# Ad libitum low-fat vegan composite diet × Superior weight loss versus another healthful diet — Comparator-specific evidence checklist

Verdict 2946 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-11

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: The original sixteen-week population of overweight adults, the seventy-four-week type 2 diabetes population, and NEW Soul's African American population are distinguished; detailed eligibility remains unread
- Ingredient, formulation and route: Historical study intervention using an ad libitum low-fat vegan composite diet; this does not establish individual-component effects or provide dietary instructions for readers
- Dose: Original sixteen-week dietary education, weekly classes and support, and no food or supplement provision are preserved as history; detailed actual intake and calories remain unverified
- Comparator: The seventy-four-week conventional diabetes diet and twelve-month low-fat omnivorous soul food comparisons are separated; the sixteen-week trial had a no-change control
- Measured outcome: Selected superiority in weight loss versus active healthy diets; endpoint, nonsignificance, and equivalence boundaries are retained
- Duration: Active comparisons at seventy-four weeks and twelve months; detailed evidence for an active comparison in the same original sixteen-week population remains a gap
- Questions outside this scope: Transferring the sixteen-week no-change effect to superiority over all active healthy diets; Confirming effects of individual components, all vegan diets, or all healthy diets; Certifying zero for all differences or equivalence from nonsignificance; Extending results to long-term maintenance, disease, death, or diabetes treatment; Diet, weight-loss, exercise, medication-change, or treatment instructions

## Checklist items

### N01 · Are the selected superiority claim against active healthy diets and the parent's no-change effect separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original subclaim is ‘Superior weight loss versus another healthful diet’, with original grade D and a note of 74-week diabetes-diet trial P=0.25. The parent is C, 54, Caution.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
- Reason for missing information: Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
- Required materials and conditions: Separate records of the selected wording, grade, note, and parent comparison
- Materials to obtain first: Absent subclaim score, status, and assessment axes are not filled with parent values. Null effects across all other healthy diets are not newly certified.
- Further research: If additional materials are provided, distinguish and connect results matched to comparator, population, and duration.
- Conditions for verification: Separate records of the selected wording, grade, note, and parent comparison
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02, R03

### N02 · Which diets were actually meant by the comparator ‘another healthful diet’?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original active controls were a conventional diabetes diet over 74 weeks and NEW Soul's low-fat omnivorous soul food diet.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
- Reason for missing information: All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
- Required materials and conditions: Composition, education, exposure, support, and denominators for a specific active diet
- Materials to obtain first: All other healthy diets are not treated as one identical comparator. Detailed composition, exposure, and education for each diet remain unread.
- Further research: Obtain original descriptions, common management, and actual intake materials for each active diet.
- Conditions for verification: Composition, education, exposure, support, and denominators for a specific active diet
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02, R03

### N03 · Was the actual control in the sixteen-week trial an active healthy diet?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The 16-week trial of 244 participants compared 122 assigned to a vegan diet with 122 assigned to no diet change.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
- Reason for missing information: The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
- Required materials and conditions: Identity of the control and direct comparison in the relevant sixteen-week trial
- Materials to obtain first: The direct −5.9kg result does not fill the gap in superiority over another healthy diet in the same population at sixteen weeks.
- Further research: If materials on a specific active healthy-diet control in the same population and duration are provided, connect them separately.
- Conditions for verification: Identity of the control and direct comparison in the relevant sixteen-week trial
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01

### N04 · What were the population and denominators for the seventy-four-week diabetes-diet comparison?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The 74-week trial is recorded as randomizing 99 participants with type 2 diabetes.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
- Reason for missing information: This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
- Required materials and conditions: Type 2 diabetes population, eligibility, and group allocation and analysis denominators
- Materials to obtain first: This is not transferred to the same population as general overweight adults. Eligibility, group allocation and analysis, baseline weight, and treatment details remain unread.
- Further research: Obtain original eligibility, baseline status, group denominators, and concomitant-treatment tables.
- Conditions for verification: Type 2 diabetes population, eligibility, and group allocation and analysis denominators
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02

### N05 · What were the composite components and accompanying management of the seventy-four-week intervention and control?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original study design was a randomized trial of a low-fat vegan diet versus a conventional diabetes diet.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
- Reason for missing information: Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
- Required materials and conditions: Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment
- Materials to obtain first: Calories, nutritional composition, attention, support, and medication changes are not newly assumed equal between groups. No dietary or medication instructions are created.
- Further research: Obtain records of each composite diet's composition, actual intake, contact, and concomitant treatment.
- Conditions for verification: Original records of low-fat vegan and conventional diabetes diets, education, and concomitant treatment
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02

### N06 · Are the seventy-four-week weight results and gaps in the between-group effect preserved?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: At 74 weeks, weight changes were −4.4kg with the vegan diet versus −3.0kg with a conventional diabetes diet, between-group P=0.25.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
- Reason for missing information: No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
- Required materials and conditions: Group changes, between-group effect, CI, testing, and denominators
- Materials to obtain first: No new mean difference, CI, quantitative response, or NNT is calculated. The original between-group effect, CI, analysis model, and denominators are absent from the summary.
- Further research: Obtain the original effect, interval, model, denominators, and weight-measurement methods.
- Conditions for verification: Group changes, between-group effect, CI, testing, and denominators
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02

### N07 · Are seventy-four-week follow-up, attrition, ITT, and missing-data details directly verified?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The 74-week duration and 99 randomized participants are preserved.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
- Reason for missing information: Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
- Required materials and conditions: Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure
- Materials to obtain first: Wording about 222 completers, repeated measures, and ITT including all participants concerns the sixteen-week trial and is not transferred to seventy-four weeks.
- Further research: Obtain original participant flow, missing-data handling, analysis populations, and adherence materials for the seventy-four-week trial.
- Conditions for verification: Group follow-up, analysis populations, reasons for missing data, sensitivity, and actual exposure
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02

### N08 · What were NEW Soul's actual population and application boundaries?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The NEW Soul bibliography specifies African Americans and records 159 randomized participants.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
- Reason for missing information: Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
- Required materials and conditions: Original materials on recruitment, baseline status, group denominators, and existing diet
- Materials to obtain first: Detailed eligibility, including age, BMI, and comorbidities, remains unread. Results are not newly extended to all overweight adults or all regions.
- Further research: Obtain original recruitment, eligibility, baseline status, and group denominators.
- Conditions for verification: Original materials on recruitment, baseline status, group denominators, and existing diet
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R03

### N09 · What were the actual vegan and low-fat omnivorous soul food diets compared in NEW Soul?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original study design was a randomized active-control trial of vegan versus low-fat omnivorous soul food diets.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
- Reason for missing information: Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
- Required materials and conditions: Composition, exposure, education, support, and accompanying management for the two composite diets
- Materials to obtain first: Results are not generalized to all vegan diets or all omnivorous healthy diets, and the sixteen-week diet composition is not copied unchanged.
- Further research: Obtain NEW Soul's original diet composition, contact, support, actual intake, and adherence.
- Conditions for verification: Composition, exposure, education, support, and accompanying management for the two composite diets
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R03

### N10 · Is NEW Soul's twelve-month primary weight result preserved as recorded?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: At 12 months, primary weight changes were −2.39kg with the vegan diet versus −2.03kg with the low-fat omnivorous diet, between-group P=.64.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
- Reason for missing information: No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
- Required materials and conditions: Primary outcome, group changes, original between-group effect, CI, and testing
- Materials to obtain first: No new mean difference, response count, CI, or equivalence verdict is created. Group analysis denominators, original CI, and model remain unread.
- Further research: Obtain the original primary-outcome plan, group denominators, effect, CI, and measurement materials.
- Conditions for verification: Primary outcome, group changes, original between-group effect, CI, and testing
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R03

### N11 · Are NEW Soul's long-term follow-up, denominators, and missing-data details directly presented?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The original materials record 159 randomized participants and 12-month results.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
- Reason for missing information: The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
- Required materials and conditions: Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
- Materials to obtain first: The 159 randomized participants are not confirmed as the analysis denominator for every twelve-month result, and the sixteen-week 91.0% completion rate is not transferred.
- Further research: Obtain original participant flow, group missing data, ITT, analysis populations, and adherence materials.
- Conditions for verification: Records of allocation, twelve-month observations, ITT, attrition, missing data, and sensitivity
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R03

### N12 · Are nonsignificant P values in active comparisons distinguished from limits on superiority and equivalence?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The stored summary records that 74-week P=0.25 and NEW Soul P=.64 did not show superiority over active controls.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
- Reason for missing information: Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
- Required materials and conditions: Effect, CI, importance, and prespecified superiority or equivalence plans
- Materials to obtain first: Without CI, thresholds, or an equivalence design, zero for every difference or equivalence with all healthy diets is not newly confirmed.
- Further research: Connect the relevant comparison scope when the original CI, testing plan, and importance threshold are provided.
- Conditions for verification: Effect, CI, importance, and prespecified superiority or equivalence plans
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02, R03

### N13 · Does the direct-evidence gap remain for an active control with matching population, duration, and support?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The current active comparisons concern type 2 diabetes at 74 weeks and NEW Soul at 12 months; their populations, durations, and controls differ from the 16-week no-change trial.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
- Reason for missing information: Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
- Required materials and conditions: Direct materials with an active control, population, and duration matching the original sixteen-week question
- Materials to obtain first: Existing active comparisons are not erased as nonexistent, but a direct comparison matching the original sixteen-week conditions is not newly confirmed.
- Further research: Direct materials for a specific active healthy-diet comparison with matched population, duration, education, and attention are needed.
- Conditions for verification: Direct materials with an active control, population, and duration matching the original sixteen-week question
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N14 · Are the large no-change effect and active comparisons preserved separately?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original 16-week values are retained: vegan −6.4kg versus no change −0.5kg, treatment effect −5.9kg (95% CI −6.8~−5.0), group×time P<0.001.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
- Reason for missing information: These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
- Required materials and conditions: Effect, interval, testing, time point, and denominators for each comparison
- Materials to obtain first: These are not transferred to a mean difference or CI versus an active healthy diet. The original verdict that sixteen-week E+ was unchanged because the comparator differed is retained.
- Further research: Connect each comparison's original model, effect, interval, population, and duration separately.
- Conditions for verification: Effect, interval, testing, time point, and denominators for each comparison
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01

### N15 · Are common education, attention, and calorie conditions in the sixteen-week trial distinguished from active comparisons?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The 16-week vegan group received weekly classes and support; food and supplements were not provided. Ad libitum meant no prescribed calorie restriction.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
- Reason for missing information: Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
- Required materials and conditions: Original group materials on education, contact, support, actual calories, and exposure
- Materials to obtain first: Education differences in the sixteen-week trial are not ignored or copied as identical conditions across all active comparisons. Equal actual calories or an independent mechanism is not newly asserted.
- Further research: Obtain education, attention, calories, intake, and accompanying-exposure materials for each trial separately.
- Conditions for verification: Original group materials on education, contact, support, actual calories, and exposure
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N16 · What was the original scope of open dietary allocation, masking, and measurement procedures?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The stored summary records the 16-week trial as open-label and parallel-group, with infeasible participant masking and calibrated-scale measurement.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
- Reason for missing information: These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
- Required materials and conditions: Original trial-specific materials on allocation concealment, masking, assessors, and analysts
- Materials to obtain first: These details are not transferred to allocation and measurement procedures in the seventy-four-week trial or NEW Soul. The parent's B0 is historical.
- Further research: Obtain original allocation, concealment, measurement, and analysis procedures for each active-comparison trial.
- Conditions for verification: Original trial-specific materials on allocation concealment, masking, assessors, and analysts
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N17 · Are prespecified endpoint hierarchies, multiple outcomes, and testing plans separated by trial?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The record quotes multiple primary outcomes including weight for the 16-week trial and primary 12-month weight for NEW Soul.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
- Reason for missing information: The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
- Required materials and conditions: Trial-specific registration, protocol, SAP, multiplicity, and change records
- Materials to obtain first: The seventy-four-week weight hierarchy or multiplicity adjustment in active comparisons is not invented. The sixteen-week coprimary split is preserved as its original false value.
- Further research: Obtain each trial's original registration, protocol, SAP, change history, and outcome hierarchy.
- Conditions for verification: Trial-specific registration, protocol, SAP, multiplicity, and change records
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N18 · Are results for weight, body composition, lipids, insulin, and mechanisms separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original 16-week bibliography includes insulin sensitivity, metabolism, and intracellular lipids; NEW Soul's bibliography includes weight and lipids.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
- Reason for missing information: Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
- Required materials and conditions: Actual measurements, effects, denominators, and prespecified plans for each measure
- Materials to obtain first: Original weight values are not copied as effects on other measures, body composition, or mechanisms. Those numerical results are not invented in this stored summary.
- Further research: Obtain original measurements, effect, CI, and denominators for each measure separately.
- Conditions for verification: Actual measurements, effects, denominators, and prespecified plans for each measure
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R03

### N19 · Were results kept from being extended to long-term maintenance, disease, death, or diabetes treatment?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The parent explicitly identifies long-term maintenance, clinical events, and superiority over another healthy diet as separate questions. Weight results at 74 weeks and 12 months concern those durations.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
- Reason for missing information: Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
- Required materials and conditions: Long-term direct materials separated by endpoint, population, and duration
- Materials to obtain first: Some longer durations are not extended to benefits or null effects for all long-term maintenance, disease, death, or treatment outcomes.
- Further research: Connect direct follow-up, effects, and denominators for each long-term question separately.
- Conditions for verification: Long-term direct materials separated by endpoint, population, and duration
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N20 · Are shared bibliography, trials, populations, and sibling sheets preserved?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The two subclaim sheets share three reports and registration identifiers. The original 16-week single-trial, R1, and mixed-independence wording belongs to parent history.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
- Reason for missing information: Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
- Required materials and conditions: Study-family connections among reports, original trials, the same populations, endpoints, and time points
- Materials to obtain first: Two sheets, multiple endpoints, and long-term measurements are not added up as unique trials, total participants, or new independent replication.
- Further research: Connect additional reports to existing identifiers without confirming a final independent count.
- Conditions for verification: Study-family connections among reports, original trials, the same populations, endpoints, and time points
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N21 · Are PCRM, public funding, and authors who were advocacy-organization officers preserved for the sixteen-week trial?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: PCRM, Yale, and NIH funding and participation by PCRM clinical-research director Kahleova and president Barnard are preserved. PCRM advocates the study diet.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
- Reason for missing information: Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
- Required materials and conditions: Records of each funder, organizational affiliation, provision, analysis, and writing role
- Materials to obtain first: Public support alone is not described as confirming independence, and organizational officers are not newly classified as pharmaceutical-manufacturer employees.
- Further research: Obtain original support, affiliation, design, analysis, writing, and data-access disclosures separately.
- Conditions for verification: Records of each funder, organizational affiliation, provision, analysis, and writing role
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01

### N22 · Are gaps in support, provision, authors, and external analysis kept separate for active-comparison trials?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: Funding information for the 74-week trial records NIH R01 DK059362 and other support; NEW Soul is recorded as ‘Reported trial funding’.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
- Reason for missing information: No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
- Required materials and conditions: Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
- Materials to obtain first: No food provision and PCRM disclosures in the sixteen-week trial are not copied to other trials, and vague funding is not filled as absent or public. External analysis services also remain unverified.
- Further research: Obtain original support, provision, affiliation, and analysis disclosures for each active-comparison trial.
- Conditions for verification: Trial-specific records of monetary support, products, affiliated authors, and external analysis roles
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02, R03

### N23 · Are there direct comparative safety materials between active controls?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The original materials record that the 16-week trial did not report a prespecified primary safety outcome or between-group adverse-event table.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
- Reason for missing information: This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
- Required materials and conditions: Group harm definitions, collection, events, exposure, denominators, and plans
- Materials to obtain first: This non-reporting wording is not copied to all harm results in the two active-comparison trials. Detailed harm tables for the selected comparisons remain unread.
- Further research: Obtain original harm collection, group events, exposure, denominators, and discontinuation materials for each active-comparison trial.
- Conditions for verification: Group harm definitions, collection, events, exposure, denominators, and plans
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N24 · Are gaps in long-term exposure, rare harms, and discontinuation retained?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The original active-comparison durations were 74 weeks and 12 months. The parent's safety status is preserved as Caution.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
- Reason for missing information: Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
- Required materials and conditions: Actual exposure, discontinuation, serious events, and long-term follow-up by duration
- Materials to obtain first: Duration alone does not confirm long-term safety. Counts, rates, severity, or CIs for nutritional harms absent from the original text are not generated.
- Further research: Original group harm and discontinuation materials with actual exposure and sufficient duration for each diet are needed.
- Conditions for verification: Actual exposure, discontinuation, serious events, and long-term follow-up by duration
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R02, R03

### N25 · Are special populations, concomitant treatment, replication of harms, and application scope distinguished?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The original safety context includes pregnancy, breastfeeding, eating disorders, and people undergoing medication treatment.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
- Reason for missing information: No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
- Required materials and conditions: Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
- Materials to obtain first: No new instructions for diet or treatment changes are created for them, and direct effects or replication of harms in those populations are not confirmed.
- Further research: If direct materials for those populations are provided, connect original trials, exposure, and denominators separately.
- Conditions for verification: Population-specific direct comparisons, harms, concomitant treatment, and independent-report relationships
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N26 · Is actual access to external papers, registrations, protocols, and SAPs recorded separately?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The three PubMed URLs and NCT02939638, NCT00276939, and NCT03354377 are connected as recorded, and the summary was read for production.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
- Reason for missing information: No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
- Required materials and conditions: Original links, identifiers, stored summaries, and actual access records for each material
- Materials to obtain first: No new URL is constructed from an identifier; external abstracts, full texts, registrations, protocols, and SAPs remain unread. No separate external-link checks were performed.
- Further research: Connect only materials obtained by the user, with separate type and access status.
- Conditions for verification: Original links, identifiers, stored summaries, and actual access records for each material
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N27 · Are original dates, Korean and English text, corrections, axes, empty values, and subclaim D preserved?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The reference date 2026-08-26, an empty corrections array, an empty deliberation string, Korean and English text, parent C54, Caution, original assessment axes, and subclaim D are preserved.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
- Reason for missing information: Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
- Required materials and conditions: Separate preservation of the full parent stored summary, selected record, languages, and historical values
- Materials to obtain first: Absent subclaim values are not filled with the parent score. Historical cross-checking is not described as completed review here.
- Further research: Connect new materials or decisions through preservation of original text and separate events.
- Conditions for verification: Separate preservation of the full parent stored summary, selected record, languages, and historical values
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

### N28 · Are original content-review status, existing candidate history, and production completion separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: Existing candidate pending and production-eligibility markers and boundary requirements are preserved as history, while the current marker indicates incomplete original content review. Active pending and completion flags for model, content, and boundary review are false.
- Why unverified: Only the relevant information from the stored summary is recorded; detailed original materials remain unread and the original content review is incomplete. There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded.
- Reason for missing information: There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded.
- Required materials and conditions: Records of historical candidate values and current production and review status
- Materials to obtain first: There is no new main claim, split, or independent certification; additional units are 0 and the final independent count is not recorded.
- Further research: Reflect only user-provided decisions and materials as separate events.
- Conditions for verification: Records of historical candidate values and current production and review status
- Why this condition is needed: An individual production condition recording original values, direct comparisons and application boundaries for the selected question
- Application exceptions: Unread external materials, different comparisons or out-of-scope results do not substitute for fulfilled conditions, zero effect or safety.
- Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
- Referenced methods: Superior weight loss versus another healthful diet
- Related sources: R01, R02, R03

## Evidence and sources

### R01

Kahleova H, Petersen KF, Shulman GI, et al. Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults. JAMA Netw Open. 2020;3:e2025454. PMID: 33252690.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/33252690/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: −6.4 kg versus −0.5 kg; treatment effect −5.9 kg (95% CI −6.8~−5.0), group×time P<0.001  
Record level: Stored review summary; not a result of directly reading the original paper or registration  
Independent replication: NCT02939638 is a sixteen-week no-change-control trial whose report is shared by two subclaims. NCT00276939 is a seventy-four-week active diabetes-diet comparison in a different population and duration. NCT03354377 NEW Soul is a twelve-month active comparison whose report is shared by two subclaims. Report relationships do not certify a unique-trial count; reports, subclaims, and participants are not newly added up as independent materials.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary |
| abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |

### R02

Barnard ND, Cohen J, Jenkins DJA, et al. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009. PMID: 19339401.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/19339401/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: −4.4 kg versus −3.0 kg, between-group P=0.25  
Record level: Stored review summary; not a result of directly reading the original paper or registration  
Independent replication: NCT02939638 is a sixteen-week no-change-control trial whose report is shared by two subclaims. NCT00276939 is a seventy-four-week active diabetes-diet comparison in a different population and duration. NCT03354377 NEW Soul is a twelve-month active comparison whose report is shared by two subclaims. Report relationships do not certify a unique-trial count; reports, subclaims, and participants are not newly added up as independent materials.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary |
| abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |

### R03

Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African Americans. PMID: 36633848. NCT03354377.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/36633848/)

Materials actually read: Summary read; external materials not read  
Findings recorded in the summary: −2.39 kg versus −2.03 kg, between-group P=.64  
Record level: Stored review summary; not a result of directly reading the original paper or registration  
Independent replication: NCT02939638 is a sixteen-week no-change-control trial whose report is shared by two subclaims. NCT00276939 is a seventy-four-week active diabetes-diet comparison in a different population and duration. NCT03354377 NEW Soul is a twelve-month active comparison whose report is shared by two subclaims. Report relationships do not certify a unique-trial count; reports, subclaims, and participants are not newly added up as independent materials.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| local_summary | Original source link preserved | Summary read | Summary read | Preserved parent verdict summary |
| abstract | Original source link preserved | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| fulltext | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| registration | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |
| protocol_sap | No separate URL in the original material | Not read | Not read | External material unread; a URL does not mean acquisition, reading or completed review |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

## What the statuses mean

- 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

## Change history

2026-10-11 · Public page/materials 1.0. Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed.
