Evidence map›Paper›PMID 29759063›Full record

ArticleBMC musculoskeletal disorders2018

Discontinuation of the PACE Plus trial: problems in patient recruitment in general practice.

M Schreijenberg, P A J Luijsterburg, Y D M Van Trier, D Rizopoulos, M A Koopmanschap, L Voogt, C G Maher, B W Koes

Abstract read
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In one paragraph

Article in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. 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

8 authors.

M SchreijenbergDepartment of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands. m.schreijenberg@erasmusmc.nl.
P A J LuijsterburgDepartment of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.
Y D M Van TrierDepartment of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.
D RizopoulosDepartment of Biostatistics, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.
M A KoopmanschapDepartment of Health Policy and Management/iMTA, Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, The Netherlands.
L VoogtDutch Association for Back Pain Patients 'The Spine', Bentinckstraat 21, Lichtenvoorde, The Netherlands.
C G MaherSydney School of Public Health, Sydney Medical School, The University of Sydney, PO Box M179, Sydney, NSW, 2050, Australia.
B W KoesDepartment of General Practice, Erasmus MC, University Medical Center, PO box 2040, 3000 CA, Rotterdam, The Netherlands.

Funding

ZonMw 836041009
6 · The paper itself

Abstract

backgroundThe PACE Plus trial was a multi-center, double-blinded, superiority randomized controlled trial (RCT) conducted in patients from Dutch general practice to investigate the efficacy of paracetamol and NSAIDs in acute non-specific low back pain (LBP). Because insufficient numbers of patients could be recruited (only four out of the required 800 patients could be recruited over a period of 6 months), the trial was prematurely terminated in February 2017, 6 months after the start of recruitment. This article aims to transparently communicate the discontinuation of PACE Plus and to make recommendations for future studies.

methodsGeneral Practitioners (GPs) from 36 participating practices received a one-question survey in which they were asked to give the three most important factors that in their opinion contributed to failure of patient recruitment.

resultsGPs of 33 out of 36 (92%) participating practices sent a response. A total of 81 factors were reported. These have been categorized into patient factors (26 out of 81 comments, 32%), GP factors (39 out of 81 comments, 48%) and research factors (16 out of 81 comments, 20%). DISCUSSION: Patient recruitment in the PACE Plus trial may have failed due to inefficient medication distribution, recruitment of incident rather than prevalent cases, a design that was too complicated, adequate self-management of LBP, patient expectations different from the trial's scope and lack of time of participating GPs. Substantial differences in design may explain why the preceding PACE trial did manage to successfully complete patient recruitment.

conclusionAlthough the PACE Plus trial was terminated as a result of insufficient patient inclusion, the research questions addressed in this trial remain relevant but unanswered. We hope that lessons learned from the discontinuation of PACE Plus and corresponding recommendations may be helpful in the design of upcoming research projects in LBP in general practice.

trial registrationDutch Trial Registration NTR6089, registered September 14th 2016.

Indexed as

Patient SelectionSurveys and QuestionnairesAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodGeneral PracticeGeneral PractitionersHumansLow Back PainMulticenter Studies as TopicNetherlandsRandomized Controlled Trials as TopicAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-Steroidal

Identifiers

PMID29759063
PMCPMC5952647

What Socratic holds

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LicenceCC BY
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Registered trials

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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.