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Table 1 Terms and definitions of trial characteristics analysed in the reporta

From: Landscape of clinical trial activity focusing on Indigenous health in Australia: an overview using clinical trial registry data from 2008-2018

Term

Definition

Sample size

Target sample size was used as a proxy for actual sample size if this metric was unavailable

Allocation

Whether a trial was randomised or non-randomised

Masking

Whether a trial was open or blinded

Intervention type

Categorised as diagnosis/prognosis, early detection/screening, prevention, treatment (surgery), treatment (devices), treatment (drugs), treatment (other), rehabilitation, lifestyle, behaviour, other interventions.

Treatment: any encompasses treatment in surgery, devices, drugs and/or other. Each trial can select up to three intervention codes.

Diagnosis / prognosis: study designed to evaluate one or more tests aimed at identifying a disease or health condition, or determining a patient’s prognosis.

Early detection / screening: study that involves the systematic examination of a group of participants, in order to separate well persons from those who have an undiagnosed pathologic condition or who are at high risk. It could also refer to the initial evaluation of an individual, intended to determine suitability for a particular treatment modality or to detect specific markers or characteristics that may require further investigation.

Prevention: study designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.

Treatment: drugs: study designed to assess the effect(s) of one or more chemical or biological agents including vaccines.

Treatment: surgery: study designed to assess the effect(s) of one or more manual or operative surgical techniques, whether in the fields of cosmetic, elective, experimental, plastic, or replacement surgery (performed to diagnose, treat, or prevent disease or other abnormal conditions).

Treatment: devices: study designed to evaluate the use of any physical item used in medical treatment whether it be an instrument, piece of equipment, machine, apparatus, appliance, material or other article, and whether it is used alone or in combination with the intention of preventing, diagnosing, treating, and curing a disease or condition. Examples include: artificial limbs, contact lenses, ventilators, catheters, implants, vibration therapy machines.

Treatment: other: studies that do not fall under the broad definitions of drug, surgical, or device trials. Examples include interventions such as exercise, physiotherapy, cognitive therapy, special diets, herbal medicines, web-based treatments, motivational classes, music therapy, stem cell interventions.

Rehabilitation: studies designed to evaluate one or more interventions which aim to restore the physical or mental health, function and quality of life in participants who have had or are currently suffering from an illness or injury. Rehabilitation may be performed through physical therapy (e.g. physiotherapy, chiropractic) and/or education (e.g. diet and exercise advice/ counselling).

Lifestyle: studies designed to investigate the effect of interventions which relate to a way of life or style of living. Interventions may aim to alter the attitudes, habits and values of a person or group, and how these participants cope with their physical, psychological, social, and economic environments on a day-to-day basis. Examples include diet and nutrition plans, exercise or physical activity programs, quit smoking programs.

Behaviour: studies designed to assess the effect of interventions which aim to elicit or modify mental or physical actions, responses or conduct in a person or group. Examples of behavioural interventions include cognitive behavioural therapy, exercise behaviour interventions, and breast feeding behavioural interventions.

Other interventions: studies that do not fit under any of the above categories. This should only be selected when no other options are adequate. Examples include prayer, singing, driving.

Primary sponsor

The individual, organisation, group or other legal person taking on responsibility for securing the arrangements to initiate and/or manage a study (including government body, hospital, university, commercial/industry sector, charities/societies/foundations, other collaborative groups, individual or other)

Funding

Main source of monetary, material or infrastructure support for the study (including government body, hospital, university, commercial sector/industry, charities/societies/foundations, other collaborative groups or individuals)

Industry involvement

Any evidence of industry involvement as primary sponsor, secondary sponsor, collaborator or funding source

Health conditions

Registrants can select up to ten per study, coded from Level 1 condition categories developed by UK Clinical Research Collaboration [12]. These are alternative and complementary medicine, anaesthesiology, blood, cancer, cardiovascular, diet and nutrition, ear, emergency medicine, eye, infection, inflammatory and immune system, injuries and accidents, human genetics and inherited disorders, mental health, metabolic and endocrine, musculoskeletal, neurological, oral and gastrointestinal, physical medicine/rehabilitation, renal and urogenital, reproductive health and childbirth, respiratory, skin, surgery, stroke and other. Public health was excluded as a health condition.

  1. [12]
  2. a Refer to article for further variable definitions: Australian New Zealand Clinical Trials Registry, Data Field Definitions. 2019, https://www.anzctr.org.au/docs/ANZCTR%20Data%20field%20explanation.pdf?t=519 (March 2022, date last accessed)