Obsessive-compulsive disorder (OCD) is a debilitating neuropsychiatric illness characterized by obsessions and compulsions that are distressing, impair function, and are time-consuming, especially in severe cases. Up to 40% of people with OCD have treatment-refractory OCD and experience inadequate response to multiple trials and combinations of treatments. Neurosurgery is an important treatment option for people with severe, treatment-refractory OCD but is typically invasive. Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technology that is used to perform neurosurgery. We conducted a health technology assessment of MRgFUS neurosurgery for people with severe, treatment-refractory OCD, which included an evaluation of effectiveness, safety, the budget impact of publicly funding MRgFUS neurosurgery, and patient preferences and values. We performed a systematic literature search of the clinical evidence published since 2013. We assessed the risk of bias of each included study using the Joanna Briggs Institute's Critical Appraisal Checklist for Case Series, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We estimated the 5-year budget impact of publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario. Owing to a lack of comparative clinical evidence, we did not conduct a primary economic evaluation. To contextualize the value of MRgFUS neurosurgery, we spoke to people with treatment-refractory OCD who underwent the procedure, as well as those on the waitlist. We included 2 studies in the clinical evidence review. In these small case series, MRgFUS neurosurgery led to improvements in OCD symptoms, quality of life, and patient functioning, as well as treatment response for many but not all patients (GRADE: Very low). In a minority of cases, the procedure could not be successfully performed due to skull factors (GRADE: Very low). MRgFUS neurosurgery was also found to have a favourable safety profile (GRADE: Very low). No cases of re-treatment were reported (GRADE: Very low). No studies compared MRgFUS neurosurgery with other neurosurgeries.Due to the lack of comparative clinical evidence, the cost-effectiveness of MRgFUS neurosurgery could not be determined. Our budget impact analysis found that publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would cost an additional $1.9 million over 5 years.Patients reported the negative impacts that OCD had on their day-to-day activities, work and school, social life and family relationships, and mental health. The 6 participants who underwent MRgFUS neurosurgery commented on the positive impact that it had on their OCD symptoms, mental health, and quality of life. MRgFUS neurosurgery may be an effective and generally safe treatment option for severe, treatment-refractory OCD, but the evidence is very uncertain. The cost-effectiveness of MRgFUS neurosurgery could not be determined given the lack of comparative clinical evidence. Publicly funding MRgFUS neurosurgery for people with treatment-refractory OCD in Ontario would result in an additional cost of $1.9 million over 5 years. Patients and care partners emphasized the negative impact of OCD in their lives and highlighted the importance of having access to MRgFUS neurosurgery as a treatment option for treatment-refractory OCD.

Both malignant and benign conditions may require colorectal surgery. Anastomotic leak is a serious potential complication, and assessing tissue perfusion at the planned site of anastomosis is critical to try to prevent leaks. The approaches used by surgeons to assess anastomotic integrity and tissue perfusion involve visual assessment of the planned resection area. Indocyanine green fluorescence imaging (ICGFI) is a technology that involves the use of a fluorescent dye and a near-infrared imaging system to allow surgeons to visualize tissue perfusion intraoperatively in real time. We conducted a health technology assessment of ICGFI in colorectal surgery, which included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding ICGFI for the assessment of anastomotic perfusion during colorectal surgery, and the experiences of patients undergoing colorectal cancer surgery. We performed a systematic review of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Risk-of-Bias Assessment Tool for Nonrandomized Studies (RoBANS) for nonrandomized studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing ICGFI with visual assessment alone for the visualization of anastomotic perfusion during colorectal surgery from a public payer perspective. We also analyzed the budget impact of publicly funding ICGFI for colorectal surgery in Ontario. To contextualize the potential value of publicly funding ICGFI for colorectal surgery, we summarized a qualitative literature rapid review conducted by the Canadian Agency for Drugs and Technologies in Health (now Canada's Drug Agency). We included 6 RCTs and 13 nonrandomized studies in the clinical evidence review. Compared with visual assessment alone, the addition of ICGFI to assess anastomotic perfusion during colorectal surgery reduced anastomotic leaks (GRADE: Low) and reoperations (GRADE: Low) and slightly reduced sepsis, but the evidence for the latter is very uncertain (GRADE: Very low to Low). ICGFI appeared to have little to no effect on hospital readmissions (GRADE: Low) or length of stay (GRADE: Low to Moderate), and its effect on mortality is very uncertain (GRADE: Very low). Our primary economic evaluation found that ICGFI is more effective and less costly than visual assessment alone and is highly likely to be cost-effective at the commonly used willingness-to-pay values of $50,000 and $100,000 per quality-adjusted life-year (QALY). The use of ICGFI could prevent 22 major anastomotic leaks per 1,000 patients undergoing colorectal surgery with anastomosis. With ICGFI, 45 patients would need to be treated to prevent an additional major anastomotic leak. Publicly funding ICGFI to assess anastomotic perfusion in colorectal surgery in Ontario would lead to an annual budget impact ranging from a cost savings of $0.81 million in year 1 to a cost savings of $8.13 million in year 5, for a total 5-year budget impact of $19.03 million in cost savings. We identified a previously published rapid review that found no qualitative literature on the patient experience of ICGFI. However, qualitative studies on the experience of patients who had undergone colorectal cancer surgery identified anastomotic leak and quality of life as key patient-important outcomes. In the included studies, patients often reported not receiving enough information about surgical outcomes and experiencing anxiety regarding cancer recurrence. We did not conduct direct patient engagement since the purpose of the technology is to enhance visualization of the surgical area and because it is expected that patients' preferences and values would align with the potential for improved health outcomes from the use of ICGFI in colorectal surgery. The evidence suggests that, compared with visual assessment alone, adding ICGFI to colorectal surgery can help reduce anastomotic leaks, reoperations, and sepsis but may not have an effect on hospital readmissions or length of stay. The effect of ICGFI on mortality is unclear. ICGFI is more effective and less costly than visual assessment alone. We estimate that publicly funding ICGFI for colorectal surgery in Ontario would result in cost savings of $19.03 million over the next 5 years. No literature was found on the patient experience of ICGFI. The qualitative literature on preferences and values for patients who had undergone colorectal cancer surgery identified anastomotic leak and quality of life as key outcomes, with study participants expressing concerns about surgical outcomes and cancer recurrence.

Vertebral compression fractures are among the most common types of fracture in patients with osteoporosis and they can arise during activities of daily living without any specific trauma event. For severely painful osteoporotic vertebral compression fractures (OVCFs) that do not respond to conservative treatment, minimally invasive percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PBK) may be used. We conducted a health technology assessment of PVP and PBK for people with painful OVCFs refractory to nonsurgical treatment that included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PVP and PBK, and patient preferences and values. We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the ROBIS tool for systematic reviews, the Cochrane Risk of Bias tool for RCTs, and the ROBINS-I tool for observational studies and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year time horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PVP and PBK in adults with painful OVCFs in Ontario. To contextualize the potential value of PVP and PBK, we spoke with people with OVCF. We included 10 studies in the clinical evidence review. Compared to conservative treatment (CT), there was significant (statistical and clinical) improvement in pain (up to 3 months follow-up, GRADE Low) and physical function (up to 6 months follow-up, GRADE Very low) for patients who underwent PVP. For PBK, there was significant (statistical and clinical) improvement in pain in the short term (up to 3 months follow-up, GRADE Very low) compared with CT. Overall, there were no significant differences for either PVP or PBK compared to conservative treatment for mortality, subsequent fractures or adverse events (GRADE Low to Very low). Cement leakage occurred in 4% to 39% of treated patients (PVP vs. CT, 4.0% [8/200 patients]; PVP vs. sham, 39.4% [9/99 patients]; PBK vs. CT, 4.5% [30/731 patients]) and most leakages were asymptomatic. The incremental cost-effectiveness ratio (ICER) of PVP compared with CT is $43,324 per quality-adjusted life-year (QALY) gained. The ICER of PBK compared with CT is $65,921 per QALY gained. The annual budget impact of publicly funding PVP and PBK in Ontario over the next 5 years ranges from an additional $0.5 million in Year 1 to $11.0 million in Year 5. The people we spoke to reported that their daily activities, work, social life, family relationships, and mental health were negatively impacted by OVCF. Those who underwent vertebroplasty reported a positive impact on pain relief and quality of life. People who are refractory to first-line conservative treatment and who underwent PVP showed significant short-term clinical improvement in pain (GRADE Low) and physical function (GRADE Very low) compared to conservative treatment. Similarly, people who underwent PBK experienced significant short-term clinical improvement in pain (GRADE Very low) compared to conservative treatment. PVP and PBK were consistently more costly and more effective than CT. We estimate that publicly funding PVP and PBK in Ontario would result in additional costs of $28 million over the next 5 years. The insights shared by participants underscore the significant challenges individuals with OVCF face in managing their condition, with notable impacts on daily activities, work, social interactions, and mental health. Despite these challenges, participants highlighted the positive outcomes of vertebroplasty for those who underwent the procedure, particularly in terms of pain relief and improved quality of life.

Stress urinary incontinence, fecal incontinence, and pelvic organ prolapse are common forms of pelvic floor dysfunction. Pelvic floor muscle training is used to improve pelvic floor function, through a program of exercises. We conducted a health technology assessment of pelvic floor muscle training for people with stress urinary incontinence, fecal incontinence, or pelvic organ prolapse, which included an evaluation of effectiveness, safety, and the budget impact of publicly funding pelvic floor muscle training, and patient preferences and values. We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of included studies using the ROBIS tool, for systematic reviews, and the Cochrane Risk of Bias tool, for randomized controlled trials, and we assessed the quality of the body of evidence according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search but did not conduct a primary economic evaluation. We also analyzed the budget impact of publicly funding pelvic floor muscle training in adults with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse in Ontario. To contextualize the potential value of pelvic floor muscle training as a treatment, we spoke with people with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse. We included 6 studies (4 systematic reviews and 2 randomized controlled trials) in the clinical evidence review. In comparison with no treatment, pelvic floor muscle training significantly improved symptom severity and increased patient satisfaction in women with stress urinary incontinence or pelvic organ prolapse (GRADE: Moderate). For men with stress urinary incontinence after prostatectomy, pelvic floor muscle training yielded mixed results for symptom improvement (GRADE: Very low). For adults with fecal incontinence, pelvic floor muscle training did not improve symptoms in comparison with standard care (GRADE: Very low).In the economic literature review, we included 6 cost-utility analyses that had evaluated the cost-effectiveness of pelvic floor muscle training as a treatment for people with pelvic organ prolapse or urinary incontinence. We did not identify any economic studies on pelvic floor muscle training for women or men with fecal incontinence or men with pelvic organ prolapse. The analyses included in our review found that, for women with stress urinary incontinence, pelvic floor muscle training was likely cost-effective in comparison with other nonsurgical interventions. For men with urinary incontinence after prostate surgery, pelvic floor muscle training was likely not cost-effective in comparison with standard care. For women with pelvic organ prolapse, the cost-effectiveness of pelvic floor muscle training in comparison with no active treatment was uncertain.The average cost of pelvic floor muscle training was approximately $763 per patient. Publicly funding pelvic floor muscle training for women with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse would result in additional costs over 5 years of $185.3 million, $275.6 million, and $85.8 million, respectively. Publicly funding pelvic floor muscle training for men with stress urinary incontinence and fecal incontinence would result in additional costs over 5 years of $10.8 million and $131.1 million, respectively. The people we spoke with reported that stress urinary incontinence, fecal incontinence, and pelvic organ prolapse limited their social and physical activities, taking a huge emotional toll. Many were hesitant or even fearful of surgery, and most people with experience of pelvic floor muscle training reported that it relieved most or all of their symptoms and allowed them to return to normal daily activities. Pelvic floor muscle training is likely more effective (with respect to symptom improvement and patient satisfaction) than no treatment for women with stress urinary incontinence or pelvic organ prolapse. Pelvic floor muscle training may yield mixed results with respect to symptom improvement for men with stress urinary incontinence after prostatectomy and have little to no effect on symptom improvement for adults with fecal incontinence. We estimate that publicly funding pelvic floor muscle training for adults with pelvic floor dysfunction (stress urinary incontinence, fecal incontinence, and pelvic organ prolapse) in Ontario would result in a substantial budget increase over the next 5 years. People with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse shared the negative impact these conditions have on their social and physical life and valued pelvic floor muscle training as a nonsurgical treatment option.

Chronic neuropathic pain is a major health problem that adversely affects people's physical and mental well-being, as well as their quality of life. Percutaneous peripheral nerve stimulation (PNS) may offer a minimally invasive option earlier in the treatment continuum for adults with chronic neuropathic pain that is refractory to conventional medical management. We conducted a health technology assessment of PNS for adults with chronic neuropathic pain, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PNS, and patient preferences and values. We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane risk-of-bias tool for randomized controlled trials and the Risk of Bias in Non-randomized Studies - of Interventions for observational studies, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 3-year horizon from a public payer perspective. We also analyzed the budget impact of publicly funding PNS in adults with chronic neuropathic pain in Ontario. To contextualize the potential value of PNS, we spoke to people with chronic pain, and to care partners of patients with chronic pain. We included 17 publications (2 randomized controlled trials and 12 nonrandomized studies) in the clinical evidence review. These studies included chronic neuropathic pain in the trunk and the upper and lower extremities. Compared with placebo controls in adults with chronic neuropathic pain that is refractory to conventional medical management, permanent PNS likely decreases pain scores, likely improves functional outcomes, and likely improves health-related quality of life, but it has little to no effect on the use of pain medications (all GRADEs: Moderate). Compared with before implantation in adults with chronic neuropathic pain, permanent PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with placebo controls in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). Compared with before implantation in adults with chronic postamputation pain, temporary PNS may decrease pain scores, may decrease the use of pain medications, may improve functional outcomes, and may improve health-related quality of life (all GRADEs: Low). We did not find any studies that compared permanent PNS to temporary PNS. Implantation of a PNS system is a reasonably safe procedure; most adverse events were localized and mild in intensity (GRADEs: Moderate to Low).The incremental cost-effectiveness ratio of PNS in addition to standard care compared with standard care alone is $87,211 per quality-adjusted life-year (QALY) gained. The probability of PNS in addition to standard care being cost-effective versus standard care alone is 1.02% at a willingness-to-pay of $50,000 per QALY gained and 64.88% at a willingness-to-pay of $100,000 per QALY gained. The annual budget impact of publicly funding PNS in Ontario over the next 5 years ranges from an additional $0.97 million in year 1, increasing to $3.15 million in year 5, for a total of $10.09 million over 5 years. People with chronic pain and their family members and care partners viewed PNS favourably. Those who had direct experience with permanent PNS perceived it to be effective in reducing their pain levels, leading to a positive impact on their quality of life and mental health. Current barriers to accessing PNS include lack of awareness, cost, and geography. In adults with chronic neuropathic pain that is refractory to conventional medical management, permanent PNS likely improves pain outcomes, functional outcomes, and health-related quality of life but has little to no effect on the use of pain medications compared with placebo controls. Temporary PNS may improve pain outcomes, functional outcomes, and health-related quality of life, and it may reduce the use of pain medications. Implantation of a permanent or temporary PNS system is reasonably safe. The incremental cost-effectiveness ratio of PNS in addition to standard care compared with standard care alone is $87,211 per QALY gained. We estimate that publicly funding PNS in Ontario would result in additional costs of $10.09 million over the next 5 years. People who had direct experience with permanent PNS spoke of its effectiveness in reducing their pain levels and its positive impact on their quality of life and mental health. Barriers to accessing PNS include lack of awareness, cost, and geography.

Rectal cancer is a disease in which cancer cells form in the rectum, which has the primary function of temporarily storing feces, controlling defecation, and maintaining continence. Surgery is the most common treatment for rectal cancer; surgical approaches include open, laparoscopic, and robotic assisted. We conducted an expedited summary of the clinical evidence for robotic-assisted surgery for rectal cancer, which included an evaluation of effectiveness and safety. We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and randomized controlled trials (RCTs). We assessed the risk of bias in the included systematic reviews using AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews, version 2), and we assessed the risk of bias in the included RCT using the Cochrane Risk-of-Bias Tool for Randomized Trials, version 1. We reported the quality of the body of evidence as evaluated in the included systematic reviews according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group criteria if it was evaluated. We included 14 studies in the clinical evidence review (12 systematic reviews and 1 RCT on robotic-assisted vs. laparoscopic rectal cancer surgery and 1 systematic review on robotic-assisted vs. open rectal cancer surgery). Compared with laparoscopic rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival; similar rates of conversion, blood transfusion, and readmission,· reduced blood loss; shorter length of stay; and improved quality of life. Compared with open rectal cancer surgery, robotic-assisted rectal cancer surgery may result in similar overall survival, reduced blood loss, and shorter length of stay. Robotic-assisted rectal cancer surgery may result in similar or improved clinical outcomes compared with laparoscopic and open rectal cancer surgery.