Example Accompaniment

Lecture 21: Preparing a concept paper for

research project

Basic Course in Biomedical Research

As mandated by the National Medical Commission

https://onlinecourses.nptel.ac.in/noc21_md04
Basic Course in Biomedical Research

Lecture 21: Preparing a concept paper for research projects

Objective
To write a concept paper for the example study.

Background
The PG is required to submit a concept paper by her department. Therefore, the guide
suggests to her that it will be useful to write a concept paper and submit it to the department
for review by member of the departmental PG thesis committee. He also tells her that this
concept paper will guide her in preparing the full protocol (Lecture 22) that is to be submitted
to the institute ethics committee.

A concept paper provides a structured way to convey a preliminary research idea to a bigger
audience, like a funding agency or peer group. It is a concise yet sufficiently informative
document that succinctly captures the main points of the health research. In this document,
we will provide a sample concept paper based on the example study.

1
Basic Course in Biomedical Research

Concept paper

Title: Prevalence and determinants of urinary incontinence after vaginal hysterectomy for
uterine prolapse in a tertiary care hospital during XXX-XXX 2020 – a cross-sectional study.

Background:
Pelvic floor dysfunction is a major health issue among women. During their lifetime 11% of
women undergo at least one operation for pelvic organ prolapse, urinary incontinence, or
both.1 Severe genitourinary prolapse may mask urinary incontinence in clinically continent
women, and these women are considered to be at high risk for developing symptomatic
urinary incontinence after pelvic reconstructive surgery. These women may become
incontinent once the prolapse is reduced by a pessary or following vaginal reconstructive
surgery.2 Vaginal hysterectomy with pelvic floor repair is the conventional method of treating
pelvic organ prolapse, but the development of urinary incontinence after prolapse correction
in a previously continent patient is a distressing problem. According to the literature, 36% to
80% of women with advanced vaginal prolapse are at the risk of urinary incontinence after
vaginal reconstructive surgery.3 Many epidemiological studies done in western countries
have estimated the prevalence of occult urinary incontinence following vaginal hysterectomy
but there is a dearth of studies in India. Therefore, the present study will be carried with the
following objectives.

Objectives:
Primary objective: To estimate the prevalence of urinary incontinence (within 3 months of
surgery) among adult women who underwent vaginal hysterectomy for third degree uterine
prolapse in a tertiary care hospital.
Secondary objective: To determine the demographic and clinical factors associated with
urinary incontinence among adult women who underwent vaginal hysterectomy for third
degree uterine prolapse in a tertiary care hospital.

Methods:
Study population:Adult women aged ≥18 years who underwent hysterectomy for third degree
uterine prolapse in this facility 3-4 months prior to the study start will be included.
Study design: This study will be conducted as a hospital-based cross-sectional study.

2
Basic Course in Biomedical Research

Operational definition: Urinary incontinence will be measured as self-reported leakage of

urine. Also, a validated structured scale called Urinary Incontinence Assessment Tool will be
used to measure the degree of urinary incontinence on a continuous scale.
Sampling procedure:We will performconvenient samplingin the Gynaecology OPD of the
study hospital.
Sample size:For an estimated prevalence of 42% urinary incontinence among women of
India4, with 8% absolute precision, 95% confidence level, and 20% non-response proportion,
we will require a sample size of 183.
Data collection:Aface-to-face interview will be conducted using a semi-structured
questionnaire.Trained investigators will be involved. Double data entry will be done to
reduce entry errors.
Human participant protection:Ethics committee approval and written informed consent from
participants will be obtained.

Expected benefits:
In this study, we will estimate the burden and associated factors of urinary incontinence in
this hospital setting which will fill the current knowledge gap on this topic. This will provide
the basis for early diagnosis, treatment and prevention of the condition in this setting.

Proposed budget: INR 1,00,000 (salary, equipment and stationaries)

References
1. Olsen AL, Smith VJ, Bergstrom JO, et al. Epidemiology of surgically managed pelvic
organ prolapse and urinary incontinence. Obstet Gynecol1997;89:501–6.
doi:10.1016/S0029-7844(97)00058-6
2. Richardson DA, Bent AE, Ostergard DR. The effect of uterovaginal prolapse on
urethrovesical pressure dynamics. Am J Obstet Gynecol1983;146:901–5.
doi:10.1016/0002-9378(83)90961-4
3. Reena C, Kekre AN, Kekre N. Occult stress incontinence in women with pelvic organ
prolapse. Int J Gynaecol Obstet2007;97:31–4. doi:10.1016/j.ijgo.2006.12.011
4. Singh U, Agarwal P, Verma ML, Dalela D, Singh N, Shankhwar P. Prevalence and
risk factors of urinary incontinence in Indian women: A hospital-based survey. Indian
J Urol 2013;29(1):31-36. doi:10.4103/0970-1591.109981

3
Basic Course in Biomedical Research

Concluding remarks

The above conceptpaper is only an example and you may have to modify this to suit the
requirements of your institution/funding agency.