| 1 |
Met |
Full text not readStored summary read |
N01 · Claim and boundaries of the independent questionWhich adults, oral intervention and recurrent-stone event does this table address?Required |
The current claim concerns change in symptomatic new-stone recurrence in adults with a confirmed history of calcium-oxalate stones. The question compares added single-ingredient pure oral L-ascorbic acid with no addition, placebo or matched care. The actual dose, duration and direct comparative values are unverified. |
The original claim's identity and exclusion boundaries have been linked. Met does not mean that an eligible trial or a recurrence effect has been verified. |
The original /ko/effect and question specifications for population, ingredient, route, event, comparison and time |
Subsequent research should define symptomatic new calcium-oxalate stone recurrence as the main outcome and report imaging-only events, residual-stone growth and first incident stones separately. |
| 2 |
Met |
Full text not readStored summary read |
N02 · Reference date and reading scopeWhat materials were actually read this time, and what are the historical access records?Required |
The retained evidence through 2026-09-16 was transformed on 2026-10-05. The 17 Korean fields, designated structure and 17 sources/bibliographic entries were actually read in that work. Reading S01's 6-page PDF, part of S10 on p.1563 and official documents is recorded in the historical manuscript; all external materials remain unread this time. |
Current summary reading and historical access levels have been separated by material. No new searches or reading of original full texts or old separate logs were performed. |
The retained summary's evidence cutoff, access records for each source, locations actually read in the current work and file SHA |
For subsequent material verification, separately record material type, version, access attempts, sections actually read and the SHA of acquired files, and cross-check them against historical summaries. |
| 3 |
Met |
Full text not readStored summary read |
N03 · Reports and study familiesHave the 17 reports been kept from being double-counted as independent recurrence trials?Required |
The 17 sources are linked to the 10 families in the retained ledger. S04 and S17 were grouped in F04 because of possible but unresolved overlap. S08's 3 cohorts, reviews and cited material are not added as other independent recurrence trials. The count of 0 verified eligible comparisons pertains to the scope at that time. |
The distinctions among reports, families and reviews have been preserved. This is not exhaustive confirmation of the number of unique studies or participants. |
A mapping of each report's source_id to study family, cohort, endpoint and repeat citations |
Create an overlap ledger that cross-checks original participant recruitment, registration, study locations and timing to verify Chai/Massey overlap and cohort reuse. |
| 4 |
Met |
Full text not readStored summary read |
N04 · Ingredient, formulation and routeHas the question's pure oral L-ascorbic acid been distinguished from other forms?Required |
The question concerns single-ingredient pure oral L-ascorbic acid. Sodium/calcium ascorbate, foods/juice, combination products and intravenous injections are excluded. This boundary does not mean that an actual eligible study product has been verified. |
The question boundaries between the pure oral preparation and other exposures have been preserved. Directly eligible product verification remains unverified under the next criterion. |
Product ingredient list, L isomer, salts, single/combined ingredients and actual administration route |
Subsequent comparisons should verify batch-specific ingredients, salts/isomers, added ingredients and administration routes, distinguishing them from food/injection exposures. |
| 5 |
Unverified |
Full text not readStored summary read |
N05 · Actual product identityHave the product, source and single-ingredient status of a directly eligible recurrence study been verified?Required |
The product and manufacturing source for a directly eligible recurrence comparison are unverified. S01 also records that single-ingredient L-isomer purity, product and source could not be established. |
The current retained scope lacks material to verify the question's pure oral L formulation as the actual trial product. |
Product, batch, manufacturing source, purity, ingredient list and original methods for a direct recurrence comparison |
Design research linking product analysis or verifiable ingredient lists to the actual comparison groups and administration records. |
| 6 |
Unverified |
Full text not readStored summary read |
N06 · Population and stone historyIs this direct evidence about adults with a confirmed history of calcium-oxalate stones?Required |
The question's population is adults with a confirmed history of calcium-oxalate stones. S01 concerns alkaline urine and mixed stones, while S02 is a short-term metabolic study in calcium-oxalate stone formers. Comparative symptomatic-recurrence values matching this population have not been verified. |
Although related human data exist, a direct result meeting the population, endpoint and comparison criteria together remains unverified. |
Age, prior stone diagnosis/composition, recurrence history, baseline status and inclusion/exclusion table |
Analyze prior stone composition and verify history before recruitment, reporting data for adults with a calcium-oxalate stone history separately from other compositions. |
| 7 |
Partly verified |
Full text not readStored summary read |
N07 · S01 selection and composition denominatorsHow are S01's 43 identified, 24 included and 17 composition-verified participants distinguished?Required |
S01 identified 43 patients and included 24. Mean age was 60.6 years (95% CI 52.7–68.5), and 11/24 were women. Among the 17 with baseline composition verified, 9 had struvite, 6 carbonate apatite and 2 calcium oxalate. Among the 3 with follow-up composition verified, 2 had struvite and 1 carbonate apatite; the calcium-oxalate cell of 0 does not provide a denominator establishing 0 recurrences. |
The retained selection and composition counts can be distinguished, but the analysis of symptomatic recurrence confined to calcium-oxalate stones and the details of missingness and selection are unverified. |
Patient selection flow, age, sex, stone-composition testing table and reasons for exclusion |
Subsequent research should disclose participant-level flow and missing tests from recruitment through composition testing and event adjudication. |
| 8 |
Partly verified |
Full text not readStored summary read |
N08 · S01 composite eventsWhat outcome and follow-up period do the 8/24 events in S01 represent?Required |
In S01, a composite event of new stones or growth/progression of existing stones was observed in 8/24 participants (33.3%). Median follow-up was 22.6 months (range 19.7–32.1 months), and the original main endpoint was urinary pH. This value is neither a symptomatic recurrence rate confined to calcium-oxalate stones nor a causal effect of vitamin C. |
The composite events and follow-up summary are retained, but a direct comparative result for the target event cannot be separately verified. |
Event tables by new-stone and residual-stone-growth component, symptom status, composition, and median or fixed follow-up information |
Comparative studies are needed that adjudicate new stones, growth of existing stones, and symptomatic events separately, and distinguish prespecified fixed-time outcomes from time to first recurrence. |
| 9 |
Partly verified |
Full text not readStored summary read |
N09 · S01 nominal exposureIs the dose in S01 a regimen from a directly eligible trial?Required |
The median daily dose of ascorbic acid in S01 was 1000 mg/day (range 500–2000 mg/day). The product, L-form purity, administration frequency, meal timing, and sustained adherence are unverified. These values were not used to fill in a dose for a directly eligible recurrence study or an individual prescription. |
Only the nominal daily dose from an indirect report is verified; there is no directly eligible exposure information. |
Nominal daily dose, product, dose per administration/frequency, meal timing, actual intake, and administration records |
Obtain the product and daily and per-administration dosing records, adherence, and changes in exposure by group to compare nominal dose with actual exposure. |
| 10 |
Unverified |
Full text not readStored summary read |
N10 · Direct comparatorHas a recurrence comparator involving no addition, placebo, or the same care been verified?Required |
No addition, placebo, and the same usual care are the comparator question in this table. S01 has no unexposed recurrence comparator, and the placebo in S02 is a short-term metabolic comparison. A directly eligible recurrence comparator is unverified. |
There is no retained result that verifies the question's comparator as an actually observed eligible group. |
Comparators, care, concomitant interventions, event counts, and correspondence with the exposure group in the same population |
Compare an added single-ingredient oral preparation with no addition/placebo on top of the same usual care, and record events by group together with differences in care. |
| 11 |
Unverified |
Full text not readStored summary read |
N11 · Duration and principal follow-up timeHave the treatment duration and principal follow-up time for comparing recurrence been verified?Required |
The treatment duration and principal follow-up time of a directly eligible recurrence comparison are unverified. The 22.6 months in S01 is median follow-up, not a fixed 24-month endpoint. The 6 days per period in S02 and the 3 days in S03 are metabolic exposure periods. |
There are no direct comparative data with which to establish the principal recurrence time point and exposure duration. |
Actual treatment start/end, discontinuation, follow-up/censoring, and prespecified principal follow-up time |
Prespecify a defensible principal time point considering event accumulation and discontinuation/censoring, and report treatment duration separately from follow-up duration. |
| 12 |
Unverified |
Full text not readStored summary read |
N12 · Event definition and measurementCan symptomatic new stones be distinguished from imaging-only events and residual-stone growth?Required |
The question's endpoint is symptomatic new calcium-oxalate stone recurrence. The manuscript does not combine new stones/residual-stone growth, imaging-only events, emergency care/procedures, and time to first recurrence. A separate result meeting this target definition was not verified within the composite events in S01. |
The question's definition is fixed, but the target event actually measured and adjudicated in a directly eligible comparison is unverified. |
Symptoms, imaging/diagnosis, stone composition, adjudicators, definitions of new and residual stones, and event collection procedures |
Apply event adjudication with group information masked where possible and standardized procedures for verifying symptoms, imaging, and composition. |
| 13 |
Unverified |
Full text not readStored summary read |
N13 · Direct effect and uncertaintyHave an effect estimate, CI, and P value for an eligible recurrence comparison been verified?Required |
In the original primary_result, source_id, estimate, CI, P, and n are all empty values, and the direction is unknown. Numerators/denominators, risk ratios/risk differences/hazard ratios/HRs, person-years, and censoring for eligible recurrence are also unverified. S01 8/24, S02 P<0.001, and the S08 HR were not transferred into these empty fields. |
A directly eligible comparative estimate cannot be verified within the retained material currently read. This does not mean an effect of 0. |
Events/denominators and time by group, original risk ratio/risk difference/HR, CI, P value, and analysis definition |
Report relative and absolute effects and intervals for prespecified symptomatic recurrence using the same analysis population and a fixed time point or a time-to-event model. |
| 14 |
Unverified |
Full text not readStored summary read |
N14 · Design, allocation, and confoundingHave an actual design and allocation that support a causal comparison of recurrence been verified?Required |
S01 is a retrospective report of an exposure group alone, S02 is a randomized double-blind metabolic crossover trial, and S08 is an observational analysis of first stones. Allocation, concealment, and baseline balance in a direct recurrence comparison were not verified. |
The actual existence of other designs does not establish a causal comparison for the target clinical event. |
Direct comparison methods, allocation/concealment, baseline risk, observational-study confounding/selection, and models |
Prespecify a randomized comparison on top of the same usual care or an appropriate comparative design that explicitly addresses confounding and selection pathways. |
| 15 |
Unverified |
Full text not readStored summary read |
N15 · Concomitant interventions, adherence, and contributionCan common treatments, deviations from medication use, and concomitant interventions be separated from vitamin C's contribution?Required |
In S01, sustained adherence, product, and frequency are unverified, and discontinuation/dose reduction related to hyperoxaluria is recorded. The acute dissolution in S09 is a case combining concurrent exposure to antibiotics and stenting with different exposure after discharge. The effects of concomitant interventions and deviations in a direct comparison are unverified. |
There is no eligible recurrence analysis that separates common care and exposure changes by group. |
Fluid intake/diet, medications/procedures, rescue treatment, adherence, exposure changes, and their handling in analysis by group |
Collect fluid intake, diet, concurrent medications/procedures, rescue treatments, and actual medication use/discontinuation by group, and analyze them in accordance with the prespecified effect of interest. |
| 16 |
Unverified |
Full text not readStored summary read |
N16 · Denominators and events/peopleHave recurrence events, people, exposure time, and analysis denominators been verified?Required |
The 8/24 in S01 is the reported value for composite events in the exposure group. Numerators/denominators by group, event counts/person counts, person-years, and censoring for directly eligible recurrence were not verified. The 2 people with spontaneous passage or populations with other stone compositions are not added to a new-recurrence numerator. |
The target event unit and the comparative analysis denominator are not verified within the currently retained scope. |
Numbers allocated/exposed, completing follow-up, and analyzed; recurrent events/people with events; follow-up time; and censoring tables |
Separate people with events from recurrent events using participant IDs and a time axis, and disclose denominators and censoring for first-recurrence and recurrent-event analyses. |
| 17 |
Unverified |
Full text not readStored summary read |
N17 · Missing data, selection, and censoringWho was included, lost to follow-up, or censored, and how was the target outcome handled?Required |
The 43 people identified and 24 included in S01 are retained, but missingness, censoring, and their handling for the target recurrence by group are unverified. Because an actually eligible comparison has not been verified, these values cannot be designated as an ITT denominator. |
The retained inclusion flow alone cannot establish the impact of missingness/censoring on the target comparison. |
Participant flow, missing outcomes, censoring, reasons for exclusion, and analysis/sensitivity-analysis plans |
Disclose losses to follow-up, missing event ascertainment, and reasons for censoring by group, and perform prespecified sensitivity analyses for missing data. |
| 18 |
Unverified |
Full text not readStored summary read |
N18 · Differences in detection and adjudicationWere symptom assessment, imaging, and event adjudication conducted under the same conditions across groups?Required |
The retained manuscript distinguishes symptomatic new stones, imaging-only findings, growth, and urinary measures. Whether the same examination schedule, assessor masking, and event adjudication were applied in a direct comparison is unverified. |
There are no direct data with which to compare the actual collection and measurement procedures for the target recurrence. |
Examination schedules, symptom collection, imaging/composition testing, masking/adjudicators, and detection/reporting pathways |
Apply the same follow-up/symptom contacts and prespecified event adjudication procedures across groups, and disclose examination frequency together with missing adjudication. |
| 19 |
Unverified |
Full text not readStored summary read |
N19 · Precision and important differencesCan the reported interval and a clinically important difference in recurrence be interpreted?Required |
The CI and effect estimate for eligible recurrence are unverified (the historical manuscript's explanation of CX/EX). A sample of 24 participants or a large sample in another cohort was not treated as sufficient precision for recurrence. An important difference and an appropriate minimum duration are also undetermined. |
Without a direct interval and a justified criterion for clinical importance, their relationship to evidence sufficiency cannot be assessed. |
Direct recurrence effect, CI, events/denominators, and a justified criterion for an important difference |
Prespecify a difference in recurrence justified from clinical and patient perspectives, and report the effect interval and basis for precision for that event and follow-up. |
| 20 |
Unverified |
Full text not readStored summary read |
N20 · Planning, registration, and reportingHave prespecified recurrence endpoints, the principal time point, and analyses been compared with actual reporting?Required |
Registration, protocol, and analysis plan for directly eligible recurrence are unverified. Preserve urinary pH as the original main endpoint and stones as a secondary endpoint in S01; unverified registration does not establish whether selective reporting occurred. Historical access to the official S15 record reached only a shell. |
The current scope contains no records with which to compare planned and actual endpoints and analyses for the target comparison. |
Registration, protocol, analysis plan, amendment history, and actual results tables for the direct trial |
Disclose the recurrence event definition, principal time point, comparator, analysis/interval, missing-data handling, and reasons for changes in advance, and compare them with the final results. |
| 21 |
Partly verified |
Full text not readStored summary read |
N21 · Short-term crossover and urinary outcomesWhich population, exposure, and comparison does the crossover metabolic result in S02 describe?Supplementary; required for attributing indirect results |
S02 compared ascorbic acid 1 g twice daily with a matching placebo during two 6-day controlled-diet periods in 12 calcium-oxalate stone formers and 12 nonformers. Testing during the final 2 days of each period reported urinary oxalate of 41.0 mg versus 30.5 mg in stone formers, P < 0.001. The authors' description of a 33% increase is preserved as originally reported and was not recalculated. This is not a recurrence event result. |
The metabolic crossover result is included in the current extraction, but it does not answer an eligible symptomatic recurrence comparison. |
Original S02 methods/results tables, population, duration, sample, crossover contrast, and urinary oxalate units |
For metabolic crossover trials, disclose the original paired comparison, diet, and sequence; assess the clinical recurrence question through separate long-term event follow-up and comparisons. |
| 22 |
Unverified |
Full text not readStored summary read |
N22 · Crossover sequence and paired uncertaintyHave the sequence, washout period, paired variance, and carryover effects in S02 been verified?Supplementary; required for interpreting crossover results |
S02 was indexed as a randomized double-blind crossover trial, but detailed values for washout, sequence, paired variance, product, and adverse events were not verified in the abstract accessed. The two populations of 12 participants each were not treated as a 24-participant parallel-group comparison of recurrence, and no new CI was calculated for the urinary outcome. |
The current abstract extraction alone cannot verify paired uncertainty between crossover periods or the handling of carryover and sequence. |
S02 full text, allocation sequence, washout period, results by period, paired variance, and carryover/deviation analyses |
Report participant-level period contrasts, period/sequence, carryover effects, and missingness from the original crossover data according to the prespecified plan, and disclose the necessary paired uncertainty. |
| 23 |
Partly verified |
Full text not readStored summary read |
N23 · Short-term before–after and healthy-participant comparisonWhat was compared in the before–after metabolic study S03?Supplementary; required for interpreting indirect data |
S03 provides before–after data from 47 adult calcium stone formers, of whom 23 received 1 g/day and 24 received 2 g/day for 3 days, plus data from 20 healthy participants receiving 1 g/day. It addresses urinary oxalate, pH, and the Tiselius crystallization index, not a long-term recurrence comparison. The healthy participants are not recurrence comparators for patients with prior stones, and the stone-former population was not verified as consisting entirely of calcium-oxalate stones. |
The population and short-term metabolic role are retained, but the population, event, and comparison for the target recurrence are not verified. |
Original S03 methods/results, stone composition, exposure/testing by group, the role of healthy participants, and paired data |
Disclose paired comparisons, composition, and diet/exposure for short-term metabolic data; study recurrence in adults with verified prior stones using a separate comparator receiving the same care. |
| 24 |
Unverified |
Full text not readStored summary read |
N24 · Bibliography and unresolved duplicationHave detailed results and participant overlap between S04 and S17 been verified?Supplementary; required for interpreting duplication and existence |
For S04 Massey 2005 and S17 Chai 2004, only indexed titles/bibliographic information from the original publications is retained; detailed results, samples, and doses are not verified in this work. Participant overlap remains unresolved, so they remain in a conservative single cluster, F04. The DOI/PMID for S17 are empty values, and the two papers were not added as independent replications. |
Because detailed original results and the overlap relationship have not been acquired, actual replication or recurrence results cannot be verified. |
Full texts of both original reports, populations/recruitment, study IDs, participant overlap, and original results tables |
Compare recruitment periods, institutions, participants, and designs in the two original reports to verify whether they belong to the same family, and update only the scope for which results have actually been acquired. |
| 25 |
Partly verified |
Full text not readStored summary read |
N25 · Cystine recurrence and passageHow are the cystine course and spontaneous passage in S05 distinguished?Supplementary; required for interpreting unfavorable results and scope |
The translated abstract of S05 reports that, among 17 people with cystine stones receiving 5 g/day, recurrence remained unchanged in 5 people and another strategy was needed. The 2 people with spontaneous passage are not a recurrence numerator. Children are also indexed, and the adult-only denominator, duration, and matched comparator are unverified. This shows that human event data exist, but it is not a direct calcium-oxalate comparison. |
The unfavorable event description is retained, but composition, age, comparator, and event definition differ from the target question or are unverified. |
S05 German full text, composition, ages, event definitions, exposure/time, comparators, and complete participant flow |
For cystine data, separately verify composition, age, recurrence versus passage, concomitant interventions/exposure, and follow-up in the original report, and analyze them separately from calcium-oxalate studies. |
| 26 |
Partly verified |
Full text not readStored summary read |
N26 · Favorable small reportTo what extent has the favorable report of 4 people in S06 been verified?Supplementary; required for retaining positive evidence |
S06 retains a description from an indexed abstract excerpt that ascorbic acid monotherapy was favorable in 4 young patients with cystinuria. Exact ages, doses, event denominators, comparators, and follow-up in the original full text are unverified. The existence of a favorable result is not erased, and it is not promoted to recurrence efficacy for this question. |
A favorable small-scale description exists, but eligibility regarding composition, age, events, exposure, and comparison is not verified. |
S06 full text, exact ages, exposure/product, events, denominators, comparison, follow-up, and concomitant interventions |
Verify the identity, ages, composition, exposure, events/time, and comparator in the original small report, then attribute the result only to the scope of the corresponding question. |
| 27 |
Partly verified |
Full text not readStored summary read |
N27 · Urinary cystine and publication timingHave the favorable urinary result in S07 and the original report date been distinguished?Supplementary; required for interpreting indirect evidence and identity |
The original publisher abstract for S07 records 31 people with cystinuria, 5 g/day, and favorable urinary cystine results. Controlled longitudinal recurrence is not verified. The later digitization date does not indicate a new study in 2010; the original report dates to 1982. |
The favorable urinary description and original publication identity are retained, but this is not a clinical recurrence comparison for the target composition. |
Original 1982 S07 report, clinical events/follow-up, composition, exposure, and publication/digital identity |
Compare the original publication identity with the actual patient data, and verify cystine urinary measures and clinical recurrence as separate outcomes and follow-up. |
| 28 |
Partly verified |
Full text not readStored summary read |
N28 · First occurrence and observational associationHow does the first-stone cohort result in S08 differ from the recurrence question?Supplementary; required for interpreting observational and indirect results |
S08 is an observational analysis reporting 6,245 first stones among 156,735 women and 40,536 men, with median follow-up of 11.3–11.7 years. For supplemental vitamin C ≥ 1,000 mg/day versus no supplementation in men, the adjusted HR was 1.19 (95% CI 1.01–1.40), with a trend P = 0.001; the abstract did not report an association in women. Distinguish dietary C, supplements, and sex, and do not use the first-occurrence association as a causal effect on recurrence in people with prior calcium-oxalate stones. |
The first-occurrence association and reported values from the large cohorts are retained, but the population, event, and design differ from a direct recurrence comparison. |
Original S08 population/history, sex, exposure, covariates, events/time, HR/CI, and records of cohort reuse |
Verify exclusions based on stone history, exposure/formulation, covariates, events/follow-up by sex, and reuse of the original cohorts; study the causal recurrence question through a separate comparison in a population with prior stones. |
| 29 |
Partly verified |
Full text not readStored summary read |
N29 · Acute dissolution and concomitant-treatment case reportTo which interventions and event is the acute dissolution course in S09 attributable?Supplementary; required for attributing case-report findings |
S09 describes the acute dissolution course in 1 older man, with antibiotics, stenting, and ascorbic acid used concurrently and different exposure after discharge. Stone composition was inferred, and these are not controlled recurrence data. The retained title is a descriptive label, not a transcription of the exact original title. |
The case's course and limitations are retained, but it is not a comparison that isolates the recurrence effect of a single ingredient. |
Original S09 case report, exact title/bibliographic information, stone composition, concurrent/subsequent exposure, and acute/recurrence follow-up |
Separately verify the exposure timeline, concomitant interventions, composition confirmation, and acute dissolution versus long-term recurrence in the original case report, and assess the isolated contribution through an appropriate separate comparison. |
| 30 |
Partly verified |
Full text not readStored summary read |
N30 · Partial page and other treatmentsHave the page actually verified in S10 and recurrence under other treatments been distinguished?Supplementary; required for partial-reading status and attribution |
S10 discusses several treatments for cystinuria; the original abstract and a single page, p.1563, were historically verified. This is not recorded as reading the entire article's full text. A controlled recurrence result for vitamin C alone was not verified, and results from other treatments or cited articles are not transferred to C-alone results. |
The role of the partial original page is linked, but this is not verification of the target recurrence result for the single ingredient alone. |
Original S10 full text, populations/compositions by treatment, exposure, comparison/recurrence, and cited original reports |
Compare original exposures, denominators, and recurrence by treatment and the cited families, and clearly record the page/full-text scope actually verified. |
| 31 |
Partly verified |
Full text not readStored summary read |
N31 · Review and search timingWhat evidence map and time frame does the S11 review provide?Supplementary; required for interpreting the review and timing |
S11 is an online review dated 2026-07-31, preceding the evidence cutoff date of 2026-09-16. Its abstract/reference list was used as an evidence map of urinary-risk studies; it is not a new recurrence trial. A review with an earlier search end date does not establish that the current search is exhaustive, nor does it provide replication independent in funding. |
The review's mapping and timing roles are retained, but these are neither direct recurrence results nor current exhaustive acquisition. |
S11 review full text, search end date/scope, original reference list, inclusion/exclusion, and funding |
Compare the review's search end date and inclusion scope with the identities of the original reports, and update the observations in the corresponding row only when a new direct comparison has actually been acquired. |
| 32 |
Unverified |
Full text not readStored summary read |
N32 · Registration shell and mirror identityHave the registration leads in S15 and S16 been distinguished from the content actually verified?Supplementary; required for registration identity |
For S15 NCT06989320, only the official registration shell was historically accessed; substantive fields, registration timing, and results are unverified. S16 Carbon-13 Ascorbic Acid oral loading is a discovery lead from a 3rd-party mirror, and the official ID/version is unverified. They are not linked as the same trial, and lack of access is not turned into a completed negative search or absence of recurrence trials. |
The substantive original registrations/protocols/results and the identities of the two leads could not be verified. |
Complete official S15 registration/amendment history, original official S16 ID/version, protocols, and results |
Verify each lead's official identity, original version, population/exposure, recurrence endpoint, and result availability, and link them only after actually checking whether they are the same study. |
| 33 |
Partly verified |
Full text not readStored summary read |
N33 · Contrary results and differences between recordsAre favorable/unfavorable results and bibliographic differences being mistaken for conflicts about the same effect?Supplementary; required for interpreting contrary evidence and conflicts |
Favorable cystine urinary results and small-scale clinical courses are retained alongside unchanged recurrence, hyperoxaluria, and first-occurrence associations. Different compositions, endpoints, and designs are not turned into statistical conflicts about the same recurrence effect. For S01, a historical bibliographic difference is recorded in which the original PDF's 2017 publication identity took precedence, but the exact value on the other page and whether a correction occurred are currently unverified. |
Indirect evidence in the contrary direction and bibliographic differences are retained, but a conflict concerning the same directly eligible effect is not verified. |
Actual contrasts, events/compositions, durations, bibliographic versions, and contrary/corrected material for each original report |
Compare original populations, ingredients, contrasts, time points, and outcomes/versions to establish whether a conflict concerns the same question/analysis, and verify bibliographic corrections against original evidence. |
| 34 |
Unverified |
Full text not readStored summary read |
N34 · Funding, provision, and independenceHave funding, product provision, roles, and conflicts of interest for the direct evidence been verified?Required |
Because there is no directly eligible recurrence evidence, the current independence axis is an empty value. Funding records in each evidence entry and historical access to the declaration section of S01 are retained. The package's I1 is a trace of a delivery default and is not used as verification of actual mixed funding or as a new independence score. |
Funding/provision and roles for directly eligible evidence could not be verified, and the package designation alone cannot support an assessment. |
Funding/conflicts of interest, internal support, product provision, and design/analysis/publication roles in original eligible reports |
Verify funding, product provision, and actual design/analysis/publication roles for the original eligible comparison, and separately disclose unverified items and the independence of linked families. |
| 35 |
Partly verified |
Full text not readStored summary read |
N35 · Hyperoxaluria and exposure changesHave safety events in S01 been distinguished from comparative risk?Supplementary; required for interpreting harm signals |
S01 records hyperoxaluria-related exposure changes in 2 of 24 people (1 discontinuation and 1 dose reduction). This is a retained safety signal, not a recurrence numerator from the same report or a risk estimate by comparator. Event definitions, risk by exposure time, and complete collection of other adverse events are unverified. |
Exposure changes are present in the verifiable extraction, but direct comparative risk and comprehensive harm surveillance are not verified. |
S01 event definitions, exposure time, original flow of 2 people/24 people, comparator, dose reduction/discontinuation, and safety follow-up |
Collect hyperoxaluria/clinical harms and discontinuations/dose reductions by group under the same formulation, exposure-time, and testing criteria, and disclose events together with exposed participant counts and time. |
| 36 |
Partly verified |
Full text not readStored summary read |
N36 · High-dose gastritis and ageWhich population, dose, and duration does the report of gastritis-related discontinuation in S05 concern?Supplementary; required for retaining unfavorable harm findings |
The translated abstract of S05 records 3 gastritis-related treatment discontinuations among 17 people with cystine stones receiving 5 g/day. Pediatric indexing is included, and the adult-only denominator, duration, and comparator are unverified. This is not used as a comparative risk rate in the target adult calcium-oxalate population. |
The unfavorable discontinuation report is retained, but directness regarding population, time, and comparator is not verified. |
S05 gastritis definition, flow of 3 people/17 people, adults/children, 5 g/day, duration, and other treatments/risks |
Verify original ages, definitions of gastritis/discontinuation, exposure time, concurrent treatments, and events/denominators; study harms for the target formulation/population through separate comparative surveillance. |
| 37 |
Partly verified |
Full text not readStored summary read |
N37 · Intravenous label and limits of applicabilityHave the warnings in the official injection label S12 been separated from oral evidence?Supplementary; required for interpreting harms by route |
The S12 ASCOR injection label records warnings concerning intravenous oxalate nephropathy/stones, impaired renal function, dialysis, and prior oxalate stones. G6PD-related hemolysis belongs to the high-dose/intravenous context. This is a buffered intravenous preparation for short-term treatment of scurvy, distinct from a pure oral supplement, so intravenous event rates or safety are not transferred to oral use. |
The routes and populations of the historical official warnings are retained, but they do not constitute a quantitative comparison of the target oral risk. |
Route/formulation, warnings, and at-risk populations in the original ASCOR label, and actual comparative data on oral harms |
Verify route, formulation, at-risk populations, and event definitions in the official label, and study renal/hemolytic harms of the target oral exposure through separate exposure-specific comparisons and surveillance. |
| 38 |
Partly verified |
Full text not readStored summary read |
N38 · General upper limit, gastrointestinal effects, and ironHave the general upper limit and harms in S13 been distinguished from an assurance of safety for stone patients?Supplementary; required for interpreting upper limits and general harms |
S13 records diarrhea, nausea, and abdominal pain from the NIH consumer document, together with the context of high-dose iron overload in hemochromatosis. The adult upper limit of 2,000 mg/day is a general limit for the total from all sources, not an assurance of safety for stone patients. The consumer document was historically read; this is distinguished from the failed access to the health-professional page. |
General official information is retained, but it does not verify comparative safety or a prescription for the target patients/exposure. |
Upper limit/population and gastrointestinal/iron warnings in the NIH consumer material, and actual exposure-specific safety data in the target patients |
Separately verify total dietary/supplemental exposure, stone history, and iron metabolism/symptoms, and assess patient-specific safety questions through actual exposure- and population-specific comparisons/surveillance. |
| 39 |
Partly verified |
Full text not readStored summary read |
N39 · Guideline caution and quantitative resultsWhat outcome does the guidance to avoid excessive intake in S14 verify?Supplementary; required for interpreting guidelines |
The S14 EAU section advises calcium-oxalate stone formers to avoid excessive vitamin C and explains that stone risk is controversial. This provides context for caution; it does not provide a randomized quantitative recurrence effect or a safety threshold dose for a pure single-ingredient oral preparation. |
Guideline caution is linked, but it is neither a quantitative comparison of the target recurrence/harms nor a safe prescription. |
Original EAU section, population, evidence/warnings, and actual comparative recurrence/harm data for the target oral formulation |
Compare the original evidence cited by the guideline, formulation/population, and dose context, and assess quantitative recurrence/harm questions using actual comparative data. |
| 40 |
Unverified |
Full text not readStored summary read |
N40 · Special populations and long-term gapsHave gaps concerning renal risk, special populations, and long-term exposure been retained?Supplementary; required for limits on safety applicability |
The current safety designation is Caution. Uncertainties concerning impaired renal function, dialysis, oxalate nephropathy, high-dose/intravenous G6PD, iron overload, pregnancy, lactation, children, and long-term high-dose exposure are retained separately. Historical reports of 500–2,000 mg/day or 5 g/day are not used as safe prescriptions for the target patients. |
The current scope contains no data that verify comparative harms of the target oral preparation in special populations or over the long term. |
Formulation- and route-specific data on renal risks, dialysis, prior oxalate stones/G6PD, iron, pregnancy/lactation, children, and long-term harms |
Prespecify special populations, independently monitor total exposure/duration, renal function/hemolysis/iron, and gastrointestinal/stone events, and disclose adequate follow-up and denominators. |
| 41 |
Met |
Full text not readStored summary read |
N41 · Preservation of the original assessment and calculationsHave the current assessment and package/calculator designations been distinguished with their original values preserved?Required for preservation and traceability; not a condition establishing efficacy |
The current grade ?, empty score, and safety Caution are maintained. Eligible effect, SE, CI, P, and n remain empty values, and no calculation is performed in this work. Distinguish the unassigned current axes from the package's I1/EX/CX and the raw C resulting from the calculator's format error. Completion of a technical transformation is not independent clinical/methodological certification. |
The boundaries between the original assessment, historical designations, current unverified information, and absence of new calculations are preserved. This does not mean that recurrence efficacy has been established. |
Original records of current grade/score, axes, primary_result, historical package/calculations, and editorial decisions |
If new direct evidence is actually acquired, handle any update to the original assessment under separate authorization, versioning, and evidence review; this transformation table only links the original content and change events. |