LIFELAX - diet and LIFEstyle versus LAXatives in the management of chronic constipation in older people: Randomised controlled trial

Article (PDF Available) · November 2010with66 Reads
DOI: 10.3310/hta14520 · Source: PubMed
Abstract
To investigate the clinical effectiveness and cost-effectiveness of laxatives versus dietary and lifestyle advice, and standardised versus personalised dietary and lifestyle advice. A prospective, pragmatic, three-armed cluster randomised trial with an economic evaluation. General practices in England and Scotland, UK. People aged ≥ 55 years with chronic constipation, living in private households. Participants were identified as those who had been prescribed laxatives three or more times in the previous 12 months, or with a recorded diagnosis of chronic functional constipation. Prescription of laxatives, with class of laxative and dose at the discretion of the GP and patient (standard care control arm); standardised, non-personalised dietary and lifestyle advice; and, personalised dietary and lifestyle advice, with reinforcement. The primary outcome was the constipation-specific Patient Assessment of Constipation-Symptoms (PAC-SYM)/Patient Assessment of Constipation-Quality of Life (PAC-QOL). The trial planned to recruit and retain 1425 patients from 57 practices (19 per arm); however, only 154 patients were recruited from 19 practices. Due to these low recruitment rates it was not possible to report the conventional trial findings. Baseline characteristics of the sample from data gathered from both postal self-completion questionnaires and face-to-face interviews suggest that our sample experienced very few symptoms of constipation (PAC-SYM) and that the condition itself did not have a major impact upon their quality of life (PAC-QOL). The low level of symptoms of constipation is most likely explained by 90% of the sample using a laxative in the previous week. Most participants in our sample were satisfied with the performance of their laxatives, and levels of anxiety and depression were low. Their fibre consumption was classified as 'moderate' but their average water consumption fell below the recommended guidelines. Daily diaries, completed each day for a period of 6 months, were analysed primarily in terms of overall response rate and item response rates, and the participants accepted this method of data collection. For the economic evaluation, all of the trial arms experienced a reduction in utility, as measured by EQ-5D. There was no statistical evidence to suggest that either the personalised intervention arm or the standardised intervention arm was associated with significant changes in utility at 3 months compared with the control arm. Data on related health-care costs show a cost saving of £13.34 for those in the personalised arm, compared with the control arm, and a smaller cost saving for the standardised arm. These savings primarily occurred because of reduced hospital costs. There was no significant change measured in utility, so the personalised arm appeared to be the preferred course, producing the greatest cost savings. Due to the low number of participants in the trial, no firm conclusions could be drawn about the effectiveness of the interventions. However, a number of factors that contributed to the conduct and progress of the trial are highlighted, which may be relevant to others conducting research on a similar topic or population. ISRCTN73881345. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 14, No. 52. See the HTA programme website for further project information.
Health Technology Assessment 2010; Vol. 14: No. 52
DOI: 10.3310/hta14520
Health Technology Assessment
NIHR HTA programme
www.hta.ac.uk
Executive summary
LIFELAX – diet and LIFEstyle versus
LAXatives in the management of
chronic constipation in older people:
randomised controlled trial
C Speed,
1
B Heaven,
2
A Adamson,
2,3
J Bond,
1,4
S Corbett,
5
AA Lake,
2,3
C May,
2
A Vanoli,
2
P McMeekin,
2
P Moynihan,
3,4,6
G Rubin,
7,8
IN Steen
2
and E McColl
1
*
1
Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle
University, Newcastle, UK
2
Institute of Health and Society, Newcastle University, Newcastle, UK
3
Human Nutrition Research Centre, Newcastle University, Newcastle, UK
4
Institute for Ageing and Health, Newcastle University, Newcastle, UK
5
North Tyneside General Hospital, Northumbria Healthcare Trust,
North Shields, UK
6
Dental School, Newcastle University, Newcastle, UK
7
Department of Primary Care, University of Sunderland, Sunderland, UK
8
Northern & Yorkshire Primary Care Research Network,
Stockton-on-Tees, UK
*Corresponding author
LIFELAX – diet and LIFEstyle vs LAXatives in
chronic constipation management in older people
Executive summary: LIFELAX – diet and LIFEstyle vs LAXatives in chronic constipation management in older people
Executive summary
Background
The management of constipation in the over-
55s is costly, generating far in excess of 450,000
general practitioner (GP) consultations per year in
the UK, at an estimated cost of more than £4.5M
per year. In older adults living in the community,
approximately 20–25% have symptoms of
constipation. The propensity to consult increases
with age – for a GP with an average list size of
2000, approximately 16 patients aged 55 and
over will consult about constipation each year
(McCormick A, Fleming DF, Charlton J. Morbidity
statistics from general practice: fourth national study.
OPCS: London; 1995).
Though often trivialised as a medical problem, for
people with chronic constipation the impact on
quality of life (QoL) is considerable and the burden
on health-care resources is substantial.
Objectives
To investigate the clinical effectiveness and cost-
effectiveness of:
1. laxatives versus dietary and lifestyle advice
2. standardised versus personalised dietary and
lifestyle advice.
Methods
Design
A prospective, pragmatic, three-armed cluster
randomised trial with an economic evaluation.
Health technologies
being assessed
1. Prescription of laxatives, with class of laxative
and dose at the discretion of the GP and
patient (standard care control arm).
2. Standardised, non-personalised dietary and
lifestyle advice.
3. Personalised dietary and lifestyle advice, with
reinforcement.
Setting
General practices in England and Scotland, UK.
Participants
People aged 55 years (lowered to 50 years during
the course of the trial) with chronic constipation,
living in private households. Participants were
identified as those who had been prescribed
laxatives three or more times in the previous
12 months, or with a recorded diagnosis of chronic
functional constipation.
Outcome measures
The primary outcome was the constipation-specific
Patient Assessment of Constipation-Symptoms
(PAC-SYM)/Patient Assessment of Constipation-
Quality of Life (PAC-QOL). Secondary outcomes
comprised: European Quality of Life-5 Dimensions
(EQ-5D), reported number of bowel movements
per week; the presence/absence of the other Rome
II criteria for constipation; and adverse effects of
treatment; and relapse rates.
Intervention development
The content and mode of delivery of the two
intervention arms was developed by working
closely with patients and practice staff from two
GP practices. The patient information underwent
a series of revisions following extensive patient
feedback using a range of cognitive interview
techniques.
Results
Baseline data
The trial planned to recruit and retain 1425
patients from 57 practices (19 per arm); ultimately,
154 patients were recruited from 19 practices. Due
to the low recruitment rates, we are not able to
report the conventional trial findings. We report
the baseline characteristics of our sample from
data gathered from both the postal self-completion
questionnaire and the face-to-face interview. These
data suggest that our sample experienced very
few symptoms of constipation (PAC-SYM – Frank
Health Technology Assessment 2010; Vol. 14: No. 52 (Executive summary)
L, et al. Psychometric validation of a constipation
symptom assessment questionnaire. Scand J
Gastroenterol 1999;34:8707) and the condition
itself does not have a major impact upon their QoL
(PAC-QOL – Marquis P, et al. Development and
validation of patient assessment of constipation
quality of life questionnaire. Scand J Gastroenterol
2005;40:54051). The low level of symptoms of
constipation is most likely explained by the fact
that 90% of the sample had used a laxative in
the previous week and thus were asymptomatic
for constipation. Most people in our sample were
satisfied with their laxatives in terms of the time
they took to work and the effect they had on their
stools. Levels of anxiety and depression were low in
this group.
Fibre consumption can be classified as ‘moderate’
(Roe L, et al. Dietary intervention in primary
care: validity of the DINE method for diet
assessment. Fam Pract 1994;11:37581). There
was therefore scope for an intervention that
focused on increasing dietary fibre to be effective.
Characteristically in a sample of this age, average
water consumption fell below the recommended
guidelines.
Diary data
The daily diaries were analysed primarily in
terms of overall response rate and item response
rates. The diary was completed each day for a
period of 6 months. The results show that the
daily diary developed for the diet and LIFEstyle
versus LAXatives in the management of chronic
constipation in older people (LIFELAX) trial
was an acceptable method of data collection for
participants.
Economic data
With regard to the economic evaluation, all of
the trial arms experienced a reduction in utility,
as measured by EQ-5D. There was no statistical
evidence to suggest that either the personalised
intervention arm or the standardised intervention
arm was associated with significant changes in
utility at 3 months compared with the control
arm. Data on related health-care costs show a cost
saving of £13.34 for those in the personalised arm,
compared with the control arm, and a smaller cost
saving for the standardised arm. These savings
primarily occurred because of reduced hospital
costs, offset by a smaller increase in costs incurred
through additional telephone consultations. As
there was no significant change measured in
utility, cost minimisation would suggest that the
personalised arm would be the preferred course,
as it produced the greatest cost savings. This
finding is qualified by the fact that the statistically
significant reduction in health-care costs was
due to a relative small number of cases in this
relatively small sample; confidence limits around
all estimates are large.
Integrated qualitative
process evaluation
Background
The randomised controlled trial (RCT) is the
primary means by which clinically reliable
knowledge and ‘evidence’ is constructed within
the field of health technology assessment (HTA).
The importance of the RCT lies not simply in
its apparent methodological security, but in the
social and political uses to which its results might
be put. Evidence is a vital element of the politics
of health care at the beginning of the twenty-
first century: its production and application are
politically contested both within the NHS and by
specific interest groups, ranging from political
parties to advocacy groups for particular groups
of service users. Given the importance of the
RCT in contemporary health care it is surprising
that this crucial means of the social organisation
and production of knowledge about health care
has not been subject to sustained empirical
attention in depth – but has instead been mainly
the focus of macro-level analyses, such as that
by Faulkner (Faulkner A. Strange bedfellows’ in
the laboratory of the NHS? An analysis of the
new science of health technology assessment in
the United Kingdom. In Elston MA, editor. The
sociology of medical science and technology. Oxford:
Blackwell; 1997. pp. 183–207). The process
evaluation embedded within the LIFELAX
RCT contributed toward addressing this gap,
through the application of ethnographic research
techniques to the empirical investigation of the
social organisation, production, and effects, of the
RCT in practice.
Objectives
The process evaluation addressed the following
specific questions:
1. Formation How are ideas about the
appropriateness of health technologies
and their clinical applications formed and
mobilised in practice; and how are the interests
of consumers and other users defined and
incorporated in the organisation of the trial?
2. Integration How are specific clinical and
methodological problems within an RCT
Executive summary: LIFELAX – diet and LIFEstyle vs LAXatives in chronic constipation management in older people
identified and resolved within professional
groups and networks; how is the trial
integrated into the existing organisation
of clinical service provision, and what
professional and organisational dynamics
are involved in this integration; and how
is participation in the RCT negotiated and
understood by subjects?
3. Implementation How is the production of
results negotiated and organised within
networks of researchers; how are its results
mediated to the wider community and how is
this negotiated and organised, both formally
(through report writing and presentation);
and, informally, how are the mechanisms and
results of the trial understood by subjects?
4. What lessons can be learned that will improve the
organisation and conduct of HTA RCTs in the UK
– and further afield? This study has important
implications for the organisation and conduct
of HTA. It is important that its results can
inform and develop both policy and practice.
Methods
Study group
Purposive sampling from three specific groups of
participants in the trial: (1) project management
and steering group (n = 11); (2) general
practitioners (GPs), practice managers (n = 6)
and nurses (n = 9) working to recruit and deliver
patients to the trial and conduct the interventions;
and (3) patients (n = 23) participating in the trial.
Data collection and analysis
A combination of qualitative research techniques
were used, broadly following the precepts of Glaser
and Strauss’ (1967) model of constant comparison
to develop first order analyses of the data.
Throughout the contact period with each group
a programme of semistructured interviews was
undertaken. Some members of the trial team were
interviewed iteratively across the life of the trial
as new issues arose. All semistructured interviews
were audio-taped with the respondent’s consent,
and transcripts formed the data subjected to
formal analysis. The constant comparative method
of qualitative analysis was carried out. Emerging
themes were applied to the Normalisation Process
Model (NPM) (May C. A rational model for
assessing and evaluating complex interventions in
health care. BMC Health Serv Res 2006;6:86).
Fieldwork commenced with initial mapping of the
technical and social components of the trial. This
mapping identified both the stakeholders and
key structures of the system, from which a sample
of both intervention situations and interviewees
were chosen. Where observation was possible
(e.g. at meetings or presentations), it involved
the production of contemporaneous field notes
from which analytic themes and categories were
identified. It was important to observe routine
and problematic applications of the trial, such
as negotiations regarding the implementation
of the protocol in busy primary care practices.
Local documentary materials (e.g. protocols,
correspondence, minutes of meetings, notices,
leaflets, entries in newsletters) in which the trial
was explained to professionals and subjects were
analysed for comparison with themes emergent in
the interview data, and with the wider literature
concerning the particular form of intervention,
and with HTA as a discrete field.
Results
The trial team followed the guidelines set out
by the Research Management and Governance
framework (RM&G – Central Services Agency,
2008) for clinical trials in the UK. However, certain
milestones proved difficult to attain. In particular,
the experience of the trial team was that RM&G
guidelines were subject to localised, and sometimes
inflexible, interpretation by governance bodies
implicated in the research, whereas the Multi-
Centre Research Ethics Committee (MREC)
stipulations were also difficult to negotiate in
practice. As an example, observation of the trial
team revealed that they had significant difficulty
in implementing the multicentre RCT when a
shared understanding of what constituted ‘risk
to patients’ was lacking across sites. A great deal
of the trial team’s resources were therefore spent
in developing creative and workable solutions to
emerging practical problems of implementation.
As demonstrated by a growing number of reports
in the literature (e.g. Wald DS. Bureaucracy of
ethics applications. BMJ 2004;329:2824), the
LIFELAX trial was not alone in experiencing these
difficulties.
The LIFELAX trial depended on cooperation
between the trial team and key individuals from
a number of external organisations. To facilitate
administrative work, the trial manager actively
identified key contacts and developed working
relationships with them through a sequence of
telephone calls and/or written communication. In
this regard the trial relied heavily upon the ‘social
aptitude’ of the trial manager and his tactful
approach in requesting additional resources.
Social skills are infrequently identified as a key
component of a trial manager’s repertoire, yet they
proved to be pivotal in the development of the
LIFELAX trial, despite its early closure.
Health Technology Assessment 2010; Vol. 14: No. 52 (Executive summary)
In following the research brief to assess the cost-
effectiveness of diet and lifestyle interventions for
the treatment of chronic constipation, the trial
team developed nurse training packages based on
Behaviour Change Counselling (BCC) techniques.
Despite the time, expertise and financial resources
spent on these interventions, the feedback from
the interviewed primary care staff was that chronic
constipation was a comparatively low priority issue
for general practices. The perspective of practice
staff can be summarised in three key points:
1. Chronic constipation was regarded as being
successfully managed via laxatives.
2. Patients with chronic constipation typically saw
their GP or a community nurse, therefore the
practice nurses viewed the issue of constipation
management as falling outside their remit of
work
3. Some practice nurses described the BCC
approaches as part of their current skill set,
and therefore reported that the training
interventions had little practical benefit for
their routine patterns of work.
In this respect, the trial was perceived by
some staff as giving nurses additional work,
for a condition of low priority, and offering an
intervention that, at best, was seen as relatively
elementary to professional nursing practice. The
participants interviewed through the process
evaluation struggled to articulate whether they had
benefitted from taking part in the research, while
most of those attending practices randomised to
the BCC arm did not view their consultation as
differing from a routine nurse-led interaction.
Recommendations
for research
A number of issues regarding the development
and implementation of RCTs have been identified
through the conduct of the process evaluation.
The problem of the trials topic, setting and
training packages may have been identified had
a prior feasibility study been conducted. At the
time of the LIFELAX trial the HTA programme
did not fund pilot studies of this nature, although
the HTA have now changed their policy in this
regard. However, numerous system-wide problems
– such as the changing RM&G guidelines and
research briefs that did not match General Medical
Services contracts – also taxed the capacity of the
trial to be successful. Following the results of the
process evaluation, and the input of several of the
reviewers of this report, we suggest the following:
1. Improved means and methods of communication
are required between governance bodies,
MRECs and researchers regarding the
best way to conduct RCTs that are ethically,
methodologically and practically sound.
2. There is a need for a clear and consistent
means of applying for RM&G approval across
Primary Care Trusts.
3. There is a clear need for pilot studies prior to
the design and implementation of HTA RCTs:
i. Pilot studies should assess the feasibility of
all aspects of the intended research but,
specifically, ensure that the assumptions
underpinning the study are correct. These
assumptions may be multiple but should
ensure that: (1) there is an identified need
for a technological intervention; (2) the
intended beneficiaries also perceive a
need for intervention and are in equipoise
between the proposed interventions and
control; and (3) the definition of the need
or problem is commensurate between
researchers, users and beneficiaries.
ii. Pilot studies should assess whether the
interventions will enable the intended
users and/or beneficiaries to achieve
relevant goals (such as disposal of
symptoms).
iii. Pilot studies should assess whether the
intended interventions fit within existing
patterns of work, and where they do
not, assess the likely disruption and
acceptability to intended users.
iv. Pilot studies designed to assess the
feasibility of the research should be
conducted prior to any significant
investment in the development of an RCT.
Trial registration
This trial is registered as ISRCTN73881345.
Funding
The National Institute for Health Research
Health Technology Assessment programme.
Publication
Speed C, Heaven B, Adamson A, Bond J, Corbett
S, Lake AA, et al. LIFELAX – diet and LIFEstyle
versus LAXatives in the management of chronic
constipation in older people: randomised
controlled trial. Health Technol Assess 2010;14(52).
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T
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Research (NIHR), was set up in 1993. It produces high-quality research information on the
effectiveness, costs and broader impact of health technologies for those who use, manage and provide care
in the NHS. ‘Health technologies’ are broadly defined as all interventions used to promote health, prevent
and treat disease, and improve rehabilitation and long-term care.
The research findings from the HTA programme directly influence decision-making bodies such as the
National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee
(NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they
form a key component of the ‘National Knowledge Service’.
The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three
routes to the start of projects.
First is the commissioned route. Suggestions for research are actively sought from people working in the
NHS, from the public and consumer groups and from professional bodies such as royal colleges and NHS
trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service
users). The HTA programme then commissions the research by competitive tender.
Second, the HTA programme provides grants for clinical trials for researchers who identify research
questions. These are assessed for importance to patients and the NHS, and scientific rigour.
Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme
commissions bespoke reports, principally for NICE, but also for other policy-makers. TARs bring together
evidence on the value of specific technologies.
Some HTA research projects, including TARs, may take only months, others need several years. They
can cost from as little as £40,000 to over £1 million, and may involve synthesising existing evidence,
undertaking a trial, or other research collecting new data to answer a research problem.
The final reports from HTA projects are peer reviewed by a number of independent expert referees before
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Reviews in Health Technology Assessment are termed ‘systematic’ when the account of the search, appraisal
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commissioning brief, the HTA programme specified the research question and study design. The authors
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accept liability for damages or losses arising from material published in this report.
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programme or the Department of Health.
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ISSN 1366-5278
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