Excerpt
The O in PICO refers to the outcome(s) measured in a review or study.

Table of Contents

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Which outcomes to annotate

Reviews (methods)
all primary outcomes secondary outcomes are NOT being annotated unless they are found in the Summary of FIndings table (SoFt) all outcomes in the Summary of Findings Table table (SoFt) only annotate an outcome once if it is reported in both the SoFT and in the primary outcomes use separate (new) group for each outcome except for Composite Outcomes (see below)

Domain & Measure

Outcome Domain refers to “what” is being measured for the outcome (e.g. anxiety, symptoms, exacerbations, quality of life, pain, etc.)
Outcome Measure refers to the way the outcome was measured (e.g. Glasgow Outcome Scale, McGill Pain Questionnaire)

Domain & Measure with identical or synonymous concepts

No need to annotate both Domain and Measure with identical or synonymous concepts
Wherever possible annotate Domain using an appropriate Domain concept or Measure using an appropriate Measure concept - i.e. if the concept is available from the correct dropdown
If a Measure concept isn't available in the Measure dropdown but is available in the Domain dropdown, then go ahead & annotate as if it was a domain

Composite Outcomes

These outcomes should be annotated in the same Outcome group using OR or AND

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title	Expand for examples

Group	Outcome	Category	Vocabulary term	Boolean operator	Category	Vocabulary term
1	perinatal death or severe morbidity	Mortality	Perinatal Death	OR	Physiological or clinical	severe morbidity
2	maternal death or severe morbidity	Mortality	Maternal Death	OR	Physiological or clinical	severe morbidity
3	death and morbidity	Mortality	Death	AND	Physiological or clinical	morbidity

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Classification categories

The classification categories come from the COMET (Core Outcome Measures in Effectiveness Trials) Initiative. Their Outcome Taxonomy Guide is available HERE.

The expandable tables below list a number of examples but are by far definitive lists.

List of Categories with examples of concepts that all within each category

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title	Classification categories and examples for each category

Category

Types & examples

Adverse events

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Outcomes that have been explicitly labelled as some form of unintended consequence of the treatment

Types	Examples
Adverse event Adverse effect	Adverse effects
	Adverse events
	Complications
	Death
	Drug reactions
	Harm
	Hospitalisation
	Negative effects
	Safety
	Serious Adverse Events
	Toxicity

Compliance with treatment

Expand

Types	Examples
Adherence to intervention	patient adherence
Adherence to intervention	health promotions behaviour questionnaire findings

Device/intervention failure

Expand

Type	Examples
Device failure Intervention failure	Any treatment failures

Function

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Type	Impact of disease or condition on
Physical functioning	ability to work physical activities of daily living (e.g. ability to walk, independence, performance status, disability index, measures relating to exercise, sleep, motor skills, sexual dysfunction)
Social functioning	social functioning (e.g. ability to socialise, behaviour within society, communication, psychosocial development, aggression, recidivism, life enjoyment, participation)
Role functioning	role ability to care for children work status
Emotional functioning/wellbeing	emotions overall wellbeing (e.g. ability to cope, worry, frustration, confidence, self-esteem, psychological status)
Cognitive functioning	cognitive function (e.g. memory lapse, lack of concentration, attention)

Infection

Expand

Types	Examples
Infection Infectious diseases	Sepsis
	Bacteraemia
	Specific infectious diseases e.g. malaria
	Markers of infection e.g. parasitaemia
	Viral load
	HIV status

Mental health

Expand

Type	Examples	Notes
Mental Health	depression	any mental health-related conditions
	addiction	assessments of signs or symptoms relating to these conditions
	psychosis
	dementia
	anxiety
	schizophrenia
	post-traumatic stress disorder

Mortality

Expand

Type	Examples
Death Mortality	All Cause Mortality
	Overall Mortality
	All Cause Survival
	Overall Survival
	Cause-specific survival
	Cause-specific mortality

Pain

Expand

Type	Examples
Pain Pain relief	Pain
	Pain Scores
	Pain Measures
	Pain Scales

Physiological or clinical

Expand

Type	Examples
Signs & symptoms	presence of disease or symptoms absence of disease or symptoms remission duration of symptoms number of relapses improvement no improvement clinical success person’s own view of general health
Biological Markers	blood components tissue analysis urinalysis bacteriological measures microbial measures oxygen saturation arterial blood gas test cholesterol
General physical health measures	blood pressure respiratory and heart rates BMI, lung function measures infant weight oxygen saturation fingerclip
Major morbidity event	Stroke

Psychosocial

Expand

Type	Example
Social	social problems
	smoking cessation
	smoking abstinence
	Levels of maternal inconvenience
	number of parental visits
	mother's view of a child
	parent-child interaction
	Consumption of healthier food, drink etc.

Quality of Life

Expand

Type	Example
Quality of Life	health-related quality of life (HRQL)
Quality of Life	quality of life

Resource use

Expand

Type	Examples
Economic	Cost analysis general costs
Hospital	inpatient or day case hospital care (e.g. duration of hospital stay, admission to ICU) number of admissions readmission following treatment
Operative	surgical procedures (e.g. caesarean delivery, time to transplantation) number of procedures
Medication	medication (e.g. concomitant medications, pain relief, rescue medication, medication errors) need for additional drugs or “dose of drug”
Societal/carer burden	financial or time implications on carer or society as a whole (e.g. need for home help, entry to institutional care, effect on family income, care burden)

Satisfaction with care

Expand

Type	Examples
Satisfaction with care	patient's views about the services they receive
	clinician's assessment of adequacy of care or appropriateness of treatment
	Carer's views on treatment received by those being care for

Withdrawals or dropouts from study

Expand

Type	Example
Withdrawal from study	Dropouts
	Withdrawals
	Cancellations

List of Concepts and what category to use for each one

Expand

title	Concept (term) list and their categories

Concept	Category
All cause mortality	Mortality
All cause survival	Mortality
Cause specific mortality	Mortality
Cause specific survival	Mortality
Clinical Success	Physiological or clinical
Death	Mortality
Duration of symptoms	Physiological or clinical
Improvement/no improvement	Physiological or clinical
Life Expectancy	Mortality
Number of relapses	Physiological or clinical
Overall mortality	Mortality
Overall survival	Mortality
Person’s own view of general health	Physiological or clinical
Presence/absence of disease or symptoms	Physiological or clinical
Remission	Physiological or clinical

How to Annotate

The table lists examples of which terms to select for commonly used outcomes

Outcome

Annotation (terms, categories, decisions)

Compliance with ...

Compliance with Treatment

Discontinuation of ...

Treatment Discontinued

Disease Specific Mortality

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Example	Annotation	Category
COPD-specific mortality	COPD AND Death	Mortality

Frequency of Medication Use

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Term

JIRA comment

Administration Of Medication

Jira

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Life expectancy

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Term

JIRA ticket for more information

Survival

Jira

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serverId	84faf8a3-76e6-3cf7-862e-a59f68644f2d
key	LDO-1292

Resolution of symptoms

Clinical Resolution

Response rate/Response to treatment

Expand

Synonyms	Domain term to use for all synonyms
Response rate	Therapeutic Response
Response to treatment
Clinical response to treatment
Response to therapy
Finding related to therapeutic response
Complete response

Safety and Tolerability

Expand

Outcome

Survival

Expand

Terms to use	Category	Notes
Progression free survival	Mortality	There are several narrower terms under the broader term Survival If survival outcomes are mentioned on their own, then use the specific term
Event free survival
Disease free survival
Overall survival

Review	Outcome	Domain	Measure	Classifcation	Notes
CD008981	Survival free of any disability	Disability	Event-Free Survival	Mortality	The aim is to annotate the "free of X" part in Outcome Domain and use the appropriate "Y-free Survival" term in Outcome Measure

Symptom Burden

D uration of Symptom or Morbidity Index

Time to ...

Expand

Time to Clinical Improvement
Time to Clinical Recovery
Time to defervescence
Time to cough	Cough
Time to Dyspnea	Dyspnea
Time till the virus nucleic acid test goes negative/ Transition time of novel coronavirus nucleic acid	2019-nCoV RT-PCR

Withdrawals due to Adverse Events

Withdrawal Due to Adverse Events

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Versions Compared

Old Version 17

New Version Current

Key

Which outcomes to annotate

Domain & Measure

Composite Outcomes

Classification categories

How to Annotate

Compliance with ...

Discontinuation of ...

Disease Specific Mortality

Frequency of Medication Use

Life expectancy

Resolution of symptoms

Response rate/Response to treatment

Safety and Tolerability

Survival

Symptom Burden

Time to ...

Withdrawals due to Adverse Events

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Page History

Versions Compared

Old Version 17

New Version Current

Key

Which outcomes to annotate

Domain & Measure

Composite Outcomes

Classification categories

How to Annotate

Compliance with ...

Discontinuation of ...

Disease Specific Mortality

Frequency of Medication Use

Life expectancy

Resolution of symptoms

Response rate/Response to treatment

Safety and Tolerability

Survival

Symptom Burden

Time to ...

Withdrawals due to Adverse Events