Extraction form for project: SGS 2021 Fibroids PFD

Design Details

1. Rejection reason
Skip if you are extracting. If you reject, do not fill anything else out. If extraction is (partly) done, you can leave everything else entered. Choose just one reason. Either the "most important" or in D-PICO order.
Single Choice
D: Systematic review (reference list checked for articles of interest)
D: Not primary study (or SR)
D: Not human study
D: N<10 (with pelvic floor symptoms) per group
D: Not study design of interest (e.g., cross-sectional)
P: Not fibroid w/PFD
I: Not surgery or IR
O: No outcome of interest
Duplicate (no unique data)
Other...
2. Study design
Single Choice
RCT
Comparative (between interventions)
Single group (one intervention)
Registry etc.
Systematic review
Other
3. Directionality
Prospective = study designed prior to participant enrollment or intervention. Retrospective = Intervention occurred before study conceived.
Single Choice
Prospective
Retrospective
4. Countr(ies)
Where participants were treated
5. Inclusion criteria
As appropriate, describe criteria related to fibroids/myomas, pelvic floor disorders or any other inclusion criteria. Be concise. Use well-understood abbreviations. Omit non-salient feature (e.g., informed consent, language). If you copy and paste, please go back and edit/clean up.
List inclusion criteria for fibroids (ie, fibroids identified by clinical exam, symptoms, imaging. Any size or location criteria for fibroids for study inclusion)
List inclusion criteria for PFDs (ie, any specific symptoms that were required for inclusion in to the study specific to pelvic floor)
List other inclusion criteria
6. Exclusion criteria
Be concise. Use well-understood abbreviations. Omit redundancies with inclusion criteria. Omit non-salient features. OK to leave this blank if nothing unique to add.
7. Centers
Number of centers participants were collected from
Single Choice
Single center
Multiple centers
Registry based study
Unclear/Not reported
8. Procedure performed by (select all that apply):
Select all that apply over all the arms
Multiple Choice
Surgeon
Radiologist
Unclear/Not reported (NR)
Other
9. Funding source
Single Choice
Industry (fully or in part, including provision of materials)
Non-industry (fully)
Unclear/Not reported
10. Comments/Notes
11. SECONDARY REVIEWER: Corrections
List corrections (from your perspective). You don't need to list trivial corrections (like typos; except number typos).
12. SECONDARY REVIEWER: Completed
Single Choice
Yes, reviewed
No, in process
13. Ankita: Finalized
Single Choice
Yes, finalized
14. New Question
Description

Arm Details

1. Comments/ Details about specific intervention if listed.
List details about the arm selected including method of performing procedure. Also record if route of procedure was not specified. Can be copy pasted from material & methods of text.
No fibroids:

Sample Characteristics

1. Numbers of participants (each arm and total)
Number enrolled = before dropouts, etc. May be the same as number analyzed (particularly in retrospective studies). Type in NR if not reported.
No fibroids:
2. Age
if NR, select this in the Mean row. FOR ALL CHARACTERISTICS, PREFERENTIALLY COMPLETE "TOTAL" INSTEAD OF EACH ARM (unless there's a substantive difference between groups). BUT NO NEED TO CALCULATE.
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
3. Body Mass Index (BMI)
if NR, select this in the Mean row.
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
4. Parity
if NR, select this in the Mean row.
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
n (%)
5. Race/Ethnicity
Extract or Calculate the %. List Other 1-4 in order mentioned in manuscript.
No fibroids:
Not reported/ Unable to calculate
Single Choice

White (all), %
White, Non-Hispanic, %
Black/AA (all), %
Black/AA, Non-Hispanic, %
Hispanic/Latina, %
Asian, %
Other_1, %
Other_2, %
Other_3, %
Other_4, %
6. Uterine size
Select unit near the bottom of the table. Select Not Reported in the Mean row if not reported
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
Units
Single Choice
Weeks
Grams
cc
Other
Single Choice

7. Number of fibroids
if NR, select this in the Mean row.
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
8. Size of fibroids
Select unit near the bottom of the table. Select Not Reported in the Mean row if not reported
No fibroids:
Lower LimitHigher Limit
Mean
Single Choice
Not reported
95% CI
Standard Deviation (SD)
Single Choice

Standard Error (SE)
Single Choice

Median
Single Choice

Interquartile Range (IQR)
Full range
Units
Single Choice
Weeks
Grams
cc
Other
Single Choice

9. Location of fibroids
For each location, enter percent (0-100%) of total cases, not proportion (0-1) or n/N. Leave blank if particular location not reported, select NR if this question is not reported upon in the manuscript
No fibroids:
Anterior
Posterior
Fundal
Cervical
Other
Not Reported (NR)
Single Choice

10. Fibroid symptoms leading to intervention
For each symptom, enter percent (0-100%) of total cases, not proportion (0-1) or n/N. Leave blank if particular location not reported, select NR if this question is not reported upon in the manuscript
No fibroids:
AUB/HMB/menorrhagia
Abdominal/pelvic pressure
Pelvic pain or Dyspareunia
“Bulk” symptoms
Urinary symptoms
Other
Not Reported (NR)
Single Choice

11. Comorbidities
List all comorbidities reported (DM, HTN, Asthma etc)
No fibroids:
12. P values between groups
If a comparative study, extract the P value between arms, with a description/explanation as needed. If NR for all, select that in the first row. If in your judgment, there's a large difference (even if P NR or NS), comment in the Explanation/Description column. If there are more than 2 arms with differences reported, include reported p values and provide explanation If a single arm study, skip the question.
No fibroids:
P valueDifference
All NS (or NR)
Single Choice
All NS
Single Choice
P value not reported
Age
BMI
Parity
Race/ethnicity
Uterine size
No. fibroids
Size of fibroids
Location of fibroids
Fibroid Sxs
Comorbidities
Other

Outcome Details

1. Please add specifics on how the outcomes were recorded or measured
Urinary Frequency:

Risk of Bias Assessment

1. Clear reporting with no discrepancies
Rating
Single Choice
Yes
No
Notes/Comments
2. Were eligibility criteria clear?
Rating
Single Choice
Yes
No
Notes/Comments
3. Were interventions adequately described?
Rating
Single Choice
Yes
No
Notes/Comments
4. Were the outcomes fully defined?
Rating
Single Choice
Yes
No
Notes/Comments
5. Was selection bias likely?
Rating
Single Choice
Yes
No
Notes/Comments
6. If multicenter, was this accounted for in analysis?
Rating
Single Choice
Yes
No
Not applicable
Notes/Comments
7. Were potential confounders properly accounted for?
Rating
Single Choice
Yes
No
No data
Not applicable
Notes/Comments
8. Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as: sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
9. Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
There is a low risk of selection bias if the participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization); sequentially numbered drug containers of identical appearance; or sequentially numbered, opaque, sealed envelopes. There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
10. Blinding of participants and personnel: Performance bias due to knowledge of the allocated interventions by participants during the study
There is a low risk of performance bias if blinding of participants and key studding personnel was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
11. Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.; or: >> for patient-reported outcomes in which the patient was the outcome assessor (e.g., pain, disability): there is a low risk of bias for outcome assessors if there is a low risk of bias for participant blinding. >> for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (e.g., co-interventions, length of hospitalization, treatment failure), in which the care provider is the outcome assessor: there is a low risk of bias for outcome assessors if there is a low risk of bias for care providers. >> for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the treatment could not be noticed in the extracted data.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
12. Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data
There is a low risk of attrition bias if there were no missing outcome data; reasons for missing outcome data were unlikely to be related to the true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data were balanced in numbers, with similar reasons for missing data across groups (The percentage of withdrawals and drop-outs should not exceed 20% for short-term follow-up and 30% for long-term follow-up and should not lead to substantial bias. Note: these percentages are commonly used but arbitrary, not supported by the literature); missing data were imputed using appropriate methods. For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate. For continuous outcome data, the plausible effect size (difference in means or standardized difference in means) among missing outcomes were not enough to have a clinically relevant impact on observed effect size. Note: if drop-outs are very large, imputation using even ‘acceptable’ methods may still suggest a high risk of bias.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
13. Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
There is low risk of reporting bias if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way, or if the study protocol is not available but it is clear that the published reports include all expected outcome, including those that were pre-specified (convincing text of this nature may be uncommon). There is a high risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; one or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
14. Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation
There is low risk of bias if all randomized patients were reported/analyzed in the group to which they were allocated by randomization.
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments
15. Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
There is a low risk of bias if the study appears to be free of other sources of bias not addressed elsewhere
Rating
Single Choice
Low bias
High bias
Unclear
Notes/Comments

Suggested Arms

NameDescription
Abdominal HysterectomyOpen cases. If route not specified, use this arm.
Abdominal MyomectomyOpen cases. If route not specified, use this arm.
Conservative/ expectant managementHave fibroids but no intervention planned
CryomyolysisRegardless of route
High intensity focused ultrasoundAbbreviated as HIFU in many papers
Laparoscopic hysterectomy
Laparoscopic Myomectomy
Laparoscopic radiofrequency volumetric thermal ablation (Acessa)
Magnetic resonance guided radiofrequency ablation
Medical managementIncludes all medical management (hormonal, GnRH)
No fibroidsHas a comparison group of patients without fibroids.
Non-surgical device Includes IUDs, Nexplanon
Robotic hysterectomy
Robotic myomectomy
Total All arms combined
Ultrasound guided focused radiofrequency ablationIf route of radiofrequency ablation not specified and definitely not done laparoscopically, use this.
uterine artery embolization
Vaginal Hysterectomy

Please see downloadable data for more

Suggested Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
CategoricalConstipation
CategoricalFecal incontinence
CategoricalNonspecific bowel symptoms
CategoricalPatient satisfaction
CategoricalProlapse symptoms
CategoricalStress urinary incontinence
CategoricalUrge Urinary incontinence
CategoricalUrinary dysfunction or urinary symptoms not otherwise specified
CategoricalUrinary Frequency
CategoricalUrinary incontinence (not specified which type)
CategoricalUrinary retention
Categoricalurinary urgency
ContinuousCRAD-8Colorectal-Anal distress Inventory 8 (CRAD-8)
ContinuousCRAIQ-7Colorectal-Anal Impact questionnaire (CRAIQ-7)
ContinuousIIQ-7Incontinence Impact Questionnaire, Short Form (IIQ-7)
ContinuousOABSSOveractive Bladder Symtom Score (OABSS)
ContinuousOther Questionnaire (Non Validated)
ContinuousPFDI-20Total score Pelvic Floor Disability Index
ContinuousPFIQ-7Total score Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7)
ContinuousPOPDI-6Pelvic Organ prolapse Distress Inventory 6 (POPDI-6)
ContinuousPOPIQ-7Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7)
ContinuousUDI-6Urinary distress Inventory 6 (UDI-6)
ContinuousUIQ-7Urinary Impact Questionnaire (UIQ-7)

Please see downloadable data for more