CASP Checklist: 12 questions to help you make sense of a Cohort Study

How to use this appraisal tool: Three broad issues need to be considered when appraising a
cohort study:

Are the results of the study valid? (Section A)

What are the results? (Section B)
Will the results help locally? (Section C)

The 12 questions on the following pages are designed to help you think about these issues
systematically. The first two questions are screening questions and can be answered
quickly. If the answer to both is “yes”, it is worth proceeding with the remaining questions.
There is some degree of overlap between the questions, you are asked to record a “yes”,
“no” or “can’t tell” to most of the questions. A number of italicised prompts are given after
each question. These are designed to remind you why the question is important. Record
your reasons for your answers in the spaces provided.

About: These checklists were designed to be used as educational pedagogic tools, as part of a
workshop setting, therefore we do not suggest a scoring system. The core CASP checklists
(randomised controlled trial & systematic review) were based on JAMA 'Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL, and Cook DJ), and piloted with
health care practitioners.
For each new checklist, a group of experts were assembled to develop and pilot the checklist
and the workshop format with which it would be used. Over the years overall adjustments
have been made to the format, but a recent survey of checklist users reiterated that the basic
format continues to be useful and appropriate.
Referencing: we recommend using the Harvard style citation, i.e.: Critical Appraisal Skills
Programme (2018). CASP (insert name of checklist i.e. Cohort Study) Checklist. [online]
Available at: URL. Accessed: Date Accessed.

©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial-
Share A like. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-
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Paper for appraisal and reference: Functional Outcomes After Localized Prostate Cancer Treatment
Section A: Are the results of the study valid?

1. Did the study address a clearly Yes HINT: A question can be ‘focused’
focused issue? YES in terms of
Can’t Tell • the population studied
• the risk factors studied
No
• is it clear whether the study tried to
detect a beneficial or harmful effect
• the outcomes considered

Comments: This is an observational study of 2445 people treated for localized prostate cancer and follow up
for 10 years. The study compared the associations between specific treatment such as radiotherapy, radical
prostate ectomy and functional outcomes such as urinary incontinence and sexual dysfunction. (page 302,
303)

2. Was the cohort recruited in Yes HINT: Look for selection bias which might
an acceptable way? YES compromise the generalisability of the
Can’t Tell findings:
• was the cohort representative of a
No
defined population
• was there something special about the
cohort
• was everybody included who should
have been

Comments: The cohort recruited in an acceptable way. Despite some of the bias, 2445 people were
included and were observed in 10 years with several periods of time such as 6 months, 12 months, 3
years, 5 years, 10 years of treatment. In the analysis, something special is that they excludud men who
did not answer questionnaires at baseline and at least once thereafter or who had missing clinical
information. (page 303)

Is it worth continuing?
 3. Was the exposure accurately
measured to minimise bias? YES
Can’t Tell
Yes HINT: Look for measurement or
classification bias:
• did they use subjective or objective
measurements
No • do the measurements truly reflect what
you want them to (have they been
validated)
• were all the subjects classified
into exposure groups using the
same procedure

Comments: the population was divided into two groups: favorable-prognosis and unfavorable-prognosis. This
helps minimize the bias and helps the readers have a broader view. In the favorable-prognosis PC group, they
compared radical prostatectomy, external beam radiotherapy (EBRT) without ADT, low-dose-rate brachytherapy,
and AS, defined as no definitive treatment within 1 year of diagnosis or medical record documentation of AS. In
the unfavorable-prognosis PC group, they compared radical prostatectomy vs EBRT with ADT (page 303)

4. Was the outcome accurately Yes HINT: Look for measurement or

measured to minimise bias? YES classification bias:
Can’t Tell • did they use subjective or objective
measurements
No • do the measurements truly reflect what
you want them to (have they been
validated)
• has a reliable system
been established for detecting all the
cases (for measuring disease occurrence)
• were the measurement
methods similar in the different groups
• were the subjects and/or
the outcome assessor blinded to
exposure (does this matter)

Comments: The outcome was measured with the 26-item Expanded Prostate Cancer Index Composite (EPIC-26).
Minimum clinically important differences (MCIDs) were also analized. Prespecified secondary outcomes measuring
functional quality-of-life concerns were used included overall sexual, urinary, and bowel function, in addition to
urinary leakage, burning on urination, frequent urination, and bowel urgency. Other prespecified secondary
outcomes were health-related quality-of-life domains for physical and mental health, measured using the Medical
Outcomes Study 12-Item Short Form at 10 years, and overall and PC-specific survival. (page 303)
5. (a) Have the authors identified Yes HINT:
all important confounding • list the ones you think might be
factors? CAN’T TELL Can’t Tell important, and ones the author missed

No

Comments: The authors have mentioned about the confounding by indication. One that could be an
important confounding is that the hormone function can be influenced by age, ethnicity... (page 304)

5. (b) Have they taken account of Yes HINT:

the confounding factors in the
design and/or analysis? NO
• look for restriction in design, and
Can’t Tell techniques e.g. modelling, stratified-,
regression-, or sensitivity analysis to
No correct, control or adjust for
confounding factors

Comments:

6. (a) Was the follow up of Yes HINT: Consider

subjects complete enough? CAN’T TELL • the good or bad effects should
have had long enough to
Can’t Tell reveal themselves
• the persons that are lost to follow-up
No may have different outcomes than
those available for assessment
• in an open or dynamic cohort, was
there anything special about the
outcome of the people leaving, or the
exposure of the people entering the
cohort
6. (b) Was the follow up of Yes
subjects long enough? YES
Can’t Tell

No
Comments: : the participants were required to answer a questionnaire at
various points in time (the overall research period was 10 years). The total
following time is long enough to carefully analyze the complications after
treatment. (page 302)

Section B: What are the results?

HINT: Consider
• what are the bottom line results
7. What are the results of this study?
• have they reported the rate or
Page 305
the proportion between the
exposed/unexposed, the
ratio/rate difference
• how strong is the association
between exposure and outcome
(RR)
• what is the absolute risk reduction
(ARR)

Comments: The study included 2445 patients with localized prostate cancer,
with a median age of 64 years and diverse racial representation. Survival data
were available for 98% of the analyzed cohort. At 10 years, 12% of men with
favorable-prognosis prostate cancer had died, with only 0.4% of deaths
attributed to prostate cancer itself. Conversely, among men with
unfavorable-prognosis prostate cancer, the mortality rate was higher, with
20% dying, including 5% from prostate cancer. The 10-year estimated
prostate cancer-specific survival rates varied by treatment modality: for
favorable-prognosis cases, rates ranged from 99.3% to 100%, while for
unfavorable-prognosis cases, rates ranged from 91.7% to 96.4%. The study
provides crucial insights into survival outcomes stratified by prognosis and
treatment type in localized prostate cancer.
8. How precise are the results?
Page 305
HINT:
• look for the range of the confidence
intervals, if given

Comments:
For radical prostatectomy vs. active surveillance in patients with favorable prognosis:
Urinary incontinence: adjusted mean difference, -12.1 [95% CI, -16.2 to -8.0]
Sexual function: adjusted mean difference, -7.2 [95% CI, -12.3 to -2.0]
For radical prostatectomy vs. external beam radiotherapy with androgen deprivation therapy in patients
with unfavorable prognosis:
Urinary incontinence: adjusted mean difference, -26.6 [95% CI, -35.0 to -18.2]
Sexual function: adjusted mean difference, -1.4 [95% CI, -11.1 to 8.3]
For external beam radiotherapy with androgen deprivation therapy vs. radical prostatectomy in patients
with unfavorable prognosis:
Bowel function: adjusted mean difference, -4.9 [95% CI, -9.2 to -0.7]
Hormone function: adjusted mean difference, -4.9 [95% CI, -9.5 to -0.3]
The confidence intervals are relatively narrow, suggesting a reasonably precise estimate of the
differences in outcomes between the treatment modalities.
9. Do you believe the results? HINT: Consider
Can’t tell (n/a) Yes • big effect is hard to ignore
• can it be due to bias, chance or
Can’t Tell confounding
• are the design and methods of this
No study sufficiently flawed to make the
results unreliable
• Bradford Hills criteria (e.g. time
sequence, dose-response gradient,
biological plausibility, consistency)

Comments: The study examining treatments for localized prostate cancer reveals associations
between interventions and outcomes such as urinary incontinence and sexual function. While the
data encompass a significant patient cohort over a considerable timeframe, limitations must be
acknowledged. The observational design leaves results susceptible to confounding and bias, while
subjective determinations of clinically important differences and potential response bias and
missing data introduce further uncertainty. Small sample sizes in certain subgroups and changes in
treatment paradigms over time also temper the study's generalizability. While informative,
cautious interpretation is warranted, and further research, potentially employing randomized
controlled trials, is necessary to validate and augment these findings.

Section C: Will the results help locally?

10. Can the results be applied to Yes HINT: Consider whether

the local population? Can’t tell • a cohort study was the appropriate
(n/a) method to answer this question
Can’t Tell • the subjects covered in this study could
be sufficiently different from your
No population to cause concern
• your local setting is likely to differ
much from that of the study
• you can quantify the local benefits and
harms

Comments: The results of this study may have limited applicability to the local population due to
several factors. First, the study utilized an observational design, which is prone to confounding and
bias, potentially limiting the generalizability of the findings. Second, the study population may differ
from the local population in terms of demographics, healthcare access, and treatment preferences,
which could affect the applicability of the results. Third, changes in diagnostic and treatment
paradigms since the study inception may render the findings less relevant to current clinical practice.
Fourth, the study excluded men with locally advanced disease (cT3+) and those older than 80 years,
further limiting the generalizability of the results to these populations.
11. Do the results of this study fit Yes
with other available
evidence? Yes (page 305,315) Can’t Tell

No

Comments: The results of this observational study of patients with

localized prostate cancer (PC) align with some findings from previous
research while also highlighting certain differences. The study
demonstrates that functional outcomes varied by treatment modality
and prognosis, with notable differences observed in sexual function,
urinary incontinence, bowel function, and hormone function.
 12. What are the implications of Yes HINT: Consider
this study for practice? Yes (page 305,315) • one observational study rarely
provides sufficiently robust
Can’t Tell
evidence to recommend changes
to clinical practice or within
No health policy decision making
• for certain
questions, observational studies
provide the only evidence
• recommendations from
observational studies are always
stronger when supported by
other evidence

Comments: The implications of this study for practice highlight several key points. Firstly,
the study underscores the importance of considering treatment and prognosis in localized
prostate cancer (PC) management, as functional outcomes varied by treatment modality
and prognostic risk. Secondly, the findings suggest that radical prostatectomy may lead to
worse sexual function compared to other treatments during the initial years, particularly for
patients with favorable-prognosis PC, while urinary incontinence persisted up to 10 years
post-surgery for both favorable and unfavorable prognostic risk groups. Thirdly, the study
sheds light on the impact of contemporary techniques, such as robotic surgery and
intensity-modulated radiotherapy, in potentially mitigating adverse functional outcomes
associated with PC treatment. However, the study acknowledges limitations, including the
observational nature of the research, potential confounding, subjective measures of
clinically meaningful differences, response bias, and changes in diagnostic and treatment
paradigms over time.
 Functional Outcomes After Localized Prostate Cancer Treatment
Prostate cancer has an overall good prognosis when compared with other types of cancer,
yet the clinical treatments tend to affect patients' lives. With that concern, in the article
"Functional Outcomes After Localized Prostate Cancer Treatment", the authors revolved around
the treatment's impact on prostate cancer patients' quality of life.
The study includes four primary treatment approaches: radical prostatectomy, external
beam radiation therapy (EBRT) with or without Androgen Deprivation Therapy (ADT),
brachytherapy, and active surveillance. A radical prostatectomy is a surgery in which the prostate
and its surrounding tissue are removed, while external beam radiotherapy uses high-energy
beams to target and destroy cancer cells. Brachytherapy involves the insertion of radioactive
sources directly into the prostate gland. On the other hand, active surveillance involves closely
monitoring the cancer's progression without immediate intervention. This study aimed to assess
the rates of adverse functional outcomes among men who underwent those treatments for
localized prostate with the purpose of guiding treatment selection.
This is an observational cohort study with the target population including men less than 80
years old diagnosed with localized prostate cancer, which is appropriate to answer the research
question. The total sample size is large (2445 people); however, at first, the number of eligible
patients was more than 3000, meaning that approximately 20% of the total sample size was
neglected for many reasons, and it needs to be carefully considered. Next, the population was
divided into two groups: favorable-prognosis (treatment options include radical prostatectomy;
EBRT without ADT; low-dose-rate brachytherapy; AS) and unfavorable-prognosis (treatment
options include radical prostatectomy; ERBT with ADT). In each group, the authors compared
various functional outcomes, namely urinary incontinence, urinary irritation, sexual dysfunction,
bowel and hormone function to detect if there was any association between them and specific
treatments. It helps us to have a broader view and simpler approach instead of only one research
group. Moreover, the participants were required to answer a questionnaire at various times (the
overall research period was 10 years). Then, the Wilcoxon rank sum, Kruskal-Wallis, and Chi-
square test were used to analyze the data.
The study found that the mortality rate from prostate cancer is quite low, with 0,4% in the
favorable-prognosis group and 5% in the unfavorable-prognosis group, which highlights the
importance of understanding the associations of each treatment with long-term functional
outcomes. Notably, the urinary incontinence rate turned out to be higher throughout 10 years
after radical prostatectomy compared to other treatments regardless of prognostic risk. In terms
of sexual function, there was no difference between treatments in both groups in 10 years of
follow-up. However, during the first 3 to 5 years in the favorable-prognostic group, patients who
underwent radical prostatectomy experienced worse sexual life than other treatments. Bowel
function was quite different between two groups. No significant differences were found among
treatment options for patients with favorable-prognosis PC, but in unfavorable-prognosis group,
bowel function when treated with EBRT and ADT was worse as compared to radical
prostatectomy. Also, hormone function score is lower in EBRT with ADT treatment than in radical
prostatectomy.
The strengths of this study lie in its well-built methods and comprehensive data analysis. As
mentioned above, the study includes a large sample size, which allows the authors to analyze
further aspects of treatment outcomes as well as reduce potential biases. The analysis tools were
the Wilcoxon rank sum, Kruskal-Wallis, and Chi-square test, which provided more precise
observations and the ability to compare different measurements. On top of it, the extensive
follow-up data collected through the questionnaire also focused on various functional and
emotional outcomes, which covered the full status of one patient. Plus, the duration of follow-up
was 10 years, which gives us insights into the long-term effects of all the treatments. However, it
is also one of the limitations of this study: 10 years is usually hard to follow closely, and missing
data may occur due to forgotten memories or death of the included population. Another
noticeable limitation is the exclusion of certain patient populations, and some patients’ groups
may not well-represent the disease. It raises questions about the generalizability of the findings.
Overall, the merits of this study still outweigh its limitations, making it a valuable study for clinical
practice.
In conclusion, the study effectively highlights the influence of treatment for localized
prostate cancer regarding various aspects of a patient's health. This observational paper also
provided a broad view of functional and emotional outcomes following different methods'
choices, therefore proposing valuable insights for both clinicians and patients in making informed
decisions on treatment options. Nevertheless, limitations still need to be examined and reviewed
in order to provide more unbiased, generalized advice for patients with prostate cancer.