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Listening to the patients' voice: a conceptual framework of the walking experience

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Abstract

Background: walking is crucial for an active and healthy ageing, but the perspectives of individuals living with walking impairment are still poorly understood. Objectives: to identify and synthesise evidence describing walking as experienced by adults living with mobility-impairing health conditions and to propose an empirical conceptual framework of walking experience. Methods: we performed a systematic review and meta-ethnography of qualitative evidence, searching seven electronic databases for records that explored personal experiences of walking in individuals living with conditions of diverse aetiology. Conditions included Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture, heart failure, frailty and sarcopenia. Data were extracted, critically appraised using the NICE quality checklist and synthesised using standardised best practices. Results: from 2,552 unique records, 117 were eligible. Walking experience was similar across conditions and described by seven themes: (i) becoming aware of the personal walking experience, (ii) the walking experience as a link between individuals' activities and sense of self, (iii) the physical walking experience, (iv) the mental and emotional walking experience, (v) the social walking experience, (vi) the context of the walking experience and (vii) behavioural and attitudinal adaptations resulting from the walking experience. We propose a novel conceptual framework that visually represents the walking experience, informed by the interplay between these themes. Conclusion: a multi-faceted and dynamic experience of walking was common across health conditions. Our conceptual framework of the walking experience provides a novel theoretical structure for patient-centred clinical practice, research and public health.
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Age and Ageing 2023; 52: 110
https://doi.org/10.1093/ageing/afac233
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QUALITATIVE PAPER
Listening to the patients’ voice: a conceptual
framework of the walking experience
Laura Delgado-Ortiz1,2,3,,Ashley Polhemus4,,Alison Keogh5,Norman Sutton6,
Werner Remmele6,Clint Hansen7,Felix Kluge8,Basil Sharrack9,Clemens Becker10,
Thierry Troosters11,12,Walter Maetzler7,Lynn Rochester13,Anja Frei4,Milo A. Puhan4,
Judith Garcia-Aymerich1,2,3,
1Non-communicable diseases and Environment Programme, ISGlobal, Barcelona, Spain
2Department of Medicine and Life Sciences, Universitat Pompeu Fabra, Barcelona, Spain
3CIBER Epidemiología y Salud Pública, Barcelona, Spain
4Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
5Insight Centre for Data Analytics, University College Dublin, Dublin, Ireland
6Mobilise-D Patient and Public Advisory Group
7Department of Neurology, University Medical Center Schleswig-Holstein, Kiel, Germany
8Department of Articial Intelligence in Biomedical Engineering, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU),
Erlangen, Germany
9Department of Neuroscience and Shefeld NIHR Translational Neuroscience BRC, Shefeld Teaching Hospitals NHS Foundation
Trust & University of Shefeld, Shefeld, UK
10Depar tment of Clinical Gerontology, Robert-Bosch-Hospital, Stuttgar t, Germany
11Depar tment of Rehabilitation Sciences, KU Leuven, Leuven, Belgium
12Depar tment of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium
13Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne NE4 5PL,
UK
Address correspondence to: Judith Garcia-Aymerich, Non-communicable Diseases and Environment Programme, ISGlobal. Av.
Dr. Aiguader 88, PRBB08003 Barcelona, Spain.
Te l : ( +34) 93 214 73 80; Email: judith.garcia@isglobal.org
These authors contributed equally to this publication.
Abstract
Background: walking is crucial for an active and healthy ageing, but the perspectives of individuals living with walking
impairment are still poorly understood.
Objectives: to identify and synthesise evidence describing walking as experienced by adults living with mobility-impairing
health conditions and to propose an empirical conceptual framework of walking experience.
Methods: we performed a systematic review and meta-ethnography of qualitative evidence, searching seven electronic
databases for records that explored personal experiences of walking in individuals living with conditions of diverse aetiology.
Conditions included Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture, heart failure,
frailty and sarcopenia. Data were extracted, critically appraised using the NICE quality checklist and synthesised using
standardised best practices.
Results: from 2,552 unique records, 117 were eligible. Walking experience was similar across conditions and described by
seven themes: (i) becoming aware of the personal walking experience, (ii) the walking experience as a link between individuals’
activities and sense of self, (iii) the physical walking experience, (iv) the mental and emotional walking experience, (v) the social
walking experience, (vi) the context of the walking experience and (vii) behavioural and attitudinal adaptations resulting from
the walking experience. We propose a novel conceptual framework that visually represents the walking experience, informed
by the interplay between these themes.
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L. Delgado-Ortiz et al.
Conclusion: a multi-faceted and dynamic experience of walking was common across health conditions. Our conceptual
framework of the walking experience provides a novel theoretical structure for patient-centred clinical practice, research and
public health.
Keywords: walking, qualitative research, chronic condition, frailty, ageing, older people
Key Points
By considering the voice of the patient, we defined previously unconceptualised aspects of walking and the walking
experience.
Our findings suggest that the walking experience is similar across health conditions of diverse etiology, despite specific signs
and symptoms.
Our findings support the notion that walking experience is both a complex and meaningful aspect of health for individuals
living with diverse health conditions and that it is multi-faceted, dynamic and universal.
We propose a conceptual framework of the experience of walking, which provides a novel theoretical structure for patient-
centred clinical practice, research and public health.
Future healthy ageing efforts can be built upon our framework to remain grounded in the needs and lived experiences of
individuals.
Introduction
Walking is crucial for an active and healthy ageing [1,2].
Both the rapidly ageing population and the rise of chronic
and disabling health conditions worldwide [3] forecast an
increase in the proportion of people living with walking
impairment, as people tend to slow down and walk less
with increasing age [4,5] and in the presence of diverse
health conditions [69]. To face this challenge, research on
how to assess and modify walking and walking impairment
has become a global priority [1012]. However, for this
research to be impactful, it is imperative to understand what
is walking, and which aspects are meaningful to measure and
modify it, specifically from the perspectives of those living
with mobility-impairing health conditions.
Previous research has contributed directly or indirectly
to the conceptualisation of walking, frequently framing it
within the context of ageing [1317]. Walking is generally
defined as a method of locomotion which involves the
use of the two legs to provide both support and propul-
sion [18]. However, there is consensus that walking is not
an isolated activity and that it is influenced by contextual
barriers and facilitators [1317]. us, the International
Classification of Functioning, Disability, and Health (ICF)
[13], perhaps the best-known framework contributing to the
conceptualisation of health constructs, formulates walking
in terms of ‘body structure and function’, ‘activities and
participation’ and ‘contextual factors’ [13]. ese existing
definitions and frameworks have made important contribu-
tions to the understanding of walking and have been fre-
quently used in public health and research initiatives. How-
ever, they are all based on theoretical and clinical knowledge
and ignore the evidence arising from personal experiences.
Considered a pillar of quality in health care [19,20], personal
experiences are an important aspect of disease management,
outcome development and intervention evaluation [2124],
and they are increasingly used in decision-making processes
for health priority setting [19,20,23]. In the case of walk-
ing, personal experiences can clarify the impact of walking
impairment on people’s lives, thus suggesting priorities for
future research and public health initiatives. Despite the
existence of disease-specific evidence [2530], no attempt
has been made to conceptualise it in a broader manner, gen-
eralizable to diverse health conditions and usable in research
of multiple conditions and in health systems’ initiatives.
is study aimed to identify and synthesise evidence
describing walking as experienced by adults living with
diverse health conditions and to propose an empirical
conceptual framework of the walking experience. We
focused on a set of pre-defined, purposively selected
health conditions, representing different aetiologies (i.e.
neurological, cardiopulmonary and geriatric conditions)
of walking impairment, namely Parkinson’s disease (PD),
multiple sclerosis (MS), chronic obstructive pulmonary
disease (COPD), hip fracture, heart failure (HF), sarcopenia
and frailty.
Methods
is study consisted of a systematic review of qualitative evi-
dence and subsequent meta-ethnography (i.e. a qualitative
synthesis method that is able to generate new theory from
the comparison and interpretation of individual qualitative
studies; Figure 1)[3134]. Methods are reported adhering
to the Preferred Reporting Items for Systematic Reviews and
Meta-Analyses and the eMERGe meta-ethnography report-
ing guidance [35,36] and are described in greater detail
in the study protocol (CRD42020175038) [37]andinthe
Supplementary Appendices.
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Conceptual framework of the walking experience
Figure 1. Phases of a systematic review and meta-ethnography.
Meta-ethnography phases 1 and 2: getting started
and deciding what is relevant
We developed a systematic review search strategy in collab-
oration with clinical experts in geriatric medicine, neurol-
ogy, pneumology and physiotherapy, epidemiologists and
experts in qualitative patient experience research and an
experienced research librarian. Preliminary searches demon-
strated that an exhaustive review of walking impairment in
all health conditions was not feasible, therefore we limited
the study scope to seven highly prevalent health conditions
with diverse aetiologies and impact on walking: PD, MS,
COPD, hip fracture, HF, sarcopenia and frailty [11,2530].
We searched seven electronic databases (Medline, CINAHL,
PsychINFO, Web of Science, the Cochrane Library, Embase
and Scopus) from inception until March 2020 (Supple-
mentary Appendix 1). ese searches were supplemented
by Google Scholar searches and manual reference screening.
All peer-reviewed and grey literature were eligible, though
conference abstracts were excluded. We reviewed full-text
articles written in English, German, Spanish, French, Dutch,
Norwegian, Hebrew, Italian, Catalan or Portuguese.
Eligible records had to address research questions
related to individuals’ experiences of walking in one of
the included health conditions using qualitative research
methods. We assessed eligibility in title, abstract and full-text
screening stages, testing for consistency between reviewers
(Supplementary Appendix 2)[
38]. During title and abstract
screening, records passed to the subsequent stage if at
least one of two independent reviewers (LD-O, AP, FK or
CH) deemed them eligible. During full-text screening, two
reviewers (LD-O and AP) screened all records independently,
noting reasons for exclusion and solving disagreements
through discussion.
One reviewer (LD-O) extracted relevant information
from all studies, and another reviewer (AP) checked
extractions for accuracy (Supplementary Appendix 3).
Consistent with previous literature [39,40], studies were
critically appraised for their methodological quality using the
NICE quality appraisal checklist [41] and were classified as
acceptable or fatally flawed. Of note, methodological quality
was used to classify papers but was not considered as an
eligibility criterion. In addition, according to impact on
our study, papers were classified as key (conceptually rich
with potentially important contributions to our synthesis),
satisfactory (less conceptually rich but relevant to the
synthesis) or minimal impact papers (relevant but provided
little content of value to the synthesis; Supplementary
Appendix 4)[
39]. e impact categories were used to
organise and interpret studies during the synthesis process
but not as eligibility criterion. During meta-ethnography
3
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L. Delgado-Ortiz et al.
phases 3–6 (see below), we focused first on key papers; then,
we used satisfactory papers to refute or validate our initial
findings; and finally, we used minimal impact papers to
confirm data saturation of our results. In congruence with
the iterative nature of our work, we met frequently to discuss
emerging perceptions, assumptions and interpretations [32]
and to re-assess papers’ contributions if needed.
Meta-ethnography phase 3: reading included studies
Once all eligible studies were identified, we established a
synthesis team composed of three reviewers (LD-O, AP and
AK) with diverse backgrounds. is team re-read included
studies and individually extracted primary data coming from
participants’ quotations (labelled as first-order constructs)
and authors’ metaphors and interpretations of primary
data (labelled as second-order constructs; Supplementary
Appendix 5)[
31,32].
Meta-ethnography phase 4: determining how
studies are related
We assessed commonalities and differences between the
second-order constructs of all studies and compiled an initial
set of third-order constructs (i.e. reviewers’ interpretations
of second-order constructs) that were named as key concepts
(Supplementary Appendices 6 and 7)[32].
Meta-ethnography phase 5: translating studies into
one another
In this phase, we followed a process known in meta-
ethnographies as ‘translation’ [3134]inwhichwere-
interpreted the second-order constructs and key concepts
in each study from the perspectives of other included
studies. is re-framing allowed us to explore the nuances
of each key concept, identifying similarities and differences
between studies, contexts and patient populations. As the
starting point of translations can influence the trajectory
of the synthesis [3134], we first grouped studies by
condition and translated them within conditions following
a chronological order. en, we translated the translations
from each condition into the others, with each reviewer
starting from a different point. is prevented a dispro-
portionate influence of one condition or study over the
rest and forced us to actively challenge the conceptions
formed during earlier phases of the synthesis. During
the translation process, we grouped key concepts into
a second set of third-order constructs that we named
themes (i.e. reviewers’ interpretations of key concepts;
Supplementary Appendix 8).
Meta-ethnography phases 6 and 7: synthesizing
translations and expressing the synthesis
We addressed themes as a whole using several standardised
synthesis techniques (i.e. reciprocal, refutational and line
of argument synthesis) [3134] and proposed a concep-
tual framework that described how walking is experienced
across diverse health conditions. We invited five members
of Mobilise-D Patient and Public Advisory Group [42](two
diagnosed with PD, two with MS and one with COPD) to
assess the proposed conceptual framework for face validity
(i.e. to discuss it within the context of their own experiences
and perspectives). Where appropriate, we took their feed-
back into consideration to clarify or re-frame our results.
Moreover, we invited two of them to critically review and
co-author this publication (NS and WR).
Results
Search results
Searches identified 2,552 unique records of which 450
underwent full-text review. Ultimately, 117 studies were
eligible for the meta-ethnography (Figure 2). Eligible studies
represented all included conditions except for sarcopenia.
Agreement among reviewers was substantial (Fleiss’ K=0.64
between four raters) and almost perfect (Cohen’s K= 0.98)
during abstract and full-text screening, respectively. Seven-
teen of the included studies were classified as key papers,
36 as satisfactory papers and 64 as minimal impact papers.
With regard to methodological quality, 102 studies were
considered acceptable and 15 were considered fatally flawed.
Characteristics and critical appraisal of included studies are
described in greater detail in Supplementary Appendices 3
and 4.
Themes of the walking experience
From eligible studies, we extracted the first- and second-
order constructs and subsequently identified 32 key con-
cepts describing different aspects of the walking experience
(Supplementary Appendixes 6 and 7). ese key concepts
were common to all conditions and therefore were grouped
into seven inter-related themes that explain the experience of
walking in the presence of diverse health conditions (Supple-
mentary Appendix 8). emes were identified in all included
conditions and are described as in the following text.
Becoming aware of the personal walking experience
We consistently identified that, in the presence of signs and
symptoms of mobility-impairing health conditions, walking
deteriorates and begins to require conscious effort, resulting
in an awareness of walking which is not present when
walking is unimpaired. From the moment (or moments) in
which changes in walking are noticed, individuals become
increasingly aware of their need to increase physical exertion,
concentrate, plan ahead and adapt to complex environments.
From then on, they realise the integral role of walking in their
daily activities and often compare their current experiences
to an effortless past in which walking was perceived as easy
and automatic (Supplementary Appendix 8).
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Conceptual framework of the walking experience
Figure 2. Flow diagram of included studies.
The walking experience as a link between individuals’ activities
and sense of self
e walking experience relates to individuals’ desire to per-
form activities which could potentially be hampered by
impairment. ese walking-related activities of daily living
may be basic (such as bathing or dressing), instrumental
(such as performing household chores or grocery shopping),
leisurely (such as engaging in a hobby or dog walking) or
work-related. Experiences reflect both the ability to per-
form these activities as well as the walking-related adverse
events experienced during these activities, such as falls or
symptom exacerbations. Walking is symbolic of indepen-
dence, control, normalcy and well-being because it governs
one’s ability to engage in activities safely. When walking
impairments affect activities associated with domestic and
social roles, they indirectly challenge individuals’ sense of
self. us, individuals’ sense of self is inextricably linked to
the walking-related activity through the walking experience
(Supplementary Appendix 8).
The physical walking experience
Individuals consistently described a physical experience
of walking, which is characterised by an overall loss of
physical function. Common signs and symptoms of each
condition affect—or are affected by—walking performance
both directly and indirectly. Many of these signs and
symptoms are common across conditions, including fatigue,
pain, weakness and lack of balance. Changes to walking
performance, such as slowed walking speed, altered step
patterns and reduced ability to take long walks, are also
common. Unpredictable symptoms cause walking ability
and walking experiences to vary from day to day and
even hour to hour. Walking impairments also raise notable
physical safety risks associated with falling, exacerbation
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L. Delgado-Ortiz et al.
or becoming stranded when the walking ability suddenly
changes (Supplementary Appendix 8).
The mental and emotional walking experience
Across all conditions, individuals describe walking as a com-
plex mental and emotional experience. Initial experiences
of mourning and loss are almost universal as individuals
become aware of their walking impairments. ereafter,
walking is often accompanied by feelings of fear, anxiety,
stress, anger, frustration and embarrassment during or in
anticipation of walking activities. Fear and anxiety often
cause withdrawal and reduced participation, resulting in
feelings of loneliness and hopelessness. As walking becomes
increasingly effortful, additional motivation is required to
initiate and complete activities, though the desire to main-
tain fitness or health increases motivation to walk. In this
context, walking-related activities are frequently framed as
goals that, when successfully completed, lead to positive
feelings of satisfaction, fulfilment and achievement (Supple-
mentary Appendix 8).
The social walking experience
Individuals describe a social experience of walking which
can be enhanced or hindered by walking impairments.
Individuals’ social networks influence walking experiences at
home, at work and in the broader community and therefore
moderate the ability to sustain participation in daily life.
Individuals assume different roles and identities within these
networks, which are typically influenced by social and gender
norms and frequently threatened by walking impairment.
e availability of social support often influences individuals’
engagement in activities which require walking, with lack of
support leading to withdrawal, decreased participation and
social isolation. Supportive networks accommodate walking
impairments and foster a sense of belonging, whereas
unsupportive networks prompt a sense of otherness when
unwanted visible impairments lead to social judgement or
misconceptions (Supplementary Appendix 8).
The context of the walking experience
Physical, mental and emotional and social experiences of
walking are framed within physical, social-cultural and per-
sonal contexts. Physical contexts include indoor and out-
door environments in individuals’ life spaces. e home is
perceivedbothasasafe,familiarspaceandasachallenging
space where falls often occur and obstacles are difficult to
navigate. Neighbourhoods and communal spaces challenge
individuals with uneven surfaces and crowds, demanding
extra attention and often triggering additional walking diffi-
culties. At the community level, walking impairments limit
individuals’ ability to use powered transportation such as
buses. Furthermore, weather and climate often make walk-
ing more dangerous or difficult. e socio-cultural context
includes social and cultural norms, which determine whether
individuals engage in certain walking-related activities or
not. Individuals often compare themselves to others to assess
and contextualise their own level of walking impairment.
Finally, the personal context includes personal attitudes, past
experiences, ageing, the presence of comorbidities and other
characteristics that could impact the walking experience
(Supplementary Appendix 8).
Behavioural and attitudinal adaptations resulting from the
walking experience
Walking experiences frequently prompt attitudinal and
behavioural responses, many of which entail strategies
for coping with the effects of walking impairment. Some
strategies, such as engaging in structured exercise or
participating in interventions, aim to maintain function.
Others aim to manage changing abilities through staying
positive, planning ahead, pacing or adopting assistive
technologies. Many of these strategies, especially the
adoption of assistive technologies, carry a psychological
toll as individuals grapple with their changing abilities and
identities. In many cases, individuals are forced to prioritise
among activities that are considered of high value and
may ultimately choose to forego activities that become too
dangerous, difficult or psychologically daunting. Changes in
behaviour often reflect attitudinal changes towards walking-
related activities, physical activity, social priorities and the
future (Supplementary Appendix 8).
Conceptual framework describing walking as
experienced in the presence of chronic conditions
Using the seven identified themes, we developed a concep-
tual framework that visually represents the experience of
walking for individuals living with health conditions which
impair walking (Figure 3). Briefly, walking experience is
multi-faceted, with constant interplay between its physical,
emotional and social components. Walking experience is
framed by the context (physical, socio-cultural and/or per-
sonal) and the activities individuals aim to perform. More-
over, the walking experience creates a link between daily
activities and the sense of self as changing abilities shape
social roles, attitudes and behaviours over time.
Discussion
In this systematic review and meta-ethnography, we synthe-
sised 117 qualitative research studies addressing the walking
experience from the perspective of individuals living with
diverse health conditions. We found that the experience of
walking is: (i) multi-faceted, as it is composed by seven inter-
related themes; (ii) similar across conditions of diverse aeti-
ologies and (iii) dynamic, as the walking experience is con-
stantly modifying and modified by the context, the specific
activities and the individual’s behaviour and sense of self.
Based on these findings, we propose a novel framework to
describe walking, informed by the experiences of individuals
living with diverse health conditions.
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Conceptual framework of the walking experience
Figure 3. Conceptual framework describing walking as experienced in the presence of diverse health conditions. e framework
uses the metaphor of a mechanical system to explain how people experience walking from the moment they become aware of it.
Physical, social and mental walking experiences are framed by context and the activity at hand. ese experiences link an individual’s
walking-related activities to their sense of self through behavioural and attitudinal adaptations. Reflexively, the individual’s newly
revised sense of self, behaviours and attitudes affect future experiences and participation in walking-related activities.
Main results and comparison with previous research
We identified the experience of walking as a multi-faceted
concept, supporting and advancing previous conceptualisa-
tions of walking. e aspects of our framework related to
activities, physical and social experiences, and adaptations
align with the concepts ‘body structure and function’ and
‘activities and participation’ of the ICF model [13]. Simi-
larly, context and adaptations are consistent with previous
frameworks considering these factors as part of walking [13
17]. Importantly, our study identified themes that were
not addressed by previous conceptualisations, such as the
awareness, sense of self, mental experience and attitudes.
ese themes were closely interrelated with, but distinct
from, previously identified concepts. By considering the
voice of the patient, we defined previously unconceptu-
alised aspects of walking which are meaningful to individ-
uals, thus contributing directly into one of the four action
areas of the United Nations’ Decade of Healthy Ageing
(2021–2030) [1].
A surprising finding of this meta-ethnography is that
walking experiences are similar across health conditions
despite diverse signs and symptoms. is finding chal-
lenges traditional disease-focused and function-centric
perspectives which interpret walking impairments in terms
of a condition’s hallmark symptoms. Our results show
that walking should be assessed not only according to
clinical milestones but also according to its personal
meaning and impact [24]. is reflection resembles early
discussions on integrated care when the care for patients
with chronic or disabling health conditions faced problems
of fragmentation, incoordination, discontinuity across time,
place and discipline [4347]. By assuming the patient-
centred perspective of integrated care also in the walking
field [43,46], walking impairments remain disease-specific,
but walking experience becomes a universal concept.
Our conceptual framework suggests a dynamic mecha-
nism by which the physical, mental and social experiences
of walking constantly change, modify and are modified by
the performance of walking-related activities and by the
individual’s sense of self. At the same time and in response
to walking experiences, individuals are constantly changing
their attitudes and adapting their behaviour. As an exam-
ple, an individual who can no longer go grocery shopping
independently (activities and sense of self) due to a disabling
health condition may decide to start using a cane regularly
(adaptations) which changes their physical, mental and social
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L. Delgado-Ortiz et al.
experiences of walking. is dynamic nature of the walking
experience aligns with established theories describing the
impact of health conditions on life experiences, such as
normalisation (i.e. constant adaptation to a ‘new normal’)
[48] or the shifting perspectives model [49]. us, our frame-
work of walking experience suggests that repeated walking
assessments should complement current clinical assessments
of disabling health conditions to enable appropriate and
meaningful health care.
Clinical relevance
Our findings confirm that walking is a meaningful aspect
of health which should be addressed in regular clinical
practice even when it is only indirectly affected by a
condition’s underlying aetiology. As key providers of
healthcare treatments and advice, clinicians are encouraged
to: (i) assess walking experience regularly and repeatedly as a
multi-faceted vital sign, since this will provide them with
useful information on how they can help patients meet
their long term care needs, improve their quality of life
and maintain independence at older ages. Assessment may
include a conversation with patients to ask about how they
perceive and experience changes in their everyday walking
(i.e. how this affects their ability to carry out their daily
routine activities such as going to the shops, crossing the road
and any other personal, social and work-related challenges
they experience). It may also include the perceptions of
carers/partners or other family members where possible,
and it may also consider formal tools to assess patients’
perception and capacity of walking and if this has changed;
(ii) provide adequate and targeted walking advise to patients
according to their individual physical, mental and social
conditions and needs, and (iii) eventually refer them to allied
professionals to prompt secondary or tertiary prevention
strategies [50] that also take into consideration the walking-
related activities patients want to perform, the context in
which they walk and the changes in their attitudes and
adaptations to the presence of walking impairment.
Implications
is study provides a novel theoretical structure for future
work in the context of an active and healthy ageing [1,
2,51], and therefore it also has important implications
for research and public health. First, future research should
complement current methods for measuring walking, which
predominantly reflect mechanics and lower limb function,
with innovative tools which reflect the lived experience of
walking [11,12,52]. ese tools should capture aspects of
the walking experience which are meaningful to individuals
[12,24] and, once validated, should be used as outcome
measures in drug and non-drug therapeutic and preventive
trials as well as in observational studies to describe levels,
correlates and changes over time in walking experience [12,
52]. As an example, the recently developed and validated
PROactive Physical Activity (PPAC) suite of instruments
in COPD measure patients’ experience of physical activity
[53,54] and have provided both better characterisation of
physical activity [55] and a deeper understanding of the
effectiveness of drug interventions [56,57] than objectively
measured physical activity. Second, our results contribute to
current healthy ageing international efforts by establishing a
detailed list of interrelated themes and a conceptual frame-
work upon which new public health interventions and care
delivery modes can be built [1].
Strengths and limitations
Our study has some limitations. First, we considered evi-
dence arising from six chronic conditions with variable levels
of evidence. To avoid bias or the undue influence of a
single condition, these six were chosen carefully to reflect
diversity, and evidence was considered through a thorough,
standardised synthesis process. Still, the generalizability of
our framework to other health conditions, such as rheumatic
diseases, should be confirmed. Second, by excluding studies
written in languages unfamiliar to the review team, we
might have missed evidence arising from different socio-
cultural contexts. ird, we considered evidence available
until March 2020 and it is possible that potentially relevant
studies have been published since then. However, taking into
consideration that we reached conceptual saturation during
the synthesis process [58], the inclusion of more recent
studies would likely yield similar results.
Our review also has several strengths. First, we ensured
methodological rigour by strictly adhering to appropriate
guidance for synthesizing qualitative evidence [35,36]. Sec-
ond, the review and synthesis teams included researchers
from diverse personal and professional backgrounds. is
diversity fostered discussion and challenged each member
to evaluate studies from multiple perspectives. ird, we
considered the theoretical and methodological contexts of
individual studies while discussing our findings and inter-
pretations. Finally, we assessed the validity of our synthesis
and conceptual framework through member checking with
individuals living with the health conditions under study.
Conclusion
We found that a multi-faceted and dynamic experience of
walking is common across mobility-impairing health condi-
tions and proposed a conceptual framework of the walking
experience which provides a novel theoretical structure for
patient-centred clinical practice, research and public health.
Supplementary Data: Supplementary data mentioned in
the text are available to subscribers in Age and Ageing online.
Acknowledgements: is work was supported by the
Mobilise-D project that has received funding from the
Innovative Medicines Initiative 2 Joint Undertaking (JU)
under grant agreement No. 820820. is JU receives support
from the European Union’s Horizon 2020 research and
innovation programme and the European Federation of
8
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Conceptual framework of the walking experience
Pharmaceutical Industries and Associations (EFPIA). Con-
tent in this publication reflects the authors’ view and neither
IMI nor the European Union, EFPIA or any associated
partners are responsible for any use that may be made of
the information contained herein. ISGlobal acknowledges
support from the Spanish Ministry of Science, Innovation,
and Universities through the ‘Centro de Excelencia Severo
Ochoa 2019–2023’ Programme (CEX2018-000806-S) and
support from the Generalitat de Catalunya through the
CERCA Programme.
Declaration of Conflicts of Interest: W.M. receives or
received funding from the European Union, the German
Federal Ministry of Education of Research, Michael J.
Fox Foundation, Robert Bosch Foundation, Neuroalliance,
Lundbeck and Janssen. He received speaker honoraria from
Abbvie, Bayer, GlaxoSmithKline, Licher MT, Rölke Pharma
and UCB and was invited to Advisory Boards of Abbvie,
Biogen, Lundbeck and Market Access & Pricing Strategy
GmbH and is an advisory board member of the Critical
Path for Parkinson’s Consortium. He serves as the co-chair
of the MDS Technology Task Force. L.R. is supported
by the National Institute for Health Research Newcastle
Biomedical Research Centre (BRC) based at Newcastle upon
Tyne Hospital NHS Foundation Trust and Newcastle Uni-
versity. B.S. is supported by the Sheffield BRC based at the
Sheffield Teaching Hospital and the University of Sheffield.
e remaining authors declare no competing interests.
Declaration of Sources of Funding: is work was sup-
ported by Mobilise-D, a European project that has received
funding from the Innovative Medicines Initiative 2 Joint
Undertaking under grant agreement No. 820820. e fun-
der did not play a role in the study design, data collection,
analysis, interpretation of data, writing of the report or in the
decision to submit the paper for publication.
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... One such area in which PPIE work has the potential to be hugely impactful is the measurement of mobility. Mobility is heralded as the sixth vital sign [25], as it is a significant indicator of mortality and quality of life [26][27][28][29]. Measuring mobility in the real world is a complex task that requires significant clinical and technical expertise [30], which would greatly benefit from the insights of patients with chronic conditions that impact their mobility. ...
... The PPAG contributors supported the interpretation of results on a key research output around the perception and experience of real-world mo-Conceptual framework of walking bility from the patient perspective. The contributors coauthored the manuscript [29]. ...
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Although the value of patient and public involvement and engagement (PPIE) activities in the development of new interventions and tools is well known, little guidance exists on how to perform these activities in a meaningful way. This is particularly true within large research consortia that target multiple objectives, include multiple patient groups, and work across many countries. Without clear guidance, there is a risk that PPIE may not capture patient opinions and needs correctly, thereby reducing the usefulness and effectiveness of new tools. Mobilise-D is an example of a large research consortium that aims to develop new digital outcome measures for real-world walking in 4 patient cohorts. Mobility is an important indicator of physical health. As such, there is potential clinical value in being able to accurately measure a person’s mobility in their daily life environment to help researchers and clinicians better track changes and patterns in a person’s daily life and activities. To achieve this, there is a need to create new ways of measuring walking. Recent advancements in digital technology help researchers meet this need. However, before any new measure can be used, researchers, health care professionals, and regulators need to know that the digital method is accurate and both accepted by and produces meaningful outcomes for patients and clinicians. Therefore, this paper outlines how PPIE structures were developed in the Mobilise-D consortium, providing details about the steps taken to implement PPIE, the experiences PPIE contributors had within this process, the lessons learned from the experiences, and recommendations for others who may want to do similar work in the future. The work outlined in this paper provided the Mobilise-D consortium with a foundation from which future PPIE tasks can be created and managed with clearly defined collaboration between researchers and patient representatives across Europe. This paper provides guidance on the work required to set up PPIE structures within a large consortium to promote and support the creation of meaningful and efficient PPIE related to the development of digital mobility outcomes.
... One such area in which PPIE work has the potential to be hugely impactful is the measurement of mobility. Mobility is heralded as the sixth vital sign [25], as it is a significant indicator of mortality and quality of life [26][27][28][29]. Measuring mobility in the real world is a complex task that requires significant clinical and technical expertise [30], which would greatly benefit from the insights of patients with chronic conditions that impact their mobility. ...
... The PPAG contributors supported the interpretation of results on a key research output around the perception and experience of real-world mo-Conceptual framework of walking bility from the patient perspective. The contributors coauthored the manuscript [29]. ...
Preprint
Full-text available
UNSTRUCTURED Mobility is an important indicator of physical health. As such there is potential clinical value in being able to measure mobility accurately in a person’s home and daily life environment to help researchers and clinicians to better track changes and patterns in a person’s daily lives and activities. To do this, there is a need to create new ways of measuring walking. Recent advancements in digital technology are helping researchers to do this. However, before any new measure can be used, researchers, healthcare professionals and regulators need to know that the digital method is accurate and that it is both accepted and produces meaningful outcomes for the patients and clinicians. Researchers must therefore include patients, or members of patient organisations, in the development of such new tools in a process known as patient and public involvement and engagement (PPIE). Although the value and importance of PPIE activities is well-known, little guidance exists on how to do this in a meaningful way. This is particularly true within large research consortia that target multiple objectives, include multiple patient groups and work across many countries. Without clear guidance, the risk is that PPIE does not capture patient opinions and needs correctly, thereby reducing the usefulness and effectiveness of new tools. Mobilise-D is an example of such a large research consortium, that is looking to develop new digital outcome measures for real-world walking in patients with Parkinson’s Disease, Multiple Sclerosis, Chronic Obstructive Pulmonary Disease, and Proximal Femoral Fracture. This paper outlines how PPIE structures were developed in this consortium, providing detail about how this happened, the steps taken to implement PPIE, the experiences PPIE contributors have had within this process, the lessons learned from it, and recommendations for others who may want to do similar work in the future. The work outlined within this paper has provided the Mobilise-D consortium with a foundation from which future PPIE tasks can be created and managed with clearly defined collaboration between researchers and patient representatives across Europe. This paper provides guidance around the work required to set up PPIE structures within a large consortium, to promote and support the creation of meaningful and efficient PPIE related to the development of digital mobility outcomes.
... Their work includes an exhaustive literature review of qualitative evidence of meaningfulness of walking. Patients were directly involved in the interpretation of the findings, where they helped identify several concepts of walking experience that are universally meaningful 42,43 . This level of patient engagement confirms that development efforts are rooted in patient experience. ...
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Digital health technologies (DHTs) have the potential to modernize drug development and clinical trial operations by remotely, passively, and continuously collecting ecologically valid evidence that is meaningful to patients’ lived experiences. Such evidence holds potential for all drug development stakeholders, including regulatory agencies, as it will help create a stronger evidentiary link between approval of new therapeutics and the ultimate aim of improving patient lives. However, only a very small number of novel digital measures have matured from exploratory usage into regulatory qualification or efficacy endpoints. This shows that despite the clear potential, actually gaining regulatory agreement that a new measure is both fit-for-purpose and delivers value remains a serious challenge. One of the key stumbling blocks for developers has been the requirement to demonstrate that a digital measure is meaningful to patients. This viewpoint aims to examine the co-evolution of regulatory guidance in the United States (U.S.) and best practice for integration of DHTs into the development of clinical outcome assessments. Contextualizing guidance on meaningfulness within the larger shift towards a patient-centric drug development approach, this paper reviews the U.S. Food and Drug Administration (FDA) guidance and existing literature surrounding the development of meaningful digital measures and patient engagement, including the recent examples of rejections by the FDA that further emphasize patient-centricity in digital measures. Finally, this paper highlights remaining hurdles and provides insights into the established frameworks for development and adoption of digital measures in clinical research.
... Physical mobility, such as walking, is a key predictor of health [1], and is considered a multi-faceted experience which interconnects the physical, mental, social and emotional needs of an individual with their sense of self [2,3]. Loss of physical mobility (e.g., reduced volume of walking) is associated with increased safety risks (e.g., falls), social withdrawal and poorer wellbeing [4,5]. ...
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Background Walking is important for maintaining physical and mental well-being in aged residential care (ARC). Walking behaviors are not well characterized in ARC due to inconsistencies in assessment methods and metrics as well as limited research regarding the impact of care environment, cognition, or physical function on these behaviors. It is recommended that walking behaviors in ARC are assessed using validated digital methods that can capture low volumes of walking activity. Objective This study aims to characterize and compare accelerometry-derived walking behaviors in ARC residents across different care levels, cognitive abilities, and physical capacities. Methods A total of 306 ARC residents were recruited from the Staying UpRight randomized controlled trial from 3 care levels: rest home (n=164), hospital (n=117), and dementia care (n=25). Participants’ cognitive status was classified as mild (n=87), moderate (n=128), or severe impairment (n=61); physical function was classified as high-moderate (n=74) and low-very low (n=222) using the Montreal Cognitive Assessment and the Short Physical Performance Battery cutoff scores, respectively. To assess walking, participants wore an accelerometer (Axivity AX3; dimensions: 23×32.5×7.6 mm; weight: 11 g; sampling rate: 100 Hz; range: ±8 g; and memory: 512 MB) on their lower back for 7 days. Outcomes included volume (ie, daily time spent walking, steps, and bouts), pattern (ie, mean walking bout duration and alpha), and variability (of bout length) of walking. Analysis of covariance was used to assess differences in walking behaviors between groups categorized by level of care, cognition, or physical function while controlling for age and sex. Tukey honest significant difference tests for multiple comparisons were used to determine where significant differences occurred. The effect sizes of group differences were calculated using Hedges g (0.2-0.4: small, 0.5-0.7: medium, and 0.8: large). Results Dementia care residents showed greater volumes of walking ( P <.001; Hedges g =1.0-2.0), with longer ( P <.001; Hedges g =0.7-0.8), more variable ( P =.008 vs hospital; P <.001 vs rest home; Hedges g =0.6-0.9) bouts compared to other care levels with a lower alpha score (vs hospital: P <.001; Hedges g =0.9, vs rest home: P =.004; Hedges g =0.8). Residents with severe cognitive impairment took longer ( P <.001; Hedges g =0.5-0.6), more variable ( P< .001; Hedges g =0.4-0.6) bouts, compared to those with mild and moderate cognitive impairment. Residents with low-very low physical function had lower walking volumes (total walk time and bouts per day: P <.001; steps per day: P =.005; Hedges g =0.4-0.5) and higher variability ( P =.04; Hedges g =0.2) compared to those with high-moderate capacity. Conclusions ARC residents across different levels of care, cognition, and physical function demonstrate different walking behaviors. However, ARC residents often present with varying levels of both cognitive and physical abilities, reflecting their complex multimorbid nature, which should be considered in further work. This work has demonstrated the importance of considering a nuanced framework of digital outcomes relating to volume, pattern, and variability of walking behaviors among ARC residents.
... Reduced physical mobility is associated with poorer health outcomes in healthy individuals as well as those with chronic disease [1][2][3][4][5]. People with COPD regard mobility limitation as a key aspect of their health [6] and there is considerable evidence linking reduced mobility, especially walking ability, to lung function decline, quality of life, hospitalisation risk, falls, acute exacerbations and mortality [7][8][9][10][11][12]. ...
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Background Reduced mobility is a central feature of COPD. Assessment of mobility outcomes that can be measured digitally (digital mobility outcomes (DMOs)) in daily life such as gait speed and steps per day is increasingly possible using devices such as pedometers and accelerometers, but the predictive value of these measures remains unclear in relation to key outcomes such as hospital admission and survival. Methods We conducted a systematic review, nested within a larger scoping review by the MOBILISE-D consortium, addressing DMOs in a range of chronic conditions. Qualitative and quantitative analysis considering steps per day and gait speed and their association with clinical outcomes in COPD patients was performed. Results 21 studies (6076 participants) were included. Nine studies evaluated steps per day and 11 evaluated a measure reflecting gait speed in daily life. Negative associations were demonstrated between mortality risk and steps per day (per 1000 steps) (hazard ratio (HR) 0.81, 95% CI 0.75–0.88, p<0.001), gait speed (<0.80 m·s ⁻¹ ) (HR 3.55, 95% CI 1.72–7.36, p<0.001) and gait speed (per 1.0 m·s ⁻¹ ) (HR 7.55, 95% CI 1.11–51.3, p=0.04). Fewer steps per day (per 1000) and slow gait speed (<0.80 m·s ⁻¹ ) were also associated with increased healthcare utilisation (HR 0.80, 95% CI 0.72–0.88, p<0.001; OR 3.36, 95% CI 1.42–7.94, p=0.01, respectively). Available evidence was of low-moderate quality with few studies eligible for meta-analysis. Conclusion Daily step count and gait speed are negatively associated with mortality risk and other important outcomes in people with COPD and therefore may have value as prognostic indicators in clinical trials, but the quantity and quality of evidence is limited. Larger studies with consistent methodologies are called for.
... Based on a recent expert consensus, physical mobility includes several domains that should be addressed, including gait volume, pace, cadence, asymmetry, gait phases, and gait variability [57]. This is also mirrored in a recent meta-ethnography of more than 120 qualitative studies summarizing patient perception of walking and mobility [58]. In this paper, patients largely agreed that aspects such as walking distance, perceived safety and balance concerns, and additional cognitive effort of walking are major features of walking capacity and affect walking activities, irrespective of their underlying conditions. ...
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Few older adults regain their pre-fracture mobility after a hip fracture. Intervention studies evaluating effects on gait typically use short clinical tests or in-lab parameters that are often limited to gait speed only. Measurements of mobility in daily life settings exist and should be considered to a greater extent than today. Less than half of hip fracture patients regain their pre-fracture mobility. Mobility recovery is closely linked to health status and quality of life, but there is no comprehensive overview of how gait has been evaluated in intervention studies on hip fracture patients. The purpose was to identify what gait parameters have been used in randomized controlled trials to assess intervention effects on older people’s mobility recovery after hip fracture. This scoping review is a secondary paper that identified relevant peer-reviewed and grey literature from 11 databases. After abstract and full-text screening, 24 papers from the original review and 8 from an updated search and manual screening were included. Records were eligible if they included gait parameters in RCTs on hip fracture patients. We included 32 papers from 29 trials (2754 unique participants). Gait parameters were primary endpoint in six studies only. Gait was predominantly evaluated as short walking, with gait speed being most frequently studied. Only five studies reported gait parameters from wearable sensors. Evidence on mobility improvement after interventions in hip fracture patients is largely limited to gait speed as assessed in a controlled setting. The transition from traditional clinical and in-lab to out-of-lab gait assessment is needed to assess effects of interventions on mobility recovery after hip fracture at higher granularity in all aspects of patients’ lives, so that optimal care pathways can be defined.
... In this Research Topic, we called for papers exploring the link between mobility and cognitive impairment in older adults. Being mobile, i.e., being able to walk or transport oneself safely and efficiently, is vital for independence and wellbeing, as well as for connecting our physical, mental, social and emotional needs with our sense of self (Rantakokko et al., 2013;Delgado-Ortiz et al., 2023). Additionally, gait and mobility are useful actions to analyze, as multiple (if not all) organ systems and body segments are involved (Hausdorff, 2005). ...
... Ownership for patient involvement should be across the consortium, and the identification of needs and expectations for the process should be undertaken early on with patient advisers. This approach has already demonstrated positive impact on the larger project and on study protocols, including articulating measurement concepts which form the basis of all study protocols and regulatory proceedings [58] and very high levels of acceptability for the digital technologies being explored in the project [59]. ...
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Background: Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers, and the clinical evidence used to drive drug development and disease management. Reaching this vision will require achieving a new level of co-creation between the stakeholders who design, develop, use, and make decisions using evidence from digital measures. Summary: In September 2022, the second in a series of meetings hosted by the Swiss Federal Institute of Technology in Zürich, the Foundation for the National Institutes of Health Biomarkers Consortium, and sponsored by Wellcome Trust, entitled "Reverse Engineering of Digital Measures," was held in Zurich, Switzerland, with a broad range of stakeholders sharing their experience across four case studies to examine how patient centricity is essential in shaping development and validation of digital evidence generation tools. Key messages: In this paper, we discuss progress and the remaining barriers to widespread use of digital measures for evidence generation in clinical development and care delivery. We also present key discussion points and takeaways in order to continue discourse and provide a basis for dissemination and outreach to the wider community and other stakeholders. The work presented here shows us a blueprint for how and why the patient voice can be thoughtfully integrated into digital measure development and that continued multistakeholder engagement is critical for further progress.
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Introduction The clinical validity of real-world walking cadence in people with chronic obstructive pulmonary disease (COPD) is unsettled. Objective: to assess the levels, variability and association with clinically relevant COPD characteristics and outcomes of real-world walking cadence. Methods We assessed walking cadence (steps per minute during walking bouts >10 s) from 7-days accelerometer data in 593 individuals with COPD from five European countries, and clinical and functional characteristics from validated questionnaires and standardised tests. Severe exacerbations during 12-months follow-up were recorded from patient reports and medical registries. Results Participants were mostly male (80%) and had mean ( sd ) age 68 (8) years, post-bronchodilator FEV 1 57 (19)%, and 6880 (3926) steps/day. Mean walking cadence was 88 steps/min, followed a normal distribution ( sd =9), and was highly stable within-person (ICC 0.92 (95%CI 0.90–0.93)). After adjusting for age, sex, height and number of walking bouts in fractional polynomial or linear regressions, walking cadence was positively associated with FEV 1, 6-min walk distance, physical activity (steps/day, time in moderate-to-vigorous physical activity, vector magnitude units, walking time, intensity during locomotion), physical activity experience and health-related quality of life; and negatively associated with breathlessness and depression (all p<0.05). These associations remained after further adjustment for daily steps. In negative binomial regression adjusted for multiple confounders, walking cadence related to lower number of severe exacerbations during follow-up (IRR 0.94 per step/min, 95%CI 0.91–0.99, p=0.009). Conclusions Higher real-world walking cadence is associated with better COPD status and lower severe exacerbations risk, which makes it attractive as future prognostic marker and clinical outcome.
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Introduction Existing mobility endpoints based on functional performance, physical assessments and patient self-reporting are often affected by lack of sensitivity, limiting their utility in clinical practice. Wearable devices including inertial measurement units (IMUs) can overcome these limitations by quantifying digital mobility outcomes (DMOs) both during supervised structured assessments and in real-world conditions. The validity of IMU-based methods in the real-world, however, is still limited in patient populations. Rigorous validation procedures should cover the device metrological verification, the validation of the algorithms for the DMOs computation specifically for the population of interest and in daily life situations, and the users’ perspective on the device. Methods and analysis This protocol was designed to establish the technical validity and patient acceptability of the approach used to quantify digital mobility in the real world by Mobilise-D, a consortium funded by the European Union (EU) as part of the Innovative Medicine Initiative, aiming at fostering regulatory approval and clinical adoption of DMOs. After defining the procedures for the metrological verification of an IMU-based device, the experimental procedures for the validation of algorithms used to calculate the DMOs are presented. These include laboratory and real-world assessment in 120 participants from five groups: healthy older adults; chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, proximal femoral fracture and congestive heart failure. DMOs extracted from the monitoring device will be compared with those from different reference systems, chosen according to the contexts of observation. Questionnaires and interviews will evaluate the users’ perspective on the deployed technology and relevance of the mobility assessment. Ethics and dissemination The study has been granted ethics approval by the centre’s committees (London—Bloomsbury Research Ethics committee; Helsinki Committee, Tel Aviv Sourasky Medical Centre; Medical Faculties of The University of Tübingen and of the University of Kiel). Data and algorithms will be made publicly available. Trial registration number ISRCTN (12246987).
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Physical mobility is essential to health, and patients often rate it as a high-priority clinical outcome. Digital mobility outcomes (DMOs), such as real-world gait speed or step count, show promise as clinical measures in many medical conditions. However, current research is nascent and fragmented by discipline. This scoping review maps existing evidence on the clinical utility of DMOs, identifying commonalities across traditional disciplinary divides. In November 2019, 11 databases were searched for records investigating the validity and responsiveness of 34 DMOs in four diverse medical conditions (Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture). Searches yielded 19,672 unique records. After screening, 855 records representing 775 studies were included and charted in systematic maps. Studies frequently investigated gait speed (70.4% of studies), step length (30.7%), cadence (21.4%), and daily step count (20.7%). They studied differences between healthy and pathological gait (36.4%), associations between DMOs and clinical measures (48.8%) or outcomes (4.3%), and responsiveness to interventions (26.8%). Gait speed, step length, cadence, step time and step count exhibited consistent evidence of validity and responsiveness in multiple conditions, although the evidence was inconsistent or lacking for other DMOs. If DMOs are to be adopted as mainstream tools, further work is needed to establish their predictive validity, responsiveness, and ecological validity. Cross-disciplinary efforts to align methodology and validate DMOs may facilitate their adoption into clinical practice.
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Digital mobility assessment using wearable sensor systems has the potential to capture walking performance in a patient’s natural environment. It enables monitoring of health status and disease progression and evaluation of interventions in real-world situations. In contrast to laboratory settings, real-world walking occurs in non-conventional environments and under unconstrained and uncontrolled conditions. Despite the general understanding, there is a lack of agreed definitions about what constitutes real-world walking, impeding the comparison and interpretation of the acquired data across systems and studies. The goal of this study was to obtain expert-based consensus on specific aspects of real-world walking and to provide respective definitions in a common terminological framework. An adapted Delphi method was used to obtain agreed definitions related to real-world walking. In an online survey, 162 participants from a panel of academic, clinical and industrial experts with experience in the field of gait analysis were asked for agreement on previously specified definitions. Descriptive statistics was used to evaluate whether consent (> 75% agreement as defined a priori) was reached. Of 162 experts invited to participate, 51 completed all rounds (31.5% response rate). We obtained consensus on all definitions (“Walking” > 90%, “Purposeful” > 75%, “Real-world” > 90%, “Walking bout” > 80%, “Walking speed” > 75%, “Turning” > 90% agreement) after two rounds. The identification of a consented set of real-world walking definitions has important implications for the development of assessment and analysis protocols, as well as for the reporting and comparison of digital mobility outcomes across studies and systems. The definitions will serve as a common framework for implementing digital and mobile technologies for gait assessment and are an important link for the transition from supervised to unsupervised gait assessment.
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The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. © 2021 Page et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Background The Daily-PROactive and Clinical visit-PROactive Physical Activity (D-PPAC and C-PPAC) instruments in chronic obstructive pulmonary disease (COPD) combines questionnaire with activity monitor data to measure patients’ experience of physical activity. Their amount, difficulty and total scores range from 0 (worst) to 100 (best) but require further psychometric evaluation. Objective To test reliability, validity and responsiveness, and to define minimal important difference (MID), of the D-PPAC and C-PPAC instruments, in a large population of patients with stable COPD from diverse severities, settings and countries. Methods We used data from seven randomised controlled trials to evaluate D-PPAC and C-PPAC internal consistency and construct validity by sex, age groups, COPD severity, country and language as well as responsiveness to interventions, ability to detect change and MID. Results We included 1324 patients (mean (SD) age 66 (8) years, forced expiratory volume in 1 s 55 (17)% predicted). Scores covered almost the full range from 0 to 100, showed strong internal consistency after stratification and correlated as a priori hypothesised with dyspnoea, health-related quality of life and exercise capacity. Difficulty scores improved after pharmacological treatment and pulmonary rehabilitation, while amount scores improved after behavioural physical activity interventions. All scores were responsive to changes in self-reported physical activity experience (both worsening and improvement) and to the occurrence of COPD exacerbations during follow-up. The MID was estimated to 6 for amount and difficulty scores and 4 for total score. Conclusions The D-PPAC and C-PPAC instruments are reliable and valid across diverse COPD populations and responsive to pharmacological and non-pharmacological interventions and changes in clinically relevant variables.
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Background Qualitative synthesis approaches are increasingly used in healthcare research. One of the most commonly utilised approaches is meta-ethnography. This is a systematic approach which synthesises data from multiple studies to enable new insights into patients’ and healthcare professionals’ experiences and perspectives. Meta-ethnographies can provide important theoretical and conceptual contributions and generate evidence for healthcare practice and policy. However, there is currently a lack of clarity and guidance surrounding the data synthesis stages and process. Method This paper aimed to outline a step-by-step method for conducting a meta-ethnography with illustrative examples. Results A practical step-by-step guide for conducting meta-ethnography based on the original seven steps as developed by Noblit & Hare (Meta-ethnography: Synthesizing qualitative studies.,1998) is presented. The stages include getting started, deciding what is relevant to the initial interest, reading the studies, determining how the studies are related, translating the studies into one another, synthesising the translations and expressing the synthesis. We have incorporated adaptations and developments from recent publications. Annotations based on a previous meta-ethnography are provided. These are particularly detailed for stages 4–6, as these are often described as being the most challenging to conduct, but with the most limited amount of guidance available. Conclusion Meta-ethnographic synthesis is an important and increasingly used tool in healthcare research, which can be used to inform policy and practice. The guide presented clarifies how the stages and processes involved in conducting a meta-synthesis can be operationalised.
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Background: In an era of shifting global agendas and expanded emphasis on non-communicable diseases and injuries along with communicable diseases, sound evidence on trends by cause at the national level is essential. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) provides a systematic scientific assessment of published, publicly available, and contributed data on incidence, prevalence, and mortality for a mutually exclusive and collectively exhaustive list of diseases and injuries. Methods: GBD estimates incidence, prevalence, mortality, years of life lost (YLLs), years lived with disability (YLDs), and disability-adjusted life-years (DALYs) due to 369 diseases and injuries, for two sexes, and for 204 countries and territories. Input data were extracted from censuses, household surveys, civil registration and vital statistics, disease registries, health service use, air pollution monitors, satellite imaging, disease notifications, and other sources. Cause-specific death rates and cause fractions were calculated using the Cause of Death Ensemble model and spatiotemporal Gaussian process regression. Cause-specific deaths were adjusted to match the total all-cause deaths calculated as part of the GBD population, fertility, and mortality estimates. Deaths were multiplied by standard life expectancy at each age to calculate YLLs. A Bayesian meta-regression modelling tool, DisMod-MR 2.1, was used to ensure consistency between incidence, prevalence, remission, excess mortality, and cause-specific mortality for most causes. Prevalence estimates were multiplied by disability weights for mutually exclusive sequelae of diseases and injuries to calculate YLDs. We considered results in the context of the Socio-demographic Index (SDI), a composite indicator of income per capita, years of schooling, and fertility rate in females younger than 25 years. Uncertainty intervals (UIs) were generated for every metric using the 25th and 975th ordered 1000 draw values of the posterior distribution. Findings: Global health has steadily improved over the past 30 years as measured by age-standardised DALY rates. After taking into account population growth and ageing, the absolute number of DALYs has remained stable. Since 2010, the pace of decline in global age-standardised DALY rates has accelerated in age groups younger than 50 years compared with the 1990-2010 time period, with the greatest annualised rate of decline occurring in the 0-9-year age group. Six infectious diseases were among the top ten causes of DALYs in children younger than 10 years in 2019: lower respiratory infections (ranked second), diarrhoeal diseases (third), malaria (fifth), meningitis (sixth), whooping cough (ninth), and sexually transmitted infections (which, in this age group, is fully accounted for by congenital syphilis; ranked tenth). In adolescents aged 10-24 years, three injury causes were among the top causes of DALYs: road injuries (ranked first), self-harm (third), and interpersonal violence (fifth). Five of the causes that were in the top ten for ages 10-24 years were also in the top ten in the 25-49-year age group: road injuries (ranked first), HIV/AIDS (second), low back pain (fourth), headache disorders (fifth), and depressive disorders (sixth). In 2019, ischaemic heart disease and stroke were the top-ranked causes of DALYs in both the 50-74-year and 75-years-and-older age groups. Since 1990, there has been a marked shift towards a greater proportion of burden due to YLDs from non-communicable diseases and injuries. In 2019, there were 11 countries where non-communicable disease and injury YLDs constituted more than half of all disease burden. Decreases in age-standardised DALY rates have accelerated over the past decade in countries at the lower end of the SDI range, while improvements have started to stagnate or even reverse in countries with higher SDI. Interpretation: As disability becomes an increasingly large component of disease burden and a larger component of health expenditure, greater research and development investment is needed to identify new, more effective intervention strategies. With a rapidly ageing global population, the demands on health services to deal with disabling outcomes, which increase with age, will require policy makers to anticipate these changes. The mix of universal and more geographically specific influences on health reinforces the need for regular reporting on population health in detail and by underlying cause to help decision makers to identify success stories of disease control to emulate, as well as opportunities to improve. Funding: Bill & Melinda Gates Foundation.
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Background: With the rise of connected sensor technologies, there are seemingly endless possibilities for new ways to measure health. These technologies offer researchers and clinicians opportunities to go beyond brief snapshots of data captured by traditional in-clinic assessments, to redefine health and disease. Given the myriad opportunities for measurement, how do research or clinical teams know what they should be measuring? Patient engagement, early and often, is paramount to thoughtfully selecting what is most important. Regulators encourage stakeholders to have a patient focus but actionable steps for continuous engagement are not well defined. Without patient-focused measurement, stakeholders risk entrenching digital versions of poor traditional assessments and proliferating low-value tools that are ineffective, burdensome, and reduce both quality and efficiency in clinical care and research. Summary: This article synthesizes and defines a sequential framework of core principles for selecting and developing measurements in research and clinical care that are meaningful for patients. We propose next steps to drive forward the science of high-quality patient engagement in support of measures of health that matter in the era of digital medicine. Key messages: All measures of health should be meaningful, regardless of the product's regulatory classification, type of measure, or context of use. To evaluate meaningfulness of signals derived from digital sensors, the following four-level framework is useful: Meaningful Aspect of Health, Concept of Interest, Outcome to be measured, and Endpoint (exclusive to research). Incorporating patient input is a dynamic process that requires more than a single, transactional touch point but rather should be conducted continuously throughout the measurement selection process. We recommend that developers, clinicians, and researchers reevaluate processes for more continuous patient engagement in the development, deployment, and interpretation of digital measures of health.
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Introduction Although mean physical activity in COPD patients declines by 400–500 steps/day annually, it is unknown whether the natural progression is the same for all patients. We aimed to identify distinct physical activity progression patterns using a hypothesis-free approach and to assess their determinants. Methods We pooled data from two cohorts (usual care arm of Urban Training [NCT01897298] and PROactive initial validation [NCT01388218] studies) measuring physical activity at baseline and 12 months (Dynaport MoveMonitor). We identified clusters (patterns) of physical activity progression (based on levels and changes of steps/day) using k-means, and compared baseline sociodemographic, interpersonal, environmental, clinical and psychological characteristics across patterns. Results In 291 COPD patients (mean ± SD 68 ± 8 years, 81% male, FEV1 59 ± 19%pred) we identified three distinct physical activity progression patterns: Inactive (n = 173 [59%], baseline: 4621 ± 1757 steps/day, 12-month change (Δ): −487 ± 1201 steps/day), Active Improvers (n = 49 [17%], baseline: 7727 ± 3275 steps/day, Δ: + 3378 ± 2203 steps/day) and Active Decliners (n = 69 [24%], baseline: 11 267 ± 3009 steps/day, Δ: −2217 ± 2085 steps/day). After adjustment in a mixed multinomial logistic regression model using Active Decliners as reference pattern, a lower 6-min walking distance (RRR [95% CI] 0.94 [0.90–0.98] per 10 m, P = .001) and a higher mMRC dyspnea score (1.71 [1.12–2.60] per 1 point, P = .012) were independently related with being Inactive. No baseline variable was independently associated with being an Active Improver. Conclusions The natural progression in physical activity over time in COPD patients is heterogeneous. While Inactive patients relate to worse scores for clinical COPD characteristics, Active Improvers and Decliners cannot be predicted at baseline.