Evidence map›Paper›PMID 25978402›Full record

Trial reportPloS one2015

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

Patricia Bourgault, Anaïs Lacasse, Serge Marchand, Roxanne Courtemanche-Harel, Jacques Charest, Isabelle Gaumond, Juliana Barcellos de Souza, Manon Choinière

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 7 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

36 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Are OMERACT recommendations followed in clinical trials on fibromyalgia? A systematic review of patient-reported outcomes and their measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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.

Patricia BourgaultÉcole des sciences infirmières, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada; Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.
Anaïs LacasseCentre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada; Département des sciences de la santé, Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.
Serge MarchandCentre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada; Département de neurochirurgie, Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, QC, Canada.
Roxanne Courtemanche-HarelCentre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Jacques CharestDépartement des sciences de la santé, Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.
Isabelle GaumondCentre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Juliana Barcellos de SouzaCentre de recherche clinique Étienne-Le Bel du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, QC, Canada.
Manon ChoinièreCentre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada; Département d'anesthésiologie, Faculté de médecine, Université de Montréal, Montréal, QC, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.

methodsA mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.

resultsThe intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.

conclusionThe PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.

trial registrationInternational Standard Randomized Controlled Trial Number Register ISRCTN14526380.

Indexed as

AdolescentAdultAgedFemaleFibromyalgiaHumansMaleMiddle AgedPain MeasurementQuality of LifeSelf CareTreatment OutcomeYoung Adult

Identifiers

PMID25978402
PMCPMC4433106

What OpenQuestion 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 OpenQuestion graph.