| 1. IDENTIFICATION & BASIC DESCRIPTION |
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Cohort name
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OCTOPUS (Occupational Carpal Tunnel Syndrome Observational Prospective Unified Study)
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Country
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Please provide any other information on the cohort location/s if needed
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North-Eastern Italy
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Name
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Francesco Violante
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Institution
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University of Bologna
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Email
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francesco.violante@unibo.it
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Name
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Stefano Mattioli
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Institution
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University of Bologna
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Email
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s.mattioli@unibo.it
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Do you want to add another Principal Investigator for occupational analyses
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- Add another Principal Investigator for occupational analyses
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Name
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Stefania Curti
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Institution
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University of Bologna
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Email
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stefania.curti@unibo.it
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Website
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Name of committee
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Institutional Review Board of the University Hospital of Bologna
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Upload files
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Data access policy (briefly describe)
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Data access could be considered after an agreement between Principal Investigators
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Is this cohort part of a consortium? (name consortium)
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No, but an agreement has been made with the US colleagues of the Consortium study of carpal tunnel syndrome
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Participation in pooled analyses
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- The cohort is potentially interested in participating in pooled analyses of (European) occupational cohort studies (note pooled analyses also includes remote decentralized analyses that would not require any transfer of primary data as well as meta-analyses).
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Main aim of cohort, please briefly describe the main objectives of the cohort
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To investigate the role of ergonomic and personal risk factors in the genesis of carpal tunnel syndrome (CTS)
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Comparators (please select as many as appropriate)
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- Internal study population
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Inclusion criteria
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1) Workers performing jobs for which the ACGIH TLV could be evaluated from job observations; 2) no history of surgical treatment for CTS; 3) not meeting the case definition for CTS at baseline
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Exclusion criteria
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1) Workers previously surgically treated for CTS; 2) ACGIH TLVs method not applicable
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Enrollment
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Completed
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Age range at entry (main cohort)
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| Minimum |
Maximum |
Mean |
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38.4 |
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Men at enrollment
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1082
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Women at enrollment
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2196
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Children (<18 years) at enrollment
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N/A
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Men at last follow-up
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1099
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Women at last follow-up
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2032
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Children (<18 years) at last follow-up
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N/A
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Participation rate at enrollment (if known)
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89
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Comments
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The OCTOPUS cohort was established in 2000–2001. Workers enrolled in the study were full-time employees of seven industrial (tiles, small appliance, large appliances, garment and shoes – two companies – manufacturing) and service (nursery and early childhood centers) organizations. All the seven factories were located in the North-East of Italy (mainly in the Province of Bologna plus Verona)
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| 2. OUTCOME FOLLOW-UP |
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Type of data for outcome follow-up (please select as many as appropriate)
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- Active (contact with participants)
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Active (contact with participants) (specify)
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- Each worker underwent a clinical examination by a trained physician to collect symptoms of CTS and other personal variables using a structured questionnaire
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First follow-up period (provide year)
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2001-2002
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Last follow-up period (provide year)
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2008-2011
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Number of follow-ups after baseline (provide number)
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3
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Participation at last follow-up (if known)
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70
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Comments
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The OCTOPUS cohort was established in 2000–2001. During the study period three follow-ups were performed: 2001–2002, 2002–2003, 2008–2011. Newly hired workers in each company where invited to participate in the study (open cohort design).
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| 3. OCCUPATIONAL EXPOSURES |
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Source of exposure data collected (please select as many as appropriate)
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- Questionnaire, Personal (Self-reporting or interview)
- Job-employment records
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Occupational history/time frame
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Lifetime
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Occupational coding performed
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No
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Types of exposure measurements
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Specify: Other
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For each task, the ergonomists evaluated the exposure level of the hand-wrist system in terms of hand activity level (HAL) and normalized peak force (nPF) according to ACGIH TLV method.
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Methods for exposure assessment (please select as many as appropriate)
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Specify: Other
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Assessments were performed mainly on observation (with videotapes whenever possible) by a team of trained professionals (ergonomists and industrial hygienists) according to ACGIH TLV method.
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Main categories
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- Physical agents
- Ergonomics, physical workload, and injury related
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Physical agents
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Ergonomics, physical workload, and injury related
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- Awkward work postures (e.g. kneeling/squatting, elevated arms, neck flection, back bent forward without support)
- Repetitive work movements
- Other (specify)
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Ergonomics, physical workload, and injury related | Specify: Other
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exposure to forceful movements of hand and wrist
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Comments
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Exposure to fast and forceful manual work was assessed according to the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV)® method by a team of trained professionals (ergonomists and industrial hygienists) who rated all suitable jobs in each company. Assessment was performed at task level, based mainly on observation (with videotapes whenever possible) and was complemented, where available, by standard production times and data.
Exposure to hand–arm vibrations was assessed in terms of presence or absence.
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| 4. OUTCOMES EVALUATED |
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Baseline - type of outcome data collected (select more than one if applicable)
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- Questionnaire, individual (self-recording or interview)
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Follow-up - type of outcome data collected (select more than one if applicable)
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- Questionnaire, individual (self-recording or interview)
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Outcome type (please select as many as appropriate)
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Diagnostic groups based on ICD10
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- G Disease in the nervous system
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G Disease in the nervous system
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| 5. BIOLOGICAL SAMPLES & ANALYSIS |
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Comments
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N/A
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| 6. Other Information |
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- Alcohol
- Anthropometry
- Demographics
- Education
- Medical history
- Physical exercise
- Socioeconomic status
- Smoking
- Other (specify)
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Specify: Other
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Family history of CTS in first-degree relatives, hobbies and household chores. Women were also asked to specify use of oral contraception, parity, and menopause.
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Possibility for linkage to data registries/data enrichment via data linkage
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