Research Method | Clinical Audit in Primary Care

Running head: RESEARCH METHOD
Research method
Name of the student:
Name of the University:
Author’s note

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Answer 1
a. The main purpose of this literature search is to find out answer to the research question
whether a bicycle helmet reduce the chance of dental injuries for children if they are
involved in an accident. Hence, the intention is to find those incidences that link facial
injuries and cycling accidents together. The search for literature will be done in databases
like CINAHL and PubMed. Various search terms will guide the search process. The
primary search terms for this research literature will include ‘dental injury’, ‘facial
injury’, ‘bicycle helmet’, ‘cycling’ and ‘accident’. Certain search filters were applied to
make the search process more specific. For example, date of publication was set from
2010 to 2019 and the source type was set to peer reviewed journal articles. The keywords
were combined with Boolean operator ‘AND’ to get relevant results and retrieved studies
relevant to the research question. The following search terms were used during the
literature searching process:
 Dental injury AND bicycle helmet AND accidents
 Facial injury AND cycling AND accidents in children
 Dental injury AND bicycle accidents
 Dental injury AND use of bicycle helmets
The significance of the above combination of search term was that it resulted in
retrieving only those sources which had all the key terms as stated above.
However, these search terms alone cannot confirm choosing the right paper for review.
To get the right paper that addresses the research question, the following inclusion and exclusion
criteria would be chosen:

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 All the articles must have wearing bicycle helmet as one of the intervention
 The sample population for all the studies must be children involved in bicycle accident
 The key outcome of interest for all the papers must be evaluation of the rate or incidence
of dental/facial injuries
 Articles published before 2010 will be excluded.
 Articles must be published in English only
The title and the abstract of the articles will be reviewed first and selected if they address
the research question. In addition, the articles will be matched with the inclusion and exclusion
criteria to confirm the eligibility of the articles and include it in the reviews.
b. One article that has been found to give idea about the impact of bicycle helmet in the
reduction of facial injuries in children includes the article by Kaushik et al. (2015) which
investigated about the incidence of pediatric bicycle related injuries in Olmsted Country
and also assessed the differences in injuries between those wearing helmets versus those
not wearing the helmets. The full reference for the article is as follows:
Kaushik, R. Krisch, I. M. Schroeder, D. R. Flick, R. and Nemergut, M. E. (2015). ‘Pediatric
bicycle-related head injuries: a population-based study in a county without a helmet
law’, Injury epidemiology, 2(1), 16. doi:10.1186/s40621-015-0048-1
c. My position on the question posed by the parent is that children who wear bicycle
helmets are less likely to be involved in dental or facial injuries following accident. The
main rationale for selecting this article is that it gives robust evidence regarding for the
benefits of bicycle helmets in preventing facial injuries. By the assessment of patient with
severe head and facial injuries and the recording of the rate of accidents in those wearing

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helmets and those not wearing the helmets, the paper demonstrated that majority of the
accidents or injuries were for those not wearing the helmet. In case of those wearing the
helmet, the rate of injury was very low up to 17.4%.
d. The article by Kaushik et al. (2015) used cohort based study design by evaluated injury
occurring due to use of bicycle between 2002 and 2011 among Minnesota residents aged
5-18 years. The data related to the number of persons living in Olmsted County and the
medical records related to bicycle accident were taken from REP (Rochester
Epidemiology Project) database. The significance of collecting data from this database is
that it is easily accessible and target subjects were easily identified through this database.
Individual records were retrospectively reviewed and those using other forms of transport
like scooters or those riding as bicycle passenger were excluded. This process enhanced
the rigor and validity of the research data. The location and type of head and facial injury
was calculated. Appropriate statistical analysis was done to evaluate the frequency
percentage for each variable. However, one limitation of the study is that it only 47.7%
helmet use was documented in medical records which is not true representation of the
protective effects of helmet.
Answer 2:
a. Osteoarthritis is a common problem in elderly people which leads to intense pain, loss
of function and disability in an individual. This is the reason for impaired quality of
life. As there is no cure for osteoarthritis, looking for non-pharmacological
interventions to control progression of the disease and relieve symptom is important
(Loeser and Lotz, 2016). Exercise therapy is a safe and low cost treatment method

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and the hypothesis is that exercise therapy is likely to relieve pain and improve knee
functioning of elderly people with osteoarthritis.
b. The main of this research is to evaluate the effectiveness of exercise therapy on
controlling symptoms of elderly patients with osteoarthritis and improve the quality
of life of an individual. The following are some of the research objectives
 To assess the efficacy of exercise therapy in improving knee functioning and
symptoms of osteoarthritis in elderly
 To analyze the efficacy of exercise intervention in improve quality of life of
an individual
 To assess the cost effectiveness of the intervention for elderly patient with
osteoarthritis.
c. It is planned to use randomized controlled trial (RCT) method as a research design to
investigate about the topic. The main rationale for choosing this research design is
that is an effective design for impact evaluation. As this research aims to assess the
impact of exercise intervention, RCT design is likely to give a true picture of the
effectiveness of the intervention. RCT methods comes is regarded as one of the top
quality of research design in evidence hierarchy and the main rationale for this being
that RCT uses rigorous method to increase the validity of the data. There are several
advantages of taking RCT as a research design (Mick, 2016). Firstly, RCT is regarded
as hallmark of evidence based practice because of the presence of techniques like
randomization, blinding and allocation concealment which helps in controlling biases.
Blinding is a measure that helps to identify and reduce detection and performance
bias (Probst et al. 2016). Hence, this research design has the advantage of controlling

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biases and as well as evaluation efficacy of intervention by comparing outcomes in
intervention as well as control group. The disadvantage of RCT is that as it is done in
a small sample group, it may not representative of the entire target population.
d. The RCT trial on effectiveness of exercise therapy in improving symptoms of elderly
patient with osteoarthritis will be done by implementing the intervention in the
population setting. The following are steps proposed to complete the study:
Setting:
The research will be completed in four community centers of England. The main
rationale for selecting more than one center is to enhance the generalizability of the
findings and recruits heterogeneous samples for the study.
Sample recruitment:
The population of interest for the proposed study is community dwelling elder
adults greater than 60 years old with symptoms of knee pain. Only those participants will
be included whose diagnosis of knee osteoarthritis will be confirmed by a community
nurse. The participants will be invited to take part in the study by means of print media
and social media advertisements.
After selection of final samples, the participants will be randomly allocated to the
intervention group and the control group. An independent researcher who will not be
involved in providing the intervention and assessment will randomly allocated
participants into two groups. Although participants will be aware about the random
allocation, however the assessors and analysts were blinded to participant’s allocation.

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The significance of this method of allocation concealment is that it can minimize the
chances of selection bias (Clark, Fairhurst and Torgerson, 2016).
Details of the intervention:
The main intervention for the study will be different types of home based exercise
intervention and the intervention will be completed at home. The intervention will
consists of six one hour weekly sessions that will be delivered by a physiotherapist. The
exercise program will be developed based on review of research papers and identifying
those exercise which is known to give maximum functional benefits to people with
osteoarthritis (Chen et al., 2019). It is planned to select at least six home based exercises
for participants and the physiotherapist will also educate the participants and take
feedback from them during the exercise sessions. In addition, the control group will
receive only educational sessions and telephone follow-ups, but no exercise intervention.
The education session will not cover any details about exercise intervention.
Outcomes measurement:
The primary outcome of interest for the study will be level of pain and joint
stiffness. A reliable evidence based tool will be chosen for assessment of pain and
priority will be given to those tools whose internal reliability and consistency has been
proved by research. The secondary outcome of interest will be walking ability and quality
of life of sample groups. Walking ability will be measured by the six-minute walk test
and the quality of life will be judged by a self-assessment scale. During data collection
and analysis, two staffs with experience in physiotherapy will be selected and they will
be given training about the tools and the way to measure them. The analysis of the data

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will be done using SPSS and descriptive statistics and standard deviation will be used to
judge the statistical significance of each outcome.
e. To minimize the effect of confounding factors, several exclusion criteria have been
developed to ensure recruitment of the right population of interest. For example,
participants with surgery in the knee will be excluded and those with health problems
like angina, neurological dysfunction, myocardial infarction and high blood pressure
will be excluded. After assessing for these factors, the final list of participants will be
confirmed after completion of informed consent process.
Any bias will be minimized by selection of valid instruments to assess outcome
instead of relying of self-reported data. Furthermore, more than two assessors will be
used to analyze and collect data. The main rational for selecting two analysts is that final
data entry will be done after both the staffs agree with the data or give consensus for the
data.
Answer 3:
a. Voluntary consent is important to ensure that no participants are recruited without their
free will and avoid risk of conflict occurring due to disagreement between researcher and
participants. It is also important as part of ethical research to fulfill the ethical
responsibility of informed consent process and ensure that participants are able to engage
in informed decision making process (Grady, 2018). The Nuremberg Code aimed to
protect human subjects from enduring the cruelty that prisoners had to endure at
concentration camps and to achieve, voluntary consent was made essential (Merz, 2018).

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b. No, research without advanced informed consent is never justified because all
participants have the right to know what is the purpose and intended benefit of the
research. Completing any research without informed consent is a violation of rights of
participants.
c. No, there is no need for informed consent from participants during a clinical audit as the
audit is intended to assess whether care is delivered based on best available evidence or
not. There is no need for informed consent unless confidentiality and anonymity are
preserved (Chambers and Wakley, 2018).
d. In a clinical trial, informed consent can be taken by researchers, health care staffs or the
institute’s authorized members
e. Participant Information Sheet (PIS) is needed during the informed consent process to
provide the participants information about the necessary procedures of research and the
motivation behind conducting the research. A PIS should provide them with the
following information:
 Details about the research procedure
 The main objectives of conducting the research
 The benefits and risk associated with the research
 The process to maintain privacy and confidentiality of research participants
 The process of informed consent process
 The likelihood of adverse things happening at the site (Regmi et al., 2017)
F)
i. No

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ii. Yes
iii. No
iv. Yes
v. No
vi. Yes
Answer 4:
a. The article by Forbes et al. (2015) aimed to conduct a review of literature to assess
exercise programs for people with dementia and identify its effect in improving
cognition, activities of daily living, depression and mortality. The review included
seventeen randomized controlled trials of both parallel and cross-over design. The choice
of study design is commendable as RCT is the best research design to test the efficacy of
an intervention (O’Reilly and Vingilis, 2018). As it evaluated the effect of an intervention
by recruiting a control group, such study design gives a clear idea about the extent to
which the intervention is beneficial for the control group. The review included both
parallel and cross-over design. The difference between this two designs are that in
parallel trials, participants are randomized to the same intervention in a single period of
time, whereas in crossover trials, participants are allocated to two or more interventions
over two or more periods. The advantage of crossover trial is that it can give precise
impact about intervention effect (Krogh et al., 2019).

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b. Standardized mean difference is used to express the size of the intervention effect in a
study and it is used in the meta-analysis to identify the group in which the intervention
has the maximum effect (Johnson and Huedo-Medina, 2013).
c. Statistical heterogeneity is defined as the percentage of random variations in performance
measurements within a study sample (Goodman, Fanelli & Ioannidis, 2016). In the figure
1, the heterogeneity value is found to be 77% and this shows that the outcome was not
consistent across studies and greater variations were found in different articles based on
different in sample type. Hence, as the value is greater than 50%, it means presence of
statistical heterogeneity in the analysis
d. The review of the forest plot in figure 1 depicts more number of studies which gave
evidence for effectiveness of physical exercise in improving ADLs compared to usual
care. For example, the study by Conradsson (2010), Rolland (2007), Vreugdenhil (2012),
Venturelli (2011) and Santana-Sosa (2008) gave favorable results for exercise
intervention. Highest variation in outcome was seen for Vreugdenhil (2012) and lowest
was seen for Francese (1997).
e. Random effect model would lead to a greater confidence interval for a pooled estimate
compared to a fixed effect pooled estimate
f. The systematic review mainly included different types of RCT papers and the most
notable bias found in the studies included in the systematic review was publication bias.
This was seen as 12 studies reported cognitive outcomes, however data related to the
same was available only for 9 studies. Similarly, 5 studies measures neuropsychiatric
outcomes. However, only one of the studies provided usable data (Forbes et al., 2015).

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Such kind of biases occurs in RCT papers because statistically significant effects are
more likely to be reported compared to non significant effects (Mansournia et al. 2017).

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References:
Chambers, R. and Wakley, G. (2018). ‘Clinical audit in primary care: demonstrating quality and
outcomes’, CRC Press.
Chen, H., Zheng, X., Huang, H., Liu, C., Wan, Q. and Shang, S. (2019). ‘The effects of a home-
based exercise intervention on elderly patients with knee osteoarthritis: a quasi-experimental
study’, BMC musculoskeletal disorders, 20(1), p.160.
Clark, L., Fairhurst, C. and Torgerson, D.J., (2016). ‘Allocation concealment in randomised
controlled trials: are we getting better?’, Bmj, 355, p.i5663.
Forbes, D., Thiessen, E.J., Blake, C.M., Forbes, S.C. and Forbes, S. (2015) ‘Exercise programs
for people with dementia’. Cochrane Database of Systematic Reviews, Issue 4. Art. No.:
CD006489.
Goodman, S. N., Fanelli, D., and Ioannidis, J. P. (2016). What does research reproducibility
mean?. Science translational medicine, 8(341), 341ps12-341ps12.
Grady, C., (2018), ‘Ethical principles in clinical research’, In Principles and practice of clinical
research (pp. 19-31). Academic Press.
Johnson, B.T. and Huedo-Medina, T.B., 2013. Meta-analytic statistical inferences for continuous
measure outcomes as a function of effect size metric and other assumptions. Retrieved from:
https://www.ncbi.nlm.nih.gov/books/NBK140574/

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Kaushik, R., Krisch, I. M., Schroeder, D. R., Flick, R., and Nemergut, M. E. (2015). ‘Pediatric
bicycle-related head injuries: a population-based study in a county without a helmet law’, Injury
epidemiology, 2(1), 16. doi:10.1186/s40621-015-0048-1
Krogh, H.B., Storebø, O.J., Faltinsen, E., Todorovac, A., Ydedahl-Jensen, E., Magnusson, F.L.,
Holmskov, M., Gerner, T., Gluud, C. and Simonsen, E., (2019). ‘Methodological advantages and
disadvantages of parallel and crossover randomised clinical trials on methylphenidate for
attention deficit hyperactivity disorder: a systematic review and meta-analyses’. BMJ open, 9(3),
p.e026478.
Loeser, R.F. and Lotz, M. (2016). ‘Osteoarthritis in the Elderly. In Advances in Geroscience (pp.
309-353). Springer, Cham.
Mansournia, M. A., Higgins, J. P., Sterne, J. A., and Hernán, M. A., (2017). Biases in
randomized trials: a conversation between trialists and epidemiologists. Epidemiology
(Cambridge, Mass.), 28(1), 54.
Merz, J.F., (2018). ‘The Nuremberg Code and Informed Consent for Research’. Jama, 319(1),
pp.85-86.
Mick, J. (2016). ‘The appraising evidence game’, Worldviews on Evidence
‐Based
Nursing, 13(2), pp.176-179.
O’Reilly, R. and Vingilis, E., (2018). ‘Are randomized control trials the best method to assess
the effectiveness of community treatment orders?’, Administration and Policy in Mental Health
and Mental Health Services Research, 45(4), pp.565-574.

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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. doi:10.1186/s13643-016-0226-
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Regmi, P.R., Aryal, N., Kurmi, O., Pant, P.R. Van Teijlingen, E. and Wasti, S.P. 2017.
‘Informed consent in health research: challenges and barriers in low‐and middle‐income
countries with specific reference to Nepal’, Developing world bioethics, 17(2), pp.84-89.