V. Nadine Gall
Dr. Peter Faris
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
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
TABLE OF CONTENTS
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25
Pilot Studies ..
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Supplementary Reading .. 27
Study Problem
Observation/Idea
Issues to consider/discuss
Relevance of Project
Informal Questions
Justification of research:
Why is the research important?
Are there gaps in the literature?
Would the answers have clinical value?
Literature Review
Research Questions/Objectives
No Hypotheses
(Exploratory Research)
Study Methods
Hypotheses
(Explanatory Research)
Study Design
Survey
Cohort
Study
Case-Control
Study
Survey
Cohort
Study
Case-Control
Study
Randomized
Control Trial
Be Consistent!
Variables
Primary Outcome(s)
Secondary Outcome(s)
Covariates
Variables of Interest
(Covariates)
Subjects
Precision (Power)
Descriptive (Inferential)
Potential biases
Feasibility
Cost
Level of Evidence (Causal Inference)
Ethics
Relevance to questions/hypotheses
Confounding
Justification in literature/practice
Psychometric properties
Who will be studied?
How will you select and recruit them?
How will you allocate them to groups?
Can your study detect meaningful effects?
How precise will estimates be?
Power
Inferential (Descriptive)
Ethical Considerations
Limitations
Personnel costs/consultants.
Overhead, supplies, patient care.
Justify!!!
Budget
Proposal
Writing 2006 NG
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Centre for Advancement of Health
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
Example 1:
Naturopathic Practice
Example 2:
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 / 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 professions 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.
Example 2:
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
8
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 youve 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.).
Example 1:
Naturopathic Practice
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 medicines scope of practice as identified by
federal and provincial governing authorities with practitioners perceptions.
Example 2:
Research Questions:
Primary research question
How effective is TOT compared to TVT in terms of objective cure (determined using a 1hour pad test) at 12 months postoperatively?
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METHODS
Study Design
Types of Designs:
Descriptive (Survey, cross-sectional, correlational)
Observational/analytic
Cohort studies
Prospective
Retrospective
Case-control studies
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
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Example 2:
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.
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 shortterm 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.
Subjects
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Example 1:
Naturopathic Practice
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)
Example 2:
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 Alzheimers or Parkinsons disease, progressive neurological disease such
as multiple sclerosis, or are immunocompromised
- are unable to understand English
- will be unavailable for follow-up.
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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)
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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 medicines
scope of practice
Referral policies
Rationale and philosophy underlying scope of practice.
16
Example 2:
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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
Inference
In research, we usually cant 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 wont be able to detect effects of interest.
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)
.wed 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
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Naturopathic Practice
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.
20
Example 2:
21
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 womans 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
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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.
Example 2:
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
23
will be stored separately from the study data. Study data will be entered into a passwordprotected 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
-
24
Budget
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.
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General Tips
http://www.mediclicks.net/Nexium/cartoons.asp
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