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FACULTY OF HEALTH AND LIFE SCIENCES
Research: increasing value and reducing waste
Lancet series on waste in research, 2014
FACULTY OF HEALTH AND LIFE SCIENCES
Without a complete descrip7on of an interven7on … • other researchers cannot replicate or build on findings
• for effecIve intervenIons, clinicians, paIents, and other decision makers are leM unclear about how to reliably implement the intervenIon
FACULTY OF HEALTH AND LIFE SCIENCES
How big is the problem of inadequate interven7on repor7ng?
Hoffmann et al. (2013): -‐ 137 non-‐pharmacological intervenIons
-‐ Only 53 (39%) were adequately described in trial reports
-‐ Increased to 81 (59%) aMer contacIng authors
Hoffmann et al. (2013). BMJ 347:f3755.
FACULTY OF HEALTH AND LIFE SCIENCES
What about the repor7ng of exercise interven7ons?
Abell et al. (2015): -‐ 74 exercise-‐based cardiac rehabilitaIon intervenIons
-‐ Only 11 (15%) were adequately described in trial reports
-‐ Increased to 32 (43%) aMer contacIng authors
Abell et al. (2015). Circ Cardiovasc Qual Outcomes 8:187-‐194.
FACULTY OF HEALTH AND LIFE SCIENCES
Supervised exercise training for peripheral arterial disease (PAD)
NICE (2012): “2 hours of supervised exercise a week for a 3-‐month period encouraging people to exercise to the point of maximal pain.”
BeFer repor7ng of interven7ons: template for interven7on descrip7on and replica7on (TIDieR)
Hoffmann et al. (2014). BMJ 348:g1687.
FACULTY OF HEALTH AND LIFE SCIENCES
Aims of this review
• to use the TIDieR checklist to evaluate the completeness of intervenIon descripIons in RCT’s of supervised exercise training in people with PAD
• to assess if incomplete intervenIon descripIons could be improved by reviewing addiIonal published material and contacIng trial authors
FACULTY OF HEALTH AND LIFE SCIENCES
Methods – Search strategy Eligibility: P – PAD (not criIcal limb ischaemia) I – supervised exercise training C – anything O – walking ability or quality of life S – randomised trials
Search strategy: • Methods of Lauret et al. (2014) • Three electronic databases
(EMBASE, MEDLINE, CENTRAL) searched up to June 2015
• Study selecIon was done independently by two reviewers
Assessment of interven7on descrip7on Item # Item name Item descrip7on 1 Brief name A name or a phrase which describes the intervenIon 2 Why Describe the raIonale, theory, or goal of the elements essenIal to the intervenIon 3 What: materials Describe any physical or informaIonal materials used in the intervenIon, including the make
and model of exercise equipment and what materials were provided to parIcipants or used in intervenIon delivery or in training of intervenIon providers
4 What: procedures Describe each of the procedures, acIviIes, and/or processes used in the intervenIon, including any enabling or support acIviIes
5 Provider Describes the intervenIon provider(s) and their experIse, background, and any specific training given
6 How Describe whether the supervised exercise programme was delivered individually or in a group; if group, then state the maximum number of parIcipants per session
7 Where Describe the type(s) of locaIon(s) where the intervenIon occurred, including any necessary infrastructure or relevant features
8
When and how much (a) Intensity (b) Frequency (c) Session Ime (d) Overall duraIon
Describes the dose/schedule of the intervenIon including the following: The intensity of exercise used in the intervenIon (e.g., target heart rate or walking speed) The frequency of exercise sessions The duraIon of each individual exercise session The overall duraIon of the supervised exercise programme
9 Tailoring If the intervenIon was planned to be personalised, Itrated or adapted, then describe what, why, when and how
10 ModificaIons Describes any modificaIons to the intervenIon during the course of the study 11
How well: planned (a) fidelity strategies (b) fidelity assessment
Describe any strategies that were used to maintain or improve intervenIon fidelity Describe what procedures were used to assess intervenIon adherence or fidelity
12 How well: actual Describe the extent to which the delivered intervenIon varied from the intended intervenIon, e.g., through the provision of data about how many exercise sessions were completed, and the duraIon and intensity of those sessions
Data extrac7on process
• Data extracIon was done in Excel by two independent reviewers
• Completeness of intervenIon descripIon assessed up to 3 Imes: 1. AMer reviewing main trial
publicaIon 2. AMer reviewing addiIonal
published material 3. AMer requesIng
informaIon from authors via email
Author contact process
• Corresponding authors were sent up to 3 emails, each a fortnight apart • Co-‐authors were contacted where necessary • We used the authors’ first informaIve response to update our Excel file
Results – summary of included studies
• Final sample comprised 58 RCT’s reporIng on 76 intervenIons
• 43 corresponding authors
• Trials were published between 1973 and 2014 (64% were published in the last 10 years)
• PopulaIon: all but two studies limited recruitment to people with intermihent claudicaIon
• IntervenIon: 67% aerobic (walking most common), 11% resistance, 16% combined, 7% unclear; DuraIon – 2 w to 18 m
• Comparator: Usual care was most common (21 trials; 36%)
Results – completeness of interven7on descrip7ons (published sources)
• Addi7onal sources of informa7on were found for 67% of the trials • Highlights of insufficient descrip7ons: Mode, 20%; Intensity planned, 24%;
Tailoring/progression, 26%; AFendance, 62%; Intensity performed, 89%
Results – completeness of interven7on descrip7ons (a^er author contact)
• 11 out of 43 authors did not respond (26%) • Many responses were incomplete/unhelpful
Examples – The Good, the Bad and the Ugly The Good: • McDermoh et al. (2009)
“. . . . . exercise three =mes a week for 24 weeks. . . Par=cipants began with 15 minutes of exercise and increased to 40 minutes by week eight . . . Between weeks eight and 24, aGempts to increase exercise intensity were made at least weekly either by increasing treadmill speed or by increasing the treadmill grade. Par=cipants with leg symptoms were encouraged to exercise to near maximal leg symptoms. Asymptoma=c par=cipants were encouraged to exercise to a level of 12 to 14 . . . . on the Borg ra=ng of perceived exer=on scale [reference]”
Examples – The Bad • Lundgren et al. (1989)
“The training program was comprised of three sessions per week of dynamic leg exercise beyond the appearance of leg pain due to arterial insufficiency. The training sessions, supervised by a physiotherapist, lasted for 30 minutes, and the pa=ents were also encouraged to perform the exercises during their leisure-‐=me. The pa=ent group randomized to receive combined treatment started their training 6 weeks aOer the last opera=on. The minimum training period was 6 months.”
Examples – The Ugly • Murphy et al. (2012) • Main paper from influenIal
CLEVER trial published in CirculaIon (IF = 14.43)
“SE consisted of 26 weeks of exercise, 3 =mes a week, for 1 hour at a =me. Sites were trained to provide SE using a common protocol, and the progress of each par=cipant was monitored by an oversight commiGee.23”
Discussion – How well are exercise-‐based interven7ons described in other clinical popula7ons?
• Campbell KL, Neil SE, Winters-‐Stone KM. Review of exercise studies in breast cancer survivors: ahenIon to principles of exercise training. Br J Sports Med. 2012;46: 909–916.
• Winters-‐Stone KM, Neil SE, Campbell KL. AhenIon to principles of exercise training: a review of exercise studies for survivors of cancers other than breast. Br J Sports Med. 2014;48: 987–995.
• Ammann BC, Knols RH, Baschung P, de Bie RA, de Bruin ED. ApplicaIon of principles of exercise training in sub-‐acute and chronic stroke survivors: a systemaIc review. BMC Neurol. 2014;14: 167.
• Abell B, Glasziou P, Hoffmann T. ReporIng and replicaIng trials of
exercise-‐based cardiac rehabilita7on: do we know what the researchers actually did? Circ Cardiovasc Qual Outcomes 2015;8: 187–194.
Discussion – How well are exercise-‐based interven7ons described in other clinical popula7ons?
Table – Percentage of intervenIons which completely report the FITT components in the main trial publicaIon
Popula7on Frequency Intensity Time Type
Breast cancer (n=29*)
97% 79% 79% 83%
Other cancer (n=33*)
91% 70% 85% 94%
Stroke (n=37*)
95% 60% 92% 95%
Cardiac (n=74**)
69% 50% 58% 57%
PAD (n=76**)
95% 76% 97% 72%
* Number of studies; ** Number of intervenIons
Strengths and limita7ons
Strengths • SystemaIc search strategy
• Duplicate screening and data extracIon
• TIDieR checklist – recognised by CONSORT and EQUATOR
• Author contact process
Limita7ons • Trials not wrihen in English
excluded – 8 non-‐English reports rejected
at full-‐text screening stage
• Some TIDieR items are open to interpretaIon
• Checklist was not applied to comparator
Summary points • Inadequate reporIng of supervised exercise programmes in
the PAD trial literature is a substanIal problem, with essenIal informaIon frequently missing, and for almost two-‐thirds of all intervenIons, unobtainable aMer publicaIon
• This has implicaIons for the interpretaIon of outcome data, the invesIgaIon of dose-‐response effects, and the replicaIon of protocols in future studies and clinical pracIce
• The TIDieR checklist and guide can be used by authors to structure reports of their intervenIons, by reviewers and editors to assess completeness of descripIons, and by readers who want to use the informaIon
