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The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

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Aims/hypothesis It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. Methods Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM’s content validity included reviewer ratings ( N = 16) of relevance, comprehensiveness and comprehensibility: by researchers ( n = 6); clinicians ( n = 6); and adults with diabetes ( n = 4). Results Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as ‘inconsistent’, with most as ‘(very) low’ quality, while structural validity was deemed ‘unsatisfactory’. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a ‘gold standard’ measure of the impact of hypoglycaemia on QoL against which to compare the PROMS. Conclusions/interpretation None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL. Prospero registration CRD42019125153 Graphical abstract
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ARTICLE
The suitability of patient-reported outcome measures used to assess
the impact of hypoglycaemia on quality of life in people
with diabetes: a systematic review using COSMIN methods
Jill Carlton
1
&Joanna Leaviss
1
&Frans Pouwer
2,3,4
&Christel Hendrieckx
3,5
&Melanie M. Broadley
2
&
Mark Clowes
1
&Rory J. McCrimmon
6
&Simon R. Heller
7
&Jane Speight
2,3,5
Received: 14 October 2020 / Accepted: 19 November 2020
#The Author(s) 2021, corrected publication 2022
Abstract
Aims/hypothesis It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with
diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim
of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality
and psychometric properties.
Methods Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were under-
taken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess
the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with
PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer.
Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of
articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection
of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against
COSMIN criteria. Assessment of each PROMs content validity included reviewer ratings (N= 16) of relevance, comprehen-
siveness and comprehensibility: by researchers (n= 6); clinicians (n=6);andadultswithdiabetes(n=4).
Results Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), eight hypoglycaemia-
specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia
Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic
Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; the QoLHYPO questionnaire and the Treatment-Related
Impact Measure-Non-severe Hypoglycemic Events (TRIM-HYPO) questionnaire. Content validity was rated as inconsistent,
with most as (very) lowquality, while structural validity was deemed unsatisfactoryor 'indeterminate'. Other measurement
properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed
cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a gold
standardmeasure of the impact of hypoglycaemia on QoL against which to compare the PROMS.
Conclusions/interpretation None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfac-
tory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for
assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content
validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL.
Prospero registration CRD42019125153
*Jill Carlton
j.carlton@sheffield.ac.uk
1
School of Health and Related Research (ScHARR), University of
Sheffield, Sheffield, UK
2
Department of Psychology, University of Southern Denmark,
Odense, Denmark
3
School of Psychology, Deakin University, Geelong, VIC, Australia
4
Steno Diabetes Center Odense, Odense, Denmark
5
The Australian Centre for Behavioural Research in Diabetes
(ACBRD), Melbourne, VIC, Australia
6
School of Medicine, University of Dundee, Dundee, UK
7
Department of Oncology and Metabolism, University of Sheffield,
Sheffield, UK
Diabetologia
https://doi.org/10.1007/s00125-021-05382-x
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Keywords COSMIN .Diabetes .Hypoglycaemia .Patient-reported outcome measures .Psychometric properties .Quality of
life .Questionnaire .Systematic review
Abbreviations
COSMIN COnsensus-based Standards for the
selection of health Measurement
INstruments
EFA Exploratory factor analysis
FH-15 Fear of Hypoglycemia 15-item scale
GRADE Grading of Recommendations
Assessment, Development
and Evaluation
HABS Hypoglycemic Attitudes and
Behavior Scale
HCS Hypoglycemic Confidence Scale
HFS Hypoglycemia Fear Survey
HFS-II Hypoglycemia Fear Survey
version II
Hypo-RESOLVE Hypoglycaemia REdefining
SOLutions for better liVEs
PAC Patient Advisory Committee
NSHE Non-severe hypoglycaemic event
PROM Patient-reported outcome measure
QoL Quality of life
QoLHYPO QoLHYPO questionnaire
TRIM-HYPO Treatment-Related Impact
Measure-Non-severe
Hypoglycemic Events
Introduction
Both the experience and the risk of hypoglycaemia can have a
serious negative impact on the quality of life (QoL) of adults
with diabetes [18]. Living a life of quality is perhaps the
ultimate goal, so protecting QoL is a daily burden for people
experiencing or at risk of hypoglycaemia, and one that can be
contradictory to the goals of medical therapy [8]. This may
particularly be the case in those who aim for very tight glucose
targets. The extent of this impact on QoL can be assessed
using patient-reported outcome measures (PROMs). PROMs
are questionnaires that can be used in both research and/or
clinical care. PROMs complement objective data (e.g. actual
blood glucose levels) by capturing the individuals experi-
ences in a quantifiable and standardised manner, across a
range of concepts, e.g. health-related QoL, satisfaction with
treatment oremotional well-being [9,10]. When applied to the
study of hypoglycaemia in diabetes, PROMs can facilitate an
assessment of the psychological and economic burden of
hypoglycaemia, which can be used to determine the value of
therapeutic approaches to reducing hypoglycaemia frequency
and severity.
Given the large number of PROMs available, it can be
challenging to determine which PROM(s) to select for a given
clinical or research purpose. Factors such as response burden
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(e.g. mode of administration, number of items [questions]),
type of PROM (generic or condition-specific) and the purpose
of the data collection will influence choice. However, a more
fundamental issue is whether the PROM has been evaluated as
fit for purpose. This evaluation should include assessment of
three overall domains (validity, reliability and responsive-
ness), for which consensus-based standards (COnsensus-
based Standards for the selection of health Measurement
Instruments [COSMIN]) can be applied [11]. The COSMIN
methodology and standards derive from widespread interna-
tional expert consensus [11,12] and have been applied to
other PROM measures [1317], but not yet to the assessment
of the impact of hypoglycaemia on QoL.
QoL is highly subjective and has been defined in many
ways and most people, intuitively, have an understanding of
what it means to them [18]. Perhaps the simplest definition is
that QoL is a personal evaluation of how good or bad ones
life is [19]. For the purpose of this review, and consistent with
the general consensus [9], we operationalised QoL as: (1) a
multidimensional construct including components such as
physical well-being (e.g. pain/discomfort, mobility, fatigue),
psychological well-being (e.g. mood, fear, confidence) and
social well-being (e.g. stigma, participation) [20]; (2) a subjec-
tive construct based on feelings, values, experiences and prior-
ities (therefore, we do not include objective measures, or pure-
ly functional performance or assessment instruments); and (3)
a dynamic construct, which changes over time according to
the persons priorities, experiences and situation.
The objectives of this review were to: (1) identify PROMs
used to assess the impact of hypoglycaemia on QoL in adults
with diabetes; and (2) formally evaluate their content validity,
structural validity and other measurement properties. Our
intention was to provide researchers and clinicians with a
robust evidence base to assist them when selecting PROMs
for this purpose. The review was undertaken as part of the
Hypoglycaemia REdefining SOLutions for better liVEs
(Hypo-RESOLVE) project, an international collaboration of
clinicians, scientists, industry partners and people with diabe-
tes [21].
Methods
We used the updated COSMIN guidance [12,2224].
Data sources and searches A protocol was developed and
registered with PROSPERO [25]. A systematic literature
search was conducted during 2628 November 2018 to iden-
tify published evidence around the four concepts of: (diabetes)
and (hypoglycaemia) and (psychosocial outcomes) and
(measurement properties of measurement instruments).
Databases searched include MEDLINE, EMBASE,
PsycINFO, CINAHL and The Cochrane Library. Terms for
psychosocial outcomes were chosen to include both generic,
umbrellaterms for quality and lifeand well-being
(sourced from published search filters) and specific psychoso-
cial outcomes of diabetes known to the Hypo-RESOLVE
team (e.g. fear of hypoglycaemia). In order to identify studies
for the present systematic review, a validated search filter
devised for retrieving studies on measurement properties of
instruments in PubMed was used [26]. An example search
strategy is shown in the electronic supplementary material
(ESM) Methods.
Study selection Inclusion criteria consisted of any study
design that included the primary development and/or valida-
tion of a hypoglycaemia-specific PROM used to assess the
impact of hypoglycaemia on QoL in adults diagnosed with
diabetes with any type, e.g. type 1, type 2 and gestational,
and who have experienced hypoglycaemia. Studies of
hypoglycaemia/hypoglycaemic episodes not associated with
diabetes were excluded. Commentaries, reviews, opinion
pieces and any other non-empirical work were also excluded.
Studies were assessed for inclusion at title and abstract stage
by one reviewer (JL). Full-text articles were scrutinised where
considered as relevant or potentially relevant or where doubt
existed. Twenty per cent of studies were assessed by a second
reviewer (JC) to check for consistency. Disagreements were
resolved through discussion.
Data extraction Data extraction included study characteristics
(e.g. language; participant characteristics; recall period; anal-
ysis model), a brief summary of results and measurement
properties of the PROMs. Primary outcomes included
measurement properties of identified PROMs, consistent with
the COSMIN checklist: PROM development; content validi-
ty; structural validity; internal consistency; cross-cultural
validity/measurement invariance; reliability; measurement
error; criterion validity; hypothesis testing for construct valid-
ity; and responsiveness. Definitions of the measurement prop-
erties are detailed in Table 1. In accordance with COSMIN
guidelines, all data relating to PROM measurement properties
were extracted independently by two reviewers (JL and JC)
against the respective COSMIN criteria. Discrepancies were
resolved through discussion.
Content validity assessment Content validity is the extent to
which a PROM is deemed to reflect the construct of interest
and, arguably, the most fundamental aspect of scale selection
[27]. The methodological quality of the PROM development
studies and other studies supplementing content validity were
assessed using COSMIN standards [28]. The assessment
involves three steps (see Fig. 1): (1) evaluation of the quality
of the PROM development; (2) evaluation of the quality of
any additional content validity studies on the PROM (if avail-
able); and (3) evaluation of the content validity of the PROM
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based on the quality and results of the available studies and the
PROM itself. Steps 1 and 2 result in a rating of each COSMIN
standard ranked on a four-point scale: very good,adequate,
doubtfuland inadequate. Total ratings are then determined
Table 1 Definitions of measurement properties
Measurement property Definition
Content validity The extent to which the items in a PROM are representative of the construct they
areintendedtomeasure
Structural validity The extent to which the items in a PROM reflect the dimensionality of the construct
(i.e. the items form a single [unidimensional] scale or multiple subscales
[a multidimensional scale])
Reliability: internal consistency The extent to which there is consistency of results across items in the PROM
(i.e. within a specified scale or subscale)
Reliability: testretest The extent to which the PROM yields scores that are reproducible (stable) over
time when there has been no change in the concept being assessed
Measurement error The systematic and random error of a persons score on the PROM that is not attributed
to changes in the construct to be measured
Criterion validity The extent to which the scores of a PROM reflect the scores of a test or measure
considered to be the gold standard
Hypothesis testing for construct validity The extent to which the scores of a PROM are consistent with hypotheses. For
example, with regard to internal relationships, relationships to scores of other
instruments or differences between relevant groups. It is based on the assumption
that the PROM is a valid measure of the construct
Responsiveness The ability of a PROM to detect change, as expected, over time in the construct to
be measured when there is a true change in a persons condition or treatment
Cross-cultural validity The extent to which the measurement properties of the translated or culturally
adapted PROM reflect the performance of the original version of the PROM
STEP 1
Evaluate the quality of PROM
development
Assess against 35 COSMIN standards,
evaluating the quality of PROM design
and cognitive interviewing/pilot testing
Results in rating of ‘very good’,
‘adequate’, ‘doubtful’ or ‘inadequate’
STEP 2
Evaluate the quality of content validity
studies
Assess against 31 COSMIN standards,
evaluating studies that asked patients or
professionals about: relevance,
comprehensiveness and/or
comprehensibility
Results in rating of ‘very good’,
‘adequate’, ‘doubtful’ or ‘inadequate’
STEP 3
Evaluate the content validity of
the PROM
3a: PROM development and
content validity studies are rated
individually on ten COSMIN
criteria for content validity.
Reviewers also provide ratings:
sufficient (+), insufficient (−),
inconsistent (±) or indeterminate
(?)
3b: The ratings from 3a are
combined, producing an
OVERALL rating for relevance,
comprehensiveness and
comprehensibility, and content
validity overall, of sufficient (+),
insufficient (−), inconsistent (±) or
indeterminate (?)
3c: The ratings produced in 3b are
accompanied by a grading for
evidence quality using a modified
GRADE approach of ‘high’,
‘moderate’, ‘low’ or ‘very low’
Fig. 1 COSMIN assessment of
content validity
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using the lowest rating for any item for that study (i.e. worst
score counts) [22].
Step 3 consists of three sub-stages. Step 3a incorporates
reviewer ratings of the identified PROMs whereby
reviewers consider relevance, comprehensiveness and
comprehensibility. We sought ratings from three key stake-
holder groups: (1) researchers (including those with exper-
tise in systematic reviewing, QoL research and psycholog-
ical aspects of diabetes) (n= 6); (2) clinicians (n=6); and
(3) adults with diabetes (n= 4), including two representa-
tives of the Hypo-RESOLVE Patient Advisory Committee
(PAC). All reviewers provided independent ratings of the
PROMs based on several criteria: (1) the construct of inter-
est (i.e. does the PROM include items that are relevant in
measuring the impact of hypoglycaemia on QoL?); (2) the
population of interest; (3) the context of use of interest (i.e.
is the PROM suitable for use in research and/or clinical
practice?); (4) the appropriateness of response options;
(5) the appropriateness of the recall period; (6) the compre-
hensiveness (i.e. does the PROM assess the impact of
hypoglycaemia on QoL as a whole, or only on select
domains of QoL?); (7) the suitability/clarity of the PROM
instructions; (8) whether PROM items and response
options are understandable; (9) the appropriateness of
PROM item wording; and (10) the extent to which
response options are appropriate to the question being
asked. A majority rating was determined for each group
(researcher, clinician and PAC). The group ratings were
then consolidated to produce an overall reviewer rating
for each PROM. Table 2details how relevance, compre-
hensiveness and comprehensibility were assessed.
Step 3b involves summarising the results of all available
studies to provide an overall rating of relevance, comprehen-
siveness and comprehensibility and an overall content validity
rating. This results in an outcome of sufficient,insufficient,
inconsistentor indeterminate. Finally, in Step 3c, the over-
all ratings determined in Step 3b are accompanied by a grad-
ing of the quality of the evidence using a modified Grading of
Recommendations Assessment, Development and Evaluation
(GRADE) approach [29]. Using the modified GRADE
approach, the quality of evidence is graded as high,moder-
ate,lowor very low. The GRADE approach uses five
factors to consider the quality of the evidence: risk of bias,
inconsistency, indirectness, imprecision and publication bias
[29]. Detailed information of the rating process is reported
elsewhere [28]. The resultant evaluation of content validity
includes an overall rating of: + (satisfactory); (unsatisfac-
tory); ± (inconsistent); or ? (indeterminate), with a
measure of the quality of the evidence to support the content
validity rating (high,moderate,low,very low). A
worked example of content validity rating and scoring is
shown in Table 2. Detailed information on the COSMIN
methodology applied is reported elsewhere [28].
Assessment of other psychometric properties Table 1defines
each of the psychometric properties assessed. As above, a
COSMIN rating was determined by assessment across the
criteria for measurement properties using the same rating scale
(sufficient,insufficient,inconsistentor indeterminate).
The assessment of the quality of the evidence was applied
using the GRADE approach. This results in a rating of: +
(satisfactory); (unsatisfactory); ± (inconsistent); or ?
(indeterminate), with a measure of the quality of the
evidence to support the structural validity rating (high,
moderate,low,very low). Full information on the
COSMIN methodology applied in this review is reported else-
where [23].
Quality assurance of the review The quality of this review was
assessed against a COSMIN checklist that was designed to
evaluate the quality of systematic reviews of PROMs [30]
(ESM Table 1).
Results
The search returned a total of 3661 unique records, from
which 214 PROMs were identified as used in studies to assess
the impact of hypoglycaemia on QoL or subdomains of QoL
(Fig. 2,Table3). Of these, 17 PROMs were initially identified
as hypoglycaemia-specific and for consideration in this
review, and nine were subsequently excluded following
further scrutiny of the instruments. PROMs were excluded if
they were: hypoglycaemia symptom measures that assessed
attitudes, awareness and/or attitudes to awareness of symp-
toms (n= 3); related to specific treatments (n= 2); only a
subscale of an overall PROM (n= 2); or not available for full
inspection (n= 2). Consequently, the current review includes
eight hypoglycaemia-specific PROMs that have been used to
assess the impact of hypoglycaemia on QoL or at least one
aspect of QoL: the Fear of Hypoglycemia 15-item scale (FH-
15); the Hypoglycemia FearSurvey (HFS); the Hypoglycemia
Fear Survey version II (HFS-II); the HFS-II short-form; the
Hypoglycemic Attitudes and Behavior Scale (HABS); the
Hypoglycemic Confidence Scale (HCS); the QoLHYPO
questionnaire and the Treatment-Related Impact Measure-
Non-severe Hypoglycemic Events (TRIM-HYPO) (Table 4).
Overall COSMIN assessment of PROMs The overall results of
the COSMIN assessment are shown in Table 5. There are
considerable evidence gaps for the measurement properties
of most of the PROMs. The HFS-II, QoLHYPO and TRIM-
HYPO were the only instruments that could be rated across all
the measurement properties.
Content validity ESM Table 2summarises the key character-
istics and COSMIN quality assessment of the PROM
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Table 2 COSMIN criteria and rating system for evaluating the content validity of the PROMs (adapted from Terwee et al [28]), with an example shown in italics
Name of PROM (or subscale) PROM development
study
(+//±/?)
Content validity
study 1
(+//±/?)
Content validity
study 2
a
(+//±/?)
Rating of reviewers
(+//±/?)
Overall ratings
per PROM
(+//±/?)
Quality of evidence
(High, moderate,
low, very low)
The ABC-QoL Jones et al, 2015 Smith et al, 2016
Relevance
1. Are the included items relevant for the construct of interest?
b
++ +
2. Are the included items relevant for the target population of interest?
c
++ +
3. Are the included items relevant for the context of use and interest?
d
−− −
4. Are the response options appropriate? + +
5. Is the recall period appropriate? + + +
RELEVANCE RATING + + + +
Comprehensiveness
6. Are all key concepts covered? −− −
COMPREHENSIVENESS RATING −− −
Comprehensibility
7. Are the PROM instructions understood by the population
of interest as intended?
++
8. Are the PROM items and response options understood by
the population of interest as intended?
++
9. Are the PROM items appropriately worded? +
10. Do the response options match the question? +
COMPREHENSIBILITY RATING ± ± ± ±
CONTENT VALIDITY RATING ±High
+, , ±, and ? denote sufficient, insufficient, inconsistent, indeterminate
a
More columns to be added if more content validity studies are available
b
For this review, the construct of interest was impact of hypoglycaemia on QoL
c
For this review, the population was adults with diabetes
d
For this review, the context of interest was research use in a clinical and/or research setting
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development studies. For five of the seven PROMs, there was
evidence that adults with diabetes were involved in item
generation (HFS, HABS, HCS, QoLHYPO and TRIM-
HYPO). COSMIN quality ratings ranged from inadequate
(HFS, HABS and QoLHYPO), to doubtful(HFS-II, HCS
and TRIM-HYPO), to very good(FH-15). The developers
of the HFS-II short-form do not report on content validity, due
to the scale being developed based on existing items in the
HFS-II [31].
ESM Table 3details characteristics of the PROM develop-
ment studies. The overall quality of the PROM development
studies was classified as very good(FH-15), inadequate
(HFS, HABS and QoLHYPO) or doubtful(HFS-II, HCS
and TRIM-HYPO). Only five of the PROMs provided
evidence of concept elicitation (all of which were of doubtful
or inadequatequality) (HFS, HABS, HCS, QoLHYPO and
TRIM-HYPO). The COSMIN rating for the PROM design
ranged from inadequate(HFS, HABS and QoLHYPO), to
doubtful(HFS-II, HCS and TRIM-HYPO), to very good
(FH-15). Three of the PROMs (HFS, QoLHYPO and TRIM-
HYPO) reported on content validity. During the development
of the HFS, health professionals were asked about the rele-
vance and comprehensiveness of the PROM (doubtful
COSMIN quality rating) [32]. For the QoLHYPO, adults with
diabetes were asked about the comprehensibility, but not rele-
vance, of the PROM (doubtfulCOSMIN quality rating)
[33]. During the development of the TRIM-HYPO, adults
with diabetes were asked about the comprehensibility and
relevance of the PROM, but were not asked about compre-
hensiveness of the PROM ('doubtful' COSMIN quality rating)
Screening
Eligibility
Studies included in full COSMIN
review
(n=13)
Full-text arcles screened
(n=60)
Full-text arcles
excluded, with reasons
(n=35)
Hypoglycaemia-specific PROMs:
psychometric papers reviewed
(n=25)
Records idenfied through
database searching
(n=4685)
Records idenfied through
addional searching
(n=2)
Records aer duplicates removed
(n=3661)
Title and abstract screened
(n=3661)
Records excluded
(n=3601)
Idenficaon
Included
Studies not included in
full COSMIN
(n=12)
Fig. 2 PRISMA 2009 Flow Diagram: hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL
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[34]. Aside from the development studies, no further studies
were identified that independently assessed the content valid-
ity of the PROMs.
ESM Table 4details the consensus ratings for the three
groups of reviewers (researchers, clinicians, people living
with diabetes), and an overall reviewer consensus rating
for each PROM. FH-15 had an overall reviewer rating of
sufficient; HFS-II, HABS, HCS and TRIM-HYPO were
rated as inconsistent. For two of the PROMs (HFS and
QoLHYPO), relevance, comprehensiveness and compre-
hensibility ratings resultedinacombinationwhereby
COSMIN guidance is not explicit, and, thus, an overall
rating could not be applied [28].
Structural validity Twelve studies assessed the structural
validity of the PROMs, all of which were reported in the
development papers (ESM Table 5). No independent assess-
ments of the structural validity were identified. Four studies
examined the structural validity of a cultural adaptation/
language translation of the HFS [3538]. A further study
assessed the structural validity of the short-form of HFS-II
[31]. COSMIN quality ratings of the HFS-Norwegian, HFS-
Singapore and HFS short-form were very goodand ratings
were adequatefor the remaining PROMs. The same princi-
ples as noted above were applied to assess the quality of the
evidence for these instruments. The quality of evidence for the
HFS-Norwegian, HFS-Singapore and HFS-II short-form
instruments was assessed as high.The HFS-Spanish, HFS-
Swedish and TRIM-HYPO instruments were assessed as
moderate. Many of the studies reported exploratory factor
analysis (EFA) (rather than the confirmatory factor analysis
required to receive a satisfactoryrating). Those studies
reporting confirmatory factor analysis (language versions of
the HFS) did so to examine whether the expected two-factor
structure (observed for the original HFS) fitted their dataset.
Table 4 PROMs identified that have been used to assess the impact of hypoglycaemia on QoL (or its subdomains) in people with diabetes
PROM Recall period Ndomains
(items)
Domains assessed by
PROM (nitems)
Response options Total score
range
Origin Validated English
version available
for review
FH-15 Not stated 3 (15) Fear (7), avoidance
(3), interference (5)
Never, almost never,
sometimes, almost
always, every day.
15scale
1575 Spain NoSpanish
only version
HFS Not stated 2 (27) Behaviour (10),
worry (17)
Never, rarely, sometimes,
often, very often.
15scale
27135 USA Yes
HFS-II 6 months 2 (33) Behaviour (15),
worry (18)
Never, rarely, sometimes,
often, almost always.
04scale
0132 USA Yes
HFS-II
short-form
6 months 2 (11) Behaviour (5),
worry (6)
Never, rarely, sometimes,
often, almost always.
04scale
044 USA Yes
HABS Present 3 (14) Avoidance (4),
confidence (5),
anxiety (5)
Strongly disagree, disagree,
neutral, agree, strongly
agree. 15scale
1470 USA Yes
HCS Not stated 1 (9) Confidence (9) Not confident at all, a
little confident, moderately
confident, very confident.
14scale
936 USA Yes
QoLHYPO Not stated Not stated
(13)
Not reported Never, rarely, sometimes,
often, always. 04scale
052 Spain NoSpanish
only version
TRIM-HYPO Past 30
days
5 (33) Daily function (7),
Emotional wellbeing (7),
Work productivity (9),
Sleep disruption (5),
Diabetes management (5)
Varies per item.
15scale
0100 France,
Germany,
UK, USA
Yes
Table 3 Type and number of PROMs identified in title and abstract sift
Type of PROM measure Number of PROMs
Designed for completion by children/adolescents 22
Designed for completion by adults 192
Generic 82
Diabetes-specific 51
Treatment-specific 37
Glucose-monitoring-specific 5
Hypoglycaemia-specific 17
Total 214
Diabetologia
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However, they all rejected this a priori-defined structure, and
therefore went on to explore the latent structure of the tool
using EFA.
Internal consistency reliability Thirteen studies were identified
that reported evidence of the internal consistency of the
PROMs [3134,3643]. Some were undertaken by the instru-
ment developers and some were independent assessments
(ESM Table 6). Most studies [32,33,36,39,40,42,43]had
an adequateCOSMIN quality rating. Five studies had a
very goodCOSMIN quality rating [31,34,37,38,41].
Reliability (testretest) Seven studies were identified that
assessed the testretest reliability of a PROM measure. Four
of the studies were conducted by the instrument developers
(FH-15, HFS-II, QoLHYPO and TRIM-HYPO). The remain-
ing studies were assessments of the language versions of the
HFS instrument (ESM Table 7). Four studies had an
adequateCOSMIN quality rating [32,33,36,40]. Two stud-
ies had a very goodCOSMIN quality rating [37,38]. One
study had a 'doubtful' COSMIN quality rating [34].
Hypothesis testing for construct validity Ten studies reported
on hypothesis testing for construct validity (ESM Table 8)
[31,3336,3840,42,43]. Of these, nine were comparing
with other outcome measurement instruments (convergent
validity) [31,3336,38,40,42,43]. These were HFS-II,
HFS-Spanish, HFS-Singapore, HFS-Sweden, HFS-II short-
form, HABS, HCS, QoLHYPO and TRIM-HYPO. Six stud-
ies included comparisons between subgroups (discriminative
or known-groups validity) [34,3840,42,43]. These were
FH-15, HFS-II, HFS-Singapore, HABS, HCS and TRIM-
HYPO instruments.
Other psychometric properties No studies were found to
demonstrate evidence for cross-cultural validity, measurement
error, criterion validity or responsiveness.
Discussion
This systematic review has summarised and critically evalu-
ated published evidence on the psychometric characteristics of
PROMs used to assess the impact of hypoglycaemia on QoL
in adults with diabetes using COSMIN methodology. Our
intention was to provide an evidence base that would help
researchers and clinicians when selecting PROMs, based on
the robust and comprehensive consensus-based COSMIN
criteria. We identified eight PROMs that had been developed
to assess the subjective impact of hypoglycaemia on QoL or a
subdomain of QoL.
None of the PROMs included in this review had a high
rating for content validity (in relation to assessing the impact
Table 5 Summary of psychometric properties of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL
PROM Content validity Structural validity Reliability: internal consistency Reliability: testretest Hypothesis testing for
construct validity
Rating of results Quality of evidence Rating of
results
Quality of
evidence
Rating of results Quality of
evidence
Rating of
results
Quality of
evidence
Rating of
results
Quality of
evidence
FH-15 ± Low Moderate + Moderate NR NR ? Moderate
HFS ± Moderate Moderate ? Moderate Very low NR NR
HFS-II ± Low Moderate + Moderate Moderate ? Moderate
HFS-Norwegian NR NR High + High + High NR NR
HFS-Singapore NR NR High + High ? High ? High
HFS-Spanish NR NR Moderate ? Moderate ? Very low ? Moderate
HFS-Swedish NR NR Moderate + Moderate NR NR ? Moderate
HFS-II short-form NR NR High + High NR NR ? High
HABS ± Very low Moderate + Moderate NR NR ? Moderate
HCS ± Low Moderate + Moderate NR NR ? Moderate
QoLHYPO ± Moderate Moderate + Moderate + Moderate ? Moderate
TRIM-HYPO ± Low ? Moderate ± Moderate Very low ± Moderate
±, inconsistent results; , unsatisfactory results; +, satisfactory results; NR, not reported; ?, indeterminate
Diabetologia
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of hypoglycaemia on QoL), which is arguably the most
important measurement property of a PROM [28,44]. All
had inconsistentCOSMIN ratings for content validity, but
the quality of the evidence to support those ratings was greater
for the HFS and QoLHYPO. To that end, there is some
support to recommend the use of HFS and QoLHYPO instru-
ments in research studies and/or clinical practice. However, it
is important to acknowledge the conceptual framework from
which these two instruments were developed, and how this
diverges from our operationalisation of the concept of QoL
(i.e. multidimensional, subjective and changing over time).
The HFS was developed to measure fear of hypoglycaemia
through two subscalesbehaviour and worry. Fear is argu-
ably a very specific aspect of the psychological subdomain of
QoL. Furthermore, the developers were not explicit in describ-
ing the target population for the instrument (i.e. their sample
included people with insulin-dependentdiabetes, but it is
unclear whether this included people type 1 and/or type 2
diabetes, and whether it is also applicable to people who
manage their diabetes without insulin but experience
hypoglycaemia). While the content of the QoLHYPO instru-
ment includes items that assess various domains of QoL (e.g.
social relationships, mood, daily activities), it was designed
for use only by people with type 2 diabetes. Furthermore,
there have been no translations beyond the original Spanish
version. Consequently, the format and layout of the
QoLHYPO is not clear for English-speaking researchers,
and the developers provide no information on domains.
Further investigation would be required to determine the suit-
ability of the QoLHYPO instrument in measuring the impact
of hypoglycaemia in people with type 1 diabetes and in other
language groups.
We have included details of psychometric properties of the
PROMs identified as part of the original literature search.
However, it is plausible that additional papers have also
reported psychometric properties for one or more of the
included PROMs (particularly in intervention studies). To that
end, the information on measurement properties reported here
should not be considered exhaustive. We did not adopt the
approach taken by (some of) the PROM authors to consider
HbA
1c
as the gold standardin the assessment of criterion
validity and criterion approach to responsiveness. Studies
have shown that HbA
1c
it is not a reliable indicator of whether
an individual experiences hypoglycaemia [45,46], nor a
surrogate for QoL [47], nor of the impact or burden of
hypoglycaemia. Advances in glucose monitoring technolo-
gies are continually changing our understanding of diabetes
and are contributing to a better understanding of the lived
experience of diabetes and hypoglycaemia. Consequently, it
may be appropriate in future studies to consider time in
rangeor time in hypoglycaemiaas a marker for the impact
of hypoglycaemia on QoLbut the extent to which this will
reflect the subjective experience has yet to be elucidated. In
the absence of an agreed gold standard, it is not possible to
determine the assessment of any criterion validity or criterion
approach to responsiveness for any PROM.
In this systematic review, we followed the robust and
comprehensive guidance developed by the COSMIN initia-
tive [23,28]. However, it is not without its limitations. The
assessment of content validity and psychometric performance
of PROMs is determined by taking the lowest rating of any
standard in the criteria (i.e. the worst score countsprinciple)
[22,28]. This means that a study could be rated as very good
or goodon all but one criterion; however, the overall rating
could be affected by a doubtfulor inadequaterating, thus
reducing the overall score to doubtful(or inadequate). The
omission of one key component in reporting (such as whether
interviews were recorded and transcribed verbatim) can result
in a lower overall content validity rating, which could be
argued as overly harsh and should be recognised as a limita-
tion of the COSMIN approach. Where appropriate within this
review, we consistently rated in favour of the PROM (rather
than assuming the worst). Another limitation of the COSMIN
approach was identified in the guidance for determining
content validity ratings of studies. Here we noted that there
was no information on how to determine overall content valid-
ity rating with the combinations achieved. We have docu-
mented our approach; however, if the review was to be repli-
cated, others may opt to down-gradethe overall content
validity rating. Furthermore, as part of the content validity
assessment, we sought to include the opinion of stakeholders.
The COSMIN guidance does not advise on how to ratify
ratings should there be conflicting opinions between or within
stakeholder groups.
It should be noted thatsome of the PROMs included within
this review are legacy or first generationmeasures; that is,
they were developed at a time when there were no internation-
al standards for instrument development methods, so these
were either not reported, or reported selectively or in little
detail. Similarly, the way in which PROMs are developed
has changed over time [27]. It is now more common to report
the methodological steps undertaken during the instrument
development phase. The COSMIN ratings should therefore
be interpreted with a degree of caution, and do not provide
evidence that the instrument development was not rigorous or
that the instruments are not fit for purpose, but rather expose
an absence of key evidence.
While there is published evidence of studies that report
hypoglycaemia to negatively impact upon QoL [18], we
have identified that those that utilise hypoglycaemia-
specific PROMs have inadequate reliability and validity
for this specific purpose. Thus, the current literature on
the impact of hypoglycaemia on QoL is limited (if not
flawed) and needs to be interpreted with caution. Given
that the content validity of the instruments was lacking, it
is plausible that hypoglycaemia impacts individuals in
Diabetologia
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ways that are currently not being measured. It may be that
the items within the instruments are no longer relevant (e.g.
due to changes in diabetes treatments, monitoring, society,
language use), or that the items are not comprehensive
enough to fully capture the ways in which hypoglycaemia
affects adults in the modern world.
In conclusion, none of the PROMs identified had suffi-
cient evidence to demonstrate satisfactory content validity,
i.e. they do not assess the impact of hypoglycaemia on QoL
in adults living with diabetes. Furthermore, most were also
limited in their published evidence of reliability, validity
and responsiveness. There is an urgent need to follow
contemporary guidance [27,4850] to develop new instru-
ments that can assess the impact of hypoglycaemia on QoL.
Supplementary Information The online version contains peer-reviewed
but unedited supplementary material available at https://doi.org/10.1007/
s00125-021-05382-x.
Acknowledgements We would like to acknowledge the following indi-
viduals who helped with the rating of PROMs included within this
review: N. Ali (Radboud University Medical Center, the Netherlands);
S. A. Amiel (Department of Diabetes, Faculty of Life Sciences and
Medicine, Kings College London, UK); M. Hamid (Moroccan League
for the Fight against Diabetes, Morocco); O. Mast (Consumer Health
Care, Sanofi, Germany); E. Renard (Department of Endocrinology,
Diabetes, Nutrition, Montpellier University Hospital, Montpellier,
France); B. Riley (member of Lay ADvice for Diabetes and
Endocrinology Research group, Sheffield Teaching Hospitals NHS
Foundation Trust, UK); R. Scibilia (Diabetes Australia, Australia); and
C. Tack (Radboud University Medical Center, the Netherlands).
Data availability Data are available on request from the authors.
Funding Hypo-RESOLVE has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking (JU) (https://www.imi.europa.
eu/) under grant agreement No. 777460. The JU receives support from the
European Unions Horizon 2020 research and innovation programme and
EFPIA and T1D Exchange, JDRF, the International Diabetes Federation
(IDF) and The Leona M. and Harry B. Helmsley Charitable Trust. The
authors are solely responsible for the content of this work, which reflects
only the authorsviews, and the IMI JU is not responsible for any use that
may be made of the information it contains. JS and CH are supported by
the core funding to the Australian Centre for Behavioural Research in
Diabetes provided by the collaboration between Diabetes Victoria and
Deakin University.
Authorsrelationships and activities JC and JS have developed and
validated diabetes-specific PROMs that are not included in this review.
SRH has acted as a consultant or speaker for NovoNordisk, Eli Lilly,
Sanofi Aventis, Mannkind, Zealand, MSD and Boehringer Ingelheim.
All other authors declare that there are no relationships or activities that
might bias, or be perceived to bias, their work.
Contribution statement JC, JL, FP, CH, MMB, MC, RJM, SRH and JS
made substantial contributions to conception and design, acquisition of
data, or analysis and interpretation of data. JC was responsible for initial
drafting of the article. JC, JL, FP, CH, MMB, MC, RJM, SRH and JS
revised the manuscript critically for important intellectual content. JC, JL,
FP, CH, MMB, MC, RJM, SRH and JS gave final approval of the version
to be published. JC is the guarantor of this work.
Open Access This article is licensed under a Creative Commons
Attribution 4.0 International License, which permits use, sharing, adap-
tation, distribution and reproduction in any medium or format, as long as
you give appropriate credit to the original author(s) and the source,
provide a link to the Creative Commons licence, and indicate if changes
were made. The images or other third party material in this article are
included in the article's Creative Commons licence, unless indicated
otherwise in a credit line to the material. If material is not included in
the article's Creative Commons licence and your intended use is not
permitted by statutory regulation or exceeds the permitted use, you will
need to obtain permission directly from the copyright holder. To view a
copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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... This systematic review has been designed to evaluate the content and psychometric properties of instruments used to measure QoL in informal carers of people with DMD using the COSMIN approach [12,15]. COSMIN methodology is becoming increasingly used within systematic reviews evaluating the quality of QoL measures in particular health contexts [13,[16][17][18][19], including in a recent review of self-report measures used to assess QoL in people with DMD [20], which contributed to the rationale for the development of a new condition-specific QoL measure in this population [21]. ...
... The PedsQL ™ Measurement Model includes not only generic health-related quality of life [11][12][13] and disease-specific measurement instruments [14][15][16][17][18], but also generic measures of fatigue [15,19], healthcare satisfaction [20,21] and evaluations of the healthcare built environment [21]. " ...
... This review is not without its limitations. Whilst the methodological approach adopted is recognised and robust, it does have some limitations, as previously noted [16,20]. Firstly, the COSMIN appraisal tools assume a worst score counts system. ...
Article
Full-text available
Introduction Duchenne muscular dystrophy is a rare, progressive, life-limiting genetic neuromuscular condition that significantly impacts the quality of life of informal caregivers. Carer quality of life is measured using heterogeneous self-report scales, yet their suitability for Duchenne remains unclear. This review aimed to identify and evaluate the reliability and validity of quality of life instruments in Duchenne carers. Materials and methods Systematic searches were conducted in Embase, MEDLINE, CINAHL, PsycINFO, Cochrane Library and Google Scholar. Full research articles reporting data on multiple-item self-report quality of life instruments in informal Duchenne carers were included. Extracted evidence was qualitatively synthesised and evaluated, including risk of bias, against the Consensus-based Standards for the selection of health Measurement Instruments. Duchenne carer collaborators (N = 17) helped rate the instruments’ content validity. Results Thirty-one articles featuring thirty-two quality of life instruments were included. Content validity was rated as “inconsistent” based on very low quality evidence. For Duchenne carer collaborators, the best instrument was PedsQL Family Impact Module. Only one instrument had evidence for structural validity (rated “unsatisfactory”) and measurement invariance (rated “satisfactory”). Instruments received “satisfactory” ratings for internal consistency and mixed ratings for construct validity and responsiveness. There was no evidence for reliability, measurement error, or criterion validity. Discussion Instruments used to measure Duchenne carer quality of life have limited and often inconsistent supportive psychometric evidence. Further work must investigate instruments’ measurement properties in Duchenne carers and/or the development of new tools. In the interim, we recommend considering the PedsQL Family Impact Module based on Duchenne carer ratings.
... While some studies used well-defined PROMs to measure PROs, a large proportion of the studies in patients with acromegaly assessed a standardized set of symptoms, without clear definition of a PRO. The use of non-disease-specific or unvalidated PROs has also been observed in other areas, such as diabetes mellitus 34 , and oncology. 35 This is a point of concern, since validation of PROMs is important to ensure their relevance, validity, reliability, and sensitivity to change (i.e., responsiveness). ...
Article
Full-text available
Context Insight into the current landscape of patient-reported outcome (PRO) measures (PROM) and differences between PROs and conventional biochemical outcomes is pivotal for future implementation of PROs in research and clinical practice. Therefore, in studies among patients with acromegaly and growth hormone deficiency (GHD), we evaluated: I) used PROMs, II) their validity, III) quality of PRO reporting, IV) agreement between PROs and biochemical outcomes, and V) determinants of discrepancies. Evidence acquisition We searched eight electronic databases for prospective studies describing both PROs and biochemical outcomes in acromegaly and GHD patients. Quality of PRO reporting was assessed using the ISOQOL criteria. Logistic regression analysis was used to evaluate determinants. Evidence synthesis Ninety studies were included (acromegaly: n=53; GHD: n=37). Besides non-validated symptom lists (used in 37% of studies), 36 formal PROMs were used (predominantly AcroQoL in acromegaly [43%] and QoL-AGHDA in GHD [43%]). Reporting of PROs was poor, with a median of 37-47% of ISOQOL items being reported per study. Eighteen (34%) acromegaly studies and twelve (32%) GHD studies reported discrepancies between PROs and biochemical outcomes, most often improvement in biochemical outcomes without change in PROs. Conclusions Prospective studies among patients with acromegaly and GHD use a multitude of PROMs, often poorly reported. Since a substantial proportion of studies report discrepancies between PROs and biochemical outcomes, PROMs are pivotal in the evaluation of disease activity. Therefore, harmonization of PROs in clinical practice and research by development of Core Outcome Sets is an important unmet need.
... Further longitudinal research is needed targeting more varied facets of QoL, particularly in the social domain. Research delineating impacts on individual facets of QoL based on hypoglycaemic severity will also be important for improving existing measures, 50 developing new hypoglycaemiaspecific measures which better capture the breadth of QoL and designing targeted interventions aimed at improving QoL on an outcome-by-outcome basis. ...
Article
Full-text available
Aim To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life in adults with type 2 diabetes. Method Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL, and PsycINFO. Studies were included for review if they used a longitudinal design (e.g., cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to quality of life. Results Twenty longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis (SWiM) guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress, and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support, or overall diabetes-specific quality of life. Conclusions Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of quality of life. Nonetheless, additional longitudinal research is needed—in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of quality of life, and outcomes assessed using hypoglycaemia-specific measures.
Article
Full-text available
Introduction Diabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality. Methods We will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials—Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs. Ethics and dissemination Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences. Systematic review registration This systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.
Article
Letter to the editor. Comment on "Henriksen, M. M., Andersen, H. U., Thorsteinsson, B., & Pedersen-Bjergaard, U. (2021). Effects of continuous glucose monitor-recorded nocturnal hypoglycaemia on quality of life and mood during daily life in type 1 diabetes. Diabetologia, 64(4), 903-913." Read-only share link: https://rdcu.be/ck1Xw
Article
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Duchenne muscular dystrophy (DMD) is an inherited X-linked neuromuscular disorder. A number of questionnaires are available to assess quality of life in DMD, but there are concerns about their validity. This systematic review aimed to appraise critically the content and structural validity of quality of life instruments for DMD. Five databases (EMBASE, MEDLINE, CINAHL, PsycINFO, and Cochrane Library) were searched, with supplementary searches in Google Scholar. We included articles with evidence on the content and/or structural validity of quality of life instruments in DMD, and/or instrument development. Evidence was evaluated against the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. Fifty five articles featured a questionnaire assessing quality of life in DMD. Forty instruments were extracted and 26 underwent assessment. Forty-one articles contained evidence on content or structural validity (including 37 development papers). Most instruments demonstrated low quality evidence and unsatisfactory or inconsistent validity in DMD, with the majority not featuring direct validation studies in this population. Only KIDSCREEN received an adequate rating for instrument design and a satisfactory result for content validity based on its development, yet, like the majority of PROMs, the measure has not been directly validated for use in DMD. Further research is needed on the validity of quality of life instruments in DMD, including content and structural validity studies in this population.
Article
Full-text available
Background: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm. Aim: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. Methods: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems. Results: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement. Conclusion: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.
Article
Full-text available
Purpose To systematically assess the measurement properties and the quality of the evidence for measures of inclusion or exclusion at work. Methods Comprehensive searches of five electronic databases were conducted up to February 2019. Eligible studies aimed to develop a measure of workplace inclusion or exclusion or assessed at least one measurement property. Pairs of reviewers independently screened articles and assessed risk of bias. Methodological quality was appraised with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best-evidence synthesis approach guided the analysis. For each measurement property, evidence quality was rated as high, moderate, low, or very low and results were classified as sufficient, insufficient, or inconsistent. Results The titles and abstracts of 14,380 articles were screened, with 151 full-text articles reviewed for eligibility. Of these, 27 studies were identified, 10 of which were measure development studies. Included measures were the Workplace Ostracism Scale, Ostracism Interventionary Behaviour Scale, Workplace Culture Survey, Workplace Exclusion Scale, Perceived Group Inclusion Scale, Organizational Cultural Intelligence Scale, Inclusion–Exclusion Scale, Climate for Inclusion Scale, Workplace Social Inclusion Scale and the Inclusion-Diversity Scale. Most workplace inclusion instruments were not examined for some form of validity or reliability and evidence for responsiveness was absent. The quality of the evidence for content validity was low for 30% of studies and very low for 70% of studies. Conclusion Future research should focus on comprehensive evaluations of the psychometric properties of existing measures, with an emphasis on content validity, measurement error, reliability and responsiveness.
Article
Full-text available
Abstract Patient-reported outcome measures (PROMs) are widely used in the United Kingdom (UK) and internationally to report and monitor patients’ subjective assessments of their symptoms and functional status and also their quality of life. Whilst the importance of involving the public in PROM development to increase the quality of the developed PROM has been highlighted this practice is not widespread. There is a lack of guidance on how public involvement (PI) could be embedded in the development of PROMs, where the roles can be more complex than in other types of research. This paper provides a timely review and sets out an emerging framework for fully incorporating PI into PROM development.
Article
Full-text available
Background and aims: Hypoglycemia represents a relevant burden in people with diabetes. Consequences of hypoglycemia/fear of hypoglycemia on quality of life (QoL) and behaviors of patients with T1DM and T2DM were assessed. Methods and results: HYPOS-1 was an observational retrospective study. Fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FHQ), general health status (visual analog scale of EuroQol questionnaire, EQ5D-VAS) psychological well-being (WHO-5 well being index, WHO-5), diabetes related distress (Problem Areas in Diabetes 5, PAID-5), and corrective/preventive behaviors following hypoglycemia were compared between people with and without previous experience of severe and symptomatic hypoglycemia and by tertiles of FHQ scores. A multivariate analysis was performed to identify factors associated with the likelihood of being in the third tertile of FHQ score. Overall, 2229 patients were involved. Severe hypoglycemia had statistically significant and clinically relevant (measured as effect sizes) negative impact on EQ5D-VAS, WHO-5, PAID-5, and FHQ both in T1DM and T2DM. In T2DM, symptomatic episodes had similar impact of severe hypoglycemia. Moving from the first to the third FHQ tertile, lower scores of EQ-5D VAS and WHO-5, and higher levels of PAID-5 were found. Patients in the third tertile performed more frequently corrective/preventive actions that negatively impact on metabolic control. Previous hypoglycemia, insulin treatment, female gender, age, and school education were the independent factors associated with increased likelihood to be in the third tertile. Conclusion: Not only severe but also symptomatic hypoglycemia negatively affect patient QoL, especially in T2DM. Addressing fear of hypoglycemia should be a goal of diabetes education.
Article
Almost 100 years since the discovery of insulin, hypoglycaemia remains a barrier for people with type 1 diabetes to achieve and maintain blood glucose at levels which prevent long‐term diabetes‐related complications. Although hypoglycaemia is primarily attributable to the limitations of current treatment and defective hormonal counter‐regulation in type 1 diabetes, the central role of psycho‐behavioural factors in preventing, recognizing and treating hypoglycaemia has been acknowledged since the early 1980s. Over the past 25 years, as documented in the present review, there has been a substantial increase in psycho‐behavioural research focused on understanding the experience and impact of hypoglycaemia. The significant contributions have been in understanding the impact of hypoglycaemia on a person’s emotional well‐being and aspects of life (e.g. sleep, driving, work/social life), identifying modifiable psychological and behavioural risk factors, as well as in developing psycho‐behavioural interventions to prevent and better manage (severe) hypoglycaemia. The impact of hypoglycaemia on family members has also been confirmed. Structured diabetes education programmes and psycho‐behavioural interventions with a focus on hypoglycaemia have both been shown to be effective in addressing problematic hypoglycaemia. However, the findings have also revealed the complexity of the problem and the need for a personalized approach, taking into account the individual’s knowledge of, and emotional/behavioural reactions to hypoglycaemia. Evidence is emerging that people with persistent and recurrent severe hypoglycaemia, characterized by deeply entrenched cognitions and lack of concern around hypoglycaemia, can benefit from tailored cognitive behavioural therapy.
Article
Over the past 25 years, there has been significant acknowledgement of the importance of assessing the impact of diabetes on quality of life. Yet, despite the development of several diabetes‐specific quality‐of‐life measures, the challenges we faced in 1995 remain. There is little consensus on the definition of quality of life because of the complexity and subjectivity of the concept. General quality of life comprises several domains of life, and these are highly individualized. Assessing the impact of diabetes on these life domains adds to the complexity. While comprehensive diabetes‐specific quality‐of‐life measures typically increase respondent burden, brief questionnaires may not capture all relevant/important domains. Today, the lack of resolution of these challenges may explain why the impact of diabetes on quality of life is not systematically assessed in research or clinical care. Few researchers report detailed rationales for assessment, there is often a mismatch between the concept of interest and the measure selected, and data are misinterpreted as assessing the impact of diabetes on quality of life when, in reality, related but distinct constructs have been assessed, such as diabetes distress, treatment satisfaction or health status. While significant efforts are being made to increase routine monitoring of psychological well‐being and understand the lived experience, no guidelines currently recommend routine clinical assessment of diabetes‐specific quality of life, and there is no consensus on which questionnaire(s) to use. The gaps identified in this review need urgent attention, starting with recognition that assessment of diabetes‐specific quality of life is as important as biomedical markers, if we are to improve the lives of people with diabetes.
Article
Aim: Hypoglycaemia affects many people with Type 2 diabetes using insulin and other glucose-lowering therapies. This systematic review examined the impact of severe hypoglycaemia (episodes requiring external assistance) on psychological outcomes (e.g. emotional well-being, health status and quality of life) in adults with Type 2 diabetes. Methods: MEDLINE Complete, PsycINFO and CINAHL databases were searched for peer-reviewed empirical studies, published in English, reporting the occurrence and severity of hypoglycaemia and its relationship with patient-reported outcomes (PROs) in adults with Type 2 diabetes. Data were extracted from published reports and analysed. Results: Of 3756 potentially relevant abstracts, 29 studies met the inclusion criteria. Most reported cross-sectional data and sample sizes varied widely (N = 71 to 17 563). Although definitions of mild and severe hypoglycaemia were largely consistent between studies, additional non-standard categorizations (e.g. moderate, very severe) were apparent and recall periods varied. Overall, severe hypoglycaemia was associated with increased fear of hypoglycaemia and decreased emotional well-being, health status and diabetes-specific quality of life. Effect sizes show that the association with fear of hypoglycaemia was stronger than with general health status. Conclusions: Notwithstanding the limitations of the empirical studies, these findings indicate that severe hypoglycaemia in adults with Type 2 diabetes (insulin- and non-insulin-treated) is associated with impaired psychological outcomes. Healthcare professionals should address the psychological impact of severe hypoglycaemia during clinical consultations, to support individuals to minimize exposure to, and the psychological consequences of, severe hypoglycaemia. This article is protected by copyright. All rights reserved.
Article
Purpose: The incidence of invasive treatment of rib fracture has increased significantly over the last decade however the evidence of improved patient outcomes to support this is lacking. A systematic review was performed to identify patient reported outcome measures (PROMs) used in the assessment of outcomes following chest wall injury. The quality of evidence for the psychometric properties of the identified PROMs was graded using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Methods: Rib fracture studies measuring patient reported outcomes were identified using PubMed/Medline, EMBASE, AMED and PsycINFO. Methodological quality of measurement properties was evaluated with the COnsensus-based Standards for selection of health status Measurement INstruments (COSMIN) checklist. Results: A total of 64 studies were identified including 19 different PROM instruments. Domains included in the reported PROMs included pain, breathlessness, general health quality of life, physical function and physiological health. No rib fracture specific PROM was identified. The most frequently reported instrument was the SF-36 reporting overall quality of life (HRQoL) although there was very low quality evidence for its content validity. There was low quality evidence to support good content validity for the Medical Research Council (MRC) dyspnoea scale, Brief Pain Index (BPI) and McGill Pain Questionnaire (MPQ). No PROM had undergone validation in a rib fracture population. The overall quality of the PROM development studies was poor. While we were unable to identify a clear "gold standard", based on the limited current evidence, we recommend that the EQ-5D-5L is used in combination with the MRC and BPI or MPQ for future rib fracture studies. Conclusion: The lack of validated outcome measures for rib fracture patients is a significant limitation of the current literature. Further studies are needed to provide validated outcome measures to ensure accuracy of the reported results and conclusions. As interventions for rib fractures have become more common in both research and clinical practice this has become an urgent priority.
Article
Purpose: The primary purpose of this study is to report a systematic review of evidence and gaps in the literature among well-conducted studies assessing the impact of diabetes education on hypoglycemia outcomes and secondarily reporting the impact on other included target outcomes. Methods: The authors used a modified Cochrane method to systematically search and review English-language titles, abstracts, and full-text articles published in the United States between January 2001 and December 2017, with diabetes education specified as an intervention and a directly measurable outcome for hypoglycemia risk or events included. Results: Fourteen quasi-experimental, experimental, and case-control studies met the inclusion criteria, with 8 articles reporting a positive impact of diabetes self-management education and support (DSMES) on hypoglycemia outcomes; 2 of the 8 reported decreased hypoglycemia events, and 1 reported decreased events in both the intervention and control groups. In addition, 5 studies targeted change in reported hypoglycemia symptoms, with all 5 reporting a significant decrease. DSMES also demonstrated an impact on intermediate (knowledge gain, behavior change) and long-term (humanistic and economic/utilization) outcomes. An absence of common hypoglycemia measures and terminology and suboptimal descriptions of DSMES programs for content, delivery, duration, practitioner types, and participants were identified as gaps in the literature. Conclusions: Most retained studies reported that diabetes education positively affected varied measures of hypoglycemia outcomes (number of events, reported symptoms) as well as other targeted outcomes. Diabetes education is an important intervention for reducing hypoglycemia events and/or symptoms and should be included as a component of future hypoglycemia risk mitigation studies.