Ontario Health Technology Assessment Series

BACKGROUND: A blockage to the blood vessels in the lower extremities may cause pain and discomfort. If left unmanaged, it may lead to amputation or chronic disability, such as in the form of post-thrombotic syndrome. We conducted a health technology assessment of mechanical thrombectomy (MT) devices, which are proposed to remove a blood clot, which may form in the arteries or veins of the lower legs. This evaluation considered blockages in the veins and arteries separately, and included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MT for lower limb blockages, patient preferences and values, and clinical and health system stakeholders' perspectives...

BACKGROUND: Staphylococcus aureus (S. aureus) is the most common cause of surgical site infections, and the nose is the most common site for S. aureus colonization. Pre-surgical (in the days prior to surgery) nasal decolonization of S. aureus may reduce the bacterial load and prevent the organisms from being transferred to the surgical site, thus reducing the risk of surgical site infection. We conducted a health technology assessment of nasal decolonization of S. aureus (including methicillin-susceptible and methicillin-resistant strains) with or without topical antiseptic body wash to prevent surgical site infection in patients undergoing scheduled surgery, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nasal decolonization of S...

Background: Familial hypercholesterolemia (FH) is an inherited disorder characterized by abnormally elevated low-density lipoprotein (LDL) cholesterol serum levels from birth, which increases the risk of premature atherosclerotic cardiovascular disease. Genetic testing is a type of a medical test that looks for changes in genes or chromosome structure to discover genetic differences, anomalies, or mutations that may prove pathological. It is regarded as the gold standard for screening and diagnosing FH...

Background: The thyroid is a gland in the lower neck that is responsible for secreting hormones related to growth and metabolism. A cancer growth in the thyroid can spread to other parts of the body, but most thyroid nodules (growths) are benign, and some types of thyroid cancer are nonaggressive and can be managed with active surveillance only. We conducted a health technology assessment of molecular testing in people with thyroid nodules of indeterminate cytology, which included an evaluation of diagnostic accuracy, clinical utility, cost-effectiveness, the budget impact of publicly funding molecular testing, and patient preferences and values...

Background: Post-traumatic stress disorder (PTSD) and acute stress disorder (ASD) are mental health conditions that may emerge following a frightening or traumatic event in a person's life. We conducted a health technology assessment of internet-delivered cognitive behavioural therapy (iCBT) for adults with PTSD or ASD, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding iCBT for PTSD or ADS, and patient preferences and values...

Background: Fluoropyrimidine drugs (such as 5-fluorouracil and capecitabine) are used to treat different types of cancer. However, these drugs may cause severe toxicity in about 10% to 40% of patients. A deficiency in the dihydropyrimidine dehydrogenase (DPD) enzyme, encoded by the DPYD gene, increases the risk of severe toxicity. DPYD genotyping aims to identify variants that lead to DPD deficiency and may help to identify people who are at higher risk of developing severe toxicity, allowing their treatment to be modified before it begins...

Background: Major depression is a substantial public health concern that can affect personal relationships, reduce people's ability to go to school or work, and lead to social isolation. Multi-gene pharmacogenomic testing that includes decision-support tools can help predict which depression medications and dosages are most likely to result in a strong response to treatment or to have the lowest risk of adverse events on the basis of people's genes.We conducted a health technology assessment of multi-gene pharmacogenomic testing that includes decision-support tools for people with major depression...

Background: Bladder cancer begins in the innermost lining of the bladder wall and, on histological examination, is classified as one of two types: non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer. Transurethral resection of bladder tumour (TURBT) is the standard treatment for people with NMIBC, but the high rate of cancer recurrence after first TURBT is a challenge that physicians and patients face. Tumours seen during follow-up may have been missed or incompletely resected during first TURBT...

Background: Knee instability can arise from various causes and conditions such as neuromuscular disease, central nervous system conditions, and trauma. For people with knee instability, knee orthosis devices are prescribed to help with standing, walking, and performing tasks. We conducted a health technology assessment of stance-control knee-ankle-foot orthoses (SCKAFOs) for people with knee instability, which included an evaluation of the effectiveness, safety, and budget impact of publicly funding SCKAFOs, as well as patient preferences and values...

Background: Glaucoma is a condition that causes progressive damage to the optic nerve, which can lead to visual impairment and potentially to irreversible blindness. The iStent and iStent inject are devices implanted in the eye during a type of minimally invasive glaucoma surgery (MIGS) to reduce intraocular pressure by increasing trabecular outflow by bypassing the trabecular meshwork. We summarized two health technology assessments and additional recent publications that evaluated iStent for people with glaucoma, including effectiveness, safety, cost-effectiveness, the budget impact of publicly funding iStent, and patient preferences and values...

BACKGROUND: Varicose veins are part of the spectrum of chronic venous disease and are a sign of underlying chronic venous insufficiency. Treatments to address varicose veins include surgical vein removal under general anesthesia, or endovenous laser (EVLA) or radiofrequency ablation (RFA) under tumescent anesthesia. Two newer nonthermal endovenous procedures can close veins without any tumescent anesthesia, using either mechanochemical ablation (MOCA, a combination of mechanical and chemical techniques) or cyanoacrylate adhesive closure (CAC)...

Background: Wounds may be caused in a variety of ways. Some wounds are difficult to heal, such as diabetic foot ulcers and venous leg ulcers. We conducted a health technology assessment of skin substitutes for adults with neuropathic diabetic foot ulcers and venous leg ulcers, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding skin substitutes, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence...

Background: Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate that commonly affects older people with prostates and may lead to obstructive urinary symptoms. Symptoms may initially be mild but tend to worsen over time. Prostatic artery embolization (PAE) is an endovascular procedure to treat BPH, wherein an interventional radiologist inserts a catheter into the patient to inject tiny particles intended to reduce blood flow to the enlarged prostate, causing it to shrink in size...

Background: Early detection of melanoma is key, as survival rates are substantially better when the cancer is detected in its early stages. Currently, the standard of care is to biopsy any lesion suspected of melanoma for diagnostic confirmation by histopathology. As a result, most people who undergo biopsy receive negative melanoma results. If effective, a non-invasive alternative, such as pigmented lesion assay, could minimize the number of unnecessary biopsies performed. We conducted a health technology assessment of pigmented lesion assay for people with suspected melanoma lesions, which included an evaluation of diagnostic accuracy, clinical utility, the budget impact of publicly funding pigmented lesion assay, and the preferences and values of people who have undergone biopsy for suspected melanoma...

Background: Major depression is one of the most diagnosed mental illnesses in Canada. Generally, people are treated successfully with antidepressants or psychotherapy, but some people do not respond to these treatments (called treatment-resistant depression [TRD]). Repetitive transcranial magnetic stimulation (rTMS) delivers magnetic pulses to stimulate the areas of the brain associated with mood regulation. Several modalities of rTMS exist (e.g., high frequency rTMS, intermittent theta burst stimulation [iTBS], deep transcranial magnetic stimulation)...

Background: Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pessaries for the treatment of POP and SUI, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding vaginal pessaries, and patient preferences and values...

Background: Heart failure is a complex clinical syndrome that usually presents with breathlessness, leg edema, and fatigue. Clinically measurable natriuretic neurohormones such as B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) are elevated in people with heart failure. We conducted a health technology assessment of BNP and NT-proBNP tests for people with suspected heart failure, which included an evaluation of diagnostic accuracy, clinical impact, cost-effectiveness, the budget impact of publicly funding BNP and NT-proBNP tests, and patient preferences and values...

Background: Proton beam therapy has potential to reduce late toxicity in cancer treatment by reducing the risk of damage to surrounding healthy tissues. We conducted a health technology assessment of proton beam therapy, compared with photon therapy, for children and adults with cancer requiring radiotherapy. Our assessment included an evaluation of safety, effectiveness, cost-effectiveness, the budget impact of publicly funding the construction and use of proton beam therapy in Ontario, and patient preferences and values...

Background: Bioprosthetic valves used to treat mitral or tricuspid valve disease can be expected to deteriorate and eventually fail after 10 to 15 years. For patients who are considered inoperable or high-risk for surgery, medical management (i.e., drug therapy, the current standard of care in Ontario) does not significantly alter the course of valvular heart disease or improve degenerated bioprosthetic valves. An alternative for these patients is transcatheter mitral or tricuspid valve-in-valve implantation (TMViV or TTViV)...

Background: RhD blood group incompatibility during pregnancy can cause serious health problems for the fetus. Noninvasive fetal RhD blood group genotyping is a test for fetal RhD status that may help prevent unnecessary preventive treatment (Rh immunoglobulin [RhIG] injections) and intensive pregnancy monitoring. We conducted a health technology assessment of noninvasive fetal RhD blood group genotyping for RhD-negative (RhD-) pregnancies. Our assessment evaluated the test's diagnostic accuracy, clinical utility, and cost-effectiveness, the budget impact of publicly funding this test, and patients' and providers' preferences and values...