Quality Assessment of a Physical Activity Intervention Study Report

This report provides a comprehensive quality assessment of a randomized controlled trial (RCT) focused on a physical activity intervention designed to increase moderate to vigorous physical activity (MVPA) in low-income and minority adolescents. The study, conducted across 24 middle schools, employed a structured PICO (Patient, Intervention, Comparison, Outcome) framework to evaluate the intervention's effectiveness. The assessment critically examines key aspects of the study, including selection bias, study design (specifically, the use of an RCT), the methods of randomization, and the control of confounding factors such as age, race, and socioeconomic status. The analysis also addresses blinding of outcome assessors and the handling of potential biases. The report highlights the study's strengths in its design and implementation, particularly in its efforts to mitigate confounding variables through stratified sampling and matching. The study's methodological rigor is emphasized, along with the implications of the findings for public health interventions aimed at promoting physical activity among adolescents. The report concludes with a discussion on the overall validity and reliability of the study's conclusions.

OPTION 1: Individual submission (begin with this template and use it to submit your draft)
Structured 3,500 word essay maximum excluding the words of these
questions and your list of references. Expand the explanation boxes as
required. This template contains approximately 1464 words.
You must use this worksheet to complete the assessment and
submit it through Turnitin.
Pair number
Name and student
number
Second reviewer,
name and student
number
Date draft submitted
through TurnitIn.
Word count (not including the
words for the form and the
references):
Date of exchange
individual work and
discussion with
partner
Study assessed as described in:
Wilson, Dawn K., et al. "Results of the “Active by Choice Today”(ACT) randomized
trial for increasing physical activity in low-income and minority adolescents." Health
Psychology 30.4 (2011): 463.
Remember, you are assessing the study which is described, and not this single
publication. You will need to check and identify if additional information about
this study is available. If so then you can incorporate the information into the
responses. Please be aware that sometimes the information may conflict.
QUALITY ASSESSMENT TOOL FOR QUANTITATIVE STUDIES
Please complete these the questions presented as structured
paragraphs as you would in an essay. Highlight your selection
or cross-out the choice not applicable. Demonstrate your
knowledge of epidemiological principles within each section and
support your statements.

Part 1: (Initially undertaken on your own)
Show the structured PICO question of the study
Patient- The respondents being targeted by this study are the Adolescents in
twenty four middle schools with mean age of 11.3 years.
Intervention- Active by choice behaviour intervention program
Comparison- Two school children intervention program one put on intervention and
the other one control group
Outcome – The main outcome measure was moderate to vigorous physical activity
in low income and minority adolescents
COMPONENT RATINGS
A) SELECTION BIAS
(Q1) Are the individuals selected to participate in the study likely to be representative of the target
population?
1. Very likely
2. Somewhat likely
3.Not likely
4. Can’t tell
Very likely
Selecting representative sample in research process is geared towards having strong validity and building
relationship to the target population in which the sample is meant to represent. Thus when appropriate
approaches are used in cross sectional studies, is geared towards gaining confidence in generalizing findings in
the general population. Thus appropriate research methods are essential in ensuring that a representative
sample is achieved from the population. The study targeted school going children and those that are physically
active, (Mann, 2003). This is due to their growth patterns and it is with this reason that the study choose to
select 6th grade children among schools that were randomised selected. 12 intervention schools and 12
comparison schools were selected, with an aim of identifying the individuals to be engaged in the study. When
the target population is large, it is important definitely to draw down on the subset population to work with, thus
the essence of identifying sample population top form a representative sample size. Thus this will inform how
the study findings can be applied to the general population. Hence for a sample such as in this randomised
control study, it is of essence to ensure there is consistency through an elaborate understanding of the
population case by case. The sample population must also incorporate diversity, hence that is why the study
sample representatives are homogenous, representative the school going students from the diverse
backgrounds, (Hertzog, 2008).
(Q2) What percentage of selected individuals agreed to participate?
1. 80 - 100% agreement
2. 60 – 79% agreement
3. less than 60% agreement
4. Not applicable
5. Can’t tell
60-79% agreement
With the selection of all 6th grade students in the 24 public schools, they were put into participation program,
and the inclusion and exclusion criteria was the parental consent and selection through the random assignment.

Hence with these criteria, a total of 71% of the initial sample qualified to participate in the study. Exclusion
criteria used was that if the students had medical condition and had developmental issues.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Strong
The above section gives a represenative view of question analysis and gives an overview of the general research
framework. Getting concepts on the response rate gives you an opportunity to gauge the quality of evidence and
findings which support the proposition of the study.
B) STUDY DESIGN
Indicate the study design
1. Randomized controlled trial
2. Controlled clinical trial
3. Cohort analytic (two group pre + post)
4. Case-control
5. Cohort (one group pre + post (before and after))
6. Interrupted time series
7.Other, please specify:
8. Can’t tell
Was the study described as randomized? If NO, go to Component C.
Yes
If Yes, was the method of randomization described? (See dictionary)
Yes
If Yes, was the method appropriate? (See dictionary)
Yes
The active by choice behaviour change adopted randomised control trial in that cohort design was selected
having two treatment groups. This involved the intervention group and comparison group or the control group.
Randomised control trials have been structured to give a fair comparison between the new treatment effect and
existing treatment. Control trial compares two or more groups which one acts as an experimental group and the
other acting one acting as a placebo. Randomised trials allows for random assigning of participants into
experimental group and control group. Randomised in essence refers to the volunteering by the respondents
through division into groups and being tested through treatment effect, (Raudenbush, 1997). The study is
expected to bring the difference between the two groups based on the treatment behaviour being implemented.
The advantages of this kind of study design are that, having good randomization will definitely remove any
population basis, it allows for easier blinding process, results are analysed with well known statistical tools and
that it allows for the study population to be easily identified. The two differential treatments of the groups allows
for effects to be observed and to make sure that the groups are not similar from the start, (Gomes et al 2013).
Randomised controlled trials are used as gold standards for clinical research process for therapy and prevention
and transparency in reporting process design for analysis and plays crucial role in informing evidence based
practices which are essential in conduct and design of analysis, (Alexander & Emerson, 2005). This tool is the

most appropriate tools to estimate of effects of medical intervention. Number of issues relating statistical
analysis of RCT in relation to possible approaches. Conducting a cluster randomised trials are aimed at selecting
few participants and has been increasingly used for complex interventions. These designs have utilise in
conducting health interventions. Hence there is need for balance of participants to minimise biases issues
among them, (Thomson et al., 2009).
In the study the randomization process was followed with the ACT program being at the school based trial
efficacy of the motivational behavioural skills. In the study 24 middle level schools were matched on the size
with percentages, minorities and urban rural settings being initiated before randomization process tool place.
However the exact randomization process was described, as per how the treatment and randomization took
place for the children. Amid intervention students were engaged in 4.87 minutes duration time of moderate to
vigorous physical activity per day than the control group. Further the students in the intervention group were
engaged in 9.11 minutes more per day than those of MVPA, thus indicating a 27 minutes per week increase in
physical exercise practice. The method employed was appropriate in the study as it gives an equal treatment
opportunity to the sample respondents both in the treatment and control groups.
The method used in this study is appropriate in that it allows for randomised controlled trial to each participant
receiving treatment at random chance. Thus allows that results are not biased on how participants are selected.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Strong
The methodological process selected is strong and the result which yields an opportunity to ensure that the
results are strong and effect treatment can be replicated to bring the desired change to the respondents.
C) CONFOUNDERS
(Q1) Were there important differences between groups prior to the intervention?
1.Yes
2. No
3. Can’t tell
The following are examples of confounders:
1. Race
2. Sex
3. Marital status/family
4. Age
5. SES (income or class)
6. Education
7. Health status
8. Pre-intervention score on outcome measure
Yes
When there is an occurrence in the outcome between the exposure groups and the treatment groups, there is
need to consider whether the effect is truly because of the associated effect or not. Thus there is need to
evaluate the factors that might distort the true associated or the influence the interpretation will have. Thus
evaluating the role of biasness in the study is crucial. Considering biasness effect is key to such study. Bias
relates to the systematic sources of errors which have to be considered. This is key in analysing the internal
validity of the study findings which the biases have been accounted for and initiative measure being undertaken
to ensure that they are mitigated appropriately. In study that is rated poorly, bias may be accounted to this
effect thus results obtained are statistically significant. Thus bias entails preclude that the finding are true effect
and it lead to inaccurate estimate of the true measurements, (Rothman, 2004).
Confounding biases are referred to mixing effects where the effects of the exposure under the study on a given

outcome are mixed in with effects of an additional factor. In clinical trials it can happen when the unknown
distribution of a known parameter differs greatly in the groups when compared. Confounding factors have been
found to have arisen in association or falsely demonstrate an apparent association between the treatment and
outcome exposure when the real association between them do occur, (Hayes & Moulton, 2009).
The presence of confounding factors and variables in any study often makes it difficult to link the relationship
between the treatment and outcome measures unless treatment methods that are effective are used.
Confounding variables are those that compete with the exposure of interest in the study. The created amount of
association can explain the confounding factors which provide appreciate estimate true association linked to
exposure, (Weiss,2006).
In the study the following confounding factors were observed, gender, age, race, and education status. These
factors were mitigated using various approaches. Systematic and stratified sampling techniques were utilised.
Matching of the schools to ensure equality was adopted to ensure that the different schools were equally
selected to avoid biases. Parameter which can be attributed by this study in ensuring that the factors were
assessed included proper measure and reporting the potential confounders. Often in practice these confounding
factors are often under reported thus affecting the final study findings. Thus effective planning as indicative in
this study are crucial in ensuring that they are mitigated appropriately. Thus in general, failure to report the
potential demographic and clinical confounders has big impact on the final results.
(Q2) If yes, indicate the percentage of relevant confounders that were controlled (either in the
design (e.g. stratification, matching) or analysis)?
1. 80 – 100% (most)
2. 60 – 79% (some)
3. Less than 60% (few or none)
4. Can’t Tell
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Strong
The confounders here are strongly illustrated with effective approaches to mitigate them. the researchers have
shown and highlighted the confounders available and they have shown how these confounders which have an
effect on the study.
Yes 80-100%
Based on the study Assesment most of the common confounders were addressed in the study. The choice of
sampling design adopted was able to take care of confounding factors reducing them to a level that limits its
effect on the study outcomes.
D) BLINDING
(Q1) Was (were) the outcome assessor(s) aware of the intervention or exposure status of
participants?
1. Yes
2. No
3. Can’t tell
No
In the study the study participants were able to blind so as not know what they were being treated for in the
study. The baseline respondents were obtained through blind folding measurements of the staff and the schools
randomised with the help of computer generated ransom numbers after completing of the baseline data.
Blinding in research refers to the concealment of group allocation front he individuals or from the more
individuals involved in clinical research. This common in most of randomised control trials, (Probst et al 2016).

Randomization effect minimises the differential treatments in the outset of trail, it is unable to prevent treatment
of the groups later in the trail phase. Thus the paramount strategy to prevent the likelihood of preferential
treatment on assessments of outcomes is to ensure that appropriate blinding is undertaken to many individuals
as possible, (Schuklz et al., 2010).
The main factor which causes blinding to take effect or be undertaken is the presence of biasness. Biases as
described above are the systematic errors which are linked to deviations of the measured effect away from the
true value of intervention. Studies done especially by Cochrane Collaboration have formulated a standard
guideline for domains of biases, blinding of respondents are inclusive of these recommendations. Blinding of
personnel, outcome assessments and non selective data approaches. Thus an evident measure of reducing
biases is to ensure blinding is initiated. Blinding of the respondents and personnel in any randomised trials
ensure that performance biases are reduced. In the study if the student trusts in the particular physical activity
practice, they may perceive that treatment to be accounted to that effect, (Cochrane, 2011).
(Q2) Were the study participants aware of the research question?
1. Yes
2. No
3. Can’t tell
NO
The study participants were not aware of the study question, thus they were subjected to blinding effect. This
was crucial for the study in order to ensure no outcomes were subjected to biasness and the effect could be
attributed to the treatment given in the study methodological approach.
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Moderate:
The assessment of the blinding effect on the respondents and being aware of the study questions were handled
in the study, however the specifics aspects and clarity on blinding effect was not elaborated in the study.
E) DATA COLLECTION METHODS
(Q1) Were data collection tools shown to be valid?
1. Yes
2. No
3. Can’t tell
Yes
The study used various tools for data collection. Motivational assessment were obtained using Intrinsic
motivation inventory measurement tools It is a multidimensional tools which is used to assed to asses subjective
data of participants related to physical exercises in this case. The tool measures the participant’s interest and
enjoyment which is perceived to competence, effort, usefulness and choice perceived while doing the physical
activity. The tool incorporate subscale measure which incorporates self measure of intrinsic motivation. The
intrinsic motivation inventory consistent in this study entails varied subscales which have common analytical
factor which is coherent and stable accords tasks. Its nature of being a multidimensional report with Like art type
of questions on a rating scale is suitable for measurement of physical activity measures. The tool has 6
subscales and 54 items that gauge the subjective experiences of the student’s intrinsic factors. When viewed
Intrinsic motivation inventory has various variability, however for this study it was structured to suit the needs of

Assesment as to pertaining the students, thus this informed the validation of the tool to suit the student
population. Further the MVPA assessments were obtained using the omnidirectional arctical accelerometers.
Physical activity measurement has been measured using this instrument. Accelerometers are popular, reliable
and objective tools for assessing physical activity. This is affected with their small size and their ability to
measure accelerations that are produced by the body movements and are ideal for MPVA. The accelerometer
has been made to utilize the onimidirectional sensor which is effective in adding capturing of activities through
the accelerometer. Hence for the purpose of this study it was found out the instruments were validated and
calibrated against each component, (Hale et al 2007).
It is important to note that the accelerometers have been used to measure vibrations and detect motions in
various industrial functions. Based on this knowledge of the force acting in human body in dynamic states, they
have been modified to measure the prominence of physical activity in humans. Thus the introduction of
accelerometer in monitoring activities has led researchers to have reliable and accurate monitors. this has
enabled measuring of physical activity with a lot of ease. Thus the usage of accelerometer in this study is
reliable tool to give the accurate information as to pertaining MVPA, (Sirard et al 2011 ).
(Q2) Were data collection tools shown to be reliable?
1. Yes
2. No
3. Can’t tell
Can’t tell
As much the tools used have been used across wide in behavioural measure and have been shown to be reliable,
for this study this was not mention as per say. Reliability of the tool for the student population needed to be
shown if it is reliable and accurate. For the intrinsic motivation inventory, it is a multidimensional measurement
device which is intended to measure the subjectivity of the physical activity to the students and relate it to
target activity. It is used in several studies and assesses the following four categories of aspects which include
enjoyment, perceived competence, perceive choice and tension. Studies have shown the accelerometers are
popular and their small size allows it for reusability and ability to measure accelerations produces by the body
movements which is ideal for measuring the physical activity among children, (Tlve et al 2007)
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3
Weak
The data illustration from the study provides vague explanation on the reliability of the data tools. Further its
validity are not well elaborated, however through literature there variety of evidence that support the validity
and the reliability of these tools towards practice. Hence this adoption has led to the tools giving accurate
information and the needed data for assessment for further interpretation with regard to physical activities and
exercises.
F) WITHDRAWALS AND DROP-OUTS
(Q1) Were withdrawals and drop-outs reported in terms of numbers and/or reasons per group?
1. Yes
2. No
3. Can’t tell
4. Not Applicable (i.e. one time surveys or interviews)
Yes

In the study the participants assessed for eligibility totalled to 1560, in this number 55 of them refused to
participate while 9 of the participants moved while other 60 had other alternate reasons while 1 refused to
participate for other unknown reasons
(Q2) Indicate the percentage of participants completing the study. (If the percentage differs by
groups, record the lowest).
1. 80 -100%
2. 60 - 79%
3. less than 60%
4. Can’t tell
5. Not Applicable (i.e. Retrospective case-control)
80-100%
The participants allocated to treatment interventions were found to be 92 % of the total participants, while those in
the control group were 91%, thus there was high percentage of participants in the groups. High response rates for
any study ensure that the study result is valid and inference can be made on the findings, (Bakeman, 2005).
RATE THIS SECTION STRONG MODERATE WEAK
See dictionary 1 2 3 Not Applicable
Strong
The aspects of withdrawals from the study and response rates were strongly illustrated in the study. The
tabulated information in a table was able to give an overview of the response rate and how the participants were
able to be rated in the study. The table given shows effectively how the rating of the study was able to give an
overview of the whole participants from the initial stage of inception till the end of the treatment process of the
study.
G) INTERVENTION INTEGRITY
(Q1) What percentage of participants received the allocated intervention or exposure of interest?
1. 80 -100%
2. 60 - 79%
3. less than 60%
4. Can’t tell
Less than 60%
The total percentage of the participants who received treatment were 51% while those who were allocated
general health intervention were 49%
(Q2) Was the consistency of the intervention measured?
1. Yes
2. No
3. Can’t tell
Yes
Based on the information given it seems that intervention were undertaken in that there were measured in
terms of process evaluation, whereby there were point monitoring and end point monitoring. It is with this view
that the intervention was regularly being monitored to see if it was responsible for the intended target effect on

the students physical activity and behaviour change.
(Q3) Is it likely that subjects received an unintended intervention (contamination or co-
intervention) that may influence the results?
1. Yes
2. No
3. Can’t tell
No:
From the study results this was not evident. Subjects were found out to receive the intended physical activities
intended in the study. This was continuously assessed through the midpoint assessment and post intervention
measures as the study was being conducted.
H) ANALYSES
(Q1) Indicate the unit of allocation (circle one)
community / a group of people / individual or patient
(Q2) Indicate the unit of analysis (circle one)
community / a group of people / individual or patient
Provide your explanation to Q1 & Q2:
The treatment was offered to groups of students who participated in the study from the 24 primary schools from
6th grade. The analysis was done in a group whereby the average age of years was 11.3 years attending primary
school education. The allocation of treatments was undertaken through the groups which were group into
allotment group and control group.
(Q3) Are the statistical methods appropriate for the study design? [Please attempt to answer this
question within your current knowledge of statistics. You may wish to state the limitations of your
knowledge]
1. Yes
2. No
3. Can’t tell
Yes
The statistics design adopted in the study design was appropriate in that the regression analysis and the ANOVA
treatment for differential groups were undertaken in the study. In groups assessments odd ration can be utilised
to measure the strength of effect between association and risk factor and the health outcome of interest.
Randomised controlled trials are used as gold standards in evaluating outcomes in research process and used in
efficacy investigations, (Maxwell, Scott & David, 2007). Hence clarification process of concepts and practices are
crucial in ensuring the rig statistical; issues are sorted for the research analysis to be undertaken. This synthesis
is geared towards providing succinct information and clear analytical concepts. Us e of tests significance is
crucial in comparing baseline data information between the groups in determining with covariate data analysis.
Adoption of covariate analysis, there is need to utilize information which in cooperate correlation between the
covariate and outcome analysis, thus the essence of statistical principles based on tests given. The use of
stratification process and minimisation are not allowed for covariate analysis. Randomised clinical trials are
preferred method for determining such efficacy and giving appropriate treatment. Various strategies are
relevant in determining data analysis in data formulation. These strategies are geared towards ensuring that

analysis of data and the analytical approaches provide meaning full information and knowledge. . Randomised
control trials ensure that the use of ANOVA and other multivariate analysis are ensured so as to provide key data
results.
(Q4) Is the analysis performed by intervention allocation status (i.e. intention to treat) rather than
the actual intervention received?
1. Yes
2. No
3. Can’t tell
No
The intervention analysis is conducted through the actual intervention undertaken, thus the effect strength is
measured rather than the perceived strength of association in the study. Intention to treat process method is the
preferred method for the evaluation of the primary outcome measures and research process in order to
determine whether the interventions should be followed. Major utilization of the results from the sub group
analysis is to give a generation of hypothesis s for future ACT practices in future. RCTs have been adopted as
gold standards for comparison of medical treatment interventions. As a researcher in this area, distortion of the
allocation statistical procedures are important for experimental designs.;
GLOBAL RATING
COMPONENT RATINGS
Please transcribe the information from the grey boxes on pages 1-4 onto this page. See dictionary on how to rate
this section.
A SELECTION BIAS STRONG MODERATE WEAK
1
B STUDY DESIGN STRONG MODERATE WEAK
1
C CONFOUNDERS STRONG MODERATE WEAK
2
D BLINDING STRONG MODERATE WEAK
2
E DATA COLLECTION METHOD STRONG MODERATE WEAK
1
F WITHDRAWALS AND
DROPOUTS
STRONG MODERATE WEAK
1 Not Applicable
CIISM.Ma01988
GLOBAL RATING FOR THIS PAPER (circle one):
1 STRONG (no WEAK ratings)

2 MODERATE (one WEAK rating)
3 WEAK (two or more WEAK ratings)
Part 2:
Discuss now your report with your partner working through each item and the
epidemiological principles. Complete the remainder of these questions. You may change
your initial responses from the independent draft that was submitted prior to discussion.
With both reviewers discussing the ratings:
Is there a discrepancy between the two reviewers with respect to the component (A-F) ratings?
No
The comparative analysis with my colleague was beneficial in learning deep analysis of the insights as to
pertaining to epidemiological process. Deeper analysis and explanations provided were essential in getting a
deeper understanding of the research process.
If you were unable to complete the above comparison, please describe the reason and state the risk of failing to
undertake a comparative assessment after initial independent assessment.
Final decision of both reviewers (circle one):
1 STRONG
The reviews review gives a strong evaluation of the articles in the manner in which they have articulated how
evidences were analysed in the studies. Further the methodological approaches utilised in the study have been
critically analysed going a positive preview and analysis for study interpretation.
Results:
How large was the effect of the intervention? Is the effect clinically meaningful? (consider the
outcomes measured, whether the primary outcome is clearly specified, and the key results for each
outcome)
The clinical implications of the findings were meaningful in that they offered both deep understanding of the
various precepts of research as to relating obesity management. The study found out that motivational and
behavioural skills are effective in increasing physical exercises as to pertaining the obesity levels of the school
going children. The adoption of active by choice lifestyle is essential in increasing moderate to vigorous physical
activity among the school going adolescents. Randomised controlled trials are potential in providing the highest
level of evidence to inform clinical practices and provide effective decision making process. Effective use of
statistical methods is a critical aspect of the clinical research process especially randomised controlled trials. The
inclusion of flexible approach for analysis of trial data. There are evident aspects of analysis plan that entail
outcome and sub group analysis. There are crucial aspects components of analysis plan which should be
considered for pre-trial aspects of analysis. Determination if a treatment works ensures that proper analysis sis
concerned.
Your overall conclusions about this study:
Considering both the trustworthiness of the study and the findings, make a brief overall conclusion and describe
what you think the implications would be in practice.
The study is essential in ensuring that clinical practice is embedded in behavioural behaviours of the children so
as to achieve a healthy lifestyle adoption so as to prevent obesity related behaviours. The study gives an
elaborate validity of how behaviour change can impact significant inputs into how to conduct and encourage
physical activities. The implication for these study shows that effective healthy behaviour practice are essential
in promoting good behaviours.

References: (may be in addition to the 4,000 word limit)
Alexander, N., & Emerson, P. (2005). Analysis of incidence rates in cluster‐randomized trials of interventions
against recurrent infections, with an application to trachoma. Statistics in medicine, 24(17), 2637-2647.
Bakeman, R. (2005). Recommended effect size statistics for repeated measures designs. Behavior research
methods, 37(3), 379-384.
Cochrane Handbook: Higgins JPT. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0
[updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
(Accessed 01 Nov 2015)
Díaz‐Ordaz, K. A. R. L. A., Kenward, M. G., & Grieve, R. (2014). Handling missing values in cost effectiveness
analyses that use data from cluster randomized trials. Journal of the Royal Statistical Society: Series A
(Statistics in Society), 177(2), 457-474.
Hale L, Williams K, Ashton C, Connole T, McDowell H, Taylor C. Reliability of RT3 accelerometer for measuring
mobility in people with multiple sclerosis: Pilot study. J Rehabil Res Dev. 2007;44(4):619–627
Hayes RJ, Moulton LH. Cluster Randomised Trials. Taylor & Francis; 2009. 338 p. Hayes RJ, Alexander ND, Bennett
S, Cousens SN. ... Thomson A, Hayes R, Cousens S. Measures of between-cluster variability in cluster
randomized trials with binary outcomes.
Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research in nursing & health,
31(2), 180-191.
Mann, C. J. (2003). Observational research methods. Research design II: cohort, cross sectional, and case-control
studies. Emergency medicine journal, 20(1), 54-60.
Maxwell, S. E., & Cole, D. A. (2007). Bias in cross-sectional analyses of longitudinal mediation. Psychological
methods, 12(1), 23.
Probst, P., Grummich, K., Heger, P., Zaschke, S., Knebel, P., Ulrich, A., … Diener, M. K. (2016). Blinding in
randomized controlled trials in general and abdominal surgery: protocol for a systematic review and
empirical study. Systematic Reviews, 5, 48. http://doi.org/10.1186/s13643-016-0226-4
Raudenbush, S. W. (1997). Statistical analysis and optimal design for cluster randomized trials. Psychological
Methods, 2(2), 173.
Rothman K J. A potential bias in safety evaluation during open-label extensions of randomized clinical trials.
Pharmacoepidemiol Drug Saf. 2004;13(5):295–298. [PubMed Weiss N S. New York: Oxford University Press;
2006. Clinical Epidemiology: The Study of the Outcome of Illness. 2nd ed.
Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting
parallel group randomised trials. Trials. 2010;11:32. doi: 10.1186/1745-6215-11-32
Sirard JR, Forsyth A, Oakes JM, Schmitz KH. Accelerometer test-retest reliability by data processing algorithms:
Results from the twin cities walking study. J Phys Act Health. 2011;8(5):668–674.
Tulve NS, Jones PA, McCurdy T, Croghan CW. A pilot study using an accelerometer to evaluate a caregiver's
interpretation of an infant or toddler's activity level as recorded in a time activity diary. Res Q Exerc Sport.

2007;78(4):375–383
This worksheet is based upon the EPHPP “Qualitative Assessment Tool for Quantitative Studies”
and with permission was modified for teaching purposes. Incorporated are components from the
CASP Randomised Controlled Trial Checklist.
M.Ma019
Complete this checklist for final submission (Compulsory)
|_|This is your own original work.
|_|Pair number and partners are stated
|_| Word count is stated on the first page and the maximum is not exceeded.
|_| Draft copy (word document) was uploaded to Turnitin no later than the due draft date.
|_| Exchange of drafts and discussion has occurred with the persons stated as the partners.
|_|The discussion and exchange with the partner occurred after only a substantial undertaking of
the assignment.
|_| Appropriate citation and referencing has used.
|_| Submission (MS-Word document), uploaded through Turnitin by the due date.
Declaration of editorial assistance (Compulsory)
Did this essay have the benefit of professional editorial advice, of any form? |_| Yes |_| No
 If yes, is the name of the editor and a brief description of the service rendered, listed as part
of the acknowledgements or other prefatory matter in the submitted essay? |_| Yes |_| No
 Was the intent to use an editorial service declared this in advance? |_| Yes (required) |_| No