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Prevalence of Maternal Morbidity in
Bangladesh, 2016
A National Estimation
Objective
Implemented by
Funded by
Data Collection Agency
Background
• The burden of maternal ill-health includes not only
maternal mortality but also maternal morbidity
• Globally, true burden of maternal morbidity is still
unknown; for every maternal death, 20-30 other women
suffer from acute or chronic morbidity
• The extent of the global burden of chronic morbid
conditions – specifically for obstetric fistula (OF) and
pelvic organ prolapse (POP) – is largely unknown
Measuring maternal morbidity
Its importance
• There is also a paucity of national level
estimation on OF and POP in Bangladesh
• A 2003 cross sectional study estimated that, 1.69
per 1000 ever married Bangladeshi women are
living with OF
• The prevalence of POP was estimated to be 15%
among Bangladeshi women in a 1996 cross
sectional study
Measuring maternal morbidity
Bangladesh Situation
• Self-reported data from surveys are known to
have low diagnostic value
• Clinical examination is considered as gold
standard for correctly diagnosing OF and POP,
however this method is resource intensive
Measuring maternal morbidity
The Challenges
• One of the objectives of BMMS 2016 was to estimate
national level prevalence of OF and 3rd/4th Stage POP
• However, clinical examination of self reported cases of OF
and POP from BMMS 2016 was not feasible
• Thus, for estimation, a complementary study for clinical
validation of self reported morbidities was conducted to
derive adjustment factors
• This study is known as maternal morbidity validation
study (MMVS) 2016
Estimating maternal morbidity in
Bangladesh
Methodology
• A screening questionnaire was developed to
identify possible cases of OF and POP
• The same screening questionnaire was
administered in both BMMS 2016 and MMVS
2016
• The suspected OF and POP cases identified from
the screening questionnaire in the MMVS were
clinically examined for confirmation
Maternal Morbidity Validation Study
(MMVS) 2016
• Based on the clinical examination, adjustment factors
were derived from the sensitivity and specificity of self
reported OF and POP cases
• These adjustment factors were applied to the BMMS self
reported OF and POP cases to estimate the national
prevalence of OF and 3rd/4th Stage POP
• MMVS also collected information on health seeking
behaviors of women living with OF and 3rd/4th Stage POP
MMVS 2016
MMVS 2016
Household Survey Sample Selection
Selected two Upazila from Habigonj (with
total 28 unions)
Randomly selected 12 unions from
rest of the 18 unions
Covered all 291 villages from 12
unions
Visited: 51,642 HH
Completed: 48,816 HH
Age 13-64 Y Women Found: 65,740
Eligible Women Interviewed: 56,140
Excluding 10 unions that had
BMMS clusters
• Three phases
• Screening questionnaire administered;
• Community sensitization; and
• Clinical examination for self reported
cases
MMVS 2016
Study Phases
• The household survey was
conducted to screen eligible
respondents (married women of
age 13-64 years with at least one
birth)
• A screening questionnaire was
administered to identify women
with self reported symptoms of OF
and POP
Household level Screening of OF and
POP
Screening Questions
Self Reported OF cases
• Does your urine leak continuously, even when you are
not urinating/ trying to urinate?
• Do you currently experience feces passing through the
birth canal that you can not stop, even when you are
defecating?
Self Reported 3rd and 4th Stage POP cases
• In the last one year did you feel any bulge or something
falling out in your vaginal area?
Screening Questions
Self Reported UI cases
• Do you leak urine when you in stress – like laughing,
coughing, sneezing or heavy weight lifting?
• Do you suddenly feel the urge to go to the toilet, and
accidently leak urine?
• Women selected for clinical examination
• All self reported OF
• A sample of self reported POP cases
• A sample of self reported stress and urge
urinary incontinence (UI) cases – who were
considered as “Control”
Household level Screening of OF and
POP
• MaMoni HSS field workers
provided relevant information,
motivated through a community
mobilization session
• All women selected for clinical
examination were visited at home
by the field workers
• These women received a referral
card with the date and location of
examination
Community Sensitization
• The referral cards were double blinded to
prevent compromise of the validation
• MaMoni HSS organized transport – as and when
required – for the women
• On the day of clinical examination the women
were accompanied by MaMoni HSS field workers
to the nearby site
Community Sensitization
• 11 UHFWC and 1 MCWC were refurbished by FC+, MaMoni HSS and
GoB, to use as Clinical Examination Sites
• Several visits from all relevant parties were made to ensure facility
readiness (equipment, consumables, running water, electricity,
infection control, waste management, lighting, privacy, cleanliness)
• Clinical examination team included
• Trained female medical doctors (3)
• Trained female nurses (4)
• Paramedics (5)
• Support Staff (5)
Clinical Examination
Clinical Examination
Flow Diagram (Station One and Two)
Registration and counselling on process
Consent Given Refused
Station One
Station Two
Measurement
of Wt, Ht, BP,
Pulse
Last menstrual
period (LMP)
Medical and
surgical history
Information related to OF, POP and UI symptoms
Consent taking for clinical examination
Clinical examination: External genitalia, Vagina,
Perineum, Cervix, Rectum
Station Three
Eligible for
POP-Q
Clinical Examination
Flow Diagram (Station Three)
POP-Q Staging
Check eligibility for Blue Test
Eligible for Blue Test Not eligible for Blue Test
Blue Test Done
Final diagnosis
Not eligible for
POP-Q
Treatment and care
seeking history
Station Four
Provided appropriate treatment and counseling
Referred for further treatment
Clinical Examination
Flow Diagram (Station Four)
Confirmed for OF and
POP
Confirmed for other
maternal morbidity
Final Diagnosis
Clinical Examination
Summary
Suspected OF
Cases (67)
Invited for
clinical exam
(67)
Attended clinical
exam (58)
Completed
clinical exam
(57)
Sampled
suspected POP
Cases (181)
Sample invited
for clinical exam
(181)
Attended clinical
exam (150)
Completed
clinical exam
(149)
Sampled control
(244)
Invited for
clinical exam
(244)
Attended clinical
exam (200)
Completed
clinical exam
(191)
Total clinically examined = 397
National Estimates of Pelvic Organ Prolapse
(POP) and Obstetric Fistula (OF) in
Bangladesh: Validation Results of the BMMS
Instrument and the Estimation of Prevalence and
Burden of Diseases
• How GOOD is the BMMS SURVEY tool
/instrument for diagnosing POP and OF from
self-reporting (without clinical examination)?
• The utilization of the BMMS to estimate true
POP and OF prevalence at population level,
adjusted for misclassification in self-reporting.
Validation of the Survey Instrument for
diagnosing Pelvic Organ Prolapse (POP)
and Obstetric Fistula (OF)
Performed in two steps
First
Conducted Maternal Morbidity Validation Study
(MMVS) for assessing the diagnostic properties of
the BMMS tool
Second
Applied the diagnostic performance estimate to
adjust the self-reported symptoms of POP and OF
in BMMS 2016 to estimate the national prevalence
levels
Validation Study
• Surveyed 48,816 Households
• Listed 269,217 members
• Identified 65,740 eligible women (ever married aged 13-
64) and successfully interviewed 61,930 women
• 56,098 women aged 15-64 had at least one birth who are
included in this analysis
• 397 women were examined by a physician for clinical
diagnosis
MMVS 2016
MMVS 2016
Eligible women
age 15-64
interviewed:
56,098
Reported POP:
13,171
Sampled POP
cases for clinical
exam:
181
Completed
clinical exam:
149
Reported OF:
67
All reported OF
cases for clinical
exam:
67
Completed
clinical exam:
57
Reported
urge/stress
urinary
incontinence (UI):
14,244
Sampled UI cases
for clinical exam:
244
Completed
clinical exam:
191
Clinical Validation of POP reporting
3rd/4th stage confirmation
Physician Diagnosis
Self-report* Yes No Total
Yes 28 121 149
No 8 240 248
Total 36 361 397
*In the last one year, did you have a bulge or something falling out that you can see or feel in
your vaginal area?
Clinical Validation of POP reporting
3rd/4th stage confirmation
Physician Diagnosis
Self-report* Yes No Total
Yes 28 121 149
No 8 240 248
Total 36 361 397
Pelvic Organ Prolapse Quantification System (POP-Q)
The International Continence Society, the American Urogynecologic Society
Stage Definition
0 No prolapse is demonstrated
I The most distal portion of the prolapse is >1 cm above the level of the hymen
II The most distal portion of the prolapse is ≤1 cm proximal or distal to the plane
the hymen
III The most distal portion of the prolapse is >1 cm below the hymen but protrudes
no further than 2 cm less than the total vaginal length
IV Complete eversion of the total length of the vagina. The distal portion protrudes
at least the total vaginal length minus 2 cm beyond the hymen
Clinical Validation of POP reporting
3rd/4th stage confirmation
Physician Diagnosis
Self-report* Yes No Total
Yes 28 121 149
No 8 240 248
Total 36 361 397
Sensitivity = 28/36 = 0.778
[if one has the condition, the probability of identifying POP by the survey
instrument is 77.8%]
Specificity = 240/361 = 0.665
[Among those without the condition, the probability of identifying the
absence of POP by the survey instrument is 66.5%]
Clinical Validation of POP reporting
3rd/4th stage confirmation
Physician Diagnosis
Self-report* Yes No Total
Yes 28 121 149
No 8 240 248
Total 36 361 397
Positive Predictive Value (PPV) = 28/149 = 0.188
[Among those who reported having POP symptoms, 18.8% had
actually 3rd and 4th stage POP]
Negative Predictive Value (NPV) = 240/248 = 0.968
[Among those who reported no POP symptoms, 96.8% had no
POP indeed]
A Challenge Remains:
What is the prevalence of POP 3rd/4th stage
at population level?
Physician Diagnosis
Self-report* Yes No Total
Yes 28 121 149
No 8 240 248
Total 36 361 397
Sensitivity = 28/36 = 0.778
Specificity = 240/361 = 0.665
Positive Predictive Value (PPV) = 28/149 = 0.188
Negative Predictive Value (NPV) = 240/248 = 0.968
We utilized Sensitivity and Specificity to estimate unbiased
population level prevalence of POP and obstetric fistula
Adjustment for Verification Bias
Diagnosis
Self-report Yes No Unverified* Total
Yes 28 121 13022 13171
No
UI symptoms
OF symptoms
1
7
190
50
42669
10
42927
Total 36 361 55701 56098
*were not examined for clinical confirmation of diagnosis
Adjustment for Verification Bias
Diagnosis
Self-report Yes No Unverified Total
Yes 28+2447 121 13022 13171
No
UI symptoms
OF symptoms
1+224
7+1
190
50
42669
10
42927
Total 36+2672 361 55701 56098
Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447
would be positive if they had undergone clinical examination
Among UNVERIFIED self-reported NO respondents: 42669*(1/190) +
10(7/57) = 225 would be positive if they had undergone clinical
examination
Adjustment for Verification Bias
Diagnosis
Self-report Yes No Unverified Total
Yes 28+2447 121 13022 13171
No 1+7*+225 50*+190 10*+42669 42927
Total 36+2672 361 55701 56098
Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447.0872
would be positive if they had undergone clinical examination
Among UNVERIFIED self-reported NO respondents: 42679*(8/248) = 1376.7419 2
would be positive if they had undergone clinical examination
Observed Sensitivity = 28/36 = 0.778
Verification Corrected Sensitivity = (28+2447)/(36+2672) = 0.914
Adjustment for Verification Bias
Diagnosis
Self-report Yes No Unverified Total
Yes 28+2,447 121 13,022 13,171
No 1+7*+225 50*+190 10*+42,669 42,927
Total 36+2,672 361 55,701 56,098
Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447.0872
would be positive if they had undergone clinical examination
Among UNVERIFIED self-reported NO respondents: 42679*(8/248) = 1376.7419 2
would be positive if they had undergone clinical examination
Observed Sensitivity = 28/36 = 0.778
Verification Corrected Sensitivity = (28+2447)/(36+2672) = 0.914
Self-reported prevalence of POP symptoms = 13,171/56,098 = 0.235 (23.5%)
True prevalence of 3rd & 4th POP = (36+2672)/56,098 = 0.0483 (4.83%)
Sensitivity, specificity, positive and negative predictive
values and prevalence of POP, MMVS 2016
Diagnostic performance indicators
and POP prevalence
Estimates
(%)
Sensitivity
Observed
Adjusted
77.8
91.4
Specificity
Observed
Adjusted
66.5
80.0
Positive predictive value (PPV) 18.8
Negative predictive value (NPV) 99.5
Self-reported prevalence 23.3
Adjusted prevalence*
(among ever married women aged
15-64 with at least one birth)
4.8
Sensitivity, specificity, positive and negative predictive
values and prevalence of POP, MMVS 2016
Age Group Total
(%)15-49
(%)
50-64
(%)
Self-reported
prevalence
23.2 24.2 23.5
Adjusted prevalence
(among ever-married
women aged 15-64 with
at least one birth) 3.5 9.6 4.8
• Added the same MMVS questions in the BMMS 2016
• Total BMMS sample: 315,723 women of aged 13-49
• POP and OF questions were administered to a sample of
204,035 women
• The POP and OF prevalence analyses for national
estimates are based on 183,544 ever married women
aged 15-49 who had at least one birth
National Level Estimates Based on
the BMMS 2016
Prevalence of 3rd and 4th stage POP by selected
variables among ever married women 15-49 with at least
one birth, BMMS 2016 (National Estimates)
Self-reported prevalence
of POP (%)
Adjusted prevalence of
POP (%)
Residence
Urban
Rural
4.35
5.96
0.7
0.9
Women’s Education
No education
Primary
Secondary
Higher
6.99
6.67
4.46
2.13
1.1
1.0
0.7
0.3
Wealth quintile
Lowest
Second
Middle
Fourth
Highest
7.11
6.40
5.66
4.62
3.88
1.1
1.0
0.9
0.7
0.6
Total 5.5 0.8
Burden of POP in Bangladesh
Age
15-49
Age
50-64
Total
POP 289,487 183,013* 472,500
Female
population
with at least
one birth
34,840,027 8,014,556 46,554,408
*adjusted for reporting differences in POP symptoms between MMVS
and BMMS studies.
Clinical Validation of OF reporting
Physician Diagnosis
Self-report* Yes No Total
Yes 19 38 57
No 0 340 340
Total 19 378 397
Clinical Validation of OF reporting
Diagnostic performance
indicators and OF prevalence
(per 100,000 women)
Estimates
Sensitivity
Observed
Adjusted
100.0
100.0
Specificity
Observed
Adjusted
89.7
99.9
Positive predictive value (PPV) 33.3
Negative predictive value (NPV) 100.0
Self-reported prevalence
(per 100,000 women)
119.0
Adjusted prevalence
(per 100,000 women)
40.0
Clinical Validation of OF reporting
Diagnostic performance indicators and OF
prevalence (per 100,000 women)
Estimates (per 100,000 women)
(95% Confidence Interval)
Sensitivity
Observed
Adjusted
100.0 (82.4 -100.0)
100.0 (84.6 -100.0)
Specificity
Observed
Adjusted
89.7 (86.2 - 92.6)
99.9 (99.8 - 100.0)
Positive predictive value (PPV) 33.3 (21.4-47.1)
Negative predictive value (NPV) 100.0 (98.9-100.0)
Self-reported prevalence 119.0 (94.0-152.0)
Adjusted prevalence 40.0
• Positive predictive value (PPV) of 33% suggests that one-third of the
self-reported cases were true OF cases.
• 100% sensitivity suggests that the true OF cases will be correctly
identified by the survey questions (instrument) in the field.
• Very high specificity (99.9%) suggests that true non-cases will be
extremely unlikely to be characterized falsely as the OF case (false
positive) [and unlikely to be referred for clinical examination]
Sensitivity, specificity, positive and negative
predictive values and prevalence of OF by age
group, Bangladesh MMVS Study 2016
Age Group Total
(per 100,000
women )
15-49
(per 100,000
women)
50-64
(per 100,000
women )
Observed prevalence 115 137 119.0
Adjusted prevalence
(among ever married women
aged 15-64 with at least one
birth)
37 53 40.0
Prevalence of OF by selected variables among ever
married women 15-49 with at least one birth, BMMS
2016 (National Estimates)
Self-reported prevalence of
obstetric fistula
(per 100,000 women)
Adjusted prevalence of
obstetric fistula
(per 100,000 women)
Residence
Urban
Rural
116
122
37
39
Women’s
Education
No education
Primary
Secondary
Higher
176
163
74
27
56
52
23
9
Wealth quintile
Lowest
Second
Middle
Fourth
Highest
126
157
117
107
95
40
50
37
34
30
Total 121 38
Burden of OF in Bangladesh
Age
15-49
Age
50-64
Total
OF 13, 357 4,218 17,575
Female
population
with at least
one birth
34,840,027 8,014,556 46,554,408
Summary of Results
BMMS-MMVS study: the largest study ever
undertaken – in the world - to validate the survey
tool and estimate POP and OF at national level
Barber et al, Can we screen for pelvic organ prolapse without physical
examination in epidemiological studies, AJOG, 2006: 195, 942-8.
• The survey tool has high Se and Sp, but low PPV.
• The reported prevalence of POP in the study area was 23.5% among
ever married women 15-64 who had given a birth. Unbiased
(adjusted) prevalence was 4.8%.
• Unbiased POP prevalence at national level was 8 per 1,000 among
ever married women 15-49 who had given a birth.
• It is estimated that there are approximately half-a million women
with at least a birth are suffering from 3rd and 4th stage POP in
Bangladesh.
Summary of Results … cont.
• The OF tool has almost perfect sensitivity and specificity. However,
two-thirds of the self-reported cases were not true OF cases
• Approximately 121 per 100,000 women* reported OF-like symptoms
(continuous, involuntary incontinence). This rate was lower than the
earlier report of 169 per 100,000 ever married women in Bangladesh
(Engender Health Report 2003).
• The true prevalence of OF is about 38 per 100,000 women*
• There are about 17,500 women (15-64) with OF in Bangladesh
Summary of Results … cont.
*ever married women 15-49 who had given a birth
• It is estimated that there are approximately
17,500 women suffering from OF in Bangladesh.
• The surgical repair rate is low for OF (~300
women per year), which most affect the poorest
of the poor women. With the current rate of
surgical repair, it will take more than 58 years to
treat the existing cases provided there is no
more new cases!
Summary of Results … cont.
• An alarming finding was high number of
women with perineal tear
• Needs to explore harmful delivery practice and
utilization of episiotomy, including its practice
Summary of Results … cont.
Supplemental Slides
Sensitivity, specificity, positive and negative predictive values and prevalence of POP by age
group, Bangladesh MMVS Study 2016
Age Group Total
15-49 50-64
Sensitivity
Observed
Adjusted
90.0 (68.3 - 100.0)
80.9 (84.6-100.0)
62.5 (35.4 – 84.8)
52.8 (30.0-75.6)
77.8 (60.8 -89.9)
64.1 (46.7 -81.6)
Specificity
Observed
Adjusted
64.4 (58.6 – 70.0)
79.3 (78.0-80.7)
74.0 (35.4 -84.8)
80.9 (76.8 -85.1)
66.5 (61.4 – 71.3)
79.5 (78.1 – 80.9)
Positive predictive value
(PPV) 15.1 (9.2 – 22.8) 33.3 (17.3 -52.8) 18.8 (12.9-26.0)
Negative predictive value
(NPV) 98.9 (96.1-99.9) 90.5 (80.4 -96.5) 96.8 (93.7-98.6)
Self-reported prevalence* 23.2 (22.9-23.7) 24.2 (23.5-25.0) 23.5 (23.1-98.6)
Adjusted prevalence*
(among ever married women aged
15-64 with at least one birth) 4.35 15.29 6.88
•Per 100 women
•Per 100 women
Sensitivity, specificity, positive and negative predictive values and prevalence of OF by age group, Bangladesh
MMVS Study 2016
Age Group Total
15-49 50-64
Sensitivity
Observed
Adjusted
100.0 (76.8 - 100.0)
100.0 (79.4 -100.0)
100.0 (47.8 - 100.0)
100.0 (54.1 -100.0)
100.0 (82.4 -100.0)
100.0 (84.6 -100.0)
Specificity
Observed
Adjusted
89.7 (85.6-92.9)
99.9 (99.8-100.0)
90.9 (82.9 - 96.0)
99.9 (99.8 -100.0)
89.7 (86.2 - 92.6)
99.9 (99.8 - 100.0)
Positive predictive value
(PPV) 31.8 (18.6 – 47.6) 38.5 (13.9 -68.4) 33.3 (21.4-47.1)
Negative predictive value
(NPV) 100.0 (98.6-100.0) 100.0 (95.5 -100.0) 100.0 (98.9-100.0)
Observed prevalence* 115 (87-151) 137 (83-223) 119 (94-152)
Adjusted prevalence*
(among ever married women aged
15-64 with at least one birth)
37 53 40

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Prevalence of Maternal Morbidity in Bangladesh, 2016: A National Estimation

  • 1. Prevalence of Maternal Morbidity in Bangladesh, 2016 A National Estimation
  • 6. • The burden of maternal ill-health includes not only maternal mortality but also maternal morbidity • Globally, true burden of maternal morbidity is still unknown; for every maternal death, 20-30 other women suffer from acute or chronic morbidity • The extent of the global burden of chronic morbid conditions – specifically for obstetric fistula (OF) and pelvic organ prolapse (POP) – is largely unknown Measuring maternal morbidity Its importance
  • 7. • There is also a paucity of national level estimation on OF and POP in Bangladesh • A 2003 cross sectional study estimated that, 1.69 per 1000 ever married Bangladeshi women are living with OF • The prevalence of POP was estimated to be 15% among Bangladeshi women in a 1996 cross sectional study Measuring maternal morbidity Bangladesh Situation
  • 8. • Self-reported data from surveys are known to have low diagnostic value • Clinical examination is considered as gold standard for correctly diagnosing OF and POP, however this method is resource intensive Measuring maternal morbidity The Challenges
  • 9. • One of the objectives of BMMS 2016 was to estimate national level prevalence of OF and 3rd/4th Stage POP • However, clinical examination of self reported cases of OF and POP from BMMS 2016 was not feasible • Thus, for estimation, a complementary study for clinical validation of self reported morbidities was conducted to derive adjustment factors • This study is known as maternal morbidity validation study (MMVS) 2016 Estimating maternal morbidity in Bangladesh
  • 11. • A screening questionnaire was developed to identify possible cases of OF and POP • The same screening questionnaire was administered in both BMMS 2016 and MMVS 2016 • The suspected OF and POP cases identified from the screening questionnaire in the MMVS were clinically examined for confirmation Maternal Morbidity Validation Study (MMVS) 2016
  • 12. • Based on the clinical examination, adjustment factors were derived from the sensitivity and specificity of self reported OF and POP cases • These adjustment factors were applied to the BMMS self reported OF and POP cases to estimate the national prevalence of OF and 3rd/4th Stage POP • MMVS also collected information on health seeking behaviors of women living with OF and 3rd/4th Stage POP MMVS 2016
  • 13. MMVS 2016 Household Survey Sample Selection Selected two Upazila from Habigonj (with total 28 unions) Randomly selected 12 unions from rest of the 18 unions Covered all 291 villages from 12 unions Visited: 51,642 HH Completed: 48,816 HH Age 13-64 Y Women Found: 65,740 Eligible Women Interviewed: 56,140 Excluding 10 unions that had BMMS clusters
  • 14. • Three phases • Screening questionnaire administered; • Community sensitization; and • Clinical examination for self reported cases MMVS 2016 Study Phases
  • 15. • The household survey was conducted to screen eligible respondents (married women of age 13-64 years with at least one birth) • A screening questionnaire was administered to identify women with self reported symptoms of OF and POP Household level Screening of OF and POP
  • 16. Screening Questions Self Reported OF cases • Does your urine leak continuously, even when you are not urinating/ trying to urinate? • Do you currently experience feces passing through the birth canal that you can not stop, even when you are defecating? Self Reported 3rd and 4th Stage POP cases • In the last one year did you feel any bulge or something falling out in your vaginal area?
  • 17. Screening Questions Self Reported UI cases • Do you leak urine when you in stress – like laughing, coughing, sneezing or heavy weight lifting? • Do you suddenly feel the urge to go to the toilet, and accidently leak urine?
  • 18. • Women selected for clinical examination • All self reported OF • A sample of self reported POP cases • A sample of self reported stress and urge urinary incontinence (UI) cases – who were considered as “Control” Household level Screening of OF and POP
  • 19. • MaMoni HSS field workers provided relevant information, motivated through a community mobilization session • All women selected for clinical examination were visited at home by the field workers • These women received a referral card with the date and location of examination Community Sensitization
  • 20. • The referral cards were double blinded to prevent compromise of the validation • MaMoni HSS organized transport – as and when required – for the women • On the day of clinical examination the women were accompanied by MaMoni HSS field workers to the nearby site Community Sensitization
  • 21. • 11 UHFWC and 1 MCWC were refurbished by FC+, MaMoni HSS and GoB, to use as Clinical Examination Sites • Several visits from all relevant parties were made to ensure facility readiness (equipment, consumables, running water, electricity, infection control, waste management, lighting, privacy, cleanliness) • Clinical examination team included • Trained female medical doctors (3) • Trained female nurses (4) • Paramedics (5) • Support Staff (5) Clinical Examination
  • 22. Clinical Examination Flow Diagram (Station One and Two) Registration and counselling on process Consent Given Refused Station One Station Two Measurement of Wt, Ht, BP, Pulse Last menstrual period (LMP) Medical and surgical history Information related to OF, POP and UI symptoms Consent taking for clinical examination
  • 23. Clinical examination: External genitalia, Vagina, Perineum, Cervix, Rectum Station Three Eligible for POP-Q Clinical Examination Flow Diagram (Station Three) POP-Q Staging Check eligibility for Blue Test Eligible for Blue Test Not eligible for Blue Test Blue Test Done Final diagnosis Not eligible for POP-Q
  • 24. Treatment and care seeking history Station Four Provided appropriate treatment and counseling Referred for further treatment Clinical Examination Flow Diagram (Station Four) Confirmed for OF and POP Confirmed for other maternal morbidity Final Diagnosis
  • 25. Clinical Examination Summary Suspected OF Cases (67) Invited for clinical exam (67) Attended clinical exam (58) Completed clinical exam (57) Sampled suspected POP Cases (181) Sample invited for clinical exam (181) Attended clinical exam (150) Completed clinical exam (149) Sampled control (244) Invited for clinical exam (244) Attended clinical exam (200) Completed clinical exam (191) Total clinically examined = 397
  • 26. National Estimates of Pelvic Organ Prolapse (POP) and Obstetric Fistula (OF) in Bangladesh: Validation Results of the BMMS Instrument and the Estimation of Prevalence and Burden of Diseases
  • 27. • How GOOD is the BMMS SURVEY tool /instrument for diagnosing POP and OF from self-reporting (without clinical examination)? • The utilization of the BMMS to estimate true POP and OF prevalence at population level, adjusted for misclassification in self-reporting. Validation of the Survey Instrument for diagnosing Pelvic Organ Prolapse (POP) and Obstetric Fistula (OF)
  • 28. Performed in two steps First Conducted Maternal Morbidity Validation Study (MMVS) for assessing the diagnostic properties of the BMMS tool Second Applied the diagnostic performance estimate to adjust the self-reported symptoms of POP and OF in BMMS 2016 to estimate the national prevalence levels Validation Study
  • 29. • Surveyed 48,816 Households • Listed 269,217 members • Identified 65,740 eligible women (ever married aged 13- 64) and successfully interviewed 61,930 women • 56,098 women aged 15-64 had at least one birth who are included in this analysis • 397 women were examined by a physician for clinical diagnosis MMVS 2016
  • 30. MMVS 2016 Eligible women age 15-64 interviewed: 56,098 Reported POP: 13,171 Sampled POP cases for clinical exam: 181 Completed clinical exam: 149 Reported OF: 67 All reported OF cases for clinical exam: 67 Completed clinical exam: 57 Reported urge/stress urinary incontinence (UI): 14,244 Sampled UI cases for clinical exam: 244 Completed clinical exam: 191
  • 31. Clinical Validation of POP reporting 3rd/4th stage confirmation Physician Diagnosis Self-report* Yes No Total Yes 28 121 149 No 8 240 248 Total 36 361 397 *In the last one year, did you have a bulge or something falling out that you can see or feel in your vaginal area?
  • 32. Clinical Validation of POP reporting 3rd/4th stage confirmation Physician Diagnosis Self-report* Yes No Total Yes 28 121 149 No 8 240 248 Total 36 361 397 Pelvic Organ Prolapse Quantification System (POP-Q) The International Continence Society, the American Urogynecologic Society Stage Definition 0 No prolapse is demonstrated I The most distal portion of the prolapse is >1 cm above the level of the hymen II The most distal portion of the prolapse is ≤1 cm proximal or distal to the plane the hymen III The most distal portion of the prolapse is >1 cm below the hymen but protrudes no further than 2 cm less than the total vaginal length IV Complete eversion of the total length of the vagina. The distal portion protrudes at least the total vaginal length minus 2 cm beyond the hymen
  • 33. Clinical Validation of POP reporting 3rd/4th stage confirmation Physician Diagnosis Self-report* Yes No Total Yes 28 121 149 No 8 240 248 Total 36 361 397 Sensitivity = 28/36 = 0.778 [if one has the condition, the probability of identifying POP by the survey instrument is 77.8%] Specificity = 240/361 = 0.665 [Among those without the condition, the probability of identifying the absence of POP by the survey instrument is 66.5%]
  • 34. Clinical Validation of POP reporting 3rd/4th stage confirmation Physician Diagnosis Self-report* Yes No Total Yes 28 121 149 No 8 240 248 Total 36 361 397 Positive Predictive Value (PPV) = 28/149 = 0.188 [Among those who reported having POP symptoms, 18.8% had actually 3rd and 4th stage POP] Negative Predictive Value (NPV) = 240/248 = 0.968 [Among those who reported no POP symptoms, 96.8% had no POP indeed]
  • 35. A Challenge Remains: What is the prevalence of POP 3rd/4th stage at population level? Physician Diagnosis Self-report* Yes No Total Yes 28 121 149 No 8 240 248 Total 36 361 397 Sensitivity = 28/36 = 0.778 Specificity = 240/361 = 0.665 Positive Predictive Value (PPV) = 28/149 = 0.188 Negative Predictive Value (NPV) = 240/248 = 0.968 We utilized Sensitivity and Specificity to estimate unbiased population level prevalence of POP and obstetric fistula
  • 36. Adjustment for Verification Bias Diagnosis Self-report Yes No Unverified* Total Yes 28 121 13022 13171 No UI symptoms OF symptoms 1 7 190 50 42669 10 42927 Total 36 361 55701 56098 *were not examined for clinical confirmation of diagnosis
  • 37. Adjustment for Verification Bias Diagnosis Self-report Yes No Unverified Total Yes 28+2447 121 13022 13171 No UI symptoms OF symptoms 1+224 7+1 190 50 42669 10 42927 Total 36+2672 361 55701 56098 Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447 would be positive if they had undergone clinical examination Among UNVERIFIED self-reported NO respondents: 42669*(1/190) + 10(7/57) = 225 would be positive if they had undergone clinical examination
  • 38. Adjustment for Verification Bias Diagnosis Self-report Yes No Unverified Total Yes 28+2447 121 13022 13171 No 1+7*+225 50*+190 10*+42669 42927 Total 36+2672 361 55701 56098 Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447.0872 would be positive if they had undergone clinical examination Among UNVERIFIED self-reported NO respondents: 42679*(8/248) = 1376.7419 2 would be positive if they had undergone clinical examination Observed Sensitivity = 28/36 = 0.778 Verification Corrected Sensitivity = (28+2447)/(36+2672) = 0.914
  • 39. Adjustment for Verification Bias Diagnosis Self-report Yes No Unverified Total Yes 28+2,447 121 13,022 13,171 No 1+7*+225 50*+190 10*+42,669 42,927 Total 36+2,672 361 55,701 56,098 Among UNVERIFIED self-reported YES respondents: 13022*(28/149) = 2447.0872 would be positive if they had undergone clinical examination Among UNVERIFIED self-reported NO respondents: 42679*(8/248) = 1376.7419 2 would be positive if they had undergone clinical examination Observed Sensitivity = 28/36 = 0.778 Verification Corrected Sensitivity = (28+2447)/(36+2672) = 0.914 Self-reported prevalence of POP symptoms = 13,171/56,098 = 0.235 (23.5%) True prevalence of 3rd & 4th POP = (36+2672)/56,098 = 0.0483 (4.83%)
  • 40. Sensitivity, specificity, positive and negative predictive values and prevalence of POP, MMVS 2016 Diagnostic performance indicators and POP prevalence Estimates (%) Sensitivity Observed Adjusted 77.8 91.4 Specificity Observed Adjusted 66.5 80.0 Positive predictive value (PPV) 18.8 Negative predictive value (NPV) 99.5 Self-reported prevalence 23.3 Adjusted prevalence* (among ever married women aged 15-64 with at least one birth) 4.8
  • 41. Sensitivity, specificity, positive and negative predictive values and prevalence of POP, MMVS 2016 Age Group Total (%)15-49 (%) 50-64 (%) Self-reported prevalence 23.2 24.2 23.5 Adjusted prevalence (among ever-married women aged 15-64 with at least one birth) 3.5 9.6 4.8
  • 42. • Added the same MMVS questions in the BMMS 2016 • Total BMMS sample: 315,723 women of aged 13-49 • POP and OF questions were administered to a sample of 204,035 women • The POP and OF prevalence analyses for national estimates are based on 183,544 ever married women aged 15-49 who had at least one birth National Level Estimates Based on the BMMS 2016
  • 43. Prevalence of 3rd and 4th stage POP by selected variables among ever married women 15-49 with at least one birth, BMMS 2016 (National Estimates) Self-reported prevalence of POP (%) Adjusted prevalence of POP (%) Residence Urban Rural 4.35 5.96 0.7 0.9 Women’s Education No education Primary Secondary Higher 6.99 6.67 4.46 2.13 1.1 1.0 0.7 0.3 Wealth quintile Lowest Second Middle Fourth Highest 7.11 6.40 5.66 4.62 3.88 1.1 1.0 0.9 0.7 0.6 Total 5.5 0.8
  • 44. Burden of POP in Bangladesh Age 15-49 Age 50-64 Total POP 289,487 183,013* 472,500 Female population with at least one birth 34,840,027 8,014,556 46,554,408 *adjusted for reporting differences in POP symptoms between MMVS and BMMS studies.
  • 45. Clinical Validation of OF reporting Physician Diagnosis Self-report* Yes No Total Yes 19 38 57 No 0 340 340 Total 19 378 397
  • 46. Clinical Validation of OF reporting Diagnostic performance indicators and OF prevalence (per 100,000 women) Estimates Sensitivity Observed Adjusted 100.0 100.0 Specificity Observed Adjusted 89.7 99.9 Positive predictive value (PPV) 33.3 Negative predictive value (NPV) 100.0 Self-reported prevalence (per 100,000 women) 119.0 Adjusted prevalence (per 100,000 women) 40.0
  • 47. Clinical Validation of OF reporting Diagnostic performance indicators and OF prevalence (per 100,000 women) Estimates (per 100,000 women) (95% Confidence Interval) Sensitivity Observed Adjusted 100.0 (82.4 -100.0) 100.0 (84.6 -100.0) Specificity Observed Adjusted 89.7 (86.2 - 92.6) 99.9 (99.8 - 100.0) Positive predictive value (PPV) 33.3 (21.4-47.1) Negative predictive value (NPV) 100.0 (98.9-100.0) Self-reported prevalence 119.0 (94.0-152.0) Adjusted prevalence 40.0 • Positive predictive value (PPV) of 33% suggests that one-third of the self-reported cases were true OF cases. • 100% sensitivity suggests that the true OF cases will be correctly identified by the survey questions (instrument) in the field. • Very high specificity (99.9%) suggests that true non-cases will be extremely unlikely to be characterized falsely as the OF case (false positive) [and unlikely to be referred for clinical examination]
  • 48. Sensitivity, specificity, positive and negative predictive values and prevalence of OF by age group, Bangladesh MMVS Study 2016 Age Group Total (per 100,000 women ) 15-49 (per 100,000 women) 50-64 (per 100,000 women ) Observed prevalence 115 137 119.0 Adjusted prevalence (among ever married women aged 15-64 with at least one birth) 37 53 40.0
  • 49. Prevalence of OF by selected variables among ever married women 15-49 with at least one birth, BMMS 2016 (National Estimates) Self-reported prevalence of obstetric fistula (per 100,000 women) Adjusted prevalence of obstetric fistula (per 100,000 women) Residence Urban Rural 116 122 37 39 Women’s Education No education Primary Secondary Higher 176 163 74 27 56 52 23 9 Wealth quintile Lowest Second Middle Fourth Highest 126 157 117 107 95 40 50 37 34 30 Total 121 38
  • 50. Burden of OF in Bangladesh Age 15-49 Age 50-64 Total OF 13, 357 4,218 17,575 Female population with at least one birth 34,840,027 8,014,556 46,554,408
  • 51. Summary of Results BMMS-MMVS study: the largest study ever undertaken – in the world - to validate the survey tool and estimate POP and OF at national level Barber et al, Can we screen for pelvic organ prolapse without physical examination in epidemiological studies, AJOG, 2006: 195, 942-8.
  • 52. • The survey tool has high Se and Sp, but low PPV. • The reported prevalence of POP in the study area was 23.5% among ever married women 15-64 who had given a birth. Unbiased (adjusted) prevalence was 4.8%. • Unbiased POP prevalence at national level was 8 per 1,000 among ever married women 15-49 who had given a birth. • It is estimated that there are approximately half-a million women with at least a birth are suffering from 3rd and 4th stage POP in Bangladesh. Summary of Results … cont.
  • 53. • The OF tool has almost perfect sensitivity and specificity. However, two-thirds of the self-reported cases were not true OF cases • Approximately 121 per 100,000 women* reported OF-like symptoms (continuous, involuntary incontinence). This rate was lower than the earlier report of 169 per 100,000 ever married women in Bangladesh (Engender Health Report 2003). • The true prevalence of OF is about 38 per 100,000 women* • There are about 17,500 women (15-64) with OF in Bangladesh Summary of Results … cont. *ever married women 15-49 who had given a birth
  • 54. • It is estimated that there are approximately 17,500 women suffering from OF in Bangladesh. • The surgical repair rate is low for OF (~300 women per year), which most affect the poorest of the poor women. With the current rate of surgical repair, it will take more than 58 years to treat the existing cases provided there is no more new cases! Summary of Results … cont.
  • 55. • An alarming finding was high number of women with perineal tear • Needs to explore harmful delivery practice and utilization of episiotomy, including its practice Summary of Results … cont.
  • 57. Sensitivity, specificity, positive and negative predictive values and prevalence of POP by age group, Bangladesh MMVS Study 2016 Age Group Total 15-49 50-64 Sensitivity Observed Adjusted 90.0 (68.3 - 100.0) 80.9 (84.6-100.0) 62.5 (35.4 – 84.8) 52.8 (30.0-75.6) 77.8 (60.8 -89.9) 64.1 (46.7 -81.6) Specificity Observed Adjusted 64.4 (58.6 – 70.0) 79.3 (78.0-80.7) 74.0 (35.4 -84.8) 80.9 (76.8 -85.1) 66.5 (61.4 – 71.3) 79.5 (78.1 – 80.9) Positive predictive value (PPV) 15.1 (9.2 – 22.8) 33.3 (17.3 -52.8) 18.8 (12.9-26.0) Negative predictive value (NPV) 98.9 (96.1-99.9) 90.5 (80.4 -96.5) 96.8 (93.7-98.6) Self-reported prevalence* 23.2 (22.9-23.7) 24.2 (23.5-25.0) 23.5 (23.1-98.6) Adjusted prevalence* (among ever married women aged 15-64 with at least one birth) 4.35 15.29 6.88 •Per 100 women
  • 58. •Per 100 women Sensitivity, specificity, positive and negative predictive values and prevalence of OF by age group, Bangladesh MMVS Study 2016 Age Group Total 15-49 50-64 Sensitivity Observed Adjusted 100.0 (76.8 - 100.0) 100.0 (79.4 -100.0) 100.0 (47.8 - 100.0) 100.0 (54.1 -100.0) 100.0 (82.4 -100.0) 100.0 (84.6 -100.0) Specificity Observed Adjusted 89.7 (85.6-92.9) 99.9 (99.8-100.0) 90.9 (82.9 - 96.0) 99.9 (99.8 -100.0) 89.7 (86.2 - 92.6) 99.9 (99.8 - 100.0) Positive predictive value (PPV) 31.8 (18.6 – 47.6) 38.5 (13.9 -68.4) 33.3 (21.4-47.1) Negative predictive value (NPV) 100.0 (98.6-100.0) 100.0 (95.5 -100.0) 100.0 (98.9-100.0) Observed prevalence* 115 (87-151) 137 (83-223) 119 (94-152) Adjusted prevalence* (among ever married women aged 15-64 with at least one birth) 37 53 40