Date of filling in this questionnaire or last update: 02/11/2020
1. IDENTIFICATION & BASIC DESCRIPTION
Cohort name
  OCTOPUS (Occupational Carpal Tunnel Syndrome Observational Prospective Unified Study)
Country
 

  • Italy

Please provide any other information on the cohort location/s if needed
  North-Eastern Italy
Name
  Francesco Violante
Institution
  University of Bologna
Email
  francesco.violante@unibo.it
Name
  Stefano Mattioli
Institution
  University of Bologna
Email
  s.mattioli@unibo.it
Do you want to add another Principal Investigator for occupational analyses
 

  • Add another Principal Investigator for occupational analyses

Name
  Stefania Curti
Institution
  University of Bologna
Email
  stefania.curti@unibo.it
Website
 

  • N/A

Name of committee
  Institutional Review Board of the University Hospital of Bologna
Upload files
 

Data access policy (briefly describe)
  Data access could be considered after an agreement between Principal Investigators
Is this cohort part of a consortium? (name consortium)
  No, but an agreement has been made with the US colleagues of the Consortium study of carpal tunnel syndrome
Participation in pooled analyses
 

  • 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).

Main aim of cohort, please briefly describe the main objectives of the cohort
  To investigate the role of ergonomic and personal risk factors in the genesis of carpal tunnel syndrome (CTS)
Comparators (please select as many as appropriate)
 

  • Internal study population

Inclusion criteria
  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
Exclusion criteria
  1) Workers previously surgically treated for CTS; 2) ACGIH TLVs method not applicable
Enrollment
  Completed
Age range at entry (main cohort)
 

Minimum Maximum Mean
38.4

Men at enrollment
  1082
Women at enrollment
  2196
Children (<18 years) at enrollment
  N/A
Men at last follow-up
  1099
Women at last follow-up
  2032
Children (<18 years) at last follow-up
  N/A
Participation rate at enrollment (if known)
  89
Comments
  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)
2. OUTCOME FOLLOW-UP
Type of data for outcome follow-up (please select as many as appropriate)
 

  • Active (contact with participants)

Active (contact with participants) (specify)
 

  • Each worker underwent a clinical examination by a trained physician to collect symptoms of CTS and other personal variables using a structured questionnaire

First follow-up period (provide year)
  2001-2002
Last follow-up period (provide year)
  2008-2011
Number of follow-ups after baseline (provide number)
  3
Participation at last follow-up (if known)
  70
Comments
  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).
3. OCCUPATIONAL EXPOSURES
Source of exposure data collected (please select as many as appropriate)
 

  • Questionnaire, Personal (Self-reporting or interview)
  • Job-employment records

Occupational history/time frame
  Lifetime
Occupational coding performed
  No
Types of exposure measurements
 

  • Other (specify)

Specify: Other
  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.
Methods for exposure assessment (please select as many as appropriate)
 

  • Other (specify)

Specify: Other
  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.
Main categories
 

  • Physical agents
  • Ergonomics, physical workload, and injury related

Physical agents
 

  • Hand-arm vibration

Ergonomics, physical workload, and injury related
 

  • Awkward work postures (e.g. kneeling/squatting, elevated arms, neck flection, back bent forward without support)
  • Repetitive work movements
  • Other (specify)

Ergonomics, physical workload, and injury related | Specify: Other
  exposure to forceful movements of hand and wrist
Comments
  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.
4. OUTCOMES EVALUATED
Baseline - type of outcome data collected (select more than one if applicable)
 

  • Questionnaire, individual (self-recording or interview)

Follow-up - type of outcome data collected (select more than one if applicable)
 

  • Questionnaire, individual (self-recording or interview)

Outcome type (please select as many as appropriate)
 

  • Morbidity

Diagnostic groups based on ICD10
 

  • G Disease in the nervous system

G Disease in the nervous system
 

  • Carpal tunnel syndrome

5. BIOLOGICAL SAMPLES & ANALYSIS
Comments
  N/A
6. Other Information
 

  • Alcohol
  • Anthropometry
  • Demographics
  • Education
  • Medical history
  • Physical exercise
  • Socioeconomic status
  • Smoking
  • Other (specify)

Specify: Other
  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.
Possibility for linkage to data registries/data enrichment via data linkage
 

  • Hospital discharge