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RESEARCH

Acupuncture treatment for pain: systematic review ofrandomised clinical trials with acupuncture, placeboacupuncture, and no acupuncture groups

Matias Vested Madsen, Peter C Gtzsche, Asbjrn Hrobjartsson

ABS TRA CT

Objectives To study the analgesic effect of acupuncture

andplaceboacupuncture andto explore whether thetype

of the placebo acupuncture is associated with the

estimated effect of acupuncture.

Design Systematic review and meta-analysis of three

armed randomised clinical trials.

Data sources Cochrane Library, Medline, Embase,

Biological Abstracts, and PsycLIT.

Data extraction and analysis Standardised mean

differencesfromeachtrialwereusedtoestimatetheeffect

of acupuncture and placebo acupuncture. The different

types of placebo acupuncture were ranked from 1 to 5

according to assessment of the possibility of a

physiological effect, and this ranking was meta-regressed

with the effect of acupuncture.

Data synthesis Thirteen trials (3025 patients) involving avariety of pain conditions were eligible. The allocation of

patients was adequately concealed in eight trials. The

clinicians managing the acupuncture and placebo

acupuncturetreatmentswere not blindedin anyof thetrials.

One clearly outlyingtrial (70patients)was excluded. A small

difference was found between acupuncture and placebo

acupuncture: standardised mean difference0.17 (95%

confidenceinterval0.26 to0.08), corresponding to 4 mm

(2 mm to 6 mm) on a 100 mm visual analogue scale. No

statistically significant heterogeneity was present (P=0.10,

I2=36%). A moderatedifferencewasfound between placebo

acupuncture and no acupuncture: standardised mean

difference0.42 (0.60 to 0.23). However, considerable

heterogeneity (P

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Data analysisFor each trial, we calculated thestandardised mean difference. We pooled the standar-dised mean differences from the trials by using meta-analysis, comparing the effect of acupuncture with thatof placebo acupuncture and the effect of placeboacupuncture with that of no acupuncture. In a pre-

planned sensitivity analysis, we used the authors

primary outcome.1011 In unplanned sensitivity ana-lyses, we studied the impact of the methodologicalquality of the trials and of the type of acupuncture. Weassumed that trials in which experienced acupunctur-ists were allowed to use individually chosen acupunc-ture points could differ in effect from other trials. Westudied whether the difference between acupunctureand placebo acupuncture was related to the type ofplacebo, by using meta-regression.

RESULTS

The search included 234 trials eligible for our

Cochrane review of placebo interventions (inprogress).7-9 We identified 20 potentially eligible trialsfor this review. We excluded seven trials because theystudied transcutaneous electrical nerve stimulation ormanual acupressure. We included 13 trials of acupunc-ture for pain (3025 patients) (see bmj.com).w1-w13

The patients type of painful conditions varied, anddurationof treatmentrangedfromone dayto 12weeks.Eight trials had concealed the allocation ofpatients.w1 w2 w7-w11 w13 No trials reported blinding ofthe clinicians, whereas blinding of the patients wasreported in 10 trials.w1-w3 w6-w12 In five trials theacupuncture treatment involved sessions with acu-

puncturists who could choose additional acupuncturepoints.w1 w2 w4 w7 w11 In twotrials theplacebo proceduresconsisted of non-penetrative needling.w4 w9 In 11 trialsthe placebo procedure penetrated the skin.

In all trials, all patients were provided with standardconcomitant care, typically consisting of analgesics(n=13) and physiotherapy (n=5). The patients in the noacupuncture groups used moreconcomitant treatmentthan did the patients in the placebo acupuncture andacupuncture groups.

Acupuncture versus placebo acupuncture

Substantial heterogeneity was present in the comparisonbetween acupuncture and placebo acupuncture(P

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When werestricted theanalysisto theseven trialswithleast risk of bias, substantial heterogeneity existed in thecomparisonbetweenacupunctureandplaceboacupunc-ture (P=0.01, I2=63%). The pooled standardised meandifference was 0.19 (0.35 to 0.02) (P=0.03). Hetero-geneity was also present in the similar comparisonbetween placebo acupuncture and no acupuncture(P=0.001, I2=72%). The pooled standardised meandifference was 0.54 (0.75 to 0.33) (P

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the placebo intervention was procedural and notmerely a placebo tablet.

Meaning of our review

On the basis of the trials that used visual analoguescales, the effect of acupuncture corresponds to areductionof4(2to6)mmona100mmscale.Theeffectof placebo acupuncture corresponds to a reduction of10 (6 to 15) mm. A consensus report characterised a10 mm reduction on a 100mm visualanalogue scale asrepresenting aminimal change.23 Thus, the apparentanalgesic effect of acupuncture seems to be below aclinically relevant improvement.

Considerable heterogeneity existed when we com-pared placebo acupuncture with no acupuncture butnotwhen we compared acupuncture with placebo acupunc-ture. Lack of blinding is inherent in the no acupuncture

groups.24

Variations in reporting bias, in use ofconcomitant treatment, and in the patient-providerinteraction could explain someof the observedvariationin the effect of placebo. Insufficient blinding is also aproblem for the comparison between acupuncture andplacebo acupuncture. The incomplete blinding of thepatients, and the interaction between the unblindedacupuncturist and the patients, could explain theobserved small effect.

Unanswered questions and future research

Our findings question both the traditional foundation ofacupuncture and the prevailing hypothesis that acu-

puncture has an effect on pain in general. Importantheterogeneity in the effect of placebo acupunctureremains unexplained and calls for further studies onthe underlying mechanisms of the effects of placeboacupuncture.

We suggest that futuretrials on acupuncture for painfocus on two strategies. Firstly, reducing bias byensuring blinding when possible. Secondly, separatingtheeffectsinvolved:thephysiologicaleffectofneedlingat acupuncture sites and the psychological effect of thetreatment ritual or patient-provider interaction.25

Conclusion

We found a small analgesic effect of acupuncture thatseems to lack clinical relevance and cannot be clearly

distinguished from bias. Whether needling at acupunc-ture points, or at any site, reduces pain independently ofthe psychological impact of the treatment ritual isunclear.

Contributors: See bmj.com.

Funding: None.

Competing interests: None declared.

Ethical approval: Not needed.Provenance and peerreview: Not commissioned; externally peer

reviewed.

1 Irnich D, Beyer A. Neurobiological mechanisms of acupunctureanalgesia. Schmerz2002;16:93-102.

2 Ghia JM,MaoW, Toomey TC,Gregg JM.Acupuncture and chronicpainmechanisms.Pain 1976;2:285-99.

3 Lewit K. Theneedle effect in therelief of myofascial pain.Pain1979;6:83-90.

4 Melzack R, Wall PD.Pain mechanisms: a newtheory.Science1965;150:171-9.

5 Melzack R. Acupuncture andpain mechanisms.Anaesthesist1976;25:204-7.

6 HanJS. Acupuncture and endorphins: mini review. Neurosci Lett2004;361:258-61.

7 HrbjartssonA,GtzschePC.Istheplacebopowerless?Ananalysisofclinical trials comparing placebo with no-treatment.N EnglJ Med

2001;344:1594-602.8 HrbjartssonA, GtzschePC. Is theplacebo powerless? Update of a

systematic review with52 new randomised trials comparing placebowith no-treatment.J Intern Med2004;256:91-100.

9 HrbjartssonA, Gtzsche PC. Placebo interventions for all clinicalconditions.CochraneDatabaseSyst Rev2004;(2):CD003974.

10 ChanAW, Hrbjartsson A, Haahr MT, Gtzsche PC,Altman DG.Empirical evidencefor selectivereportingof outcomesin randomizedtrials: comparison of protocols to published articles.JAMA2004;291:2457-65.

11 Higgins JPT, Green S.Cochranehandbook for systematicreviews ofinterventions. Version 5.0.1 [updated September 2008]. CochraneCollaboration, 2008 (availablefrom www.cochrane-handbook.org/).

12 Berman BM,Lao L, LangenbergP, LeeWL, GilpinAM, Hochberg MC.Effectivenessof acupunctureas adjunctivetherapyin osteoarthritisofthe knee: a randomized, controlled trial.Ann Intern Med2004;141:901-10.

13 DienerHC, KronfeldK, Boewing G, Lungenhausen M, Maier C,Molsberger A, et al. Efficacy of acupuncture for the prophylaxis of

migraine: a multicentre randomised controlled clinical trial.Lancet

Neurol 2006;5:310-6.14 Haake M,Mller HH, Schade-Brittinger C, Basler HD, Schfer H,

Maier C,et al.Germanacupuncture trials(GERAC)forchroniclowbackpain: randomized, multicenter, blinded, parallel-group trial with3 groups.ArchIntern Med2007;167:1892-8.

15 Assefi NP, Sherman KJ,JacobsenC, GoldbergJ, Smith WR,Buchwald D. A randomized clinical trial of acupuncture comparedwith shamacupuncture in fibromyalgia.Ann Intern Med2005;143:10-9

16 FurlanAD,vanTulder MW,Cherkin DC,TsukayamaH,Lao L,KoesBW,et al. Acupuncture and dry-needlingfor low back pain. CochraneDatabase Syst Rev2005;(1):CD001351.

17 CasimiroL, Barnsley L, Brosseau L, Milne S, RobinsonVA, Tugwell P,et al. Acupuncture and electroacupuncture for the treatment ofrheumatoid arthritis. CochraneDatabaseSyst Rev2005;(4):CD003788.

18 MelchartD, Linde K,Berman B, White A, Vickers A, AllaisG, et al.Acupuncture for idiopathic headache.CochraneDatabaseSyst Rev2001;(1):CD001218.

19 Green S, Buchbinder R, BarnsleyL, Hall S, White M, Smidt N, et al.Acupuncture for lateral elbow pain.CochraneDatabaseSystRev2002;(1):CD003527.

20 Trinh KV,Graham N, Gross AR,Goldsmith CH,Wang E, Cameron ID,et al. Acupuncture for neck disorders.CochraneDatabaseSyst Rev2006;(3):CD004870.

21 GreenS, Buchbinder R, Hetrick S. Acupuncture for shoulder pain.CochraneDatabaseSystRev2005(2):CD005319.

22 Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneouselectrical nerve stimulation and acupuncture for primarydysmenorrhoea. CochraneDatabaseSystRev2002;(1):CD002123.

23 Dworkin RH, Turk DC,Wyrwich KW, Beaton D, Cleeland CS,Farrar JT.Interpretingthe clinicalimportanceof treatment outcomesin chronicpain clinical trials: IMMPACT recommendations.J Pain2008;9:105-21.

24 Hr bjartsson A. What are the mainmethodological problemsin theestimation of placebo effects?J Clin Epidemiol2002;55:430-5.

25 Kaptchuk TJ,Kelley JM, Conboy LA,DavisRB, Kerr CE,Jacobson EE,et al. Components of placebo effect: randomised controlled trial inpatients with irritable bowel syndrome. BMJ2008;336:999-1003.

Accepted: 20 October 2008

WHAT IS ALREADY KNOWN ON THIS TOPIC

Acupuncture is commonly used for the treatment of pain

Acupuncture involves close patient-provider interaction with suggestive components

Blinding patients and especially treatment providers in acupuncture trials is a challenge

WHAT THIS STUDY ADDSThe analgesic effect of acupuncture is small and cannot be distinguished from bias resultingfrom incomplete blinding

Theanalgesic effect of placebo acupunctureis moderatebut veryvariable as some large trialsreport substantial effects

Theeffect of acupuncture seems to be unrelated to the type of placebo acupuncture used ascontrol

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Effectiveness of acute geriatric units on functional decline,living at home, and case fatality among older patientsadmitted to hospital for acute medical disorders:

meta-analysisJuan J Baztan,1 Francisco M Suarez-Garca,2Jesus Lopez-Arrieta,3 Leocadio Rodrguez-Manas,4

Fernando Rodrguez-Artalejo5,6

ABS TRA CT

Objective To assess the effectiveness of acute geriatric

units compared with conventional care units in adultsaged 65 or more admitted to hospital for acute medical

disorders.

Design Systematic review and meta-analysis.

Data sources Medline, Embase, and the Cochrane Library

up to 31 August 2008, and references from publishedliterature.

Review methods Randomised trials, non-randomised

trials, and case-control studies were included. Exclusions

were studies based on administrative databases, those

that assessed care for a single disorder, those that

evaluated acute and subacute care units, and those in

which patients were admitted to the acute geriatric unit

after three or more days ofbeingadmitted to hospital. Two

investigators independently selected the studies and

extracted the data.

Results 11 studies were included of which five were

randomised trials, four non-randomised trials, and two

case-control studies. The randomised trials showed thatcompared with older people admitted to conventional

care units those admitted to acute geriatric units had a

lower risk of functional decline at discharge (combined

oddsratio0.82,95%confidenceinterval0.68to0.99)and

were more likelyto live athomeafterdischarge(1.30,1.11

to 1.52), with no differences in case fatality (0.83, 0.60 to

1.14). The global analysis of all studies, including non-

randomised trials, showed similar results.

Conclusions Care of people aged 65 or more with acute

medical disorders in acute geriatric units produces a

functional benefit compared with conventional hospital

care, and increases the likelihood of living at home after

discharge.

INTRODUCTION

Several interventions have been proposed to improvethe effectiveness of hospital care for older people(65 years) with acute medical disorders. Assessmentof patients by a multidisciplinary team has not,however, shown benefits for case fatality, functionaldecline, or living situation at discharge.1 2 Hospital athomecare forelderly medical patientsreduceshospitalstay but increases overall length of care.3 Another typeof intervention is that provided by multidisciplinaryteams in acute geriatric units.4

We reviewed the effect of acute geriatric unitscompared with conventional hospital care on

functional decline, living at home after discharge,case fatality, and hospital stay in older people withacute medical disorders.

METHODS

Our review included randomised trials, non-rando-mised trials, and case-control studies that comparedoutcome of care in acute geriatric units with that inconventional hospital units in patients aged 65 years ormore with acute medical disorders. Acute geriatricunits were defined as hospital units with their ownlocation and structure and run by a multidisciplinaryteam with responsibility for the care of elderly peoplewith acute medical disorders that do not requiretreatment in other specialised units.

The primary outcomes were functional decline,living at home, and case fatality at discharge andthree months. We considered functional decline to beloss of independence in one or more basic activities ofdaily living compared with before admission,4 5 usingthe Katz index and the Barthel index; activities wereclassified as independent or dependent according tothe need for assistance.5 w3 w6 w10 Secondary outcomeswere hospital stay during the index admission and thecost of the index admission.

We searched Medline, Embase, and the CochraneLibrary up to 31 August 2008 and reference lists ofrelevant articles. Authors were contacted for missinginformation. JJB and FS independently extracted andcompared data. For randomised trials we extractedinformation on allocation concealment, the proportionof patients lost to follow-up, intention to treat analysis,

andwhetherassessmentofoutcomeswasdoneblindedtointervention.Fornon-randomisedtrialswerecordedonly losses to follow-up and outcome assessment.

We summarised the overall quality of randomisedtrials with the Jadad scale6 and the quality of all studieswith the Van Tulder scale.7

Data synthesis

For dichotomous outcomes we give the results ascombined odds ratios with 95% confidence intervalsand for quantitative outcomes as differences in meanswith standard errors. We used fixed effects methods tocombine outcomes across studies, except when impor-

tant heterogeneity was observed. Heterogeneity wasquantified with the I2 statistic, with I2 more than 30%

This article is an abridged version

of a paper that was published on

bmj.com. Cite this article as: BMJ2009;338:b50

1Department of Geriatrics,Hospital Central Cruz Roja,Madrid, Spain2Health Department, Principadode Asturias, Oviedo, Spain3Department of Geriatrics,La Paz-Cantoblanco UniversitaryHospital, Madrid, Spain

4Department of Geriatrics,Universitary Hospital, Getafe,Madrid, Spain5Department of PreventiveMedicine and Public Health,School of Medicine, UniversidadAutnoma de Madrid, Madrid,Spain6Biomedical Research CentreNetwork for Epidemiology andPublic Health (CIBERESP), Spain

Correspondence to: J J [email protected]

Cite this as: BMJ 2009;338:b50doi:10.1136/bmj.b50

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considered as important. We used random effectsmethods when results had to be combined.8 StatisticalanalyseswerecarriedoutusingRevMan4.3(CochraneCollaboration).

Whenappropriate we approximated standarddevia-tions from thestandarderrorand 95%confidence inter

vals.9

For two centres participating in one study,w1

weconsidered them as independent for the analysis ofhospital stay and its cost.

RESULTS

Twelve articles totalling 11 studies met the inclusioncriteria (see bmj.com). Seven were from the UnitedStates, the remainderfrom Australia, Canada, Sweden,and Peru. Authors of five studies were contacted fordata,w3 w5 w6 w9 w10 but for only onew6 was unpublisheddata on patients living at home after discharge and atthree months used.

Five studies were randomised trials,w1-w6 four non-randomised trials,w7-w10 and two retrospective case-control studies (see bmj.com).w11 w12 The quality of thestudies was heterogeneous, especially for non-rando-mised trials. Three of the randomised trialsused sealedenvelopes for allocation concealment.w3 w5 w6 Only onedid an intentionto treat analysis at discharge, but notatfollow-up.w6 Of the four non-randomised trials, threeused informal procedures for allocation based on bedavailability.w7 w9 w10

Criteria for patient selection were ageplus a medicalcondition not requiring admission to specialty units.Five studies included patients aged 70 or more,w2 w7

three aged 65 or more,w1 w10 w11

and one aged 75 ormore.w9 One study selected patients aged 75 or morewith at least one geriatric condition.w8 One studyselected patients aged 65 or more admitted for heartfailure, pneumonia, or urinary tract infection.w12 Twostudies excluded older people (70 years) living innursing homes,w2 w6 and onew11 included only thoseliving in nursing homes.

In four of the five randomised trials all the patientscame from emergency services,w2-w6 whereas in threenon-randomised studies more than 62% came fromemergency services.w7 w9 w10 Three studies did notprovide this information.w8 w11 w12

The intervention units functioned in similar ways,generally having four characteristics that distinguishedthem from conventional units: comprehensive assess-ment of patients, use of standardised instruments formeasurements, weekly multidisciplinary meetings,and early planning of discharge. The composition ofthe basic multidisciplinary team typically included atleast one geriatrician, nurses trained in geriatrics, asocial worker, and therapists.

The follow-up period varied. All the randomisedstudies except onew1 provided follow-up data at threemonths, at a minimum. Five studies reported on

readmissions, two at three monthsw3 w5

and three atone month.w6 w9 w11

Functional decline

Only three studies presented results on functionaldecline at discharge, two of which were randomisedtrials(seebmj.com). In these twostudies, thepatients inacute geriatric units showed a lower risk of functionaldecline than those in conventional units (combined

odds ratio 0.82, 95% confidence interval 0.68 to 0.99).After the inclusion of a non-randomised study, resultswere similar (0.78, 0.65 to 0.94) but showed greaterheterogeneity (I2=55.7%) because of the large reduc-tion in functional decline in the acute geriatric unit inthat study (0.35, 0.17 to 0.76).w10

Only one studyw6 provided data on functionaldecline at three months after discharge, with nodifferences between the groups. Another three rando-mised studies provided data that could not be analysedbut reported an absence of differences in functionaldecline at three months.w2 w3 w5

Living at homeIn randomised studies, patients cared for in acutegeriatric units were more likely to return home afterdischarge (1.30, 1.11 to 1.52), a benefit that wasmarginally maintained three months after discharge(see bmj.com). Results at discharge still held whenanalyses were repeated including non-randomisedstudies (1.28, 1.12 to 1.47).

Acute geriatric units and conventional care unitsshowed no differences in frequency of admission to anursing home at discharge (0.76, 0.51 to 1.28) or threemonths (0.90, 0.74 to 1.14).

Case fatalityNo significant differences were found in case fatalitybetween acute geriatric units and conventional careunits either in hospital or three months after discharge(see bmj.com).

Length of hospital stay and cost of admission

All the included studies reported on length ofhospital stay, but three did not report dispersionmeasures.w1 w3 w11 The length of stay in the acutegeriatric units was fewer than 12 days; fewer thanninein studies published from1995. In nine ofthe 11studies a trend was towards a reduced length of stay,

of 6-39%,w1 w3 w5 w6 w8-w12

but was heterogeneousamong studies (I2 was 49.4% in randomised studies,74.1% in non-randomised studies).

Dataonthecostofhospitalstaywerereportedinfourof thefive randomised studiesw1 w3-w6 andinthreeofthesix non-randomised studies.w7 w8 w12 Although the dataaredifficult to interpret because they did notallowcosteffectiveness ratios to be estimated, a slightly, yetsignificant, lower cost of hospital care was found inacute geriatricunits (combinedmean difference 0.31,95% confidence interval 0.52 to 0.09; I2=0%).

Sensitivity analysis

Results for separate analyses for the randomisedstudies and the other studies were similar, except that

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the reduction in hospital stay was larger in the non-randomised studies. The analysis was repeated afterexcluding the oldest studies (published before 1995

and lacking a geriatrician), and after assuming adverseresults in people lost to follow-up or lacking data onoutcomes. No substantial changes were found.

DISCUSSION

The results of this meta-analysis suggest that care ofolder people (65 years) with acute medical disordersin acute geriatricunitsleads to less functional decline atdischarge and a higher probability of returning home.

The 18% reduction in functional decline associatedwith acute geriatric units is similar to that found in astudy of patients aged 65 or more with acute medicaldisorders who received physiotherapy within multi-

disciplinary care.10 The benefit of returning home wasalso comparable tothat reportedin another studyin thecombined analysis of acute and subacute hospital careunits.1 Although the tendency towards a higherprobability of living at home was maintained at threemonths after dischargefrom an acute geriatric unit, thereduction in functional decline was seen only atdischarge. We did not find a reduction in case fatalityeither at discharge or at three months.

Thestudiesreviewedprovidelimitedinformationonthe characteristics and form of operation of theconventional hospital units. This is important because

the effect of acute geriatric units is measured bycomparison with these units and could vary dependingon the characteristics of conventional units. Althoughthe acute geriatric units in this review includedtherapists, in general they did not have more staffthan the conventional units so that differences seem tocentre on specialisation and organisation of work. Thedistinctive feature of acute geriatric units is thecomprehensive assessment and care focusing onpatients needs, interdisciplinary work carried out bya core team of professionals, and early planning ofdischarge. Other studies have evaluated partial aspectsof this care, such as early discharge planning or

physiotherapy alone,1011

without finding conclusiveresults, indicating that the benefit may derive from a

combination of these interventions.1 Specialisation inthe care of elderly people and formal interdisciplinarymeetingsmay contribute to thebenefitsof care in acutegeriatric units, as has been shown in patients withstroke.12 Another aspect of acute geriatric units thatmight contribute to their effectiveness is direct

responsibility for the patient, which ensures compli-ance with diagnostic and therapeutic recommenda-tions and the implementation of the care plan. 1 w29

This review has some limitations. The number ofrandomised trials included is small, and our findingsmight reflect usual clinical practice until 2000 (date ofthemost recentrandomisedstudy in this review). Thusthe effect of acute geriatric units compared withconventional hospital units may have changed. How-ever, more recent controlled studiesw9 w10 w12 suggestthat the differences between acute geriatric units andconventional units still remain. Finally, the studiesevaluated do not provide data on the components ofthe intervention responsible for the benefits observed,nor do they permit us to draw firm conclusions on theeffect of acute geriatric units on other relevant out-comes in the medium and long term, except forreturning home to live.

In conclusion, acute geriatricunits reduce functionaldecline at discharge and increase the probability ofliving at home at discharge and at three months afterdischargewithoutincreasing casefatalityor the costsofhospital care.

We thank Mercedes Corrales for her help with the literature search.


Funding: This study was partially funded by grant N o FIS PI05/90212 and

research on fragility and the elderly (RETICEF) grant No RD06/0013,

Instituto de Salud Carlos III, Ministry of Health and Consumer Affairs.Competing interests: None declared.

Ethical approval: Not required.

1 EllisG, Langhorne P. Comprehensive geriatric assessment for olderhospital patients. BrMed Bull2005;71:45-9.

2 Gray L. Geriatricconsultation: is there a future?AgeAgeing2007;36:1-2.

3 ShepperdS, IliffeS. Hospital athomeversusin-patienthospital care.CochraneDatabase SystRev2005;(3):CD000356.

4 Palmer RM,Counsell SR,Landefeld SC. Acute care forelders units.Practicalconsiderationsfor optimizing healthoutcomes.DisManageHealth Outcomes2003;11:507-17.

5 SagerMA,FrankeT, InouyeSK,LandefeldS, MorganTM,RudbergMA,et al. Functional outcomes of acute medical illness andhospitalization in older persons.ArchIntern Med1996;156:645-52.

6 JadadA, MooreRA, CarrollD, Jenkinson C,Reynolds JM,Gavaghan DJ,

et al. Assessing the quality of reportson randomizedclinicaltrials: isblinding necessary?Control ClinTrials 1996;17:1-12.7 Van Haastregt JCM,DiederiksJPM,vanRossum E,de Witte LP,

Crebolder HFJM. Effects of preventive homevisits to elderly peopleliving in the community: systematic review.BMJ2000;320:754-8.

8 Higgins JP, ThompsonSG, Deeks JJ, Altman DG.Measuringinconsistency in meta-analyses. BMJ2003;327:557-60.

9 Altman DG.Confidence intervals. In: Sackett DL,Straus SE,Richardson WS,Rosenberg W, HaynesRB, eds. Evidence-basedmedicine, 2nd ed. Toronto: Harcourt, 2000:211-20.

10 De MortonNA, Keating JL,Jeffs K. Exercise for acutelyhospitalisedolder medical patients.CochraneDatabaseSyst Rev2007;(1):CD005955.

11 Shepperd S, ParkesJ, McClaren J, Philips C. Discharge planning fromhospital to home. CochraneDatabaseSystRev2004;(1):CD000313.

12 Stroke Unit Trialist Collaboration. Collaborative systematic review oftherandomisedof organised inpatients(strokeunit)care after stroke.BMJ1997;314:1151-9.



The effect of geriatric assessment has been evaluated inhospital and community settings

In older people admitted to hospital with acute disorders,the intervention of consultation teams has not shownclinical or administrative benefits

WHAT THIS STUDY ADDS

Care of older people with acute disorders in acute geriatricunits reduces the riskof functional decline at discharge andincreases the probability of returning home

This benefit is not accompanied by an increase in casefatality or hospital costs

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Comparing hospital and telephone follow-up aftertreatment for breast cancer: randomised equivalence trial

Kinta Beaver,1 Debbie Tysver-Robinson,2 Malcolm Campbell,1 Mary Twomey,1 Susan Williamson,1

Andrew Hindley,3

Shabbir Susnerwala,3

Graham Dunn,4

Karen Luker1

ABS TRA CT

Objective To compare traditional hospital follow-up with

telephone follow-up by specialist nurses after treatment

for breast cancer.

Design Atwocentrerandomisedequivalencetrialinwhich

women remained in the study for a mean of 24 months.

SettingOutpatient clinics in twoNHS hospitaltrustsin the

north west of England

Participants 374 women treated for breast cancer who

were at low to moderate risk of recurrence.

Interventions Participants were randomisedto traditionalhospital follow-up (consultation, clinical examination,

and mammography as per hospital policy) or telephone

follow-up by specialist nurses (consultation with

structured intervention and mammography according to

hospital policy).

Main outcome measures Psychological morbidity (state-

trait anxiety inventory, general health questionnaire

(GHQ-12)), participants needs for information,

participants satisfaction, clinical investigations ordered,

and time to detection of recurrent disease.

Results The 95% confidence interval for difference in mean

state-trait scores adjusted for treatment received (3.33 to

2.07) was within the predefined equivalenceregion (3.5 to3.5). The women in the telephone group were no more

anxiousasaresultofforegoingclinicexaminationsandface-

to-face consultations and reported higher levels of

satisfaction than those attending hospital clinics (intention

to treat P

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Participants randomised to telephone follow-upreceived telephone appointments from breast carenurses at intervals consistent with hospital follow-up.Eachtelephoneappointmentwasallocated30minutes;20 minutes for conducting the consultation and10 minutes to dictate the outcome of consultations.

Throughout the study the same specialist nursecontacted each participant in the telephone group forall appointments.

We developed a structured telephone interventionfrompreviousfindingsoninformationneedsofwomenwith breast cancer,1213 adapting a research instrumentforuseasaclinicalguide.14 Specific questions related tochanges in condition, new symptoms, and informationrequirements about spread of disease, treatment andside effects, genetic risk, sexual attractiveness, self care(diet, support groups, finances), and family concerns.

Outcome measures

Outcomesincludedpsychological morbidity, informa-tion needs, participants satisfaction, clinical investiga-tions ordered, and time to detection of recurrentdisease. We measured psychological morbidity using

two instruments: the Spielberger state-trait anxietyinventory (STAI) and the general health questionnaire(GHQ-12).

Clinical data were collected prospectively. We usedtwo key index dates to establish time to diagnosis ofrecurrence: date of first presentation of symptoms (or

indicator of recurrence) and date recurrence wasconfirmed to participants. Time to diagnosis ofrecurrence was taken as the difference between thetwo index dates. At the end of the study we retro-spectively examined all participants case notes tocheck accuracy of data on recurrence.

We sent initial questionnaires to patients immedi-ately after randomisation, a minimum of three monthsbefore their next appointment. Questionnaires werealso posted to participants at themiddle and end of thetrial.

Statistical analysis

Contrary to a standard comparative trial, an equiva-lencetrialhasanalternativehypothesisofnodifferencebetween treatments or services.15 We entered andanalysed data with SPSS, release 15. Our study waspowered on the basis of a 95% equivalence region of3.5 to 3.5 for the difference in mean state-trait scoresbetween groups at the end of the trial, 3.5 being 10% ofthe expected control mean, with an expected SD of10.0.

RESULTS

Recruitment took place between March 2003 andAugust 2005. Data collection continued until October

2006; patients remained in the study for a mean of24 months (range 2-43 months). Most patientsapproached who metthe inclusioncriteria werewillingto participate (374/629,60%);215 patients whodid nottake part provided sociodemographic and treatmentinformationandareasonforrefusal.Reasonsincluded:preference for face-to-face consultations; preferencefor clinical examination; and family members fearingexclusions from consultations if the appointment wasconducted by telephone. Participants were rando-mised to hospital (183, 49%) or telephone (191, 51%)follow-up. Sociodemographic and clinical character-istics for those randomised were broadly similar in the

twostudygroups.ThesamplewasrepresentativeoftheUKbreastcancerpopulationintermsofage,withmoreparticipants in the 55-64 year age group than the otherage group categories, in line with data from the UKOffice for National Statistics.16 Participants were amedian of 20 months from diagnosis, although most(63%) were 24 months or less from diagnosis Thosewho refused to take part differed from participants instudy site, social class, and follow-up status. Patients atthespecialistbreast unit (71%) were morelikely towantto participate than those at the district general hospital(61%,2=5.01,df=1, P=0.025),participantsfromhighersocial classes (professional occupations) were more

likely to want to participate than those from lowersocial classes (2=15.77, df=8, P=0.046), and

Table 1 | Satisfaction with information received by randomised group (intention to treat

analysis). Figures are numbers (percentages) of women

Level o f s atisfaction Hospital Telephone

Between groups comparison P value

All categories* First 4 categories

Start of trial

Very satisfied 79 (46) 78 (45)

0.671

2trend=0.31, 0.576

Satisfied 67 (39) 71 (41)

Not very satisfied 4 (2) 8 (5)

Very unsatisfied 1 (1) 0 (0.0)

Did not receiveinformation

10 (6) 6 (4)

Did not needinformation

10 (6) 10 (6)

Overall 171 (100) 173 (100)

Middle of trial

Very satisfied 57 (49) 110 (80)

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participants with three to 12 months between visits(67.7%, 70.6%) were more likely to participate thanthose on six monthly follow-up (58.1%, 2=7.66, df=2,P=0.022). Time from diagnosis did not differ signifi-cantly for those who did or did not take part ( t=0.26,P=0.80)

Sociodemographic and clinical data were collectedfor all randomised participants. Eight patients fromthespecialist breast unit and 17 from the district generalhospitaldidnotreturnquestionnairesatanytimepoint.Those participating at the end of the trial had a shortertime from diagnosis at the start of the trial (median18 months) than those who had dropped out afterparticipatingatleastonce(median25.5months,Mann-Whitney U=5902.5, P=0.019), and a shorter time frompost-treatment visit at the start of the trial (15 v25 months, U=6046.0, P=0.033).

Psychological morbidity

Differencesbetweengroupsinstate-traitscorewerenotsignificant at the start, middle, or end of the trial underintention to treat or adjusted treatment receivedanalyses, although means were consistently lower forthetelephonegroup(seebmj.com). Mean score didnotsignificantly improve during the trial and the 95%confidence intervals for the differences between meanvalues (hospital v telephone) of state-trait scores forintention to treat and adjusted for treatment (forinstance, 3.33 to 2.07 for) were within the prestatedequivalence region indicated equivalence (seebmj.com for further details).15

Information needsWithin both randomised groups, information needsreduced over time for all items, and there was littledifference between the groups in information needs.The need for information on genetic risk remained thehighest at the end of the trial, with 92 of the 296respondents to the question (31%) still requiringinformation.

Participants satisfaction

There were no significant differences between rando-mised groups initially regarding satisfaction withinformation received (table 1). The telephone group

showed significantly more satisfaction at the middleandendofthetrial(P

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telephonegroup(Mann-WhitneyU=

21.0,P=

0.228,fordifference).

DISCUSSION

Telephone follow-up by specialist breast care nurseshas benefits for women with breast cancer. Thetelephone intervention provided a service to womenthat met their needs, with no evidence of physical orpsychological disadvantage. We weretherefore able toshowequivalence,intermsofpsychologicalmorbidity,between hospital and telephone follow-up.

Scores on the state-trait anxiety inventory did notsignificantly improve in either group during the trial,

although this measure has been used successfully inpatients with breast cancer in previous studies. Find-ings for the anxiety inventory and GHQ-12 indicatedthat there were no differences between scores forstudygroups at any point in the trial.

Those in the telephone group reported greatersatisfaction with the information received andreported appointments as more helpful in meetingtheir needs. There were no differences in terms ofinvestigations ordered between groups. These find-ings, however, are based on participants retrospec-tive recall of investigations ordered; response mighthave been subject to inaccuracies. Participants in the

telephone group were no more likely to consult withother health professionals between visits thanthose inthe hospital group and so were not using additionalhealthcare resources.

Only 17 (4.5%) recurrences were detected. Thesewere mostly interval events; no recurrences weredetected in patients without symptoms at routineappointments. There were no differences in time todetectionof recurrence between the groups. Follow-updoes not usually have a different format for high riskgroupsbutatthisstageourfindingscanbeappliedwithconfidence only to women at low risk of recurrence.

Alternating telephone and hospital follow-up,

accordingtopatients

preferences,couldbeasuitableapproach, whilehospital follow-up might continue to

be preferred by those who do not feel comfortablediscussing their concerns over the telephone. Tele-phone follow-up is convenient, especially in ruralareas where patients might have to travel longdistances for hospital appointments and for thosewith limited mobility. Telephone follow-up might

have broader applicability to other groups ofpatients.Therearenursespecialistsformanydiseasesand their skills could be harnessed to provide aquality service while reducing the burden on busyhospital clinics.

We thank the following collaborators whose continued support was vital

to the successful completion of the study: A Baildam, L Barr, G Byrne,

V Chadwick, F Danwata, S Foster, P Kiriparan, M Noblet, F O Regan,

S Rajan, L Thomson, C Turner. Lesley Degners seminal work on

information needs of cancer patients has provided continued inspiration.

We also thank all the patients who participated in this study.


Funding: The trial was funded by the Medical Research Council (UK) and a

project grant from Rosemere Cancer Foundation (UK). The funding

agencies had no role in the design and conduct of the study, in the

collection, analysis and interpretation of the data, or in the preparation,

review or approval of the manuscript.


Ethicalapproval:Thisstudy was approved by the central office of research

ethics committees in England and research and development

departments at both study sites. All participants gave both verbal and

written consent to take part in the study.

Provenance and peerreview: Not commissioned; externally peer

reviewed.

1 RojasMP, Telaro E,Russo A,MoschettiI, Coe L,Fossati R,et al. Followup strategies for women treated for early breast cancer. CochraneDatabase Syst Rev2005;(1):CD001768.

2 ChurnM, KellyV. Outpatient follow-upafter treatment forearlybreastcancer: updated results after 5 years. ClinOncol 2001;13:187-94.

3 Dewar J,Kerr G.Valueof routine followup ofwomentreatedfor early

carcinomaof the breast.BMJ1985;291:1464-67.4 DonnellyJ, MackP, DonaldsonLA.Follow-up ofbreastcancer:time for

a newapproach? Int J ClinPract2001;55:431-3.5 GrunfeldE, MantD, YudkinP, Adewuyi-DaltonR, Cole D,Stewart J,

et al.Routine followup of breastcancer in primary care: randomisedtrial. BMJ1996;313:665-9.

6 Snee M. Routine follow-up of breast cancer patients. ClinOncol1994;6:154-6.

7 NationalInstitute for Health and Clinical Excellence. Improvingoutcomes in breast cancer. London: NICE, 2002.

8 McArdle J, GeorgeWD, McArdle CS, Smith DC, MoodieAR,Hughson AV, et al. Psychological support for patients undergoingbreast cancer surgery: a randomised study. BMJ1996;312:813-6.

9 Baildam A, Keeling F, NobletM, Thomson L, Bundred N, Hopwood P.Nurse ledfollow-up clinics forwomentreatedfor primary breastcancer: a randomised controlled trial. EurJ Cancer2002;38(suppl 3):136.

10 Piaggio G, Elbourne DR,Altman DG,Pocock SJ,EvansSJW. Reporting

of noninferiority and equivalence randomised trials: an extension ofthe CONSORT statement.JAMA2006;295:1152-60.11 GaleaMH, Blamey RW,ElstonCE, Ellis IO. The Nottinghamprognostic

index in primary breast cancer.BreastCancer ResTreat1992;22:207-19.

12 Degner LF,Kristjanson LJ,Bowman D, Sloan JA,CarriereKC, ONeilJet al. Informationneeds and decisional preferences in women withbreast cancer.JAMA1997;277:1485-92.

13 Luker KA,Beaver K, Leinster SJ, Owens RG. Theinformation needs ofwomen with breast cancer: a follow up study.J AdvNurs1996;23:487-95.

14 Beaver K, TwomeyM, WithamG, FoyS, Luker K. Meeting theinformationneeds of women with breast cancer: pilotinga nurse ledintervention. Eur J Oncol Nurs2006;10:378-90.

15 JonesB, JarvisP, LewisJA, EbbuttAF.Trialsto assessequivalence:theimportance of rigorous methods.BMJ1996;313:36-9.

16 Office for National Statistics.Health: breast cancer. www.statistics.gov.uk/cci/nugget.asp?id=575.



UK national guidelines recommend that routine long termfollow-up after treatment for breast cancer is noteffective atprolonging survival

Brief consultations aimed at detection of recurrence do notprovide opportunities for discussion of information and

psychosocial needs


Participants in a telephone follow-up group were no moreanxious as a result of foregoing clinical examinations andface-to-face contact

Telephone follow-up was associated with high levels ofsatisfaction in patients

Telephone follow-up might decrease the burden on busyhospital clinics

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Long term survival after evidence based treatment of acutemyocardial infarction and revascularisation: follow-up ofpopulation based Perth MONICA cohort, 1984-2005

Tom Briffa,1 S Hickling,1 M Knuiman,1 M Hobbs,1J Hung,2 F M Sanfilippo,1 K Jamrozik,3 P L Thompson2

ABS TRA CT

Objective To examine trends in long term survival in

patients alive 28 days after myocardial infarction and the

impact of evidence based medical treatments and

coronary revascularisation during or near the event.

Design Population based cohort with 12 year follow-up.

SettingPerth, Australia.

Participants 4451 consecutive patients with a definite

acute myocardial infarction accordingto the WorldHealth

Organization MONICA (monitoring trends anddeterminants in cardiovascular disease) criteria admitted

to hospital during 1984-7, 1988-90, and 1991-3.

Main outcome measures All cause mortality identified

from official mortality records and the hospital morbidity

data, with death from cardiovascular disease as a

secondary end point.

Results In the 1991-3 cohort, 28 day survivors of acute

myocardial infarction had a 7.6% absolute event

reduction (95% confidence interval 4% to 11%) or a 28%

lowerrelativerisk reduction (16%to 38%), unadjusted for

risk of death, over 12 years after the incident admission

comparedwiththe1984-7cohort,similartothesurvivalof

the 1988-90 cohort. The improved survival for the 1991-3cohort persisted after adjustment for demographic

factors, coronary risk factors, severity of disease, and

event complications with an adjusted relative risk

reductionof 26% (14% to 37%),but this wasnot apparent

afterfurtheradjustment for medicaltreatmentsin hospital

and coronary revascularisation procedures within

12 months of the incident myocardial infarction.

Conclusion Theimprovingtrends in12 year survivalaftera

definite acute myocardial infarction are associated with

progressive use of evidence based treatments during the

initial admissionto hospitaland inthe 12months afterthe

event. These changes in the management of acute

myocardial infarction are probably contributing to thecontinuing decline in mortality from coronary heart

disease in Australia.

INTRODUCTION

The long term decline in mortality from coronaryheart disease in Australia and elsewhere has beenwidely attributed to both declining incidence andadvances in medical treatment.1 2 Previous studies inPerth, including the World Health OrganizationMONICA project (monitoring trends and determi-nants in cardiovascular disease), have shown rapid

and progressive uptake in aspects of medical careshown in randomised clinical trials to reduce both

acute and medium term mortality after acute myo-cardial infarction.3-5 Such treatment included anti-platelet therapy, thrombolysis, blockers, lipidlowering drugs, angiotensin converting enzymeinhibitors, and coronary artery revascularisation.6-10

Thereare,however,fewstudiesdocumentingthelongterm impact at the population level on survival afteracute myocardial infarction or on death rates fromcoronary heart disease.

We examined trends in long term survival in peopleregistered as having an acute myocardial infarctionover a 10 year period in Australia.

METHODS

Study populationThe study population comprised allresidents of the Perth Statistical Division (populationsize 1.19 million in 1991) aged 35-64 who wereadmitted to hospital with a first non-fatal definiteacute myocardial infarction, andwith no admission forischaemic heart disease in the previous four years,registered by thePerthMONICA project during1984-

93.11

Only individuals who survived 28 days after anincident acute myocardial infarction were included.

Data sources and record linkageWe linked records inthe Perth MONICA register to a file of all hospitaladmissions for cardiovascular disease and relateddeaths in Western Australia from 1980-2005, repre-senting a minimum follow-up period of 12 years.

Follow-up and end pointsOur principal end pointwas all cause mortality, with death fromcardiovasculardisease as a secondary end point. We examined theincidenceof coronary artery revascularisation within ayearofanindexeventasacovariaterelatingtosurvivalafter one year.

Possible factors influencing long survival after acutemyocardial infarctionWe divided the cohort intothree subcohorts (1984-7, 1988-90, and 1991-3).Other factors selected for analysis included age andsex, smoking status, medical history, and measures ofdiseaseseverity and treatmentincluding selecteddrugsused during the acute event, or at discharge, orcoronary artery revascularisation within 12 months.

Analysis of dataWe examined differences in thedistribution of demographicand clinicalcharacteristicsfor the three subcohorts (1984-7, 1988-90, 1991-3) andplotted Kaplan Meier curves of time to death to

determine differences in survival. We used Coxregression to examine the hazard ratio for death over

This article is an abridged version

of a paper that was published on

bmj.com. Cite this article as: BMJ2009;338:b36

1School of Population HealthM431, University of WesternAustralia, Crawley, WesternAustralia 60092School of Medicine andPharmacology M503, Universityof Western Australia, CrawleyWestern Australia 60093School of Population Health andClinical Sciences NG45, Universityof Adelaide, South Australia 5005

Correspondence to: T [email protected]

Cite this as: BMJ 2009;338:b36doi:10.1136/bmj.b36

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12 months and 12 years, with adjustment for possiblefactors influencing survival.

RESULTS

Baseline characteristics

From 1984 to 1993, 5340people were admitted to hospital with first acutemyocardial infarction and survived at least 28 days.Some 889 (16%) were excluded for admission tohospital with ischaemic heart disease within four yearsof the index event. Their mean age was 54.4 (SD 7.3)years. Overall, 18% were women, 10% had a history ofdiabetes, 51% were current smokers, and 40% had ahistory of hypertension. The prevalence of diabetesincreased with each successive subcohort, smokingdecreased, and hypertension was unchanged. Whilethe median creatine kinase ratio was unchanged overtime, the prognostic markers of Q wave acute myo-

cardial infarction and ST deviation successively fellwith each subcohort. This was associated with com-plementary changes in the electrocardiogram score.Likewise, the proportion with changes on anteriorelectrocardiogram increased after the first subcohort.There were significant changes in treatment with eachsuccessive subcohort: a marked increase in the useof blockers,antiplatelets, and thrombolytic treatmentduring the acute episode, and significant uptakeof antiplatelets, angiotensin converting enzyme

inhibitors, blockers, and lipid lowering drugs at thetime of discharge from hospital.

Trends in revascularisationThe proportion of revas-cularisationwithin12monthswas2%in1984-7,31%in1988-90, and 38% in 1991-3 (P

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adjustment for medical treatment during admissionand coronary artery revascularisation within12 months of the incident acute myocardial infarction.The improvement in survival over 12 years betweenthe 1984-7 and 1988-90 subcohorts was borderline(P=0.055) (fig 1). Twelve year survival trends for

cardiovascular death by subcohort were comparablewith findings for all cause mortality (fig 2). Theproportion of total deaths after 12 years caused bycardiovascular disease in first, second, and thirdsubcohorts was 70%, 66%, and 61%, respectively.

DISCUSSION

Thispopulationbasedstudyshowsimprovingtrendsinone and 12 year survival in those alive at least 28 daysafter a definite acute myocardial infarction. Improvedsurvival in the early 1990s over the early 1980scorresponds with the introduction of new treatmentsrather than changes in risk factors beforethe infarction

or severity of infarction.

Strengths and weaknesses of study

Our study covers a 10 year period during whichtreatment for coronary heart disease was changingrapidly in response to published research. We appliedunchanging criteria for definite acute myocardialinfarction which would overcome diagnostic driftover time. Near complete follow-up (estimated at99%) wasachieved.Our analysisreconfirmed the mainpredictorsof survivalafter acute myocardial infarction,similar to previous studies1213 but over a longer term.

The use of proved medical treatment, as exemplifiedby antiplatelets, thrombolysis, and blockers duringadmission to hospital, and performance of coronaryartery revascularisation within 12 months after anincident acute myocardial infarction accounted for thegreatest improvement in survival over 12 years.Proportionately 9% fewer cardiovascular deathsoccurred over 12 years in the 1991-3 subcohort thanin the 1984-7 subcohort.

This study has some limitations. Severity of diseasedid not account for differences in survival between thesubcohorts. More sophisticated and comprehensivemeasures of disease severity might indicate a contribu-tion of altered severity to the change in longer termsurvival. Although our findings involve a relatively

younger population (age 35-64) they are consistentwith findings from an unrestricted cohort of adults inScotland.14 Our study was observational in nature andthe results should be interpreted with caution.

Relevance of our findings

Other studies have reported improvements in survivalafter acute myocardial infarction during similar histor-ical periods, with improvement in short term survivalattributed to treatment, and the long term survivaladvantage linked to diet, smoking cessation, andcontinuing treatment with aspirin and blockers.1415

A registry study of residents with acute myocardial

infarction from Gerona, Spain, showed no significantdifferences in the three year mortality in 28 daysurvivors between periods 1978-85 and 1986-8,16

although the observational period in this study werebefore the widespread uptake of thrombolytic treat-ment, antiplatelets, and coronary artery revascularisa-tion.Improvements in long termsurvival are probablyattributable to a combination of various treatmentsrather than any single treatment.

Prescriptions for lipid lowering drugs and angioten-sinconvertingenzymeinhibitorshaveincreasednearly20-fold from 1991 to2004.Thissuggests that patientsinthe1991-3subcohortwereprobablyexposedtogreater

use of such drugs than those in the earlier subcohorts.Changes in lifestyle characteristics and dietary prac-tices might also have contributed to trends insurvival.1718 We have controlled for hypertensionand diabetes mellitus that are partly consequences ofoverweight and lifestyle. Data on body mass index,physicalinactivity,andsmokingwerenotavailableandso cannot directly be adjusted for.

Changes in severity of disease could also improvelong term survival, though we found no change increatine kinase ratios from the 1984-7 to the 1991-3subcohort. Adjustment for markers of disease severitydid not alter the one and 12 year survival differencesseen between the 1991-3 and 1984-7 subcohorts.

Conclusion

One and 12 year survival increased in patients aged35-64 who were alive 28 days after an incident acutemyocardial infarction from 1984 to 1993. Theimprovement is associated with changes in treatmentduring and wi thin 12 months of the event .The magnitude of the contribution of evidencebased treatment to the decline in mortality fromcoronary heart disease remains unanswered asdoes the contribution of chronic cardioprotectivepharmacotherapy.

We thank Steve Ridout for his programming skills in linking the largedatasets used in this analysis.


Medical care and control of coronary risk factors bothcontribute to the decline in mortality from coronary heartdisease

Littleis knownaboutthe impactof adoptingrobustevidencefrom clinical trials on long term survival after acutemyocardial infarction


Patients with acute myocardial infarction who receive drugtreatments of proved value during presentation to hospitaland undergo coronary revascularisation within 12 monthsare more likely to survive over 12 years

Evidence based treatment of acute myocardial infarction isassociated with improved long term survival and probablycontributes to the continuing decline in mortality from

coronary heart disease in Australia

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Funding: The study was supported by the University of Western Australia

and the WHO MONICA project.


Ethical approval: The protocol for the study was approved by the human

research ethics committees of the University of Western Australia and

independent State Department of Health.

1 Tunstall-Pedoe H, Vanuzzo D, Hobbs M, Mahonen M, CepaitisZ,KuulasmaaK, et al. Estimation of contribution of changesin coronarycare to improving survival, event rates, and coronary heart diseasemortality across the WHO MONICA project populations.Lancet2000;355:688-700.

2 BeagleholeR, StewartAW, JacksonR, DobsonAJ,McElduff P,DEsteK,et al. Decliningrates of coronary heart disease in New Zealand andAustralia,1983-1993.Am J Epidemiol1997;145:707-13.

3 McElduffP, DobsonA, JamrozikK, Hobbs M.TheWHOMONICAstudyinAustralia,1984-93:asummaryof theNewcastleandPerthMONICAprojects. Canberra: Australian Institute of Health and Welfare;2000. (Report No AIHW, CatNo 11.)

4 ThompsonPL, NidorfSM, ParsonsRW, JamrozikKD, HobbsMS. Thebenefits of beta-blockade at the time of myocardial infarction.JHypertensSuppl1991;9:S35-7.

5 Czarn AO,JamrozikK, Hobbs MS,ThompsonPL. Follow-upcare afteracute myocardial infarction.MedJ Aust1992;157:302-5.

6 ISIS-2. Randomised trial of intravenous streptokinase, oral aspirin,

both, or neither among 17,187 cases of suspected acute myocardialinfarction: ISIS-2. ISIS-2 (second international study of infarctsurvival) collaborative group. Lancet1988;2:349-60.

7 Yusuf S, WittesJ, Friedman L. Overview of results of randomizedclinical trials in heart disease. I. Treatments following myocardialinfarction. JAMA1988;260:2088-93.

8 AntiplateletTrialists Collaboration.Secondary preventionof vasculardisease by prolonged antiplatelet treatment. Antiplatelet TrialistsCollaboration. BMJ1988;296:320-31.

9 LagerqvistB, HustedS,KontnyF,NaslundU, StahleE,SwahnE, etal.Along-termperspective on the protective effects of an early invasivestrategyin unstablecoronaryarterydisease:two-year follow-upof theFRISC-II invasive study.J Am CollCardiol2002;40:1902-14.

10 Fox KA,Poole-Wilson PA,Henderson RA,ClaytonTC, ChamberlainDA,Shaw TR, et al. Interventional versus conservative treatment forpatients with unstable angina or non-ST-elevation myocardialinfarction: the British Heart Foundation RITA 3 randomised trial.Randomized interventiontrial of unstable angina.Lancet2002;360:743-51.

11 Tunstall-Pedoe H, Kuulasmaa K, Amouyel P, Arveiler D,RajakangasAM, PajakA. Myocardialinfarctionandcoronarydeathsinthe World Health Organization MONICA Project. Registration

procedures, event rates, and case-fatality rates in 38 populationsfrom 21 countries in four continents.Circulation1994;90:583-612.

12 Herlitz J, Bang A, SjolinM, KarlsonBW. Five-year mortality after acutemyocardial infarction in relationto previous history,level of care,complications in hospital, and medication at discharge.CardiovascDrugsTher1996;10:485-90.

13 BotkinNF, Spencer FA,GoldbergRJ, Lessard D, YarzebskiJ, Gore JM.Changingtrends in the long-term prognosis of patientswith acutemyocardial infarction: a population-based perspective.AmHeart J2006;151:199-205.

14 Capewell S, Livingston BM,MacIntyre K, ChalmersJWT, Boyd J,Finlayson A, etal. Trendsin case-fatality in117 718patientsadmittedwith acute myocardial infarction in Scotland. Eur Heart J2000;21:1833-40.

15 McGovern PG,Jacobs DR Jr,Shahar E, Arnett DK,Folsom AR,Blackburn H, et al. Trends in acute coronary heart disease mortality,morbidity, andmedicalcare from1985 through1997: theMinnesotaheart survey. Circulation2001;104:19-24.

16 Sala J,Marrugat J,MasiaR, Porta M, The Regicor I.Improvementinsurvivalafter myocardial infarctionbetween1978-85and 1986-88inthe REGICOR Study. Eur Heart J1995;16:779-84.

17 Hobbs MS,KnuimanMW, Briffa TG,Ngo H, Jamrozik K. Plasmacholesterol levels continueto decline despitethe risingprevalence ofobesity: population trends in Perth, Western Australia, 1980-1999.Eur J Cardiovasc Prev Rehabil 2008;15:319-24.

18 TaylorR, Dobson A,Mirzaei M.Contributionof changesin risk factorsto the decline of coronary heart disease mortality in Australia overthree decades.EurJ Cardiovasc Prev Rehabil 2006;13:760-8.


CORRECTIONS AND CLARIFICATIONS

Why Oregonwent wrongIn this Feature article by Vidhya Alakeson (BMJ2008;337:

a2044,14 Oct;doi:10.1136/bmj.a2044)an swasmissing

from the authors email address. The correct address is

[email protected].

Trust decides against legal actionto force girl to

receivehearttransplant

In the final paragraph ofthisNewsarticle by Clare Dyer(BMJ

2008;337:a2526, 12 Nov; doi:10.1136/bmj.a2526) we

gave thewronglegal positionon consent andchildpatients.

ThecorrectpositioninEnglishlawisthataparentmaygivea

valid consent to treatment even though the child refuses it,

and a childs refusal can also be overridden by the court.

However,doctors would be unlikely to perform surgery such

as heart transplantation in an unwilling teenage patient

merely on the consent of the parents and without the

authorisation of thecourts.And,althoughthey undoubtedly

have power to do so, the case of Re M in 1999 (BMJ

1999;319:209) indicates that the courts are reluctant to

exercise their inherent jurisdiction to override a childs

refusal if the child is old enough and capable of making an

informed choice.

In that case, where the parents wanted the heart transplant

surgery and theteenage patient refused, although thecourt

hadpower tooverrideherdecision, thejudge andtheofficial

solicitor took steps to find out whether she was capable of

making an informed choice and decided that she was not.

JokingapartDuringtheeditingofthisReviewoftheWeekbyRichardSmith

(BMJ2008;337:a2719, 9 Dec; doi:10.1136/bmj.a2719), the

authors term pisshouse was changed to pub in the

sentence: Then,in true Britishand male style,Hammondmet

Ian Hislop, editor ofPrivate Eye, inthepub and did a deal.

However, a pisshouse is apparentlya gentlemans toilet,and

(in the authors social circle at least) the phrase pisshouse

deal iswellknown.(Italludestothetendencyofmentomake

deals whilestanding side by side and urinating.) In the more

genteel confines of the BMJEditorial Office, however, this

term was unknown and a mistake was made in translating it

into more standard English. We apologise for any

misunderstanding this may have caused.

Minerva

A typing error during production of this Minerva picture by

Hawraman Ramadan and colleagues (BMJ2008;337:

a3007, 23 Dec; doi:10.1136/bmj.a3007) led to the text for

the picture mentioningno papillary defect. This should, of

course, be no pupillary defect.

Antibiotics for spontaneous pretermbirth

In their editorial (BMJ2008;337:a3015, 30 Dec;

doi:10.1136/bmj.a3015) Andrew Shennan and Manju

Chandiramaniwrote:ORACLE 1 didnot show any increase in

cerebral palsy(when fetalmembraneswere ruptured).Thisis

a mistake, and the sentence should begin: In the ORACLE 1

study,antibioticsdid notincreasetherisk ofcerebral palsy....

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