Intervention vs Control Arm: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

Measures 6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

Measure	Value	95% interval, lower	95% interval, upper	Method	Source
Risk in group 1	0.00242	0.00199	0.00293	wilson	ClinicalTrials.gov
Risk in group 2	0.000996	0.000675	0.00147	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	0.00142	0.000785	0.00202	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	2.42	1.57	3.75	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	2.43	1.57	3.76	log	ClinicalTrials.gov
Number needed to harm, for one more participant with a serious adverse event on Intervention than on Control Arm	705	495	1,270	from the risk difference interval	ClinicalTrials.gov

Groups 2

Group 2 names the comparator: control.

Group	Title	Description	With the outcome	Analysed	ClinicalTrials.gov code	Source
Group 1	Intervention	Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches in which the intervention will be implemented per the study schedule.~Conversation Guide + Clinical Support: The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.	104	43,054	EG001	ClinicalTrials.gov
Group 2	Control Arm	Per a stepped-wedge cluster randomized pragmatic clinical trial design, all patients within whole surgical practices will be randomized to implementation tranches. The control arm consists of all patients receiving surgery in implementation tranches in which the intervention has not been implemented yet (per the study schedule).	25	25,088	EG000	ClinicalTrials.gov

Harm 2

Field	Value	Source
What it counts	Total, serious adverse events	ClinicalTrials.gov
Time frame	Adverse events were collected from baseline to end of study participation for up to 3 Months Post-Surgery for all participants. Sites were monitored for the duration of the study (40 months)	ClinicalTrials.gov

Trial 8

Field	Value	Source
Title	Non-pharmacological Pain Management After Surgery	ClinicalTrials.gov
NCT number	NCT04570371	ClinicalTrials.gov
Phases	NA	ClinicalTrials.gov
Conditions	Surgical Procedure, Unspecified	ClinicalTrials.gov
Interventions	Conversation Guide + Clinical Support	ClinicalTrials.gov
Lead sponsor	Mayo Clinic	ClinicalTrials.gov
Results first posted	2025-11-13	ClinicalTrials.gov
Results on ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT04570371?tab=results	ClinicalTrials.gov

Source 4

Field	Value	Source
Release	trial-comparisons-2026-03-23-0.1.0	ClinicalTrials.gov
Release manifest SHA-256	f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57	ClinicalTrials.gov
AACT copy	2026-03-23	ClinicalTrials.gov
Tables read	outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet	ClinicalTrials.gov

The same record as JSON

Release trial-comparisons-2026-03-23-0.1.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.