Table 1

Score 1: very explanatory; score 2: rather explanatory; score 3: equally pragmatic and explanatory; score 4: rather pragmatic; score 5: very pragmatic

DomainScoreRationale
1. Eligibility criteria5iHOPE will include a broad spectrum of elderly patients identical to the patients in the usual care. Legally not competent patients (due to, eg, dementia) will also be included in this trial.
2. Recruitment5iHOPE will recruit the patients during the clinical routine in the hospitals.
3. Setting5Identical setting to usual care setting. iHOPE will engage hospitals with tertiary as well as secondary care. This includes both academic and community hospitals.
4. Organisation intervention5Usual attending anaesthesia team will conduct the intervention. Care provider instructions regarding the study protocol will be provided, but there is no need for an advanced expertise for provision of the intervention.
5. Flexibility (delivery)5The intervention has to be provided according to the clinical routine. Cotreatment is not restricted and may be delivered as judged by the anaesthetist in charge.
6. Flexibility (adherence)5Treatment changes are allowed, if clinically necessary.
7. Follow-up4Brief in-hospital follow-up will occur during the first four postoperative days and at the discharge day. Blinding will be encouraged during the first four postoperative visits, but it is not mandatory. This will facilitate study conduction during the clinical routine in the different settings. The visit on the discharge day has not to be blinded, due to the requirement of extensive medical chart review.
A blinded outcome assessor (eg, study nurse) will be required for the follow-up visits after hospital discharge at day 30±3, day 180±45 and day 365±60. The follow-up will consist of a short telephone interview of the patient or the proxy.
8. Primary outcome5The primary outcome (binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary events until postoperative day 30) is obviously relevant for the patients.
9. Primary analysis4An intention-to-treat analysis will be performed with all available data. A per-protocol analysis, sensitivity and prespecified subgroup analyses will be performed in addition.
  • iHOPE, Improve hip fracture outcome in the elderly patient.