Re: checklist items in CONSORT 2010 STATEMENT

[Guest guest]

In the recent discussion about CONSORT statement, Rangeel wrote the following: " Hypotheses are pre-specified questions being

tested to help meet the objectives. Hypotheses are more specific than objectives and are amenable to explicit statistical evaluation. " Rangeel did not specify the source of this definition (Rangeel, could you kindly let us know the source of this defnition?), but wrote the phrase " pre-specified questions " in bold, putting an emphasis on the importance of this phrase. This prompted this post, :-)

Reading this definition of hypothesis, following points of reflection comes to mind. I'd like to write on the fundamental difference between asking a question and making a definitive statement, an assertion, which is what hypotheses really are. It's not apparent, but there is a world of difference between the two.

Hypothesis refers to literally " beneath thesis " , or something like, " a stage prior to 'thesis' " or something that goes to build on a thesis or a way to explain the world. Thesis, in turn, is an assertion to explain the workings of the world, a term I think first gained prominence in scientific communications among the sixteenth century philosophers attempting to explain the workings of the world. So, you see, this is not really a matter of asking open-ended waiting-to-be-answered questions, it moves beyond the stage of " asking " . The " answers " , if you will, in the context of " hypotheses " are as Bob Dylan would have said, " blowin' in the wind " . When you state a hypothesis, you are at a stage where you need to verify what you propose of the world around you is true indeed.  Right? :-)

Thus, from the persepective of science and philosophy, hypotheses are " very " specific statements about the way the world is supposed to work. Which is fundamentally different from " questions " , which is " asking " , groping for answers, not knowing what it could be. As an aside, one may wonder use of the other bold term " pre-specified " . Now what can that be? We can specify something, but what about pre-specify? Determinism? And this is relevant only because our context of discussion are checklists such as CONSORT statements that differentitate doing something correctly versus doing something " less than correctly " :. I'd invite you to think about the term " pre-specified " .  What does the term mean or supposed to mean in a scientific discussion? Can you " post " -specify a statement?

Coming back to where I began. Hypothese are specific statements, as Bill Trochim writes in " socialresearchmethods.net " , " An hypothesis is a specific statement of prediction. It describes in concrete (rather

than theoretical) terms what you expect will happen in your study. " (check http://www.socialresearchmethods.net/kb/hypothes.php). These are statements that describe a state of the world, rather than about asking questions.

The other point to muse I guess is why does one need to learn about checklists such as consort statement? What are some of the utilities and dangers of accepting checklist based approaches such as this? I am almost tempted to write about " amenable " to " explicit " statistical whatever, but oh well.

:-),ArinOn Mon, Aug 8, 2011 at 1:48 PM, Rangeel <rainarangeel@...> wrote:

 

Dear members, Today we will start the discussion on latest version of consort i.e. CONSORT statement 2010.There are number of changes

 in this updated statement. The CONSORT website (http://www.consort-statement.org.) contains a side by side comparison of the 2001and

 2010 versions along with summary of the noteworthy general changes.

CONSORT 2010STATEMENTCONSORT 2010 is developed to assist:

Ø  Authors in writing reports of randomized controlled trials,

Ø  Editors and Peer reviewers in reviewing manuscripts for publication, and

Ø  Readers in critically appraising published articles.

The CONSORT 2010 statement is also published along with explanation and elaboration. This document is intended to enhance the use,understanding and dissemination of the CONSORT Statement. Through examples and explanations, the meaning and rationale for each checklist item are presented.

The CONSORT Statement comprises a 25-item checklist and a flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial.

The ChecklistThe checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, Discussion, and Other information. The checklist includes the 25 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings.

Templates of the CONSORT 2010 checklist are available to download in MS Word and in PDF

TheFlow DiagramThe flow diagram is intended to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment,intervention allocation, follow-up, and analysis).

The diagram shows the number of participants, for each intervention group, included in the primary data analysis.

Templates of the CONSORT 2010 flow diagram are available to download in MS Word and in PDF.

CONSORT 2010 focuses predominantly on the two groups, parallel randomized controlled trial, which accounts for over half of trials in the literature. Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomized trials.

The format of articles should abide by journal style, editorial directions, the traditions of the research field addressed,and, where possible, author preferences. There is no standardised structure of reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity.

                           Checklist items along with explanation and elaboration in consort 2010

Title and AbstractItem 1a -  Identification as a randomized trial in the title.

To help ensure that a study is appropriately indexed and easily identified, authors should use the word " randomized " in the title to indicate that the participants were randomly assigned to their comparison groups.

Item 1b (title and abstract) -Providing a structured summary of trial design, methods, results, and conclusions and referenced. It should be clear, transparent, and sufficiently detailed.

 Introduction

Item 2a -  Scientific background and explanation of rationale.

The introduction should mainly consist of explanation about the scientific background and rationale for their trial and its general outline.

The rationale could be explanatory (for example, to assess the possible influence of a drug on renal function) or pragmatic (for example, to guide practice by comparing the benefits and harms of two treatments.

Authors should report any evidence of the benefits and harms of active interventions and should suggest a plausible explanation for how the interventions might work.Thus, the need for a new trial should be justified in the introduction.Ideally, it should include a reference to a systematic review of previous similar trials or a note of the absence of such trials.

 Item 2b - Specific objectives or hypotheses

In practice,objectives and hypotheses are not always easily differentiated.

Objectives are the questions that the trial was designed to answer. They often relate to the efficacy of a particular therapeutic or preventive intervention.

Hypotheses are pre-specified questions being tested to help meet the objectives. Hypotheses are more specific than objectives and are amenable to explicit statistical evaluation.

contd........ 

[Guest guest]

Dear Arin,

Thank you for your valuable inputs and enlightened guidance, which is

appreciated.

About source of the material quoted by me,I took this definition from the

explanatory and elaboration part(item 2b) of the consort 2010 statement

(http://www.consort-statement.org).

I consider myself as a learner in scientific research and looking forward to

your masterly posts on the subject under discussion.

With kind requests,

Rangeel

>

> > **

> >

> >

> > Dear members, Today we will start the discussion on latest version of

> > consort i.e. CONSORT statement 2010.There are number of changes

> >

> > in this updated statement. The CONSORT website (*

> > http://www.consort-statement.org*.) contains a side by side comparison of

> > the 2001and

> >

> > 2010 versions along with summary of the noteworthy general changes. ****

> >

> > *CONSORT 2010STATEMENT*

> >

> > CONSORT 2010 is developed to assist:****

> >

> > Ø *Authors** *in writing reports of randomized controlled trials*,*

> >

> > Ø *Editors and Peer reviewers** *in reviewing manuscripts for

> > publication, and****

> >

> > Ø *Readers** *in critically appraising published articles*.*

> >

> > The CONSORT 2010 statement is also published along with explanation and

> > elaboration. This document is intended to enhance the use,understanding

> > and dissemination of the CONSORT Statement. Through examples and

> > explanations, the meaning and rationale for each checklist item are

> > presented.****

> >

> > The CONSORT Statement comprises a 25-item

*checklist<http://www.consort-statement.org/consort-statement/overview0/>

> > * and a *flow

diagram<http://www.consort-statement.org/consort-statement/overview0/>

> > *, along with some brief descriptive text. The checklist items focus on

> > reporting how the trial was designed, analyzed, and interpreted; the flow

> > diagram displays the progress of all participants through the trial.****

> >

> > *The Checklist*

> >

> > The checklist items pertain to the content of the *Title, Abstract,

> > Introduction, Methods, Results, Discussion, and Other information*. The

> > checklist includes the 25 items selected because empirical evidence

> > indicates that not reporting the information is associated with biased

> > estimates of treatment effect, or because the information is essential to

> > judge the reliability or relevance of the findings.****

> >

> > Templates of the CONSORT 2010 checklist are available to download in *MS

> > Word <http://www.consort-statement.org/index.aspx?o=2964>* and in

*PDF<http://www.consort-statement.org/index.aspx?o=2965>

> > *****

> >

> > *TheFlow Diagram*

> >

> > The *flow

diagram<http://www.consort-statement.org/consort-statement/flow-diagram0/>

> > * is intended to depict the passage of participants through an RCT. The

> > revised flow diagram depicts information from four stages of a trial

(*enrollment,intervention

> > allocation, follow-up, and analysis).*

> >

> > The diagram shows the number of participants, for each intervention group,

> > included in the primary data analysis.****

> >

> > Templates of the CONSORT 2010 flow diagram are available to download in *MS

> > Word <http://www.consort-statement.org/index.aspx?o=2966>* and in

*PDF<http://www.consort-statement.org/index.aspx?o=2967>

> > .*

> >

> > *

> > *

> >

> > CONSORT 2010 focuses predominantly on the *two groups, parallel randomized

> > controlled trial*, which accounts for over half of trials in the

> > literature. Most of the items from the CONSORT 2010 Statement, however,

> > pertain to all types of randomized trials.****

> >

> > The format of articles should abide by journal style, editorial directions,

> > the traditions of the research field addressed,and, where possible, author

> > preferences. *There is no standardised structure of reporting*. Authors

> > should simply address checklist items somewhere in the article, with ample

> > detail and lucidity.**

> >

> > * *

> >

> > * Checklist items along with explanation and elaboration in consort 2010*

> >

> > *Title and Abstract*

> >

> > Item 1a - Identification as a randomized trial in the title.****

> >

> > To help ensure that a study is appropriately indexed and easily identified,

> > authors should use the word " randomized " in the title to indicate that the

> > participants were randomly assigned to their comparison groups.****

> >

> > *Item 1b (*title and abstract) -Providing a structured summary of trial

> > design, methods, results, and conclusions and referenced. It should be

> > clear, transparent, and sufficiently detailed.**

> >

> > ** **

> >

> > *Introduction*

> >

> > Item 2a - Scientific background and explanation of rationale.****

> >

> > The introduction should mainly consist of explanation about the scientific

> > background and rationale for their trial and its general outline.****

> >

> > The rationale could be explanatory (for example, to assess the possible

> > influence of a drug on renal function) or pragmatic (for example, to guide

> > practice by comparing the benefits and harms of two treatments.****

> >

> > Authors should report any evidence of the benefits and harms of active

> > interventions and should suggest a plausible explanation for how the

> > interventions might work.Thus, the need for a new trial should be justified

> > in the introduction.Ideally, it should include a reference to a systematic

> > review of previous similar trials or a note of the absence of such trials.

> > ****

> >

> > * *

> >

> > *Item 2b *- *Specific objectives or hypotheses*****

> >

> > In practice,objectives and hypotheses are not always easily differentiated.

> > ****

> >

> > *Objectives* are the questions that the trial was designed to answer. They

> > often relate to the efficacy of a particular therapeutic or preventive

> > intervention.****

> >

> > *Hypotheses* are *pre-specified questions *being tested to help meet the

> > objectives. Hypotheses are more specific than objectives and are amenable to

> > explicit statistical evaluation.****

> >

> > contd........

> >

> > ** **

> >

> >

> >

>