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C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents ondansetronvsgranisetron O verallAE s H errington constipation:3 cytotec 100mcg low price treatment goals for depression. C= cyclophospham ide;M = m ethotrex ate;F or5-F U = 5-fluourouracil;A = dox orubicin;E = epirubicinM TX -m ethotrex ate;D TIC -ductualcarcinom a insitu order cytotec 100 mcg medicine used to treat bv. W ithdrawalinform ation:Incycle1 discount 100 mcg cytotec fast delivery medications 2355,datawasgivenfor161of 166 Jantunen O ndansetronvsG ranisetronvsTropisetron pts(noreasonsgivenastowhythose5notaccountedfor);forall3cycles, 1993 Headache therewere36ptstotalwhocouldnotevaluated inthecross-overanalysis M ulticenter (no. O f these,18hadtheirchem ochangedduetoprogressive 3,4 35% vs35% vs34%, diseaseandnolongerfittheinclusioncriteria;4hadchem odose reductionsduetolow bloodcounts;5hadincom pletedataonem esis;4 requestedtobewithdrawnafterCycle1duetoinadequatecontrolof em esis(2inO nd,2inTrop);2em igratedandwerelosttoF /u;1didnotfit inclusioncriteria (astrocytom a);1receivedTrop 2X which wasconsideredtobe am ajorviolationof studyprotocol;1requestedtobewithdrawnafterrandom Antiemetics Page 54 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity K alaycio G ranisetroniv0. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics Prim aryTum or:Breast:100% K alaycio Chem otherapyN on-N aïve:100% 1998 Historyof alcoholuse:18% 48/48/48 3/45/45 N R Historyof em esis:38% 5 Historyof ondansetron:62% Historyof granisetron:31% Patientsreceiving m oderatelyem etogenic chem o:41% Ptsreceiving highlyem etogenic chem otherapy:59% L eonardi E CO G Perform anceStatus0-3:100% 1996 N R /N R /118 3/0/118 Breastcancer:36% M ulticenter L ung cancer:24% 3,4,5 Hodgkinsornon-Hodgkinslym phom a:16% O therm alignancies:24% Antiemetics Page 56 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults G ranisetronvsO ndansetron K alaycio M eannum berof salvageanti-em etics:15. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents G ranisetronvsO ndansetron Allptsreceivedaninfusionof autologousstem cells3daysafterthechem o K alaycio headache:36% vs39%,N S regim enwascom plete. Allptsreceivedhem atopoietic growth factorsafter 1998 diarrhea:36% vs39%,N S ASCT untilengraftm entwasachieved. M oderatelyem etogenic (M E )chem o:aregim encontaining Adriam ycin>25 m g/m 2orepidox orubicin>40m g/m 2and/orcyclophospham ide>500 D eath:Both drugs:1. Highlyem etogenic (HE )chem o:aregim encontaining cisplatin>50m g/m 2aloneorin L eonardi O ndansetronvsG ranisetron associationwith otherantiblastic agents. D ataispresentedasaresultof 1996 Headache:24% vs23%,N S cycles,notpatients;O ndwasfirstadm inisteredin65patientsandG ranin M ulticenter L ightheadedness:13% vs18%,N S 53patients. Therewereatotalof 233cycles(3patientsdidnotcom pletea 3,4,5 Constipation:11% vs6%,N R secondcycle-2diedbeforethesecondcyclebeganandonerefuseda O therAE s(notspecified):6% vs6%,N R secondcycle)evaluatedforthe118patients. Therewere93HE cycles N um berof cycleswithoutanyAE s:62% vs68%,N S (40%)and140M E cycles(60%);andtherewere116cycleswith O ndand 117with G ran. Antiemetics Page 58 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity M antovani O ndansetroniv24m g N otex plicitlystated 58. N R 5 M artoni N ootherantiem etic 62 1995 O penR CT O ndansetroniv24m g drugsallowed, none N R /N R 75%m ale SingleCenter Crossover G ranisetroniv3m g including N R 5 corticosteroids. Antiemetics Page 59 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics N o. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults O ndansetronvsG ranisetronvsTropisetron Com pleteresponse(CR ):nonauseaof vom iting oronlym ildnauseainthe24h afterstarting chem o: 82. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents Allptswereonstudydrugsform ultiplecoursesof chem otherapy. Headache,acom m oncom plaintam ong ptsreceiving 5-HT3 during aperiodof 4h ondays2-5;and20m g/m 2of vinorelbineivover20 1995 antagonists,was<10% andnotsignificantlydifferentinanyof the3 m inondays2and8. R esponsedatagivenforthefirstchem ocycleonly SingleCenter treatm entarm s. Ptsdidnotknow towhich antiem etic 5 ptsduring treatm ent theyhadbeenassigned,evenif theywerecrossedovertoadifferent antiem etic duetofailure. D atawasgivenm ostlyinterm sof num berof cycles, notnum berof pts. E ligibleptsrandom iz edtoO ndorG ranatthefirstcycle;theycrossedover toseconddrug atthesecondcycle. J ustbeforethethirdcycle,theywere askedwhich antiem etic theypreferred. W ereportonlydatafrom thefirst antiem etic drug usedforthefirstcycle. Chem oincluded5different regim enscontaining CP (m ediandose= 60m g/m 2;doserange= 50-70 O ndansetronvsG ranisetron m g/m 2)and1or2otherdrugsincluding epirubicin(E PI;50-120m g/m 2)or Headache: cyclophospham ide(CTX ;500m g/m 2)orm ethotrex ate(M TX ;40m g/m 2)or M artoni D atafrom both cyclescom bined/aftercrossover:18. Allregim enswereadm inisteredIV onD ay1 1995 F irstcycleonly:15. Antiemetics Page 62 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity O ndansetroniv8m g M assidda G ranisetroniv3m g 51. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics Perform ancestatus:0:42% Perform ancestatus:1:58% M assidda K inetosis:yes:7%;no:93% 1996b Alcoholuse:>150m lof table-wineorequivalent:57% N R /N R /60 N R /N R /60 N R Benz odiaz epinesconcom itantuse:10% 3 H2antagonistsconcom itantuse:5% Chem o:E pirubicinhigh dose:27%;m itom ycinC +m ethotrex ate+ m itox antrone:15%;cyclophospham ideregim ens:58% M eanweight-73. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults O ndiv8vsG raniv3vsTrop iv5 Com pleteresponse:absenceof vom iting andnoneorm ildnausea Acute(within24h of chem o):74% vs58. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents M assidda AE datagiven:"AE scorrelatedwith the3antiem eticswerem ildand Theonlyp-valuesof significancewereforO ndvs. Allivadm inistrationsoccurredovera15m ininfusion Constipation: fortotalN :14%,N S ratherthanrecom m ended5-m ininfusionforgranisetron. Alcoholunit-150 N avari F ever:fortotalN :12%,N S m L wine,0. M eanvaluesareaverageunits/week 1995 Anorex ia:fortotal:11%,N S overtheprevious12m onths. Theoutcom esforthesubgroup of patients M ulticenter F atigue:fortotal:10%,N S receiving ahigh cisplatindosewerefurtherstratifiedbygender(butwedo 5 notreporttheseresultsinourtables). Therewerenodifferencesin% of pts Therewerenosignificantdifferencesbetweentreatm entgroupsfor whoreceivedrescuem edication;ineach group 43% of patientsreceived incidenceortypeof AE reported. Tim etofirstnauseaandtim etofirstem esiswere param eterswerecom parableacrossstudygroupsandwereconsidered sim ilarforalltreatm entgroups(datagivenasgraphicalrepresentation). Antiemetics Page 66 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear A ge Setting A llow oth er G ender H esketh rating Design Subpopulation Intervention m edication R un-in/W ash -out Eth nicity N oble O ndansetroniv24m g/d(8m g tid) 51. Antiemetics Page 67 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 1. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Screened/ W ith drawn/ Setting Eligible/ L ostto fu/ H esketh rating Enrolled A nalyz ed O th erpopulationch aracteristics M eanweight= 67. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults G ranisetronvsO ndansetronvsundecided Patientpreference:34% vs25. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents D oubledum m ystudy. O nd= 9pts(of 183)andG ran= 9pts Anyadverseevent,cycle1 (of 176)]. Ptswhoex periencedbreakthrough nauseaand/orvom iting AnyseriousAE (non-specific):6.
Condat B order generic cytotec on-line medicine on airplanes, Pessione F cytotec 100mcg lowest price medications prescribed for depression, Helene Denninger M purchase discount cytotec on line symptoms gallbladder, Hillaire S, Valla D. Douma RA, Kok MG, Verberne LM, Kamphuisen PW, Buller HR. Plessier A, Darwish-Murad S, Hernandez-Guerra M, et al. Acute portal thrombosis: evaluation and determinants of survival during long-term vein thrombosis unrelated to cirrhosis: a prospective multicenter follow-up. Clinical features and etiology of splanchnic venous thrombosis. Often unsuspected, usually uncompli- Budd-Chiari syndrome in Chinese patients: a single-center study. Natural history of mesenteric venous clinical features of portal vein thrombosis: a multicentre study. Aliment thrombosis in patients treated with vitamin K antagonists: a multi- Pharmacol Ther. Hoekstra J, Bresser EL, Smalberg JH, Spaander MC, Leebeek FW, 504. Long-term follow-up of patients with portal vein thrombo- 9. Spaander MC, Hoekstra J, Hansen BE, Van Buuren HR, Leebeek FW, sis and myeloproliferative neoplasms. Anticoagulant therapy in patients with non-cirrhotic portal 2208-2214. Lee1 1Vancouver Coastal Health Vancouver General Hospital, British Columbia Cancer Agency, Department of Medicine, University of British Columbia, Vancouver, BC Robust evidence remains scarce in guiding best practice in the prevention and treatment of venous thromboembolism in patients living with cancer. Recommendations from major consensus guidelines are largely based on extrapolated data from trials performed mostly in noncancer patients, observational studies and registries, studies using surrogate outcomes, and underpowered randomized controlled trials. Nonetheless, a personalized approach based on individual risk assess- ment is uniformly recommended for inpatient and outpatient thromboprophylaxis and there is consensus that anticoagulant prophylaxis is warranted in selected patients with a high risk of thrombosis. Prediction tools for estimating the risk of thrombosis in the hospital setting have not been validated, but the use of prophylaxis in the ambulatory setting in those with a high Khorana score is under active investigation. Symptomatic and incidental thrombosis should be treated with anticoagulant therapy, but little is known about the optimal duration. Pharmacologic options for prophylaxis and treatment are still restricted to unfractionated heparin, low molecular weight heparin, and vitamin K antagonists because there is currently insufﬁcient evidence to support the use of target-speciﬁc, non-vitamin K-antagonist oral anticoagulants. Although these agents offer practical advantages over traditional anticoagulants, potential drug interaction with chemotherapeutic agents, gastrointestinal problems, hepatic and renal impairment, and the lack of rapid reversal agents are important limitations that may reduce the efﬁcacy and safety of these drugs in patients with active cancer. Clinicians and patients are encouraged to participate in clinical trials to advance the care of patients with cancer-associated thrombosis. Physical Learning Objectives examination is signiﬁcant for crackles and dullness at the right ● To review the evidence and guideline recommendations on posterior lung base, lymphadenopathy in her left groin, and 1 the use of anticoagulant therapy for the prevention and edema in both ankles. Peripheral smear showed postsplenec- associated thrombosis tomy changes, but no RBC fragmentation or abnormal lymphocytes. Her international normalized ratio and activated partial thromboplas- tin time are normal. Her estimated glomerular ﬁltration rate is 45 Introduction mL/min with normal electrolyte results. She has elevated levels of Venous thromboembolism (VTE) is a leading cause of death in gamma-glutamyltransferase and lactate dehydrogenase at 1. The risk of VTE varies depending on patient-, the upper limit of normal. Computed tomography showed a small cancer- and cancer-treatment-related risk factors and is effectively right pleural effusion with basal atelectasis, mediastinal adenopathy, reduced with anticoagulant prophylaxis. Treatment of cancer- and retroperitoneal adenopathy in the portal and periaortic region, associated thrombosis also requires anticoagulant therapy, but the with a large mass in the left iliac fossa and inguinal region. She is drug choices remain limited and are complicated by heterogeneous admitted to hospital for diagnostic workup for probable lymphoma. This review uses a case scenario to illustrate Question 1: Is our patient a candidate for inpatient the knowledge gaps and complexities in prescribing thromboprophy- thromboprophylaxis? The evidence available ranging from patients undergoing surgery, having an acute medical for target-speciﬁc non-vitamin K-antagonist oral anticoagulants illness, receiving scheduled antineoplastic therapy, or requiring (NOACs) is emphasized in these settings. The risks of VTE and bleeding differ across these settings and, therefore, in-hospital Scenario anticoagulant prophylaxis may not be beneﬁcial or necessary in A 68-year-old woman presents with a 1-month history of progres- every patient. Few studies have reported on the incidence of these sive anorexia, fever, weight loss, and night sweats. She was risks and there are no validated risk assessment tools for this patient previously well and has a remote history of primary immune population. Older, post-hoc data show that 10% of cancer patients thrombocytopenia treated with splenectomy. She is not on any admitted with an acute medical illness develop thrombosis detected medication. Vital signs are unremarkable except for a low-grade on routine screening,1-4 whereas contemporary data suggest that 312 American Society of Hematology 2% of these patients receiving in-hospital prophylaxis develops The direct oral anti-Xa inhibitors rivaroxaban and apixaban have major or clinically relevant nonmajor bleeding. Therefore, robust evidence is lacking to compared an extended course of NOAC for 30–35 days with a short determine the risk-beneﬁt ratio of in-hospital thromboprophylaxis in course of enoxaparin for 7–10 days. Results for the cancer subgroup during the hospital- patients with cancer when they are admitted to the hospital if they do ization phase of the studies have not been published. Therefore, the not have contraindications to anticoagulation. The 2013 update of the American Society of Clinical Oncology (ASCO) VTE Guideline recommends anticoagulant pro- Scenario phylaxis in patients who have active malignancy and are admitted Our patient is given LMWH prophylaxis while in the hospital. Systemic chemo- advocates the use of the Padua prediction score for VTE risk therapy with R-CHOP (rituximab cyclophosphamide hydroxy- stratiﬁcation. She wants to start therapy on an outpatient basis at a center laxis. These factors include older age ( 70 years), obesity (BMI closer to her sister. Finally, the European Society of Medical Oncology hospitalization. The EXCLAIM trial, which assessed extended (ESMO) Guideline has the most “restrictive” recommendation, thromboprophylaxis with enoxaparin compared with placebo, re- stating that prophylaxis is indicated in hospitalized cancer patients ported a reduction of VTE (2. In this high-risk she likely has reduced mobility; and (4) postsplenectomy status is patient group, 9. Rivaroxaban borderline renal impairment are not severe enough to justify was also associated with a statistically signiﬁcant higher risk of withholding anticoagulant prophylaxis.
Risperidone in preschool children with autistic spectrum disorders: an investigation of safety and efficacy generic cytotec 200mcg free shipping treatment quincke edema. Risperidone in children with autism: randomized buy cytotec 200 mcg visa treatment zit, placebo- controlled purchase cytotec australia medicine x boston, double-blind study. Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder. Malone RP, Cater J, Sheikh RM, Choudhury MS, Delaney MA. Olanzapine versus haloperidol in children with autistic disorder: an open pilot study. Effect of aripiprazole on quality of life and caregiver strain in the treatment of irritability associated with autistic disorder (CN139- 178/179) [poster]. Paper presented at: 162nd American Psychiatric Association (APA) Annual Meeting; May 16-21, 2009; San Francisco, CA. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder. Paper presented at: 162nd American Psychiatric Association (APA) Annual Meeting, 2009; San Francisco, CA. Miral S, Gencer O, Inal-Emiroglu FN, Baykara B, Baykara A, Dirik E. Risperidone versus haloperidol in children and adolescents with AD : a randomized, controlled, double-blind trial. Gencer O, Emiroglu FNI, Miral S, Baykara B, Baykara A, Dirik E. Comparison of long- term efficacy and safety of risperidone and haloperidol in children and adolescents with autistic disorder. Risperidone in the treatment of childhood autistic disorder: an open pilot study. Corson AH, Barkenbus JE, Posey DJ, Stigler KA, McDougle CJ. A Retrospective Analysis of Quetiapine in the Treatment of Pervasive Developmental Disorders. An open clinical trial of risperidone monotherapy in young children with autistic disorder. Risperidone treatment of children with autistic disorder: effectiveness, tolerability, and pharmacokinetic implications. Risperidone monotherapy in preschool children with pervasive developmental disorders. Atypical antipsychotic drugs Page 192 of 230 Final Report Update 3 Drug Effectiveness Review Project 526. An open trial of risperidone in young autistic children. An open-label trial of risperidone in children with autism. Open-label risperidone treatment of 6 children and adolescents with autism. NR163: Quetiapine open-label trial in children and adolescents with developmental disorders. Paper presented at: 156th Annual Meeting of the American Psychiatric Association May 17-22, 2003; San Francisco, California. Snyder R, Turgay A, Aman M, Binder C, Fisman S, Carroll A. Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs. Findling RI, McNamara NK, Branicky LA, Schluchter MD, Lemon E, Blumer JL. A double-blind pilot study of risperidone in the treatment of conduct disorder. Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL. Double-blind, placebo- controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Buitelaar JK, van der Gaag RJ, Cohen-Kettenis P, Melman CT. A randomized controlled trial of risperidone in the treatment of aggression in hospitalized adolescents with subaverage cognitive abilities. Reyes M, Buitelaar J, Toren P, Augustyns I, Eerdekens M. A randomized, double-blind, placebo-controlled study of risperidone maintenance treatment in children and adolescents with disruptive behavior disorders. Randomized controlled pilot study of quetiapine in the treatment of adolescent conduct disorder. Long-term safety and efficacy of risperidone in children with disruptive behaviour disorders. Acute and long-term safety and tolerability of risperidone in children with autism. Weight and leptin changes among risperidone- treated youths with autism: 6-month prospective data. Long-term, open-label study of risperidone in children with severe disruptive behaviors and below-average IQ. Discontinuation of risperidone and reversibility of weight gain in children with disruptive behavior disorders. Long-term safety and efficacy of risperidone for the treatment of disruptive behavior disorders in children with subaverage IQs. Atypical antipsychotic drugs Page 193 of 230 Final Report Update 3 Drug Effectiveness Review Project 542. Harrison-Woolrych M, Garcia-Quiroga J, Ashton J, Herbison P. Safety and usage of atypical antipsychotic medicines in children: a nationwide prospective cohort study.
For example buy cytotec online medications ibs, testing whether one treatment is better than another (rather than testing whether one treatment is either better or worse than another) cytotec 200mcg cheap treatment jammed finger. Open-label trial: A clinical trial in which the investigator and participant are aware which intervention is being used for which participant (that is 200 mcg cytotec free shipping symptoms joint pain fatigue, not blinded). Random allocation may or may not be used in open-label trials. Per protocol: The subset of participants from a randomized controlled trial who complied with the protocol sufficiently to ensure that their data would be likely to exhibit the effect of treatment. Per protocol analyses are sometimes misidentified in published trials as intention-to- treat analyses. Pharmacokinetics: the characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism, and excretion. Placebo: An inactive substance commonly called a "sugar pill. It does not contain anything that could harm a person. It is not necessarily true that a placebo has no effect on the person taking it. Placebo-controlled trial: A study in which the effect of a drug is compared with the effect of a placebo (an inactive substance designed to resemble the drug). In placebo-controlled clinical trials, participants receive either the drug being studied or a placebo. The results of the drug and placebo groups are then compared to see if the drug is more effective in treating the condition than the placebo is. Triptans Page 60 of 80 Final Report Update 4 Drug Effectiveness Review Project Point estimate: The results (e. A confidence interval is a measure of the uncertainty (due to the play of chance) associated with that estimate. Pooling: The practice of combing data from several studies to draw conclusions about treatment effects. Power: The probability that a trial will detect statistically significant differences among intervention effects. Studies with small sample sizes can frequently be underpowered to detect difference. Precision: The likelihood of random errors in the results of a study, meta-analysis, or measurement. The greater the precision, the less the random error. Confidence intervals around the estimate of effect are one way of expressing precision, with a narrower confidence interval meaning more precision. Prospective study: A study in which participants are identified according to current risk status or exposure and followed forward through time to observe outcome. Prevalence: How often or how frequently a disease or condition occurs in a group of people. Prevalence is calculated by dividing the number of people who have the disease or condition by the total number of people in the group. Probability: The likelihood (or chance) that an event will occur. In a clinical research study, it is the number of times a condition or event occurs in a study group divided by the number of people being studied. Publication bias: A bias caused by only a subset of the relevant data being available. The publication of research can depend on the nature and direction of the study results. Studies in which an intervention is not found to be effective are sometimes not published. Because of this, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention. In addition, a published report might present a biased set of results (for example, only outcomes or subgroups for which a statistically significant difference was found). P value: The probability (ranging from zero to one) that the results observed in a study could have occurred by chance if the null hypothesis was true. Q-statistic: A measure of statistical heterogeneity of the estimates of effect from studies. It is calculated as the weighted sum of the squared difference of each estimate from the mean estimate. Random-effects model: A statistical model in which both within-study sampling error (variance) and between-studies variation are included in the assessment of the uncertainty (confidence interval) of the results of a meta-analysis. When there is heterogeneity among the results of the included studies beyond chance, random-effects models will give wider confidence intervals than fixed-effect models. Randomization: The process by which study participants are allocated to treatment groups in a trial. Adequate (that is, unbiased) methods of randomization include computer generated schedules and random-numbers tables. Triptans Page 61 of 80 Final Report Update 4 Drug Effectiveness Review Project Randomized controlled trial: A trial in which two or more interventions are compared through random allocation of participants. Regression analysis: A statistical modeling technique used to estimate or predict the influence of one or more independent variables on a dependent variable, for example, the effect of age, sex, or confounding disease on the effectiveness of an intervention. Relative risk: The ratio of risks in two groups; same as a risk ratio. Retrospective study: A study in which the outcomes have occurred prior to study entry. Risk: A way of expressing the chance that something will happen. It is a measure of the association between exposure to something and what happens (the outcome). Risk is the same as probability, but it usually is used to describe the probability of an adverse event. It is the rate of events (such as breast cancer) in the total population of people who could have the event (such as women of a certain age). Risk difference: The difference in size of risk between two groups. In intervention studies, it is the ratio of the risk in the intervention group to the risk in the control group. A risk ratio of 1 indicates no difference between comparison groups. For undesirable outcomes, a risk ratio that is <1 indicates that the intervention was effective in reducing the risk of that outcome.