HLTH2024 Assessment 2 — Autumn 2022

CASP quantitative evaluation

1. Clearly focussed research question?

Yes

The study aimed to evaluate the weather bright light treatment via ear canals can

be a tool to improve depressive mood and sleep disorder for IT employees. This

was addressed through a randomized, controlled, crossover design. Participants

were assigned to Early treatment or later treatment groups with a four-week

intervention (during weekdays as overworked businessmen with depressive

symptoms were the target of the treatment) and a four-week observation period.

Outcomes were measured every Friday with self-administered questionnaires to

evaluate subjective mental status.

Did the study address a clearly focused research question? CONSIDER: Was the

study designed to assess the outcomes of an intervention? Is the research

question ‘focused’ in terms of: • Population studied • Intervention given •

Comparator chosen • Outcomes measured?

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 HLTH2024 Assessment 2 — Autumn 2022

2. Assignment randomised?

Can’t tell

According to section 2.2, participants were randomly allocated to early or later

treatment groups. However, there is no evidence that suggested that allocation

was concealed from investigators or participants.

Was the assignment of participants to interventions randomised? CONSIDER: •

How was randomisation carried out? Was the method appropriate? • Was

randomisation sufficient to eliminate systematic bias? • Was the allocation

sequence concealed from investigators and participants?

3. Participants who entered accounted for at conclusion?

Select an answer.

According to Fig 1, during this study one participant from the later treatment group

dropped out after the one week waiting/washout period. However, there is no

evidence to suggest why the participant did not continue.

Were all participants who entered the study accounted for at its conclusion?

CONSIDER: • Were losses to follow-up and exclusions after randomisation

accounted for? • Were participants analysed in the study groups to which they

were randomised (intention-to-treat analysis)? • Was the study stopped early? If

so, what was the reason?

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 HLTH2024 Assessment 2 — Autumn 2022

4. Blinding?

Answer all three questions for Question 4.

Were participants ‘blind’?

Were investigators ‘blind’?

Were people assessing and analysing outcomes ‘blinded’?

Yes, participants were blind to the intervention they were given. Fig 1 suggests

blinding during the treatment period and one-week waiting/washout period.

However, during the observation period there was confirmation of no blinding.

This study does not reveal evidence of blinding for the investigators or the people

analysing intervention outcomes.

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 HLTH2024 Assessment 2 — Autumn 2022

5. Groups similar?

Yes

Participants were volunteers that were selected if they met within the criteria of 20

years or older and presenting with mild to intermediate degrees of depression

symptoms in the Self-rating Depression Scale (SDS) (at pre-screening). However,

out of the 27 participants 17 were male and 10 were female, therefore

underrepresenting the female population, which could affect results and reduce

generalisability to other populations.

Were the study groups similar at the start of the randomised controlled trial?

CONSIDER: • Were the baseline characteristics of each study group (e.g. age,

sex, socio-economic group) clearly set out? • Were there any differences between

the study groups that could affect the outcome/s?

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 HLTH2024 Assessment 2 — Autumn 2022

6. Treated equally?

Yes

Both the early treatment group and the later treatment group were given the

intervention for a four-week period (weekdays) and a four-week observation period,

with a weekly Friday questionnaire of the SDS, the Athens Insomnia Scale (AIS),

and Profile od Mood States (POMS).

Apart from the experimental intervention, did each study group receive the same

level of care (that is, were they treated equally)? CONSIDER: • Was there a clearly

defined study protocol? • If any additional interventions were given (e.g. tests or

treatments), were they similar between the study groups? • Were the follow-up

intervals the same for each study group?

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 HLTH2024 Assessment 2 — Autumn 2022

7. Effects reported?

Yes

Outcomes were measured through questionnaires; SDS evaluating depressive

symptoms (primary endpoint), AIS evaluating insomnia symptoms, and POMS

evaluating total mood. Results were expressed on a table, representing the

baseline characteristics of participants, values were expressed as mean and

standard deviation. All outcome measures were accounted for in the table. P value

was reported on this table. To statistically analyse the change in the scores of the

questionnaires between the treatment and observation period, a linear mixed

model was used.

Were the effects of intervention reported comprehensively? CONSIDER: • Was a

power calculation undertaken? • What outcomes were measured, and were they

clearly specified? • How were the results expressed? For binary outcomes, were

relative and absolute effects reported? • Were the results reported for each

outcome in each study group at each follow-up interval? • Was there any missing

or incomplete data? • Was there differential drop-out between the study groups that

could affect the results? • Were potential sources of bias identified? • Which

statistical tests were used? • Were p values reported?

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 HLTH2024 Assessment 2 — Autumn 2022

8. Precision reported? (Refers to confidence intervals, SD)

No

There is no evidence of confidence intervals being reported in this study.

Was the precision of the estimate of the intervention or treatment effect reported?

CONSIDER: • Were confidence intervals (CIs) reported?

9. Benefits outweigh? (outweigh risks)

Select an answer.

Vy

Do the benefits of the experimental intervention outweigh the harms and costs?

CONSIDER: • What was the size of the intervention or treatment effect? • Were

harms or unintended effects reported for each study group? • Was a cost-

effectiveness analysis undertaken? (Cost-effectiveness analysis allows a

comparison to be made between different interventions used in the care of the

same condition or problem.)

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 HLTH2024 Assessment 2 — Autumn 2022

10. Results applicable?

Select an answer.

Can the results be applied to your local population/in your context? CONSIDER: •

Are the study participants similar to the people in your care? • Would any

differences between your population and the study participants alter the outcomes

reported in the study? • Are the outcomes important to your population? • Are there

any outcomes you would have wanted information on that have not been studied or

reported? • Are there any limitations of the study that would affect your decision?

11. Appraisal summary

Replace this text with CASP appraisal summary. Suggested length so that entire

assignment is no more than 1,200 total word count on Turnitin, including

references and all other document text.

References

Critical Appraisal Skills Programme (2020). CASP Randomised Controlled Trials

Checklist. CASP CHECKLISTS - CASP - Critical Appraisal Skills Programme

(casp-uk.net)

Kinoshita, T., Tanigawa, T., Maruyama, K., & Morimoto, K. (2020). The effects of

bright light treatment via ear canals on quality of sleep and depressive mood

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 HLTH2024 Assessment 2 — Autumn 2022

among overworked employees: A randomized-controlled clinical trial. Work,

67(1), 323-329. https://doi.org/10.3233/WOR-203282

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