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. 2019 Feb 1;3:63. Originally published 2018 May 29. [Version 2] doi: 10.12688/wellcomeopenres.14576.2

Table 5. Inclusion and exclusion criteria for the longitudinal cohorts for the DOLORisk protocol.

Inclusion criteria Exclusion criteria
Chemotherapy •   ≥18 years.
•   Diagnosed with high-risk colorectal cancer.
•   Planned adjuvant treatment with oxaliplatin and
    flourouracil (5-FU) or capecitabine (Pro 5-FU).
•   Known metastatic cancer.
•   Previous treatment with chemotherapy.
•   Significant mental illness.
•   Alcohol abuse.
•   Known diabetes.
•   Significant neuropathic diseases.
•   Spinal cord stenosis.
•   Peripheral vascular diseases (Fontaine >2).
•   Chronic pain with a pain intensity on a 0-10 numeric
    rating scale >5.
•   Patients who do not speak, read or understand Danish.
Thoracotomy •   ≥ 18 years.
•   Scheduled for lung cancer resection performed
    via thoracoscopy and/or thoracotomy, including
    lobectomy, bilobectomy, pneumonectomy,
    resection of the tracheobronchial bifurcation,
    wedge resection, sleeve resection and
    combinations hereof.
•   Willingness and ability to comply with study
    procedures as judged by the site investigator/
    manager.
•   Expected availability for follow-up throughout the
    study.
•   Mental incapacity or language barriers precluding
    adequate understanding of study procedures.
•   Current alcohol or substance abuse according to the
    site investigator’s medical judgement.
•   Unsuitability for participation in the study for any other
    reason, e.g. due to a significant serious underlying
    condition (e.g. other cancer or AIDS), as determined by
    the site investigator/manager.
    ADDITIONALLY in FR:
•   Previous surgery on the same area.
•   Surgery targeting only the pleura or mediastinum.
•   Peripheral neurological pathology or central (brain
    damage, multiple sclerosis) susceptible to interfere with
    the evaluation of the post-operative pain.
•   History of significant mental illness: psychosis, severe
    depression having motivated a hospitalisation, suicide
    attempt.
•   Current major depressive episode at the time of the
    evaluation.
•   Abuse of drug or psychoactive substance during the last
    six months.
•   Patients participating in another protocol of biomedical
    research.
Mastectomy •   Women ≥ 18 years.
•   Scheduled for breast cancer resection performed
    via lumpectomy (partial or segmental mastectomy)
    or mastectomy with or without sentinel lymph node
    biopsy and axillary lymph node dissection, and
    any combinations hereof.
•   Affiliated to a social security scheme.
•   Danish/French language (read, written and
    spoken).
•   Willingness and ability to comply with study
    procedures as judged by the site investigator.
•   Expected availability for follow-up throughout the
    study.
•   Cognitive or psychological disorders incompatible with
    the respect and/or the understanding of the protocol.
•   Current alcohol or substance abuse according to the site
    investigator's medical judgement.
•   Unsuitability for participation in the study for any other
    reason, e.g. due to a significant serious underlying
    condition (e.g. other cancer or AIDS), as determined by
    the site investigator.
•   Previous surgery on the same area.
•   Peripheral neurological pathology or central (brain
    damage, multiple sclerosis) susceptible to interfere with
    the evaluation of the post-operative pain.
•   History of significant mental illness: psychosis, severe
    depression having motivated a hospitalisation, suicide
    attempt.
•   Current major depressive episode at the time of
    assessment.
•   Abuse of drug or psychoactive substance during the last
    six months
•   Participating in another protocol of biomedical research.
•   Other cancer or AIDS.
•   Scheduled for bilateral mastectomy.
•   Presence of chronic pain before the breast cancer
    surgery.
•   Workplace accident, litigation or search for
    compensation.