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Priority List of Patient Preference-Sensitive Areas

Patient preference-sensitive areas may be cross-cutting topics related to approaches of delivering treatment (such as minimally invasive approaches) or related to specific diseases and conditions.

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This proposed priority list is not an exhaustive list of all patient preference-sensitive areas for medical devices but is intended to provide examples of these areas. In addition, these areas may shift over time as more patient preference studies are done and as technology evolves.

For more information: Patient Preference-Sensitive Areas: Using Patient Preference Information (PPI) in Medical Device Evaluation

List of Patient Preference-Sensitive Areas by Category

Medical Specialty
Patient Values in Diagnosis and Treatment
Patient Values in Diagnosis and Treatment

Broadly applicable

Device treatments that stabilize current disease/condition symptoms vs. disease progression (morbidity)

Broadly applicable

Device treatments that stabilize a disease or condition vs. improve survival (mortality)

Broadly applicable

Personal experience with the device

Broadly applicable

Ranking of factors in decision-making such as quality of life, length of life, need for repeat procedures, subsequent hospitalization rates, success and failure rates, and relative improvement rates

Broadly applicable

Patient values impacted by clinically meaningful subgroups, such as pediatric patients

Cardiology

Treatments for atrial fibrillation as impacted by the number of episodes, outcome, comfort, and type of atrial fibrillation (permanent vs. paroxysmal)

Diagnostics

Benefits and risks of direct-to-consumer genetic testing

Endocrinology

Attributes of diabetes devices, including interoperability

Oncology

Incremental increase in survival vs. risk of device-related toxicity

Oncology

Oncology device treatments: quality of life vs. survival

Oncology: Breast Cancer

Risk of positive margins vs. cosmetic satisfaction

Transplantation

Organ preservation during implantation: benefits and risks of devices

Urology

Urinary incontinence, fecal incontinence, and fluid management: benefits and risks of device treatments

Wound Healing

Characteristics of wound dressings for patients with chronic wounds (dressings (wear time, ability to reduce odor, and others)

Relevant Clinical Endpoints for Specific Patient Populations

Cardiology

Patients with critical limb ischemia

Gastroenterology

Patients with gastroesophageal reflux disease (GERD)

Oncology: Breast Cancer

Patients being screened for breast cancer

Patient Benefit-Risk Tradeoffs for Treatment Options or Diagnostic Approaches

Broadly applicable

Minimally invasive surgery (including robotic surgery) vs. conventional open surgery. Considerations: operating time, blood loss, adverse events, and recovery time.

Broadly applicable

Interim treatments (may require repetition) vs. definitive treatments. Considerations: success rates and therapeutic effect

Broadly applicable

Attributes of chronic pain therapy: quality of life, length of life, and pain relief

Broadly applicable

Attributes of digital health applications: uncertainty, cybersecurity, and convenience

Broadly applicable

Attributes of drug delivery systems (like injectors and pumps) for rheumatoid arthritis, multiple sclerosis, diabetes, pulmonary hypertension, chronic pain, and other conditions: injection time, injection modality, pain, and convenience

Aesthetic

Breast implants

Aesthetic

Dermal fillers (pain, duration of adverse events, duration of product, physical and chemical device characteristics, and the feel of the device)

Bariatrics

Treatments for obesity

Cardiology

Treatments for aortic valve stenosis

Cardiology

Treatments for moderate to extreme cases of hypertension (device treatments vs. other treatment options, such as medication)

Cardiology

Treatments for atrial fibrillation (device treatments vs. anticoagulants)

Cardiology

Device treatments for critical limb ischemia as impacted by the level of amputation

Dental

Dental devices (procedure duration, convenience, durability, pain)

Diagnostics

Point-of-care testing vs. other testing venues

Diagnostics

Over-the-counter sample collection vs. laboratory sample collection (with lab testing for both) for respiratory diseases, sexually transmitted infectious diseases, anti-microbial resistance markers, and others

Diagnostics

Home-use diagnostics for diseases such as colon cancer, bladder cancer, and others

Diagnostics

Choice of diagnostic (such as in vitro device or imaging) for diseases such as colon cancer, bladder cancer, prostate cancer, fecal occult blood testing, lupus, rheumatoid arthritis, and others

Ear, Nose, and Throat

Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment options)

Ear, Nose, and Throat

Treatments for hyperthyroidism (radiation therapy treatment vs. surgical treatment)

Ear, Nose, and Throat

Treatments for head and neck cancers (laryngectomy vs. chemotherapy)

Endocrinology

Treatments for diabetes

Gastroenterology

Treatments for ulcerative colitis (non-invasive imaging devices vs. endoscopy: convenience, accuracy, and other attributes)

Genetic Testing

Prenatal testing (preimplantation genetic diagnosis vs. ultrasound diagnosis)

Nephrology

Treatments for end-stage renal disease (surgical implantation vs. recurring surgical treatment)

Neurology

Treatments for multiple neurological conditions (implanted brain stimulators vs. other treatment options)

Obstetrics/Gynecology

Contraceptive device treatments

Oncology

Device treatments for various cancers (device-related toxicity, success rates, and duration of therapeutic effect)

Oncology: Breast Cancer

Detection of breast cancer: attributes in diagnostic imaging (sensitivity and specificity)

Oncology: Breast Cancer

Treatment of breast cancer (focal ablation vs. lumpectomy: visit frequency, treatment-associated invasiveness, and outcome uncertainty)

Oncology: Breast Cancer

Treatment of breast cancer: Partial breast radiation

Oncology: Prostate Cancer

Treatments for benign prostatic hyperplasia and prostate cancer (focal ablation of prostate tissue)

Ophthalmology

Treatments for glaucoma (conventional surgery vs. minimally invasive surgery vs. other treatment options)

Ophthalmology

Treatments for vision correction (refractive surgical devices vs. glasses vs. contacts: convenience, dry eyes, glare, and other visual symptoms)

Orthopedics

Treatments for pediatric spinal deformity: (growth-friendly, non-fusion spinal procedures vs. procedures that require spinal fusion)

Radiology

Interventional procedures involving radiation exposure vs. other treatment options

Radiology

Microsphere device radiation vs. conventional chemotherapy

Radiology

Detection of breast cancer (ultrasound, mammography, and other diagnostic imaging options)

Urology

Treatments for erectile dysfunction (devices vs. other treatment options: risk of infection and surgery)

Impact of Uncertainty in Benefit-Risk Tradeoffs

Broadly applicable

Uncertainty related to secondary prevention of disease. In other words, patients have been identified at risk for a certain disease (treatment vs. no treatment, benefit-risk of treatment and side effects) but do not yet have the condition.

Broadly applicable

Uncertainty related to more clinical trials to determine a device’s short- and long-term efficacy vs. desire to have product available to patients as soon as possible.

Oncology

Uncertainty related to unknown long-term outcome associated with ablation tools to treat malignant tumors vs. known outcome of standard surgery

Oncology

Uncertainty related to benefits of oncology device treatments vs. unknown risk and/or high risk

 

List of Patient Preference-Sensitive Areas by Medical Specialty

Category
Area
Broadly Applicable to Many Diseases or Conditions

Patient Benefit-Risk Tradeoffs Related to:

Minimally invasive surgery (including robotic surgery) vs. conventional open surgery. Considerations: operating time, blood loss, adverse events, and recovery time.

Patient Benefit-Risk Tradeoffs Related to:

Interim treatments (may require repetition) vs. definitive treatments. Considerations: success rates and therapeutic effect

Patient Benefit-Risk Tradeoffs Related to:

Attributes of chronic pain therapy: quality of life, length of life, and pain relief

Patient Benefit-Risk Tradeoffs Related to:

Attributes of digital health applications: uncertainty, cybersecurity, and convenience

Patient Benefit-Risk Tradeoffs Related to:

Attributes of drug delivery systems (like injectors and pumps) for rheumatoid arthritis, multiple sclerosis, diabetes, pulmonary hypertension, chronic pain, and other conditions: injection time, injection modality, pain, and convenience

Patient Values in Diagnosis and Treatment

Device treatments that stabilize current disease/condition symptoms vs. disease progression (morbidity)

Patient Values in Diagnosis and Treatment

Device treatments that stabilize a disease or condition vs. improve survival (mortality)

Patient Values in Diagnosis and Treatment

Personal experience with the device

Patient Values in Diagnosis and Treatment

Ranking of factors in decision-making such as quality of life, length of life, need for repeat procedures, subsequent hospitalization rates, success and failure rates, and relative improvement rates

Patient Values in Diagnosis and Treatment

Patient values impacted by clinically meaningful subgroups, such as pediatric patients

Impact of Uncertainty in Benefit-Risk Tradeoffs

Uncertainty related to secondary prevention of disease. In other words, patients have been identified at risk for a certain disease (treatment vs. no treatment, benefit-risk of treatment and side effects) but do not yet have the condition.

Impact of Uncertainty in Benefit-Risk Tradeoffs

Uncertainty related to more clinical trials to determine a device’s short- and long-term efficacy vs. desire to have product available to patients as soon as possible.

Aesthetic

Patient Benefit-Risk Tradeoffs Related to:

Breast implants

Patient Benefit-Risk Tradeoffs Related to:

Dermal fillers (pain, duration of adverse events, duration of product, physical and chemical device characteristics, and the feel of the device)

Bariatrics

Patient Benefit-Risk Tradeoffs Related to:

Treatments for obesity

Cardiology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for aortic valve stenosis

Patient Benefit-Risk Tradeoffs Related to:

Treatments for moderate to extreme cases of hypertension (device treatments vs. other treatment options, such as medication)

Patient Benefit-Risk Tradeoffs Related to:

Treatments for atrial fibrillation (device treatments vs. anticoagulants)

Patient Benefit-Risk Tradeoffs Related to:

Device treatments for critical limb ischemia as impacted by the level of amputation

Patient Values in Diagnosis and Treatment

Treatments for atrial fibrillation as impacted by the number of episodes, outcome, comfort, and type of atrial fibrillation (permanent vs. paroxysmal)

Relevant Clinical Endpoints for Specific Patient Populations

Patients with critical limb ischemia

Dental

Patient Benefit-Risk Tradeoffs Related to:

Dental devices (procedure duration, convenience, durability, pain)

Diagnostics

Patient Benefit-Risk Tradeoffs Related to:

Point-of-care testing vs. other testing venues

Patient Benefit-Risk Tradeoffs Related to:

Over-the-counter sample collection vs. laboratory sample collection (with lab testing for both) for respiratory diseases, sexually transmitted infectious diseases, anti-microbial resistance markers, and others

Patient Benefit-Risk Tradeoffs Related to:

Home-use diagnostics for diseases such as colon cancer, bladder cancer, and others

Patient Benefit-Risk Tradeoffs Related to:

Choice of diagnostic (such as in vitro device or imaging) for diseases such as colon cancer, bladder cancer, prostate cancer, fecal occult blood testing, lupus, rheumatoid arthritis, and others

Patient Values in Diagnosis and Treatment

Benefits and risks of direct-to-consumer genetic testing

Ear, Nose, and Throat

Patient Benefit-Risk Tradeoffs Related to:

Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment options)

Patient Benefit-Risk Tradeoffs Related to:

Treatments for hyperthyroidism (radiation therapy treatment vs. surgical treatment)

Patient Benefit-Risk Tradeoffs Related to:

Treatments for head and neck cancers (laryngectomy vs. chemotherapy)

Endocrinology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for diabetes

Patient Values in Diagnosis and Treatment

Attributes of diabetes devices, including interoperability

Gastroenterology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for ulcerative colitis (non-invasive imaging devices vs. endoscopy: convenience, accuracy, and other attributes)

Relevant Clinical Endpoints for Specific Patient Populations

Patients with gastroesophageal reflux disease (GERD)

Genetic Testing

Patient Benefit-Risk Tradeoffs Related to:

Prenatal testing (preimplantation genetic diagnosis vs. ultrasound diagnosis)

Nephrology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for end-stage renal disease (surgical implantation vs. recurring surgical treatment)

Neurology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for multiple neurological conditions (implanted brain stimulators vs. other treatment options)

Obstetrics/Gynecology

Patient Benefit-Risk Tradeoffs Related to:

Contraceptive device treatments

Oncology (including breast cancer and prostate cancer)

Patient Benefit-Risk Tradeoffs Related to:

Device treatments for various cancers (device-related toxicity, success rates, and duration of therapeutic effect)

Patient Benefit-Risk Tradeoffs Related to:

Detection of breast cancer: attributes in diagnostic imaging (sensitivity and specificity)

Patient Benefit-Risk Tradeoffs Related to:

Treatment of breast cancer (focal ablation vs. lumpectomy: visit frequency, treatment-associated invasiveness, and outcome uncertainty)

Patient Benefit-Risk Tradeoffs Related to:

Treatment of breast cancer: Partial breast radiation

Patient Benefit-Risk Tradeoffs Related to:

Treatments for benign prostatic hyperplasia and prostate cancer (focal ablation of prostate tissue)

Patient Values in Diagnosis and Treatment

Incremental increase in survival vs. risk of device-related toxicity

Patient Values in Diagnosis and Treatment

Oncology device treatments: quality of life vs. survival

Patient Values in Diagnosis and Treatment

Breast cancer: Risk of positive margins vs. cosmetic satisfaction

Impact of Uncertainty in Benefit-Risk Tradeoffs

Uncertainty related to unknown long-term outcome associated with ablation tools to treat malignant tumors vs. known outcome of standard surgery

Impact of Uncertainty in Benefit-Risk Tradeoffs

Uncertainty related to benefits of oncology device treatments vs. unknown risk and/or high risk

Relevant Clinical Endpoints for Specific Patient Populations

Patients being screened for breast cancer

Ophthalmology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for glaucoma (conventional surgery vs. minimally invasive surgery vs. other treatment options)

Patient Benefit-Risk Tradeoffs Related to:

Treatments for vision correction (refractive surgical devices vs. glasses vs. contacts: convenience, dry eyes, glare, and other visual symptoms)

Orthopedics

Patient Benefit-Risk Tradeoffs Related to:

Treatments for pediatric spinal deformity: (growth-friendly, non-fusion spinal procedures vs. procedures that require spinal fusion)

Radiology

Patient Benefit-Risk Tradeoffs Related to:

Interventional procedures involving radiation exposure vs. other treatment options

Patient Benefit-Risk Tradeoffs Related to:

Microsphere device radiation vs. conventional chemotherapy

Patient Benefit-Risk Tradeoffs Related to:

Detection of breast cancer (ultrasound, mammography, and other diagnostic imaging options)

Transplantation

Patient Values in Diagnosis and Treatment

Organ preservation during implantation: benefits and risks of devices

Urology

Patient Benefit-Risk Tradeoffs Related to:

Treatments for erectile dysfunction (devices vs. other treatment options: risk of infection and surgery)

Patient Values in Diagnosis and Treatment

Urinary incontinence, fecal incontinence, and fluid management: benefits and risks of device treatments

Wound Healing

Patient Values in Diagnosis and Treatment

Characteristics of wound dressings for patients with chronic wounds (dressings (wear time, ability to reduce odor, and others)