Evidence map›Paper›PMID 32299515›Full record

ArticleTrials2020

Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial.

T M Mackay, F J Smits, A E J Latenstein, A Bogte, B A Bonsing, H Bos, K Bosscha, L A A Brosens, L Hol, O R C Busch and 56 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03513705 (Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 14% of its field
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.

NCT03513705 nacompletednot on this map

Impact of Nationwide Enhanced Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): a Multicenter Stepped-wedge Cluster Randomized Controlled Trial

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2018 to 2021Enrolled4,000ConditionsCarcinoma, Pancreatic DuctalArmsBest practices in pancreatic cancer care
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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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

66 authors at 16 institutions in 1 country.

T M MackayDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.ORCID http://orcid.org/0000-0002-3730-6893
F J SmitsDepartment of surgery, University Medical Center Utrecht, Utrecht, the Netherlands.
A E J LatensteinDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
A BogteDepartment of gastroenterology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
B A BonsingDepartment of surgery, Leiden University Medical Center, Leiden, the Netherlands.
H BosDepartment of medical oncology, Tjongerschans Hospital, Heerenveen, the Netherlands.
K BosschaDepartment of surgery, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
L A A BrosensDepartment of pathology, University Medical Center Utrecht, Utrecht, the Netherlands.
L HolDepartment of gastroenterology, Maasstad Hospital, Rotterdam, the Netherlands.
O R C BuschDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
G J CreemersDepartment of medical oncology, Catharina Hospital, Eindhoven, the Netherlands.
W L CurversDepartment of gastroenterology, Catharina Hospital, Eindhoven, the Netherlands.
M den DulkDepartment of surgery, Maastricht UMC+, Maastricht, the Netherlands.
S van DierenDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
L M J W van DrielDepartment of gastroenterology, Erasmus Medical Center, Rotterdam, the Netherlands.
S FestenDepartment of surgery, OLVG, Amsterdam, the Netherlands.
E J M van GeenenDepartment of gastroenterology, Radboud UMC, Nijmegen, the Netherlands.
L G van der GeestDepartment of Research, Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, the Netherlands.
D J A de GrootDepartment of medical oncology, University Medical Center Groningen, Groningen, the Netherlands.
J W B de GrootDepartment of medical oncology, Oncology Center Isala, Zwolle, the Netherlands.
N Haj MohammadDepartment of Medical Oncology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
B C M HaberkornDepartment of medical oncology, Maasstad Hospital, Rotterdam, the Netherlands.
J T HaverDepartment of nutrition and dietetics, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
E van der HarstDepartment of surgery, Maasstad Hospital, Rotterdam, the Netherlands.
G J M HemminkDepartment of gastroenterology, Oncology Center Isala, Zwolle, the Netherlands.
I H de HinghDepartment of surgery, Catharina Hospital, Eindhoven, the Netherlands.
C HogeDepartment of gastroenterology, Maastricht UMC+, Maastricht, the Netherlands.
M Y V HomsDepartment of medical oncology, Erasmus Medical Center, Rotterdam, the Netherlands.
N C van HuijgevoortDepartment of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
M A J M JacobsDepartment of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, VU Medical Center, Amsterdam, the Netherlands.
E D KerverDepartment of medical oncology, OLVG, Amsterdam, the Netherlands.
M S L LiemDepartment of surgery, Medisch Spectrum Twente, Enschede, the Netherlands.
M LosDepartment of Medical Oncology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
H LubbingeDepartment of gastroenterology, Tjongerschans Hospital, Heerenveen, the Netherlands.
S A C LuelmoDepartment of medical oncology, Leiden University Medical Center, Leiden, the Netherlands.
V E de MeijerDepartment of surgery, University Medical Center Groningen, Groningen, the Netherlands.
L MekenkampDepartment of medical oncology, Medisch Spectrum Twente, Enschede, the Netherlands.
I Q MolenaarDepartment of surgery, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
M G H van OijenDepartment of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
G A PatijnDepartment of surgery, Oncology Center Isala, Zwolle, the Netherlands.
R QuispelDepartment of gastroenterology, Reinier de Graaf Hospital, Delft, the Netherlands.
L B van RijssenDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
T E H RömkensDepartment of gastroenterology, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
H C van SantvoortDepartment of surgery, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
J M J SchreinemakersDepartment of surgery, Amphia Hospital, Breda, the Netherlands.
H SchutDepartment of medical oncology, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
T SeerdenDepartment of gastroenterology, Amphia Hospital, Breda, the Netherlands.
M W J StommelDepartment of surgery, Radboud UMC, Nijmegen, the Netherlands.
A J Ten TijeDepartment of medical oncology, Amphia Hospital, Breda, the Netherlands.
N G VennemanDepartment of gastroenterology and hepatology, Medisch Spectrum Twente, Enschede, the Netherlands.
R C VerdonkDepartment of gastroenterology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
J VerheijDepartment of pathology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
F G I van VilsterenDepartment of gastroenterology, University Medical Center Groningen, Groningen, the Netherlands.
J de Vos-GeelenDepartment of medical oncology, Maastricht UMC+, Maastricht, the Netherlands.
A VulinkDepartment of medical oncology, Reinier de Graaf Hospital, Delft, the Netherlands.
C WientjesDepartment of gastroenterology, OLVG, Amsterdam, the Netherlands.
F WitDepartment of surgery, Tjongerschans Hospital, Heerenveen, the Netherlands.
F J WesselsDepartment of radiology, Regional Academic Cancer Center Utrecht, University Medical Center Utrecht & St. Antonius Hospital, Nieuwegein, the Netherlands.
B ZonderhuisDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, VU Medical Center, Amsterdam, the Netherlands.
C H van WerkhovenJulius Center for Health Sciences and primary care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
J E van HooftDepartment of gastroenterology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
C H J van EijckDepartment of surgery, Erasmus Medical Center, Rotterdam, the Netherlands.
J W WilminkDepartment of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
H W M van LaarhovenDepartment of medical oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
M G BesselinkDepartment of surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, the Netherlands. m.g.besselink@amsterdamumc.nl.
Dutch Pancreatic Cancer Group
Utrecht University · NLRadboud University Nijmegen · NLUniversity Medical Center Groningen · NLAmsterdam University Medical Centers · NLErasmus MC · NLMaasstad Ziekenhuis · NLMaastricht University Medical Centre · NLReinier de Graaf Hospital · NLUniversity Medical Center Utrecht · NLAmphia Ziekenhuis · NLLeiden University Medical Center · NLMedisch Spectrum Twente · NLOLVG · NLGGD Amsterdam · NLIsala · NL's Heeren Loo · NL

Funding

KWF Kankerbestrijding UVA2013-5842
6 · The paper itself

Abstract

backgroundPancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/

designPACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life.

trial registrationClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.

Indexed as

Health Plan ImplementationQuality of LifeAdolescentAdultAgedAged, 80 and overBiliary Tract Surgical ProceduresCarcinoma, Pancreatic DuctalChildChild, PreschoolCluster AnalysisDrainageEnzyme Replacement TherapyEquivalence Trials as TopicFemaleHumansBest practicesBiliary drainageChemotherapyImplementationPancreatic cancerPancreatic enzyme replacement therapyQuality of lifeRegistryStepped-wedge cluster randomized controlled trialSurvival

Identifiers

PMID32299515
PMCPMC7161112
OpenAlexW3016433233

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Registered trials

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 OpenQuestion graph.