Sex life and sexual function in men and women before and after total disc.docx
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Sex life and sexual function in men and women before and after total disc.docx
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Sexlifeandsexualfunctioninmenandwomenbeforeandaftertotaldisc
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
Sexlifeandsexualfunctioninmenandwomenbeforeandaftertotaldisc
replacementcomparedwithposteriorlumbarfusion
否
1b
结构式摘要,包括试验设计、方法、结果、结论几个部分
BACKGROUNDCONTEXT:
Sexlifeandsexualfunctionmaybeaffectedbylowbackpain(LBP).
Sexualdysfunctionafteranteriorlumbarfusionisreportedinbothmenandwomen,butfocusismainly
onimpairedmalebiologicalfunction(retrogradeejaculation)asthismaycauseinfertility.Thishasled
toconcernastowhetheranteriorsurgeryshouldbeemployedinmen,atleastinyoungeragegroups.
PURPOSE:
Toinvestigatehowchroniclowbackpain(CLBP)ofassumeddiscogenicoriginaffects
sexlifeandsexualfunctioninpatientsconsideredforsurgicaltreatment,whetherthisisaffectedby
surgicaltreatment(totaldiscreplacement[TDR]orposterolateralfusion[PLF]/posteriorlumbar
interbodyfusion[PLIF]),andifso,aretheredifferencesbetweenthesurgicalproceduresundertaken.
STUDYDESIGN:
ArandomizedcontrolledtrialcomparingTDRandinstrumentedlumbarspine
fusion,performedeitherasaPLForPLIF.
PATIENTSAMPLE:
Onehundredfifty-twopatientswereincludedinthisrandomizedcontrolled
trialtocomparetheeffectonCLBPofeitherTDRviaananteriorretroperitonealapproachorin-
strumentedposteriorlumbarfusion,PLForPLIF.
OUTCOMEMEASURES:
Globalassessmentofbackpain,backpain(visualanalogscale[VAS]
0-100),function(OswestryDisabilityIndex[ODI]0–100),qualityoflife(EQ5D[EuroQol]0–1),
andanswersonspecificsexualfunction.
METHODS:
OutcomewasassessedusingdatafromtheSwedishSpineRegister(SweSpine).In
ODI,onequestion,ODI8,reflectstheimpactofbackpainonsexlife.Thisquestionwasanalyzed
separately.Patientsalsoansweredagender-specificquestionnairepreoperativelyandatthe2-year
follow-uptodetermineanysexualdysfunctionregardingerection,orgasm,andejaculation.Follow-
upwasat1and2years.
RESULTS:
Beforesurgery,34%reportedthattheirsexlifecausedsomeextraLBP,andanadditional
30%thattheirsexlifewasseverelyrestrictedbyLBP.Aftersurgery,sexlifeimprovedinbothgroups,
withastrongcorrelationtoareductionofLBP.Thegender-specificquestionnaireusedtomeasuresex-
ualfunctionafter2yearsrevealednonegativeeffectofTDRorFusioninmenregardingerectionor
retrogradeejaculation.However,26%ofallmenintheFusiongroup,comparedwith3%intheTDR
group,reportedpostoperativedeteriorationintheabilitytoachieveorgasm,despiteareductionofLBP.
CONCLUSIONS:
ImpairmentofsexlifeappearstoberelatedtoCLBP.Animprovementinsex
lifeafterTDRorlumbarfusionwaspositivelycorrelatedtoareductioninLBP.Totaldiscreplace-
mentinthisstudy,performedthroughananteriorretroperitonealapproach,wasnotassociatedwith
greatersexualdysfunctioncomparedwithinstrumentedlumbarfusionperformedeitherasaPLFor
asaPLIF.Sexualfunction,expressedasorgasm,deterioratedinmenintheFusiongrouppostop-
eratively,inspiteofthisgroupreportinglessLBPafter2years.
引言
背景和
目的
2a
科学背景和对试验理由的解释
Totaldiscreplacement(TDR)isseenbymanyasanalternativetofusioninpatientswithchroniclowbackpain
(CLBP).Althoughfusiontodayshouldberegardedas
agoldstandard,thefrequencyofpatientstreatedwith
TDRisincreasing[1].Today,severalTDRimplantsare
FoodandDrugAdministrationapproved[2,3]orarein
theprocessofbeingapproved.Totaldiscreplacementaims
atpainreliefthroughremovalofanassumedpainfuldisc
whilepreserving/restoringspinalmotion.Fusionaimsat
painreliefthroughankylosisoftheassumedpainfulmotion
segment,mainlythediscandthefacetjoints.
Sexlifeingeneral,andalsospecificsexualfunctionsexpressedastheabilitytoachieveerection,normalejacula-
tion,andorgasm,maybepartofthepatient’s
psychosocialsituation,butitsrelationtoCLBPinthepatientgroupconsideredforsurgeryisnotfullyexplored
[4–7].Sexualdysfunctionhasalsobeenreportedafteranteriorlumbarinterbodyfusion.Thishasbeenassumedtobe
relatedtodamagetothehypogastricnervousplexusandto
mainlyaffectthemalebiologicalfunction.Retrogradeejaculationafteranteriorspinalsurgery,withconsequentinfertility,hasareportedincidenceof0%to28%[8–13].Thiscomplicationissuggestedtobetechniquedependentandpossiblymorefrequentwhenatransperitoneal/laparoscopicapproachisusedcomparedwitharetroperitoneal
dissection.Weconductedaprospectiverandomizedtrialin-
cluding152surgicalcandidatessufferingfromCLBPand
comparedtheclinicaleffectsofTDRwithinstrumented
posteriorfusion
2b
具体目的或假设
Theaimofthissubstudywasfourfold:
1.ToexaminehowCLBPofassumeddiscogenicorigin
inpatientsconsideredforsurgeryrelatedtosexlifein
generalandtospecificsexualfunctions:
erection,or-
gasm,andejaculation.
2.Toevaluatewhethersexlifeandsexualfunctionim-
provedwhenlowbackpain(LBP)wasrelieved.
3.Tocomparepain-relatedeffectsonsexlifeaftertreat-
mentwitheitheroftwosurgicaltechniques,TDRand
instrumentedPLF/posteriorlumbarinterbodyfusion
(PLIF).
4.Toevaluatewhethertherearegender-specificadverse
effectsonspecificsexualfunctions,suchasproblems
witherection,orgasm,orretrogradeejaculation,asso-
ciatedwitheitherofthetwosurgicalprocedures.
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
patientswererandomizedbetweenfusionandTDRata1:
1ratiousingasealedenvelopetechnique.EightypatientsweretreatedwithTDR
(26–27patientswitheachoftheprosthesis)and72withinstrumentedfusion.Forty-fourpatientshadPLFand28PLIF.
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
TheinclusionandexclusioncriteriaaresummarizedinTable1.
4b
资料收集的场所和地点
Weconductedasingle-center(StockholmSpineCenter,
Stockholm,Sweden),
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
Generalsexlife(ODI8)
Specificsexfunctions(specificquestionnaire)
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
AllpatientsweremonitoredthroughtheSwedishSpine
Register(SweSpine),includingbackpain(VAS1–100),
‘‘globalassessmentofbackpain,’’[19]andODI[20]preoperativelyandat1-and2-yearfollow-up.Inthissubstudy,
LBPasassociatedwith‘‘generalsexlife’’(ODI8)andwith
specificsexualfunctions[21],erection,orgasm,andejaculation,wasevaluated.
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
usingasealedenvelopetechnique.
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
Thesurgeonswerenotinformedoftheresultoftherandomizationuntilthepatientarrivedatthehospitalforsurgery.
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
Thepowerestimationforthissubstudywas
basedonthefigurespresentedbyHa¨ggetal.[21]basedon
32patientsofeachgenderineachgroup.Categoricaldata
weretestedwithFisherexacttestorthechi-squaretestand
continuousdatawiththeMann-WhitneyUtest.Multiple
regressionanalyseswereperformedseparatelyformen
andwomenandforthosewhounderwenteachsurgical
technique.Differencesbetweengroupsweretestedusing
nonparametrictests(Mann-WhitneyUtestandchi-square).
CorrelationswerecalculatedwithSpearmanrankR.
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
Table4
Men:
specificsexualfunctionpreoperativelyandafter2years
Table5
women:
specificsexualfunctionpreoperativelyandafter2years
13b
随机分组后,各组脱落和被剔除的例数,并说明原因
募集
受试者
14a
招募期和随访时间的长短,并说明具体日期
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
纳入
分析例数
16
各组纳入每种分析的受试者数目(分母),以及是否按最初的分组分析
是
结果和估计值
17a
各组每一项主要和次要结局指标的结果,效应估计值及其精确性(如95%可信区间)
Theprimaryoutcomeparameterdifferedbetweenthe
twogroupsatthe2-yearfollow-up.IntheTDRgroup,
30%werepainfree,whereasintheFusiongroup,15%
werepainfreeat2years(p5.031).
TheTDRgroupmadegreaterimprovementthanthe
FusiongroupregardingbackpainVASat2years
(p5.048),buttherewasnodifferenceinimprovementin
legpainVAS.
Seventy-onepercentintheTDRgroupand67%inthe
Fusiongroupweresatisfiedwiththeirtreatmentat2years
(p5.586).
17b
对于二分类结局,建议同时提供相对效应值和绝对效应值
辅助
分析
18
所做的其他分析结果,包括亚组分析和校正分析,指出哪些是预先设定的,哪些是新尝试的分析
危害
19
各组出现的所有严重危害或意外效应
讨论
局限性
20
试验的局限性,报告潜在偏倚和不精确的原因,以及出现多种分析结果的原因
可推
广性
21
实验结果被推广的可能性(外部可靠性,实用性)
ThepreoperativeODI8questionnaireusedtoevaluate
sexlifeinthisstudyshowedthatsignificantdisturbances
ofsexlifewerecommonamongpatientswithCLBPdue
todegenerativediscdiseasebeingconsideredforsurgery,
31%ofpatientsreportingtheirsexlifeasbeingseverelyrestrictedorevenpreventedbyLBP.
ThiscorrespondstopreviousreportsonLBP[4–7].In
thestudybyZigleretal.[3],amodifiedversionofODI
wasused,sotherewerenoquestionsonsexlife.
BothTDRandinstrumentedposteriorlumbarfusion(PLF
orPLIF)improvedsexlifeasmeasuredwithODI8,andthis
stronglycorrelatedwithanimprovementinbackpainmea-
suredas‘‘patient’sglobalassessment’’andasbackpain
VAS.Thisimprovementdidnotdi
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