Chris Cameron

The quality of reporting methods and results of cost-effectiveness analyses in Spain: a methodological systematic review

BackgroundCost-effectiveness analysis has been recognized as an important tool to determine the efficiency of healthcare interventions and services. There is a need for evaluating the reporting of methods and results of cost-effectiveness analyses and establishing their validity. We describe and examine reporting characteristics of methods and results of cost-effectiveness analyses conducted in Spain during more than two decades.MethodsA methodological systematic review was conducted with the information obtained through an updated literature review in PubMed and complementary databases (e.g. Scopus, ISI Web of Science, National Health Service Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases from Centre for Reviews and Dissemination (CRD), Índice Médico Español (IME) Índice Bibliográfico Español en Ciencias de la Salud (IBECS)). We identified cost-effectiveness analyses conducted in Spain that used quality-adjusted life yearsxa0(QALYs) as outcome measures (period 1989–December 2014). Two reviewers independently extracted the data from each paper. The data were analysed descriptively.ResultsIn total, 223 studies were included. Very few studies (10; 4.5xa0%) reported working from a protocol. Most studies (200; 89.7xa0%) were simulation models and included a median of 1000 patients. Only 105 (47.1xa0%) studies presented an adequate description of the characteristics of the target population. Most study interventions were categorized as therapeutic (189; 84.8xa0%) and nearly half (111; 49.8xa0%) considered an active alternative as the comparator. Effectiveness of data was derived from a single study in 87 (39.0xa0%) reports, and only few (40; 17.9xa0%) used evidence synthesis-based estimates. Few studies (42; 18.8xa0%) reported a full description of methods for QALY calculation. The majority of the studies (147; 65.9xa0%) reported that the study intervention produced “more costs and more QALYs” than the comparator. Most studies (200; 89.7xa0%) reported favourable conclusions. Main funding source was the private for-profit sector (135; 60.5xa0%). Conflicts of interest were not disclosed in 88 (39.5xa0%) studies.ConclusionsThis methodological review reflects that reporting of several important aspects of methods and results are frequently missing in published cost-effectiveness analyses. Without full and transparent reporting of how studies were designed and conducted, it is difficult to assess the validity of study findings and conclusions.

Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer

PurposeTo compare palbociclibxa0+xa0letrozole and palbociclibxa0+xa0fulvestrant with chemotherapy agents in postmenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (ABC/MBC) who had no prior systemic treatment for advanced disease (first line) or whose disease progressed after prior endocrine therapy or chemotherapy (second line).MethodsA systematic search identified randomized controlled trials (RCTs) published from January 2000 to January 2016 that compared endocrine-based therapies, chemotherapy agents, and/or chemotherapy agentsxa0+xa0biological therapies in the first- and second-line treatment of postmenopausal women with HR+/HER2− ABC/MBC. The main outcome of interest was progression-free survival (PFS)/time to progression (TTP). Bayesian network meta-analyses (NMAs) and pairwise meta-analyses were conducted. Heterogeneity and inconsistency were assessed.ResultsSixty RCTs met eligibility criteria and were stratified by line of therapy. In the first line, palbociclibxa0+xa0letrozole showed statistically significant improvements in PFS/TTP versus capecitabine [intermittent: HR 0.28 (95% CrI 0.11–0.72)] and mitoxantrone [HR 0.28 (0.13–0.61)], and trended toward improvements versus paclitaxel [HR 0.59 (0.19–1.96)], docetaxel [HR 0.51 (0.14–2.03)] and other monotherapy or combination agents (HRs ranging from 0.24 to 0.99). In the second line, palbociclibxa0+xa0fulvestrant showed statistically significant improvements in PFS/TTP versus capecitabine [intermittent: HR 0.28 (0.13–0.65)], mitoxantrone [HR 0.26 (0.12–0.53)], and pegylated liposomal doxorubicin [HR 0.19 (0.07–0.50)], and trended toward improvements versus paclitaxel [HR 0.48 (0.16–1.44)], docetaxel [HR 0.71 (0.24–2.13)] and other monotherapy or combination agents (HRs ranging from 0.23–0.89). NMA findings aligned with direct evidence and were robust to sensitivity analyses.ConclusionsPalbociclibxa0+xa0letrozole and palbociclibxa0+xa0fulvestrant demonstrate trends in incremental efficacy compared with chemotherapy agents for the first- and second-line treatment of HRxa0+/HER2− ABC/MBC.

Transient elastography for the diagnosis of liver fibrosis: a systematic review of economic evaluations

Liver biopsy remains the gold standard for the diagnosis of liver fibrosis, but its use as a diagnostic tool is limited by its invasive nature and high cost.

Hospital costs associated with thyroidectomy performed with a Harmonic device compared to conventional techniques: a systematic review and meta-analysis.

Abstract Objectives: Harmonic devices have become a world-wide standard for dissection and hemostasis in thyroidectomy. Numerous systematic reviews have reported superior operating times, blood loss, post-operative pain, length of stay, and overall safety outcomes. What has not been extensively evaluated in a robust manner is their economic impact. The purpose of this study is to evaluate the hospital costs associated with open thyroidectomy using Harmonic devices compared with conventional techniques for hemostasis. Methods: A systematic review of Medline, Scopus, and CENTRAL was performed from January 1, 2000 to May 23, 2014 without language restrictions for randomized clinical trials comparing Harmonic surgical devices to conventional methods in thyroidectomy. The main outcome measure was total reported costs. Costs were pooled using the ratio of means and a random effects model. Sensitivity analyses assessed whether differences in patient and trial characteristics, healthcare setting, or choice of statistical model affected outcomes. Results: Seven studies met the inclusion criteria. A total of 476 participants had procedures performed with Harmonic devices and 478 with conventional monopolar electrosurgery and clamp, cut and tie techniques. Compared with conventional techniques, Harmonic devices reduced total reported costs by 10% (pu2009=u20090.007), resulting in a

Comparison of physical interventions, behavioral interventions, natural health products, and pharmacologics to manage hot flashes in patients with breast or prostate cancer: protocol for a systematic review incorporating network meta-analyses

229u2009US dollars (USD) absolute reduction from mean baseline costs. Results remained relatively robust to additional sensitivity analyses. Conclusions: This systematic review and meta-analysis demonstrates that the Harmonic family of surgical devices is associated with a reduction in total reported costs in thyroidectomy compared with conventional techniques. A large portion of the overall savings derives from a reduction in operative costs.

Effectiveness and Value of Treatment Options for Obesity—A Report for the California Technology Assessment Forum

BackgroundBreast and prostate cancers are the most commonly diagnosed non-dermatologic malignancies in Canada. Agents including endocrine therapies (e.g., aromatase inhibitors, gonadotrophin-releasing hormone analogs, anti-androgens, tamoxifen) and chemotherapy have improved survival for both conditions. As endocrine manipulation is a mainstay of treatment, it is not surprising that hot flashes are a common and troublesome adverse effect. Hot flashes can cause chills, night sweats, anxiety, and insomnia, lessening patients’ quality of life. These symptoms impact treatment adherence, worsening prognosis. While short-term estrogen replacement therapy is frequently used to manage hot flashes in healthy menopausal women, its use is contraindicated in breast cancer. Similarly, testosterone replacement therapy is contraindicated in prostate cancer. It is therefore not surprising that non-hormonal pharmacological treatments (anti-depressants, anti-epilectics, anti-hypertensives), physical/behavioral treatments (e.g., acupuncture, yoga/exercise, relaxation techniques, cognitive behavioral therapy), and natural health products (e.g., black cohosh, flax, vitamin E, ginseng) have been studied for control of hot flashes. There is a need to identify which interventions minimize the frequency and severity of hot flashes and their impact on quality of life. This systematic review and network meta-analysis of randomized studies will synthesize available evidence addressing this knowledge gap.Methods/designAn electronic search of Medline, Embase, AMED, PsycINFO, and the Cochrane Register of Controlled Trials has been designed by an information specialist and peer reviewed by a second information specialist. Study selection and data collection will be performed by two reviewers independently. Risk of bias assessments will be completed using the Cochrane Risk of Bias Scale. Outcomes of interest will include validated measures of hot flash severity, hot flash frequency, quality of life, and harms. Bayesian network meta-analyses will be performed where judged appropriate based on review of clinical and methodologic features of included studies.DiscussionOur review will include a broad range of interventions that patients with breast and prostate cancer have attempted to use to manage hot flashes. Our work will establish the extent of evidence underlying these interventions and will employ an inclusive approach to analysis to inform comparisons between them. Our findings will be shared with Cancer Care Ontario for consideration in the development of guidance related to supportive care in these patients.Systematic review registrationPROSPERO: CRD42015024286

A systematic review and meta-analysis of Harmonic technology compared with conventional techniques in mastectomy and breast-conserving surgery with lymphadenectomy for breast cancer.

Source of Review The Institute for Clinical and Economic Review developed an evidence report, including a systematic review of the literature, a cost-effectivenessmodel, anda budgetary impact analysis, to support a publicmeeting of the California Technology Assessment Forum (CTAF) on July 14, 2015.1 The focus was on the comparative clinical effectiveness and comparative value of surgical procedures, devices, and new medications vs conventional weight-lossmanagement (eg, lifestyle and dietarymodification, older medications).

Evaluating the Importance of Heterogeneity of Treatment Effect: Variation in Patient Utilities Can Influence Choice of the “Optimal” Oral Anticoagulant for Atrial Fibrillation

Background Mastectomy and breast-conserving surgery (BCS) are important treatment options for breast cancer patients. A previous meta-analysis demonstrated that the risk of certain complications can be reduced with the Harmonic technology compared with conventional methods in mastectomy. However, the meta-analysis did not include studies of BCS patients and focused on a subset of surgical complications. The objective of this study was to compare Harmonic technology and conventional techniques for a range of clinical outcomes and complications in both mastectomy and BCS patients, including axillary lymph node dissection. Methods A comprehensive literature search was performed for randomized controlled trials comparing Harmonic technology and conventional methods in breast cancer surgery. Outcome measures included blood loss, drainage volume, total complications, seroma, necrosis, wound infections, ecchymosis, hematoma, hospital length of stay, and operating time. Risk of bias was analyzed for all studies. Meta-analysis was performed using random-effects models for mean differences of continuous variables and a fixed-effects model for risk ratios of dichotomous variables. Results Twelve studies met the inclusion criteria. Across surgery types, compared to conventional techniques, Harmonic technology reduced total complications by 52% (P=0.002), seroma by 46% (P<0.0001), necrosis by 49% (P=0.04), postoperative chest wall drainage by 46% (P=0.0005), blood loss by 38% (P=0.0005), and length of stay by 22% (P=0.007). Although benefits generally appeared greatest in mastectomy patients with lymph node dissection, Harmonic technology showed significant reductions in complications in the BCS study subgroup. Conclusion In this meta-analysis of both mastectomy and BCS procedures, the use of Harmonic technology reduced the risk of most complications by about half across breast cancer surgery patients. These benefits may be due to superior hemostatic capabilities of Harmonic technology and better dissection, particularly lymph node dissection. Reduction in complications and other resource outcomes may engender lower downstream health care costs.

Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison

OBJECTIVESnTo investigate heterogeneity of treatment effect (HTE) for anticoagulants in atrial fibrillation across subgroups defined by 1) clinical characteristics and 2) variation in patient utilities for benefits and harms of treatment.nnnMETHODSnWe reanalyzed aggregate data from a published network meta-analysis that compared four anticoagulants for atrial fibrillation (apixaban, dabigatran, edoxaban, and rivaroxaban) as well as warfarin. Event rates for stroke/systemic embolism (SE) and major bleeding were generated for each agent across seven subgroups, and rankings were developed on the basis of clinical performance. Utilities were derived from a national catalog and then applied to generate summary measures of benefit. The choice between any two agents was examined across a range of plausible utility values, defined as the interquartile range for stroke/SE and major bleeding.nnnRESULTSnLittle HTE was apparent in clinical and utility-adjusted analyses. Dabigatran 150 mg produced the lowest rates of stroke/SE, and edoxaban 30 mg had the lowest rate of major bleeding. Greater HTE was observed when utilities were varied across a plausible utility range. For example, among patients 75 years and older, dabigatran 150 mg would be preferred over edoxaban 30 mg when mean utility estimates are used. The preferred agent, however, would change at plausible utility thresholds of 0.6 and 0.7 for major bleeding and stroke/SE, respectively. Nearly 25% of all possible comparisons would see a change in preferred treatment within the plausible utility range.nnnCONCLUSIONSnThe optimal choice of anticoagulant in atrial fibrillation differs across subgroups defined by clinical characteristics and reasonable ranges of utilities.

Performance of Harmonic devices in surgical oncology: an umbrella review of the evidence

BACKGROUNDnAripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. There are no direct-comparison studies with paliperidone palmitate (PP; long-acting antipsychotic used most often in acute settings) for the acute psychotic episode.nnnOBJECTIVESnTo indirectly compare efficacy and safety of the pivotal AL study with all PP studies meeting indirect comparison criteria.nnnMETHODSnSystematic searches of MEDLINE, Embase, Cochrane CENTRAL, PsycINFO, ClinicalTrials.gov, International Clinical Trials Registry Platform, and gray literature were performed to identify randomized controlled trials of PP with similar designs to the AL trial. Bayesian network meta-analysis compared treatments with respect to symptom response and tolerability issues including weight gain, akathisia, parkinsonism, and likelihood of treatment-emergent adverse events.nnnRESULTSnThree appropriate PP studies were identified for indirect comparison. Both doses of AL (441 mg and 882 mg monthly) were used and compared with two efficacious doses of PP (156 mg and 234 mg monthly). All four active-treatment conditions were associated with comparable reductions in acute symptoms (Positive and Negative Syndrome Scale) versus placebo and were of similar magnitude (range of mean difference -8.12 to -12.01, with overlapping 95% credible intervals). Between-group comparisons of active-treatment arms were associated with summary estimates of magnitude near 0. No clinically meaningful differences in selected safety or tolerability parameter incidence were found between active treatments.nnnCONCLUSIONSnThese results suggest that both AL and PP are effective for treatment of adults experiencing acute exacerbation of schizophrenia.