Items reviewed in each document: | ||||
---|---|---|---|---|
Protocol – eligibility criteria | Patient information material | Case report forms – data collection | Patient completed questionnaires – data collection | |
Demographic factors | ||||
Age extremes (e.g., under 18 and over 75) | Minimum/ maximum age | N/A | Date of birth | Date of birth |
Women of childbearing age | Pregnancy status/ age/ sex | N/A | Date of birth / sex | N/A |
Black, Asian and Ethnic Minorities | Ethnic group | N/A | Ethnic group | Ethnic group |
Male/female sex (depending on trial context) | Sex/gender | Use of gendered words | Sex/gender | Sex/gender |
LGBTQ + /sexual orientation | Sexual orientation | Use of gendered words | Sexual orientation | Sexual orientation |
Educational disadvantage | N/A | Readability scores and word counts, availability in non-written format | Highest education level | Highest education level |
Social and economic factors | ||||
In full time employment | N/A | N/A | Employment status | Employment status collection |
Unemployed/ low incomeab | N/A | N/A | Employment status/ income | Employment status/ income |
Military veterans | N/A | N/A | Military veteran status | Military veteran status |
People in alternative residential circumstances (migrants, asylum seekers, prison populations, care homes, traveller communities and homeless)ab | N/A | N/A | Residence details | Residence details |
People living in remote areasa | Geographical area/access to hospital | N/A | Residence details/ postcode | Residence details/ postcode |
Religious minorities | N/A | N/A | Religion | Religion |
Carersa | N/A | N/A | N/A | Carer status |
People not fluent in the majority language | Fluent in English | Availability of patient information in alternative languages | Main language | Main language, availability in alternative languages |
People who do not attend regular medical appointments | Not possible to identify from trial documents | |||
People in multiple excluded categories | Not possible to identify from trial documents | |||
Socially marginalised peoplea | Not possible to identify directly – possible other groups in this category indicated with a | |||
Stigmatised populationsb | Not possible to identify directly – possible other groups in this category indicated with b | |||
Looked after children | Not relevant to ICR-CTSU trials – all conducted in adult population | |||
Health status | ||||
Mental health conditionsab | Mental health condition exclusions | N/A | N/A | N/A |
People who lack the capacity to consent for themselvesab | Not relevant to ICR-CTSU trials – all require capacity to consent | |||
Cognitive impairmentab | Brain metastasis | N/A | N/A | N/A |
Learning disabilityab | Learning disability | Availability in different formats | N/A | N/A |
People with addictionsab | Substance addiction | N/A | Medical history collection | Medical history collection |
Pregnant women | Pregnancy status | N/A | N/A | N/A |
People with multiple health conditionsa | HIV status / prior malignancies | N/A | Baseline symptoms/ medical history collection | Baseline symptoms/ medical history collection |
Physical disabilitiesa | Physical accessibilty requirements /performance status | N/A | Baseline symptoms/ medical history collection | Baseline symptoms/ medical history collection |
Visually/ hearing impaireda | N/A | Availability of documents in different formats | N/A | N/A |
Too severely ill | Performance status | N/A | Baseline symptoms/ medical history/ performance status collection | Baseline symptoms/ medical history/ performance status collection |
Smokersb | N/A | N/A | Smoking status collection | Smoking status collection |
People living with obesityb | N/A | N/A | Weight collection | Weight collection |
Rare diseases and genetic disease sub-types | N/A | N/A | Medical history collection | Medical history collection |
People in cancer trials with brain metastases | Brain metastasis status | N/A | Medical history collection | Medical history collection |