{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2951-s1", "verdict_number": "2951", "title": "Pelvic floor muscle training itself × Female urinary incontinence — Common treatment and added device effects distinguished", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Women with stress or mixed urinary incontinence able to contract in OPAL; parent comparison context excluding urgency-only incontinence and inability to contract", "intervention": "Supervised PFMT; treatment common to both OPAL groups", "dose": "Specific training schedules and actual exposure are unverified in the stored summary; no instructions are generated", "comparator": "The selected question requires a direct comparison of PFMT itself; OPAL compared PFMT plus EMG biofeedback with PFMT", "endpoint": "The selected question concerns PFMT itself; the parent OPAL outcome is ICIQ-UI SF at 24 months", "duration": "Parent OPAL follow-up was 24 months; duration of direct PFMT-itself comparisons is unverified", "excluded_extensions": [ "Transferring the added device effect to PFMT itself", "Automatic application to women unable to contract or with urgency-only incontinence", "Establishing efficacy of devices, apps or all forms of training", "Instructions for training or treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy", "question": "Is the selected subclaim preserved separately from the added device effect?", "needed": "Separate records of the original PFMT claim, verdict and boundaries", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Separate records of the original PFMT claim, verdict and boundaries", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "If a direct comparison evaluating PFMT itself is linked, review of the existing content can clarify its applicable scope.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The original subclaim is ‘Benefit of PFMT itself’, with grade B and the note ‘It was common to both arms and is not the target claim.’ The parent verdict concerns the added device effect and is D with 34 points.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.", "missingness": "The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The subclaim has no score, status or assessment axes, and parent values are not used to fill them. Its B grade has not been reassessed during this production." }, { "item_id": "N02", "question_type": "Comparative efficacy", "question": "Does OPAL's comparison identify the causal effect of PFMT itself?", "needed": "Direct evidence comparing PFMT with an appropriate comparison without that training", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Direct evidence comparing PFMT with an appropriate comparison without that training", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "A study with a comparator suitable for the PFMT-itself question, or preserved material containing such direct evidence, is needed.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Both OPAL groups received supervised PFMT; the difference was the addition of home vaginal-probe EMG biofeedback. The original text explicitly places PFMT itself outside this verdict's scope.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.", "missingness": "This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "This active-control design provides no estimate separating the shared training effect from natural history, expectations and accompanying care." }, { "item_id": "N03", "question_type": "Comparative efficacy", "question": "What are the women's incontinence types and baseline ability to contract?", "needed": "Eligible populations and denominators by diagnosis, baseline severity and contraction ability", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Eligible populations and denominators by diagnosis, baseline severity and contraction ability", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain the original trial's eligibility criteria and baseline characteristics to distinguish populations appropriate to the PFMT-itself question.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL included 600 women with stress or mixed urinary incontinence at 23 UK centers. Women with urgency-only incontinence or no ability to contract their pelvic floor muscles were excluded.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.", "missingness": "The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The stored summary does not provide denominators by baseline severity or incontinence type, or direct effects of PFMT itself within them." }, { "item_id": "N04", "question_type": "Comparative efficacy", "question": "Are the shared PFMT program and accompanying treatments preserved?", "needed": "Research records of training, supervision, contact and accompanying treatments common to both groups", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Research records of training, supervision, contact and accompanying treatments common to both groups", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link the original protocol's program components and actual exposure and accompanying-treatment data.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Supervised PFMT in both groups is stated, but this summary does not specify the training schedule, actual exposure or accompanying treatments.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.", "missingness": "Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Research training methods are not invented or turned into instructions. Separation of the contributions of shared care remains unverified." }, { "item_id": "N05", "question_type": "Comparative efficacy", "question": "Are the home probe's characteristics distinguished from the effect of PFMT itself?", "needed": "Material identifying training and the added device intervention separately", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Material identifying training and the added device intervention separately", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link direct comparisons by device use and training components separately when available.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text describes a vaginal probe displaying pelvic-floor electrical activity as a training aid. The warning against relabeling training benefit as device benefit is preserved.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The B grade for PFMT itself is not extended to every probe or every form of PFMT.", "missingness": "The B grade for PFMT itself is not extended to every probe or every form of PFMT.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The B grade for PFMT itself is not extended to every probe or every form of PFMT." }, { "item_id": "N06", "question_type": "Comparative efficacy", "question": "To which comparison do randomization and blinding details apply?", "needed": "Records of the selected question's comparator, allocation concealment and outcome-assessment blinding", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Records of the selected question's comparator, allocation concealment and outcome-assessment blinding", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain allocation and measurement procedures together with a direct comparison design for the selected question.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL was a multicenter randomized active-control trial assigning 300 women to each group. Participants and therapists could not be blinded because of the nature of the interventions.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.", "missingness": "These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "These randomized results are not transferred to a comparison of PFMT itself. Allocation concealment and detailed questionnaire measurement procedures are unread." }, { "item_id": "N07", "question_type": "Comparative efficacy", "question": "What does the 24-month ICIQ-UI SF result show about PFMT itself?", "needed": "Baseline, comparator, between-group estimates and scale definitions for PFMT itself", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Baseline, comparator, between-group estimates and scale definitions for PFMT itself", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Preserve between-group effects and CIs on the same scale from a direct comparison of PFMT itself.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL's 24-month scores were 8.2 versus 8.5, comparing added-device treatment with the shared-training group. The original text states that both groups improved.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.", "missingness": "Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Within-group improvement is not converted into an effect size or CI for PFMT itself versus a comparator. Specific changes from baseline are not provided." }, { "item_id": "N08", "question_type": "Comparative efficacy", "question": "Are the added-device mean difference, CI and P value separated from PFMT-itself values?", "needed": "Original effects, intervals and significance results matched to each question", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Original effects, intervals and significance results matched to each question", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain original effects, intervals and analytical denominators from research directly comparing PFMT itself.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The adjusted mean difference of −0.09 points, 95% CI −0.92 to 0.75 and P=0.84 describe the added device effect at 24 months. They are not effect estimates for PFMT itself.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. A mean difference, CI and P value for PFMT itself were not directly established from this material.", "missingness": "A mean difference, CI and P value for PFMT itself were not directly established from this material.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A mean difference, CI and P value for PFMT itself were not directly established from this material." }, { "item_id": "N09", "question_type": "Comparative efficacy", "question": "To which question do the 1.9-point and 2.5-point clinical thresholds apply?", "needed": "Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Clinical-importance thresholds and plans appropriate to the selected comparison, population and duration", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Preserve clinical importance and prespecified plans for a PFMT-itself comparison separately from the subsequent anchor analysis's applicability conditions.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The between-group threshold used for sample-size calculation was 2.5 points. A subsequent anchor analysis using the same OPAL data estimated a two-year minimal important difference of 1.9 points (95% CI 1.1 to 2.7) for conservative treatment. The original text judges that the added-device CI excludes both thresholds.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.", "missingness": "Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exclusion of an added device benefit is not transferred into direct proof that PFMT itself is ineffective or effective. The subsequent anchor analysis is not a new independent efficacy trial." }, { "item_id": "N10", "question_type": "Comparative efficacy", "question": "To which outcome do analytical counts, questionnaire return and missing data apply?", "needed": "Original randomized and outcome-analysis denominators, attrition and missing-data handling", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Original randomized and outcome-analysis denominators, attrition and missing-data handling", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain group-specific reasons and handling of missing questionnaires, sensitivity analyses and denominators for a direct PFMT comparison.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL randomized 600 women, with 225 and 235 in the 24-month primary analysis; the original text records 460. The Korean questionnaire-return wording of about 78% and English attrition wording of about 22% are preserved as originally written.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.", "missingness": "No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new participant totals or percentages are calculated. Denominators, missing-data handling and reasons for missingness for a PFMT-itself comparison are unverified." }, { "item_id": "N11", "question_type": "Comparative efficacy", "question": "Are training adherence, actual exposure and departures distinguished in effect interpretation?", "needed": "Links between actual training exposure, adherence, crossover, departures and outcomes", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Links between actual training exposure, adherence, crossover, departures and outcomes", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link actual exposure, adherence and departure data from the original report and protocol.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The summary states that both groups received supervised training, but this preserved material contains no data on training frequency, adherence, crossover or maintenance over time.", "condition_status": "Unverified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unread material is not interpreted as no adherence or no training effect.", "missingness": "Unread material is not interpreted as no adherence or no training effect.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unread material is not interpreted as no adherence or no training effect." }, { "item_id": "N12", "question_type": "Comparative efficacy", "question": "Are the outcome, time point and analytical hierarchy specified directly for PFMT effects?", "needed": "Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Primary outcome, duration and prespecified analysis plan for a PFMT-itself comparison", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link the registry, protocol, SAP and amendment history of a direct PFMT-itself comparison.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL's original key outcome was ICIQ-UI SF at 24 months, and the evidence record contains registration identifier ISRCTN57746448.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.", "missingness": "The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The source provides no registry URL, and the registry, protocol and SAP have not been newly read. The device comparison's primary-outcome hierarchy is not transferred to PFMT itself." }, { "item_id": "N13", "question_type": "Comparative efficacy", "question": "Are incontinence episodes, quality of life, cure or improvement and symptom scores distinguished?", "needed": "Outcome-specific definitions, denominators, time points and direct-comparison scope", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Outcome-specific definitions, denominators, time points and direct-comparison scope", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link each outcome definition and report from a PFMT-itself comparison separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL summarizes ICIQ-UI SF, Burgio summarizes reductions in incontinence episodes, and Cochrane summarizes quality of life and cure or improvement.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.", "missingness": "Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Different scales or composite responses are not combined as the same value for PFMT itself on 24-month symptoms." }, { "item_id": "N14", "question_type": "Comparative efficacy", "question": "Did Burgio 2002 directly test the selected question?", "needed": "Direct effect evidence with appropriate populations, interventions and comparisons", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Direct effect evidence with appropriate populations, interventions and comparisons", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain original components of each multicomponent program and material directly comparing PFMT.", "current_reports": [ "R02" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Burgio compared three different multicomponent behavioral programs in 222 women with urge or urge-predominant mixed incontinence. Episode reductions were 63.1% versus 69.4% versus 58.6%, P=0.23.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.", "missingness": "Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Those values are not the effect of PFMT itself versus no treatment. Group denominators, CIs and component-specific effects are absent from the summary." }, { "item_id": "N15", "question_type": "Comparative efficacy", "question": "What are the Cochrane review's overall comparison and outcome-specific denominators?", "needed": "Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Eligible review comparisons, outcome-specific trial and participant counts, and overlap lists", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Preserve the review's included-trial table, direct comparisons appropriate to the selected question and overlap mapping.", "current_reports": [ "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The overall PFMT-plus-biofeedback versus PFMT comparison included 33 trials and 3,031 women. Quality of life included 11 trials and 1,169 women; cure or improvement included 14 trials and 1,383 women.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.", "missingness": "The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The 33 trials are not relabeled as direct trials of training versus no training or independent replications. Outcome-specific participant counts are not added together." }, { "item_id": "N16", "question_type": "Comparative efficacy", "question": "Do the review's effects and CIs concern PFMT itself?", "needed": "Original effects and CIs by outcome for comparisons appropriate to the selected question", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Original effects and CIs by outcome for comparisons appropriate to the selected question", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain outcome-specific effects and CIs, heterogeneity and analysis plans for PFMT-itself comparisons.", "current_reports": [ "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Quality-of-life SMD −0.07 (95% CI −0.18 to 0.05) and cure-or-improvement OR 1.26 (95% CI 1.00 to 1.58) concern added feedback. The original text records that the OR's lower bound of 1.00 prevents a conclusive characterization as either null or beneficial.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review effects are not transferred to PFMT itself or treated as a confirmed null effect.", "missingness": "The review effects are not transferred to PFMT itself or treated as a confirmed null effect.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The review effects are not transferred to PFMT itself or treated as a confirmed null effect." }, { "item_id": "N17", "question_type": "Comparative efficacy", "question": "Are the same reports and OPAL data kept from being counted as independent replications?", "needed": "Study-family links between original trials, subsequent analyses and reviews", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Study-family links between original trials, subsequent analyses and reviews", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link identifiers for original trials, subsequent analyses and reviews containing them without newly certifying independence.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The OPAL summary and subsequent clinical-importance anchor analysis using the same data are preserved within one trial context. The original text did not count Burgio or Cochrane as independent replications of the same claim because their populations and comparisons differ.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.", "missingness": "Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Overlap between review trials and individual reports is unread externally. Final unique-trial and participant totals are not established." }, { "item_id": "N18", "question_type": "Comparative efficacy", "question": "Are sufficient direct sources linked for PFMT itself?", "needed": "Separate direct sources and effect scope corresponding to the subclaim's B grade", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Separate direct sources and effect scope corresponding to the subclaim's B grade", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "If existing direct sources for PFMT itself are provided, link their population, comparator and outcome scope separately.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The subclaim's B grade is preserved as an original value, but the original text explicitly says that it is not the target of this device comparison. The three current references concern added devices or other behavioral-training contexts.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No separate direct material to newly establish the B grade for PFMT itself was searched during this production.", "missingness": "No separate direct material to newly establish the B grade for PFMT itself was searched during this production.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No separate direct material to newly establish the B grade for PFMT itself was searched during this production." }, { "item_id": "N19", "question_type": "Comparative efficacy", "question": "Is the result applied to other incontinence types or women unable to contract?", "needed": "Direct comparisons and denominators appropriate to population subgroups", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Direct comparisons and denominators appropriate to population subgroups", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Direct comparisons by incontinence type and baseline contraction ability are needed.", "current_reports": [ "R01", "R02" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "OPAL's exclusions of women unable to contract and urgency-only incontinence are preserved. The original text does not rule out a role in helping women first learn to contract.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.", "missingness": "Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Possible learning support is not turned into established efficacy, and studies of other types are not transferred unchanged." }, { "item_id": "N20", "question_type": "Comparative efficacy", "question": "Is training benefit extended to long-term clinical function or every product?", "needed": "Direct evidence for the selected symptoms and function- or product-specific applications", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Direct evidence for the selected symptoms and function- or product-specific applications", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link direct comparisons appropriate to each outcome, product and time point separately when available.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The selected claim concerns PFMT itself, while the parent material concerns urinary-incontinence symptoms at 24 months. Product advertising scope is separately cautioned about.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new efficacy or instructions are created for other clinical functions, products, apps or devices.", "missingness": "No new efficacy or instructions are created for other clinical functions, products, apps or devices.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new efficacy or instructions are created for other clinical functions, products, apps or devices." }, { "item_id": "N21", "question_type": "Comparative efficacy", "question": "Are public funding and sponsorship distinguished from the manufacturer's four roles?", "needed": "Separate records of cash funding, free equipment, employed authors and outsourced analysis", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Separate records of cash funding, free equipment, employed authors and outsourced analysis", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain original disclosures for funding, equipment provision, affiliations and analytical roles separately.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Full funding by NIHR HTA project 11/71/03 and sponsorship by Glasgow Caledonian University are stated. The original text records manufacturer cash funding, free equipment, employed authors and outsourced analysis as unverified.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.", "missingness": "Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unverified relationships are not converted into certification that all were absent or that independence was established. Funding structures for PFMT-itself evidence are separately unverified." }, { "item_id": "N22", "question_type": "Comparative efficacy", "question": "Are Burgio and review funding details kept separate from another trial's funding?", "needed": "Separate funding, investigator and comparison identities for each source", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Separate funding, investigator and comparison identities for each source", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link each report's original disclosures and funding mapping for its included trials.", "current_reports": [ "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Burgio's evidence record lists US NIA/NIH, and the review is recorded as a Cochrane review. Both are preserved separately from OPAL's public funding.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.", "missingness": "The review's funding wording alone does not establish manufacturer involvement or independence of its included trials.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The review's funding wording alone does not establish manufacturer involvement or independence of its included trials." }, { "item_id": "N23", "question_type": "Supplementary harm evidence", "question": "To which intervention do participant counts and relatedness of adverse events belong?", "needed": "Group-specific harm definitions, exposure, denominators, collection procedures and original event data", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Group-specific harm definitions, exposure, denominators, collection procedures and original event data", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Obtain original safety tables and group-specific events and relatedness, distinguishing training from the probe.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The original safety text records 48 participants reporting non-serious adverse events, with events in 23 judged related or possibly related to the intervention. Probe-associated discomfort and bleeding are recorded.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.", "missingness": "The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The 48 and 23 are not converted into event counts or harm rates for PFMT itself. Group-specific harm denominators and event tables are unread." }, { "item_id": "N24", "question_type": "Supplementary harm evidence", "question": "Are serious related complications distinguished from gaps in long-term and rare harms?", "needed": "Adequate observations by severity, relatedness, follow-up and rare harms", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Adequate observations by severity, relatedness, follow-up and rare harms", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Link original group-specific serious events, long-term follow-up, rare harms and reasons for discontinuation.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The original text records no serious related complications, and the parent's safety label is Caution.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.", "missingness": "No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No reported serious related complications is not extended to no serious events of any kind or established safety of PFMT itself." }, { "item_id": "N25", "question_type": "Supplementary harm evidence", "question": "Is material available to separately replicate and verify harms of training and the probe?", "needed": "Exposure, comparator and replicated harm evidence appropriate to PFMT itself", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Exposure, comparator and replicated harm evidence appropriate to PFMT itself", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "Harm data distinguishing training from probe exposure and follow-up of sufficient duration are needed.", "current_reports": [ "R01" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "Currently preserved harm information summarizes an active-control trial of an added device. Separate repeated harm evidence for PFMT itself is not provided.", "condition_status": "Unverified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.", "missingness": "Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Device-related discomfort and bleeding are not transferred to PFMT-itself harms. No new certification of replicated harms is performed." }, { "item_id": "N26", "question_type": "Comparative efficacy", "question": "Are stored-summary reading and unread external sources distinguished?", "needed": "Individual access records for summaries, papers, reviews, registries, protocols and SAPs", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Individual access records for summaries, papers, reviews, registries, protocols and SAPs", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "If obtained original material is provided, link actual access and evidence for the relevant question separately for each source.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The entire parent JSON, including Korean and English text, evidence, citations and subclaims, was read for production. The three bibliographic URLs were linked as originally recorded; external material was not opened.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.", "missingness": "Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Having a URL does not upgrade an abstract, full text, registry, protocol or SAP to having been read during this work." }, { "item_id": "N27", "question_type": "Comparative efficacy", "question": "Are dates, corrections, Korean and English text and original-verdict history preserved?", "needed": "Unchanged preservation of original values, language-specific wording, dates and corrections", "role": "Required", "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Unchanged preservation of original values, language-specific wording, dates and corrections", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "If additional material arises, preserve the original text and link a separate update event to review of the existing content.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The entire source copy preserves the original date 2026-08-26, an empty corrections array, Korean and English text, parent grade D with 34 points and Caution with its assessment axes, and subclaim grade B.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.", "missingness": "No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No new-date verification, clinical-grade change or correction-target check was performed. This production date is not a new evidence date." }, { "item_id": "N28", "question_type": "Comparative efficacy", "question": "Is current production distinguished from independence or completed content review?", "needed": "Separate records of produced files, candidate history and existing-content review status", "role": "Supplementary", "role_reason": "Supplementary condition separating production status and scope of application", "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.", "criterion": "Separate records of produced files, candidate history and existing-content review status", "basis": "Benefit of PFMT itself", "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition", "proposed_research": "After content review, reflect only provided decisions and material in a separate event.", "current_reports": [ "R01", "R02", "R03" ], "existence": "Material information linked to the stored summary", "acquired_read": "Summary read; external materials not read", "observation": "The original candidate's need for boundary review and production-eligibility values are preserved as history. Existing content review remains incomplete, and model, content and boundary review activation and completion flags are false.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material and review of the existing content remain outstanding. Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.", "missingness": "Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded.", "uncertainty": "Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Production itself is neither clinical certification of the subclaim's B grade or independence nor completed review. No structural unit was added, and the final independent count remains unrecorded." } ], "reports": [ { "report_id": "R01", "title": "Hagen S, Bugge C, Dean SG, et al. BMJ. 2020;371:m3719. PMID: 33055247.", "url": "https://pubmed.ncbi.nlm.nih.gov/33055247/", "report_type": "Trial report", "existence": "Identifiers preserved in the original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F01", "independent_replication": false, "observed_result": "8.2 versus 8.5; adjusted difference −0.09 (95% CI −0.92 to 0.75), P=0.84", "result_level": "Preserved review summary; not a result of actually reading external papers or communications", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent summary" }, { "material_type": "External abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "External full text or regulatory source", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Registration material", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Protocol and statistical analysis plan", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/33055247/" } ] }, { "report_id": "R02", "title": "Burgio KL, et al. JAMA. 2002;288:2293-2299. PMID: 12425706.", "url": "https://pubmed.ncbi.nlm.nih.gov/12425706/", "report_type": "Trial report", "existence": "Identifiers preserved in the original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F02", "independent_replication": false, "observed_result": "63.1% versus 69.4% versus 58.6%, P=0.23", "result_level": "Preserved review summary; not a result of actually reading external papers or communications", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent summary" }, { "material_type": "External abstract", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "External full text or regulatory source", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Registration material", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Protocol and statistical analysis plan", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/12425706/" } ] }, { "report_id": "R03", "title": "Fernandes ACNL, et al. Cochrane Database Syst Rev. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women.", "url": "https://www.cochrane.org/evidence/CD009252_exercise-pelvic-floor-muscles-more-effective-treating-unintentional-passing-urine-incontinence-women", "report_type": "Systematic review", "existence": "Identifiers preserved in the original citation and evidence lists", "acquired_read": "Summary read; external materials not read", "study_family": "F03", "independent_replication": false, "observed_result": "Quality of life: 11 trials, 1,169 women, SMD −0.07 (95% CI −0.18 to 0.05); cure or improvement: 14 trials, 1,383 women, OR 1.26 (95% CI 1.00 to 1.58)", "result_level": "Preserved review summary; not a result of actually reading external papers or communications", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Original source link preserved", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Preserved parent summary" }, { "material_type": "External abstract", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "External full text or regulatory source", "public_status": "Original source link preserved", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Registration material", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" }, { "material_type": "Protocol and statistical analysis plan", "public_status": "No separate URL in the original material", "access_status": "Not read", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "External material unread; the presence or absence of a URL does not mean material acquisition or completed review" } ], "links": [ { "label": "Official source", "url": "https://www.cochrane.org/evidence/CD009252_exercise-pelvic-floor-muscles-more-effective-treating-unintentional-passing-urine-incontinence-women" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "OPAL: a subsequent anchor analysis of the same trial is not counted as another trial; Burgio 2002: different population and multicomponent behavioral comparisons; Cochrane review: included-trial overlap and the list of direct PFMT comparisons are unread; reports, reviews, reanalyses and the same population are not summed as new independent trials or participants. Family identifiers link relationships and do not certify unique-trial counts." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-11" }