CONSORT

7/21/2019 CONSORT

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STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA):extending the CONSORT Statement

Citation: MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A,

Moher D; STR!TA Re"ision Group# Re"ise$ STan$ar$s %or Reporting nter"entions in

!linical Trials o% Acupuncture &STR!TA'( exten$ing the !)*S)RT statement# PLoS Me$#

+- .un /;0&1'(e-+1-

Tale !: STRICTA "#!# chec$list of information to include %hen reporting interventions in aclinical trial of acupuncture (&xpansion of Item ' from CONSORT "#!# chec$list)

Item etail

! Acupuncture rationale 1a) Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese,Korean, Western medical, i!e "lement, ear acupuncture, etc)

1#) $easoning for treatment pro!ided, #ased on historical conte%t,literature sources, and&or consensus methods, 'ith references 'hereappropriate

1c) "%tent to 'hich treatment 'as !aried

" etails of needling a) um#er of needle insertions per su#*ect per session (mean andrange 'here rele!ant)

#) ames (or location if no standard name) of points used

(uni&#ilateral)c) +epth of insertion, #ased on a specified unit of measurement, oron a particular tissue le!el

d) $esponse sought (e.g. de qi or muscle t'itch response)

e) eedle stimulation (e.g. manual, electrical)

f) eedle retention time

g) eedle type (diameter, length, and manufacturer or material)

* Treatment regimen a) um#er of treatment sessions

#) re-uency and duration of treatment sessions

+ Other components oftreatment

a) +etails of other inter!entions administered to the acupuncturegroup (e.g. mo%i#ustion, cupping, her#s, e%ercises, lifestyle ad!ice)

#) Setting and conte%t of treatment, including instructions to

practitioners, and information and e%planations to patients' ,ractitioner ac$ground /) +escription of participating acupuncturists (-ualification orprofessional affiliation, years in acupuncture practice, other rele!ante%perience)

- Control or comparatorinterventions

0a) $ationale for the control or comparator in the conte%t of theresearch -uestion, 'ith sources that *ustify this choice

0#) recise description of the control or comparator. 2f shamacupuncture or any other type of acupuncture3li4e control is used,pro!ide details as for 2tems 1 to a#o!e.

ote5 This chec4list, 'hich should #e read in con*unction 'ith the e%planations of the ST$2CT6 itemspro!ided in the main te%t, is designed to replace C7S7$T 8189s item / 'hen reporting an acupuncture trial.

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Tale ": CONSORT "#!# chec$list %ith the Non.pharmacological Trials &xtension toCONSORT (%ith STRICTA "#!# extending CONSORT Item ' for acupuncture trials)

Section/Topic Item 0 CONSORT "#!# Statement1:Chec$list item2!#3 escrie:

Additional items from the Non.pharmacological Trials&xtension to CONSORT2!+3

Add:

TITLE AND ABSTRACT

1.a 2dentification as a randomi:ed trial inthe title

2n the a#stract, description of thee%perimental treatment,comparator, care pro!iders,centres and #linding status.

1.# Structured summary of trial design,methods, results, and conclusions;for specific guidance see C7S7$Tfor 6#stracts </=,/>?

INTRODUCTION

@ac4ground ando#*ecti!es

.a Scientific #ac4ground ande%planation of rationale

.# Specific o#*ecti!es or hypotheses

METHODS

Trial design .a +escription of trial design (e.g.,parallel, factorial) including allocationratio

.# 2mportant changes to methods aftertrial commencement (e.g. eligi#ilitycriteria), 'ith reasons

articipants .a "ligi#ility criteria for participants When applica#le, eligi#ility criteriafor centers and those performingthe inter!entions.

.# Settings and locations 'here the data'ere collected

Interventions ' The interventions for each group%ith sufficient details to allo%replication4 including ho% and%hen the5 %ere actuall5administered

,recise details of oth theexperimental treatment andcomparator . see Tale ! fordetails

7utcomes 0.a Completely defined pre3specifiedprimary and secondary outcomemeasures, including ho' and 'henthey 'ere assessed

0.# 6ny changes to trial outcomes afterthe trial commenced 'ith reasons

Sample si:e A.a Bo' sample si:e 'as determined When applica#le, details of

'hether and ho' the clustering#y care pro!iders or centers 'asaddressed.

A.# When applica#le, e%planation of anyinterim analyses and stoppingguidelines

$andomi:ation

Sequencegeneration

=.a Method used to generate the randomallocation se-uence

When applica#le, ho' carepro!iders 'ere allocated to eachtrial group.=.# Type of randomi:ation; details of any

restriction (e.g., #loc4ing and #loc4si:e)

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Additional items from the Non.pharmacological Trials&xtension to CONSORT2!+3Add:

Allocationconcealment

> Mechanism used to implement therandom allocation se-uence (e.g.,se-uentially num#ered containers),descri#ing any steps ta4en to concealthe se-uence until inter!entions 'ereassigned

Implementation

18 Who generated the randomallocation se-uence, 'ho enrolledparticipants, and 'ho assignedparticipants to inter!entions

@linding 11.a 2f done, 'ho 'as #linded afterassignment to inter!entions (e.g.participants, care pro!iders, thoseassessing outcomes) and ho'

Whether or not thoseadministering co3inter!entions'ere #linded to groupassignment. 2f #linded, method of

#linding and description of thesimilarity of inter!entions.11.# 2f rele!ant, description of thesimilarity of inter!entions

Statisticalmethods

1.a Statistical methods used to comparegroups for primary and secondaryoutcomes

When applica#le, details of'hether and ho' the clustering#y care pro!iders or centers 'asaddressed.1.# Methods for additional analyses,

such as su#group analyses andad*usted analyses

RESULTS

articipant flo'(6 diagram isstrongly

recommended)

1.a or each group, the num#ers ofparticipants 'ho 'ere randomlyassigned, recei!ed intended

treatment, and 'ere analy:ed for theprimary outcome

The num#er of care pro!iders orcenters performing theinter!ention in each group and

the num#er of patients treated #yeach care pro!ider or in eachcenter.1.# or each group, losses and

e%clusions after randomi:ation,together 'ith reasons

2mplementationof inter!ention

+etails of the e%perimentaltreatment and comparator as they'ere implemented.

$ecruitment 1.a +ates defining the periods ofrecruitment and follo'3up

1.# Why the trial ended or 'as stopped

@aseline data 1/ 6 ta#le sho'ing #aseline

demographic and clinicalcharacteristics for each group

When applica#le, a description of

care pro!iders (case !olume,-ualification, e%pertise, etc.) andcenters (!olume) in each group.

um#ersanaly:ed

10 or each group, num#er ofparticipants (denominator) includedin each analysis and 'hether theanalysis 'as #y original assignedgroups

7utcomes andestimation

1A.a or each primary and secondaryoutcome, results for each group, andthe estimated effect si:e and itsprecision (e.g., >/ confidenceinter!al)

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Additional items from the Non.pharmacological Trials&xtension to CONSORT2!+3Add:

1A.# or #inary outcomes, presentation of

#oth a#solute and relati!e effectsi:es is recommended

6ncillaryanalyses

1= $esults of any other analysesperformed, including su#groupanalyses and ad*usted analyses,distinguishing pre3specified frome%ploratory

Barms 1> 6ll important harms or unintendedeffects in each group; for specificguidance see C7S7$T for Barms<08?

DISCUSSION

Dimitations 8 Trial limitations, addressing sources

of potential #ias, imprecision, and, ifrele!ant, multiplicity of analyses

Eenerali:a#ility 1 Eenerali:a#ility (e%ternal !alidity,applica#ility) of the trial findings

Eenerali:a#ility (e%ternal !alidity)of the trial findings according tothe inter!ention, comparators,patients and care pro!iders andcenters in!ol!ed in the trial.

2nterpretation 2nterpretation consistent 'ith results,#alancing #enefits and harms, andconsidering other rele!ant e!idence

2n addition, ta4e into account thechoice of the comparator, lac4 ofor partial #linding, une-uale%pertise of care pro!iders orcenters in each group.

OTHER

INORMATION

$egistration $egistration num#er and name oftrial registry

rotocol Where the full trial protocol can #eaccessed, if a!aila#le

unding / Sources of funding and other support(e.g., supply of drugs); role of funders

F We strongly recommend reading this Statement in con*unction 'ith the C7S7$T 818e%planation and ela#oration <11? for important clarifications on all the items. 2f rele!ant, 'e alsorecommend reading C7S7$T e%tensions for cluster randomi:ed trials <01?, noninferiority ande-ui!alence trials <0?, her#al inter!entions <0?, and pragmatic trials <10?. Moreo!er, additionale%tensions are forthcoming. or those and also for up3to3date references rele!ant to this chec4list,

see http5&&'''.consort3statement.org.

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