Mechanical Thrombectomy for Acute and Subacute Blocked Arteries and Veins in the Lower Limbs: A Health Technology Assessment.

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. We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane tool for randomized controlled trials or the risk of bias among non-randomized studies (RoBANS) tool for nonrandomized 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. We did not conduct a primary economic evaluation since the clinical evidence is highly uncertain. We also analyzed the budget impact of publicly funding MT treatment for inpatients with arterial acute limb ischemia and acute deep vein thrombosis (DVT) in the lower limb in Ontario. To contextualize the potential value of MT, we spoke with people with acute DVT. To understand the barriers and facilitators of accessing MT, we surveyed clinical and health system stakeholders to gain their perspectives. We included 40 studies (3 randomized controlled trials and 37 observational studies) in the clinical evidence review. For patients who experience arterial acute limb ischemia, compared with catheter-directed thrombolysis (CDT) alone, MT has greater technical success and patency and reduced hospital length of stay, but the evidence for these outcomes is uncertain (GRADE: Very low). Mechanical thrombectomy may reduce the volume of thrombolytic medication required and CDT infusion time (a determinant for intensive care unit [ICU] need) in patients experiencing acute DVT, but it is uncertain if this is to a meaningful degree (GRADE: Moderate to Very low). It may also reduce the proportion of people who experience post-thrombotic syndrome and overall hospital length of stay, but it is uncertain (GRADE: Very low).We estimated that publicly funding MT for people with arterial acute limb ischemia in Ontario would lead to an annual cost savings of $0.17 million in year 1 to $0.14 million in year 5, for a total savings of $0.83 million over 5 years. This cost savings was mainly attributed to reduced ICU stays among people who received MT, but the results had considerable uncertainty. For the population with acute DVT, publicly funding MT would lead to an additional cost of $0.77 million in year 1 to $1.44 million in year 5, for a total additional cost of $5.5 million over 5 years.The people with acute DVT with whom we spoke reported that MT was generally seen as a positive option, and those who had undergone the procedure reported positively on its value as a treatment to quickly remove a clot. Accessing treatment for DVT could be a barrier, especially in more remote areas of Ontario.Clinicians using the technology advised that facilitators to accessing the technology included perceived improvements in patient outcomes, resourcing requirements, addressing unmet needs, and avoidance of ICU stay. The main barrier identified was cost. Clinicians who were not using the technology advised that barriers were low case-use volume, along with costs for the equipment and for health human resources. Mechanical thrombectomy may have greater technical success and patency and reduce hospital length of stay for patients experiencing an arterial acute limb ischemia and, for patients with an acute DVT, it may reduce CDT volume and infusion time, the proportion of people who experience post-thrombotic syndrome, and hospital length of stay. Mechanical thrombectomy may reduce the associated ICU costs, but it has higher equipment costs compared with usual care. Publicly funding MT in Ontario for populations with arterial acute limb ischemia may not lead to a substantial budget increase to the province. Publicly funding MT for acute DVT would lead to an additional cost of $5.5 million over 5 years. For people with acute DVT, MT was seen as a potential positive treatment option to remove the clot quickly. Overall, the majority of clinical stakeholders we engaged with (including both those with and without experience with MT) were supportive of the use of the technology.

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Multi-gene Pharmacogenomic Testing That Includes Decision-Support Tools to Guide Medication Selection for Major Depression: A Health Technology Assessment.

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. Our assessment evaluated effectiveness, safety, cost-effectiveness, the budget impact of publicly funding multi-gene pharmacogenomic testing, 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 and the Risk of Bias Assessment Tool for Nonrandomized studies (RoBANS) 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 to review published cost-effectiveness studies on multi-gene pharmacogenomic testing that includes a decision-support tool in people with major depression. We developed a state-transition model and conducted a probabilistic analysis to determine the incremental cost of multi-gene pharmacogenomic testing versus treatment as usual per quality-adjusted life-year (QALY) gained for people with major depression who had inadequate response to one or more antidepressant medications. In the reference case (with GeneSight-guided care), we considered a 1-year time horizon with an Ontario Ministry of Health perspective. We also estimated the 5-year budget impact of publicly funding multi-gene pharmacogenomic testing for people with major depression in Ontario.To contextualize the potential value of multi-gene pharmacogenomic testing that includes decision-support tools, we spoke with people who have major depression and their families. We included 14 studies in the clinical evidence review that evaluated six multi-gene pharmacogenomic tests. Although all tests included decision-support tools, they otherwise differed greatly, as did study design, populations included in studies, and outcomes reported. Little or no improvement was observed on change in HAM-D17 depression score compared with treatment as usual for any test evaluated (GRADE: Low-Very Low). GeneSight- and NeuroIDgenetix-guided medication selection led to statistically significant improvements in response (GRADE: Low-Very Low) and remission (GRADE: Low-Very Low), while treatment guided by CNSdose led to significant improvement in remission rates (GRADE: Low), but the study did not report on response. Results were inconsistent and uncertain for the impact of Neuropharmagen, and no significant improvement was observed for Genecept or another unspecified test for either response or remission (GRADE: Low-Very Low). Neuropharmagen may reduce adverse events and CNSDose may reduce intolerability to medication, while no difference was observed in adverse events with GeneSight, Genecept, or another unspecified test (GRADE: Moderate-Very Low). No studies reported data on suicide, treatment adherence, relapse, recovery, or recurrence of depression symptoms.Our review included four model-based economic studies and found that multi-gene pharmacogenomic testing was associated with greater effectiveness and cost savings than treatment as usual, over long-term (i.e., 3-,5-year and lifetime) time horizons. Since none of the included studies was fully applicable to the Ontario health care system, we conducted a primary economic evaluation.Our reference case analysis over the 1-year time horizon found that multi-gene pharmacogenomic testing (with GeneSight) was associated with additional QALYs (0.03, 95% credible interval [CrI]: 0.005; 0.072) and additional costs ($1,906, 95% Crl: $688; $3,360). An incremental cost-effectiveness ratio was $60,564 per QALY gained. The probability of the intervention being cost-effective (vs. treatment as usual) was 36.8% at a willingness-to-pay amount of $50,000 per QALY (i.e., moderately likely not to be cost-effective), rising to 70.7% at a willingness-to-pay amount of $100,000 per QALY (i.e., moderately likely to be cost-effective). Evidence informing economic modeling of the reference case with GeneSight and other multi-gene pharmacogenomic tests was of low to very low quality, implying considerable uncertainty or low confidence in the effectiveness estimates. The price of the test, efficacy of the intervention on remission, time horizon, and analytic perspective were major determinants of the cost-effectiveness results. If the test price were assumed to be $2,162 (compared with $2,500 in the reference case), the intervention would be cost-effective at a willingness-to-pay amount of $50,000 per QALY; moreover, if the price decreased to $595, the intervention would be cost saving (or dominant) compared with treatment as usual.At an increasing uptake of 1% per year and a test price of $2,500, the annual budget impact of publicly funding multi-gene pharmacogenomic testing in Ontario over the next 5 years ranged from an additional $3.5 million in year 1 (at uptake of 1%) to $16.8 million in year 5. The 5-year budget impact was estimated at about $52 million.People with major depression and caregivers generally supported multi-gene pharmacogenomic testing because they believed it could provide guidance that fit their values. They hoped such guidance would speed symptom relief, would reduce side effects and help inform their medication choices. Some patients expressed concerns over maintaining confidentiality of test results and the possibility that physicians would sacrifice patient-centred care to follow pharmacogenomic guidance. Multi-gene pharmacogenomic testing that includes decision-support tools to guide medication selection for depression varies widely. Differences between individual tests must be considered, as clinical utility observed with one test might not apply to other tests. Overall, effectiveness was inconsistent among the six multi-gene pharmacogenomic tests we identified. Multi-gene pharmacogenomic tests may result in little or no difference in improvement in depression scores compared with treatment as usual, but some tests may improve response to treatment or remission from depression. The impact on adverse events is uncertain. The evidence, however, is uncertain, and therefore our confidence that these observed effects reflect the true effects is low to very low.For the management of major depression in people who had inadequate response to at least one medication, some multi-gene pharmacogenomic tests that include decision support tools are associated with additional costs and QALYs over the 1-year time horizon, and maybe be cost-effective at the willingness-to-pay amount of $100,000 per QALY. Publicly funding multi-gene pharmacogenomic testing in Ontario would result in additional annual costs of between $3.5 million and $16.8 million, with a total budget impact of about $52 million over the next 5 years.People with major depression and caregivers generally supported multi-gene pharmacogenomic testing because they believed it could provide guidance that fit their values. They hoped such guidance would speed symptom relief, would reduce side and help inform their medication choices. Some patients expressed concerns over maintaining confidentiality of test results and the possibility that physicians would sacrifice patient-centred care to follow pharmacogenomic guidance.

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Supplemental Screening as an Adjunct to Mammography for Breast Cancer Screening in People With Dense Breasts: A Health Technology Assessment.

Screening with mammography aims to detect breast cancer before clinical symptoms appear. Among people with dense breasts, some cancers may be missed using mammography alone. The addition of supplemental imaging as an adjunct to screening mammography has been suggested to detect breast cancers missed on mammography, potentially reducing the number of deaths associated with the disease. We conducted a health technology assessment of supplemental screening with contrast-enhanced mammography, ultrasound, digital breast tomosynthesis (DBT), or magnetic resonance imaging (MRI) as an adjunct to mammography for people with dense breasts, which included an evaluation of effectiveness, harms, cost-effectiveness, the budget impact of publicly funding supplemental screening, the preferences and values of patients and health care providers, and ethical issues. We performed a systematic literature search of the clinical evidence published from January 2015 to October 2021. We assessed the risk of bias of each included study using the Cochrane Risk of Bias or RoBANS tools, 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 review and conducted cost-effectiveness analyses with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding supplemental screening as an adjunct to mammography for people with dense breasts in Ontario. To contextualize the potential value of supplemental screening for dense breasts, we spoke with people with dense breasts who had undergone supplemental screening; performed a rapid review of the qualitative literature; and conducted an ethical analysis of supplemental screening as an adjunct to mammography. We included eight primary studies in the clinical evidence review. No studies evaluated contrast-enhanced mammography. Nonrandomized and randomized evidence (GRADE: Very low to Moderate) suggests that mammography plus ultrasound was more sensitive and less specific, and detected more cancers compared to mammography alone. Fewer interval cancers occurred after mammography plus ultrasound (GRADE: Very low to Low), but recall rates were nearly double that of mammography alone (GRADE: Very low to Moderate). Evidence of Low to Very low quality suggested that compared with supplemental DBT, supplemental ultrasound was more sensitive, detected more cancers, and led to more recalls. Among people with extremely dense breasts, fewer interval cancers occurred after mammography plus supplemental MRI compared to mammography alone (GRADE: High). Supplemental MRI after negative mammography was highly accurate in people with extremely dense breasts and heterogeneously dense breasts in nonrandomized and randomized studies (GRADE: Very Low and Moderate). In people with extremely dense breasts, MRI after negative mammography detected 16.5 cancers per 1,000 screens (GRADE: Moderate), and up to 9.5% of all people screened were recalled (GRADE: Moderate). Contrast-related adverse events were infrequent (GRADE: Moderate). No study reported psychological impacts, breast cancer-specific mortality, or overall mortality.We included nine studies in the economic evidence, but none of the study findings was directly applicable to the Ontario context. Our lifetime cost-effectiveness analyses showed that supplemental screening with ultrasound, MRI, or DBT found more screen-detected cancers, decreased the number of interval cancers, had small gains in life-years or quality-adjusted life-years (QALYs), and was associated with savings in cancer management costs. However, supplemental screening also increased imaging costs and the number of false-positive cases. Compared to mammography alone, the incremental cost-effectiveness ratios (ICERs) for supplemental screening with handheld ultrasound, MRI, or DBT for people with dense breasts were $119,943, $314,170, and $212,707 per QALY gained, respectively. The ICERs for people with extremely dense breasts were $83,529, $101,813, and $142,730 per QALY gained, respectively. In sensitivity analyses, the diagnostic test sensitivity of mammography alone and of mammography plus supplemental screening had the greatest effect on ICER estimates. The total budget impact of publicly funding supplemental screening with handheld ultrasound, MRI, or DBT for people with dense breasts over the next 5 years is estimated at $15 million, $41 million, or $33 million, respectively. The corresponding total budget impact for people with extremely dense breasts is $4 million, $10 million, or $9 million.We engaged directly with 70 people via interviews and an online survey. The participants provided diverse perspectives on broad access to supplemental screening for people with dense breasts in Ontario. Themes discussed in the interviews included self-advocacy, patient-doctor partnership, preventive care, and a shared preference for broad access to screening modalities that are clinically effective in detecting breast cancer in people with dense breasts.We included 10 studies in the qualitative evidence rapid review. Thematic synthesis of these reports yielded three analytical themes: coming to know and understand breast density, which included introductions to and making sense of breast density; experiences of vulnerability, which influenced or were influenced by understandings and misunderstandings of breast density and responses to breast density; and choosing supplemental screening, which was influenced by knowledge and perception of the risks and benefits of supplemental screening, and the availability of resources.The ethics review determined that the main harms of supplemental screening for people with dense breasts are false-positives and overdiagnosis, both of which lead to unnecessary and burdensome health care treatments. Screening programs raise inherent tensions between individual- and population-level interests; they may yield population-level benefit, but are statistically of very little benefit to individuals. Entrenched cultural beliefs about the value of breast cancer screening, combined with uncertainty about the effects of supplemental screening on some outcomes and the discomfort of many health care providers in discussing screening options for people with dense breasts suggest that it may be difficult to ensure that patients can provide informed consent to engage in supplemental screening. Funding supplemental screening for people with dense breasts may lead to improved equity in the effectiveness of identifying cancers in people with dense breasts (compared to mammography alone), but it is not clear whether it would lead to equity in terms of improved survival and decreased morbidity. Supplemental screening with ultrasound, DBT, or MRI as an adjunct to mammography detected more cancers and increased the number of recalls and biopsies, including false-positive results. Fewer interval cancers tended to occur after supplemental screening compared to mammography alone. It is unclear whether supplemental screening as an adjunct to mammography would reduce breast cancer-related or overall mortality among people with dense breasts.Supplemental screening with ultrasound, DBT, or MRI as an adjunct to mammography in people aged 50 to 74 years improved cancer detection but increased costs. Depending on the type of imaging modality, publicly funding supplemental screening in Ontario over the next 5 years would require additional total costs between $15 million and $41 million for people with dense breasts, and between $4 million and $10 million for people with extremely dense breasts.The people we engaged with directly valued the potential clinical benefits of supplemental screening and emphasized that patient education and equitable access should be a requirement for implementation in Ontario. Our review of the qualitative literature found that the concept of breast density is poorly understood, both by people with dense breasts and by some general practitioners. People with dense breasts who receive routine mammography (especially those who receive health care in their nonpreferred language or are perceived to have lower economic status or health literacy) and their general practitioners may not have the awareness or knowledge to make informed decisions about supplemental screening. Some people with dense breasts experienced emotional distress from barriers to accessing supplemental screening, and many wanted to engage in supplemental screening, even when educated about its potential harms, including false-positives and overdiagnosis.Given an overall lack of robust evidence about morbidity and mortality associated with supplemental screening for people with dense breasts, it is not possible to determine whether funding supplemental screening for dense breasts delivers on the ethical duties to maximize benefits and minimize harms for populations and individuals. It is likely that existing inequities in access to breast screening and cancer treatment will persist, even if supplemental screening for dense breasts is funded. Continued efforts to address these inequities by removing barriers to screening might mitigate this concern. It will be important to identify and minimize sources of uncertainty related to benefits and risks of supplemental screening for dense breasts to optimize the capacity for everyone involved to live up to their ethical obligations. Some of these may be resolved with further evidence related to the outcomes of supplemental screening for dense breasts.

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Nonthermal Endovenous Procedures for Varicose Veins: A Health Technology Assessment.

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). We conducted a health technology assessment of these nonthermal endovenous procedures for people with symptomatic varicose veins, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding MOCA and CAC, 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 or RoBANS tool, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Meta-analysis was conducted using Review Manager 5.2, where appropriate.We performed a systematic economic literature search and conducted a cost-utility analysis with a 5-year time horizon from the perspective of Ontario Ministry of Health. In our primary economic evaluation, we assessed the cost-effectiveness of nonthermal endovenous procedures (CAC and MOCA) compared with surgical vein stripping and thermal endovenous therapies (EVLA and RFA). We also analyzed the budget impact of publicly funding nonthermal and thermal endovenous therapies for adults with symptomatic varicose veins in Ontario over the next 5 years. Costs are expressed in 2020 Canadian dollars.To contextualize the potential value of nonthermal endovenous treatments, we spoke with 13 people with varicose veins who had sought various treatment options. We conducted phone interviews and qualitatively analyzed their responses regarding their care journey and the impact of different treatment options; the only nonthermal treatment that participants had experience with was CAC. We included 19 primary studies reported in 25 publications comparing either MOCA or CAC with at least one other invasive treatment for symptomatic varicose veins. No studies compared MOCA with CAC. Based on evidence of low to moderate quality, MOCA resulted in slightly poorer technical outcomes (vein closure and recanalization) than thermal endovenous ablation procedures. However, clinical outcomes, quality of life improvement, and patient satisfaction were similar compared with RFA (GRADE: Very low to Moderate) and EVLA (GRADE: High). Cyanoacrylate adhesive closure resulted in little to no difference in technical outcomes, clinical outcomes, and quality of life improvement compared with RFA and EVLA (GRADE: Moderate). Patient satisfaction may also be similar (GRADE: Low). Recovery time was slightly reduced with nonthermal endovenous procedures compared with thermal ablation (GRADE: Moderate). The effect of CAC compared with surgical vein stripping is very uncertain (GRADE: Very low). Major complications of any procedure were rare, with minor complications occurring as expected and resolving.We included two European studies in the economic evidence review that were partially applicable to the Ontario context. Both studies found that thermal ablation procedures (RFA, EVLA, or steam vein sclerosis) were the most cost-effective treatments, compared with surgical vein stripping and nonthermal therapies. Our cost-utility analysis showed that surgical vein stripping is the least effective and most costly treatment among five treatments for varicose veins. Differences in quality-adjusted life-years (QALYs) between endovenous treatments (CAC, MOCA, RFA, and EVLA) were small. When the willingness-to-pay (WTP) value was $50,000 per QALY gained, the probabilities of being cost-effective were 55.6%, 18.8%, 15.6%, 10.0%, and 0%, for EVLA, CAC, MOCA, RFA, and surgical vein stripping, respectively. When the WTP was $100,000 per QALY gained, the probabilities of being cost-effective were 40.2%, 30.0%, 17.7%, 12.1%, and 0%, for EVLA, CAC, RFA, MOCA, and surgical vein stripping, respectively. Publicly funding endovenous procedures (both nonthermal and thermal) would increase the total volume of treatments, resulting in a total 5-year budget impact of around $17 million.People with varicose veins with whom we spoke reported positively on their experiences with the CAC procedure and its outcomes. They also described geographic and financial barriers to accessing the range of available treatment options. Cyanoacrylate adhesive closure and MOCA produced similar patient-important outcomes, and slightly shorter recovery compared with thermal ablation. Cyanoacrylate adhesive closure yielded similar anatomical outcomes as thermal endovenous ablation, but the technical outcomes of MOCA were slightly poorer.Compared with surgical vein stripping, all endovenous treatments were more effective and less expensive. If we were to look at the most cost-effective strategy (at WTP less than $100,000 per QALY), EVLA is most likely to be cost-effective. Assuming an 80% increase in the number of eligible people over the next 5 years, we estimate that publicly funding nonthermal and thermal endovenous treatments for varicose veins in Ontario would range from $2.59 million in year 1 to $4.35 million in year 5, and that the total 5-year budget impact would be around $17 million.For people with varicose veins, the CAC procedure was seen as a positive treatment method that reduced their symptoms and improved their quality of life.

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Internet-Delivered Cognitive Behavioural Therapy for Post-traumatic Stress Disorder or Acute Stress Disorder: A Health Technology Assessment.

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. We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of systematic reviews using ROBIS and of randomized controlled trials (RCTs) using the Cochrane Risk of Bias Tool, 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 to summarize the economic evidence on the cost-effectiveness of iCBT for adults with PTSD or ASD. We did not conduct a primary economic evaluation on iCBT for adults with PTSD, as an existing cost-utility analysis is directly applicable to this research question. We did not conduct a primary economic evaluation on iCBT for adults with ASD, as there is limited clinical evidence on this topic and because evidence on iCBT for PTSD may be generalizable to iCBT for ASD at risk of progressing to PTSD. We analyzed the budget impact of publicly funding iCBT for adults with PTSD or ASD in Ontario over the next 5 years.To contextualize the potential value of iCBT for PTSD, we reviewed relevant literature on patients' preferences and values and spoke with people who have lived experience with PTSD to explore their values, needs, and priorities. We identified no studies on the use of iCBT for prevention of PTSD or studies on the use of iCBT to treat ASD, nor studies that directly compared iCBT with face-to-face CBT for the treatment of PTSD. We included one systematic review of the use of iCBT to treat PTSD (10 RCTs, N = 720). Overall, iCBT is more effective than wait-list (waiting for iCBT) or usual care alone for reducing the severity of PTSD symptoms (standardized mean difference [SMD] = -0.60 [95% CI -0.97 to -0.24]; N = 560, 8 RCTs) (GRADE: Very low). Internet-delivered CBT is not more effective than non-CBT internet-delivered interventions for reducing the severity of PTSD symptoms (SMD = -0.08 [-0.52 to 0.35]; N = 82, 2 RCTs) (GRADE: Very low).We identified one economic evaluation on the cost-effectiveness of iCBT for adults with PTSD. For adults with PTSD, iCBT was found to be dominant (i.e., less costly and more effective) compared with usual care. The model used a Canadian public health care payer perspective, and there were no major limitations to the model structure, time horizon, or source of model inputs. The annual budget impact of publicly funding iCBT in Ontario over the next 5 years ranges from an additional $2.43 million in year 1 to $2.37 million in year 5, for a total additional cost of $16.53 million over the next 5 years. If treatment costs alone are considered, the annual budget impact ranges from an additional $3.37 million in year 1 to $17.84 million in year 5, for a total additional cost of $52.61 million over the next 5 years.Our review of the quantitative literature on patient preferences found that adults with PTSD may experience iCBT as a generally acceptable form of treatment, but there is uncertainty in the evidence due to incomplete follow-up in studies and variability in the nature and extent of the therapist-patient relationship. The 10 people we spoke with had all been diagnosed with PTSD. They reported on its negative impact on their quality of life, including difficulty in managing everyday activities, relationships, and employment. Participants viewed iCBT as beneficial to managing their PTSD symptoms but stressed the importance of combining it with face-to-face CBT. However, wait times for PTSD services are long, and out-of-pocket expenses could be a barrier for people without private insurance. Internet-delivered CBT may reduce the severity of PTSD symptoms compared with wait-list or usual care, but the evidence is very uncertain, and iCBT may have little to no effect on improving PTSD symptoms compared with non-CBT interventions delivered online, but here as well the evidence is very uncertain.For adults with PTSD, iCBT may be cost-effective compared with usual care. We estimate that publicly funding iCBT in Ontario would result in additional costs of between $2.37 million and $2.43 million per year over the next 5 years.People with PTSD seem to generally find iCBT as an acceptable treatment option. People with PTSD with whom we spoke viewed iCBT to be effective and recommended it be combined with in-person psychotherapy.

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