Health Research Proposal Writing L1 +1 PDF

Health Research Proposal Writing
Tips for Writing Quantitative Research Proposals
Centre for Advancement of Health
Knowledge Into Action (K2A)
Calgary Health Research
V. Nadine Gall
Dr. Peter Faris
(Adapted from MJ Verhoef and RJ Hilsden 2001, 2004)
CALGARY HEALTH RESEARCH

A partnership of the Calgary Health Region and the Faculty of Medicine
A note about this document:
The examples provided throughout this document have been summarized from
successful research proposals (references below). The examples are intended
to give you a sense of how to write the various sections and suggestions re the
format. It is important to note that these examples are merely ‘summaries’ of the
various sections, so may not represent the full detail that review committees will
be looking for.
References:
Verhoef MJ, Boon HS, Mutasingwa DH. The scope of practice of naturopathic
medicine in Canada: An emerging profession. Soc Sci Med 2006; 63; 409-417
Robert M, Ross S, Brasher P, Fischer B, Jacobs P. Surgical Management of Stress

Incontinence in Women: Randomized Trial of Trans-Obturator Tape versus Tension-
free Vaginal Tape
http://www.obgyn.ucalgary.ca/Documents/TOTv%5B1%5D.TVT.pdf
Acknowledgements:
Special thanks to Dr. Sue Ross, Dr. Marja Verhoef, Dr. Magali Robert, Christy
Woolcott, Tanis Fenton, Dr. Cathie Scott, and Judy Seidel for their contributions
in developing this document.
We welcome your feedback about this document. Please let us know how
you are using it:
Contact:
The Centre for Advancement of Health
602 South Tower, 1403 29th Street NW, Calgary AB
(403) 944-1093
E-Mail: vngall@ucalgary.ca
Download Proposal Writing Guide at:

https://my.calgaryhealthregion.ca/http://www.calgaryhealthregion.ca/research/publications.htm
2 Proposal Writing 2006 NG

TABLE OF CONTENTS
Proposal Writing Overview………………………………………………….. 4
Elements of a Research Proposal
Title……………………………………………………………………….. 6
Study Problem / Purpose………………………………………………. 6
Relevance / Study Rationale………………………………………….. 7
Literature Review……………………………………………………….. 8
Research Objectives / Research Question………………………….. 9
Study Methods
Study Design ……………………………………………………………. 10
Subjects …………………………………………………………………. 12
Allocation of Study Groups and Intervention ……………………….. 14
Variables / Data Collection……………………………………………. 15
Statistical Analysis and Sample Size………………………………… 18
Ethical Considerations…………………………………………………. 22
Limitations ……………………………………………………………… 24
Budget ………………………………………………………………….. 25
Plans for Dissemination ………………………………………………. 25
Other Possible Sections ……………………………………….……… 25
General Tips…………………………………………………………….…….. 25
Pilot Studies ……………………………………………………….…. 26
Supplementary Reading ……………………………………………….……. 27

HEALTH RESEARCH PROPOSAL WRITING
Research Proposals are intended to demonstrate:

That your project should be done
Specifically what you intend to accomplish and how you will do it
A workplan that demonstrates you have thought through all of the
elements of your project
Potential Audience:
Funders, committees overseeing institutional approval (science, ethics),
thesis committees etc.
Keys to Success in Writing a Good Proposal
Overall Quality of the Study
Good research question (relevant, justified)

Appropriate research design
Rigorous, feasible, and ethical methods
Qualified research team
Quality of the Proposal
Informative title
Clear research questions
Thorough and relevant background
Convincing rationale/significance
Clearly defined (and measurable) research objectives
Appropriate population and sample
Appropriate measurement and intervention methods
Adequate sample size
Sound analysis plan
Ethical issues well addressed
Tight budget
Realistic timelines
Quality of the Presentation
Clear, concise, well-organized

Helpful table of contents and subheadings
Good schematic diagrams and tables
Consistent throughout
(Adapted from Hulley & Cummings)

Observation/Idea Study Problem
Issues to consider/discuss
Informal Questions Relevance of Project

Justification of research:
Why is the research important?
Literature Review Are there gaps in the literature?
Would the answers have clinical value?
Research Questions/Objectives
No Hypotheses Hypotheses
(Exploratory Research) (Explanatory Research)
Study Methods Potential biases
Feasibility
Cost
Study Design Level of Evidence (Causal Inference)
Ethics
Survey Cohort Case-Control Survey Cohort Case-Control Randomized
Study Study Study Study Control Trial
Relevance to questions/hypotheses
Be Consistent!
Confounding
Justification in literature/practice
Variables Psychometric properties
Variables of Interest Primary Outcome(s)
(Covariates) Secondary Outcome(s) Who will be studied?
Covariates How will you select and recruit them?
How will you allocate them to groups?
Subjects
Can your study detect meaningful effects?
How precise will estimates be?
Precision (Power) Sample Size Calculations
Power
How will you record, store, reduce data?
Data Analysis How will you assess data quality?
Descriptive (Inferential) Inferential (Descriptive) What statistical analyses will you use?
Ethical Considerations Will data be anonymous?

How will you ensure confidentiality?
Informed consent (consent form)
Limitations
Personnel costs/consultants.
Overhead, supplies, patient care.
Budget
Justify!!!
Proposal
5 Writing 2006 NG
HEALTH RESEARCH PROPOSAL WRITING
Title
The title should be informative, succinct and interesting. It should include the
population of interest and the condition/issue being investigated.
Example 1
Title: “The Scope of Naturopathic Practice: An Emerging Profession”
Reference: Verhoef MJ, Boon HS, Mutasingwa DH. The scope of practice of naturopathic medicine in
Canada: An emerging profession. Soc Sci Med 2006; 63; 409-417
Example 2
Title: “Surgical Management of Stress Incontinence in Women: Randomized

Controlled Trial of Trans-Obturator Tape Versus Tension-Free Vaginal Tape”
Reference: Robert M, Ross S, Brasher P, Fischer B, Jacobs P. Surgical Management of Stress

Incontinence in Women: Randomized Trial of Trans-Obturator Tape versus Tension-free Vaginal Tape
http://www.obgyn.ucalgary.ca/Documents/TOTv%5B1%5D.TVT.pdf
Common Pitfalls
– A title that is too brief or too long
– Use of incorrect terminology
– Not specifying the population of interest
Study Problem / Purpose

A broad statement indicating the goals of the project.
– Eg. exploration, description, explanation, prediction (hypothesis
testing)
Keys to success:
– Relevant
– Clear
– Logically argued

Example 1: Naturopathic Practice
The purpose of the study is to describe naturopathic practitioners’ perception of
their current scope of practice, and of the quality of the training they receive. These
perceptions will be compared with current regulations governing naturopathic
practice in the four regulated provinces.
Example 2: Surgical Management of Stress Incontinence
The purpose of this study is to compare outcome up to one year following surgery
for stress incontinence using Trans-Obdurator Tape (TOT) versus Tension-free
Vaginal Tape (TVT).
Relevance / Study Rationale

Why should the research be done?
– Why is the research important?
– Has it been done before?
– Will the study benefit patients, increase knowledge and/or influence
policy?
– Will research resolve controversies?
– Would the answers have clinical value?
Keys to success
– Lead reviewers to answer the above questions.
– Should be reasonable given the proposed study
– Literature review will demonstrate that the research is justified
– Granting agencies may have specific priority areas, be sure to
explain how your study fits into those areas.
Relevance / Rationale
The results of this study will identify the degree of variation in naturopaths’ practices, as
well as the potential degree of overlap with other practitioners’ scope of practice. This
information is important in the debate about the profession’s identity, its role in the
Canadian health care system and the development of new health care professions. The
study results will also generate important information with respect to evaluating and
further developing national training programs. This study will allow collection of
baseline data that can be used to track the development of naturopathic medicine as a
profession over the coming years.

Relevance/ Rationale
Urinary incontinence (UI) is a common and distressing problem, affecting approximately
30 to 40% of older women.1-2 Stress urinary incontinence (SUI) is the most common
type of UI in women.2 Conservative treatments include pelvic floor muscle training, and
urethral or vaginal devices.3 However conservative treatments are often unsuccessful,
and surgery becomes a possible solution.
…..
Following the introduction of TVT, it has gradually become the surgery of choice across
much of Canada, including Calgary, and increasing numbers of women have been able to
undergo surgery. TOT, as a new procedure, is being enthusiastically promoted by the
manufacturers of the surgical devices used to carry out the procedure. However we need
proper independent evaluation to determine which surgical approach is best for women.
……
Before introducing TOT into clinical practice in Calgary, all clinicians have agreed not to
use TOT outside the context of a randomized trial. If a trial is not undertaken, it is likely
that TVT will remain the procedure of choice for stress incontinence, and that women in
Calgary may be denied the optimum surgical treatment.
ETC…..
Literature Review
A critical summary of research on a topic of interest, generally prepared to put a
research problem in context or to identify gaps and weaknesses in prior studies
so as to justify a new investigation. Generally starts off broadly addressing the
problem then becoming more narrow and leading to your specific research
question(s).
This is your chance to build a case for doing your study!
Justify the statements that you have made in your Relevance/Rationale
section.
Reviewers will be looking to see whether your proposed work is
appropriate for the level of knowledge currently existing in that area.
Keys to success:
- Identify gaps in knowledge or controversies
- Focused on and leading naturally to your research questions/objectives
- Be thorough, relevant, and up-to-date
- Use primary sources of original research
- Synthesize and be critical
- Provide local background

Research Objectives / Research Questions
Explicitly state what you propose to study.
Form the foundation for the rest of the proposal.
Will be used to assess the adequacy/appropriateness of the study's
proposed methods.
– Testable
– Logically derived from the literature review
Often includes:
– Population of interest (person, place, time)
– Variables (independent and dependent)
– Relationship between variables being investigated
Keys to success:
– Be clear and consistent
– Generally have only one or two primary research objectives
– Include the independent and dependent variables, if applicable
– Your objectives must be measurable.
– Objectives must be Relevant or novel (as you’ve established in the
literature review!).
– If it is a pilot study, state clearly the pilot objectives (e.g., testing the
feasibility of the study procedures, patient adherence to the study
protocol, drop-out rates etc.).

Research Objectives:
1. To describe naturopathic practitioners’ perceptions of their scope of practice
2. To determine naturopathic practitioners’ opinion about their current scope
of practice
3. To examine naturopathic practitioners’ satisfaction with their training and
how well it prepared them for their current scope of practice.
4. To compare naturopathic medicine’s scope of practice as identified by
federal and provincial governing authorities with practitioners’ perceptions.
Research Questions:
Primary research question

How effective is TOT compared to TVT in terms of objective cure (determined using a 1-
hour pad test) at 12 months postoperatively?

Secondary research questions
How effective is TOT compared to TVT in terms of:
• Subjective cure at 12 months postoperatively?
• Incontinence-specific quality of life at 6 weeks and 12 months postoperatively?
• Satisfaction with surgery at 12 months postoperatively?
• Return to usual activities and usual sex life after surgery?
• The prevalence of voiding dysfunction at 12 months postoperatively?
• Surgical complications, both short term and long term?
• Utility and cost? (an economic evaluation)
METHODS
Study Design
Issues to consider in design
– Exploratory versus explanatory research
– Potential biases that may emerge
– Feasibility (logistics)
– Cost
– Level of evidence, limitations
– Ethics
Types of Designs:
Descriptive (Survey, cross-sectional, correlational)
Observational/analytic
– Cohort studies
Quote of the Day:
Prospective
“My life is an experiment I never had the
Retrospective
chance to properly design”
– Case-control studies (Diana Ballard)
Interventional
– Quasi-experimental
– Randomized controlled trials
Keys to success:
– Clearly identify the type of design and justify your choice
– Describe using standard terminology
– Make sure what you have named your study fits with what will be
done

– Ensure the proposed design is appropriate to address study
objectives
– Address any design issues in the literature review and limitations
sections
Study Design
The study design will consist of two components: 1) a survey of licensed Canadian
naturopathic practitioners; and 2) an analysis of pertinent national and provincial
documents in the public domain.
SURVEY: Data will be collected by means of a standardized questionnaire, which will

be mailed to all practitioners in the study group. Questionnaires will be numbered to
identify those who have responded and, thus, to facilitate follow-up. A reminder will be
sent 2 weeks after the initial mail out. Non-responders will be sent a second
questionnaire 4 weeks after the initial mailing. Practitioners who have not responded 6
weeks after the initial mail-out will be contacted by phone and asked whether they would
be willing to participate in a brief telephone interview to assess selected socio-
demographic and practice characteristics, two brief questions assessing opinion about
scope of practice, and the reason for not responding. This information will assist in
assessing whether the sample of respondents is similar to the target group. The
questionnaire will include……
DOCUMENT COMPARISON: The document analysis will include the collection of

documents in the public domain that address issues around the scope of practice of
naturopathic medicine.
Research Design:
The proposed study is a randomized controlled trial in which women with stress
incontinence will be allocated either to receive either TOT or TVT procedures. The
main outcome is effectiveness of the procedure, determined using a 1-hour pad test,
and women will be followed up for 1 year after surgery. The study will be carried
out according to the ICH Good Clinical Practice Guidelines. All seven surgeons
participating in the trial are competent to undertake both the TOT and TVT
procedures.
Methods (in brief):

After patients agree to take part in the study and sign a consent form (should be included
as an appendix …), baseline information will be collected and patients will be asked to
complete a brief questionnaire (should be included as an appendix …). Women will be
randomized to either TOT or TVT procedures (randomization described below).
Hospital outcomes, including length of stay (hours for those passed to home care, days
for any who require longer hospital stay) and surgical complications will be documented
from hospital charts. All women receive a 6-week follow-up as standard of care: a
structured data collection form will be used by surgeons to collect information on short-
term outcome. At 12 months postoperatively, women will be asked to attend hospital for
objective measurement of incontinence, and to complete a questionnaire: by that time,
women will have recovered from surgery, and their incontinence (if remaining) will have
stabilised.
Study Design - Common Pitfall

The Incorrect Design
(or the wrong objective)
The primary objective is to determine if coffee drinking

causes pancreatic cancer.
A case-control study will be conducted
Better: The primary objective of this study is to determine if there

is an association between coffee consumption and pancreatic
cancer.
Subjects
Who will you study? Why?
Specify eligible subjects
- Target population: clinical & demographic characteristics
- Accessible population: temporal & geographic characteristics
Keys to success:
– Clearly describe the study population
– Provide appropriate inclusion/exclusion criteria
– Justify the use of the study population and the sampling method
(consider potential bias, generalizability)

– Provide all details of the sampling and recruitment methods
(including any barriers to recruitment specific to the population and
strategies you will use to address these - e.g., cultural barriers)
– Do not confuse randomization with random selection
Study Subjects
SURVEY: The study group will consist of all licensed naturopathic practitioners
(approximately 400) in Canada. Addresses will be obtained from a database maintained
by the Canadian College of Naturopathic Medicine. Letters of support have been
obtained from the Canadian Naturopathic Association and the Canadian College of
Naturopathic Medicine.
(Note: no inclusion/exclusion criteria - as all members of the target population are
eligible for inclusion in this case)
Patient Population:
All women who elect for surgical management of their type II stress incontinence
are eligible to participate in the trial. Evaluation of stress incontinence prior to
surgery will be carried out according to the SOGC guidelines.22
4.1 Inclusion criteria

Women may be included if they:
- have type II stress incontinence, defined as leaking with increased
abdominal pressure.22
- are eligible for both types of surgery.
4.2 Exclusion criteria

Women will be excluded if they:
- have vaginal prolapse requiring surgical repair
- have had previous incontinence surgery
- have overactive bladder or incontinence is caused only by bladder overflow
- intend to have further children
- have Alzheimer’s or Parkinson’s disease, progressive neurological disease such
as multiple sclerosis, or are immunocompromised
- are unable to understand English
- will be unavailable for follow-up.

4.3 Identifying and approaching patients
Women referred to any of the collaborating clinicians, who fulfill the inclusion and
exclusion criteria will be offered the opportunity to join the trial. During the period of
recruitment to the study, TOT will be available only as a study intervention.
The woman’s clinician will briefly introduce the study, then the woman will be referred
to the study nurse not involved in the woman’s routine care, who will explain the trial in
full and provide detailed information. Women are free to consult with their family before
agreeing to join the study. Women who decide to join will sign a consent form.
Allocation to Study Groups and Intervention
Baseline, randomization and interventions
5.1 Baseline data collection

After consenting to join the study, data will be extracted from the patient’s case notes
about baseline details, including date of birth, weight, smoking status, and results from
their 3 day voiding diary. All women will be asked to complete a questionnaire including
incontinence-related quality of life and expectations of surgery.
5.2 Randomization
Randomization will take place on the day of surgery. Women will be allocated to one of
the two study groups: the TOT or TVT group.
Permuted block randomisation with blocks of varying size (2 – 8) will be employed.

Randomization will be stratified by surgeon. Next treatment allocation will not be known
by the surgical team or the patient. The randomisation list will be generated by the study
statistician (using ralloc procedure in Stata). The list will be kept by the Department of
Obstetrics and Gynaecology data manager (or designated delegate not involved in the
trial or patient care if she is absent).
Women will be randomized to one procedure or the other: participating surgeons are
competent to undertake both procedures, and so patients will receive their surgery from
their chosen surgeon. That is, patients are allocated to a procedure and not to a surgeon
who specialises in only one of the procedures. Neither surgeons nor patients will be
blinded to the treatment they receive, however both procedures are minimally invasive,
and the incisions required for the surgery are similarly small.
5.3 Intervention
Women in both groups will have their surgery performed according to the usual practice
of the operating surgeon. Anaesthesia will be either general or local, depending on the
clinical state and choice of the patient, and according to the usual clinical practice of the
anaesthetist. Where possible, the operations will be planned as day procedures.

5.3.1 TOT Group
The TOT procedure will be carried out according to the recommendations of the device
manufacturer.
5.3.2 TVT Group

The TVT procedure will be carried out according to the recommendations of the device
manufacture.
5.3.3 Post-operative care for all patients

As usual in Calgary for day case patients, participants in the trial will be cared for in their
homes. If necessary for clinical reasons, women will remain in hospital.
5.3.4 Further surgery

If women require re-operation for incontinence during the 12 months following surgery,
the surgery should use the treatment as randomized, unless in the surgeon’s clinical
opinion, another operation is required.
Randomization/Random Selection
Common Pitfall
We will randomize 50 patients to either treatment or control group.
During the 4 weeks of the study, it is estimated that approximately 80
patients will be eligible. Therefore, a random sample of fifty will be
chosen.
Be clear about the difference between randomization and random

selection. They are not the same thing.
If Randomizing patients – state how random allocation will be
performed.
If random sample - indicate why and how a random sample will
be obtained (note: consecutive sample is not random)
Variables / Data Collection

Identify the: In descriptive and
Independent variable (exposure, intervention…)
exploratory studies, this
Dependent variable (outcome)
distinction is not made.
Covariates
Where will the information come from (data sources)?
Exactly how will the information be collected (data collection methods)?

Keys to success:
- Indicate relevance to research questions/objectives
- Describe the variables in detail
Primary, secondary, covariates
- Discuss psychometric properties (for measurement instruments,
scales)
- Provide justification for use (gold standards, other research, clinical
practice).
- Include letters of agreement if you will get data from a third party (eg.
AHW)
Data Collection
1) SURVEY:
Primary Variables (what will be measured):
• Scope of practice (treatment modalities, types of health conditions treated, referral
practices)
Other Relevant Variables:
• Sociodemographic information (age, gender, marital status, membership of
professional organization, and license status)
• Practice Characteristics (number of years in practice, location of practice,
involvement in teaching/research, number of patients seen each week)
• Education
Measurement Tool:
The questionnaire was developed by the research team and has used valuable information
by Boon (5) in qualitative interviews with Canadian Naturopaths. A draft copy of the
questionnaire is included for review, along with discussion of the psychometric
properties. The questionnaire will be pre-tested using a number of naturopaths, as well as
independent assessors representing medicine, research, a wide range of other health
professions, and government.
2) DOCUMENT COMPARISON: The document comparison will include legislation

from the regulated provinces, the CAN Code of Ethics and CAN Standards of Practice.
Variables to be assessed include:

• Treatment modalities and health conditions seen as part of naturopathic medicine’s
scope of practice
• Referral policies
• Rationale and philosophy underlying scope of practice.

Data collection methods

6.1 Operative and hospital details
Operative details will be collected from the operating room notes. Details will include
type of anaesthesia, length of operation, length of time in hospital (hours) and any intra-
or post-operative complications. These details are collected rigorously in the case notes.
If at the time of surgery compelling clinical circumstances occur that necessitate another
procedure being performed than that allocated, the reasons for the change of procedure,
and the actual operation performed will be noted.
6.2 Primary outcome: Objective evidence of cure

Objective evidence of SUI will be obtained using a standardised pad test undertaken at 12
months following surgery. The pad test will be carried out using a modification 1 of the
International Continence Society (ICS) recommendations:22
Description of Pad test:

• Retrograde filling of bladder with 300ml saline
• Pre-weighed collecting devide (pad) is put on and the test period begins
• During a 15 minute period the subject performs the following activities:
- walk up and down 1 flight of stairs
- standing up from sitting, 10 times
- coughing vigorously,10 times
-
running on the spot for 1 minute
At the end of the test the collecting device is removed and weighed
6.3 Secondary outcomes

• Subjective evidence of cure
Subjective symptom assessment will take place at 12 months after surgery. Subjective
cure is defined as either ‘no’ experience of stress incontinence, or if urine loss has been
‘no problem at all’:
Etc… (Data collection methods provided separately for each secondary outcome)
Data Collection - Common Pitfall

‘The Unknown Instrument’
The primary objective is to determine the degree of satisfaction
patients have with outpatient surgery. A questionnaire will be mailed
to patients asking about their degree of satisfaction with their hospital
stay.
Where did the questionnaire come from?

A Note about Questionnaires
A questionnaire is a data collection instrument
What reviewers are looking for:
– How was the questionnaire developed (and by whom)?
– Are you using a Standardized Instrument?
– Has it been tested for
Reliability
Validity
– Has the questionnaire been pre-tested among the patient population
being studied?
– How will the questionnaire be administered?
Statistical Analyses and Sample Size

In many proposals, the sample size section precedes the data analysis section.
However, it is advisable to consider the analysis section first, as the sample size
calculation should be based on the analysis of the primary research question.
Data Analysis Section

A detailed plan for handling and analyzing data, including procedures for:
– Recording, storing and reducing data
– Assessing data quality
– Statistical analyses
Keys to success
– Indicate how you will test assumptions
– Provide reasonable detail
– Make sure you have described the analysis for each stated
objective
Tips for the Data Analysis Section

Make sure your objectives are clear, simple and testable.
Think carefully about your outcome measure.

– What constitutes clinical relevance?
– Is it appropriate, relevant and measurable?
Be concrete and explicit.

Turn your research question into something testable.
Take the essential features of your problem and turn it into something
measurable.
Think carefully about your outcome measure.

What constitutes clinical relevance?
Is the outcome measure appropriate?
Select an appropriate analysis tool.
Think about how you would present your final results.
– What convincing evidence would you present?
– What could you measure and report that would demonstrate
clinical/economic impact?
Make table shells (these do not need to be included in the proposal).

How will you present the data from your study?
What features of your patients would you need to describe in a
manuscript?
– How will tests of significance or models be presented? Comparison
of means? Comparison of rates or proportions?
Sample Size Estimates: Inference

Inference
– In research, we usually can’t measure everyone.
– Forced to make inferences regarding “true” or underlying
characteristics of a population on the basis of data collected from a
sample.
– The more subjects we use or measure, the more accurate our
estimates will be.
– If we measure too many, we will waste resources. If we measure
too few, we won’t be able to detect effects of interest.
Sample Size Calculations

Keys to success:
– If possible, consult a biostatistician (there are also some online
sample size calculators available)
– Justify the elements that you put into your calculation.
For example:
…control group is expected to have this response based on
literature (eg. meta-analysis)”
….we’d like to detect this response in the intervention group based
on previous literature and clinical significance
…..the standard deviation around the change is based on the
literature…
– Base the sample size on the primary objective(s) and on the test of
significance that will be used to test your primary study hypothesis.
– If you have a fixed sample size, do a power calculation.
– If you are estimating a prevalence or mean score in a cohort study
or survey, justify the sample size on the widths of confidence

intervals (e.g. for prevalence, number of subjects needed to obtain
95% confidence intervals of +/- 10%.).
– Account for anticipated dropout rates and or non-response rates in
the sample size estimate.
Analysis Plan
SURVEY: The data analysis will be mainly descriptive. Frequencies and summary
measures will be selected according to the level of measurement for each of the key
variables of interest (components of scope of practice, satisfaction with scope of practice
and training and preparedness for practice). If numbers are sufficient, contingency
analyses will be conducted to identify whether socio-demographic, education and
practice characteristics are associated with the key variables of interest. Depending on
the level of measurement Chi-squared (discrete data, difference in proportions), t-test
(continuous data) or one-way ANOVA will be used. Data will be analyzed using SPSS
software.
DOCUMENT COMPARISON: Treatment modalities and health conditions will be

assessed using quantitative content analysis where possible. Quantitative content
analysis is “a research technique for the objective, systematic and quantitative description
of the manifest content of communication” (9). The analysis consists primarily of
counting occurrences in each identified category (eg. Scope of practice). The remaining
variables will be analyzed using qualitative content analysis. This involves analyzing the
content of the narrative to determine themes or patterns. A theme is a recurring regularity
emerging from an analysis of qualitative data and may be a phrase, sentence or paragraph
embodying ideas or making an assertion about a topic. The distinction between
quantitative and qualitative content analysis is often more a mater of degree than a clear
dichotomy.
The quantitative results of the document analysis will be compared with the survey
participants’ responses in terms of descriptive summary measures. Where required (ie.
when documents reveal major differences across provinces), the responses of the survey
participants will be stratified by province.

Sample Size and Analysis Plan
7.1 Sample size

The collaborating urogynaecologists agree that a 15% difference in cure rate would be
required to change clinical practice in Calgary: that is either to introduce TOT into usual
practice, or to restrict its introduction. Published cure rates for TVT vary considerably,
depending on the definition of “cure” used, however we believe that using our definition,
the cure rate for TVT will be 73% (based on the negative pad test results of Ward et al
12
). We wish our study to detect a 15% higher cure rate for TOT. In order to be able to
detect a difference of this order, assuming 80% power and a significance level of 0.05, a
sample of 100 patients per group would be required (total 200).
We believe that we shall be able to recruit this number of patients in one year, based on
our previous TOT study, where we recruited 52 patients over the period of 3 months.
The importance of follow-up will be stressed to patients so that we can reduce the
possibility of drop-outs during the 12 month follow-up period.
7.2 Analysis
Analysis will be by intention to treat: that is, women will remain in the group to which
they have been allocated by randomization, no matter what surgery they receive. A
single analysis is planned: when all women have completed their 12 month follow-up.
Descriptive statistics (means, standard deviations, proportions) will be calculated to

check for any major dissimilarities in the study groups with regard to baseline
information.
The primary analysis will be the comparison of the proportion of patients who
demonstrate ‘cure’ on the 1-hour pad test (pad weight gain less than 1g over the test
period) at 12 months following surgery. The proportion will be compared between
treatment groups using Fisher’s Exact Test. Point and interval estimates for the
differences will be determined. It is expected that almost all patients will be available for
follow-up at 12 months.
Analyses of the secondary outcomes will be as follows:

• Subjective urinary incontinence: the proportions of patients reporting no problematic
stress incontinence in the past 7 days, at 12 months following surgery.
• Incontinence-related quality of life: the mean scores of UDI-6 and IIQ-7 will be
compared between the two groups.
• Satisfaction with surgical outcome: will be compared at 12 months between
treatment groups for the proportions of patients who (a) would have the same
operation again, (b) would recommend the same operation to someone else, and (c)
whose outcome met expectation prior to surgery.

• Return to usual activities after surgery: the mean days to return to usual activities
will be compared between the two groups.
• Prevalence of voiding dysfunction: the proportions of patients experiencing voiding
dysfunction will be compared between groups at 12 months postoperatively.
• Surgical complications: the proportions of patients experiencing surgical
complications will be compared between groups.
• Ect.
7.3 Data management

All data will be managed in Access, with analysis carried out using SAS. Data will be
double entered, and discrepancies reviewed by an independent third person.
Data forms will be checked prior to data entry, and range and logic checks carried out
regularly on entered data to ensure the quality of the data. Any results that appear to be
out of range or do not comply with the logic checks will be checked with the hospital or
clinic case notes and the woman’s surgeon.
Charlie Brown was addressing his baseball team at the end of the
season. He recited numerous dismal statistics such as: Runs scored
by us 12, by opponents 125! At the end of the speech he yells out:
“And what are we going to do about it?” ….to which the team
answers in unison:
“Get a new Statistician!”
Ethical Consideration
Keys to success
– Describe the recruitment procedures
– Describe procedures for maintaining subject privacy
– Follow the guidelines for your organisation (consent form
templates)
– Describe harms and benefits
– Describe alternatives to study participation
– If asking for a waiver of consent, justify explicitly why you cannot
get consent (HIA)
– If using a placebo group, make sure it fits into the TCPS guidelines

Ethical Considerations
An introductory letter will be included with the questionnaire and will describe the
purpose of the study, the research team, and confidentiality of the data (see Appendix X).
Follow-up letters are also included in Appendix X. Return of the questionnaire is
considered to be consent. Practitioners who do not respond to the questionnaire 6 weeks
after two reminder letters will be telephoned and asked for a brief telephone interview. A
script outlining how practitioners will be approached is included in Appendix Y.
Ethical considerations
All women considering taking part in the trial will be given a consent form describing the
surgical options being evaluated, and given ample time to consider whether they wish to
join the trial.
TOT will be offered to women in Calgary only as part of the trial: this is a new
technology, that has been evaluated in few very limited settings. It would be unethical to
open the use of this technology more widely until it has been more thoroughly tested.
However both procedures are currently in use in the Canadian health care system, and
therefore neither technique can be considered as experimental treatments.
An important consideration for the trial is ensuring that women are not coerced to take
part: it is for this reason that we have stipulated that a research nurse not involved in the
woman's care is assigned the task of describing the study to women and obtaining their
consent. Women may take as long as they wish to decide whether to take part in the
study, and are free to discuss their decision with friends, family members or their family
physician, before deciding.
The risks of taking part in the trial are the same as the usual risks of having surgery for
stress incontinence. The additional requirements of the trial over and above those
generally associated with stress incontinence surgery are an additional visit at 12 months
for pad testing and uroflow, and additional questionnaires prior to surgery and later about
the outcome of surgery and the associated costs.
Women may benefit from the closer follow-up required by the trial.
All data for the trial will be collected on data forms designed specifically for the trial.
Personal details will be collected to ensure that the research nurse can maintain contact
with the women over the full 12 months of follow-up. However these personal details

will be stored separately from the study data. Study data will be entered into a password-
protected database, that will be accessible only to study staff. Data will be used only for
the purpose of the study, and will not be passed to anyone else. Results of the study will
be presented with the data from the groups aggregated together: no individual patient will
be identified in any way in reports of the study.
http://www.mediclicks.net/Nexium/cartoons.asp
Limitations
- Be upfront about the limitations of your study.

- This is one of the most important sections of the proposal (shows
reviewers you have thought through all aspects of your study)
- Be clear about why you are not able to overcome these limitations a priori.
- How might these impact the findings?
- If there are clear issues, better to talk about them than leave them open.
- Put a positive spin on any limitations
While this design fails to control for . . . , it allows us to . . .

Budget
Proposals are usually submitted to secure funds for research
Keys to success
– Read instructions carefully
– Itemize costs
Personnel, consultants, equipment, supplies, travel, patient care
costs, indirect costs, other expenses.
– Do not inflate costs
– Justify the budget!
Plans for Dissemination

Developing a dissemination plan is a key part of the collaborative research
process. While publication of the research in a peer reviewed journal is one
method of dissemination, it is also important to think of other strategies to get
your research findings to those who can use it (i.e., decision-makers, healthcare
providers, health organizations etc.). Working through an initial dissemination
plan can help you focus the project and identify key audiences. The Canadian
Health Services Research Foundation (CHSRF) has put together some tips for
developing a dissemination plan (available through their website).
“Communication Notes: Developing a Dissemination Plan” (CHSRF)
http://www.chsrf.ca/knowledge_transfer/pdf/dissemination_plan_e.pdf
Other Possible Sections

Introduction or abstract
Timelines
Research team (describing the research expertise of the team and the
contributions each member will make to the study)
Strengths (can be incorporated into the Limitations section)
Discussion of the Broader Research Program
The specific format will depend on the guidelines of the agency/organization to

which you are submitting.

General Tips
Consistency is important - refer back to your objectives as you develop
the proposal.
Avoid using too much jargon
http://www.mediclicks.net/Nexium/cartoons.asp
If proposing to do a ‘Pilot Study’ note:
Pilot Studies are:

¾ Preliminary studies to provide guidance in deciding how to
conduct a future full-scale study (e.g., testing feasibility,
recruitment, adherence to study protocol, etc.).
Pilot studies are NOT:

¾ To test specific hypotheses;
¾ Studies that are called pilots to justify using an inadequate
number of subjects to test a hypothesis (to avoid doing a
sample size calculation);
¾ Studies that happen to only need a small number of subjects to
have the power to address the research question.

For Further Reading on Proposal Writing
Lock LF, Spirduso WW, Silverman SJ. Proposals that work. Newbury Park, CA: Sage
Publications, 1993.
Gitlin LN, Lyons KJ. Successful grant writing. Strategies for health and human service
professionals. New York: Springer Publishing Co., 1996.
Granstmanship and Review Processes
Barnard J. Keys to writing a competitive grant. Journal of Pediatric Gastroenterology & Nutrition.
35(2):107-10, 2002 Aug. (Available online through UofC’s e-journals)
Bartz C. It all starts with an idea. Alzheimer Disease and Associated Disorders 1999;13(Suppl 1):S106-10.
(Available in print in UofC’s Health Sciences Library. A good article to review proposal writing and points
to remember. Eg. identifying limitations before your reviewers do.)
Calgary Health Region. Writing Successful Grant Applications

http://www.calgaryhealthregion.ca/hecomm/comdev/pdf/grantsbooklet_Jan2005.pdf
Canadian Institutes of Health Research. Peer Review Process http://www.cihr-irsc.gc.ca/e/4656.html
Ferrara JL, Schmaier AH. Hematology grants workshop. I. Writing successful NIH grant applications: a
primer. Hematology (Am Soc Hematol Educ Program). 2002;:484-9. (Available online through UofC’s e-
journals. A nice article describing and justifying the process of NIH grant reviews. It could be applicable to
other granting agency reviews.)
Grey M. Top 10 tips for successful grantsmanship. Res Nurs Health. 2000 Apr;23(2):91-2. (Available
online through UofC’s e-journals)
Hilsden RJ. A beginner’s guide to the research proposal. An online guide with tips and common pitfalls.
http://www.ucalgary.ca/md/CAH/research/files/hilsden/res_prop.htm
Hurley AC, Wells N. The grant application: making yours stand out across the review cycle. Alzheimer
Disease and Associated Disorders 1999;13(Suppl1):S120-2. (Available in print at UofC’s Health Sciences
Library. This article provides a description of what sorts of reviews your application would go through
when it reaches the NIH.)
Koren G. How to increase your funding chances: 15 pitfalls in medical grant applications. Annals of the
Royal College of Physicians and Surgeons of Canada 1997;30(6):335-7. (Available in print at UofC’s
Health Sciences Library. A list of frequently forgotten tips.)
Kundel HL, Walsh C. Preparing a research grant application budget. Investigative Radiology
1993;28(Suppl 2):S13-6. (Available in print at UofC’s Health Sciences Library.)
Lusk SL. Developing an outstanding grant application. Western Journal of Nursing Research
2004;26(3):367-73. (Available from publisher website – easiest to link through PubMed. An article based
on developing a successful proposal for nursing research.)
Rasey JS. The art of grant writing. Current Biology. 9(11):R387, 1999 Jun 3. (Available online through
UofC’s e-journals)


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Health Research Proposal Writing

Tips for Writing Quantitative Research Proposals

Centre for Advancement of Health

Knowledge Into Action (K2A)

Calgary Health Research

(Adapted from MJ Verhoef and RJ Hilsden 2001, 2004)

CALGARY HEALTH RESEARCH

 Robert M, Ross S, Brasher P, Fischer B, Jacobs P. Surgical Management of Stress

Download Proposal Writing Guide at:

2 Proposal Writing 2006 NG

Proposal Writing Overview………………………………………………….. 4

Elements of a Research Proposal

Plans for Dissemination ………………………………………………. 25

Other Possible Sections ……………………………………….……… 25

Pilot Studies ……………………………………………………….…. 26

Supplementary Reading ……………………………………………….……. 27

3 Proposal Writing 2006 NG

Research Proposals are intended to demonstrate:

Keys to Success in Writing a Good Proposal

Overall Quality of the Study

Good research question (relevant, justified)

Quality of the Proposal

Quality of the Presentation

Clear, concise, well-organized

4 Proposal Writing 2006 NG

Informal Questions Relevance of Project

Ethical Considerations Will data be anonymous?

Title: “Surgical Management of Stress Incontinence in Women: Randomized

Reference: Robert M, Ross S, Brasher P, Fischer B, Jacobs P. Surgical Management of Stress

Study Problem / Purpose

6 Proposal Writing 2006 NG

Example 2: Surgical Management of Stress Incontinence

Relevance / Study Rationale

Example 1: Naturopathic Practice

7 Proposal Writing 2006 NG

8 Proposal Writing 2006 NG

Example 1: Naturopathic Practice

Example 2: Surgical Management of Stress Incontinence

Primary research question

9 Proposal Writing 2006 NG

10 Proposal Writing 2006 NG

Example 1: Naturopathic Practice

SURVEY: Data will be collected by means of a standardized questionnaire, which will

DOCUMENT COMPARISON: The document analysis will include the collection of

Example 2: Surgical Management of Stress Incontinence

Methods (in brief):

Study Design - Common Pitfall

 The primary objective is to determine if coffee drinking

 A case-control study will be conducted

Better: The primary objective of this study is to determine if there

12 Proposal Writing 2006 NG

Example 1: Naturopathic Practice

Example 2: Surgical Management of Stress Incontinence

4.1 Inclusion criteria

4.2 Exclusion criteria

13 Proposal Writing 2006 NG

Allocation to Study Groups and Intervention

Example 2: Surgical Management of Stress Incontinence

Baseline, randomization and interventions

5.1 Baseline data collection

Permuted block randomisation with blocks of varying size (2 – 8) will be employed.

14 Proposal Writing 2006 NG

5.3.2 TVT Group

Robert M, Ross S, Brasher P, Fischer B, Jacobs P. Surgical Management of Stress

The primary objective is to determine if coffee drinking

A case-control study will be conducted

Be clear about the difference between randomization and random

Think carefully about your outcome measure.

Be concrete and explicit.

Think carefully about your outcome measure.

Make table shells (these do not need to be included in the proposal).

If proposing to do a ‘Pilot Study’ note: