Chapter 8 Part 5在线视频

Case 2

A Clinical Trial

Case 2 is a randomized clinical trial published

in The New England Journal of Medicine in 2020

titled A Randomized

Controlled Trial of Liraglutide for Adolescents with Obesity

First

let’s look at the structure and content of its Methods

For the overall organization of the Methods section

the authors followed the generic structure

and answered the 3 questions

What was used

What was done

How was it done

in 4 subsections

with the corresponding subtitles

“Trial Oversight”

“Participants”

“Trial Procedures and End Points” and “Statistical Analysis”

It employed a condensed way of combining the procedures

interventions and measurements into one single subsection

Although the subsections are often titled

in different words in different journals

they adopt a typically similar framework

for reporting clinical trials

In other words

they actually share the similar meaning

and with the same type of information

For example

“Trial Oversight”

here is equivalent to “trial design” in JAMA

“Trial Procedures and End Points” is equivalent to “Procedures”

“Interventions” and “Outcomes” in other journals

The first subsection “Trial Oversight”

in this case consists of 2 paragraphs

In para.1

the authors gave a highly generalized introduction

of the trial design

“This randomized double-blind

pla’cebo-controlled

phase 3 trial”

in the very first sentence clearly tells the study type

Then they stated the author

sponsor and investigators’ responsibilities

In para.2

both a statement regarding obtaining approval

from the ethics committee and a statement

that the study was conducted

according to the Declaration of Helsinki

were clearly provided

They also mentioned a statement regarding informed con’sent

The second subsection “Participants” has only one paragraph

In this single paragraph

the authors mainly described

the inclusion and exclusion criteria for study subjects

The third subsection “Trial Procedures and End Points”

is made up of 2 paragraphs

In para.1

the authors introduced in sufficient details

what was done in a 12-week run-in period

a 56-week treatment period

and a 26-week follow-up period without treatment

With much information such as

the order and duration of interventions provided

this paragraph

however

is written rather efficiently

In para.2

the order and duration of measurements were given

in a shortened and clear way

The fourth subsection “Statistical Analysis”

has one single paragraph

In this paragraph

the authors first restated the hypothesis

Then they described

the calculation for primary and secondary endpoints

How the missing data were handled was also stated

The statistical tests and models used for the analysis

and assessment of some specific endpoints

were reported respectively

Since these are well-known tests

they don’t need to be referenced

All in all

this article also described statistical methods

with enough detail

to enable a knowledgeable reader

with access to the original data

Now let’s analyze the language features of the Methods section

Consistency with Other Sections

In the last subsection of the Methods

at the beginning

the very first sentence of the paragraph

was written in accordance

with the hypothesis given at the end of the Introduction

The same key terms were used

to achieve the consistency between the Methods

and the Introduction section

“liraglutide” as the variable was used in both sections

The noun “obesity” in the research aim was changed with

“with regard to weight reduction” because

“obesity” is a relatively common English word

that can be written in its synonym

or expressions with similar meanings

Transition

The sentence we have seen just now in the last

or the 4th subsection

is also an example of transition between paragraphs

This sentence is a topic sentence

for readers to be ready

for the following statistical analysis

Precise word choice

In this article

you may find the action verbs and phrases

prepositional and adverbial

are precisely and properly used

in the Methods to report exactly

what was done and how was done

In the first subsection “Trial Oversight”

“trial” was undoubtedly one of the frequently used nouns

and it collocated with those common verbs “conduct”

“design” and “oversee”

Another familiar noun is “data”

The author chose a series of specific verbs

and verbal phrase

“gather”

“perform”

“has full access to”

“direct”

“supervise”

and “interpret”

to briefly summarize

the whole process of data analysis

Further

for “the accuracy and completeness of the data

and the fidelity of the trial to the protocol”

“vouch for” is well chosen

which means “confirm as a result of one’s own experience

the truth or accuracy of sth.”

To state

that this phase 3 trial had obtained ethical approval

the verb “approve” and the phrase “in accordance with”

were used as in other similar context

As for the written informed consent or assent

the verb “obtain” is often used

as we can see here in this article

In the second subsection “Participants”

for the inclusion criteria

“be eligible for” is used

as in other similar context

For the exclusion

“be excluded” was employed

To concisely provide the medical criteriathe the verb

“define” was well chosen

In the third subsection “Trial Procedures”

typical verbs and adverbs

were accurately used to describe the specific steps

“Participants were randomly assigned

in a 1:1 ratio…”

“…placebo administered subcutaneously”

“treatment was initiated…”

“the dose was increased weekly…”

“the 3.0-mg dose was reached”

Here

In those examples

Assign receive

administer initiate increase and reach

are frequently used verbs

in similar context in experimental procedures

Please also note

that in this paragraph

adverbs like randomly

subcutaneously

weekly and daily

are efficiently and effectively used

for better understanding of how it was done

Meanwhile

you may also find

some quite useful expressions for drug use

such as “volume-matched placebo”

“once daily”

“at a dose of 0.6 mg daily”

“the maximum tolerated dose”

“the 3.0-mg dose” and “highest dose allowed”

In the fourth subsection “Statistical Analysis”

the data calculation and analysis procedures

were also described

with some commonly used verbs

and prepositional phrases

in articles of similar types

Look at those sentences

For the primary end point of the change…

we calculated

with

Primary and secondary efficacy end

points were analyzed according to

with analyses

All missing data were handled with

For weight-related end points

an additional analysis was performed

with the use of a mixed model

The primary and continuous secondary efficacy

end points were assessed

with an analysis-of-covariance model

The categorical secondary efficacy

end points were evaluated

with a logistic-regression model

Safety end points were analyzed

in the safety population

In those example sentenses

The verbs

calculate

analye

estimate

handle with perform assess

evaluate

a frequently used verbs

In the simillar contests

Verb Tense

You can find

the Methods section in this article is mainly written

in simple past tense

describing completed actions

One exception is the simple present tense

which was used for indicating

that more information can be obtained in Appendix

The first example is from the 2nd paragreph

reporting participant

were eligible for

defined as

corresponded to

based on

were eligible

Those verbs were all used in simple past tense

while in the last sentence of the paragreph

Complete lists of inclusion

exclusion and randomization criteria

are provided in the Supplementary Appendix

Here

the simple present tense is used for it is a fact

It is the same

in another example from the 3rd subsection

was repestedly assessed

were completed

was monitored

were all used in simple present tense

were in the last sentense

A complete list of end points is provided

in the protocol

The simple present is used

The another exception of verb tense

is the present perfect tense

used at the end of the 4th subsection “Statistical Analysis”

The widths of the confidence intervals have not been adjusted

for multiplicity

so the intervals should not be used

In this sentence

the author gave the necessary explanations

for the widths of the confidence intervals

so the present perfect tense is used

Then look at the last sentenses

Additional details regarding the statistical analysis are provided

in the Supplementary Appendix

It is a fact

so it is used in simple present tense

Use of Parentheses

You can also see parentheses were used in some sentences

for not breaking up the flow of the main message

Examples of parentheses in Methods of this article

are as follows

The types of details

that were placed in parentheses include

Specific or detailed information

Clinical definitions or terms

Additional explanations

And Figures and appendix

Point of View and Voice

Another important language feature

In this article

is the point of view and voice

The Methods section of this article employed

both point of the experiment

and point of the experimenter we

That means

the subsections in Methods were written in both

passive voice and active voice

Though the point of the experiment dominated

the Methods section

the active voice was also used smartly

Let’s look at some example sentences

Firstly

“we” was used twice at the beginning of both the first

and the last subsections in order to gain readers’ attention

We conducted this randomized double-blind

placebo-controlled phase 3 trial

We hypothesized that liraglutide

would show superiority to placebo with regard to

weight reduction in adolescents

For the primary end point of the change

from baseline in the BMI

standard deviation score at week 56

we calculated

that a sample of 228 participants

would provide the trial with

90% power to show a significant treatment effect

Secondly

most trial procedures and data analysis

were described from the point of the experiment

that is in passive voice

still

they also avoid they changed

between the passive voices

and the active one in some sentences for avoiding dullness

In this paragreph

In order to show the responsibility of different individuals

they also used active words

and made a person the subject of the synthesis

Like the site investigators

all the authors

the first author

But as you can say in the same paragraph

Passive voice were also used

As in the first ascent

the trial was designed and overseen

The losses centers

the manuscript

which is subsequently revised

and improved by all the authors

Length

At last is about the length

The total word count of this section is 1,061

spreading over four subsections