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1.  Early economic evaluation of emerging health technologies: protocol of a systematic review 
Systematic Reviews  2014;3:81.
Background
The concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice.
Methods/design
This protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. Abstracted data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to identify, measure, and value the likely effectiveness and the costs and consequences of the new technology, handling of uncertainty), and whether the study results adequately address the main study question or objective. Data will be summarized overall and stratified by publication status.
Discussion
This study is timely to inform early economic evaluation practice, given the international trend in early health technology assessment initiatives.
doi:10.1186/2046-4053-3-81
PMCID: PMC4114797  PMID: 25055987
2.  Overcoming Obstacles in Accessing Unfunded Oral Chemotherapy: Physician Experience and Challenges 
Journal of Oncology Practice  2013;9(4):188-193.
The authors claim Canadian physicians use numerous methods to obtain unfunded oral chemotherapies, including falsifying claims on access forms and submitting special requests to government agencies.
Purpose:
Previous studies have shown hematologists and medical oncologists may not accept the financial limits set by governing agencies on patient access to oral chemotherapy. The purpose of this study was to capture the methods physicians used to overcome barriers to accessing chemotherapeutic regimens for their patients.
Methods:
A total of 640 medical oncologists and hematologists across Canada were surveyed using a 13-item Web-based survey tool. The survey was delivered by e-mail with three follow-up reminders. After a response period of 3 months, results were collated and analyzed with descriptive statistics.
Results:
Of the 640 invitations, 568 were successfully delivered, and 183 responses were received (response rate, 32.0%). Among respondents, 101 treated solid malignancies (55.2%), 49 treated nonsolid malignancies (26.8%), and 33 treated both (18.0%). To overcome funding barriers, participating oncologists enrolled patients onto clinical trials (90.5%), used compassionate access programs (96.1%), and made special requests to government (91.8%). Other methods included writing false claims on forms to fit funding criteria for drugs (31.1%) and using leftover drug supplies (31.0%). Physicians felt their inability to obtain unfunded medications had a negative impact on their patients' clinical outcomes (56.0%) and psychosocial quality of life (73.0%). Only 28.5% of physicians contacted their governing body with concerns about oral chemotherapy funding.
Conclusion:
Canadian physicians use numerous methods to obtain unfunded oral chemotherapies, including falsifying claims on access forms and submitting special requests to government agencies. Further study is warranted to explore the disconnection between policymakers and physicians with regard to funding of oral chemotherapies.
doi:10.1200/JOP.2012.000680
PMCID: PMC3710167  PMID: 23942919
3.  Impact of New Chemotherapeutic and Targeted Agents on Survival in Stage IV Non-Small Cell Lung Cancer 
The Oncologist  2011;16(9):1307-1315.
This retrospective study investigated whether overall survival has improved in the general population with metastatic non-small cell lung cancer over the last decade, and examined the uptake and impact of new chemotherapeutic and targeted agents introduced during this time.
Purpose.
Significant advances in the systemic management of metastatic non-small cell lung cancer (NSCLC) have occurred over the past decade, with options now including multiple lines of chemotherapy, epidermal growth factor receptor inhibitors, and antiangiogenic agents. Improvements in overall survival have been demonstrated in randomized controlled trials comparing these newer agents with best supportive care or standard therapy. This study examined uptake of these therapies in general practice and their impact on survival.
Methods.
This retrospective cohort study compared demographic, treatment, and survival data among 987 patients diagnosed with stage IV NSCLC at two institutions in 1998, 2003, and 2008. Cohorts were selected based on intervals when doublet chemotherapy, second-line chemotherapy, and targeted agents were incorporated into the standard treatment regimen.
Results.
The proportion of patients receiving systemic therapy increased over time (20% in 1998, 42% in 2008). Overall survival improved significantly across cohorts (p < .001), with 2-year survival rates of 0.3% in 1998, 4% in 2003, and 15% in 2008. In a multivariate survival analysis, the 2003 and 2008 cohorts were independently associated with longer survival, as was the use of one or more lines of systemic therapy. Elderly patients (aged ≥70 years) were also more likely to receive systemic therapy over time, with longer overall survival (p < .001).
Conclusion.
Over the past decade, there has been an increasing use of systemic therapy in stage IV NSCLC patients, including the elderly. This has been associated with significantly longer overall survival.
doi:10.1634/theoncologist.2011-0079
PMCID: PMC3228167  PMID: 21835896
Non-small cell lung cancer; Metastatic; Stage IV; Survival; Systemic therapy
4.  Perceived barriers to guideline adherence: A survey among general practitioners 
BMC Family Practice  2011;12:98.
Background
Despite considerable efforts to promote and support guideline use, adherence is often suboptimal. Barriers to adherence vary not only across guidelines but also across recommendations within guidelines. The aim of this study was to assess the perceived barriers to guideline adherence among GPs by focusing on key recommendations within guidelines.
Methods
We conducted a cross-sectional electronic survey among 703 GPs in the Netherlands. Sixteen key recommendations were derived from four national guidelines. Six statements were included to address the attitudes towards guidelines in general. In addition, GPs were asked to rate their perceived adherence (one statement) and the perceived barriers (fourteen statements) for each of the key recommendations, based on an existing framework.
Results
264 GPs (38%) completed the questionnaire. Although 35% of the GPs reported difficulties in changing routines and habits to follow guidelines, 89% believed that following guidelines leads to improved patient care. Perceived adherence varied between 52 and 95% across recommendations (mean: 77%). The most perceived barriers were related to external factors, in particular patient ability and behaviour (mean: 30%) and patient preferences (mean: 23%). Lack of applicability of recommendations in general (mean: 22%) and more specifically to individual patients (mean: 25%) were also frequently perceived as barriers. The scores on perceived barriers differed largely between recommendations [minimum range 14%; maximum range 67%].
Conclusions
Dutch GPs have a positive attitude towards the NHG guidelines, report high adherence rates and low levels of perceived barriers. However, the perceived adherence and perceived barriers varied largely across recommendations. The most perceived barriers across recommendations are patient related, suggesting that current guidelines do not always adequately incorporate patient preferences, needs and abilities. It may be useful to provide tools such as decision aids, supporting the flexible use of guidelines to individual patients in practice.
doi:10.1186/1471-2296-12-98
PMCID: PMC3197492  PMID: 21939542

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