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The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine (COMET)

15. července 2026 aktualizováno: Marco Mancinetti, University of Fribourg

Introduction.

Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap.

Methods and analysis.

COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus|PsyCoLaus cohort.

Přehled studie

Postavení

Nábor

Podmínky

Typ studie

Pozorovací

Zápis (Odhadovaný)

800

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Marco Mancinetti, MD
Telefonní číslo: 0041263062360
E-mail: marco.mancinetti@unifr.ch

Studijní místa

Švýcarsko
- - Bern, Švýcarsko
    - Nábor
    - Inselspital - University Hospital
    - Kontakt:
      
      Stefanie Mosimann
      
      Telefonní číslo: 0041316322111
      
      E-mail: stefanie.mosimann@insel.ch
  - Fribourg, Švýcarsko, 1700
    - Nábor
    - HFR - Hôpital cantonal
    - Kontakt:
      
      Marco Mancinetti, MD
      
      Telefonní číslo: 0041263062360
      
      E-mail: marco.mancinetti@unifr.ch
  - Lausanne, Švýcarsko
    - Nábor
    - CHUV - University Hospital
    - Kontakt:
      
      Vanessa Kraege
      
      Telefonní číslo: 004121 314 11 11
      
      E-mail: vanessa.kraege@chuv.ch

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dítě
Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (~1,300 eligible)

Popis

Inclusion Criteria:

Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent

Exclusion Criteria:

Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
Residents in General Internal Medicine (GIM) All residents in GIM in the participating centers in Switzerland

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The Physician Well-Being Index (resident version) comprises 7 yes/no items referring to the past month. Total score ranges from 0 to 7; higher scores indicate greater distress (worse outcome). A score of 3 or higher identifies residents at risk of distress	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in professional fulfilment measured by the Professional Fulfillment Index (PFI) - professional fulfilment subscale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The professional fulfilment subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 on 5-point scales (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater professional fulfilment (better outcome); scores of 3.0 or higher indicate professional fulfilment	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in burnout measured by the Professional Fulfillment Index (PFI) - burnout composite Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The burnout composite of the Professional Fulfillment Index comprises 10 items (4 work-exhaustion and 6 interpersonal-disengagement items) scored 0-4 on 5-point scales (past two weeks); the composite score is the item mean, ranging from 0 to 4. Higher scores indicate more severe burnout (worse outcome); scores of 1.33 or higher indicate burnout	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in depressive symptoms measured by the Center for Epidemiologic Studies-Depression scale (CES-D) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The Center for Epidemiologic Studies-Depression scale comprises 20 items scored 0-3 by symptom frequency over the past week. Total score ranges from 0 to 60; higher scores indicate more depressive symptoms (worse outcome). A score of 16 or higher indicates clinically relevant depressive symptoms.	Baseline and annually at years 1, 2, 3, 4 and 5
Percentage of participants remaining in general internal medicine training or practice Časové okno: Annually at years 1, 2, 3, 4 and 5	Proportion (%) of participants who, at each annual follow-up survey, report continuing postgraduate training or clinical activity in general internal medicine, versus having switched to another specialty or having left clinical medicine, assessed by structured self-report items (current work position and current specialty goal) of the annual COMET online survey	Annually at years 1, 2, 3, 4 and 5
Intention to leave direct patient care, measured on a single-item 5-point scale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	Single self-report item of the annual COMET survey rating the likelihood of leaving direct patient care within five years, from 1 (none) to 5 (high). Higher scores indicate a stronger intention to quit (worse outcome)	Baseline and annually at years 1, 2, 3, 4 and 5

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change from baseline in self-rated work-life balance (single-item 5-point scale) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	Single self-report item rating the current balance between personal and professional life on a 5-point scale from 1 (very good) to 5 (very bad), as used by Keeton et al. Higher scores indicate a worse perceived work-life balance.	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS-10) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The 10-item Perceived Stress Scale, referring to the past month, with items scored 0-4. Total score ranges from 0 to 40; higher scores indicate greater perceived stress (worse outcome)	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in work exhaustion measured by the Professional Fulfillment Index (PFI) - work-exhaustion subscale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The work-exhaustion subscale of the Professional Fulfillment Index comprises 4 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater work exhaustion (worse outcome).	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in interpersonal disengagement measured by the Professional Fulfillment Index (PFI) - interpersonal-disengagement subscale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	he interpersonal-disengagement subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater interpersonal disengagement (worse outcome)	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in cognitive empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - cognitive empathy subscale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The cognitive empathy subscale of the QCAE comprises 19 items rated on 4-point agreement scales (1-4). Total score ranges from 19 to 76; higher scores indicate greater cognitive empathy (better outcome)	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in affective empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - affective empathy subscale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The affective empathy subscale of the QCAE comprises 12 items rated on 4-point agreement scales (1-4). Total score ranges from 12 to 48; higher scores indicate greater affective empathy.	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in daily step count (smartphone-derived) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	Average number of steps per day, reported by participants from the default health application of their smartphone as monthly averages for the current month and the two previous months (unit: steps/day). Higher values indicate more physical activity	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in self-reported physical activity measured by the International Physical Activity Questionnaire - short form (IPAQ-SF) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The IPAQ short form comprises 7 items covering vigorous activity, moderate activity, walking and sitting time over the past 7 days; responses are converted to metabolic equivalent of task (MET)-minutes per week according to the IPAQ scoring protocol. Higher values indicate more physical activity	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in fatigue measured by the Chalder Fatigue Scale Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The Chalder Fatigue Scale comprises 11 items scored 0-3 (Likert scoring). Total score ranges from 0 to 33; higher scores indicate more severe fatigue (worse outcome).	Baseline and annually at years 1, 2, 3, 4 and 5
Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	The Insomnia Severity Index comprises 7 items scored 0-4, referring to sleep problems over the past two weeks. Total score ranges from 0 to 28; higher scores indicate more severe insomnia (worse outcome)	Baseline and annually at years 1, 2, 3, 4 and 5
Mean rating of each of 31 career pull and push factors (adapted Hauer questionnaire) Časové okno: Baseline and annually at years 1, 2, 3, 4 and 5	Each of 31 factors potentially influencing a career in internal medicine is rated on a 5-point bipolar scale from 1 (very pushed away) to 5 (very attracted toward), adapted from Hauer et al. Mean scores per factor (range 1-5) describe the relative weight of attracting and repelling factors; higher scores indicate a more attracting influence.	Baseline and annually at years 1, 2, 3, 4 and 5
Difference in CES-D depressive-symptom score between residents and age-matched general-population participants (CoLaus\|PsyCoLaus) Časové okno: Baseline	Difference in mean Center for Epidemiologic Studies-Depression scale score (20 items, total 0-60; higher = more depressive symptoms) between COMET participants and participants aged 18-35 of the population-based CoLaus\|PsyCoLaus cohort, using the identical instrument (unit: score points)	Baseline
Difference in QCAE empathy scores between residents and Swiss medical students Časové okno: Baseline and year 5	Difference in mean QCAE cognitive (19-76) and affective (12-48) empathy subscale scores between COMET participants and published values from a national cohort of Swiss medical students, using the identical instrument (unit: score points; higher = greater empathy)	Baseline and year 5

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Fribourg

Spolupracovníci

University of Lausanne Hospitals

Hôpital Fribourgeois

Insel Gruppe AG, University Hospital Bern

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. srpna 2025

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2031

Termíny zápisu do studia

První předloženo

9. července 2026

První předloženo, které splnilo kritéria kontroly kvality

15. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)