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Review of empirical comparisons of the results of randomised and non-randomised studiesTABLE 3 Clinical topics investigated in each of the medical reviews (cont’d)Clinical topicSacks, 1982 27Kunz, 1998, 28 2002 29Britton, 1998 25MacLehose, 2000 26Concato, 2000 33Benson, 2000 32Ioannidis, 2001 3452 Microsurgical vs macrosurgical salpingostomy in subfertility ✓53 Faecal occult blood screening for colorectal cancer ✓54 Intrathecal therapy for tetanus ✓55 Vitamin A supplementation ✓56 Interferon for hepatitis C ✓57 Trial of labour versus no labour for breech delivery ✓58 Surgical treatments for incontinence ✓59 Nonoxynol-9 spermicides for sexually transmitted diseases ✓60 Safety of postpartum discharge ✓61 High-dose diuretics as first-line treatment of hypertension ✓62 Aspirin for prevention of hypertension in pregnancy ✓63 Allogenic blood transfusion in cancer ✓64 Subcutaneous versus intravenous heparin in deep vein thrombosis ✓65 Low-protein diets in chronic renal insufficiency ✓66 Corticosteroids for idiopathic facial nerve palsy ✓67 Graduated compression stockings ✓68 Aspirin for primary prevention of stroke ✓69 Fixed nail plates versus sliding hip for femoral fractures ✓70 Corticosteroids for stable COPD ✓71 Treatment of hypertension in elderly people ✓72 Selective decontamination of the digestive tract ✓73 Cyclosporin withdrawal ✓74 Prehospital thrombolysis ✓75 T3-therapy in euthyroid depressed patients ✓ a76 Chemotherapy for oesophageal cancer ✓ a77 Autologous blood donation ✓ a78 Prevention of adolescent pregnancy ✓ a79 Educational interventions related to smoking and alcohol ✓ a80 Educational interventions related to nutrition and weight ✓ a81 Educational interventions related to other health behaviours ✓ a82 Medical and surgical management of coronary artery disease ✓ aaIndicates comparison added in review update.CABG, coronary artery bypass graft; PTCA, percutaneous transluminal coronary angioplasty; COPD, chronic obstructivepulmonary disease.14single randomised and non-randomised studies(14 comparisons) and secondary publications(reviews) making similar comparisons (fourcomparisons). Both observational and quasiexperimentalstudies were included in the nonrandomisedcategory. They included all four of thesecondary comparisons included in the review byKunz and colleagues 28 (Table 3). The single studycomparisons included studies where a comparisonwas made between participants who were allocatedto experimental treatment as part of a trial and agroup who declined to participate, and studies ofcentres where simultaneous randomised andpatient-preference studies had been undertaken ofthe same intervention. The studies were assessedto ensure that the randomised and nonrandomisedstudies were comparable on severaldimensions (Table 4).There were statistically significant differencesbetween randomised and non-randomised studiesfor 11 of the 18 comparisons. The direction ofthese differences was inconsistent and themagnitude extremely variable. For someinterventions the differences were very large.For example, in a review of treatments for acute
© Queen’s Printer and Controller of HMSO 2003. All rights reserved.TABLE 4 Details of methodology of empirical comparisons between randomised and non-randomised studiesMethod ofidentificationofcomparisonsSacks, 1982 27 Kunz, 1998, 28 Britton, 1998 25 MacLehose, Benson, 2000 32 Concato, 2000 33 Ioannidis, 2001 34 Lipsey, 1996, 352002 29 2000 26 Wilson, 2001 36Primary studies:Personalsystematiccollection of RCTsand HCTs inspecific fields ofinterestSimilarity of Same interventionpatients, for the sameinterventions medical conditionandoutcomesSecondarystudies: Electronicand manual searchfor studiescomparingrandomised andnon-randomisedstudies2 studies controlledfor clinicaldifferences inparticipants andinterventions, 6 didso partly and 7 didnot at allPrimary and Primary andsecondary secondarystudies: Electronic studies: Electronicsearches for studies and manualcomparing searches for studiesrandomised and comparingnon-randomised randomised andgroupsnon-randomisedgroupsSame intervention,similar setting,similar controltherapy,comparableoutcomesmeasuresSame intervention.Similarity ofeligibility, timeperiod, comorbidity,diseaseseverity and otherprognostic factorsassessedPrimary studies:Electronic search ofMedline and CCTRfor observationalstudies andmatching RCTsRestricted tointerventionsallocated byphysicians to inducecomparabilitySecondarystudies: Metaanalysespublishedin 5 leading journalsthat included nonrandomisedstudiesSecondarystudies: Metaanalyseslocated byelectronic searches(MEDLINE andCochrane library)and manualsearchesSecondarystudies: Metaanalyseslocated byelectronic searches(Psychology andSociologydatabases) andmanual searchesNot assessed Not assessed Impact ofdifferencesconsidered inmultivariateanalysisSimilarity ofother studymethodsNot assessed5 papers judgedpartly comparable,10 not comparableon double blinding,complete follow-upand othermethodologicalissuesNot assessedBlinding of outcomeassessedNot assessedAnalysis accordingto study qualitymentioned indiscussion, but nomethods or resultspresentedNot assessedImpact ofassessments ofstudy qualityconsidered inmultivariateanalysiscontinuedHealth Technology Assessment 2003; Vol. 7: No. 2715
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