Evidence map›Paper›PMID 31535302›Full record

Trial reportAnnals of surgical oncology2020

The MELFO Study: A Multicenter, Prospective, Randomized Clinical Trial on the Effects of a Reduced Stage-Adjusted Follow-Up Schedule on Cutaneous Melanoma IB-IIC Patients-Results After 3 Years.

Eric A Deckers, Josette E H M Hoekstra-Weebers, Samantha Damude, Anne Brecht Francken, Sylvia Ter Meulen, Esther Bastiaannet, Harald J Hoekstra

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  7. Article
  8. Temporal Recurrence of Cutaneous Melanoma: Analysis of a Case Series.The Journal of clinical and aesthetic dermatology · 2023
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  19. False-negative sentinel lymph node biopsy for melanoma: a single-surgeon experience.Canadian journal of surgery. Journal canadien de chirurgie
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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

7 authors.

Eric A DeckersDepartment of Surgical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Josette E H M Hoekstra-WeebersWenckebach Institute, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Samantha DamudeDepartment of Surgical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Anne Brecht FranckenDepartment of Surgical Oncology, Isala Clinics, Zwolle, The Netherlands.
Sylvia Ter MeulenSkin-Melanoma Clinic, Netherlands Cancer Institute/Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Esther BastiaannetDepartment of Surgical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Harald J HoekstraDepartment of Surgical Oncology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. h.j.hoekstra@umcg.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study compares well-being, recurrences, and deaths of early-stage cutaneous melanoma patients in follow-up, as recommended in the Dutch guideline, with that of patients in a stage-adjusted reduced follow-up schedule, 3 years after diagnosis, as well as costs.

methodsOverall, 180 eligible pathological American Joint Committee on Cancer (AJCC) stage IB-IIC, sentinel node staged, melanoma patients (response rate = 87%, 48% male, median age 57 years), randomized into a conventional (CSG, n = 93) or experimental (ESG, n = 87) follow-up schedule group, completed patient-reported outcome measures (PROMs) at diagnosis (T1): State-Trait Anxiety Inventory-State version (STAI-S), Cancer Worry Scale (CWS), Impact of Event Scale (IES), and RAND-36 (Mental and Physical Component scales [PCS/MCS]). Three years later (T3), 110 patients (CSG, n = 56; ESG, n = 54) completed PROMs, while 42 declined (23%).

resultsRepeated measures analyses of variance (ANOVAs) showed a significant group effect on the IES (p = 0.001) in favor of the ESG, and on the RAND-36 PCS (p = 0.02) favoring the CSG. Mean IES and CWS scores decreased significantly over time, while those on the RAND-36 MCS and PCS increased. Effect sizes were small. Twenty-five patients developed a recurrence or second primary melanoma, of whom 13 patients died within 3 years. Cox proportional hazards models showed no differences between groups in recurrence-free survival (hazard ratio [HR] 0.71 [0.32-1.58]; p = 0.400) and disease-free survival (HR 1.24 [0.42-3.71]; p = 0.690). Costs per patient after 3 years (computed for 77.3% of patients) were 39% lower in the ESG.

conclusionThese results seemingly support the notion that a stage-adjusted reduced follow-up schedule forms an appropriate, safe, and cost-effective alternative for pathological AJCC stage IB-IIC melanoma patients to the follow-up regimen as advised in the current melanoma guideline.

Indexed as

Patient Reported Outcome MeasuresAdultAftercareAgedAged, 80 and overAmbulatory CareCost-Benefit AnalysisFemaleGeneral PracticeHealth Care CostsHospital CostsHumansMaleMelanomaMiddle AgedMortality

Identifiers

PMID31535302
PMCPMC7138761

What OpenQuestion holds

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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 OpenQuestion graph.