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Design Analyst blinded, parallel, multi-centre, randomised controlled trial (RCT). Participants People with confirmed diagnoses of cancer (head and neck, skin or colorectal) attending follow-up consultation 3 months post-treatment between 2015 and 2020. Intervention Holistic needs assessment (HNA) or care as usual during consultation. Objective To establish whether incorporating HNA into consultations would increase patient participation, shared decision making and postconsultation self-efficacy. Outcome measures Patient participation in the consultations examined was measured using (a) dialogue ratio (DR) and (b) the proportion of consultation initiated by patient. Shared decision making was measured with CollaboRATE and self-efficacy with Lorig Scale. Consultations were audio recorded and timed. Randomisation Block randomisation. Blinding Audio recording analyst was blinded to study group. Results 147 patients were randomised: 74 control versus 73 intervention. Outcome No statistically significant differences were found between groups for DR, patient initiative, self-efficacy or shared decision making. Consultations were on average 1 min 46 s longer in the HNA group (respectively, 17 m 25 s vs 15 min 39 s). Conclusion HNA did not change the amount of conversation initiated by the patient or the level of dialogue within the consultation. HNA did not change patient sense of collaboration or feelings of self-efficacy afterwards. HNA group raised more concerns and proportionally more emotional concerns, although their consultations took longer than treatment as usual. Implications for practice This is the first RCT to test HNA in medically led outpatient settings. Results showed no difference in the way the consultations were structured or received. There is wider evidence to support the roll out of HNA as part of a proactive, multidisciplinary process, but this study did not support medical colleagues facilitating it. Trial registration number NCT02274701.
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SnowdenA, etal. BMJ Open 2023;13:e066829. doi:10.1136/bmjopen-2022-066829
Open access
Holistic needs assessment in outpatient
cancer care: a randomised
controlled trial
Austyn Snowden ,1 Jenny Young,1 Denis Roberge,2 Stefano Schipani,3,4
Esther Murray,5 Claude Richard,6 Marie- Therese Lussier,7 Craig White 4
To cite: SnowdenA, YoungJ,
RobergeD, etal. Holistic
needs assessment in outpatient
cancer care: a randomised
controlled trial. BMJ Open
2023;13:e066829. doi:10.1136/
bmjopen-2022-066829
Prepublication history for
this paper is available online.
To view these les, please visit
the journal online (http://dx.doi.
org/10.1136/bmjopen-2022-
066829).
Received 22 July 2022
Accepted 19 April 2023
For numbered afliations see
end of article.
Correspondence to
Professor Austyn Snowden;
a. snowden@ napier. ac. uk
Original research
© Author(s) (or their
employer(s)) 2023. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Design Analyst blinded, parallel, multi- centre, randomised
controlled trial (RCT).
Participants People with conrmed diagnoses of cancer
(head and neck, skin or colorectal) attending follow- up
consultation 3 months post- treatment between 2015 and
2020.
Intervention Holistic needs assessment (HNA) or care as
usual during consultation.
Objective To establish whether incorporating HNA into
consultations would increase patient participation, shared
decision making and postconsultation self- efcacy.
Outcome measures Patient participation in the
consultations examined was measured using (a) dialogue
ratio (DR) and (b) the proportion of consultation initiated
by patient. Shared decision making was measured
with CollaboRATE and self- efcacy with Lorig Scale.
Consultations were audio recorded and timed.
Randomisation Block randomisation.
Blinding Audio recording analyst was blinded to study
group.
Results 147 patients were randomised: 74 control versus
73 intervention.
Outcome No statistically signicant differences were
found between groups for DR, patient initiative, self-
efcacy or shared decision making. Consultations were on
average 1 min 46 s longer in the HNA group (respectively,
17 m 25 s vs 15 min 39 s).
Conclusion HNA did not change the amount of
conversation initiated by the patient or the level of dialogue
within the consultation. HNA did not change patient sense
of collaboration or feelings of self- efcacy afterwards.
HNA group raised more concerns and proportionally more
emotional concerns, although their consultations took
longer than treatment as usual.
Implications for practice This is the rst RCT to test HNA
in medically led outpatient settings. Results showed no
difference in the way the consultations were structured or
received. There is wider evidence to support the roll out of
HNA as part of a proactive, multidisciplinary process, but
this study did not support medical colleagues facilitating it.
Trial registration number NCT02274701.
INTRODUCTION
Patients with cancer experience a wide
range of unmet needs including prac-
tical, emotional and social concerns, with
negative consequences on general well-
being.1 Holistic needs assessment (HNA,
figure 1) is a process designed to elicit system-
atic support of all patient’s needs.2 Systematic
reviews on the role and function of HNA
broadly agree on the core domains that make
up ‘holistic’ needs in cancer care: physical,
practical, emotional, family/relationship,
spiritual, information/support.3 The HNA
used in this study was the concerns check-
list (figure 1), a list of 48 concerns grouped
under the domains described previously.
These concerns are rated by the patient at
key times in their cancer care to ensure (a)
their personally prioritised needs are identi-
fied and planned for, and that b) resources
are targeted to those in most need.2
An HNA helps focus the consultation on
the explicit needs of the patient. This person-
centred approach should help patients to
share decision making within the consulta-
tion because, in theory, HNA should support
patients to take a more active and participa-
tory role in it. Patient engagement within
consultations is associated with self- efficacy,
and self- efficacy is associated with better
health outcomes.4 5 Therefore, collaboration
within consultations, grounded in patient’s
personally prioritised needs, should lead
STRENGTHS AND LIMITATIONS OF THIS STUDY
This is the rst study to attempt to establish the
impact of a holistic needs assessment (HNA) on
the levels of patient participation within the clinical
consultation.
This is also the rst study to examine the impact of
HNA in a predominantly medical sample of clinical
consultations.
Consultation analysts were blinded to the study
group.
‘Time taken for consultation’ should have been a
primary outcome.
The study took 5 years to recruit.
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to greater patient involvement in decision making and
increased likelihood of positive outcomes.6
Despite its endorsement in clinical guidelines,
outcomes from randomised controlled trials (RCTs) of
HNA have been equivocal. A pilot trial of a bespoke HNA
tool in a palliative service in the UK found it resulted
in worse quality of life outcomes for patients than treat-
ment as usual (TAU).7 The authors acknowledged that
these findings could have been because of the lack
of connected follow- up postassessment. Subsequent
researchers8 therefore integrated care plans into their
RCT of HNA as delivered by allied health professionals.
Despite the qualitative element of the study pointing
to feelings of greater empowerment for those in the
intervention group, this study also found no significant
differences between groups (HNA and care as usual) in
health- related quality of life measures in women with
gynaecological cancer at 3 and 6 months from base-
line. They concluded that the trend towards improve-
ment seen in some of the quality- of- life subscales was a
Figure 1 Holistic needs assessment: the concerns checklist.
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function of trained health professionals using person-
centred approaches.8
Despite these RCT results the consensus in 2020
supported the use of HNA as part of a connected, system-
atic multidisciplinary process of focused assessment
followed by planned action and review.9 10 It would be
helpful to understand if and how HNA works at consulta-
tion level because operationalising person centred care is
at the heart of current strategic direction in cancer policy
in Scotland11 12 and beyond.10
This study was designed to test the impact of HNA on
consultation dynamics and patient perceptions of shared
decision making and self- efficacy. The aim of the trial
was to investigate if and how HNA impacted on patient
participation during outpatient oncology consultation
and patient perceptions of shared decision- making and
self- efficacy afterwards. Objectives were to examine:
1. The impact of HNA on consultation structure and
content.
2. The impact of HNA on shared decision- making.
3. The impact of HNA on patient- reported self- efficacy.
To meet these objectives, the study tested the following
hypotheses:
1. Use of HNA within clinical consultation will facilitate
increased levels of patient participation.
2. Use of HNA within clinical consultation will facilitate
increased levels of shared decision making.
3. Use of HNA within clinical consultation will facilitate
increased feelings of self- efficacy.
METHOD
Study design
Multi- centre, analyst blinded, RCT conducted across four
outpatient oncology clinics in Scotland, UK.13 A multidis-
ciplinary steering group oversaw the trial.
Participants: clinicians
Nine clinicians (three consultant oncologists, three
surgeons, three cancer nurse specialists) based across
four outpatient oncology clinics in Glasgow (see table 1).
Two clinics were situated in National Health Service
(NHS) general hospitals and two in an NHS specialist
cancer centre. None of the oncologists or surgeons had
used HNA previously. All attended a training session on
HNA and the study protocol, delivered by a consultant
psychologist (EM) and the research team. The aim of the
training was to familiarise the clinicians with the study
process and equip them with the skills and confidence to
respond to the patient’s needs as identified through the
HNA.
Participants: patients
Individuals with head and neck, skin and colorectal
cancer were eligible if over the age of 18, had undergone
treatment for their diagnosis and were attending post-
treatment outpatient clinic with one of the participating
clinicians. All patients had previously met their respective
clinician. Exclusion criteria included those deemed inca-
pable of consent and any reason in the opinion of the
clinician that may interfere with the patient’s ability to
take part in an audio- recorded consultation, for example,
if the patient had received a laryngectomy.
Participants: sample size
Sample size was 156, calculated on G*Power3 based on
the following assumptions11: power=0.8, alpha=0.0125,
d=0.5. Alpha was subjected to Bonferroni correction to
account for the additional risk of type 1 error in testing
four primary outcomes on the same dataset.
TRIAL PROCEDURE
Patients provided written informed consent to partici-
pate before they were randomised. Allocation conceal-
ment was maintained through sequentially numbered,
opaque, sealed envelopes. Block randomisation (block
size of 6 and 4) was used to ensure comparable number
of patients within each group. The rationale for using
different block sizes was so the sequence could not be
predicted. As this was the first RCT to examine HNA
on consultation dynamics the decision was made not to
stratify by sex or age as we did not have sufficient evidence
that these factors were related to the outcome measures.
Participants attended their appointment 15 min early, at
which point they were informed as to which study group
they had been randomised to, so that they could then
complete relevant study paperwork preconsultation.
Consultation: intervention arm
Patients completed a demographic questionnaire and
the HNA (figure 1) prior to consultation. The patient
was then asked to hand their completed HNA to their
clinician when they entered the consultation room. The
researcher accompanied the patient into the room and
switched on the voice recorder.
During the consultation the clinician incorporated
the HNA into their discussion.13 As this was usually
the patient’s first post- treatment appointment (mean
3 months post- treatment) the clinician had some
Table 1 Study participants by consultant and intervention
group
Role Intervention Control
Oncologist 1 43 38
Surgeon 1 21 14
Surgeon 2 1 8
Oncologist 2 4 3
Surgeon 3 1 7
CNS 1 3 3
Oncologist 3 1 2
CNS 2 1
CNS 3 1
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procedural issues to discuss with the patient first, for
example, results from scans, or problems post- treatment.
This was usually followed by an examination of the cancer
site. The HNA was introduced and discussed after these
routine procedures, and any subsequent actions taken
by the patient or clinician were recorded in the care
plan. The researcher made notes about pauses or non-
verbal events throughout to help the team analysing the
recordings. At the end of the consultation the recording
was stopped. Immediately postconsultation, participants
returned to the waiting room with the researcher where
they completed two short outcome measures, Collabo-
RATE14 and The Lorig Self- Efficacy scale.15 16
Control group: TAU
As with the intervention group, the researcher greeted
the patient in the waiting room and re- confirmed
consent. The patient completed the demographic ques-
tionnaire, and the researcher accompanied the patient
into the consultation room, switched on the recorder
at the beginning and switched it off at the end, making
notes on pauses, details of participants and pertinent
events as per intervention group. The control group also
completed the postconsultation self- report measures on
collaboration and self- efficacy.
OUTCOME MEASURES
Hypothesis 1 tests ‘patient participation’ within the
consultation. Patient participation was obtained by calcu-
lating two different primary outcome measures of patient
involvement during consultation:
1. Patient initiative (PI) represents the proportion of the
consultation initiated by the patient as opposed to the
clinician.
2. Dialogue ratio (DR) measures the degree of collabora-
tion between the speakers during the conversation.
To obtain these aggregate measures consultation audio-
recordings were coded by team members blinded to
group allocation. Coding was based on the MEDICODE
scheme,17 a coding framework consisting of overarching
categories and themes common to medical consultations.
The analyst coded sections of the consultation under
relevant categories and noted (a) whether the patient or
clinician initiated the theme (PI) and (b) whether the
conversation around that theme was monologue, dyad or
dialogue (DR).
Patient initiative
PI was calculated as the proportion of patient- initiated
themes within the consultation. A patient was coded as
having initiated conversation when a new theme was
introduced by them. The aggregate PI value falls between
0, meaning the patient had no initiative at all, and 1, indi-
cating the patient initiated all themes discussed within
the consultation. Any other score represents the balance
of initiative between patient and clinician.
Dialogue ratio
The DR is also presented as a value between 0 and 1.18 A
theme coded as monologue was assigned a value of 0, a
dyad 0.5 and a dialogue 1. An average score was computed
for the same aggregate of themes used for the PI score. An
average score of 0 would mean that all the themes were
covered in monologue, while a score of 1 would mean
that all the themes were discussed in dialogue. As with PI,
average DR scores were then compared between groups.
Shared decision-making
The primary outcome for hypothesis 2 was score on
CollaboRATE, a validated brief measure of shared deci-
sion making.14 It measures patient perception of how
much effort clinicians make to: explain their patients’
health issues, listen to the issues that matter most to their
patients, and integrate the patients’ views and health
beliefs.
Self-efcacy
The primary outcome for hypothesis 3 was self- efficacy,
as measured by The Lorig Self- Efficacy for Managing
Chronic Disease 6- Item Scale. The scale includes items
relevant to chronic disease measurement such as symptom
control and communicating with physicians. The scale
has good internal consistency and construct validity, and
it has been extensively used at both clinical and research
levels within the cancer patient population.19
Time taken in consultation
‘Time taken per consultation’ had not been part of the
original protocol, and previous attempts to time consulta-
tions had been quite complex.20 The focus of this study was
on consultation dynamics that required audio recording,
and the research assistant also had to ensure consent and
preclinic paperwork had been completed as well as post-
consultation metrics too. Because we had hoped other
teams would participate in the study we wanted to keep
the protocol as simple as possible to minimise dropout
due to complexity21 it was decided that timing of the
consultations might be a measure too far, and so it was
excluded from the original protocol. However, because
all the consultations were digitally recorded it was possible
to retrospectively record the exact length of time taken in
each consultation in a consistent way. This had not been
anticipated, hence its absence from the planned hypoth-
eses. It was nevertheless available for exploratory analysis.
ANALYTIC PLAN
All data were checked for input errors, missing data, and
means and SD were calculated. Data were then tested for
assumptions of normality and homogeneity of variance
associated with independent groups analysis. If the assump-
tions were met for a primary outcome, then independent
t- tests were run to test for significant differences between
the group means. If the assumptions were not met for a
particular outcome, then the optimal non- parametric test
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would be selected based on the outcomes of assumption
testing.22 Exploratory analyses were also conducted itera-
tively. For full plan, refer protocol.13
Patient and public involvement
The original idea for this study was conceived in collab-
oration with patients following a series of presentations
of findings from a pilot RCT of the distress thermometer
and concerns checklist.20 Patients from this study had fed
back that their consultations had qualitatively improved
when clinicians used the concerns checklist. When asked
to explain this in more detail they described feeling better
listened to and more involved in the consultation. They
went on to describe feeling more confident to carry out
whatever plan had been discussed in the consultation.
The study protocol focused on exploring these
dynamics. DR and PI represented proxy measures of
involvement during consultation, CollaboRATE is a
valid self- report measure of the degree to which patients
felt involved, and self- efficacy was a key element of the
improved postconsultation control that patients were
describing as a product of this improved involvement.
This study was created to replicate and articulate the
hypothetical process underpinning the positive experi-
ences reported by patients at feedback events.
RESULTS
Participants
From November 2015 to February 2020, 275 patients
appointed to outpatient follow- up were approached by
clinicians for participation (see figure 2). Eleven declined
and 264 were enrolled. There was an average of 3 months
between enrolment and follow- up, and 113 patients were
lost to the study in this time. By March 2020, 151 patients
had participated when the study was suspended due to
COVID- 19 restrictions.
All 151 participants were white, Scottish, with mean
age of 64.5 (11.5) years. There were 101 men and 50
women. Most were married and the whole sample had a
mean Scottish Indicator of Multiple Deprivation quintile
category of 4.7 (3.1), five being most deprived. Of those
declaring a highest qualification 15 had a degree, 15 A
levels/highers, two masters degrees, 25 standard grades
and 16 vocational qualifications. Apart from sex, demo-
graphics were balanced between the two groups (table 2).
The majority were treated for head and neck cancers
(n=121), with 23 treated for skin cancers and 7 colorectal.
Treatment was chemorad (n=31), radiotherapy (n=37)
and surgery (n=43). Patients were predominantly treated
by two clinicians, oncologist one (n=86) and surgeon one
(n=35), with the other seven clinicians contributing the
remaining 35 consultations. Nurses contributed eight
consultations, close to 1 in every 20 (table 1).
Use of HNA within clinical consultation will facilitate increased
levels of patient participation
Mean scores for PI and DR were computed for each group
(table 3). There were no outliers in the data, as assessed
by inspection of boxplots. Scores for PI in both groups
were normally distributed, as assessed by Shapiro- Wilk’s
Figure 2 Flow of participants through the trial.
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test (p>0.05), and there was homogeneity of variances, as
assessed by Levene’s test (p=0.055). PI scores were lower
for the intervention group (0.25±0.10) than control
group (0.26±0.13), a non- significant difference of −0.012
(95% CI −0.06 to 0.04), t(145)=−0.439, p=0.661.
Scores for DR in both groups were normally distributed,
as assessed by Shapiro- Wilk’s test (p>0.05), and there was
homogeneity of variances, as assessed by Levene’s test
(p=0.051). DR scores were lower for the intervention
group (0.38±0.15) than control group (0.40±0.19), a non-
significant difference of −0.013 (95% CI −0.05 to 0.02),
t(145)=−0.691, p=0.49.
These results did not support hypothesis 1. Use of HNA
within clinical consultation did not facilitate increased
levels of patient participation.
Use of HNA within clinical consultation will facilitate increased
levels of shared decision making
Table 3 shows the mean scores for CollaboRATE were
very similar in both groups. There were no outliers in
the data, as assessed by inspection of a boxplot. Scores
for both groups were normally distributed, as assessed
by Shapiro- Wilk’s test (p>0.05), and there was homoge-
neity of variances, as assessed by Levene’s test (p=0.649).
CollaboRATE scores were higher for the intervention
group (25.43±4.1) than control group (25.03±4.4), a
non- significant difference of 0.4 (95% CI −1.77 to 0.97),
t(149)=−0.58, p=0.562. Hypothesis 2 was not supported:
use of HNA did not lead to greater feelings of shared
decision making and collaboration.
Use of HNA within clinical consultation will facilitate increased
feelings of self-efcacy
The difference in means for the Lorig Self- Efficacy
measure were tested using independent samples t- test.
There were no outliers in the data, as assessed by inspec-
tion of a boxplot. Lorig scores for both groups were
normally distributed, as assessed by Shapiro- Wilk’s test
(p>0.05), and there was homogeneity of variances,
as assessed by Levene’s test for equality of variances
(p=0.809). Lorig scores were higher for the interven-
tion group (8.07±1.7) than control group (7.5±1.7), a
non- significant difference of 0.57 (95% CI 0.02 to 1.11),
Table 2 Participant demographics
Participant Intervention (n=74) Control (n=77) Descriptive Intervention (n=74) Control (n=77)
Age and sex Cancer
Male 52 49 Head and neck 60 61
Mean (SD) age 64.9 (10.2) years 60.3 (9.8) years Colorectal 3 4
Female 22 28 Skin 11 12
Mean (SD) age 66.9 (12.0) years 70 (10.2) years Treatment
ChemoRad 14 17
Status Radiotherapy 21 16
Single 8 11 Surgery 21 22
Married 55 50 Missing 18 22
Divorced 4 5
Widow 7 8 Clinician seen
Missing 0 3 Oncologist 48 43
Surgeon 23 29
Mean SIMD (SD) 5.21 (3.0) 4.35 (3.1) Nurse specialist 3 5
SIMD, Scottish Indicator of Multiple Deprivation.
Table 3 Primary outcome measures
Outcome measure
Intervention
(n=74)
Control
(n=77)
Mean (SD) dialogue ratio (DR) 0.384 (0.100) 0.398 (0.129)
Mean (SD) patient initiative (PI) 0.253 (0.146) 0.265 (0.185)
Mean (SD) CollaboRATE 25.43 (4.1) 25.03 (4.4)
Mean (SD) Lorig Self- Efcacy 8.1 (1.7) 7.5 (1.7) Figure 3 Barchart: Mean scores for Lorig Self- Efcacy scale
by group, with 95% CIs.
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t(146)=2.04, p=0.043 (figure 3). Use of HNA within clin-
ical consultation did not facilitate increased levels of self-
efficacy postconsultation.
Exploratory analyses
You will recall that ‘time in consultation’ was not a primary
outcome, but the digital audio- recordings provided accu-
rate timings of consultation, nonetheless. These times
were on average nearly 2 min longer for the interven-
tion group (17 min 25 s) than control group (15 min 39
s). Using HNA within these clinical consultations took
longer than not using HNA. The content of the consulta-
tions also differed (table 4), with more concerns discussed
overall in the intervention group, and a shift away from
discussing physical concerns towards emotional, practical
and other health problems.
DISCUSSION
Use of HNA within post- treatment, outpatient consulta-
tion did not facilitate increased levels of PI, did not change
the consultations in terms of overall monologue- dialogue,
did not facilitate any greater sense of collaboration and
did not increase feelings of self- efficacy immediately post-
consultation. HNA took up more consultation time than
TAU. This lack of support for HNA is consistent with
other RCTs designed to establish its impact.7 23 It is incon-
sistent with the wider literature showing that undertaken
as part of a proactive and well connected multidisciplinary
process, HNA has improved outcomes from both patients
and clinicians.10 24 It may be that the outcome measures
used were not sensitive enough, or that the impact of
HNA may have been more nuanced, given there were
observable differences between the groups.
For example, a higher number of concerns were
discussed in the intervention group (8.3 vs 6.6) (table 4).
It is possible this increase could be a function of the extra
time taken in the intervention groups, but this would not
explain the changes seen in the content of these consul-
tations. Focus tended to remain on cancer and physical
health in TAU group whereas ‘other health problems’,
‘practical’ and ‘emotional concerns’ were more preva-
lent in the intervention group (table 4). HNA apparently
facilitated a more complex consultation, giving patients
‘permission’ to discuss difficult problems they may other-
wise not have raised. If HNA could become integral
rather than additional, then it seems HNA could facilitate
a more holistic, patient targeted consultation. However,
the study did not show that this would be the best use of
consultation time.
Since this trial started, research into HNA has grown
considerably.25 A systematic review in 2019 found
mixed outcomes from the included trials, with some
finding improvement in quality of life but most not. A
similar picture emerged from a 2022 scoping review of
‘Cancer Care Reviews’ that included HNAs.26 These
reviews concluded, like Ahmed et al7 that it is the way
in which these discussions are integrated that is key. If
they are disconnected from other services they are seen
as a tick box exercise or not remembered at all.27 The
setting needs to be conducive to confidential discussions,
personnel need to be trained, confident and skilled in
delivering HNA as part of a connected multidisciplinary
process.10 24
Conditions in this study broadly met those facilitative
criteria, so it may be that oncologists and surgeons are
not the best members of the multidisciplinary team to be
facilitating HNA. This study showed oncologists gener-
ated mainly physical needs (table 4). This is consistent
with their specialism. When psychologists conduct HNA,
patients tend to prioritise mainly emotional concerns,
non- clinical social colleagues facilitate mainly money and
housing needs.28 29 Allied health professionals and nurses
generate the broadest range of needs.23 30 In other words,
patient expectations of the consultation, including the
role of any assessment in it, are largely consistent with
their interpretations of what the consultation is for.27 If
generalisable, then the best way to articulate the widest
range of holistic needs is to have the assessment facili-
tated by non- specialists.
The Western policy push for care to be personalised
and holistic has been widely accepted in principle but
remains difficult to operationalise, which is why studies
like this are useful. HNA makes sense to patients when
they know what it is for, it appears at optimal times as part
of an ongoing process, making the best use of multidis-
ciplinary specialists to support them with their evolving
Table 4 Breakdown of consultations according to
problems and concerns discussed
Complexity of the discussions Intervention Control
Total number of concerns
discussed
609 487
Average number of concerns
discussed per consultation
8.3 6.6
Proportions of different concerns
raised per category
Cancer (HNA=73; TAU=74) 12.00% 15.20%
Other health problems (HNA=59;
TAU=26)
9.70% 5.30%
Physical concerns (HNA=382;
TAU=362)
62.70% 74.30%
Emotional concerns (HNA=28;
TAU=12)
4.60% 2.50%
Practical concerns (HNA=18;
TAU=2)
3.00% 0.40%
Relationship concerns (HNA=5;
TAU=2)
0.80% 0.40%
Support needs (HNA=8; TAU=8) 1.30% 1.60%
Spiritual concerns (HNA=1; TAU=0) 0.20%
HNA level of concerns (HNA=35;
TAU=1)
5.70% 0.20%
HNA, holistic needs assessment; TAU, treatment as usual.
on May 7, 2023 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2022-066829 on 4 May 2023. Downloaded from
8SnowdenA, etal. BMJ Open 2023;13:e066829. doi:10.1136/bmjopen-2022-066829
Open access
concerns.27 This study has shown that these optimal times
and places should not include outpatient follow- up care
conducted by oncologists and surgeons.
Limitations
The main weakness of the study was that it only examined
a snapshot in time. Given HNA is ideally used at various
points on the patient journey this was problematic. The
focus of the study was on the mechanism of action during
consultation, and no study had previously examined
the HNA consultation in this depth. Nevertheless, some
follow- up would have helped further contextualise the
results. Another weakness was the study sample. It was all
white, which was unexpected as 17.3% of the local popu-
lation identified as an ethnic minority in the 2011 census,
and this is known to have subsequently increased.
An anticipated weakness was the potential for cross-
over learning, given the same clinicians delivered both
intervention and TAU (table 2). As stated in the protocol,
crossover learning would not improve the likelihood of
clinicians establishing patient’s specific holistic needs,13
but it is feasible that a consistently person- centred
approach could account for the equivalent scoring in
consultation participation. The levels of PI and DR seen
in both groups implied inclusive levels of patient centred-
ness, and this is likely to have been the case before the study.
The original plan had been to conduct some prestudy
interviews to benchmark the baseline ‘treatment as usual’
levels of all study metrics,13 but this proved impractical
when it became clear we were going to struggle to recruit
to power. We therefore had to use all data for the study,
and while this is a weakness of the study, it is evidence of
good practice from all the clinicians.
Patient participation within the consultation was quanti-
fied using MEDICODE, a method of parsing conversations
according to two simple metrics. However, aggregating
values of DR and PI to account for the whole consulta-
tion had not been done previously. Studies using MEDI-
CODE that have showed variations between consultations
have shown variation in specific themes as opposed to
the whole consultation.31 32 This appeared to be the case
again here. The intervention group discussed emotional
issues 28 times as opposed to the TAU group’s 12. This
suggests that HNA did change consultation content, and
that MEDICODE is of more use at this granular level.
There may be better metrics to summarise participation
in consultations at a more general level.
It would have been interesting to see if a change in
dynamics would have been seen had HNA been intro-
duced at the beginning of the consultation in the interven-
tion group. While developing the protocol, participating
clinicians were keen to maintain focus on the primary
purpose of their consultations, namely: disseminating
test results, organising further tests and examinations,
discussing prognosis and treatment. The research team
agreed that the study should not disturb these discussions
but rather follow them. It is therefore unsurprising that
HNA took longer, because it was conducted in addition
to TAU. Further, the only opportunity for HNA facilitated
variation in consultation style happened at the end of the
traditional consultation. These extra 1 min and 46 s would
likely have had to be completely patient led to impact on
the overall consultation metrics. It is much more likely
that the balance of the consultation continued as before
the introduction of the HNA, and this is born out in the
results for DR and PI.
CONCLUSION
The importance of being able to talk about holistic
concerns in cancer care is well understood, as is the
importance of clinicians systematically supporting people
to meet their individual health and social care needs.
HNA is known to facilitate this process, so this RCT
aimed to understand the mechanism of action of HNA
by finding out whether and how it changed consultation
dynamics in outpatient follow- up consultation. Results
showed there was no change. Both groups were equiva-
lently person- centred. There was no impact on patient
involvement during the consultation, or sense of collabo-
ration or self- efficacy just after. While there was evidence
of more emotional concerns being discussed in the inter-
vention group, these consultations were also nearly 2 min
longer.
The wider evidence supports the integration of HNA
into a multidisciplinary process of proactive, patient- led
health and social cancer care, and the results of this study
are best interpreted from that perspective. Oncologists
and surgeons are expensive, highly specialist members of
the multidisciplinary team. Results of this study suggest
that health and social care colleagues other than they are
best placed to facilitate HNA.
Author afliations
1Edinburgh Napier University, School of Nursing Midwifery and Social Care,
Edinburgh, UK
2Département de médecine de famille et de médecine d’urgence, University of
Quebec in Montreal, Montreal, Quebec, Canada
3Clinical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, UK
4School of Cancer Sciences, University of Glasgow, Glasgow, UK
5Psychology, Beatson West of Scotland Cancer Centre, Glasgow, UK
6MEDICODE, University of Quebec in Montreal, Montreal, Quebec, Canada
7Faculté de médecine - Département de médecine de famille et de médecine
d'urgence, University of Montreal, Montreal, Quebec, Canada
Twitter Austyn Snowden @austynsnowden
Acknowledgements We would like to thank all patients and clinicians involved
in this study, in particular Jeremy McMahon, Dawn Storey and Elaine Ross at The
Beatson West of Scotland Cancer Centre, Glasgow, Scotland.
Contributors AS contributed to the study design, data analysis and manuscript
writing. JY contributed to data collection, preparation of materials, data analysis
and manuscript writing. CR, DR, EM, M- TL and CW contributed to data analysis
and made comments on the paper. SS contributed to preparation of materials, data
collection and comments on manuscript. AS accepts full responsibility for the work
and the conduct of the study, had access to the data, and controlled the decision to
publish.
Funding The study was funded by Macmillan Cancer Support (grant EA/3937229).
Competing interests M- TL, CR and DR received funding to analyse the
consultation data using MEDICODE.
on May 7, 2023 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2022-066829 on 4 May 2023. Downloaded from
9
SnowdenA, etal. BMJ Open 2023;13:e066829. doi:10.1136/bmjopen-2022-066829
Open access
Patient and public involvement Patients and/or the public were involved in the
design, or conduct, or reporting, or dissemination plans of this research. Refer to
the Methods section for further details.
Patient consent for publication Not applicable.
Ethics approval This study involves human participants and was approved by
West of Scotland Research Ethics Committee (14/WS/0126) and also approved by
the Clinical Trials Executive Committee within the Beatson West of Scotland Cancer
Centre on 13 June 2014. NHS Research & Development approval followed on 26
August 2014. Participants gave informed consent to participate in the study before
taking part.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
Anonymised summary data are available on reasonable request. No audio
recordings are available.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non- commercial. See:http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iDs
AustynSnowden http://orcid.org/0000-0001-9321-622X
CraigWhite http://orcid.org/0000-0001-8695-8014
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Purpose This study assessed the feasibility of implementing a novel model of integrated prostate cancer care involving an online prostate cancer-specific holistic needs assessment (sHNA) and shared digital communication between patients and their healthcare professionals (HCPs). The sHNA produces a semi-automated care plan that is finalised in consultation between the patient and their practice nurse. Methods Men living with and beyond prostate cancer were invited to participate in a 9-month non-randomised cluster controlled feasibility study. The intervention group was asked to complete the sHNA on three occasions. Data were collected using Patient Reported Outcome Measures (PROMs) at baseline, 10 and 24 weeks, and 9 months. Outcomes included recruitment, retention, acceptability, and engagement with the sHNA and PROMs. Results Fourteen general practices (8 intervention and 6 control), and 41 men (29 intervention and 12 control) participated. Initial patient engagement with the sHNA was high, with all but one receiving practice nurse-led follow-up and an individualised care plan. The sHNA proved useful in identifying ‘red flag’ symptoms, and helping practice nurses decide when to seek further medical care for the patients. There was a high level of acceptability for patients and HCPs. However, integration of care did not occur as intended because of problems linking hospital and general practice IT systems. Conclusion While the study demonstrated the feasibility of implementing the sHNA, it did not meet the a priori progression criteria; as such, undertaking a definitive randomised controlled trial is not appropriate until the identified methodological and technical issues have been addressed.
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Background Patients are often non-adherent to topical corticosteroids (TCS). This may be in part due to poor communication between patients and dermatologists. Objectives This quality improvement (QI) study aims to describe dermatologist–patient communication about TCS treatments and to compare communication before and after the implementation of an educational intervention. Methods This QI study assesses the communication between dermatologists and new dermatology outpatients receiving a TCS prescription in a tertiary care center. The QI intervention is 2-pronged, consisting of an educational pamphlet for patients and a communication workshop for the dermatology team. Encounters were audiotaped, and communication was analyzed using a coding system (MEDICODE). Phase 1 recordings happened preintervention and reflect the usual dermatologist–patient communication in this practice setting and phase 2 recordings were postintervention. Results Phase 1 reveals that dermatologists frequently address informational medication themes, such as naming the medications and informing patients about their proper use. They less frequently discuss patient experience themes, such as goals of treatment, adverse effects of treatments, and exploring patients’ emotions about medications (such as anxiety, fears, etc.). After the intervention, there was more frequent discussion of patient experience themes without increasing consultation length. But, in both phases, physicians address most themes as a monolog with little verbal input from patients. Conclusions Our study raises awareness regarding dermatologists’ communication patterns about TCS, identifying specific areas for improvement, such as discussions of adverse effects, and explicitly addressing patients’ attitudes and emotions. This is an essential step to foster a sense-making of TCS for patients.
Article
Objective Globally, cancer services herald the use of Holistic Needs Assessments (HNA). Implementation is, however, heterogeneous. There is a need to understand what effect implementation variation has on patient experience, outcomes and service demand. This is the first study to examine whether the way in which HNA is implemented, impacts on patient outcomes. Methods MEDLINE, AMED, CINAHL, PsycINFO and the Psychological and Behavioural Sciences Collection were searched (June 2000–June 2018). Search strategy included international HNA tools and synonyms for “needs.” An overview of quality was obtained through application of the Mixed Methods Appraisal Tool. Key themes were identified through thematic synthesis. Results Twenty studies were included (RCTs [n = 4], service evaluations [n = 8] and feasibility studies [n = 8]). Implementation approaches and assessor actions were identified and through thematic synthesis were defined as detecting, discussing/dealing, directing and downstream care. The way in which HNA is implemented is more important to understanding outcomes than what is implemented. Conclusion There is a need to conceptualise HNA as a means and not an end in itself. Pursuers of HNA‐led outcomes must understand and strengthen connections between assessment and outcomes. The conceptual framework can assist development of more insightful measures of both process and outcomes.