如何更好的汇报我们的rct方案？——spirit2013声明简介 -凯发k8国际首页登录

administrative  information

title

1

descriptive title identifying the study design, population,  interventions, and, if applicable, trial acronym

trial registration

2a

trial identifier and registry name. if not yet registered, name of  intended registry.

2b

all items from the world health organization trial registration data set  (, available at )

protocol version

3

date and version identifier

funding

4

sources and types of financial, material, and other support

roles and responsibili-ties

5a

names, affiliations, and roles of protocol contributors

5b

name and contact information for the trial sponsor

5c

role of study sponsor and funders, if any, in study design; collection,  management, analysis, and interpretation of data; writing of the report; and  the decision to submit the report for publication, including whether they  will have ultimate authority over any of these activities

5d

composition, roles, and responsibilities of the coordinating center,  steering committee, end point adjudication committee, data management team,  and other individuals or groups overseeing the trial, if applicable (see item  21a for dmc)

introduction

background and rationale

6a

description of research question and justification for undertaking the  trial, including summary of relevant studies (published and unpublished)  examining benefits and harms for each intervention

6b

explanation for choice of comparators

objectives

7

specific objectives or hypotheses

trial design

8

description of trial design, including type of trial (e.g., parallel  group, crossover, factorial, single group), allocation ratio, and framework  (e.g., superiority, equivalence, noninferiority, exploratory)

methods

participants, interventions, and outcomes

study setting

9

description of study settings (e.g., community clinic, academic  hospital) and list of countries where data will be collected. reference to  where list of study sites can be obtained

eligibility criteria

10

inclusion and exclusion criteria for participants. if applicable,  eligibility criteria for study centers and individuals who will perform the  interventions (e.g., surgeons, psychotherapists)

interventions

11a

interventions for each group with sufficient detail to allow replication,  including how and when they will be administered

11b

criteria for discontinuing or modifying allocated interventions for a  given trial participant (e.g., drug dose change in response to harms,  participant request, or improving/worsening disease)

11c

strategies to improve adherence to intervention protocols, and any  procedures for monitoring adherence (e.g., drug tablet return, laboratory  tests)

11d

relevant concomitant care and interventions that are permitted or  prohibited during the trial

outcomes

12

primary, secondary, and other outcomes, including the specific  measurement variable (e.g., systolic blood pressure), analysis metric (e.g.,  change from baseline, final value, time to event), method of aggregation  (e.g., median, proportion), and time point for each outcome. explanation of  the clinical relevance of chosen efficacy and harm outcomes is strongly  recommended

participant timeline

13

time schedule of enrollment, interventions (including any runins and  washouts), assessments, and visits for participants. a schematic diagram is  highly recommended ().

sample size

14

estimated number of participants needed to achieve study objectives and  how it was determined, including clinical and statistical assumptions  supporting any sample size calculations

recruitment

15

strategies for achieving adequate participant enrollment to reach target  sample size

assignment of interventions (for controlled trials)

allocation sequence generation

16a

method of generating the allocation sequence (e.g., computer-generated  random numbers), and list of any factors for stratification. to reduce  predictability of a random sequence, details of any planned restriction  (e.g., blocking) should be provided in a separate document that is  unavailable to those who enroll participants or assign interventions.

allocation concealment mechanism

16b

mechanism of implementing the allocation sequence (e.g., central  telephone; sequentially numbered, opaque, sealed envelopes), describing any  steps to conceal the sequence until interventions are assigned

implementation

16c

who will generate the allocation sequence, who will enroll participants,  and who will assign participants to interventions

blinding (masking)

17a

who will be blinded after assignment to interventions (e.g., trial  participants, care providers, outcome assessors, data analysts), and how

blinding  (masking)

17b

if blinded, circumstances under which unblinding is permissible, and  procedure for revealing a participant’s allocated intervention during the  trial

data collection, management, and analysis

data collection methods

18a

plans for assessment and collection of outcome, baseline, and other  trial data, including any related processes to promote data quality (e.g.,  duplicate measurements, training of assessors) and a description of study  instruments (e.g., questionnaires, laboratory tests) along with their  reliability and validity, if known. reference to where data collection forms  can be found, if not in the protocol.

18b

plans to promote participant retention and complete follow-up, including  list of any outcome data to be collected for participants who discontinue or  deviate from intervention protocols

data management

19

plans for data entry, coding, security, and storage, including any  related processes to promote data quality (e.g., double data entry; range  checks for data values). reference to where details of data management  procedures can be found, if not in the protocol.

statistical methods

20a

statistical methods for analyzing primary and secondary outcomes.  reference to where other details of the statistical analysis plan can be  found, if not in the protocol.

20b

methods for any additional analyses (e.g., subgroup and adjusted  analyses)

statistical  methods

20c

definition of analysis population relating to protocol nonadherence  (e.g., as-randomized analysis), and any statistical methods to handle missing  data (e.g., multiple imputation)

monitoring

data monitoring

21a

composition of dmc; summary of its role and reporting structure;  statement of whether it is independent from the sponsor and competing  interests; and reference to where further details about its charter can be  found, if not in the protocol. alternatively, an explanation of why a dmc is  not needed.

21b

description of any interim analyses and stopping guidelines, including  who will have access to these interim results and make the final decision to  terminate the trial

harms

22

plans for collecting, assessing, reporting, and managing solicited and  spontaneously reported adverse events and other unintended effects of trial  interventions or trial conduct

auditing

23

frequency and procedures for auditing trial conduct, if any, and whether  the process will be independent from investigators and the sponsor

ethics and dissemination

research ethics  approval

24

plans for seeking rec/irb approval

protocol  amendments

25

plans for communicating important protocol modifications (e.g., changes  to eligibility criteria, outcomes, analyses) to relevant parties (e.g.,  investigators, recs/irbs, trial participants, trial registries, journals,  regulators)

consent or  assent

26a

who will obtain informed consent or assent from potential trial  participants or authorized surrogates, and how (see item 32)

26b

additional consent provisions for collection and use of participant data  and biological specimens in ancillary studies, if applicable

confidentiality

27

how personal information about potential and enrolled participants will  be collected, shared, and maintained in order to protect confidentiality  before, during, and after the trial

declaration of  interests

28

financial and other competing interests for principal investigators for  the overall trial and each study site

access to data

29

statement of who will have access to the final trial data set, and  disclosure of contractual agreements that limit such access for investigators

ancillary & post-trial  care

30

provisions, if any, for ancillary and post-trial care, and for  compensation to those who suffer harm from trial participation

dissemination policy

31a

plans for investigators and sponsor to communicate trial results to  participants, health care professionals, the public, and other relevant  groups (e.g., via publication, reporting in results databases, or other  data-sharing arrangements), including any publication restrictions

31b

authorship eligibility guidelines and any intended use of professional  writers

31c

plans, if any, for granting public access to the full protocol,  participant-level data set, and statistical code

appendices

informed consent materials

32

model consent form and other related documentation given to participants  and authorized surrogates

biological specimens

33

plans for collection, laboratory evaluation, and storage of biological  specimens for genetic or molecular analysis in the current trial and for  future use in ancillary studies, if applicable