects of the ndvdual studes though there was an mprovement n health outcomes t was only a neglgble to small effect {(hosptalzatons: ES=-0.3(-0.30,0.04); hosptal days: ES=-0.2(-0.56,0.4); subjects requrng ED vsts: OR=0.67(0.35,.30); ED vsts (number): (ES=-0.6(- 0.28, -0.04); unscheduled doctor^ vsts:(es=-0.7(-0.3, ); days lost from school:(esr-0.05(-0.26, 0.6); asthma attacks: ES-0.23 (-0.52,0.06); AM and PM asthma attacks: ES=0.04 (-0.32, 0.40), (ES=-0.37(-0.72, -0.02); daly average AM and PM PFER measurements: ES=0.04(-0.25, 0.33), (ES=0.4(-0.5, 0.43)}. n overall the educatonal nterventons n adults were more effectve than n chldren but only wth a neglgble to small effect {(hosptalzatons: (ES=-0.28(-0.85, 0.29), (ES)=-0.2(- 0.30,0.,06); ED vsts: (ES=-0.22 (-0.42, -0.02), (ES=-0.(- 0.27,0.05); unscheduled doctor vsts: (ES=-0.36(-0.56, - 0.6), (ES=-0.03(-0.20,0.5)}. The same was the case when ndvdualzed educaton compared wth the group educaton. Concluson: self-management, teachng programs seems to have neglgble to small effect n reducng the morbdty v

6 outcomes that may be due to nadequate or lmted number of studes under study or 'poor qualty' of studes or nonadherence to the natonal gudelnes. Further research wth standard crtera (both n desgn and nterventons) s recommended to come to frm concluson n ths regard. f V!

7 ACKNOWLEDGEMENTS should be very thankful to hs ntellgentsa, and hs holness, who s my teacher,,counselor, gude, and care taker for hs constant attenton:and sprtual presence wthout whom ths revew mght have been mpossble. He s none but Sr Sr Sr Guruvswasphoorth, a scentfc sant. Along wth my Guru owe a lot to my parents and my members of famly who are the sole reason for my success n lfe. ; must be equally thankful and express my sncere apprecaton to Dr.Lovett, Asst.Professor, Department Of Health Scences and Human Ecology and my thess gude for hs wholehearted support and encouragement that he gave me not only whle conductng ths study but also durng my degree program. would express my deep grattude to hm for he had devoted hs precous tme ncludng non-workng days when and as requred. ought to not forget that he was the one who had ntroduced the dscplne of evdencebased medcne (EBM) on whch my present study s based and am addcted to. 'thank Dr.Fahey from the core of my heart who was very enthusastc and nterested; sometmes more than me n v

8 my thess and made a constant enqury regardng the progress of the same. J do not deserve to forget Dr. Ellen B. Daroszewsk, Asst.Professor, Department of Nursng, Calforna State Unversty, San Bernardno and sncerely thank for her valuable tme that she had donated to.revew my thess word by word: and gave an encouragng feedback to make my thess a complete and acceptable one. ;, extend my sncere thanks to Dr.Fredrc M.Wolf, Professor and Char, Department of Medcal Educaton and Bomedcal nformatcs, Unversty of Washngton who wth no hestaton helped me wthn hours of my request n choosng and usng the approprate statstcs. t s my responsblty that should look back to my alma mater, Mahatma Gandh nsttute of Medcal Scences (MGMS), nda and thank Dr.Ulhas Jajoo, Professor, Department of nternal Medcne who had taught me clncal medcne n terms of 'most specfc' and 'most senstve' sgns and symptoms n reachng a,clncal dagnoss. could realze but very late that ths termnology s closely assocated to EBM. More than a teacher he s my caretaker who had an ndrect but an actve nvolvement n ' my successful completon of ths' study. Along wth hm v

9 also thank Dr.Kalantr, professor; n nternal medcne, MGMS for hs encouragement. A couple of couples to whom, must always be grateful are Dr.Swat Kauthubh Gokhale and Dr.Nt Yogesh Kautsh wthout whose support ths revew mght have been ncomplete and dfferent. don't deserve to forget Mr.Rav Gaddam, my elder brother,for hs fnancal support and contnuous nducton of confdence whle was workng on my thess. The thess revewers, the offce of the graduate r studes, and the faculty and thestaff of Health Servces Admnstraton, Department of Health Scence and Human Ecology, Calforna State Unversty, San Bernardno are no less than any one to me who had helped me n puttng together my work and get over myjob. Fnally, last but not the least thank all my frends and foes who had ether drectly'or ndrectly, wllngly or unwllngly helped me n completng my study. v

10 "To my Gur,u and my Parents"

11 TABLE OF CONTENTS ABSTRACT...,... ACKNOWLEDGEMENTS... '... CHAPTER:ONE: NTRODUCTON TO THE STUDY Background Statement of the Problem. '.... Purpose of the Study Lmtatons of the Study.... v CHAPTER TWO: LTERATURE REVEW ntroducton... '..., Knowledge and Skll.... '... Health Outcomes... '... Hypothess..., CHAPTER THREE: METHODOLOGY Search Strategy... Study ncluson Crtera... Study Excluson Crtera..'... Qualtatve Assessment of Studes... Varous nterventons and Ther Characterstcs Patent Outcomes of nterest... Crtcal Apprasal of Studes... Statstcal Analyses ! x,

12 CHAPTER FOUR: FNDNGS AND RESULTS ntroducton and Selecton J of Trals..., Qualtatve Revew nterventons and Comparsons t Outcome Measures CHAPTER -FVE: CONCLUSONS AND RECOMMENDATONS Conclusons... L Dscusson Recommendatons Lmtatons of the Study Desgn and Procedures... ' APPENDX A: STUDY SELECTON FLOW DAGRAM APPENDX B: VALDATED QUALTY ASSESSMENT OF STUDES..., APPENDX C: EVDENCE TABLES APPENDX D: FORMULAE USED APPENDX E: RESULTS TABLES... ' REFERENCES x

13 CHAPTER ONE NTRODUCTON TO,THE STUDY Background Asthma s one of the major publc health problems n Unted States today. t has been 'estmated that ths dsease affects approxmately 5 'mllon people, nearly j fve mllon of who are under the age of 8. The vctms of asthma experence over 00 mllon days of restrcted actvty annually and the total annual costs of the condton are estmated to be $ll.3 bllon. Ths clncal entty s also responsble for about 500,000 hosptalzatons and 5,000 deaths a year. t s the number one cause of school absenteesm. Number of people wth asthma has been ncreased9 by 02 percent between R ' and n a study released by the Pew Envronmental Health Commsson at the John Hopkns School of Publc Health t s expected that the vctms of asthma would be more than double by The commsson added that f the rates were not slowed, asthma would strke n 4 Amercans and n 5 U.S famles by the year 2020 Though the reasons for the ncreases n the morbdty and mortalty wth asthma are not clear, much asthma

14 related hosptalzatons and the deaths are preventable. Most of the asthma affected populaton are unable to avod the envronmental factors that majke asthma worse, recognze early warnng sgns of worsenng asthma, apprecate the severty of the asthma exacerbaton, take approprate medcaton, or get prompt medca help when problems occur. The clncan may not dagnose asthma, ntate approprate therapy, adequately montor the jbatent's condton, recognze serous exacerbatons, 'or educate the patent to prevent symptoms and develop a cpss plan for emergences. All the above ssues gve a ^clear ndcaton of the need for asthma educaton (for bqth patents and the health professonals). n 988 Natonal [Heart, Lung and Blood nsttute (NHLB) sponsored a workshop ttled "Asthma Educaton: A Natonal Strategy". he recommendatons made at the workshop when combned wth results of research demonstratng the benefts of the asthma educaton on dsease,outcome, became the stmulus for the development of the Natonal Asthma Educaton and Preventon Program (NAEPP) that recommends an effectve control of asthma by encouragng a partnershp among patents, physcans and other health professonals through modern treatment and educaton programs.. ;! 2 ;

15 The frst sgnfcant achevement was the development of "Expert Panel Report: Gudelnes Jfor the Dagnoss and Management of Asthma." Experts convened by the NAEPP coordnated by the NHLB of Natonal nsttutes of Health (NH) offered recommendatons for managng asthma. "The Expert Panel Report 2:Gudelnes 'for the Dagnoss and Management of Asthma" dentfed rthe four dseasej management strateges and gudelnes for the mplementaton l that would keep asthma under control and greatly mprove the qualty of lfe (QOL) for peqple wth dsease. The four strateges nclude: measures of assessment and montorng, control of factors contrbutng Bo asthma severty, pharmacologc therapy, and educaton for a partnershp n asthma care. Though the former three strateges have ther own sgnfcance n managng the ^condton the last one remans the cornerstone of the asthma management. Educaton should start at the start of asthma l : dagnoss and be ntegrated nto :every step of clncal asthma care, n the context of the medcal appontments and other clncan-patent communcaton. Asthma self- : management educaton should be talored to the needs of ; each patent, mantanng senstvty to the cultural 3

16 belefs and practces, and nvolvng the famly members, partcularly for pedatrc and elderly patents. Self-management, as the term ndcates s the actve partcpaton of the patent n the management of the dsease, whch nvolves acqurng certan basc knowledge of deteroraton and takng early steps to prevent the dsease from worsenng. Thus-, helpng the physcan treat better..the NAEPP Expert Panel rdcommend (under the component four) the clncans teach patents and famles the essental nformaton (pateryt and famly should understand the ratonale for needed acton, bref verbal descrpton of what asthma s and the ntended role of each medcaton), medcal sklls (teach the patent necessary medcal sklls, such as correct use of nhaler and space/holdng chamber and knowng when and how to take quck-relef medcatons), self-montorng technques : (symptom montorng, peak flow montorng as approprate, and recognzng early sgns of deteroraton) and envronmental control measures (teach how envronmental precptants or exposures can make the patents asthma worse).' 4

17 , ' Statement of the Problem Many trals (Randomzed Controlled Trals and Controlled Clncal Trals) have.been conducted n dfferent settngs n Unted States to measure the effectveness of the self-managerent educaton on the outcomes of health both for the adults and pedatrc age groups. Most of the educatonal programs ncrease the knowledge, but ther mpact on the health outcomes s not well establshed. Moreover, t s not clear that whch type of educatonal program (nterventon) would have the maxmum, mpact on the postve health outcomes. Purpose of the Study Many systemc revews and meta-analyss were conducted n regard to the mpact of asthma self-management educaton on the health outcomes n varous countres. There was no study dentfed specfc to Unted States of Amerca. Moreover, no study had tred to fnd the dfference n the mpact bf self-management educaton on outcome measures for adults and pedatrcs, and ndvdualzed and group educaton. The present study helps to fnd out the qualty of trals conducted and recommend for expected standard of trals. The results from ths meta-ana,lyss (systemc 5

18 revew) have sgnfcant mplcatons for further research recommendatons. The results of the study are of utmost t mportance to the evdence based practtoners. An attempt has been made n ths study to crtcally apprase, systematcally revew and aggregate the results obtaned n the ndvdual tralsj and examne the strength of evdence supportng the component four (Educaton for a Partnershp n Asthma Care) of NAEPP to test whether health t outcomes are nfluenced by educaton and self-management programs. Lmtatons of the Study. All the trals used n ths revew were conducted n Unted States of Amerca only. Hence generalzblty n USA context only. 2. The study dd not consder all the possble health outcome varables that have an mpact due to selfmanagement educaton of asthma. Smlar (postve health outcomes) results n case of other varables r are questonable. 3. Some of the outcome varables (eg.hosptal days) were measured ether n chldren or adults but not n both the' age groups. The study results of those outcome 6

19 varables cannot be generalzed for both the age groups. 4. Most of the results n ths study are based on very few trals. Therefore, one cannot reach to a strong concluson regardng the practcal applcaton of the fndngs by the evdence-bas'ed practtoners. 7

20 CHAPTER TWO LTERATURE REVEW. ntroducton Po.or self-management may be! a key factor n the hgh f morbdty of patents wth asthma. Though the gudelnes for management of asthma developed for Natonal Asthma. Educaton and Preventon Program,ncludes 'Asthma Educaton' as an essental component of the management, formal ^educaton s not a routne part of the medcal care at any age level. There s suffcent evdence to prove that self-management (control oftrgger factors, mprovement n sklls, adherence'to medcaton, and self montorng of symptoms and flow rates) decreases both the morbdty and mortalty due to asthma'4'7'42. However, a meta-analyss4 conducted to evaluate the mpact of selff management teachng programs on the morbdty of pedatrc asthma, found no reducton n morbdty. The mprovements n the outcomes followng asthma self-management are due to the acquston and performance! of self-management sklls ratherthan mproved medcal '. management, whch s n concurrent wth the self-management tranng or component of the tranng9. The health care 8!

21 costs are on enormous rse and needs a check. Ths nvolves ether ratonng medcne or adaptng self-management technques that nvolves ndvduals' greater responsblty for own health-care thereby reducng ther need to utlze health-care servces. There has been a tremendous mprovement n the drug avalablty n management of asthma, on contrary there had been an ncrease n mortalty as well as.morbdty that s attrbuted to the delays n mplementaton of approprate therapy and under treatment thanjthe drug toxcty thus, makng the educaton and sklls -dranng mportant n the ; approprate management of the condton. Knowledge and Skll Snyder and Wnder23 notced an mprovement n knowledge both n expermental and control.group followng asthma educaton. The mprovement n control group was wthout the educatonal sessons. The nvestgators concluded that mere fllng of the questonnares (askng the asthmatcs about asthma) make the ndvduals aware of, and understand the dsorder whch means that Amercans are poorly nformed about Asthma. The smlar results were also found n ' 8 another study strongly n agreement wth Snyder and Wnder. 9

22 Baley et al also found a large 'decrease n health care ' utlzaton m control groups that may be due to avalablty of comparable amount of nformaton about asthma.' However, ths s questonable as the groups dffered on adherence and two of[the measures of functonal status.' Alternately t may be a selecton bas because subjects were recruted durng clnc vsts and baselne clnc vsts may have been more lkely mmedately followng an ED vst or hosptalzaton. Takng nto consderaton ths explanaton, the baselne utlzaton measures would have been artfcally nflated, and the j decrease would represent a return to normal base state. Moreover, the research was conducted n a unversty medcal center and such settngs; are lkely to provde an unusually favorable context, due,to number and type of professonal support personnel avalable to mplement the program. The demonstraton of smlar results are however questonable n other healthcare,settngs (communty clncal settngs) due to lack of resources and cost of the nterventon24. :, Development of the self-care behavors play a vtal ; role n mplementng the self-management sklls. There were not many studes found that studed the self-care behavors 0

23 of the asthmatcs n management of the dsease. Avery and hs colleagues9 n 980 when assessed the fundamental self- care behavors (have bronchodalater medcaton avalable, use an nhaler effectvely, mantan regular physcan ' contact and when asthma symptoms,ncrease, start medcaton promptly, use approprate medcaton, and seek professonal assstance for persstent symptoms) found that a substantal proporton of asthmatcs' had napproprate self-care behavors. However, t,would be napproprate to conclude wth the fndngs of a sngle study., Health Outfcomes Self-management educatonal 'programs not only mprove the knowledge of the asthmatc ndvduals but also have a : postve mpact on the symptoms And morbdty outcomes (hosptalzatons, emergency department vsts, loss of school days, acute doctor vsts, asthma attacks, and PEFR measurements) and the mpact seemed to be drectly proporton to the ntensty and qualty of desgn of the educatonal program. Kotses et af9 reported an mprovement n asthma symptoms (p<0.05 n mornng and p<0.0 n evenng) followng educatonal program. n another study2 there was no mprovement n asthma symptoms n the

24 nterventon group contradctng the fndngs of Kotses et al9. However ths fndng possbly s attrbuted to the lack of suffcent measurement senstvty or short duraton of follow up. n a study8 wth smple nformatonal educatonal programjas nterventon, mproved knowledge (p<0.05) and patent!satsfacton were accompaned by a reducton n emergency attendance at hosptal n nterventon groups. However'the change n asthma morbdty was not sgnfcant. Self-Management practces show a sgnfcant decrease n emergency department vsts and hosptalzatons both n adults and pedatrc age group,,27,24'32. Smlar results! (p<0.005) were also notced n a study 22 but the effects were evdent n the ntal four months (short term) of the nterventon that contradcts the conclusons of the study carred on by Wlson SR7 et al n 993. However ths contradcton may not be generalzed, because the populaton under the study n former was exclusvely adults whle n the latter was the age group between 5 and 70 years of age. Moreover, there were statstcally j sgnfcant dfferences n the baselne parameters of the. expermental and control groups, and a sgnfcant numbers of the nterventon group dd not attend the educatonal 2

25 programs and more patents lost the follow up n al22 study. n a randomzed controlled study6 the Bolton et patents enrolled n the npatent asthma educaton (EP) program had sgnfcantly fewer ED vsts (P=0.04) and hosptalzatons (P=0.04) for asthma n the sx months followng EP nterventon, as compared to control patents. But, the study had several lmtatons. Clark et al3 when studed the mpact of health educaton on frequency and cost of health care use by low- ncome chldren wth asthma, found no sgnfcant dfference n subsequent health care use n the j expermental and the controlled group wthout regard to the prevous hosptalzaton. But when the comparson was restrcted to the chldren who had been hosptalzed durng the precedng year the expermental group was found to have decreased ts use of the emergency room sgnfcantly more than the control group (P<0.05) and was found to have experenced a sgnfcantly greater reducton n the mean number of hosptalzatons (p<0.05) durng the followng year. n an asthma self-management program (ndvdualzed, nstructonal asthma educaton and peak flow montorng of 8 weeks duraton) for chldren, Persaud and hs co 3

26 nvestgators reported no sgnfcant dfferences n the number of post-nterventon emergency room vsts and days absent from school. Populaton-based-programs can mprove functonal status, ncrease self-montorng and knowledge about asthma, and decrease absenteesm and hosptalzaton (p<0.0') for asthma by drectly provdng asthmatc patents wth educatonal materals and self-montorng tools28.! Homer et al8 reported a substantal declne n ED vsts of chldren n nterventon group wth asthma (mean of 2.4]pre and 0.86 post nterventon, p<0.0). Educatonal nterventons do have mpact on chldren's knowledge of asthma and also have effects on hosptalzatons and emergency room and medcal utlzaton, daly actvtes, and school absenteesm4. The reported numbers of lmted actvty days due to asthma followed a pattern smlar to that found for emergency department vsts. n a recently conducted study j to assess the effectveness of an nteractve devce programjfor the management of pedatrc asthma7 the authors found a decrease n lmtaton n actvty n both the groups (expermental and control). However, the declne n t control;group was less than that of nterventon group. 4

27 n a study the subjects n the self-management group exhbted a decrease n frequency of physcan vsts over a shortrterm perod of two months where as the subjects n the control group dd not. There was no change notced n ether emergency room vsts and the frequency and duraton of hosptalzatons. n the same study subjects both n the control and nterventon group dd not demonstrate any change n the healthcare utlzaton over the long term ndcatng that subjects' asthma was under control at the begnnng of the study. Self-management of asthma shows mprovements n patents A.M. PEFR (peak expratory flow meter) however, a statstcally sgnfcant dfference was not found n P.M. PEFR0. jn contrast to ths there was no mprovement seen n the peak flow measurements n the nterventon group n a study conducted by Berg et al. Wlson et al also reported ths fndng n 993 and there contnues to be controversy regardng the senstvty of peak flow measurements. Though all the methods- (verbal, wrtten, software, charts, pctures etc.) of educaton have a postve mpact on the knowledge, sklls and the morbdty outcomes n patents wth asthma, dfferent methods would have dfferent levels of mpact. Self-study workbook, as a 5-

28 method of educaton was not assocated wth sgnfcant changes; n behavors and sklls or alternatons n! patent!'s condton. Although some of the patents n the above study benefted from recevng the workbook, many clearly! dd not, despte the fact that the workbook ncorporated many of the same behavor change strateges as the othjer programs and was wrtten at a level approprate for the populaton ndcatng that the method or the type of educatonal nterventon has somethng to do wth the outcomes of the clncal entty. nteractve educatonal software program properly desgned s effectve n conveyng nformaton and n provdng opportuntes for chldren to safely experence the consequences of dfferent self-management actvtes8. Rubn D H and hs co-nvestgators n 98 6 reported that an nteractve program between the chld and computer wthout drect nteracton wth the health professonal declned the unscheduled doctor vsts. Baley25 and hs assocates conducted a study n 999 comparng the three standard self-management treatments n a randomzed controlled tral: () a replcaton of the self-management program developed at a unversty medcal center that was prevously shown to be effcacous; (2) a 6

29 modfed verson of ths program ncludng only the core elements (a revsed shortened workbook brefed n a 5-20 mnute 3ne to one counselng sesson, patents traned to use peak flow meters and nhalers, follow up telephone counselng sesson after one week later to revew patents medcaton regmen and nhaler and peak flow meter sklls, and a follow up letter was sent two weeks later) developed by a focus group methodology; and (3) a usual care program On analyss, the results of all the three groups demonstrated an mprovement n measures of respratory llnesses, use of health care servces, and functonal status. Nether of the asthma self-management programs was superor to usual care. Wth regard to the functonal mparment, the core elements group had a hgher proporton experencng functonal mparment relatve to the usual group. Smplcty of the asthma self-management plan and the systematc approach has a strong relaton wth the patent complance. Mayo et al2 n ther study reported that the mprovement n control of asthma' n ther patent group may well have been smply because the avalablty of clnc and ts personnel was strongly emphaszed. 7

30 Wlson SR et al n 9937 concluded that the small group educaton and ndvdual educaton were assocated wth sgnfcant benefts, but the group program was smpler to admnster, better receved by the patents, and most cost effectve. A relatvely greater reducton n medcal care utlzaton was observed among patents who receved group educaton and was not observed n ndvdual educaton. The educatonal procedures and the development of self-management behavor have a sgnfcant role n mprovements n asthma severty9. The educatonal programs that optmze the communcaton and learnng are effectve as seen n the Kotses et al study9. n the same study t was evdent that teachng the patents the aspects of records, the patents mantan prompted asthma self-management measures. The effectve educatonal programs and the use of records served as the strkng tools for the strong results obtaned n the study suggestng that results of a selfmanagement program very much depend on the educatonal and the behavoral prncples ncorporated n the desgn of the study. The mpact of the asthma educaton program on the patent outcomes depends on multple varables (method of 8

31 educaton, duraton of educaton, ndvdual or group, number of sessons and the severty of asthma). The nvestgators must consder as many varables as possble for a well-desgned educaton program that results n better patent outcomes Face-to-face nteracton of the medcal care provder and patent results n most meanngful transfer of nformaton. n a recently conducted study the authors found a'decrease n morbdty outcomes followng asthma educaton and self-montorng wth nurse coordnator as the educator. t s assumed that physcans or nurse practtoners, as the educators n a self-management educaton program would yeld better results. However, there are not many studes or suffcent documented evdence present to make a frm concluson. n addton to the method of educaton and the educator, the follow up perod too plays a sgnfcant role n the effectveness of the program. A randomzed controlled study7 found that the evaluaton of educatonal and behavoral nterventons, especally for adults wth long-stjndng dsease, requres long term follow up ( to 2 years) f the benefts of mproved management and symptom control 'are to be detected. 9

32 Self-management tools are the backbone of the asthma self-management educatonal programs. Educatonal workshops ( for famles, ndvdualzed counselng sessons, and usng asthma dary as the prmary tool of nterventon have a sgnfcant effect on the postve outcomes (prophylactc! use of antbotcs (p<0.05), symptom persstence (p<0.0), and actvty restrctons (p<0.00)) of the dsease n pedatrc age group however, the study3 has several lmtatons. The asthma dary n ths study helped patents notce the persstence of asthma,, was conceved as an! educatonal tool for the famly rather than a data source for the clncan, helped famles assocate daly medcatons at adherence wth mproved health outcomes, and was useful for alertng parents when symptoms or peak flow ndcated the need to adjust medcaton usng ther stepped acton plans. The educatonal nterventon wth famly's phase of asthma self-regulaton helps n greater 3 mprovement m the chldren's' health outcomes.! The avalable evdence s nsuffcent to demonstrate that the asthma outcomes are mproved by use of a wrtten acton p]lan, wth or wthout peak, flow montorng30. Lefevre and hs (colleagues30 n ther evdence based analyss (qualtatve meta-analyssj concluded that though the 20

33 wrtten^ acton plans as nterventon are not neffectve they wll not have a large effect on the health outcomes when appled to the general asthmatc populaton. n an other study t was found that educaton of patents and famles, ncludng the development of a wrtten acton plan for at-home management ncreases the symptom free days n chldren33. A retrospectve study 26 determned that PART (medcal management, peak flow montorng (PFM) and an acton plan) and FULL (all those n PART and multdscplnary educaton program 'stressng on trgger dentfcaton and avodance, envronmental control and proactve adjustment of antnflammatory drugs) programs can sgnfcantly mpact the frequency wth whch hosptal-based asthma care s requred and thus reduce the over all cost of carng for patents wth astjhma. The: patents of bronchal asthma treated n dfferent, clncal settngs have dfferent degrees of the dsease! (patent's treated n emergency department are usually of severe degree whle that n outpatent set up would have a mlder form of the dsease). Hence, the mprovement n the patents! wth regard to symptoms or the morbdty outcomes would bel dfferent. Patents attendng the acute care : 2

34 settng have a greater desre to know more about asthma than those get treated n preventve care settng and thus show more nterest n self-management of the dsorder23 suggestng that the development of educatonal nterventons targeted to the acute care settngs where a substan :al number of patents seek care would be benefcal. t s hypotheszed that: Hypothess. Asthma self-management educaton has a postve mpact on the varous morbdty varables (hosptal admssons, emergency department vsts, days lost from school/work, unscheduled doctor vsts, and sprometrc outcomes (PEFR)). 2. The educatonal nterventons wth asthma acton plans and asthma self-management plans and regular practtoner revew wll have optmal results. 3. The educatonal nterventon nvolvng clncan as educator; actve nvolvement of famly member (n case of chldren and elderly) and a team approach would be more effectve. 22

35 CHAPTER THREE METHODOLOGY Search Strategy A lterature search was performed for the artcles publshed n Englsh wth key words 'asthma educaton', 'self-management practces', and 'self-management programs' on MEDLNE database. The search was restrcted to randomzed controlled trals and controlled clncal trals. The other databases searched for the lterature were CNAHL and Cochrane Controlled Trals Regster. The electronc searches were supplemented by the hand j searchng. All the hand searches were carred out n Del E. Webb tkemoral Lbrary, Loma Lnda Unversty, Loma Lnda, n addton, the reference lsts of all the artcles retreved were examned for ther potental ncluson n the study. Some of the authors of the artcles were contacted by an electronc mal however response was receved from none. Study ncluson Crtera On! y Randomzed controlled trals (RCTs) or Controlled clncal Amerca trals (CCTs) conducted n Unted States of and publshed n Englsh that studed the effects 23

36 of the asthma educaton and self-management on health outcomes n adult or pedatrc age group or both were! ncluded n meta-analyss. The outcomes of nterest had to relate to one of the morbdty varables (hosptal admssons, emergency department vsts, days lost from school/jwork, unscheduled doctor vsts, and spro metrc outcomes (PEFR). The studes had to be conducted n Hosptals, Emergency departments, Out- patent clnc, Generah Practtoners, or Communty settngs., Study Excluson Crtera Al the studes wth patent dsorders other than bronchal asthma, studes measurng only the patent complance outcomes, economc evaluaton/ cost beneft analyss, studes wth major methodologcal problems, non RCT or non CCT and sgnfcant absence of study methodology were excluded from the study. Those studes n whch the results were not presented n a favorable way to use n meta-analyss were also excluded. All letters, revews, edtorals and comments were excluded from analyss., Qualtatve Assessment of Studes Tle qualty of all the studes was assessed usng valdated qualty scale38. The scale was used by many other 24

37 nvestgators who have confrmed that t was easy and quck to use and also has construct valdty39, 40. The scale uses three ((descrpton of randomzaton, double blndng, and dropouts/wthdrawals) tems that are drectly related to bas reducton and are presented as questons to elct 'yes' or 'no' answers. The scale produces scores from 0 to 5. One pont s gven to each 'yes' f the study s descrbed as randomzed, double blnd, and f the descrpton of dropouts/wthdrawals s present. Further one addtonal pont s gven f randomzaton/blndng s approprate and one pont s deducted f randomzaton/blndng s napproprate. Any score below 3 s consdered as a poor hence the study labeled as 'poor qualty ' study. The assessment of the studes ncluded n meta-analyss s shown n APPENDX A Varous nterventons and ; Ther Characterstcs Varous nterventons that are seen n the asthma self-management teachng programs ncluded n meta-analyss (systemc revew) are: Patent asthma educaton Use of self-montorng tools Self-montorng of PEFR, symptoms, and medcatons 25

38 Optmal self-management ncluded all the three components along wth regular medcal revew (asthma educaton of any type, nvolvement of acton plan, and/or asthma self-management plan, self-montorng and regular medcalj revew) Patent'Asthma Educaton Ths s the transfer of nformaton about asthma n any of the forms (wrtten, verbal, vsual, audo, software or may be a combnaton of these). Educaton was ether nteractve or non nteractve, structured or unstructured. Some of! the other educatonal materals used n the selfmanagement programs were stckers, cartoons, games, anatomc models, balloons, stores etc. Educaton was delvered ether by clncan or a non-clncan. Educaton was ether an ndvdualzed educaton or a group educaton dependng on the number of subjects nvolved. The content of educaton dealt wth the basc facts about asthma, roles of medcaton, sklls (nhaler/spacer/holdng chamber use, self-montorng), envronmental control measures, and when and how to take rescue medcatons. t was delvered ether n a sngle sesson or n multple sessons. Mnmal Educaton. Ths s characterzed by the provson of wrtten materal alone or the conduct of the t 26

39 short unstructured verbal nteracton between the health provder and the patent where the basc dea s to mprove the knowledge and the understandng of asthma. Optmal Educaton. Optmal educaton s consdered as the structured wth the use of nteractve and/or non- nterac^ve mode of delvery. Self-Mojtorng Tools Self-montorng s the regular measurement of ether peak expratory flow or symptoms. Varous self-montorng tools used were: o Wrtten acton plan o Wrtten ndvdualzed self-management plan o Asthma dary o Peak flow meter o Others (Journal of daly asthma concerns, MD! chronology) Wrtten Acton Plan. Ths tool helps the patent! manage dsthma exacerbatons and mportant for patents wth moderate-to-severe persstent asthma and patents wth hstory of severe exacerbatons. The acton plan s characterzed by beng ndvdualzed to the patents underlyng asthma severty and treatment. Acton plan drects the patent to adjust medcnes at home n response 27

40 ! to partcular sgns, symptoms, and peak flow measurements. t also(lsts the PEF levels and symptoms ndcatng for acute care and emergency telephone numbers for physcan, emergency department, rapd transportaton, and famly frend for ad and support. Wrtten ndvdualzed Self-Management Plan. Ths ncluded the recommended doses and frequences of daly medcatons and the daly self-management actvtes needed to acheve the agreed on goals. Asthma Dary. t s meant for self-montorng symptoms, peak flow measurements, frequency of daly quck relef medcaton use, and actvty restrctons! Peak Flow Meter. To measure the peak flow rates Regular Medcal Revew Thjs s regular consultaton wth a doctor durng the nterventon perod for the purpose of revewng the patent' S asthma status and medcatons. Ths may occur ether as a formal part of the nterventon or the patents may be advsed to see ther own doctor on a regular bass. nterventons are classfed as havng "regular revew" ether nsde the program (f the patents were seen as a part of the program) or outsde the program (f the 28

41 patents were merely advsed to seek regular medcal revew)! Patent Outcomes of nterest. Number of hosptalzatons 2. Number of emergency departments vsts 3. Number of Subjects vsted emergency departments 4. Number of unscheduled doctor vsts 5. Hosptal days due to asthma 6. Number of days lost from school/work 7. Number of asthma attacks (AM and PM) 8. Spro metrc outcomes (AM and PM PEFR measurements)! Crtcal Apprasal of Studes All the studes were crtcally apprased and the key nformaton was tabulated to form evdence tables. Followng ths all the possble comparsons (prmary and sub-group) were derved and the results obtaned usng the standard statstcal technques. The key(nformaton that s summarzed n the evdence tables (APPENDX:C) nclude:. Study reference 29

42 2. Methods ncludng the study desgn, method of randomzaton, concealment of allocaton, and outcome assessor blndng. 3. Detals of the partcpants ncludng the number elgble, partcpated, randomzed, dropouts and dropout rate, method of patent recrutment, ncluson and excluson crtera, and study baselne characterstcs 4. Educatonal nterventon n detal 5. Statstcal technques used n the study along wth the methods of data collecton 6. Results/Outcome measures 7. Lmtatons of the study and 8. Conclusons and remarks The qualtatve gradng of the studes was done based on valc.ated qualty scale (Jadad AR et al 996) :APPENDX B Note:' All the p-values mentoned n the studes unless otherwse relate to between group comparsons. Statstcal Analyses The outcomes reported n the studes were categorzed ether as dchotomous or the contnuous. Contnuous data was further categorzed as wth standard devatons or 30

43 mssng standard devatons. The outcomes presented n two were dchotomous, 5 studes were contnuous. Of those 5 studes seven of them had mssng standard devatons. Snce the excluson of these studes from pooled analyses results n systemc bases the estmates of standard devatons were mputed43. For ths purpose pooled standard devatons were estmated usng the standard formula for t-! statstc. The same standard devaton was used for both the control and the expermental group. When the t- statstc was not reported, the crtcal t-value correspondng to the exact p-value wth approprate degrees of freedom was used. When both the t-statstc and the p- value were not reported then the t-statstc wth approprate degrees of freedom correspondng to p=0.05 (for p<0.05) result) or p=0.50 (for a non-sgnfcant or pure chance was used. For dchotomous outcomes odds rato was calculated t. wth 95% confdence ntervals and pooled by nverse varance weght method44. For all the contnuous outcomes after computng the mssng standard devatons the effect szes (standard mean dfferences) wth.95% confdence ntervals were calculated. The effect szes were combned by nverse varance weght method and were nterpreted as 3

44 0.5(neglgble effect); and < 0.40(small effect); > and 0.75(medum effect); > 0.75 and <.0 (large effect); h.0 and Y.45(very large effeet);>.45(huge effect) Negatve effect sze favors the expermental group whle the postve favors the control group except n case of the PEFR measurements. Q - the homogenety statstc that sldstrbuted as a Ch-Square was used for examnng the homogenety. f the calculated Q-statstc value s less than the crtcal Ch-Square wth partcular degrees of freedom at p=0.05 then we fal to reject the null hypothess of homogenety. Thus the varablty of across the effect szes does not exceed what would be expected based on samplng error. 32

45 CHAPTER FOUR FNDNGS AND RESULTS ntroducton and Selecton of Trals An!ntal lterature search retreved 60 clncal trals put of whch 2 were excluded because the studes were conducted n countres other than Unted States of Amercal Of the remanng 39 on more detaled revew 3 were excluded because the outcomes measured were not of nterest (knowledge and behavor towards self-management, complance). Further on evaluaton fve of the 26 remanng studes were excluded, as the numercal data of outcomes of nterest was not provded. 2 studes were fnally ncluded n the study for meta-analyss (systemc revew) but four the studes though provded numercal data the data presented was not n a way for consderaton for statstcal analyss resultng n ncludng 7 studes for meta-analyss. Of 7 studes ncluded 6 were randomzed controlled studes and one was controlled clncal tral. (Flow dagram: APPENDX: A). When categorzed dependng o the age group ten were pedatrc (^8 years) studes and seven belonged to adult (^8 years) age group. 33

46 Qualtatve Revew Omassessng the qualty of each study based on valdated qualty scale t was found that ten studes (ncludes one CCT) were n the category of 'poor qualty' whle seven acqured a score of three. None of the studes had a score of more than three. Though the authors descrbed the studes as randomzed most of the studes ether c d not descrbe the method of randomzaton or adapted an napproprate method. Allocaton concealment (prevents selecton bas, protects randomzaton sequence before and untl the nterventons are gven to study partcpants) was seen n only three of the studes' 7' 8. All the ;three nvestgators used closed opaque envelope technque. No asthma educaton nterventon studes were conducted usng the double blndng. Sngle blndng was seen n [only very few studes. True placebo comparson s also dffcult to obtan n educatonal nterventon study settngs because of the ethcal consderatons. n some of the studes,7-9,,6 usual care from a medcal practtoner nvolvng some lmted level of educaton was used n control group. All the subjects n the studes ether had a confrmed asthma dagnoss from a physcan or were dagnosed based on certan objectve crtera, as per the 34

47 standards establshed by the Amercan Thoracc Socety, as per Natonal Heart Lung and Blood nsttute clncal practce gudelnes. Four 6,8,0,3 of the studes dd not have a menton n the artcle that how the dagnoss of asthma was made. The patents were recruted from a varety of Settngs (outpatent clncs, communty, Emergency departments, general practtoners, or hosptals). The elgble subjects were recruted by contactng them by telephone, advertsement n the newspapers, dstrbutng the brochures n the communty or drectly from the clncs] emergency departments, and hosptals. All the studes except four 6,9,0,4 (no menton of ncluson crtera) had well defned ncluson crtera based op whch the patents were recruted. The most common ncluson crtera were age, severty of asthma, objectve evdence of asthma, emergency department vsts due to asthma,[hosptalzatons due to asthma, and medcaton usage. Some of the studes had verbal fluency n Englsh as j one of fhe ncluson crtera. The patents were excluded f they had other pulmonary or debltatng dseases that would hamper the results, earler nvolved n asthma educaton program, ntellectual defcts, or other co-exstng condtons lke alcohol or 35

48 drug abuse, smokers at the tme of study. Many studes3-5'0-4'6 dd not menton the excluson crtera. studes A total of 2003 subjects were randomzed nto 7 and 9 study groups of whch 3 were n l expermental group and 890 n control group. The dropout/wthdrawal rate was as low as 0% seen n some of the stucles and as hgh4 as 30.8%, the average beng 9.7 6%. Whle of the studes gave the descrpton of the wthdrawals/dropouts the remanng just mentoned the dropoutjnumber. Sx 3,5,6,2,5,6 studes had a dropout rate of zero. Ohly n two2' 7 of the remanng studes was analyses, 2,7,7 carred on an 'ntenton to treat' bass. Four of the 7 studes ncluded n meta-analyss mentoned the adequacy of the statstcal power. There were no statstcally sgnfcant dfferences n the baselne characterstcs of the control and the expermental group n thrteen studes. A statstcally sgnfcant dfference n the baselne characterstcs (greater severty and early onset of llness seen m n control group) between both the study groups was one5 of the studes. The nvestgators n three7' 0,6 studes dd not report about the dfferences n the baselne characterstcs of the nterventon and the control group. 36

49 Two0,7 of the studes had two nterventon groups (one ndvdualzed nterventon and the other group nterventon) and a control group. For the purpose of analyss both the nterventon groups were compared wth the control group separately resultng n 9 study groups for comparson from 7 studes. nterventons and Comparsons The 7 studes descrbed several nterventons wth the content of nterventon ncluded asthma educaton, self-montorng of symptoms/peak flow/medcaton or any combnaton of the three, asthma acton plan, asthma self management plan, and asthma dary. ) Self-Management and Regular Medcal Revew Vs. Usual Care.) Optmal Self-Management.2;) Optmal Educaton and Self-Montorng.3) Optmal Educaton Only 2) 'Optmal Educaton and Self-Montorng Vs. Self- Montorng 2) joptmal Educaton and Self-Montorng Vs. Mnmal Educaton 4) Optmal Educaton Vs. Mnmal Educaton 37

50 Control Comparsons All the control patents dd not typcally have usual care. Wljle eleven studes had usual care as the management, four had mnmal educaton, and two had self- montorng. None of the control groups had ether asthma acton plan or asthma self-management plan as nterventon. Outcome Measures Fve ( adult and 4 pedatrc) studes reported number of hosptalzatons as the morbdty outcome, two (both pedatrc) reported the hosptal days, and two ( each n adult and pedatrc) studes reported number of subjects vsted to the emergency departments as the morbdty outcome. Whle a total of ten studes measured and reported number of emergency department vsts four of them were adult ard the remanng pedatrc age group. Sx (2 adult and 4 pedatrc) studes measured unscheduled/acute doctor vsts. Whle four pedatrc trals reported the number of days lost from schools due to asthma two of them also reported the number of asthma attacks. Three adult clncal trals reported the AM and PM asthma attacks and three reported the AM and PM PEFR measurements. 38

51 Hosptalzatons Asthma self-management was assocated wth decrease n number of hosptalzatons. However there was a neglgble! effect (Effect sze (ES)=-0.3(-0.30,0.04), (n=5), Q- statstc=l.67,\2=9.49 at p=0.05-table5, 23). The nterventon had more nfluence n the adult patents wth a small effect ((ES=-0.28(-0.85, 0.29), (n=l)-table6, 23) than that n chldren wth a neglgble effect (ES)=-0.2(- 0.30,0.06), (n=4), Q-statstc=l.4 9,x2=7 8' at p=0.05- tablelo, 25). Self-Management and Regular Medcal Revew Versus Usual Care. Pooled effect sze of all studes n ths category was (ES=-0.8 (-0.39, 0.03), (n=3), Q- statstc=0.4, (x2=5.99 at p=0.05-table3, 22). The effect was more evdent when t was optmal self-management wth a small effect (ES=-0.28(-0.85, 0.29) (n=l)- tablel, 2) followed by a neglgble effect n both optmal educaton only (ES=-0.7(-0.40, 0.06), (n=l)-table3, 22) and optmal educatcn and self-montorng (ES=-0.3 (-0.90, 0.64), (n=l)-table2, 2). Further when the dfference n the effect was seen for adult and pedatrc age groups the nterventon was more effectve n the adults wth a small effect (ES=-0.28(- 39

52 0.85, 0.29), (n=l)-table6, 23) than the chldren wth a neglgble effect (ES=-0.7 (-0.39, 0.05), (n=2), Q- statstc=0.0, \2= 3.84 at p=0.05)-table8, 24). All the studes [n the pedatrc age group had group selfmanagement educaton and that n the adult group had ndvdual self-management educaton. Optmal Educaton Versus Mnmal Educaton. Only a sngle pedatrc group study had ths category of nterventon where a small effect (ES=-0.23(-0.69,0.24), (n=l)-table4, 22) was notced relatve to the comparson group. No study wth ths type of nterventon was notced n adult age group. Optmal Educaton and Self-Montorng Versus Self- Montorng. There was the effectveness was (ES=0.06(-0.29,0.42), no declne n hosptalzatons. When quantfed t was found to be (n=l), table-5, 23) favorng the control;group. Hosptal Days Optmal Educaton Versus Mnmal Educaton. There were two studes (pedatrc category) that examned the effect of self-management on the number of hosptal days. The nterventon was assocated wth a decrease n number of hosptal days due to asthma and a small effect (ES=-0.2(- 40

53 0.56,0.4), (n=2), Q-statstc=0.33,y2=3.84 at p=0.05- table36, 38) was notced. Group self-management educatonal nterventon had more mpact (ES=-0.30(-0.77, 0.7), (n=l), table36, 38) than the ndvdual (ES=-0.09(-0.63, 0.44), (n=l), table36, 38) nterventon There was no other study n ether (pedatrc and adult) of morbdty the categores that reported hosptal days as the outcome. Emergency Department Vsts (Number of Subjects) There were two studes that examned the mpact of self-management educatonal program on number of subjects attendng the ED. Overall the self-management reduced the proporton of the asthmatcs needng the ED vsts (OR=0.67(0.35,.30), (n=2), Q-statstc=2.0, x2=3-84 at p=0.05-table26, 33). Optmal self-management and regular medcal revew vs. usual care led to a sgnfcant reducton (OR=0.28 (0.06,ll2)-table26, 33) n the proporton requrng the ED vsts Lhan n optmal self-management vs. mnmal educaton category (OR=0.84 (0.40,.77)-table25, 33). The 4

54 former was a pedatrc tral whle the latter examned the effect n adults. Further sub-group analyss of any knd was practcally not possble because of the non-avalablty of the studes Emergency Department Vsts (Number) Ten studes have reported number of emergency department vsts as the outcome measure. Though selfmanagement nterventons were assocated wth a declne n the ER Ajsts there was a neglgble effect (ES=-0.6(- 0.28, -0.04), (n=0), Q-statstc=3.0, x2=6.99 at p=0.05-tablel6, 28, ndcatng a heterogenety amongst the studes). t was found that the nfluence of the nterventons on the adult populaton (ES=-0.22(-0.42, ), (n=4), Q-statstc=29.04, y2=7.8 at p=0.05-table20, 30)-ndcatng heterogenety among the studes) was more than that on the pedatrc populaton (ES=-0.(- 0.27,0.05), (n=6), Q-statstc=l. 28, x2=h-0? at p=0.05- table24, 32). n two of the studes8'0 there was no effect and the results favored the comparson groups. When one of the studes0 was excluded from the analyses there was an mcrease n effect sze (ES=-0.9(-0.32, -0.06), (n=9), Q statst c=5.2, x =5-5 at p=0.05-tablel6, 28) and when 42

55 both the studes were excluded the effect ncreased to (ES=-0.22(-0.29, -0.6), (n=8), Q-statstc=3.02, x2=4.07 at p=0.05- tablel6-28). Post excluson results of the adult and the pedatrc studes were (ES=-0.33(-0.53, - 0.2), (n=3), Q-statstc=l.39, x2=5.99 at p=0.05-table20, 30) and (ES=-0.6(-0.33,0.02), (n=5), Q-statstc=0.2, x = 9.49 at! p=0.05-table24, 32) respectvely. Self-Management and Regular Medcal Revew Versus t Usual Care. Self-management educaton over the usual care patents had a small effect on the emergency department vsts (jes= 0.20 (-0.36, -0.04), (n=6), Q-statstc=2 9.02, 2 X =.0y l P=0.05-tablel4, 27). On excludng one of the studes? from analyses there was an ncrease (ES=-0.26(- 0.42, -0.0), (n=5), Q-statstc=2.3, x2=9.48 at p=0.05- tablel4,[ 27) n effect sze but the ncrease was not sgnfcant. When looked for the nfluence of the nterventon n adult ard pedatrc patents separately the results were encouragng n adult (ES=-0.26(-0.49, -0.02), (n=3), Q- statstrc=28.55, x2=5.99 at p=0.05-tablel9, 30 ndcatng heterogenety) rather than the pedatrc (ES=-0 j 0.2), (n=3), Q-statstc=0.00, x2=5-99 at p=0 5(-0.7, 05-table22 3) age group. The effect sze after excludng the study 43

56 from analyss that had no nfluence on the ED vsts n adult group was almost medum (ES=-0.39(-0.62, -0.6), (n=2), Q-statstc=-0.07, x2=3.84 at p=0.05-tablel8, 29). Further on sub-group analyss of the self-management vs. usual care t was found that optmal educaton was more effectve than the optmal self-management and optmal educaton combned wth self-montorng n case of adults. The same was the fndng notced n pedatrc trals. However there was only one study n each sub group. When looked for the dfference n the effect of the nterventon n group and ndvdual educatonal groups though a small effect was observed n both the categores t was hgher n ndvdual educaton (ES=-0.26 (-0.38, - 0.3), ( n=2), Q-statstc=0.02, \2=3.84 at p=0.05-tablel4, 27) thdn the group educaton (ES=-0.20(-0.37, -0.03), (n=4), J-statstc=28.95,x2=7.8 at p=0.05-tablel4, 27 ndcat ng heterogenety amongst the studes). But the dfference was not sgnfcant. Further on an attempt to see for the same dfferences n adult and pedatrc groups separately there was no sgnfcant dfference noted. Optmal Educaton Versus Mnmal Educaton. There were two stuc es (both pedatrc) that reported the ED vsts as outcome wth ths category of nterventon. One of them had 44

57 mpact on the outcome measure whle the other dd not. The effect sze was (ES=-0.04(-0.33,0.25)), (n=2), Q- statstrc=0.96, x2=3.84 at p=0.05-tablel6, 28) on poolng the results. After excluson of the study8 from metaanalyss there was a small effect sze (ES=-0.23(-0.69, 0.24), (n=l)-tablel6, 28) notced. Optmal Educaton and Self-Montorng Versus Self. Montorng. Two trals (one adult and one pedatrc) have examned the effect of ths nterventon on ED vsts. ' Whle tle pooled effect sze was (ES=-0. (-0.38, 0.6), (n=2), Q-statstc=0.03, y2=3.84 at p=0.05-table 5, 28) the ndvdual effect szes were -(ES=-0.08(-0.53,0.37), (n=l)-tablel5, 28) and (ES=-0.3(-0.48,0.23) (n=l)- tablel5, 28) n adult and pedatrc study respectvely, Unscheduled Doctor Vsts Unscheduled doctor vsts as a morbdty outcome was measured by sx (two adult and four pedatrc) clncal trals, n these sx trals there were seven dfferent types of nterventon, one7 of them wth group and ndvdual self-management compared wth the control group. Though the self-management educatonal nterventon was assocated wth decrease n number of acute vsts there was a neglgble effect (ES=-0.7(-0.3, -0.03), (n=7), Q- 45

58 statst! c=26.68, x=2.592 at p=0.05-table30, 35 ndcatng a heterogenety amongst the studes). t was more effectve n adult asthmatcs (ES=-0.36(-0.56, -0.6), (n=3), Q- statstc=8.0, x2=5.99 at p=0.05-table32, 36 ndcatng a heterogenety amongst the studes) than the pedatrc asthmatcs (ES=-.O. 03 (-0.20,0.5), (n=4), Q-statstc=l. 90, X2=7.8 at p=0.05-table35, 38) Self-Management and Regular Medcal Revew Versus Usual Cajre. The pooled effect of self-management over the usual ca're patents was of a small sze (SE=-0.23(- 0.4,0.05), (n=3), Q-statstc=23.3, x2=5-99 at p=0.05- table28, 34 ndcatng a heterogenety amongst the studes). Optmal educaton alone had no effect (ES=0.06(- 0.22,0.33), (n=l)-table27, 34) on the acute vsts but optmal educaton combned wth self-montorng had a medum effect (ES=-0.44(-0.67, -0.20), (n=2), Q- statstc=5.88, x2=3-84 at p=0.05-table28, 34 ndcatng a heterogenety amongst the studes). Of the two studes n ths category one had large effect (E'S=-0.93 (-.25, -0.59)- table28, 34 and the other had zero effect. The nterventon had no effect n the pedatrc age group (ES=0.06(-0.22,0.33), (n=l)-table33, 37 but a medum effect n the adult asthmatcs (ES=-0.44(-0.67, -0.20), 46

59 (n=2), Q-statstc=5.88, x2=3-84 at p=0.05-table3, 36 ndcat ng a heterogenety amongst the studes). There was a sgnfcant dfference notced n the effect of the nterventon between group (ES=-0.34(-0.55, -0.3), (n=2), Q-statstc=3.09, x2=3-84 at p=0.05-table28, 34) and the ndvdual educaton (ES=O.00), (n=l)-table28, 34. Optmal Educaton Versus Mnmal Educaton. Two trals (both pejdatrc) that studed the mpact of self-management on health outcomes have measured acute (unscheduled) doctor vsts Jnd no sgnfcant effect was found (ES=-0.03(- 0.32,0.26), (n=2), Q-statstc=0.8, x2 = 3.84 at p=0.05- table29, 35). Optmal Educaton and Self-Montorng Versus Self- Montor ng. Both (pedatrc and adult) group of studes were assocated wth decrease n acute vsts when compared to the comparson group however was more n the pedatrc tral (ES=-0.8(-0.54,0.7), (n=l)-table35, 38) than the adult (ES=-0.06(-0.5,0.39), (n=l)-table32, 36) and the mean effect sze was (ES=-0.3(-0.40,0.4), (n=2), Q- statst c=.6, x =3.84 at p=0.05-table30, 35( 47

60 Days Lost From School/Work Four pedatrc studes reported number of days lost from the' school due to asthma as an outcome measure. There was no a'dult study reported the days lost from work. A neglgble effect (ES=-0.05(-0.26, 0.6), (n=4), Q- statstjc=0.90, x2=7.8 at p=0.05-table39, 40) of asthma self-manjagement nterventon on days lost from school was observed. Seljf-Management and Regular Medcal Revew Versus Usual Care. Asthma self-management educaton had a neglgble effect (ES=-0.04(-0.27,0.9), (n=3), Q- statstc=0.88, x2=5-99 at p=0.05-table38, 39) on days lost from school when compared to the usual care subjects. n ths (category of nterventon, on sub analyss optmal educaton combned wth self-montorng had a medum effect (ES=-0.40(-.7,0.38), (n=l)- table38, 39) but optmal! educaton alone had a neglgble effect (ES=-0.0(- 0.24,0.22), (n=2), Q-statstc=0.02, x2=3.84 at p=0.05- table37,j 39). Optmal Educaton Versus Mnmal Educaton. Ths nterventon type hardly had any nfluence on school days lost (ES=-0.09(-0.63,0.44), (n=l), table39, 40). 48

61 Asthma Attacks (number) A small effect (ES-0.23 (-0.52,0.06), (n=2), Q- statst c=0.73, x=3-84 at p=0.05-table4, 4) was notced on pool ng the results of the ndvdual studes that measured the number of asthma attacks as the morbdty outcome. Self-Management and Regular Medcal Revew Versus Usual Care. Smlar to the results assocated wth the days lost frol school, optmal educaton combned wth selfm>ontorjng had more mpact on asthma attacks than the optmal educaton alone. The former had a medum effect (ES-0.55J (-.3,0.25), (n=l)-table4, 4) whle the latter nterventon had a smaller effect (ES=-0.8(-0.49,0.3), (n=l)-table40, 4) AM and PM Asthma Attacks effect (,2 Asthma self-management nterventon had no effect on the AM asthma attacks (ES=0.04(-0.32, 0.40), (n=3), Q- statstc=2.96, x2=5«99 at p=0.05-table43, 42). A small ES=-0.37(-0.72, -0.02), (n=3), Q-statstc=2.60, Xz=5.99 at p=0.05-table45, 43) was notced n case of the PM asthma attacks. Sel f-management and Regular Medcal Revew Versus Usual Care. There were two nterventon groups (ndvdual 49

62 and group) n a sngle study (adult). n case of AM asthma attacks when ndvdual self-management nterventon was compared to the group self-management nterventon there was a mddum effect (ES=-0.45(-.27, 0.39), (n=l)-table42, 42) seen n the former and a small effect (ES=-0.26(-.08,0.57), (n=l)-.table42, 42) n the latter case. On poolng jthe results the effect was small (ES=-0.35(- 0.94,0.24), (n=2), Q-statstc=0.0, x2=3.84 at p=0.05- table42,' 42). On the other hand n case of PM.asthma attacks the ndvdual self-management nterventon (ES=0.05(- 0.77,0.86), (n=l)-table44, 43) favored the comparson group ard the group self-management nterventon had a neglgble effect (ES=-0.04(-0.86,0.78), (n=l)-table44, 43). On poolng, the results (ES=0.004(0.003, 0.005), (n=2), Q-statstc=0.02, x2=3.84 at p=0.05-table44, 43) favored,the comparson group. Optmal Educaton and Self-Montorng Versus Self- Montorng. There was no effect of ths nterventon on AM asthma attacks. On the contrary the result had favored the comparson group (ER=0.28(-0.7,0.73), (n=l), table43, 42). Surprsngly there was a medum effect (ES=-0.60(-.06, -0.4), (n=l), table45, 43) on PM asthma attacks. 50

63 j Daly Average AM and PM Peak Expratory Flow Rate Measurements Both AM and PM PEFR measurements were lttle nfluenced by asthma self-management educaton. The educatonal nterventons had a neglgble effect on both! AM PEFR (ES=0.04(-0.25, 0.33), (n=4), Q-statstc=3.93, X2=7.8 kt p=0.05-table47, 44) and PM PEFR (ES=0.4(-0.5, 0.43), (n=4), Q-statstc=3.33, x2=7.8 at p=0.05-table49, 45) measurements. Sel f-management and Regular Medcal Revew Versus Usual Cajre. Asthma self-management educaton (optmal educatol and self-montorng) had an equal mpact on the AM and PM PEFR measurements. The effect was neglgble n both AM ES=0.6 (-0.23,0.55), (n=3), Q-statstc=3.09, X2=5.99 kt p=0.05-table46, 44) and PM (ES=0.8(-0.2, 0.57), (n=3), Q-statstc=3.27, \2=5.99 at p=0.05-table48, 45) PEFR measurements. There was no sgnfcant dfference between the group (ES=0.20 (ES=0.2 (0.0,0.30), (n=l)-table46, 44) and ndvdual (-0.6,.03), (n=l)-table46, 44) educatonal nterventons n AM PEFR measurements but there was a dfferenle seen n case of PM PEFR measurements (ES! (group)=0.4(0.59, -0.3), (n=l)-table48, 45) ES 5

64 (ndvdual)=0.3(-0.53,.2), (n=l)-table48, 45) favorng the ndvdual educatonal nterventon. Optmal Educaton and Self-Montorng Versus Self- Montorng. The comparson group had advantage ES=-0.2(- 0.56,0.34), (n=l)- table47, 44) over the nterventon, group n AM PEFR measurements and there was a neglgble effect ES=0.09(-0.36,0.54), (n=l)-table48, 45) n case of PM PEFR measurements. 52

65 CHAPTER FVE CONCLUSONS AND RECOMMENDATONS Conclusons Asthma self-management educaton results n mprovement of the health outcomes n both chldren and the adults but wth the neglgble effect. The: educatonal nterventons were more effectve n ndvdual rather than group nterventon, adults than the chldrenj although not wth a sgnfcant effect. Optmal Self-management was more effectve than the other lejss ntensve nterventons n self-management and, regular medcal revew vs. usual care group. n some of the studes Optmal educaton alone was more effectve than when combned wth self-montorng. The:hypothess that subjects attendng the asthma self-management educatonal program nvolvng acton plans and ndvdualzed self-management plans would experence a decrease!n morbdty through notced could not be concluded because of nsuffcent number of trals addressng n ths regard. Smlarly, the hypothess that a clncan as an educator!and a team approach wll be more effectve also 53

66 could no t be concluded for the same reason that an nsuffcent (only two) number of studes were seen to have ths method of delvery of educaton. : Dscusson Thjs meta-analyss (systemc revew) apprased 7 trals (fen were of pedatrc age group and seven of adult category') of self-management educaton wth asthma and found that ths type of nterventon results n mprovement of the health outcomes. Not all the studes measured all the morbdty outcomes selected for the revew. There was a reducton n the number of hosptalzatons, number of hosptal!days, emergency department vsts, subjects vstng!the emergency departments, unscheduled doctor vsts, clays lost from school, and epsodes of asthma attacks and mprovement n lung functon. Though the study showed ah mprovement n the morbdty varables effect was neglgble and was not large enough to be clncally sgnfcant. Ths neglgble mpact may be due to multple confoundng factors not drectly amenable to change by educaton. The other factors that may be responsble may be the 'poor qualty' of studes and less number of studes n the analyss. 54

67 On sub-analyss of the self-management educatonal nterventon and regular medcal revew vs. usual care more effect was seen n patents wth optmal self-management followec by optmal educaton or optmal educaton and self-mon torng together. The same educatonal nterventon n adults was more effectv e than n the chldren and the ndvdual educaton was more nfluental than the group educaton though wth a neglgb le or a small effect. The possble reasons for the effect jn adults was more than n chldren was unexplanable. Most of the pedatrc studes also nvolved actvely the famly members n the educatonal program but does not seem to have encouragng results. However, the number ojf studes n each category was very few restrctng the gene ralzaton of the results 6 Onljy two of the studes ' had clncan as educator and one6 of those had encouragng results when compared many studes. May be a clncan can educate the patents n a more effcent way than a non-clncan. Agan the results cannot be generalzed due to the lmtaton of the number of studes. t was practcally not possble to further stratfy the studes wthn one specfc morbdty outcome, because 55

68 the number of pooled studes under each stratum would have become smaller and napproprate for the estmaton of an overall (effect sze. Stratfcaton of studes accordng to the socpdemographc characterstcs mght have provded more nformaton on the mpact of the teachng programs. The control groups of all the studes were not true placebos. They were exposed to a varable self-management educatonal nterventon (mnmal educaton, selfmontorng of the symptoms, peak expratory flow montorng). n spte of the.contamnaton of the control subjects! there was effect notced n many of the outcome varables however the effects ether were neglgble or small. Sorte of the studes showed no nterventon effect that may be probably due to the napproprate use of the contnuous measures for outcomes,, whch are not normally dstrbuted such as hosptalzatons, ER vsts, doctor vsts and days off work or school. Moreover the dsease severty!of the subjects at the tme of the recrutment was dfferent from study to study and some of the studes had no menton of t. The nvestgators of a study3 had clearly demonstrated that comparson of groups stratfed accordng to the severty of the dsease resulted n sgnfcant 56

69 results though there was no effect when the sample was consdered as a whole. Ths study demonstrated that when the expermental group was compared wth the control group wthout re3ardng to the severty of the morbdty there was no sgnfcant reducton or morbdty found. However, when the; comparson was made wth the chldren wth j prevous hosptalzatons, the teachng program had a sgnfcant effect. Moreover, n the chldren wth the hgh baselne,, numbers of hosptalzatons and emergency vsts there wa!s greatest reducton n the morbdty. Ths was the only study that stratfed wth regard to the dsease severty, t was not possble to pool from other studes subgroup's of chldren who had more severe asthma. n ^complete agreement wth the Bernard-Bonnn et al4 certan morbdty outcomes lke hosptalzatons, emergency department vsts, and school absenteesm are not relable ndcators of the success of the nterventon because for the same asthmatc condton, one,famly may come to the emergency room, whereas another famly wll manage at home wth advce on phone. ' Heterogenety was found n emergency department,., vsts, unscheduled doctor vsts. Ths may be due to the combnaton of groups of dfferng severty. 57

70 Recommendatons. More randomzed controlled trals wth a 'good qualty' (Adequate and approprate randomzaton, : concealment of allocaton, and adequate statstcal f power and relevant statstcal technques) that study the effect of asthma self-management educaton on the heajlth outcomes are to be carred out both n pedatrc and adult age group to estmate the true effect wth varous sub-group analyss j 2. The educatonal programs should focuses on the target populaton for the optmum and accurate results. 3. Asthma educatonal programs wth acton plans and : ndvdual self-management plans, nvolvement of clncans and famly members should be serously consdered 4. There was almost no study n- ths revew that adhered strctly to the NAEPP gudelnes n delverng the educaton that mght be a possble reason for the neglgble effect of the nterventons. Hence t s recommended that studes should be conducted wth NAEPP gudelnes to obtan the optmal effect of the ( nterventons under all sub-groups. 58

71 l 5. Snce a subtle dfference n effect was found n ths study between the pedatrc and adult (more effectve n adults) age groups wth a lmted number of trals there s a further need of research to come to a strong concluson m ths regard. 6. Mor e trals wth specfc educatonal nterventon wth perfect placebo (no contamnaton) control groups are! to be conducted to fnd the mpact of that j nterventon on dfferent morbdty varables. 7. Fur'ther research s recommended to evaluate the health ; : outjcome measures wth respect to the duraton of J nterventon, number of sessons of educaton, clncan nvolvement, group and ndvdual educaton, anc} team approach. j 8. t was qute a dsappontment to notce that when ths clncal entty (bronchal asthma) n the present day stuaton n Unted States requres an utmost attenton for ts chroncty and hgh rates of morbdty and mortalty, there s a very poor and far from encouragng research s,conducted to know the mpact of self-management educatonal (back bone of the asthma management) programs on the morbdty outcomes. t s strongly recommended that a systematc 59

72 clncal trals be conducted' to both,use and produce the evdence that may help the health servces polcy! makers and the evdence based practtoners. Lmtatons of the Study Desgn and Procedures. Art cles were selected from three databases and by han d search as mentoned earler. Therefore, t s pos sble that certan artcles that were perfectly relevant n ths context mght have been mssed whle : searchng or wrongly rejected whle studyng the j absjtract wthout gong nto the complete detals of! the] study. 2. All the trals rrespectve of ther qualty are ncluded n the study. Ten of 7 studes were poor qualty and none of the other studes acqured a score more than three. The poor qualty of the studes s certanly a lmtng factor n generalzng the results 3. All the trals were crtcally apprased and revewed by a sngle revewer. Any napproprate decson n ncluson of studes or analyss of the trals s a potental bas. 60

73 : 4! Publcaton bas: Only publshed trals are ncluded n jthe ths study.t s a tendency that studes wth only postve results (ether vald or may be nvald) arel publshed and there may be qute a good number of stujdes that mght be relevant n ths context and not publshed. Language bas: Only trals publshed n Englsh are consdered for revew. Relevant trals publshed / 6 unpublshed n other languages are not ruled out. Partcpants n some of the studes were of specfc populaton (eg. Medcad, low-ncome group) hence, generalzblty of the results s questonable. Whle evaluatng the studes, aspects of the statstcal methodology (approprateness of data collected and statstcal technques used) were not covered. 8 Age was not controlled whle poolng the effect szes of Poth age! effect sze l groups. So the valdty of the combned s a matter of concern. 9. The lmtatons of the ndvdual studes whch would have an ndrect nfluence oh the meta-analyss are. Absence or napproprate randomzaton. Absence of concealment of.allocaton 6

74 . v. v. v. nadequate statstcal power!!unacceptable dropout rates : jabsence of ntenton to treat analyss! Recrutment bas (patents recruted from the joutpatent clnc would have mld form of asthma!whle that from the emergency department have severe form of asthma) 62

75 APPENDX A: STUDY SELECTON FLOW DAGRAM ; 63

76 APPENDX B: VALDATED QUALTY ASSESSMENT OF STUDES 65

77 VALDATED QUALTY ASSESSMENT OF STUDES (FROM JadadAR etalwqq) Qualty scale components Descrbed as Randomzed (Yes=; No=0) Descrbed as Double Blnd (Yesd; No=0) Descrpton of Wthdrawals and Dropouts (Yes=;No=0) Randomzaton Approprated; napproprate=0) Blndng (Approprated; lnapproprate=0) R R2 R3 R4 R5 R6 R7 R8 R9 R0 R R2 R3 R4 R5 R6 R Total score Was the study descrbed as randomzed? 2. Was the study descrbed as double blnd? 3. Was there a descrpton of wthdrawal and dropouts? (Gve a score of for each yes or 0 ponts for each no ). f randomzaton/blndng approprate (Gve addtonal pont each) 2. f randomzaton/blndng napproprate (Deduct pont each) Scorng range: 0-5 Poor qualty <3

78 APPENDX C: EVDENCE TABLES 67

79 Author and Study source Methods Partcp'ants Baley WC et al. A randomzed tral to mprove self-management practces of adults wth asthma. Arch ntern Med 990 Aug; 50 (8): Study Desgn: Randomzed controlled Method of Randomzaton: Eleven physcans wth three asthma severty levels stratfed patents. Ths resulted n 33 strata. Blockng procedures were used to ensure that every two of the four subjects n a gven stratum were assgned to nterventon. A separate randomzaton schedule for all the 33 strata (prepared n advance) however, method of randomzaton s not stated. Concealment/Concealment of Allocaton: Closed envelope technque Outcome Assessor Blndng: Not stated Elgble Not mentoned Declned/Accepted but not Partcpate Not mentoned Randomzed 267 patents (35 Usual Care and 32 Self-Management patents) Dropouts 42 (34 usual care and 8 selfmanagement patents were unavalable for follow up) Completed 225 (0 Usual Care and 24 Self- Management patents) Dropout Rate 42/267 (5.7%) Age Group and Sex Dstrbuton: Characterstc Control nterventon <20 5.%.6% Age (years) % 27.4% Sex % 37.% Male Female 7 6 How was Asthma Dagnosec? Doctor s dagnoss wth objettve crtera Method of Patent Recrutment: From a Pulmonary Medcne Clnc ncluson Crtera: ) Recurrent epsode of wheezng or dyspnea 2) objectve evdence of sgnfcantly ncreased resstance to arflow durng epsodes 3) objectve evdence of mprovement of arflow when symptom free Other Dseases Excluded: Another pulmonary or severely debltatng dsease that mght confuse the nterpretaton of results (emphysema, cystc fbross, Lfe threatenng cancer, severe RA) Other Exclusons (f any): ) Age under 8 years 2) Refusal to partcpate Baselne Characterstcs: Asthma Severty nterventon Control Mld 37.% 38.6% Moderate 47.6% 44.6% Severe 6.3% 6.8% There were no statstcally sgnfcant c fferences between the control and the expermental group n the baselne che racterstcs before the nterventon 68

80 nterventons Statstcal Analyss Settng: Out-Patent Pulmonary Medcne Clnc nterventon n detal: Type (ndvdual, verbal, wrtten, nteractve, famly member nvolved, non clncan educator, acton plan, PEFR montorng, medcal revew Vs wrtten educaton, usual medcal care) nterventon Group Characterstcs: One to one counselng for one-hour duraton. Sesson focused on use of self-care workbook and other program components, proper use of medcaton and self-montorng and self-evaluaton technques, early detecton of mpendng attacks and attack management. Workbook: For home use, and contans seven sectons desgned to provde the basc nformaton that patents need to mprove ther self-management sklls. Addtonal strateges: Asthma support group partcpaton (health educator + 4 to 6 patents + asthma control partner for each patent) Telephone calls: 2 and 4 weeks followng asthma support group meetngs (encouragng self-management and enhance self montorng). Duraton: One-hour duraton one to one counselng sesson. Subjects were not provded wth wrtten acton plan. Educator: Health Educator Control Group Standardzed set of asthma pamphlets (comprehensve nformaton about nformaton asthma, but ths nformaton was not part of an ntegrated patent educaton program). No other steps taken to read, counsel or support the groups. Data Collecton: By ntervew and fllng the observatonal check lst Analyss: Analyss of baselne data ndcated that dropouts were hghly smlar to subjects who perssted n the study, and that there was no dropout by condton nteracton. Therefore no statstcal adjustments for attrton were appled The sgnfcances of dfferences between groups were assessed by analyss of covarance adjustng the follow-up scores for several covarates (Logstc regresson procedures were used to n makng these adjustments) Adequate statstcal power (224 subjects needed for 85% power and 96 subjects for 80% power) 69

81 Results/ Outcomes! Lmtatons of the Study Conclusons/ Other Remarks j Sklls (nhaler use and nhaler adherence), medcaton adherence, severty of symptoms, bothered by asthma, fve or more days of coughng or dyspnea, emergency department vsts, vst or hosptalzatons for asthma. Outcome measures Usual Care (n=0) Self- Management (n=24) Emergency Dept. vsts Baselne 52.5% 43.9% After 2 months 6.2% 3.8% nadequate blndng Analyss not done on ntenton to treat bass P A comprehensve effort to mprove self-management practces of adults wth asthma can substantally mprove adherence to treatment regmens and as a result can mprove the functonal status. Unexpected large decrease n healthcare utlzaton n both groups, whch may due to comparable amount of educatonal materal wth both groups. However, t may be due to selecton bas (subjects recruted durng clnc vsts and clnc vsts may have been followed by the hosptalzaton or ED vsts) 70

82 Author and Study Source Methq ds Berg J et al An evaluaton of a self-management program for adults wth asthma. Clncal Nursng Research 997 Aug; 6 (3): Study Desgn: Randomzed controlled Method of Randomzaton: Subjects were stratfed on asthma severty due to the possble nfluence of severty on complance behavor and a stratfed random permuted block scheme was employed for generaton of treatment assgnments for subjects wth moderate or severe asthma. Concealment/Concealment of Allocaton: Not stated Outcome Assessor Blndng: Not mentoned Partcpjants Elgble 84 were elgble and 68 sgned consent forms Declned/Accepted but not Partcpate 6/3 Randomzed 55 Dropouts One but ncluded n the analyss Completed 54 Dropout Rate /55 (.8%) Age group and sex dstrbuton Characterstc Overall Treatment Control X2(df) Gender Age Male () Female {P=0.05} 8 years or older Note: There were no sgnfcant dfferences found n characterstcs of two groups. How was Asthma Dagnosed? Doctors' dagnoss of asthma and who were beng treated wth prescrbed wth, regularly admnstered, nhaled medcatons other than needed bronchodlaters. Method of Patent Recrutment:. Brochures were placed n physcan offces and pharmaces, and nformaton about the study was announced on the rado and n local newspapers. Potental subjects were called after they ndcated an nterest n partcpaton and were recruted after screenng. ncluson Crtera: ) Rural dwellng adults age 8 years and older wth medcal dagnoss of asthma 2) treated wth prescrbed regularly admnstered, nhaled medcatons other than as-needed bronchodalaters Other Dseases Excluded: Other respratory dsorders Other Exclusons (f any): Current smokers Baselne Characterstcs: Baselne measures were assessed daly for one week and ncluded ) Daly peak flow determnatons (usng peak flow meter and recorded n an asthma dary) 2) Complance wth nhaler use (usng both the MD Chronolog and self-report wth the dary) 3) Asthma symptoms (as self reported n the dary) 4) Questonnares to assess asthma self-management and self-effcacy 5) Classfed nto mld, moderate and severe based on based on NAEPP 99 7

83 nterventons Statst cal Analy >s There were no statstcally sgnfcant dfferences between the control and the expermental group n the baselne characterstcs before the nterventon Settng: Communty settng nterventon n Detal: Type (Group, verbal, nteractve, structured, non clncan educator, peak flow meter used, asthma dary, other nstruments (journal of daly asthma concerns, asthma selfmanagement assessment tool, self-effcacy for asthma management scale), peak flow montorng Vs usual medcal care) nterventon Group Characterstcs: Adapted from a program desgned by Creer, Reynolds, and Kotses (992) that conssted of sx sessons conducted n communty settng ncluded nformaton about the self-management behavors and sklls, asthma medcaton, asthma trggers, preventon of asthma attacks, relaxaton technques, psychologcal responses to asthma, and problem solvng sklls. All the nformaton that was gven to the subjects was scrpted n a 204- page book to the group leaders. There were fve groups wth ten subjects n each group. nstruments Used: MD Chronolog Journal of daly asthma concerns Sprometrc peak-flow meter, The Self-Effcacy for Asthma Management Scale (SEAMS) The Asthma Self-Management Assessment Tool (ASMAT) Duraton: Each sesson lasted for two hours Educator: Regstered nurses who were knowledge about asthma. Control Group Recorded nformaton daly for week followng randomzaton and agan at follow-up for treated subjects. No other nterventon apart from usual care from physcans. Data Collecton: From the nstruments used and by ntervew Analyss: All Analyss were done on ntenton to treat bass Adequate statstcal power/sample Analyss of covarance wth asthma severty as a covarate was a prmary statstcal procedure used for the Analyss. 72

84 Results/ Outcomes Lmtatons of the Study Concluso s/ Other Rerlarks Complance at outcome, average total daly symptoms, percentage of symptom free days, mornng and evenng peak flow measurements, self-effcacy or self-management. Outcome measures Treatment (n=3) Control (n=24) Stat*(df) Average peak flow (Mornng) Average peak flow (Evenng) Pre Post Pre Post Mean SD Mean SD F= (D F= 0.000() There was no sgnfcant dfference exsted at baselne or post treatment for two groups for average total daly symptoms, percentage of symptom free days, mornng or evenng peak-flow measurements. However post treatment chronolog complance revealed a sgnfcant dfference between the two groups, the expermental group showng a greater ncrease n complance at outcome. Lack of concealment of allocaton No blndng Senstvty of the nstruments used ) The hypothess that subjects who attended a self-management program would experence a decrease n the frequency of daly symptoms and an ncrease n the percentage of symptom free days was not found. 2) The hypothess that arway obstructon would decrease wth mproved complance was also not seen. 3) Nether the self-effcacy nor the self-management behavors were modfed after the sx-week program. 73

85 Author and Study Source Methods Partcpants Clark NM et al. The mpact of health educaton on frequency and cost of healthcare use by low-ncome chldren wth asthma. Journal of Allergy and Clncal mmunology 986; 78:08-5 Study Desgn: Randomzed controlled Method of Randomzaton: Not mentoned Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Elgble 558 Declned/Accepted but not Partcpate 248 Randomzed 30 subjects (nterventon 207; control 03 - randomzed n 2: rato) Dropouts Not mentoned Completed Not mentoned. All were consdered n analyss Dropout Rate Age group and sex dstrbuton: Mean age of 9.2 years 64% males j Zero How was Asthma Dagnosed? Physcans dagnoss Method of Patent Recrutment: Durng the regularly scheduled clnc vst ncluson Crtera: ) A dagnoss made by a physcan by use of commonly accepted clncal crtera 2) One or more vsts made to the clnc n the prevous two months 3) One or more epsodes of wheezng reported n the pror year 4) Aged between 4 and 7 years 5) No major handcap that would prevent beneft from an educatonal program Other Dseases Excluded: Not mentoned Other exclusons (f any): Not mentoned Baselne Characterstcs: There were no statstcally sgnfcant dfferences between both the groups before the educatonal program 74

86 nterventons Settng: Regularly scheduled outpatent clnc vst nterventon n Detal: Type (Group, verbal, nteractve, famly member nvolved, non clncan educator, regular medcal revew Vs usual medcal care) nterventon Group Characterstcs: The educatonal program emphaszed on the management steps to be taken by the chld wth asthma and chld s parents. Areas of dscusson were managng the asthma attack, takng medcne, communcatng wth the physcan, mprovng school performance, mantanng a healthy home envronment, and establshng gudelnes for the chld s physcal actvtes. The program was delvered to groups of 0-5 famles and the learnng process was a group dscusson and problem solvng Duraton: Sx one-hour sessons offered monthly n Englsh and Spansh. Of sx sessons n fve sessons parents and chldren met separately, and n one sesson they met together. Educator: Health educator Control qroup Regular medcal revew Statstcal Analyss Data Collecton: ntervewng the famles and revew of the records Analyss: All the Analyss were done on ntenton to treat bass The hypotheses were tested by one-taled t tests. To evaluate changes regardless of the chldren s prevous health care use, the mean and the change scores of the entre expermental group were compared to mean and change scores of the entre control group to test whether there was a statstcally sgnfcant effect for the health educaton program Results/ Outcomes Outcome measure Control (N=207) Follow up nterventon (N=03) Control (N=207) Change nterventon (N=03) P< Hosptalzatons 0.2 ± ± ± ± 0.60 Emergency room vsts 2.49 ± ± ± ± 5.60 N.S 75

87 Lmtatons of the Study Conclusons/ Other Remarks Though the patents represent the general communty populaton of lowncome urban chldren wth asthma, t s an untestable assumpton because no communty-wde survey was conducted. nadequate randomzaton No menton of concealment No blndng No menton of adequacy of statstcal power ) The dfference n hosptalzatons and ER vsts of both groups (all the chldren under study) was not statstcally sgnfcant after the asthma educaton program though both the groups showed fewer rates of hosptalzatons and ER vsts compared to the baselne. 2) Among those chldren who made use of health care facltes before the program there was a sgnfcant effect of the health educaton program. 3) The study ndcates demonstrates that the evdence that asthma management tranng for low-ncome parents and ther chldren wth one or more hosptalzatons can yeld cost-savngs. 76

88 Autho and study ource Meth ods Evans D et al. A School Health Educaton Program for Chldren wth Asthma Aged 8- Years. Health Educaton Quarterly (Fall) 987; Study Desgn: Randomzed controlled Method of Randomzaton: 2 schools under study pared accordng to ethnc composton and sze. One school n each par was randomly selected as an nterventon group. However the method of randomzaton s not mentoned. Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Parte Dants Elgble Not mentoned (2 schools) Declned/Accepted but not Partcpate Not rnentoned Randomzed 239 (nterventon 34; Control 05) 6 schools n nterventon and 6 schools n control group Dropouts 35 Completed 204 (nterventon 7; Control 87) Dropout Rate 35/239(4.6%) Age Group and sex Dstrbuton: Mean age of chldren was 9. years, *59% were males How was Asthma Dagnosed? Physcan dagnoss Method of Patent Recrutment: Parents whose chldren had asthma ard wanted them to take part n educaton program were nvted to the school. Upon the chld met the crtera for partcpaton n the study, the chldren were enrolled n the study after baselne telephonc ntervew and a wrtten consent. ncluson Crtera: Enrollment n the thrd, fourth and ffth grade, parental report of at least three epsodes of asthma n the past year, and wrtten parent consent for partcpaton Other Dseases Excluded; Not stated Other Exclusons (f any): Not stated,-,... Baselne Characterstcs: Baselne measures that mght reflect dfferences between schools (ethncty, grades, absences, classroom behavor ratngs by teachers and scores on standardzed tests) were examned and no statstcally sgnfcant dfferences were found between nterventon and control groups, except for slghtly hgher classroom behavor ratngs for the expermental group (+5%; p<0.005) Control group chldren had hgher scores on asthma ndex of self-management sklls (+3%; p<0.05). Baselne dfferences were adjusted by analyss of covarance. 77

89 nterven ons Statstcal Anahrss Settng: n the dstrct school premses - nterventon n Detal: Type (Group, verbal, other educatonal nterventons (games, stores, role plays), nteractve, structured, famly member nvolved, non clncan educator, medcal revew Vs Usual medcal care) nterventon Group Characterstcs: *The educaton focused on a) Basc nformaton and feelngs about asthma b) To recognze and respond to symptoms of asthma c) Usng asthma medcnes and decdng when to seek help d) how to keep actve physcally e) dentfyng and controllng trggers to asthma symptoms and f) handlng problem related to asthma and school The program focused on chldren s ndependent actons as self-managers, emphaszng the chld s responsblty for recognzng asthma symptoms and ntatng approprate management steps whether or not parent was present. Descrptve materals sent home to parents to famlarze them wth management sklls ther chldren were learnng Educatonal methods use of stores to ntate dscusson of problems wth asthma, games to practce decson makng, role play to rehearse asthma management sklls, and physcal and actvtes that were developmental^ approprate for 8- year old chldren Duraton: Sx 60-mnute sessons n whch groups of 8-2 chldren learned asthma management sklls. All the sx program sessons were held to ensure that the chldren completed the entre program. Make up sessons were held to ensure that the chldren completed entre program. Educator: Health educator Control Group The control group chldren were gven the same educaton but after the completon of the tral. No specal educaton durng the tral. Data Collecton: Data was collected from the chld s school records, medcal records of hosptal and from separate ntervews wth parent and chld. Baselne data was collected mmedately precedng the nterventon and follow up data were collected one year after the educaton program was completed. Analyss: Multvarate analyss of covarance was used to test smultaneously the hypotheszed outcomes of the health educaton program (Multvarate test of sgnfcance controls for the ncreased rsk of type error when evaluatng multple treatment effects on correlated dependent varables) 78. *.. A,,

90 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks nterventon group Control group Outcome Measure (N = 7) (N=87) P Baselne 2.3 ± ±3.4 School Post nterventon 9.4± ±2.6 Absences Change -.9± NS Unschedule Baselne 4.3 ± ±3.0 d Vsts Post nterventon 3.6 ± ±3.8 Change -0.7 ± ±4.2 NS Asthma Baselne. 0.6±.4 (93) 0.± 2. (68) Attacks Follow up 9.0 ±4.7.8 ±6.5 Change -.6 ± ± Sgnfcance levels are basec on unvarate Analyss of covarance of transformed scores There were no statstcally s gnfcant dfferences between both the groups n school attendance as well as the unscheduled vsts. nadequate randomzaton No menton of allocaton concealment No blndng The program was conducted n school chldren where the severty of asthma was mld so the generzablty of the fndngs to s questonable. Snce data was self reported there s a potental bas resultng from demand effects,.e. the tendency of the partcpants n an expermental program to report results they beleve are consstent wth the desred outcomes of the program. Self reported data are also subject to errors of memory No menton of adequacy of statstcal power Analyss not done on ntenton to treat bass School based chld centered educaton program desgned for 8- year old chldren wth asthma, and conducted wthout parent attendance, can ncrease chld's asthma management sklls, feelngs of self-effcacy, and postve nfluence on parents management decson 79

91 Author^ and Study S.ource Methods Partcpants! Freman P et al. Teachng Self-Management Sklls to Asthmatc Chldren and Ther Parents n an ambulatory Care Settng. Pedatrcs Sep 98; 68 (3): Study Desgn: Controlled clncal Method of Randomzaton: Patents were sequentally assgned to ether the study or the comparson group; groups were matched for age Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Elgble Declned/ Accepted but not partcpate Randomzed Dropouts Completed Dropout Rate Age Group and sex Dstrbuton: Characterstc nterventon group (N = 3) Not mentoned Not mentoned 26 (3 nterventon; 3 control) None All those randomzed Zero Control group (N = 3) Age mean n yrs) Sex Males 9 2 Females 4 How was Asthma Dagnosed? Physcan dagnoss Method of Patent Recrutment: All the patents were recruted from the pedatrc allergst s offce after they met the crtera and voluntary gvng of nformed consent ncluson Crtera: ) 2 to 4 years of age 2) Hstory of sx or more asthmatc epsodes Other Dseases Excluded: Not mentoned Other Exclusons (f any): Not mentoned Baselne Characterstcs: Both the groups were smlar n regard to ther type and expresson of asthma There were no statstcally sgnfcant dfferences between the control and the expermental group n the baselne characterstcs before the nterventon 80

92 nterventons Settng: Not stated nterventon Type n Detal: Type (Group, verbal, wrtten, nteractve, structured, famly member nvolved, non clncan educator, asthma dary, symptom montorng, medcaton montorng Vs usual medcal care) General nstructons All the patents and famles, whether n the study or comparson group, were gven the same general nstructons Expermental Group Characterstcs: *The educaton was focused on descrpton of anatomy of lungs, revew of elementary pulmonary physology and pathophysology, an explanaton of factors that can provoke asthma (allergens, nfectons, exercse, rrtant nhalants, and emotons), and the actons of drugs used for asthma Booklet concernng asthma, allergy, and envronmental avodance procedures was gven to each patent Symptom and medcaton dary Duraton: Four ndvdual sessons of one hour each and two two-hour group sessons durng whch health educaton personnel dscussed wth famles the varous ramfcatons of asthma and ts management. The average duraton study was 2 months. Health educator: Nurse educator Control Group No teachng sessons Tranng of Nurse Educators Prncples of symptom assessment and medcal management of asthma was gven by the pedatrc allergst and the prncples of health educaton was gven by the health educaton specalsts Statstcal Anab/ss Data Collecton: Use of symptom and medcaton dary, revew of school attendance records, and tabulaton medcal vsts to the ER and Hosptalzatons Statstcal Analyss: All the Analyss were done on ntenton to treat bass No menton of type of statstcs used 8

93 Results/ Outcomes Lmtatons of the study Conclusons/ Other remarks Outcome measure Study Group 2-6 years 6- years -4 years All ages (total) Comp. Group Study Group Comp. Group Study Group Comp. Group Study Group Comp. Group Hosptalzatons ER vsts Absent school days Absent school days per patent < Asthma attacks <0.0 The data collecton from the parents by t e telep none survey revealed that nne of :he 3 famles felt that ther chld's asthma h ad mpr< ved durng the study and nterest ngly ten of the 3 comparson famles also th ought th at ther chld's asthma had mprov 3d durng the study Small study sample nadequate randomzaton No menton of concealment of allocaton No blndng No menton of adequacy of statstcal power/sample A planned educatonal program for asthmatc chld and famly may play an mportant role n the successful management of chldren wth chronc or ntermttent asthma P 82

94 Author!and Study Source Methods! { Partcpants George MR et al. A Comprehensve Educatonal Program mproves Clncal Outcome Measures-n nner-cty Patents Wth Asthma. Archves of nternal Medcne 999; 59: Study Desgn: Randomzed controlled Method of Randomzaton: By random number generator Concealment/Concealment of Allocaton: Not stated Outcome Assessor Blndng: Decson to dscharge the patent was made by the house staff and the patents attendng physcan, who was not a study nvestgator. Elgble 88 Declned/Accepted but not Partcpate Randomzed Dropouts Completed Dropout Rate Age Group and sex Dstrbuton: Characterstcs npatent Educaton (n=44) 77 (44 n nterventon group and 33 n control group) None All the randomzed completed the study (77) No dropout rate but data not avalable for 4 nterventon and 3 control group patents Routne group (n=33) P j M/F {%) 5.9/ / (ch-square) Age (yrs) (unpared t test) Age group between 8 and 45 years of age and no sgnfcant df ferences between both the groups How was Asthma Dagnosed? Not stated. Probably by a physcan? Method of Patent Recrutment: Patents wth acute exacerbaton of asthma presented n Emergency Department ncluson Crtera: Not mentoned Other Dseases Excluded: Patents wth comorbd condtons were excluded to lmt the study to patents wth uncomplcated asthma exacerbatons Other Exclusons (f any): ) No telephone access; 2) Pregnant; 3) Dd not speak Englsh Baselne Characterstcs: No statstcally sgnfcant dfferences between the control and educatonal group before the nterventon 83

95 nterventons Statstcal Analyss Settng: Emergency department nterventon n Detal: Type (ndvdualzed, verbal, nteractve, structured, team approach, clncan educator, acton plan, PEFR montorng, regular medcal revew Vs Usual medcal care) nterventon Group Characterstcs: Repettve Teachng Sessons Goals of Teachng Sessons: mprove metered dose nhaler admnstraton technque, stress chronc nature of asthma and the need for long-term therapy wth emphass on regular outpatent follow up. #Patents were taught early sgns of asthma and they receved acton plans for approprate responses for these warnng sgns. #A the patents were screened for obstacles to care (lack of transportaton, substance abuse, lack of chld care etc) #A the patents were contacted by phone 24 hours followng the dscharge to address questons about the dscharge nstructons, medcatons and asthma symptoms. Outpatent Follow-up: Wthn the seven days of the dscharge Patents receved repeated sprometrc evaluaton of ther forced vtal capacty and forced expratory volume n -second, a physcan examnaton, and patent educaton to renforce the prncples ntroduced at the admsson. Educator: Asthma clncal nurse specalst Control Grouo No specal asthma educaton apart from usual care. Data Collecton: Data on the frequency of ED vsts and hosptalzatons were obtaned from the database of MCO Analyss: Contnuous, normally dstrbuted data were analyzed usng t-tests. Categorcal data were analyzed usng the Pearson %2 test Nonnormally dstrbuted data were analyzed usng the Mann-Whtney taes and the Wlcoxon sgned rank test. 84

96 Results/ Outcomes! Lmtatons of the Study Conclusons/ Other Remarks Hosptal length of stay (LOS), readmsson rates, attendance at subsequent out patent appontments, frequency of ED vsts, and hosptalzatons sx months pror to and followng study enrollment Outcome Measures ED Vsts Hosptalzaton s Year Sx Months Before nterventon Sx Months After nterventon Wthn Group (P*J B/w Group (P#) nterventon (30) Control (20) nterventon (30) Control (20) The hosptal use data were only avalable for those enrol ed n Medcad MCO and non-medcad patents have dfferent patterns of outp atent and acute care hosptal use and may not receve same benefts from ths program 2. Placebo effect: t s possble that the beneft that the EP group derved from the nterventon was based solely on more frequent contact v vth healthcare provder. Because the placebo vsts to the npatent rout ne care group were not made and because the follow-up vsts to the prmary care practtoners were not arranged, the benefts of the specfc educaton? al program relatve to regular health professonal contact cannot be determned. 3. Generzabltv: All the oatents who were crtcally ll and who had clncally sgnfcant co morbd condtons were excluded. These e> eluded may also have substantal beneft. 4. The asthma educaton had dfferent components and t s unclear that whch component had the maxmum effect and most benefcal for the patents. 5. Analyss were not based on ntenton to treat bass 6. No menton of adequacy of statstcal power There was an mprovement n outpatent follow-up rates resultng n mprovement n patent outcomes ncludng reduced acute care use, ncreased qualty f lfe. 85

97 Author and study S( lurce Guendelman S et al. mprovng Asthma Outcomes and Self-management Behavors of nner-cty Chldren. Archves of Pedatrc and Adolescent Medcne 2002; 56:4-20 Methc ds Study Desgn: Randomzed controlled Method of Randomzaton: Not mentoned Concealment/Concealment of Allocaton: Sealed envelope method Outcome Assessor Blndng: Not stated Partcpants Elgble 36 chldren Declned/Accepted but not Partcpate 2 Randomzed 34 Dropouts None Completed 34 (lnterventon=66 and Control=68) Dropout Rate Zero Age Group and sex Dstrbuton: Characterstc Healthy buddy Group (n=66) Asthma dary Group (control) (n=68) P value Age (Mean+SD) 2.0 (2.3) 2.2 (2.9) 0.65 (f test) Male sex 40(6%) 37 (54%) 0.47 (X2) How was Asthma Dagnosed?, NHLB clncal practce gudelnes Method of Patent Recrutment: Patents wth two or more ED vsts and/or at least npatent admsson durng the year before the study were dentfed for possble recrutment through the hosptal admnstratve servces. All the patents were recruted at the tme of ther scheduled clnc appontment for ether a healthcare mantenance or an llness vst. ncluson Crtera: Between the ages of 8 and 6 years, Englsh speakng caregver, telephone at home, dagnosed as havng persstent asthma followng NHLB clncal practce gudelnes, two or more ED vsts and/or at least npatent admsson durng the year before the study Other Dseases Excluded: Wth comorbd condtons that could affect ther qualty of lfe were also excluded Other Exclusons (f any): nvolved n other asthma or drug effcacy studes, f nvolved n research that requred behavor modfcaton, mental or physcal challenges that made t dffcult to use the Healthy Buddy. Baselne Characterstcs: Characterstc Asthma severty (Persstence ) Health Buddy Group (n=66) Asthma Dary Group (n=68) P value Mld 5 (23%) 20 (29%) 0.66 Moderate 43 (66%) 40 (59) Severe 7() 8(2) (Based on %2) ED vsts (past 2 months) 2.0(2.09) 2.40 (2.33) (.04) 0.66 (.23) 0.50 No menton of dfferences between the groups pre-nterventon 86

98 ! j nterventons Statstcal Analyss Settng: Prmary care clnc nterventon n Detal: Type (ndvdual, verbal, software, nteractve, famly member nvolved, non clncan educator peak flow meter used, peak flow montorng, symptom montorng, medcaton montorng, regular medcal revew Vs asthma dary use, PEFR montorng, symptom montorng, medcaton montorng) Standardzed teachng sesson Partcpatng chld was gven a peak flow-measurng devce and nstructed on proper technque and how to establsh hs or her personal best. Taught about green-yellow-red zone determnaton and approprate use of medcatons and of health care servces. nstructons on how to record peak flow readngs and symptoms nterventon Group (Health Buddv) Characterstcs: Healthy Buddy s a personal and nteractve communcaton devce that s connected to a home telephone and can be programmed to present questons and nformaton on a screen and to record responses. Three of the authors wth a team of software programmers and asthma specalsts at Health hero network developed ths. Chldren accessed the devce once a day at regular tmngs and themselves wthout the help of the parents. No further telephone contact was establshed. Two follow-up vsts at 6 and 2 weeks. At each follow up vst, famles were ntervewed and gven a standardzed teachng sesson that renforced peak flow measurement, complance wth medcnes, and trackng symptoms Control Group (Asthma Darv) The dary allowed the patents to log ther symptoms and to montor peak flow, medcaton use and restrcted actvty. Two follow-up vsts as n nterventon group Educator: Nurse coordnator Data collecton: The measures of the study were obtaned from the ntervews that the nurse coordnator conducted wth the chld and the prmary caregver at the vst Analyss: Adequate statstcal power/sample (85%) Sample sze calculatons were based on a comparson of two management approaches by Leu TA et al %2, Fscher exact tests and 2-sample two tests were used to compare the study groups for demographc characterstcs, asthma outcomes, and self-care behavors at baselne and at the 2 follow-up vsts. The results wth p<=0.05 were justfed as sgnfcant. The effect s presented as the nterventon odds rato, whch s the rato of odds of an outcome n the Health Buddy group to that of Asthma dary group. 87

99 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Outcome measure ' Mssed school days HBGp (n=66) Baselne 6 weeks. 2 weeks AD Gp (n=68) HBGp (n=66) AD Gp. (n=68) HBGp (n=66) ADGp. (n=68) Yes No P value ED vsts Hosptalzatons Unscheduled vsts HB Gp: Healthy Buddy group *AD Gp: Asthma Dary group No adequate randomzaton and blndng The populaton under study was predomnantly Medcad-nsured populaton and the settng was a comprehensve pedatrc health center and resdent teachng nsttute. Hence the results may not be generalzed. Case ascertanment bas due to self-reported data despte the attempts by nurse coordnators check Chldren n Asthma dary mght have overstated the complance (retrospectve fllng) Analyss not done on ntenton to treat bass Though asthma symptoms decreased more for Healthy Buddy group, symptoms also decreased n the Asthma dary group. ndcatng the result of consstent standardzed asthma educaton gven to chldren of both groups and the avalablty of a nurse coordnator. Ths nterventon took place shortly after the dssemnaton of the revsed NHLB asthma gudelnes, the fndngs may reflect enhanced care by the hosptal staff resultng from adherence to the gudelnes

100 Author and study Source Methods Partcpants! j! Homer C et al. An Evaluaton of an nnovatve Multmeda Educatonal Software Program for Asthma Management: report of a Randomzed, controlled Tral. Pedatrcs 2000; 06 (): Study Desgn: Randomzed controlled Method of Randomzaton: Separate randomzaton lsts were generated by computer for each ste, and wthn ste, for chldren less than 7 years and 7 years and older. Randomzaton dd not match or stratfy on any other characterstcs. Concealment/Concealment of Allocaton: Sealed opaque envelope Outcome Assessor Blndng: Not mentoned Elgble 47 Declned/Accepted but not Partcpate 334 Randomzed 37 (nterventon 76; Control 6)/3 Dropouts 3 Completed 06 patents (nterventon 57; Control 49) Dropout Rate 3/37 (22.6%) Age Group and sex Dstrbuton: Characterstc Control (n=6) Treatment (n=76) Total (n=37) Age (mean years) Female (%) How was Asthma Dagnosed? Not stated. Probably doctor? Method of Patent Recrutment: Chldren were recruted to partcpate at the tme of vsts to the care ste, ether for scheduled healthcare mantenance vsts or for llness related encounters, ncludng vsts for asthma ncluson Crtera: Age between 3 and 2 years and had any outpatent vsts, ED vsts, or npatent admssons for asthma durng the year before enrollment Other Dseases Excluded: Second major chronc llness wth a pulmonary component (eg. Cystc fbross) Other Exclusons (f any): Patents resdence outsde of ste of the program, nvolvement n other clncal trals or protocols related to asthma Baselne Characterstcs: Asthma severty (based on NH crtera, mean, 0=mld, 2= severe) Control Treatment Total Parents ratng asthma moderate or severe (%) Control Treatment Total There were no sgnfcant dfferences between treatment and control group 89

101 nterventons t Statstcal Analyss Settng: A hosptal-based prmary care clnc and afflated neghborhood health center. nterventon n Detal: Type (ndvdual, software, nteractve, famly member nvolved, Vs wrtten educaton and usual care) nterventon Group Characterstcs: An nteractve educatonal computer program, Asthma control, desgned to teach chldren about asthma and ts management. Usng a graphc dsplay of a chld gong through smulated daly events, the game emphaszed: ) Montorng 2) Allergen dentfcaton 3) Use of medcaton 4) Use of health servces 5) Mantenance of normal actvty, such as school attendance. Duraton: Chldren were asked to make three vsts to use the game Control Group All the chldren n ths group made three vsts n whch they revewed an ageapproprate asthma educaton book and play a non-educatonal computer game. There was no statstcally sgnfcant dfference n the number of sessons between the 2 groups *Both chldren and parents were surveyed before and after each use of the computer game to learn ther mpressons about the computer game and to assess ther knowledge and understandng of asthma. Chldren and the parents were observed by a research assstant and made qualtatve observaton and flled out a structured encounter form. Data collecton: Obtaned by parental report and revew of admnstrator encounter data Analyss: Baselne characterstcs were compared wth parametrc (t-test) and nonparametrc (Kruskal-Walls) test for contnuous measures, and x2 and Fsher's exact test for categorcal measures Changes over tme and dfferences n changes over tme between nterventon and control groups were assessed through Posson regresson and 2-way. analyss of varance All the data Analyss were performed usng STATA statstcal software; all tests of statstcal sgnfcance were two sded 90

102 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Prmary Outcomes: ) Total number of emergency department vsts 2) Acute offce vsts durng asthma study perod Secondary measures Chlds average asthma specfc symptom severty durng the study perod and functonal status at the concluson of the study Addtonal Outcome Measures: ) Satsfacton care 2) use of peak flow montorng 3) number of common trggers and allergens n the home envronment 4) knowledge of asthma ED Vsts (Mean) Acute offce vsts (Mean) Outcome Before nterventon After nterventon Before nterventon After nterventon Control (49) 2: Treatment (57) Before and After Comparson p = 0.09 P<0.0 P = 0.0 P< 0.00 Comparson Between Groups Not Statstcally Sgnfcant Not Statstcally Sgnfcant The total number of sub ects partcpated n the study are far less than the dentfed elgble populaton. No menton of statstcal power adequacy Analyss not done on ntenton to treat bass Substantal mprovements n both the treatment groups 9

103 Author 'and Study Source Methods Partcpants nterventons j Kotses et al. A self-management program for adult asthma. Part : Development and evaluaton. Journal of Allergy and Clncal mmunology 995; 95: Study Desgn: Randomzed controlled Method of Randomzaton: Not mentoned (Randomzaton was done after the baselne tranng of 2 months) Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not stated Elgble 26 Declned/Accepted but not 4 Partcpate Randomzed 85 Dropouts 9 Completed 76 (nterventon 36 and Control 40) Dropout Rate 9/85 (0.5%) Age Group and sex Dstrbuton: Characterstc nterventon Control Male 2 5 Sex Female Age Between 27 and 70 years of age average beng 49.8 years. Standard devaton^ 2.4 How was Asthma Dagnosed? As per the standards establshed by the Amercan thoracc Socety Method of Patent Recrutment: Subjects were recruted on a contnung bass. The patents asthma was under control when recruted ncluson Crtera: Not mentoned Other Dseases Excluded: rreversble arway obstructon; concurrent uncontrolled medcal condtons; asthma caused by occupatonal exposure; Other Exclusons (f any): Alcohol, tobacco or drug abuse; obesty; weght less than normal standard; ether cogntve or ntellectual defcts lkely to mpar learnng Baselne Characterstcs: FEV patents descrbed ther asthma s moderate to severe PEFR: am (nterventon 33+/-92; control 333 +/-23.7) There were no sgnfcant dfferences between treatment and control group Settng: Not specfed 92

104 l! j Statstcal Analyss l nterventon n Detal: Type (Group, verbal, nteractve, structured, non clncan, peak flow meter used, asthma dary, peak flow meter, symptom montorng, medcal revew Vs asthma dary, PEFR montorng, symptom montorng and Usual medcal care) The patents n both the groups partcpated n three operatons: baselne, selfmanagement tranng and follow up nterventon Group Characterstcs: Baselne: 2 months; Self management tranng: 2 months; follow-up: 2 months Materals Used: As Program components as well as means of assessment Weekly asthma dary; the report of epsode/ attack of asthma; mn-wrght Peak flow meter Exclusvely for evaluaton Basc nformaton book; the Beck depresson nventory, the Asthma self effcacy scale, the Qualty of well beng scale, the Revsed asthma problem behavor check lst, the Asthma cost workbook, the Medcal symptom record form and the general nformaton form (demographc record). All patents receved a patent manual for asthma and the leaders of the group receved a group manual. ntal sesson: physcal examnaton and sutablty as partcpants was evaluated and were told the requrements of the nvestgaton. ntake sesson: taught how to complete self-management materal and traned to use the Mn-Wrght peak flow meter. There were seven 90-mnute sessons durng whch group leader presented and dscussed the topcs of self-management wth the partcpants held once a week. Topcs dscussed prncples of self-management, the natures of asthma, asthma medcatons, asthma preventon, attack management, consequences of asthma, and problem solvng n management of asthma. Subjects who mssed more than two sessons were excluded from the program and the ndvdual who mssed ether frst or last sesson hs/her data was not n analyss. Weekly Asthma Dary: Completed for sx months on a daly bass, begnnng wth the frst day of baselne perod. Also recorded for data recordng purposes durng a two-week perod at the end of 2 month follow up perod. PEFR values were recorded when completed weekly asthma dary. The report of epsode/ attack of asthma was completed after each attack. Materals used for evaluaton were admnstered on three occasons: mmedately before ntaton of the baselne perod, at the end of sx month partcpaton, and at the end of.2 month follow up. Duraton: 6 months Control Group No specal educaton. Controls kept an asthma dary (symptoms and PEF) for 6 months on a daly bass and agan for 2 weeks pror to the 2 months follow up. Data Collecton: From the weekly asthma dary and from medcal symptom record forum Analyss: The changes between the baselne and the follow-up perods were examned n 2x2 repeated measures of Analyss of varance that tested the effects of group assgnment and recordng perod 93

105 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Asthma symptoms, Medcaton use, Asthma-related behavor, Cogntve measures, Use of healthcare facltes (outcomes were eva uated over short term and long term). Outcome measures Months &2 Months5&6 P AM PEFR (Daly nterventon 33.00± ±88.40 (P<0.05) Average) Control ± ±2.40 PM PEFR (Daly nterventon ± ±82.20 * Average) Control 36.00± ±.00 Physcan vsts nterventon 2.94± ±3.97 (P<0.05) j Control.67±.90.83±2.5 ER vsts nterventon 0.0± ±0. Control 0.0± ±0.4 Asthma attack frequency nterventon 4.90 ± ±2.60 Control 0.60 ± ± 0.0 Outcome measures Baselne Follow-up P AM PEFR (Daly nterventon 32.00± ±88.00 Average) Control ± ±3.00 PM PEFR (Daly nterventon 35.00± ±68.00 Average) Control ± ±2.00 Physcan vsts nterventon 0.55± ±0.84 Control 0.48± ±0.8 ER vsts nterventon. 0.04± Control 0.04± Asthma attack frequency nterventon 4.50 ± ±2.70 P<0.05 Control 2.0 ± ±.20 nadequate randomzaton No allocaton concealment No blndng No menton of statstcal power/sample sze adequacy Analyss not done on ntenton to treat bass The educatonal procedures and the development of self-management behavor have a sgnfcant role n mprovements n asthma severty. The educatonal programs that optmze the communcaton and learnng are effectve. The mprovements n the outcomes followng asthma self-management are due to the acquston and performance of self-management sklls rather than mproved medcal management, whch s n concurrent wth the self-management tranng or component of the tranng. 94

106 Author and Study Source Methods Partcpants Kotses et al. evaluaton of ndvdualzed asthma self-management Programs. Journal of Asthma 996; 33 (2): 3-8 Study Desgn: Randomzed controlled Method of Randomzaton Not stated. Group assgnments were made randomly wth the restrcton that condtons be equated for number of subjects Concealment/Concealment of Allocaton Not mentoned Outcome Assessor Blndng Not stated. Elgble 45 Declned/Accepted but not Zero Partcpate Randomzed 45 Dropouts Completed 34 ( ndvdualzed, group, 2 control) Dropout Rate /45 (24.4%) Age Group and sex Dstrbuton: 27 females and 7 males Age: Average age of 42 years How was Asthma Dagnosed? Not mentoned Method of Patent Recrutment: On advertsements for research subjects from Toledo and Oho area ncluson Crtera: Not mentoned Other Dseases Excluded: Not mentoned Other Exclusons (f any): Not mentoned Baselne Characterstcs: Self reported Severty: Mld: 4 Moderate: 27 Severe: 3 Collected for 30 days pror to nterventon. On a daly bass, the patents montored frequency of AM and PM asthma attacks, AM and PM PEFR, actvty lmtatons and vsts to emergency care facltes. All the nformaton was recorded on the dary. There was a no menton f there were any pre-nterventon statstcally sgnfcant dfferences between the two groups 95

107 nterventons Settng: Not mentoned nterventon n detal: Type (Group, verbal, vsual, audo, nteractve, structured, famly member nvolved, asthma dary, peak flow meter, medcal revew Vs Usual medcal care) (ndvdual, verbal, audo, nteractve, structured, peak flow meter, medcal revew, Vs Usual medcal care) ndvdualzed Self-Manaqement Group Characterstcs: The factors related to each patent's asthma was dscussed n a 60-mnute sesson. The dscussons ncluded the use of PEFR as the early warnng sgn of onset of asthma and methods for avodng the precptants. The patents who had asthma related to emoton were gven an audotape of progressve relaxaton nstructons. *A the patents were gven an asthma dary where the patents kept the record of all the readngs All the patents receved nstructons for reducng asthma exacerbatons. All the patents kept a record of: AM and PM asthma attacks AM and PM PEFR scores Ther contact wth at least 8 asthma precptants. Group Self-Manaqement nterventon conssted of the Wheezers Anonymous Program and an adult program derved from two pedatrc asthma self-management programs (Lvng wth asthma and the famly asthma program). Wheezers Anonymous Program outlnes the general recommendatons for the control of asthma through the use of standardzed vdeo and audo materals and dscussons facltated by a group leader. t ncludes peak flow montorng. Sessons and Duraton: two sessons each of approxmately 2.5hours n length. Duraton: 90 days Educator: Not clearly mentoned Control Group No specfc educaton or nterventon durng the nterventon perod Note: followed by nterventon was the follow up perod of 30 days n whch all the outcomes were measured 96

108 Statstcal Analyss Results/ Outcomes!! Lmtatons of the Study j Conclusons/ Other Remarks Data Collecton: ntervewng the patents and from the records Analyss: Ch-square Analyss was used to elmnate varables completely unrelated to asthma and logstc regresson to determne the degree of assocaton between asthma and all remanng varables Outcome measure Group Baselne Follow-up * P<0.05 AM PEFR W ± ±24.00* P<0.05 C 30.30± PM PEFR ± W ±20.60 C ± ±03.90 AM Attacks ±0.40* P<0.05 W 0.09± ±0.49 c PM Attacks ±9.75 w 9.09± c 9.58± ±0.40 Emergency vsts w 0 ' c #l=ndvdualzed self-management; W=Group self-management; C=Control group //mprovements n patents n both ndvdualzed and group self-management condton n AM PEFR and AM attacks n ndvdualzed asthma self-management condton. #Patents n the control condton had no change n any of the dependant varables from the baselne to the follow up. Small study populaton Hgh rate of dropouts nadequate randomzaton No menton of concealment No blndng No menton of adequacy of statstcal power/sample The personalzed programs were n the aggregate were at least as effectve as the group program The personalzed programs have several advantages lke they can be conducted durng offce vsts, more appealng as t does not contan materal rrelevant to patent and consstent wth medcal practce 97

109 Author and Study Source Methods Partcpants Lews CH et al. A Randomzed Tral of A.C.T. (Asthma Care Tranng) for Kds. Pedatrcs Oct 984; 74 (4): Study Desgn: Randomzed controlled Method of Randomzaton: From the lst of numbered elgble patents, subjects were allocated, usng a random numbers table Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Elgble 33 subjects Declned/Accepted but not Partcpate 30 Randomzed 03 (62 n nterventon; 4 n control) Dropouts 27 Completed 76(28 n control group and 48 n expermental group) Dropout Rate 27/03 (26.2%) Age Group and sex Dstrbuton: Characterstcs Control, nterventon Total Age (mean) Sex (male %) There were no dfferences n the proporton of boys or grls who faled to attend classes or who dropped out. How was Asthma Dagnosed? Physcans' dagnoss Method of Patent Recrutment: All the elgble patents were contacted by phone and then recruted f they accepted ncluson Crtera: ) Severe asthma (medcaton requred at least 25% of the days of the month) 2) age 7-2 years 3) verbal fluency n Englsh Other Dseases Excluded: Not mentoned Other Exclusons (f any): Not mentoned Baselne Characterstc: The two group chldren were smlar composton and chroncty of asthma. There were no statstcally sgnfcant dfferences n both the groups n the prenterventon group :98

110 nterventons Settng: Kaser facltes nterventon n Detal: Type (Group, verbal, other nterventons (stckers, cartoons, games), nteractve, structured, famly member nvolved, clncan and non clncan educator, regular medcal revew Vs group, verbal) nterventon Group (Asthma Care Tranng-A complement to good medcal care rather than replacement to the personal physcan) Characterstcs Chldren and parents meet n separate groups durng ntal 45 mnutes, are taught same content, and come together at the end of the perod so that both can share ther perceptons and experences The educaton focused on knowledge about the underlyng mechansms n asthma and resultant symptoms and sgns, envronmental control of rrtants and allergens, relaxaton sklls and breathng exercses, revew of prescrbed drugs, decson makng sklls, and concept of balanced lvng. The car drvng safety paradgm was used Use of stckers, cartoons, and games provded a medum for the messages about symptoms and envronmental control Duraton: Fve one hour sessons offered at weekly ntervals Educator: Thrd sesson (one to one bass on drug usage) by the physcan whle the other lessons were desgned and wrtten to be taught by elementary school teachers, health educators or nurses wth teachng nterest and experence Note: the classes were lmted to 5-7 chldren per group because of the nteractve nature Control Group Three /2-hour sessons consstng of a lecture, followed by a dscusson, held at weekly ntervals by one of the authors coverng the same content Note: the lectures were offered to larger numbers of subjects: sx to twelve famles or 2-25 persons. Stat stcal Ana lyss Collecton of Data: Medcal records were abstracted to determne use of servces. Data on scheduled offce vsts, emergency room vsts, and days of hosptalzaton were recorded for the 2 months before and after the classes Analyss: Analyss of covarance on number of vsts to the emergency room and numbers of hosptalzatons, and nonparametrc contngency Analyss on proportons of chldren and parents gvng certan responses on pretest and -year post test ntervews 99

111 Results/ Outcomes Outcome Measures Emergency Room Vsts (Mean) Pre nterventon Post nterventon Control Group (N =28) nterventon Group (N = 48) P <0.05 Hosptal Days/Chld/yr Pre nterventon <0.0 Post nterventon Hosptalzaton s Post nterventon Lmtatons of the Study Conclusons/ Other Remarks There was a sgnfcant reducton n emergency room vsts and the hosptalzatons n the expermental group when compared to the control group after the nterventon perod. The study was conducted on one group of patents (mddle class, workng famles enrolled n HMO so fnancal barrer to access the care) questonng the generalzablty of the results The research assocates knew from ther nteractons wth the subjects whch ones were n the control group and whch ones were n expermental group The group was recevng the medcal care from pedatrc allergsts and the care would be unversally hgh Analyss were not done on ntenton to treat bass No menton of adequacy of statstcal power/sample sample Asthma care tranng for kds resulted n sgnfcant reducton n ER vsts and hosptalzatons n the expermental group. There was an equvalence ncrease n knowledge and changes n belef n both the groups 00

112 Author and study source Methods Partcpants Marvella EF et al. Health outcomes among Afrcan and Caucasan adults followng a randomzed tral of an asthma educaton program. Ethncty & Health Nov 997; 2 (4): 239- Study Desgn: Randomzed controlled Method of Randomzaton: Blocked randomzaton usng randomly chosen szes of 4, 6 or 8 stratfed by ste Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Elgble 537 Declned/Accepted but not Partcpate 296 Randomzed 24 (9 nterventon, 22 control) Dropouts None Completed 24 Dropout Rate Zero Age Group and sex Dstrbuton: Characterstc Afrcan Amercans Caucasan Sex-Females (%) Age (mean, SD) 35.8 (3.3) 40.2(5.4) How was Asthma Dagnosed? Physcan's dagnoss Method of Patent Recrutment: From two dfferent hosptal Emergency departments ncluson Crtera: All asthma patents between the ages of 8 and 70 years who were seen and evaluated n two hosptal emergency departments (nner cty and suburban) between July,986, and march 5987 Other Dseases Excluded: Not mentoned Other Exclusons (f any): Language or psychatrc barrers to class attendance Baselne Characterstcs: Demographc data, yearly average ED vsts due to asthma, asthma knowledge belef scores and yearly average days of lmted actvty were noted. No statstcally sgnfcant dfferences were found n both the groups before the nterventon 0

113 ! nterventons j Settng: Emergency department nterventon n Detal: Type (Group, verbal, nteractve, structured, non clncan educator Vs usual medcal care) nterventon Group Characterstcs 3 sessons that emphaszed on Anatomy and physology of asthma Use of relaxaton technques to reduce the stress assocated wth asthma attacks Encouraged to take charge of ther health and ther nteractons wth ther physcans nformaton on common asthma medcaton (a marner was provded) nformaton on precptatng factors What to do when an asthma attack Relatonshps among smokng, exercse and asthma Note: The nterventon group partcpants who dd not attend the sessons were maled the educatonal materal. Duraton: 2 months Educator: Specally traned health care professonal Control Group No specfc nterventon apart from usual care Statstcal Analyss [! Data Collecton: By ntervewng the patents and emergency department data Analyss: ntenton to treat prncple was ncorporated n Analyss (ncludng Analyss of follow up data) Baselne dfferences were tested wth two sample Student's t-tests. Categorcal varables were tested usng ch-square test. Analyss of follow up data for nterventon and control group emergency department vsts was performed usng ANOVA model. ANCOVA used to confrm the ANOVA results Results/ Outcomes Lmtatons of the Study Outcome Measures nterventon group Control group ED Vsts (Mean +SD) No menton o No blndng No Baselne 4.85 ± ± 8.40 After nterventon 2. ± concealment of allocaton menton of adequacy of statstcal power/sample sze 02

114 Conclusons/ Other remarks Asthma educaton s useful n promotng postve asthma related health behavors Malng the educatonal materal to adults s as useful as more resource ntensve and tme consumng educatonal classes There was a lttle of changes occurred after four month post-nterventon perod, suggestng the need for refresher/ remander classes or other approaches desgned to sustan behavor change 03

115 Author and study source Methods McNabb WL et al. Self-management Educaton of Chldren wth Asthma: AR WSE. Amercan Journal of Publc Health 985; 75 (0): Study Desgn: Randomzed controlled Method of Randomzaton: Not stated Concealment/Concealment of Allocaton: Not stated Outcome Assessor Blndng: Not stated Partcpants Elgble 6 Declned/Accepted but not Partcpate None Randomzed 6 (nterventon 8; Control 8) Dropouts One control subject dropped and one matched subject from expermental group was excluded from the Analyss Completed 5 Dropout Rate /6 (6.25%) Age Group and sex Dstrbuton: Characterstcs nterventon Control Age (average) 0.5 years 0.4 years Sex Males 6 5 Females 2 How was Asthma Dagnosed? Not mentoned Method of Patent Recrutment: From two allergy clncs n the Kaser Permanente Medcal Groups n northern Calforna and who met the ncluson crtera ncluson Crtera: )9-3 years of age on a regmen of bronchodalator 2) at least one emergency treatment for asthma n the prevous year 3) no known developmental or behavoral problems Other Dseases Excluded: Not mentoned Other Exclusons (f any): Not mentoned Baselne Characterstcs: Prenterventon data was collected whch ncluded number of emergency treatments for asthma per month, number of non-emergency physcan contacts for asthma per month, and current asthma drug regmen There were no major dfferences between the groups n the dependent varables over the 2-month baselne There were no statstcally sgnfcant dfferences between the groups before the educatonal program 04

116 nterventons Statstcal Analyss Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Settng: Clncal settng (exact settng not mentoned) nterventon n Detal: Tyge (ndvdual, verbal, nteractve, team approach, famly member nvolved, non clncan educator, medcal revew Vs usual medcal care) nterventon Group (AR WSE) Characterstcs: The content based on a study of the self-management practces of chldren wth asthma. By makng use of dagnostc/prescrptve teachng technque, the educator n the AR WSE could dentty the self-management problems to each chld and then use the AR WSE materals to prepare a talored educatonal program Wrtten educatonal protocols guded the development and mplementaton of the educatonal plans, enablng educators to conduct the nterventon n a standard manner and at the same tme adaptng to the ndvdual needs of the chldren. The educaton provded to the chldren utlzed the goal settng, selfevaluaton, and sef-montorng nteractve educaton between the student and the nurse educator whle chld's parents and physcan were ncluded n the educatonal process. Duraton: Four 45 mnute sessons, admnstered on a weekly bass for 2 months Educator: Nurse educator Control Group No specal educaton Data Collecton: Not mentoned Analyss: Not mentoned Emergency Treatments (Average) Outcome Measure Baselne Post nterventon Control Expermental 6..9 No adequate randomzaton No menton of concealment f allocaton No blndng Small sample sze hence generzablty s questonable Analyss was not done on ntenton to treat bass There was no menton of adequacy of statstcal power/sample sze AR WSE can serve as an mportant adjunct to the medcal management of asthma and result n declne of the morbdty. 05

117 Author and study source Perrn JM et al. mprovng the Psychologcal Status of Chldren wth Asthma: A Randomzed Controlled Tral. Journal of Developmental and Behavoral Pedatrcs 992; 3: Methods Study Desgn: Randomzed controlled Method of Randomzaton: Not mentoned Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Not mentoned Partcpants Elgble 250 Declned/Accepted but not partcpate 69 Randomzed 8 Dropouts 25 Completed 56 Dropout Rate 25/8 (30.8%) Age Group and sex Dstrbuton: Characterstc nterventon (29) Control (27) Total (56) Age (Years) Sex 6-8 (38%) 0 (37%) 2 (38%) 9-5(52%) (4%) 26 (46%) (0%) 6 (22%) 9(6%) Male 7 (59%) 8 (67%) 35 (62%) Female 2(4%) 9 (33%) 2 (38%) How was asthma dagnosed? Doctors dagnoss Method of Patent Recrutment: 90% subjects from communty pedatrc settngs and 0% from general pedatrc and allergy clncs at a chldren s hosptal ncluson Crtera: Not mentoned Other Dseases Excluded: Not mentoned Other Exclusons (f any): Not mentoned Baselne Characterstcs: Clncal severty nterventon (29) Control (27) Total (56) Mld 7 (25%) (44%) 8 (34%) Moderate 7(6%) 2 (48%) 29 (55%) Severe 4(%) 2 (8%) 6(%) No statstcally sgnfcant dfferences notced n both the groups before the nterventon 06

118 nterventons Settng: Not mentoned. Probably communty practce settng? nterventon n Detal: Type (Group, verbal, other nterventons (anatomc models and balloons), nteractve, structured, famly member nvolved, medcal revew Vs usual medcal care) nterventon Group Characterstcs: Four sessons where n Sesson one emphaszed basc lung functon and anatomy and mechansms of breathng and breathng control Sesson two covered changes n lungs related to asthma and the effects of these changes on other bodly functons Sesson three focused on methods of preventon and treatment and mechansms by whch the medcnes and the other therapes changed the symptoms Sesson four ncluded a revew of the prevous three and dscusson of exercse, long term outcomes, and growng up wth asthma Stress management actvty conssted of relaxaton tranng and contngency copng exercses Note: Parents and chldren partcpated n the educatonal program together whle the stress management actvty was carred out wth partcpatng chldren alone and the parents had the opportunty to meet the staff physcan to ask any addtonal questons regardng condton. Although a specal currculum was used for each sesson, the educatonal component was nteractve n that chldren partcpated wth the use of anatomc models and balloons and were encouraged to ask questons about each topc area. Duraton: Each sesson of 2 hour duraton Control Group Receved same combned nterventon program but after the tral was completed. Durng the tral no asthma educaton was provded. Statstcal Analyss Data Collecton: Not mentoned clearly. Probably from school records Analyss: Ch-square test and f-test were used to determne dfferences. No dfferences were notced n between the recruted and the completed sample Multple regresson Analyss were used to determne whether the combned nterventon had an effect on psychologcal status and functonal outcomes 07

119 Results/ Outcomes Lmtatons of the Study Conclusons/ Other remarks Characterstcs School days mssed (no./month) nterventon group Control group Pre nterventon Post nterventon Pre nterventon Post nterventon 0.73 ± ± ± ±.0 Pre- to post dfferences, p<0.02 No sgnfcant dfferences between nterventon and the control group scores before nterventon No adequate randomzaton No concealment of allocaton No blndng The study populaton was predomnantly mddle class and came from communty practce settngs. The results therefore cannot be generalzed to other populatons of chldren wth asthma, such as those n hosptal settngs or those from dfferent socoeconomc backgrounds. There s a large dfference between the numbers who were elgble and those who completed the study The attrton rate s smlar to those n other group educatonal studes and probably ths knd of nterventon wll lkely work only wth motvated chldren and parents. No menton of adequacy of statstcal power/sample sze Analyss was not done on ntenton to treat Analyss The nterventon had no sgnfcant effect on numbers of school days mssed, partcpaton n after school actvtes, or tme playng wth frends, although n all cases the trend was n the desred drecton for the nterventon group but not control group. Asthma knowledge test scores ncreased wth the nterventon. 08

120 Author and Study Source Methods Persaud et al. An Asthma Self-Management Program for Chldren, ncludng nstructon n Peak Flow Montorng by School Nurses. Journal of Asthma 996; 33(); Study Desgn: Randomzed controlled Method of Randomzaton: Wthn each school, students were randomly assgned to be ether nterventon or control subjects. Concealment/Concealment of Allocaton Not mentoned Outcome Assessor Blndng: All the prmary care provders were blnded as to the assgnment to treatment or control groups. Partcpants Elgble 60 subjects but 43 were contacted Declned/Accepted but not Partcpate 7 Randomzed 36 Dropouts None Completed All those randomzed Dropout Rate Zero Age Group and sex Dstrbuton: Average age of the subjects was 0.2 years Characterstcs Control (8) nterventon (8) Age (years) ±.5 Sex (male) 72% 55% How was asthma dagnosed? Doctors dagnoss Method of Patent Recrutment: All the subjects who were elgble were dentfed from the medcal records from the pedatrc resdent group practce at the Unversty of Texas Medcal Branch. All the students attended schools n the Galveston ndependent School Dstrct ncluson Crtera: Age group between 8 and twelve years, dagnosed as asthmatc (several pror epsodes of arway obstructon, clncal response to bronchodlater, and absence of other pulmonary dsease) Other Dseases Excluded: Other pulmonary dseases Other Exclusons (f any): Not mentoned Baselne Characterstcs: Characterstcs Control Treatment Lung Functon Asthma Severty FVC 80.4 ± ±0.5 FEV 74.4 ± ±0.8 % FEV 87. ± ±8.9 %PEF 74.9 ± ±2.5 Mld 44% 44% Moderate 55% 44% Severe 0% % Greater severty and early onset of llness s seen n control group before the admnstraton of nterventon. The dfferences between all other characterstcs between both the groups before the nterventon were not statstcally sgnfcant 09

121 nterventons Settng: Pedatrc ambulatory care unt nterventon n Detal: Type (ndvdual, verbal, wrtten, nteractve, team approach, famly member nvolved, non clncan educator, peak flow meter used, self management plan, asthma dary, PEFR montorng, medcal revew Vs usual medcal care) Prentervenon ntal Assessment: conducted by physcan assstant and pedatrc resdent Hstory, physcal examnaton, pulmonary functon tests, and questonnares completed Structured ntervews conducted to obtan soco-demographc nformaton, asthma symptoms experenced, frequency of attacks, medcaton use, trggers, and precptatng events Patents and caregvers were gven wrtten gudelnes (ndvdual management plans and optmum peak expratory flow rates) for medcaton usage, asthma control, and preventon Each chld was gven a peak flow meter and an asthma dary nterventon Group Characterstcs: At every vst Revew of asthma dary wth the student, dscuss progress, symptoms, and ablty to take approprate measures to control asthma Chld demonstrated proper use of nhaled medcaton and peak flow meter Duraton: ndvdualzed, weekly, 20-mnute educaton sessons Educator: School nurse Control Group Attended the nurses offces sporadcally on ther own ntatve, but no addtonal nterventon from the school nurses Note: ) Both the groups contnued to receve the regular care from ther prmary care provder durng and after the educatonal nterventon 2) The sx partcpatng school nurses attended two 4-hour n-servce sessons presented by the prncpal nvestgator where the nurses knowledge and skll about the asthma was mproved and nurses learned how to ntate dalogue wth a student, conduct open ended ntervews, role play and provde postve renforcement. TO

122 Statstcal Analyss Results/ Outcomes Lmtatons of the Study Data Collecton: From standard questoners and the records of ER Analyss: All Analyss were done on ntenton to treat bass Group dfferences on demographc and medcal hstory varables were tested wth a ch-square test for categorcal varables (gender, severty of llness) and f-test for nterval scale varables (age, years of duraton) Analyss of covarance was used to test for post nterventon changes Outcome measures Control (n=8) Treatment (n=8) P value Emergency room vsts (post nterventon) (Percentage of subjects) 50% 22% N.S There was also no sgnfcant dlference n the school days mssed n the groups nadequate randomzaton No menton of concealment of allocaton Although the randomly assgned to groups, there were some ndcators of greater severty of llness n the control group. Control subjects reported an early onset of llness (2.6 years vs. 5.2 years) and reported more attacks (8.2 Vs. 4.3). The sample sze was too small. n a larger sample, sgnfcant dfferences between control and nterventon groups mght be demonstrated. The nterventon perod of 8 weeks s too short to show sgnfcant outcomes n the areas measured. No menton of adequacy of statstcal power/sample sze Analyss Conclusons/ Other Remarks The percentage of subjects who vsted the ER for exacerbatons of asthma was sgnfcantly hgher n control group than n the nterventon group, but the dfference dsappeared when the number of ER vsts per chld was controlled for age of onset of llness. ll

123 Author and Study Source Methods Rubn DH et al. Educatonal nterventon by Computer n Chldhood Asthma: A Randomzed Clncal Tral Testng the Use of a New Teachng nterventon n Chldhood asthma. Pedatrcs Jan 986; 77 (): -0 Study Desgn: Randomzed controlled Method of Randomzaton: Random number table. The groups were balanced after every tenth patent to ensure an equal number of patents n each group. Concealment/Concealment of Allocaton: Not mentoned Outcome Assessor Blndng: Follow data was collected by prncpal nvestgator who was blnd to group assgnment Partcpants Elgble 86 Declned/Accepted but not partcpate 9 Randomzed 65 Dropouts None Completed 65 Dropout Rate Zero Age Group and sex Dstrbuton: Characterstcs Control (N=33) Expermental (N=32) P Age (yrs) 9.5 ± ±2. <0.56 Sex (Male (%)) How was asthma D agnosed? Physcans dagnos s Method of Patent Recrutment: By contactng the patents and patents met the standard crtera of the Yale Unversty school of Medcne. ncluson Crtera: All the chldren wth asthma who were ) Patents at Yale-New Haven Hosptal, Hosptal of St. Raphael, Yale Health Plan (a unversty based HMO), and one pedatrcan s offce 2) Englsh speakng 3) 7-2 years of age; and 4) Lvng n the greater New Haven, Connectcut Wth at least three acute vsts because of asthma durng the year precedng the study to the emergency room, outpatent clnc, or physcan's offces. Other Dseases Excluded: Not mentoned Other Exclusons (f any): < Not mentoned Baselne Characterstcs: Baselne nformaton collected pror to randomzaton ncluded ) demographc nformaton 2) pror experence wth computers 3) behavors related to the management of asthma 4) Psychologcal tests 5) knowledge of asthma, 6) general behavors (not asthmaspecfc), and 7) prevous morbdty from asthma. No menton of baselne dfferences between the control and the nterventon group before the nterventon 2

124 nterventons Statstcal Analyss Settng: Yale Health Plan or at the Communty Health Care Plan nterventon n Detal: Tyge (ndvdual, software, nteractve, non clncan educator Vs Group, verbal, non clncan educator and usual medcal care) nterventon Group Characterstcs Emphaszes basc prncples n the management of asthma. *lt reflects (as close as possble) the daly routnes of the chld wth asthma Chldren use ther own specfc medcatons and allergens They are forced to antcpate potentally harmful allergens, take the correct dosage of the medcne at the rght tme, use the emergency room or physcans' offce an approprate manner, and attend school Duraton: 45 mnutes of each sesson scheduled every sx weeks durng a perod of ten months Forty mnutes were devoted to playng the game whle the last fve mnutes were spent revewng the computer prntout that detaled a subject s performance. Educator: Research assstant Control Group Forty mnutes playng wth computer games not related to asthma Fve to ten mnutes of supplemental verbal nstructons about proper management of asthma (The verbal nstructons were desgned to duplcate the basc prncples of management of the chldhood asthma contaned n the expermental group s nterventon) Data Collecton: Follow-up data was collected from the chldren and parents separately by an ntervew. The data ncluded varables that were dentcal to those examned at the baselne. Analyss: All the Analyss were done on ntenton to treat bass Dfferences between the follow-up and baselne measures n each group were compared usng the t-test for dmensonal data and y2 for categorcal data. Confoundng effects of the specfc varables were controlled by stepwse regresson wth analyss of varance. All P values are based on two-taled tests of sgnfcance. Results are ndcated n Mean ± SD 3

125 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Outcome Measure Acute vsts due to asthma Hosptal days due to asthma Control (N=33) Baselne nterventon (N=32) P< Control (N=25) Change nterventon (N=29) P< 5.2 ± ± ± ± ± ± ± ± School days absent 7.0 ± ±3.6. ± There was trend towards mprovement n the expermental group n reducng the number of acute vsts due to asthma Hgher percentage of chldren n the control group had reduced ther number of hosptal days due to asthma Small sample sze Short perod of study No concealment of allocaton No outcome assessor bndng No menton of adequacy of statstcal power/sample sze Exposure of chldren wth moderately severe asthma to an asthma specfc computer game can affect the subsequent management of ther chronc dsease 4

126 Author and study source Methods Wlson SR et al. A Controlled Tral of Two Forms of Self-Management Educaton for Adults Wth Asthma. The Amercan Journal of Medcne 993; 94: Study Desgn: Randomzed controlled Method of Randomzaton: Blocked randomzaton. Blocked accordng to severty Concealment/Concealment of Allocaton: Not stated Outcome Assessor Blndng: Physcans who assessed asthma status were blnded as to group assgnment of patents. However t s unclear whether the nurse who admnstered questonnares ad assessed MD technque was blnded Partcpants Elgble 579 patents Declned/Accepted but not 256 Partcpate Randomzed 323 (83 Group educaton, 8 ndvdual educaton, 75 nformaton control, 7 usual control) Dropouts 3 Completed 320 Dropout Rate 3/323 (0.9%) Age Group and sex Dstrbuton: 8-50 years of age. No clear dstrbuton gven however t says there was no sgnfcant dfference n age, gender, educaton level, asthma severty ratng, hosptalzaton n base year, complance ratng and source How was Asthma Dagnosed? Doctor's dagnoss and objectve lung functon Method of Patent Recrutment: From communty; Kaser Medcal Centers n CALFORNA ncluson Crtera: ) Be 8-50 years of age 2) be members of Kaser Permanente Medcal Care Program for at least one year 3) confrmed dagnoss of asthma 4) consdered by the physcan to have moderate to severe asthma 5) at least three physcan vsts for asthma durng the screenng year 6) have been on daly medcaton n the past year Other Dseases Excluded: rreversble respratory dseases (Emphysema, COPD) Other Exclusons (f any): Not mentoned Baselne Characterstcs: A change n FEVof > 5% A change n PEFR of > 20% followng bronchodlater treatment No statstcally sgnfcant dfferences n the baselne characterstcs of the nterventon and the control group 5

127 nterventons Statstcal Analyss Settng: Kaser Permanente Clncs nterventon n Detal: Type (Group, verbal, nteractve, structured, team approach, non clncan educator, peak flow meter used, asthma dary, peak flow montorng, symptom montorng, medcaton montorng, medcal revew Vs usual medcal care) (ndvdual, verbal, nteractve, structured, team approach, non clncan educator, peak flow meter used, asthma dary, peak flow montorng, symptom montorng, medcaton montorng, medcal revew Vs usual medcal care) Small Group Proqram Characterstcs: Sx to eght ndvduals n each group. Four 90 mnute sessons ncludng ntroducton to Asthma Understandng the Medcatons Preventon and Avodance and Managng the Symptoms. A detaled manual was prepared to gude educators through each sesson. ndvdual nterventon Proqram Characterstcs: A dagnostc ntervew and an educaton plannng form were used to dentfy and focus on an ndvdual patent s specfc management needs. 8 nstructonal modules (same content as n group program) were used to develop program talored to the needs of ndvdual patent. Three to fve 45-mnute meetngs between the patent and the educator at -week nterval. t requred 80 mnutes of nurse tme for educaton. Ths dd not provde peer support. However t had maxmum nteracton between the educator and the patent and attenton to the specfc needs of the ndvdual patent. Both the small group and ndvdual nterventon patents were revewed after 5 and 2 months. Workbook (nformaton) control (no formal asthma educaton) An 80-page workbook was prepared based on the same educatonal objectves as the 2 educatonal programs, t had a readablty of 8th grade level however; there was no nteracton wth peers and the health professonals. Usual Control No supplemental educaton Data Collecton: Usng questonnares that were dentcal both at the begnnng and at the end of the study (ncluded several standard scales). A chart revew was performed and all the data regardng the patent s vsts were noted n ths. Analyss: All Analyss were done on an ntent to treat bass. Adequate statstcal power/sample sze Data were descrbed usng proportons, means, standard devatons, and medans. n all Analyss, par wse comparsons between treatment groups were carred out only when the omnbus test among all four groups was sgnfcant at the 0.05 levels. 6

128 Results/ Outcomes Lmtatons of the Study Conclusons/ Other Remarks Outcome Measure nterventon Group Control Group Unschedu led doctor Vsts Group (83) ndvdual (8) nformaton (75) Usual (7) Baselne 3.9 (0.38) 3.50 (0.37) 3.5 (0.43) 3.50 (0.32) Follow up 2.9 (0.30) 2.8 (0.33) 3. (0.37) 2.6 (0.35) Group educaton was assocated wth a sgnfcantly (p<0.05) greater reducton n the annual rate of acute vsts (unscheduled doctor vsts) compared wth all other condtons. The overall hosptalzaton rate wth moderate to severe asthma was 8% n the baselne year and 3% n the 2 years after enrollment. No concealment of allocaton Hgh dfference between the elgble and the populaton partcpated Ths study suggests that the evaluaton of educatonal and behavoral nterventons, especally for adults wth long-standng dsease, requres long term follow up ( to 2 years) f the benefts of mproved management and symptom control are to be detected. Though the nstructonal modaltes as well as the workbook provded to the patents dscussed the need for elmnatng the aero-allergens n the home envronment, the health consequences of smokng, and the partcular rsks that smokng poses for the asthma patents nether the educatonal format nor the workbook pattern, effected a change n patents behavor or exposure to allergc pets n the home 7

129 APPENDX D: FORMULAE USED 8

130 SEpooled ngsrtreatment - rcgsrcortrol t-statstc FORMULAE USED SDpooed = SEpooled x square root of 'n' Mean Effect Sze (ES) = ^(w x ES) Standard Error of mean ES = Xw Z-test for the mean ES = ES s^es 95% Confdence ntervals = ES ±.96 sees 9

131 APPENDX E: RESULTS TABLES 20

132 Number of Hosptalzatons Self-Management and Regular Medcal Revew Vs, Usual Care Table Optmal Self-Management Vs. Usual Care Hosptalzatons (Number) R.No Study Expermenta Control Standardzed Efeet Sze Mean SD N Mean SD N Effect Sze (ES) and SE of Weght w*es w*es2 95% Cl ES (w) R6 George et al (-0.85, 0.29) Subtotal (R6) Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-test for the mean ES=-0.96;Q-statstc=0.00(d/=0) 2 Table 2 Optmal Educaton, Self-Montorng and Regular Medcal Revew Vs. Usual Care Hosptalzatons (Number) R.No Study Expermenta Control Standardzed Effeet Sze Mean SD N Mean SD N Effect Sze (ES) and SEof Weght w*es w*es2 95% Cl ES (w) R5 Freman et al (-0.90, 0.64) Subtotal (R5) " 0. Mean ES=-0.3(-0.90,0.64);Standard Error of mean ES=0.39;Z-test for the mean ES=-0.33;Q-statstc=0.00(d/=0)

133 Table 3 Optmal Educaton and Regular Medcal Revew Vs. Usual Care Hosptalzatons (Number) R.No Study Expermenta Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SEof Weght w*es w*es2 95% Cl ES (w) R3 Clark et al (-0.40,0.07) Subtota (R3) ' ' : Mean ES=-0.7(-0.40,0.06);Standard Error of mean ES=0.2;Z-test for the mean ES=-'.42; Q-statstc=0.00(d/= 0). Subtotal (R3, R5, R6) Mean ES=-0.8(-0.39,0.03);Standard Error of mean ES=0. ;Z-test for the mean ES=-.64; Q-s tat s t c=0.4 (d/=2) ndvdual self-management (R6) 30 : Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-testforthe mean ES=-0.96;Q-statstc=0.00(d/=0) Group self-management (R3, R5) Mean ES=-0.7(-0.39,0.05);Standard Error of mean ES=0.;Z-test for the mean ES=-.54;Q-statstc=0.0(d/=) Optmal Educaton Vs. Mnmal Educaton 22 Table 4 Optmal Educaton Vs. Mnmal Educaton Hosptalzatons (Number) R.No Study Expermental Control Standardzed E ffect Sze Mean SD N Mean SD N Effect Sze (ES) and SE of Weght w*es w*es2 95% Cl ES (w) R Lews et al (-0.69,0.24) Subtotal (R). ' 48 '. 28 ' Mean ES=-0.23(-0.69,0.24);Standard Error of mean ES=0.24;Z-test for the mean ES=-0.96;Q-statstc=0.00(d/= 0)

134 Optmal Educaton and Self-Montorng Vs. Self-Montorng Table 5 Optmal Educaton and Self-Montorng Vs. Self-Montorng Hosptalzatons (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SEof Weght w*es w*es 95% Cl ES (w) 2 R7 Guendelman et al (-0.29,0.42) Subtotal (R7) T Mean ES=0.06(-0.29, 0.42);Standard Error of mean ES=0.8;Z-test for the mean ES=0.33;Q-statstc=0.00(d/= 0) Total (R3R5,R6,R7,R) Mean ES= -0.3(-0.30,0.04);Standard Error of mean ES=0.08;Z-test for the mean ES=-.62;Q-statstc=.67(d/=4) Number of Hosptalzatons (Adults) 23 Self-Management and Regular Medcal Revew Vs. Usual Care Table 6 Optmal Self-Management Vs. Usual Care (Adults) Hosptalzatons (Number) R.No Study Expermental Control Standardzed E Ffect Sze Mean SD N Mean SD N Effect Sze (ES) and SE ofes Weght w*es w*es2 95% Cl (w) R6 George et al (-0.85,0.29) Total ( *; - ' 30 20? Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-test for the mean ES=-0.96;Q-statstc=0.00(d/=0)

135 Number of Hosptalzatons (Chldren) Self-Manaqement and Regular Medcal Revew Vs, Usual Care Table 7 Optmal Educaton, Self-Montorng and Regular Medcal Revew Vs. Usual Care (Chldren) Hosptalzatons (Number) R.No Study Expermenta Control Standardzed Etfeet Sze Mean SD N Mean SD N Effect Sze (ES) and SE of Weght w*es w*es2 95% Cl ES (w) R5 Freman et al (-0.90,0.64) Subtotal (R5) '; Mean ES=-0.3(-0.90,0.64);Standard Error of mean ES=0.39;Z-test for the mean ES=-,33;Q-statstc=0.00(d/=0) 24 Table 8 Optmal Educaton and Regular Medcal Revew Vs. Usual Care (Chldren) Hosptalzatons (Number) R.No Study Expermenta Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and 95% Cl SEof ES Weght (w) w*es w*es2 R3 Clark et al (-0.40,0.07) Subtotal (R3) 207- * Mean ES=-0.7(-0.40,0.06);Standard Error of mean ES=0.2;Z-test for the mean ES=-.42; Q-statstc=0.00(d/= 0) Group self-management(r3,r5) ,2.2 Mean ES=-0.7(-0.39,0.05);Standard Error of mean ES=0.;Z-test for the mean ES=-,54;Q-statstc=0.0 (d/=)

136 Optmal Educaton Vs. Mnmal Educaton Table 9 Optmal Educaton Vs. Mnmal Educaton (Chldren) Hosptalzatons (Number) R.No Study Expermental Control Standardzed E Ffect Sze Mean SD N Mean SD N Effect Sze (ES) and 95% Cl SE of ES Weght (w) w*es w*es2 R Lews et al (-0.69,0.24) Subtotal (R) r - 48' ' 0.92 Mean ES=-0.23(-0.69,0.24);Standard Error of mean ES=0.24;Z-testforthe mean ES=-0.96;Q-statstc=0.00(d/= 0) Optmal Educaton and Self-Montorng Vs. Self-Montorng 25 Table 0 Optmal Educaton and Self-Montorng Vs. Self-Montorng (Chldren) Hosptalzatons (Number) R.No Study Expermental Control Standardzed Effect Sze - Mean SD N Mean -SD N - Effect Sze (ES) and SE of Weght w*es w*es2 95% Cl ES (w) R7 Guendelman et al (-0.29, 0.42) Subtotal (R7) ' 62?' Mean ES=0.06(-0.29, 0.42);Standard Error of mean ES=0.8;Z-test for the mean ES=0.33;Q-statstc=0.00(d/= 0) Total (R3,R5,R7,R) Mean ES= -0.2(-0.30,0.06);Standard Error of mean ES=0.09;Z-test for the mean ES=-.33;Q-statstc=.49(d/=3)

137 Number Of Emergency Departments Vsts Self-Management and Regular Medcal Revew Vs. Usual Care Table Optmal Self-Management Vs. Usual Care Emergency Department Vsts (Number) R.No Study Expermenta Control Standardzed Effect Sze Mean SD N Mea SD N Effect Sze (ES) and SE of Weght w*es w*es2 n 95% Cl ES (w) R6 George et al (-0.85, 0.29) Subtotal (R6)~,.,. : r ; Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-test for the mean ES=0.96;Q-statstc=0.00 (d/=0) 26 Optmal Educaton and Regular Medcal Revew Vs. Usual Care Table 2 Group Optmal Educaton and Regular Medcal Revew Vs. Usual Care Emergency Department Vsts (Number) R.No Study Ex aermenta Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SEof Weght w*es w*es2 95% Cl ES (w) R3 Clark et al (-0.39,0.08) R2 Marvella et al (-0.66,-0.5) Subtota (R3.R2) '.5 Mean ES=-0.27(-0.45,-0.09);Standard Error of mean ES=0.09;Z-test for the mean ES=-3.00;Q-statstc=2.00(d/=)

138 Table 3 ndvdual Optmal Educaton and Regular Medcal Revew Vs. Usual Care Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SE of Weght w*es w*es2 95% Cl ES (w) R3 McNabb et al (-.22, 0.88) Subtotal (R3) Mean ES=-0.9(-.22,0.88);Standard Error of mean ES=0.54;Z-test for the mean ES=-0.35; Q-statstc=0.00(d/=0) Subtotal (R3,R2,R3) bls'l.. « Mean ES=-0.27(-0.45,-0.09);Standard Error of mean ES=0.09;Z-test for the mean ES=-3.00;Q-statstc=2.0(d/=2) 27 Table 4 Optmal Educaton, Self-Montorng and Regular Medcal Revew Vs. Usual Care Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mean - SD N Effect Sze (ES) and 95% Cl SE of ES Weght (w) w*es w*es2 R5 Freman et al , (-0.90,0.64) R0 Kotses et al 96G (.47, 3.68) Toteh.. ' ' Mean ES=0.78(0.5,.4);Standard Error of mean ES=0.32;Z-test for the mean ES=2.44;Q-statstc=6.83(d/=) Subtotal (R3,R5,R6,R0,R2,R3) j - - j : 35,40 Mean ES=-0.20(-0.36,0.04),'Standard Error of mean ES=0.08;Z-test for the mean ES=-2.50;Q-statstc=29.02(d/=5) Excludng.R z., 265 :, , Mean ES=-0.26(-0.42,0.0);Standard Error of mean ES=0.08;Z-test for the mean ES=-3.25;Q-statstc=2.3(d/=4) ndvdual self-management (R6.R3) ' 5,32 ' -3,98.05 Mean ES=-0.26(-0.38,-0.3);Standard Error of mean ES=0.06;Z-test for the mean ES=-4.33;Q-statstc=0.02(d/=) Group.selfmanagemeht(R3,R5,R0,R2) 350. ' : Mean ES=-0.20(-0.37,-0.03),'Standard Error of mean ES=0.08;Z-test for the mean ES=-2.5;Q-statstc=28.95(d/=3) Excludng.R0(R3,R5,R2). -, ' , Mean ES=-0.26(-0.43,-0.08);Standard Error of mean ES=0.09;Z-test for the mean ES=-2.88;Q-statstc=2.32(d/=2)

139 Optmal Educaton and Self-Montorng Vs. Self Montorng Table 5 Optmal Educaton and Self-Montorng Vs. Self Montorng Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SE of Weght w*es w*es2 95% C ES (w) R7 Guendelman et al (-0.48, 0.23) R9 Kotses et al (-0.53, 0.37) Subtotal (R7, R9). -\ > Mean ES 0. (-0.38,0.6 );Standard Error of mean ES=0.4;Z-test for the mean ES=0.78;Q-statstc=0.03(d/;=) Optmal Educaton Vs. Mnmal Educaton 28 Table 6 Optmal Educaton Vs. Mnmal Educaton Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mea SD - N -Effect Sze (ES) and SEof Weght w*es w*es2 n 95% C ES (w) R8 Homer et al (-0.32, 0,45) R Lews et al (-0.69, 0.24) Subtota (R8, R) H , Mean ES 0.04(-0.33,0.25);Standard Error of mean ES=0.5;Z-test for the mean ES 0.27;Q-statstc=0.96(d/=) Total (R3,R5,R6,R7,R8,R9,R0,R,R2,R3) Mean ES=-0.6(-0.28,-0.04);Standard Error of mean ES=0.06; Z-testforthe mean ES 2.67; Q-statstc=3.0 (d/=9) Excludng R : Mean ES=-0.9(-0.32,-0.06);Standard Error of mean ES=0.06; Z-testforthe mean ES 3.7;Q-statstc=5.2(d/=8) Excludng R8 and R ' 205: Mean ES=-0.22(-0.29, -0.6); Standard Error of mean ES=0.07; Z-testforthe mean ES 3.4;Q-statstc=3.02(d/=7)

140 Number of Emergency Departments Vsts (Adults) Self-Management and Regular Medcal Revew Vs. Usual Care Table 7 Optmal Self-Management Vs. Usual Care (Adults) Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mea SD N Effect Sze (ES) and SEof Weght w*es w*es2 n 95% Cl ES (w) R6 George et al (-0.85, 0.29) Subtotal (R6) Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-test for the mean ES=-0.96;Q-statstc=0.00 (d/=0) 29 Table 8 Optmal Educaton and Regular Medcal Revew Vs. Usual Care (Adults) Emergency Department Vsts (Number) R.No Study Exoermenta Control Standardzed Effect Sze Mean SD N ' Mean SD N Effect Sze (ES) and 95% Cl SE of ES Weght (w) w*es w*es2 R2 Marvella et al (-0.66,-0.5) Subtota (R2) ' ' ' 9-95; Mean ES=-0.4(-0.66,-0.5);Standard Error of mean ES=0.3;Z-test for the mean ES =-3.5; Q-statstc=0.00 (d/=0) Total (R6; R2) ' ' 49' Mean ES=-0.39(-0.62,-0.6);Standard Error of mean ES=0.2;Z-test for the mean ES =-3.25;Q-statstc=-0.07(d/=)

141 Table 9 Optmal Educaton, Self-Montorng and Regular Medcal Revew Vs. Usual Care (Adults) Emergency Department Vsts (Number) R.No Study Expermenta Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and SEof Weght w*es w*es2 95% Cl ES (w) R0 Kotses et al 96G (.47, 3.68) Subtotal (R0) Mean ES=2.67(.47,3.68);Standard Error of mean ES=0.56;Z-test for the mean ES=4.77;Q-statstc=0.00(d/=0) Subtotal (R6,R0,R2); ' 33.6 Mean ES=-0.26(-0.49,-0.02);Standard Error of mean ES=0.2;Z-test for the mean ES=-2.7;Q-statstc=28.55(dA=2) Group self-management (RQ, R2) Mean ES=-0.26(-0.5,-0.0);Standard Error of mean ES=0.3;Z-test for the mean ES=-2.00; Q-statstc=28.55(d/=) ndvdual self-management (R6) 30 «.o' : 20.89, Mean ES=-0.28(-0.85,0.29);Standard Error of mean ES=0.29;Z-test for the mean ES=:-0.96; Q-statstc=0.00 (d/=0) 30 Optmal Educaton and Self-Montorng Vs. Self Montorng Table 20 Optmal Educaton and Self-Montorng Vs. Self Montorng (Adults) Emergency Department Vsts (Number) R.No Study Expermental Control Standardzed Effect Sze Mean SD N Mean SD N Effect Sze (ES) and 95% Cl SEof ES Weght (w) w*es w*es2 R9 Kotses et al (-0.53,0.37) Subtotal (R9).. 36; * 40. ' (5 0.2 Mean ES=-0.08(-0.53,0.37);Standard Error of mean ES=0.23;Z-test for the mean ES=0.35;Q-statstc=0.00(d/=0) Total (R6,R9,R0,R2) Mean ES=-0.22(-0.42,-0.02);Standard Error of mean ES=0.0;Z-test for the mean ES=-2.2;Q-statstc=29.04(d/=3) Excludng R0 (R6.R9.R2) Mean ES=-0.33(-0.53,-0.2);Standard Error of mean ES=0.0;Z-test for the mean ES=-3.30;Q-statstc=.39(d/=2)