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FACTORS ENABLING QUALITY IMPROVEMENT There are factors which should be considered by the quality team as enablers for a successful quality improvement program buy discount altace 2.5 mg heart attack enrique iglesias s and love. The role of the quality Figure 1 Key components of a system team is to encourage and re-enforce these factors buy generic altace 5mg line heart attack maroon 5. Figure 2 The gynecology unit flow chart: inputs purchase altace 5mg with amex prehypertension blood pressure chart, processes and results 437 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS Table 1 Dimensions of quality2 Dimension Explanation Examples of standards How to measure quality Provider Knowledge and skills of health Gynecology department have staff Test the knowledge and knowledge providers (capability) competent in counseling for HIV/ competence of care providers and skills AIDS in the department Technical Tasks carried out by a health worker Woman of child bearing age Direct observation patient- performance or facility in their usual situation is presenting with lower abdominal provider encounter in line with set guidelines and pain should be investigated for standards ectopic pregnancy Safety Minimizing the risks of injury, No blood transfusion to be done Review of laboratory results infection and harmful side-effects or without previous testing for HIV, on a sample of blood other dangers syphilis and hepatitis B status Effectiveness Degree of achievement of desired A patient undergoing surgery Review surgical patient files results should be ambulant within 48 h in ward Efficiency The ratio of inputs of service The cost for any method of family Cost analysis processes to associated costs planning should be less than $1 per month Accessibility Degree to which health services are At least one of the staff in the Interview of the nurse not restricted by geographic, gynecology clinic can speak the economic, social, cultural, linguistic native language of the area or organizational barriers Interpersonal Trust, respect, confidentiality, All family planning clients must Exit interview of the patient. Team members should respect each The members of a quality team have to show the other’s and the staff’s ideas as well as worries. They should keep to the meet- ing schedules, practice punctuality and document Innovative thinking processes and share with the staff and management. Approaches that will become successful in one facility will not, as a rule, become successful in Honesty and respect another facility. The team and staff should think of The team has to show sincerity and humor in new ways of doing things that will bring positive working together. Open-mindedness will ensure results more efficiently and effectively. Management is expected to support these match the required standards. Absolute shortage of initiatives by providing resources and commitment health staff in poor countries has hampered most of to the initiative. On the other hand, poor quality may be the reason for shortage Support of key players of staff as well! Functional quality improvement As mentioned above, it is only through support of programs will address issues of health provider’s the management and all staff that quality programs administration and management, including plan- will become effective. Staff need to be sup- ported to use their maximum production potential In addition to the enablers mentioned above, qual- and made to see that the facility exists because ity teams should be aware of barriers as well. This does are essentially the opposite of the enablers. These not mean however, that in places where there is include insufficient commitment of resources (the shortage of staff then quality improvement should team), resistance to change (both staff and manage- not be deployed. Tangent improvements can still ment), usual thinking (in the box) and unsupportive 1 be realized by doing the following: management. The quality team has a role to over- come these obstacles in order to register success. THE ROLE OF FUNDING IN QUALITY • Allocating tasks according to knowledge, skills IMPROVEMENT OF HEALTHCARE and experiences. Note that this will necessary for quality improvement in health services mean again training and capacity building to this and care. Regardless of the fact that health financ- staff in order to be able to take up the new tasks. One important reason is that there is a mismatch in the Summary efforts to improve quality. Faulty processes and re- sources not provided according to assigned tasks • Health facility performance is a result of inter- outweigh improvement in inputs. A lot of of management functions and process of health- improvement in quality of services can be achieved care (planned, implemented, monitored, evalu- without huge increase in financial resources. Respect IMPROVEMENT IN A HEALTH FACILITY will entail listening to each other, sharing of ideas and communication. In this perspective, working Establishment of a hospital quality as a team to solve problems and decision making improvement team 6 through discussions and consensus will prevail. It is Quality improvement is always thought to be important to understand that this team aspect is vital everybody’s responsibility. In the majority of cases to its work, as otherwise, the routine hierarchy will it ends up being no one’s liability. Quality teams prevent more junior, but maybe more knowledge- have been shown to be effective in responding to able, members giving their input. Voluntary membership to this team moderator (internal or external) may be required. The size of the team depends on the capacity of the team in moderation skills, but ensure size of the facility. In moderately sized hospitals each member has opportunity to participate and (100–200 beds) 6–10 members to the team is just finally support the team in documentation of the the appropriate size. Bigger teams will not increase processes, which is key to success. The moderator efficiency or effectiveness of the team. They may should only moderate the process and not engage in even be counterproductive in the sense that it takes discussions of the content. Nevertheless, staff members who are The quality team will be in a position to perform known to be influential and capable of inspiring better if its duties are well elaborated and under- other staff, should be encouraged to become part of stood by all concerned (the quality team members, this team. The team is expected to have at least the facility staff, facility management, patients and the following characteristics: community served). It is therefore important to • Members are well motivated to undertake the handle this step with great care. The team may tasks of improving quality of services and care need support from a committed and experienced across the facility. A trained per- • Multilevel representation – from top manage- son within the hospital or from another hospital or ment to attendants and helpers. If • Mixed knowledge levels – from specialists to there are nationally developed tasks for a facility unskilled laborers. However, • Gender sensitive – proportionate representation centrally developed tasks are very general. The following are some of the tasks that A quality team for a department, e. The multilevel in this perspec- • Support translation and adaptation of national tive will refer to the units within the department. Representation from the key • Oversee that individuals and teams always per- function areas supporting the department such form according to standards. Once the nomination is complete, the team will • Advise the management in cases of complaints develop basic norms for its operation. The participants will conceptualize priate quality improvement approaches and approaches to quality improvement and build up tools. They will get to understand which tools are sustained quality practice in the facility. Moreover this training will be used to build up their realization. Topics to be covered • Support staff to design and implement correc- There is no standard in the list of topics to be cov- tive measures that will appropriately address per- ered during this training. THE QUALITY IMPROVEMENT CIRCLE • Advocate the advantages of quality improve- ment to management, staff and communities. It is in principle part of the well-known Deming Initial training and planning for quality circle, commonly known as the PDSA (Plan, Do, improvement Study, Act) circle4.
Other trials used very broad inclusion complications discount 10 mg altace fast delivery blood pressure chart by weight. Women with a history of preeclampsia buy discount altace 5 mg on line hypertension guidelines aha, with or criteria that make it difﬁcult to draw conclusions for subgroups with without inherited thrombophilia altace 2.5 mg without prescription heart attack kush, are also being counseled regarding speciﬁc pregnancy complications or thrombophilia. Some meta- the small reduction in risk of recurrence in a next pregnancy and analyses purposely pooled effects of heterogeneous interventions in prescribed aspirin on an individualized basis. It should be realized that the summary effects from such analyses do not have the same scientiﬁc Heparin, with or without aspirin, to prevent pregnancy loss strength as a randomized controlled trial of sufﬁcient size. The efﬁcacy of antithrombotic agents in women with unexplained (eg, in the absence of abnormal parental karyotype, uterine anoma- lies, or APS) recurrent pregnancy loss was compared with no Summary of randomized controlled trials and 26,27 treatment or placebo in 2 relatively large randomized trials. In meta-analyses the SPIN study, 294 women with 2 or more unexplained pregnancy Aspirin to prevent pregnancy loss losses were randomized to enoxaparin 40 mg combined with aspirin In women with APS, almost no data are available to support the use 75 mg plus standard surveillance or standard surveillance only. The pooled results effect of the medical intervention was observed (odds ratio for of 3 very small trials (total number of 71 participants) showed no successful pregnancy 0. In the ALIFE effect of aspirin only compared with no treatment [risk ratio (RR) of study, we randomized 364 women with 2 or more unexplained pregnancy loss 1. Of these starting aspirin before conception may be associated with a better women, 299 became pregnant. The chance of live birth did not pregnancy outcome than starting it once pregnancy is established. Based on the available evidence that also included trials comparing 2 active treatments,28 Aspirin to prevent preeclampsia various guidelines recommend against the use of antithrombotic A meta-analysis of individual patient data from 31 randomized agents in women with unexplained recurrent pregnancy loss. How I treat women with aspirin or LMWH to prevent pregnancy complications My approach in most patients My alternatives (not exhaustive) Recurrent pregnancy loss (2 or more), No LMWH, no aspirin unexplained Recurrent pregnancy loss (3 or more) and Aspirin 80 mg preconceptionally Start aspirin as soon as a pregnancy test is APS positive (Low-dose) LMWH as soon as a pregnancy In case of a history of venous or arterial test is positive thromboembolism and long term use of anticoagulant therapy; therapeutic dose LMWH and no aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines and no aspirin24 Recurrent pregnancy loss (2 or more) and Enroll in ALIFE2 trial after informed In case of a history of venous or arterial inherited thrombophilia consent, and randomize to either LMWH thromboembolism and long term use of or no LMWH anticoagulant therapy; therapeutic dose LMWH and no aspirin If no informed consent for trial participation, In case of a history of a single episode of venous no LMWH thromboembolism, antepartum and No aspirin postpartum LMWH according to current guidelines24 History of severe preeclampsia, unexplained Counsel about the modest risk reduction of aspirin and prescribe on an individual basis No LMWH History of severe preeclampsia, a single late Aspirin 80 mg as soon as a pregnancy test Start aspirin in the second trimester pregnancy loss, placental abruption, or is positive severe intra-uterine growth restriction and (Low dose) LMWH as soon as a pregnancy In case of a history of venous or arterial APS test is positive thromboembolism and long term use of anticoagulant therapy; therapeutic dose LMWH added to aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines added to aspirin24 History of severe preeclampsia and Counsel about the modest risk reduction of In case of a history of venous or arterial inherited thrombophilia aspirin and prescribe on an individual thromboembolism and long term use of basis anticoagulant therapy; therapeutic dose LMWH and no aspirin No LMWH In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines24 History of a single late pregnancy loss, No LMWH In case of a history of venous or arterial placental abruption or severe intra-uterine thromboembolism and long term use of growth restriction and inherited anticoagulant therapy; therapeutic dose thrombophilia LMWH and no aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines24 Forjustiﬁcation,pleaseseefulltext. In a few small studies, the use of LMWH and with aspirin only (n 109; RR 0. Comparing any heparin (unfractionated observed a profound effect of unfractionated heparin added to heparin or LMWH) combined with aspirin (n 199) with aspirin aspirin; this is markedly lower than in the comparator arms of only (n 199), the beneﬁcial effect of heparin of reducing the risk studies comparing LMWH and aspirin with aspirin only or aspirin 396 American Society of Hematology with placebo, in which the chances of a live birth varied between study, a nonsigniﬁcant increase in live birth was observed in the 2 68% and 80%. This indicates clinical heterogeneity between the active treatment arms for women with inherited thrombophilia (RR trials. We are currently performing the observed (RR for live birth for women treated with bemiparin ALIFE2 study (NTR 3361; www. The ACCP guidelines recommend unfractionated hepa- pregnancy surveillance only. The Royal College of without aspirin compared with no treatment in women with a history Obstetricians and Gynaecologists guidelines state that pregnant of various pregnancy complications, including preeclampsia, small- women with APS should be considered for treatment with aspirin for-gestational age babies, and placental abruption, to reduce the combined with heparin to prevent further miscarriage, without 29 risk of recurrence in subsequent pregnancies. These 6 studies were specifying clinical criteria of APS in the recommendation. The primary outcome was a composite of preeclampsia, birth of a small-for-gestational- Therefore, although evidence for a beneﬁcial effect of heparin th age newborn ( 10 percentile), placental abruption, or pregnancy combined with aspirin in women with APS and 3 or more loss later than 20 weeks. The effect of antithrombotic agents in mediated pregnancy complications, compared with 127 of 296 different subgroups of women with APS based on laboratory or (42. Nevertheless, based on the currently available evidence thrombophilia. Although the pooled risk reduction is statistically of studies with small numbers of participants, clinicians worldwide signiﬁcant, the results are strikingly positive in some studies, with have adopted the practice of prescribing aspirin with or without 36-39 relative risk reductions up to 85%, whereas in the 2 most heparin to all women with APS. This is reﬂected by the statistical heterogeneity that no sufﬁciently sized trials have been performed that show an effect 2 17 was also observed in the meta-analysis (I 69%). In all studies of heparin on the prognosis of a subsequent pregnancy. The combined, 25% of women had thrombophilia and only the FRUIT Habenox trial randomized women with at least 3 consecutive ﬁrst 40 study was dedicated to thrombophilic women only. In this trial, trimester miscarriages to enoxaparin 40 mg and placebo once daily women with inherited thrombophilia and a history of preeclampsia (n 68), enoxaparin 40 mg and aspirin 100 mg (n 63), or aspirin th 33 or intrauterine growth restriction, 10 percentile requiring deliv- 100 mg (n 76); there was no control group without intervention. The primary outcomes were recurrence of a hyperten- 0. Almost a quarter of the included women gestation or recurrence at any gestational age. The overall primary had either hereditary thrombophilia or anticardiolipin antibodies outcome did not differ between the 2 groups; hypertensive disorders 40 GPL or beta 2 glycoprotein I antibodies, and no differential occurred in 18. None of the women in after 10 weeks gestation and heterozygous factor V Leiden muta- the LMWH aspirin group developed recurrent hypertensive disor- tion, prothrombin G20210A mutation, or protein S deﬁciency; they ders before 34 weeks gestational age, whereas 6 (8. Women treated with enoxaparin had a much development of recurrent hypertensive disorders, with 3 women higher chance of a live birth than those allocated to aspirin (86% and delivering at 19-22 weeks (risk difference 8. The recently ﬁnished TIPPS study, which included 95% CI 7–34). However, several methodological issues were thrombophilic women either at high risk for pregnancy-mediated raised, and the results of this single study have not been conﬁrmed complications or at high risk of pregnancy-related venous thrombo- by other trials; therefore, this regimen was not endorsed by the embolism, randomized women between LMWH and no LMWH and ACCP guidelines for women with a single previous pregnancy loss 42 24,35 found no effect of the intervention. In the SPIN and ALIFE studies, small proportions of the study Why should we prescribe prudently? In the ALIFE reactions such as itching and swelling, and the rarer complications Hematology 2014 397 of heparin-induced thrombocytopenia and heparin-induced osteope- the Conﬁdential Enquiries into Maternal Deaths in the United Kingdom. Does thrombophilia testing help type allergic skin reactions due to administration of LMWH occur in the clinical management of patients? International consensus with nadroparin in the ALIFE study. Finally, the use of statement on an update of the classiﬁcation criteria for deﬁnite antithrombotic therapy raises speciﬁc issues with regard to planning antiphospholipid syndrome (APS). Antiphospholipid antibod- Conclusions, management of the clinical case, and ies prevent extravillous trophoblast differentiation. Neutrophil In my view, the body of evidence shown in the above-mentioned activation by the tissue factor/Factor VIIa/PAR2 axis mediates fetal intervention studies have not clearly and unequivocally shown the death in a mouse model of antiphospholipid syndrome. The thrombomodulin-protein C inherited thrombophilia and recurrent pregnancy loss. Women with system is essential for the maintenance of pregnancy. Heparin and aspirin attenuate recurrent severe placenta-mediated pregnancy complications in placental apoptosis in vitro: implications for early pregnancy failure. Nevertheless, we have to deal with clinical cases every day. The association between antiphospholipid antibodies and placenta mediated complica- summarized my approach in clinical practice in Table 3. For the tions: a systematic review and meta-analysis. If she will not give consent for participation, I will 13. Is thrombophilia associated only prescribe her aspirin based on her history of preeclampsia and with placenta-mediated pregnancy complications? Association between The huge evidence gaps should be ﬁlled in in the next few years by antiphospholipid antibodies and recurrent fetal loss in women without multinational collaborative studies.
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Cost effectiveness of leukotriene receptor antagonists versus inhaled corticosteroids for initial asthma controller therapy: A pragmatic trial. Outcomes after periodic use of inhaled corticosteroids in children. Evaluation of the administration time effect on the cumulative cortisol suppression and cumulative lymphocytes suppression for once-daily inhaled corticosteroids: A population modeling/simulation approach. Cortisol suppression as a surrogate marker for inhaled corticosteroid-induced growth retardation in children. European Journal of Pharmaceutical Sciences (Netherlands) 2009;36:110. Acute and chronic lung function responses to salmeterol and salmeterol plus fluticasone propionate in relation to Arg16Gly beta(2)- adrenergic polymorphisms. Influence of obesity on bone mineral density in postmenopausal asthma patients undergoing treatment with inhaled corticosteroids. Appropriate use of inhaled corticosteroid and long-acting beta(2)-adrenergic agonist combination therapy among asthma patients in a US commercially insured population. Comparable morning versus evening administration of once-daily mometasone furoate dry powder inhaler. Predicting short term response to anti-inflammatory therapy in young children with asthma. Current Medical Research and Opinion 2010;26(2):483-492. Effect of ciclesonide and fluticasone on exhaled nitric oxide in patients with mild allergic asthma. Strength of evidence for the comparative efficacy of inhaled corticosteroids No. Strength of evidence for the comparative efficacy of inhaled corticosteroids No. Strength of evidence for the comparative efficacy of leukotriene modifiers (LMs) Number Overall of studies Result and Other Strength (# of magnitude modifying of the a subjects) Design Quality Consistency Directness of effect factors evidence Overall total: LM compared with LM 1 (40) RCT (12 weeks) Fair NA Direct No difference None Low Montelukast compared with Zafirlukast 1 (40) RCT (12 weeks) Fair NA Direct No difference None Low Montelukast compared with Zileuton We did not identify any systematic reviews or head-to-head trials Zafirlukast compared with Zileuton We did not identify any systematic reviews or head-to-head trials Abbreviations: LM= Leukotriene Modifiers; MA= meta-analysis; RCT= randomized controlled trial; SR= systematic review. Strength of evidence for the comparative efficacy of LABAs Overall Number of Result and Other strength studies (# of magnitude modifying of the a subjects) Design Quality Consistency Directness of effect factors evidence Overall total: LABA compared with LABA No 3 (1107) RCTs Fair Consistent Direct None Moderate difference Eformoterol (eFM) compared with salmeterol (SM) RCTs (8-week No cross-over; 12- difference 2 (625) Fair Consistent Direct None Moderate week open- in health label) outcomes Formoterol (FM) compared with salmeterol (SM) No RCT (open- difference 1 (482) label, 6-month Fair Consistent Direct None Moderate in health trial) outcomes Formoterol (FM) compared with arformoterol (ARF) We did not identify any systematic reviews or head-to-head trials that compared FM to ARF Salmeterol (SM) compared with arformoterol (ARF) We did not identify any systematic reviews or head-to-head trials that compared SM to ARF Abbreviations: ARF= Arformoterol; eFM = Eformoterol; FM = Formoterol; LABAs = Long-Acting Beta-2 Agonists; MA= meta-analysis; RCT= randomized controlled trial; SM= Salmeterol; SR= systematic review. Controller medications for asthma 246 of 369 Final Update 1 Report Drug Effectiveness Review Project Table H-4. Strength of evidence for the comparative efficacy of omalizumab and placebo Omalizumab compared with placebo No. Strength of evidence for the comparative efficacy of BUD/FM and FP/SM No. Strength of evidence for for the comparative efficacy of BUD/FM for maintenance and as-needed relief (BUD/FM MART) and ICS/LABA with a Short- Acting Beta-Agonist (SABA) for relief No. Controller medications for asthma 248 of 369 Final Update 1 Report Drug Effectiveness Review Project Table H-7. Strength of evidence for the comparative efficacy of ICSs and LTRAs Number of Overall studies Other strength (# of Results (magnitude of modifying of subjects) Design Quality Consistency Directness effect) factors evidence Overall total of trials: ICS compared with LTRA 22 RCTs Fair Consistent Direct ICS > LTRA; ICSs had less None High (9,873) rescue medicine use (% rescue free days: SMD - 0. All were statistically significant favoring ICSs (Appendix I). FP compared with ML 9 (3,864) RCTs Fair Consistent Direct FP > ML; had less rescue None High medicine use (% rescue medicine free days: SMD - 0. BDP compared with ML 6 (3,823) RCTs Fair Consistent Direct BDP > ML; had fewer None Moderate exacerbations (SMD -0. Strength of evidence for the comparative efficacy of ICSs and LTRAs Number of Overall studies Other strength (# of Results (magnitude of modifying of subjects) Design Quality Consistency Directness effect) factors evidence symptom score: SMD - 0. Strength of evidence for the comparative efficacy of ICSs and LABAs for monotherapy Number of Overall studies (# Other strength of Results, magnitude of modifying of a subjects) Design Quality Consistency Directness effect factors evidence ICS compared with LABA for monotherapy 13 (4196) RCTs Good (1) Some Direct LABAs had a None High Fair (12) inconsistency significantly higher odds of exacerbations than ICSs (OR = 2. Strength of evidence for the comparative efficacy of leukotriene modifiers and LABAs for monotherapy Number of Overall studies Other strength (# of Results, magnitude modifying of a subjects) Design Quality Consistency Directness of effect factors evidence Montelukast compared with Salmeterol 1 (191) RCT (8 Fair NA Direct Zero compared with None Insufficient weeks) one death in one study (P = NR) Montelukast compared with Eformoterol 1 (58) RCT; Fair, NA Direct Those treated with None Insufficient cross-over unclear eFM had fewer with if one- symptoms (% of unusual week symptom-free days: 23 design; 12 washout compared with 0; P = weeks sufficient 0. Controller medications for asthma 251 of 369 Final Update 1 Report Drug Effectiveness Review Project Table H-10. Strength of evidence for the comparative efficacy of ICS + LABA and same dose ICS alone as first line therapy Number of Overall studies Other strength (# of Result (magnitude modifying of subjects) Design Quality Consistency Directness of effect) factors evidence Overall total: ICS + LABA compared with ICS alone as first line therapy 1 SR 1 SR w/ Good Some Direct No difference in None Moderate a (8050 ) MA inconsistency number of patients with exacerbations 9 RCTs 9 RCTs Fair requiring systemic (3,932) steroids (RR 1. BUD = Budesonide; CI = confidence interval; FM = Formoterol; FP = Fluticasone Propionate; ICS = Inhaled Corticosteroids; LABAs = Long-Acting Beta-2 Agonists; MA=meta-analysis; RCT= randomized controlled trial; RR = relative risk; SM = Salmeterol; SMD = standard mean difference; SR=systematic review Controller medications for asthma 252 of 369 Final Update 1 Report Drug Effectiveness Review Project Table H-11. Strength of evidence for the comparative efficacy of ICS + LABA compared with higher dose ICS Study design Number (Number of studies using 1 Overall (Number inhaler Other strength of for ICS+ Result, modifying of a b c subjects ) LABA ) Quality Consistency Directness magnitude of effect factors evidence Overall total: ICS + LABA compared with higher dose of ICS RCTs d 33 33 RCTs Good Some Direct ICS+LABA had greater None High (18,153) (2) inconsistency improvement in the Fair percentage of symptom- (31) free days (SMD = -0. Strength of evidence for the comparative efficacy of ICS + LABA compared with higher dose ICS Study design Number (Number of studies using 1 Overall (Number inhaler Other strength of for ICS+ Result, modifying of a b c subjects ) LABA ) Quality Consistency Directness magnitude of effect factors evidence (SMD = 0. Some subjects may have received other treatments as several trials had multiple treatment arms. The review looked at two groups of studies, ICS + LABA v same dose ICS and ICS + LABA v higher dose ICS. Controller medications for asthma 254 of 369 Final Update 1 Report Drug Effectiveness Review Project Table H-12. Strength of evidence for the comparative efficacy of addition of LABA to ICS compared with continuing same dose ICS Study design Number (Number of studies using Overall (Number single Other strength of combo Result (magnitude of modifying of a b subjects ) inhaler ) Quality Consistency Directness effect) factors evidence ICS + LABA compared with same dose of ICS 32 RCTs Good Consistent Direct ICS+LABA > ICS for None High (14,737) (2), symptom free days Fair (SMD 0. Abbreviations: AQLQ = Asthma Quality of Life Questionnaire; BDP = beclomethasone dipropionate; BUD = Budesonide; CI = confidence interval; eFM = Eformoterol; FM = Formoterol; FP = Fluticasone Propionate; ICS = Inhaled Corticosteroids; LABAs = Long-Acting Beta-2 Agonists; MA=meta-analysis; OCS= oral corticosteroids; RCT= randomized controlled trial; RR = relative risk; SM = Salmeterol; SMD = standard mean difference; SR=systematic review. Some subjects may have received other treatments as several trials had multiple treatment arms. Controller medications for asthma 255 of 369 Final Update 1 Report Drug Effectiveness Review Project c See Appendix I for complete results of meta-analyses. Strength of evidence for the comparative efficacy of ICS + LTRA and ICS Number of studies Overall (Number Other strength of Result, magnitude of modifying of subjects) Design Quality Consistency Directness effect factors* evidence LTRA + ICS compared with ICS same dose 1 (5,871) 1 SR Good Some Direct Exacerbations: non- Few trials Low w/ MA inconsistency statistically significant tested reduction in the risk of licensed exacerbations requiring doses of systemic steroids: RR LTRAs: just 4 0.