Evidence map›Paper›PMID 29357921›Full record

Trial reportTrials2018

Relating process evaluation measures to complex intervention outcomes: findings from the PACE-UP primary care pedometer-based walking trial.

Cheryl Furness, Emma Howard, Elizabeth Limb, Derek G Cook, Sally Kerry, Charlotte Wahlich, Christina Victor, Ulf Ekelund, Steve Iliffe, Michael Ussher and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Cheryl FurnessPopulation Health Research Institute, SGUL, London, UK.
Emma HowardPopulation Health Research Institute, SGUL, London, UK.
Elizabeth LimbPopulation Health Research Institute, SGUL, London, UK.
Derek G CookPopulation Health Research Institute, SGUL, London, UK.
Sally KerryPragmatic Clinical Trial Unit, QMUL, London, UK.
Charlotte WahlichPopulation Health Research Institute, SGUL, London, UK.
Christina VictorAgeing Studies Research theme, Institute for Environment, Health and Society, Brunel University London, London, UK.
Ulf EkelundDepartment of Sports Medicine, Norwegian School of Sports Science, Oslo, Norway.
Steve IliffeResearch Department of Primary Care and Population Health, UCL, London, UK.
Michael UssherPopulation Health Research Institute, SGUL, London, UK.
Peter WhincupPopulation Health Research Institute, SGUL, London, UK.
Julia Fox-RushbyDepartment of Population Science, King's College London, London, UK.
Judith IbisonPopulation Health Research Institute, SGUL, London, UK.
Stephen DeWildePopulation Health Research Institute, SGUL, London, UK.
Tess HarrisPopulation Health Research Institute, SGUL, London, UK. tharris@sgul.ac.uk.

Funding

Department of Health 10/32/02Health Technology Assessment Programme 10/32/02
6 · The paper itself

Abstract

backgroundThe PACE-UP trial demonstrated positive effects of a pedometer-based walking intervention on objective physical activity (PA) outcomes at three and 12 months in 45-75-year-old primary care patients, in postal and nurse-supported trial arms compared with controls. We explored associations between process evaluation measures and change in PA outcomes.

methodsThe MRC framework guided process evaluation. Three quantitative measures (nurse session attendance [dose delivered], PA diary completion [fidelity] and pedometer use [fidelity]) were selected as independent variables in multi-level models estimating intervention effectiveness on PA outcomes (changes in step-counts and time in moderate-to-vigorous PA [MVPA] levels in ≥ 10-min bouts).

resultsDose: attending all three nurse sessions compared with 0-2 sessions was associated with an increase in steps/day at three and 12 months of 1197 (95% confidence interval [CI] = 627-1766) and 605 (95% CI = 74-1137), respectively; and MVPA in bouts (min/week) at three and 12 months by 74 (95% CI = 45-103) and 30 (95% CI = 3-57), respectively. Fidelity: postal and nurse groups showed strong positive associations of diary return with steps/day at three months: postal 1458 (95% CI = 854-2061), nurse 873 (95% CI = 190-1555). MVPA in bouts (min/week): postal 64 (95% CI = 33-94), nurse 50 (95% CI = 15-85). At 12 months, only the postal group effects remained statistically significant: steps/day 1114 (95% CI = 538-1689), MVPA 47 (95% CI = 18-75). Regular pedometer use in the postal group only was associated with higher three-month and 12-month steps/day: 1029 (95% CI = 383-1675) and 606 (95% CI = 22-1190), respectively, and with MVPA in bouts at three months: 40 (95% CI = 6-73).

conclusionProcess evaluation measures demonstrated significant associations with PA outcomes at three and 12 months. We cannot infer causality, but the associations between the process measures and PA outcomes suggest that they were important in enabling the trial changes observed and should be considered core components of the PACE-UP nurse and postal interventions. We have shown the MRC framework to be a useful tool for process evaluation of intervention implementation.

trial registrationISRCTN Registry, ISRCTN98538934 . Registered on 2 March 2012.

Indexed as

ExerciseFitness TrackersHealthy AgingPrimary Health CareProcess Assessment, Health CareWalkingActigraphyAgedAge FactorsFemaleHumansLondonMaleMiddle AgedNurse's RolePatient CompliancePedometerPrimary careProcess evaluationWalking intervention

Identifiers

PMID29357921
PMCPMC5778651

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.