Bernice Tsoi

Safety of tissue expander/implant versus autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients: a systematic review and meta-analysis.

Background: Breast reconstruction after mastectomy for breast cancer should be informed by evidence-based knowledge, such as complication rates. The authors compared the safety of tissue expander/implant reconstruction with that of autologous abdominal tissue reconstruction. Methods: A systematic literature review identified peer-reviewed studies published from January of 2000 to October of 2012 that compared tissue expander/implant against autologous abdominal tissue reconstruction in the MEDLINE, EMBASE, Cochrane Library, PubMed, and ProQuest Dissertations and Theses databases. Two reviewers independently screened all reports and selected the relevant articles using specific inclusion criteria. Data were extracted from the relevant articles using a standardized abstraction form. Results: Fourteen observational studies were identified that included more than 3000 reconstructed breasts. Significant differences were found between these two approaches. The relative risk associated with reconstructive failure favored autologous abdominal tissue (relative risk, 0.14; 95 percent CI, 0.06 to 0.32; I2 = 0 percent). Surgical-site infection was significantly lower in autologous abdominal tissue reconstruction compared with tissue expander/implant (relative risk, 0.37; 95 percent CI, 0.25 to 0.55; I2 = 0 percent), although skin or flap necrosis was higher in autologous abdominal tissue reconstruction compared with tissue expander/implant (relative risk, 2.79; 95 percent CI, 1.87 to 4.17). Studies were of low to moderate quality according to the Newcastle-Ottawa scale. Conclusions: This study suggests that tissue expander/implant reconstruction has a higher risk of reconstructive failure and surgical-site infection compared with autologous abdominal tissue reconstruction. With the lack of long-term safety studies on different approaches to breast reconstruction, additional long-term comparative studies are needed to support evidence-based decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Systematic review on the patient-reported outcomes of tissue-expander/implant vs autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients.

presented at the Canadian Society of Plastic Surge Conference, Calgary, AB, June 2013. Received November 27, 2013; Accepted February 4, 2014 From the Department of Clinical Epidemiology and Bio Thoma, Campbell, O’Reilly, Goeree), the Division of (Thoma) and the Surgical Outcomes Research Centre (T ment of Surgery, McMaster University; and the PATH Re St Joseph’s Healthcare Hamilton (Tsoi, Campbell, O’ Hamilton, Ontario, Canada; and the Second Departm Vascular and Oncologic Surgery, Medical University of W Poland (Ziolkowski). Correspondence address: Bernice Tsoi, BSc, MSc, PhD(can Assessment of Technology in Health (PATH) Research In St West, Suite 2000, Hamilton, ON L8P 1H1, Canada mcmaster.ca a 2014 by the American College of Surgeons Published by Elsevier Inc. COLLECTIVE REVIEW Systematic Review on the Patient-Reported Outcomes of Tissue-Expander/Implant vs Autologous Abdominal Tissue Breast Reconstruction in Postmastectomy Breast Cancer Patients Bernice Tsoi, BSc, MSc, PhD(cand), Natalia I Ziolkowski, BCom, BSc, MD, Achilleas Thoma, MD, MSc, FACS, Kaitryn Campbell, BEd, MLIS, Daria O’Reilly, BSc, MSc, PhD, Ron Goeree, BA, MA Given recent advances in the diagnosis and treatment of breast cancer, its mortality rates have fallen. Consequently, issues relating to the quality of survivorship have become increasingly important. For most women, the threats, fears, and losses associated with the treatment of breast cancer not only concern their health and survival, but further include concerns about body image, sexuality, self-esteem, and social life. Focus in the management of breast cancer has therefore expanded to not only include survival but also restoration of a patient’s quality of life after cancer. In particular, mastectomy may lead to psychosocial problems such as anxiety, depression, poor body image, and impaired sexual function. Evolving surgical techniques have encouraged recommendations proposing that the optimal management of mastectomy patients incorporates consideration of both oncologic principles and esthetic outcomes. Breast reconstruction after mastectomy has become an available option for most women as a means to improve quality of life and well-being. The

Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences

A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.

Incorporating ulipristal acetate in the care of symptomatic uterine fibroids: a Canadian cost-utility analysis of pharmacotherapy management

Objective To present a Canadian economic evaluation on the cost-utility of ulipristal acetate (5 mg orally daily) compared to leuprolide acetate (3.75 mg intramuscular monthly) in the treatment of moderate-to-severe symptoms of uterine fibroids in women eligible for surgery. Methods A probabilistic decision tree was constructed to model the pre-operative pharmacological management of uterine fibroids under the primary perspective of the Ontario public payer. The model parameterized data from clinical trials, observational studies, and public costing databases. The outcome measure was the incremental cost-utility ratio. Uncertainty in the model was explored through sensitivity and scenario analyses. Results Ulipristal was associated with faster control of excessive menstrual bleeding, fewer symptoms of hot flashes and lower health care resource consumption. The ulipristal strategy dominated leuprolide as it provided patients with more quality-adjusted life years (0.177 versus 0.165) at a lower cost (

Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty.

1,273 versus

Do different decision-analytic modeling approaches produce different results? A systematic review of cross-validation studies

1,366). Across a range of sensitivity analyses, the results remained robust except to the dose of the comparator drug. If leuprolide was administered at 11.25 mg, once every 3 months, the expected cost for the leuprolide strategy would decline and the associated incremental cost-utility ratio for ulipristal would be

Comparative Efficacy of Angiotensin II Antagonists in Essential Hypertension: Systematic Review and Network Meta-analysis of Randomised Controlled Trials

168/quality-adjusted life year. Conclusion Ulipristal offers a unique opportunity to effectively and rapidly control menstrual bleeding in patients with uterine fibroids; thereby improving their quality of life while minimizing the probability of moderate-to-severe hot flashes that are common with leuprolide. The current economic analysis suggests that ulipristal remains the dominant strategy across extensive sensitivity analyses.

Safety of Tissue Expander/Implant Versus Autologous Abdominal Tissue Breast Reconstruction in Post-mastectomy Breast Cancer Patients

Background: A previous randomized controlled trial showed no clear superiority of vertical scar over inverted T-shaped reduction mammaplasty in terms of health-related quality of life. No economic evaluation has been undertaken comparing vertical scar reduction and inverted T -shaped reduction. Methods: A total of 255 patients were randomized to either vertical scar or inverted T -shaped reduction. The effectiveness was measured with the Health Utilities Index Mark 3. Direct and productivity costs were captured parallel to the randomized controlled trial. Perspectives of the Ministry of Health, patient, and society were considered. Results: Inverted T -shaped reduction dominated vertical scar reduction from the Ministry of Health perspective by being slightly less costly (

Systematic narrative review of decision frameworks to select the appropriate modelling approaches for health economic evaluations

3090.06 versus

Cardiovascular and cerebrovascular outcomes of long-term angiotensin receptor blockade: meta-analyses of trials in essential hypertension

3106.58) and slightly more effective (0.87 quality-adjusted life-years versus 0.86 quality-adjusted life-years). From the societal and patient perspectives, vertical scar reduction was both less costly and less effective. At the commonly quoted Canadian threshold of