Background
“…the minimum that should be measured and reported in all clinical trials... The existence or use of a core outcome set does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set. Rather, there is an expectation that the core outcomes will be collected and reported, making it easier for the results of trials to be compared, contrasted and combined as appropriate; while researchers continue to explore other outcomes as well.”
Methods
Phase 1a: qualitative research with key stakeholders
Participant groups | Interviews | Focus groups | Total Participants |
---|---|---|---|
People living with dementia | 14 | 1 (n = 3) | 17 |
Care partners | 8 | 2 (n = 5,5) | 18 |
Health & social care professionals | 8 | 1 (n = 7) | 15 |
Policy makers | 4 | 0 | 4 |
Researchers | 1 | 0 | 1 |
35 | 20 | 55 |
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Phase 1: Familiarisation: repeated reading of the data and reading the data in an active way.
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Phase 2: Generating initial codes: identifying emerging codes that relate to outcome items and areas that were considered to be important to people living with dementia.
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Phase 3: Searching for themes, looking through codes to see how they fit with each other.
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Phase 4: Themes were reviewed, including merging and collating them into groups where necessary, including use of a-priori themes adapted from Bamford and Bruce’s [18] framework to refine the themes further.
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Phase 5: Themes and outcome items were defined and names finalised.
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Phase 6: Given that we were developing a list of outcome items for a Delphi survey we did not produce an emerging narrative. Instead we developed a framework of outcome items deemed important to people living with dementia. This is the key adaption to Braun and Clarke’s [26] thematic analysis.
Phase 1b: extraction of outcomes from existing trials
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People with dementia living at home in their neighbourhood/community
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People without a diagnosis of dementia (e.g. healthy older people, people with mild cognitive impairment)
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People living with dementia in any form of residential care
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Pharmacological
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Electrophysiological
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Other medical device driven interventions
Phase 1c: developing the ‘long-list’: researcher/clinician group based workshops
Results
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79 were extracted from qualitative data collection with key stakeholders
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77 were extracted from the reviewed non-pharmacological studies registered on the ALOIS database
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13 were extracted from policy documents
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One additional area was extracted from key reviews and qualitative papers.
Source | No. | Initial grouping | Outcome | Final status |
---|---|---|---|---|
Qualitative data collection (1–79) | Living with dementia | |||
1 |
Acceptance of dementia
| In long-list | ||
2 |
Access to meaningful activity and stimulation
| In long-list | ||
3 |
Access to social contact and company
| In long-list | ||
4 |
Being personally clean and comfortable
| In long-list | ||
5 |
Choice in living arrangements
| Removed (not relevant) | ||
6 |
Feeling financially secure
| In long-list | ||
7 |
Feeling safe and secure
| In long-list | ||
8 |
Having a sense of social integration
| In long-list | ||
9 |
Living in a clean and comfortable environment
| Merged (4) | ||
10 |
Maintaining a sense of self
| In long-list | ||
11 |
Maintaining a sense of who you are, role/occupation
| In long-list | ||
12 |
Self-esteem
| In long-list | ||
13 |
Having a sense of purpose
| Merged (11) | ||
14 |
Religion/spirituality
| Merged (2) | ||
15 |
Basic Activities - being able to carry out basic self-care and basic tasks
| In long-list | ||
16 |
Instrumental/more complex activities
| In long-list | ||
Maintaining cognition | ||||
17 |
Word finding/language difficulties
| In long-list | ||
18 |
Difficulties identifying/counting money/overspending
| In long-list | ||
19 |
Deterioration (fears it will ‘spread’)
| In long-list | ||
20 |
Memory
| In long-list as 2 items (short & long term memory) | ||
21 |
Visuospatial abilities
| In long-list | ||
22 |
Confusion/getting lost
| In long-list | ||
23 |
Learning new things
| In long-list | ||
Physical functioning | ||||
24 |
Physical function
| In long-list | ||
25 |
Maintaining physical function
| Merged (27) | ||
26 |
Falls
| In long-list | ||
27 |
Keeping physically active
| In long-list | ||
28 |
Balance
| In long-list | ||
29 |
Co-morbidity
| In long-list | ||
30 |
Mobility
| In long-list | ||
Maintaining relationships | ||||
31 |
Importance of relationships with family and friends
| In long-list | ||
32 |
Loss of relationships
| Merged (31) | ||
33 |
Reaction of family and friends to diagnosis
| In long-list | ||
Maximising autonomy or independence | ||||
34 |
Maintaining independence
| Became a domain - Independence | ||
35 |
Being able to make choices/being involved in choices
| Became a domain - Independence | ||
36 |
Maximising confidence
| Merged (12) | ||
37 |
Minimising loneliness or isolation
| In long-list | ||
Living with others and the environment | ||||
38 |
Access to appropriate services
| Removed (Intermediate/service/process outcome) | ||
39 | Information, i.e. having information about available services/support | Removed (Intermediate/service/process outcome) | ||
40 |
Being able to relate to other service users
| Merged (3) | ||
41 |
Being treated as an individual
| Removed (Intermediate/service/process outcome) | ||
42 |
Communication
| In long-list | ||
43 |
Continuity of hobbies and care
| Merged (2) | ||
44 |
Feeling valued and respected by others
| In long-list | ||
45 |
Having a safe and secure home
| Merged (7) | ||
46 |
Having a safe and secure neighbourhood
| In long-list | ||
47 |
Having a say in services
| Merged (41) | ||
48 |
Neighbourhood and public awareness of dementia
| Became a domain - Friendly Neighbourhood & Home | ||
49 |
Service driven provision
| Removed (process outcome) | ||
Psychological and behavioural symptoms of dementia (BPSD) | ||||
Behaviour | ||||
50 |
Frustration
| In long-list | ||
51 |
Sleeping
| In long-list | ||
52 |
Denial
| Merged (1) | ||
53 |
Aggression/abusive behaviour
| In long-list | ||
54 |
Agitation
| In long-list | ||
55 |
Apathy
| In long-list | ||
56 |
Suspicion/paranoia
| In long-list | ||
57 |
Changes in personality
| Removed (present across BPSD outcomes) | ||
58 |
Eating
| In long-list | ||
59 |
Wandering
| In long-list | ||
60 |
Inappropriate speech/disinhibition
| In long-list | ||
61 |
Repeated questioning
| In long-list | ||
62 |
Hallucinations/delusions
| In long-list | ||
Mood | ||||
63 |
Anxiety
| In long-list | ||
64 |
Embarrassment
| In long-list | ||
65 |
Happy
| In long-list | ||
66 |
Depression
| In long-list | ||
The experience of caring for a person with dementia | ||||
67 |
The effect of caregiving on the carer
| Removed (not relevant - focus not on person living with dementia) | ||
68 |
Carer reaction
| Removed (not relevant - focus not on person living with dementia) | ||
Others | ||||
69 |
Quality of life
| Became a domain - Quality of Life | ||
70 |
Lived experience
| Removed (present across many outcomes) | ||
71 |
Health and co-morbidity
| In long-list | ||
72 |
End of life planning
| Removed (Intermediate/service/process outcome) | ||
73 |
Cultural differences
| Merged (41) | ||
74 |
Cost effectiveness of interventions
| Removed (Intermediate/service/process outcome) | ||
75 |
Managing dementia
| Became a domain - ‘Self-Managing Dementia Symptoms’ | ||
76 |
Dementia progression
| Merged (19) | ||
77 |
Medical events/falls
| Merged (26) | ||
78 |
Maintaining everyday activities
| Merged (2, 15, 16) | ||
79 |
Support
| Merged (2, 3, 31, 38) | ||
Additional outcomes from literature (80–107) | 80 |
Adverse events
| Removed (not relevant) | |
81 |
Aberrant behaviours other than wandering
| Merged (59) | ||
82 |
Secretiveness
| In long-list | ||
83 |
Hopelessness
| Merged (66) | ||
84 |
Subjective memory/cognitive problems
| Merged (17–23) | ||
85 |
General cognition
| Became a domain - ‘Self-Managing Dementia Symptoms’ | ||
86 |
Alertness
| In long-list | ||
87 |
Attachment
| Merged (31–32) | ||
88 |
Personal cost to person with dementia/family
| Removed (process outcome/cost) | ||
89 |
Mortality
| Removed (not relevant) | ||
90 |
Time to significant event
| Removed (Intermediate/service/process outcome) | ||
91 |
Physical environment
| Merged (part of ‘Friendly Neighbourhoods & Home’ domain) | ||
92 |
Medications (Type; Access; management)
| Merged (15, 16) | ||
93 |
Medical health markers (cardiac rhythm, brain activation, brain volume, blood pressure)
| Merged (29, 71) | ||
94 |
Number of contacts with health and social care professionals
| Removed (Intermediate/service/process outcome) | ||
95 |
Health Behaviours
| Removed (Intermediate/service/process outcome) | ||
96 |
Weight (also BMI)
| Merged (93) | ||
97 |
Sleep
| In long-list | ||
98 |
Quality of care process outcomes
| Removed (Intermediate/service/process outcome) | ||
99 |
Health related quality of life
| Merged (Quality of Life domain and present across outcomes) | ||
100 |
Enjoyment
| Merged (present across ‘Friendly Neighbourhoods & Home’ domain) | ||
101 |
Self-efficacy
| Merged (12) | ||
102 |
Wellbeing
| Removed (present across included outcomes) | ||
103 |
Use of healthcare
| Removed (cost related, not individual outcome) | ||
104 |
Use of social resources
| Removed (cost related, not individual outcome) | ||
105 |
Use of other organisations
| Removed (cost related, not individual outcome) | ||
106 |
Unmet needs general
| Removed (not a single outcome) | ||
107 |
Satisfaction with/acceptability of intervention
| Removed (Intermediate/service/process outcome) | ||
Additional outcomes from policy (108–120) | 108 |
Timely diagnosis
| Removed (Intermediate/service/process outcome) | |
109 |
Stigma or discrimination
| Merged (44) | ||
110 |
Sense of humour
| Merged (114) | ||
111 |
Research
| Removed (not an outcome) | ||
112 |
Reaction of others or wider community
| Merged (48) | ||
113 |
Impact of diagnosis
| Merged (present across all included outcomes) | ||
114 |
Having a laugh
| In long-list | ||
115 |
Getting out of the house
| Merged (2, 34, 36) | ||
116 |
Feeling like a burden
| In long-list | ||
117 |
Faith religion or spirituality
| Merged (2) | ||
118 |
Enjoyment
| Merged (100) | ||
119 |
Empower or protection of rights
| Removed (Intermediate/service/process outcome) | ||
120 |
Dementia friendly environments
| Merged (48) | ||
Additional outcomes from key reviews and qualitative papers | 121 |
Missing something
| Merged (2, 78) | |
Added during team workshops | 122 |
Vision and hearing
| In long-list |