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) |
