Oneyear prognosis in sicklisted low back pain patients with and without.docx
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Oneyear prognosis in sicklisted low back pain patients with and without.docx
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Oneyearprognosisinsicklistedlowbackpainpatientswithandwithout
CONSORT清单评价RCT论文
论文
部分
条目
内容
评价
VAS
文题
摘要
1a
文题能识别是随机临床试验
One-yearprognosisinsick-listedlowbackpainpatientswithandwithout
radiculopathy.Prognosticfactorsinfluencingpainanddisability
否
1b
结构式摘要,包括试验设计、方法、结果、结论几个部分
BACKGROUNDCONTEXT:
Previousresearchhasdocumentedvariouspsychosocialriskfac-
torswithinfluenceonoutcomeinlowbackpain(LBP)patients,butthevalueofclinicalpredictors
hasbeenlesswelldocumented.
PURPOSE:
Toidentifyclinicalandpsychosocialriskfactorsatbaselineinfluencingdisabilityand
painat1yearinLBPpatientssick-listed3to16weeks,andtolookfordifferencesbetweennon-
specificLBPandradiculopathy.
STUDYDESIGN:
Cohortstudywith1-yearfollow-upbasedonarandomizedclinicaltrial.
OUTCOMEMEASURES:
Disabilityandchangeofdisability,painandchangeinpainat1year.
METHODS:
Inarandomizedclinicalstudyevaluatingmultidisciplinaryversusbriefintervention,325
patientswerefollowedfor1year.Atbaseline,theycompletedaquestionnaireandwentthroughaclinical
lowbackexamination,includingmeasureofforwardflexionandsideflexionaswellastenderpointex-
amination,amethodtoestimatediffusetenderness.Furthermore,degenerativechangesonplainX-rays
ofthelumbarspinewerequantified,andsciaticawasinvestigatedbymagneticresonanceimaging.
RESULTS:
Radiculopathywasverifiedbymagneticresonanceimagingin111(34%)patients.
At1year,questionsofdisabilityindailylifeactivitiesandpainwereansweredby60%and
67%,respectively.Theintensityofbackþlegpainanddisabilitywascloselycorrelated.Statistically
significantpredictorsforbothdisabilityandbackþlegpainat1yearwereintensityofbackþleg
pain,worryingandhealthanxiety,manytenderpoints,andlittleormoderateexerciseinleisure
time.Twoadditionalriskfactorswereidentifiedinpatientswithradiculopathy:
olderageand
‘‘drinkingalcohollessthanoncepermonth.’’Furthermore,disabilityat1yearwasassociatedwith
initialdisabilityandcompensationclaim,andbackþlegpainat1yearwasassociatedwithfear
avoidanceaboutphysicalactivityandthedurationofpain.Changeindisabilitywasmoreclosely
associatedwithreturntoworkthanchangeinpain.Discdegenerationwasnotassociatedwith
disabilityorpainat1year.Generalhealthwasnotstatisticallysignificantlyassociatedwith
outcomewhenadjustedforbackþlegpain,disability,andworryingandhealthanxiety.
CONCLUSIONS:
Disabilityandpainat1yearwereassociatedwithbaselinedisabilityandpain,diffuse
tenderness,worryingandhealthanxiety,compensationclaim,fearavoidance,andbaselineexercisehabits.
Onlyinpatientswithverifiednerverootaffection,olderage,andrestrainedalcoholseemedtoplayarole.
Themultivariatemodelswereinsufficientinpredictingdisabilityandpain,partlybecausedisabilityand
painwerealsostronglyassociatedwithreturntowork.
引言
背景和
目的
2a
科学背景和对试验理由的解释
Themostimportantoutcomemeasuresinnonspecific
lowbackpain(LBP)arepain,disabilityindailylife
activities,andreturntowork(RTW)[1].Onlymeasuring
pain-relatedoutcomeisnotrelevantbecausefunction
maybenormalinspiteofpain[2].Furthermore,painreductionhaslimitedvalueinpatientswithrestrictedfunctionifthereisnoimprovementinfunction.Function-
relatedoutcomeisimportantbecauselowleveloffunction
reflectsrestrictionofdailylifeactivities.InpatientssicklistedbecauseofLBP,however,thecrucialoutcomeis
RTWbecauseoftheoverwhelmingriskoflongtimesick
listing.WhenLBPpatientsaresick-listedformorethan4
weeks,morethan20%arestilloffwork1yearlater.
Theoutcomesareinterrelated,butchangeinoneoutcomemayoccurwithoutinfluencingtheotheroutcomes.
Forinstance,inLBPpatientswhofeltatriskofdeveloping
disability,cognitiveinterventionhadimpactonsicklisting
thefollowingyearbutnoinfluenceonpainordisabilityin
thefirstplace[3].Fouryearslater,however,bothpainand
disabilitywerereducedintheinterventiongroupcompared
withthecontrolgroup.Arecentsystematicreviewincluded16publicationstoidentifypredictorsforfunction-relatedoutcome[5].Thefollowing
variableswerefoundtobeofsomeimportance:
intensityof
pain,radiatingpain,disability,fearavoidance,numberofpain
sites,somatization,depression,perceivedriskofrecovery,
age,gender,income,psychologicalandphysicaljobdemands,
andschooleducation.However,thestudieswereveryheterogeneous,andthepublishedinstrumentshadonlymoderateability
topredictorexplainfunction-relatedoutcome
2b
具体目的或假设
Thepurposeofthepresentstudywastoidentifyprognosticfactorsfordisabilityandpaininsick-listedLBPpatients
andtolookfordifferencesbetweenpatientswithandwithout
radiculopathy;investigate,ifthenumberoftenderpointswas
associatedwithdisabilityandpain;andanalyze,ifRTWwas
moreassociatedwithchangeindisabilitythanchangein
pain.RTWdataarepresentedindetailelsewhere.
方法
试验
设计
3a
描述试验设计(诸如平行设计、析因设计)包括受试者分配入各组的比例
3b
试验开始后对试验方法所作的重要改变(如合格受试者的挑选标准),并说明原因
受试
者
4a
受试者的合格标准
Inclusioncriteria:
partlyorfullysick-listedfromwork4
to12weeksbecauseofLBPwithorwithoutsymptomsand
signsofnerverootaffection,LBPshouldbetheprimerea-
sonforsicklistingandatleastasbotheringaseventualpain
elsewhere,age16to60years,referredfromawell-defined
areaofabout280,000inhabitantsinandaroundSilkeborg,
andthepatientshouldbeabletospeakandunderstand
Danish.
Exclusioncriteria:
registeredasunemployed,livingout-
sidethereferralarea,continuingorprogressivesignsorsymptomsofnerverootaffectionimplicatingplansforsurgery,lowbacksurgerywithinthelastyear,previouslumbar
fusionoperation,suspectedcaudaequinasyndrome,pro-
gressiveparesisorotherseriousbackdisease(eg,tumor),
pregnancy,knowndependencyondrugsoralcohol,orprimarypsychiatricdisease.
4b
资料收集的场所和地点
351patientswerereferredfromtheirgeneralpractitionerto
theResearchUnitoftheSpineCenter,RegionHospital
Silkeborg,Denmark.
干预
措施
5
详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的
结局
指标
6a
完整而确切的说明预先设定的主要和次要结局指标,包括它们是何时、如何测评的
Lowbackpainclassification
PatientswereclassifiedashavingnonspecificLBP
(1)orradiculopathy
(2).
6b
试验开始后对结局指标是否有任何更改,并说明原因
样本量
7a
如何确定样本量
7b
必要时,解释中期分析和试验中止原则
随机方法
序列
产生
8a
产生随机分配序列的方法
8b
随机方法的类型,任何限定的细节(怎样分区组和各区组样本多少)
分配
隐藏
9
用于执行随机分配序列的机制(如编按序编码的封藏法),描述干预措施分配之前为隐藏序列号所采取的步骤
实施
10
谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施
盲法
11a
如果实施了盲法,分配干预措施之后对谁设盲(例如受试者、医护提供者、结局评估者),以及盲法是如何实施的
11b
如有必要,描述干预措施的相似之处
统计学方法
12a
用于比较各组主要和次要结局指标的统计学方法
Morementhanwomenfailedtoanswerthe1-year
questionnaire,39.6%and26.3%,respectively(p5.011,
chi-squaretest).Thosenotansweringthequestionnaire
wereyoungerthanthoseanswering,meanage40.0(standarddeviation[SD]10.31)versus42.54(SD10.38),
p5.036(ttest).Adjustedforageandsex,nonresponders
weremoreoftenlivingtogetherwithoutbeingmarried
(p5.037)andhadmoreoftennohomeownership
(p5.025)thanresponders.Adjustedforage,nonresponders
lessoftenblamedtheworkforpain(p5.026)orhadsevere
legpain(p5.031).Furthermore,theyhadmoreseldomradiculopathy(p5.007).Theyhadbetterforwardflexion
(p5.025)butlongerpainduration(p5.003).Noneofthe
othervariablespresentedinTable1werestatisticallydifferentinnonresponderscomparedwithresponders.At1year,
theRTWwasnotdifferentfornonresponders(63.6%)comparedwithresponders(66.7%)(p5.58,chi-squaretest).Byttests,disabilityandbackþlegpainwerecompared
betweenpatientsreturnedandnotreturnedtowork.When
normaldistributioncouldbequestioned,thepvalueswere
checkedbyWilcoxonranksumtest.DifferencesofRTW
wereanalyzedbychi-squaretest.Thereliabilityexaminationofthediscdegenerationclassificationon
X-raywasanalyzedbykappastatistics.ThestatisticalpackageSTATA(version9.2;StataCorp,CollegeStation,TX,
USA)wasused,andasignificancelevelof5%waschosen.
12b
附加分析的方法,诸如亚组分析和校正分析
结果
受试者流程
13a
随机分配到各组的受试者例数,接收已知分配治疗的例数,以及纳入主要结局分析的例数
见图表
Thirty-one(9.5%)patientswereoperatedbecauseoflack
ofimprovementbyconservativetherapy;9%intheclinical
and10%inthemultidisciplinaryinterventiongroup(p5.85).
13b
随机分组后,各组脱落和被剔除的例数,并说明原因
Atotalof26patientswereexcludedforthefollowing
reasons:
metastaticmalignancyofthespine
(2),osteopo-
roticfractures(4),spondylolisthesis(6),osteomalacia
(2),
peripheralarteriosclerosis
(2),sacroiliitis
(1),severescoli-
osis
(1),hydronephrosis
(1),trochantericbursitis
(1),with-
drawingafterinclusion(4),61yearsold
(1),suddendeath
duringfollow-up
(1)leaving325patientsforthepresent
study.Self-reportedsicklistingwasmedian41days(mean,
46days,3–16weeks),24patientssick-listedforlessor
morethan4to12weeks.Eightpatientsmet1to6days
tooearly,andpostponementoftheirconsultationwasnot
possible.Sixteenpatientshadtheirfirstconsultationpost-
ponedbecauseofsummerholidays.
募集
受试者
14a
招募期和随访时间的长短,并说明具体日期
DuringtheperiodNovember2004toJuly2007,1-yearfollow-up.
14b
为什么试验中断或停止
基线
资料
15
用一张表格列出每组受试者的基线数据,包括人口学资料和临床特征
Table1
Baselinevariablesandanalysesofunivariableswithdisabilityat1yearasdependentvariable
纳入
分析例数
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