List of Patient Preference-Sensitive Priority Areas

Patient preference-sensitive priority 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 list of priority areas 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
• Patient Preference Information (PPI) in Medical Device Decision-Making

The List of Patient Preference-Sensitive Priority Areas is provided in two formats:

List of Patient Preference-Sensitive Areas by Category

• Patient values in diagnosis and treatment
• Relevant clinical endpoints for specific patient populations
• Patient benefit-risk tradeoffs for treatment options or diagnostic approaches
• Impact of uncertainty in benefit-risk tradeoffs

List of Patient Preference-Sensitive Areas by Medical Specialty

• Broadly applicable
• Aesthetic
• Bariatrics
• Cardiology
• Diagnostics
• Ear, Nose, and Throat
• Endocrinology
• Gastroenterology
• Genetic testing
• Nephrology
• Neurology
• Obstetrics/Gynecology
• Oncology
• Orthopedics
• Ophthalmology
• Pulmonary
• Radiology
• Respiratory/Sleep Disordered Breathing
• Transplantation
• Urology
• Wound Healing

List of Patient Preference-Sensitive Areas by Category

Note: An asterisk (*) indicates FDA-sponsored studies that are either ongoing or have been completed.

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
Broadly applicable	Patient values related to rare diseases
Cardiology	Treatments for atrial fibrillation as impacted by the number of episodes, outcome, comfort, and type of atrial fibrillation
Diagnostics	Benefits and risks of direct-to-consumer genetic testing
Endocrinology	Attributes of diabetes devices, including interoperability, multiple functionalities, burden of carrying multiple devices, and device alarms
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
Pulmonary	Attributes of different types of Pulmonary Medication and Delivery Devices such as inhalers
Respiratory/Sleep Disordered Breathing	Benefits and risks of different types of CPAP therapies and masks
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
Pulmonary	Patients with COPD
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	Treatments for heart failure (device treatments vs. other treatment options, such as medications)
* 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, such as devices with better accuracy
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)
Pulmonary	Treatments for COPD (standard drug vs. device)
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)
Respiratory/Sleep Disordered Breathing	Diagnosis of sleep apnea using in home-use diagnostics vs. sleep studies
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.
Diagnostics	Uncertainty related to direct-to-consumer genetic testing. For example, what patients should do with the results of a genetic test that indicate a possible marker of a disease or potential to pass on a gene to a child.
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

Note: An asterisk (*) indicates FDA-sponsored studies that are either ongoing or have been completed.

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
Patient Values in Diagnosis and Treatment	Patient values related to rare diseases
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:	Treatments for heart failure (device treatments vs. other treatment options, such as medications)
* 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
* 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
Impact of Uncertainty in Benefit-Risk Tradeoffs	Uncertainty related to direct-to-consumer genetic testing. For example, what patients should do with the results of a genetic test that indicate a possible marker of a disease or potential to pass on a gene to a child.
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, such as devices with better accuracy
Patient Values in Diagnosis and Treatment	Attributes of diabetes devices, including interoperability, multiple functionalities, burden of carrying multiple devices, and device alarms
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)
Pulmonary
Patient Benefit-Risk Tradeoffs Related to:	Treatments for COPD (standard drug vs. device)
Patient Values in Diagnosis and Treatment	Attributes of different types of Pulmonary Medication and Delivery Devices such as inhalers
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)
Respiratory/Sleep Disordered Breathing
Patient Benefit-Risk Tradeoffs Related to:	Diagnosis of sleep apnea using in home-use diagnostics vs. sleep studies
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)