Challenges in knowledge translation: the early years of Cancer Care Ontario's Program in Evidence-Based Care.

BACKGROUND: Cancer Care Ontario's Program in Evidence-Based Care (pebc) was formalized in 1997 to produce clinical practice guidelines for cancer management for the Province of Ontario. At the time, the gap between guideline development and implementation was beginning to be acknowledged. The Program implemented strategies to promote use of guidelines. METHODS: The program had to overcome numerous social challenges to survive. Prospective strategies useful to practitioners-including participation, transparent communication, a methodological vision, and methodology skills development offerings-were used to create a culture of research-informed oncology practice within a broad community of practitioners.Reactive strategies ensured the survival of the program in the early years, when some within the influential academic community and among decision-makers were skeptical about the feasibility of a rigorous methodologic approach meeting the fast turnaround times necessary for policy. RESULTS: The paper details the pebc strategies within the context of what was known about knowledge translation (kt) at the time, and it tries to identify key success factors. CONCLUSIONS: Many of the barriers faced in the implementation of kt-and the strategies for overcoming them-are unavailable in the public domain because the relevant reporting does not fit the traditional paradigm for publication. Telling the "stories behind the story" should be encouraged to enhance the practice of kt beyond the science.

Guideline adaptation: an approach to enhance efficiency in guideline development and improve utilisation.

BACKGROUND: Developing and updating high-quality guidelines requires substantial time and resources. To reduce duplication of effort and enhance efficiency, we developed a process for guideline adaptation and assessed initial perceptions of its feasibility and usefulness. METHODS: Based on preliminary developments and empirical studies, a series of meetings with guideline experts were organised to define a process for guideline adaptation (ADAPTE) and to develop a manual and a toolkit made available on a website (http://www.adapte.org). Potential users, guideline developers and implementers, were invited to register and to complete a questionnaire evaluating their perception about the proposed process. RESULTS: The ADAPTE process consists of three phases (set-up, adaptation, finalisation), 9 modules and 24 steps. The adaptation phase involves identifying specific clinical questions, searching for, retrieving and assessing available guidelines, and preparing the draft adapted guideline. Among 330 registered individuals (46 countries), 144 completed the questionnaire. A majority found the ADAPTE process clear (78%), comprehensive (69%) and feasible (60%), and the manual useful (79%). However, 21% found the ADAPTE process complex. 44% feared that they will not find appropriate and high-quality source guidelines. DISCUSSION: A comprehensive framework for guideline adaptation has been developed to meet the challenges of timely guideline development and implementation. The ADAPTE process generated important interest among guideline developers and implementers. The majority perceived the ADAPTE process to be feasible, useful and leading to improved methodological rigour and guideline quality. However, some de novo development might be needed if no high quality guideline exists for a given topic.

A controlled "before-after" study: impact of a clinical guidelines programme and regional cancer network organization on medical practice.

A regional cancer network has been set up in the Rhône-Alpes region in France. The aim of the project is to improve the quality of care and to rationalize prescriptions in the network. In this network, we assessed the impact of the implementation of a clinical practice guidelines project by assessing the conformity of practice with the guidelines and comparing this with the conformity in an external matched control group from another French region without a regional cancer network. Four hospitals (private and public) accepted to assess the impact of the clinical practice guidelines on the management of breast and colon cancer in the experimental group and three hospitals (private and public) in the control group. In 1994 and 1996, women with non-metastatic breast cancer (282 and 346 patients in the experimental group, 194 and 172 patients in the control group, respectively) and all new patients with colon cancer (95 and 94 patients in the experimental group, and 89 and 118 patients in the control group, respectively) were selected. A controlled "before-after" study, using institutional medical records of patients with breast and colon cancer. The medical decisions concerning the patients were analyzed to assess their compliance with the clinical practice guidelines. When medical decisions were judged to be non-compliant, we verified if they were based on scientific evidence in a published article, if they were not, the medical decision was classified as having "no convincing supporting scientific evidence". The compliance rates were significantly higher in 1996 than in 1994 in the experimental group; 36% (126 out of 346) vs 12% (34 out of 282) and 46% (56 out of 123) vs 14% (14 out of 103) (P<0.001) for breast and colon cancer, respectively. Whereas, in the control group the compliance rates were the same for the two periods; 7% (12 out of 173) vs 6% (12 out of 194) (P=0.46) and 39% (49 out of 126) vs 32% (31 out of 96), P=0.19. In the experimental group, in 1994, 101 of the 282 medical decisions (36%) and 27 of the 103 (26%) for breast and colon cancer, respectively, were classified as having "no convincing supporting scientific evidence" compare with 72 out of 346 in 1996 (21%) for breast cancer, and 21 of the 123 (17%) for colon cancer P<0.05. Whereas in the control group these results were 106 out of 194 in 1994 (55%) and 90 out of 172 in 1996 (52%), P=0.65 for breast cancer and 28 out of 96 in 1994 (29%) and 30 out of 126 in 1996 (24%), P=0.36 for colon cancer. The development and implementation strategy of the clinical practice guidelines programme for cancer management results in significant changes in medical practice in our cancer network. These results would suggest that introducing guidelines with specific implementation strategy might also increase the compliance rate with the guideline and "evidence-based medicine".

Funding new cancer drugs in Ontario: closing the loop in the practice guidelines development cycle.

PURPOSE: The previously described practice guidelines development cycle follows an iterative model in which recommendations are reached by a process that incorporates practitioners at all phases. A key feature is the separation of the evidence-based systematic review and the generation of recommendations from policy decisions surrounding implementation. This article describes how this implementation phase has evolved in Ontario and how implementation has affected the guidelines process. METHODS: The development of the New Drug Funding Program in Ontario and the appointment of a policy advisory committee (PAC) to make funding recommendations were reviewed. The decision-making framework of the PAC is described in this article. RESULTS: The PAC has had to address a number of issues in making funding recommendations. These issues have included dealing with evidence arising solely from phase II versus phase III trials, using economic information, and involving community representatives in its deliberations. Its activities have had a substantial impact on the practice guidelines initiative. CONCLUSION: It is possible to integrate an evidence-based, practitioner-driven approach to clinical guideline development with a funding program that takes policy considerations into account. However, even though these two roles are conceptually separate, the needs of the funding program have inevitably had an impact on the guidelines process.

Choosing a concomitant chemotherapy and radiotherapy regimen for squamous cell head and neck cancer: A systematic review of the published literature with subgroup analysis.

BACKGROUND: A systematic review was conducted to develop clinical recommendations for concomitant chemotherapy (CT) and radiotherapy (RT) in patients with locally advanced squamous cell head and neck cancer (SCHNC). METHODS: Results of published randomized controlled trials (RCTs) were pooled using Meta-analyst(0.988) software. RESULTS: A pooled analysis of 18 RCTs (20 comparisons) involving 3,192 patients detected a reduction in mortality for concomitant therapy compared with RT alone (odds ratio [OR], 0.62; 95% confidence interval [CI], 0.52-0.74; relative risk, 0.83; risk reduction, 11%; p < .00001). Platinum-based regimens involving 1,514 patients from nine trials (10 comparisons) were most effective (OR, 0.57; 95% CI, 0.46-0.71; p < .00001; risk reduction, 12%). Concomitant therapy produced more acute adverse effects than RT alone. CONCLUSION: Platinum-based concomitant CT and RT is superior to conventional RT alone in improving survival in locally advanced SCHNC. Subgroup analyses can be used to help in choosing the most appropriate concomitant regimen.

Trends in hormonal management of prostate cancer: a population-based study in Ontario.

OBJECTIVE: To provide a population-based description of current practice in the use of hormonal management of prostate cancer. DESIGN,SETTING & PARTICIPANTS: All men in Ontario, Canada, age 65 and older, with confirmed prostate cancer starting maintained hormonal therapy, from July 1992 through December 1998 (11,435 patients). Data sources included the provincial drug benefit plan, hospital services data, and Ontario Cancer Registry. OUTCOME MEASURES: Rates and trends in the use of: surgical or medical castration; total androgen blockade (TAB); and monotherapies based on steroidal or nonsteroidal antiandrogens. RESULTS: In 5.5 years, use of 'standard' therapy based on surgical or medical castration alone dropped from 36% to 26% of patients, while the use of TAB doubled from 22% to 41%. Approximately 15% of patients received nonsteroidal antiandrogens without evidence of therapy aimed at central androgen blockade. Marked regional differences were observed and not explained by patient age or practitioner specialty. CONCLUSIONS: New hormonal therapies for prostate cancer have implications in terms of disease control, patient survival, side effects, and costs. Rapid growth in prescribing of antiandrogens may represent an unnecessary expense for public or private payers, and observed regional differences likely reflect lack of consensus on the relative merit of TAB. Patients and practitioners must have current information on the advantages and disadvantages of different therapeutic options, and quality-of life, particularly with respect to emerging drug therapies.

Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials.

PURPOSE: To identify, classify, and evaluate agents used in the prophylaxis of oral mucositis in irradiated head and neck cancer patients. METHODS: Data sources included multiple databases and manual citation review of relevant literature. Based on the eligibility criteria, 59 studies were independently reviewed by two reviewers. Forty-two studies were included in the classification scheme, of which 15 met the criteria for inclusion in the meta-analysis. Data were extracted by duplicate independent review, with disagreement resolved by consensus. RESULTS: Overall, the interventions reduced the odds of developing severe oral mucositis, when assessed by clinicians, by 36% (OR: 0.64; 95% CI: 0.46, 0.88). Subgroup analysis suggested that only the narrow-spectrum antibacterial lozenges were effective (OR: 0.45; 95% CI: 0.23, 0.86); however, the power of the aggregated data in the other classes may have been insufficient to detect differences. When the outcome was assessed by patients, no significant difference was seen in the outcome between the treatment and the control groups (OR: 0.79; 95% CI: 0.56-1.12). CONCLUSIONS: Overall, interventions chosen on a sound biologic basis to prevent severe oral mucositis are effective. In particular, when oral mucositis is assessed by clinicians, narrow-spectrum antibiotic lozenges appear to be beneficial. Methodologic limitations were evident in many of the studies. Further research using validated measurement tools in larger, methodologically sound trials is warranted.

Systematic reviews and meta-analyses on treatment of asthma: critical evaluation.

OBJECTIVE: To evaluate the clinical, methodological, and reporting aspects of systematic reviews and meta-analyses on the treatment of asthma and to compare those published by the Cochrane Collaboration with those published in paper based journals. DESIGN: Analysis of studies identified from Medline, CINAHL, HealthSTAR, EMBASE, Cochrane Library, personal collections, and reference lists. STUDIES: Articles describing a systematic review or a meta-analysis of the treatment of asthma that were published as a full report, in any language or format, in a peer reviewed journal or the Cochrane Library. MAIN OUTCOME MEASURES: General characteristics of studies reviewed and methodological characteristics (sources of articles; language restrictions; format, design, and publication status of studies included; type of data synthesis; and methodological quality). RESULTS: 50 systematic reviews and meta-analyses were included. More than half were published in the past two years. Twelve reviews were published in the Cochrane Library and 38 were published in 22 peer reviewed journals. Forced expiratory volume in one second was the most frequently used outcome, but few reviews evaluated the effect of treatment on costs or patient preferences. Forty reviews were judged to have serious or extensive flaws. All six reviews associated with industry were in this group. Seven of the 10 most rigorous reviews were published in the Cochrane Library. CONCLUSIONS: Most reviews published in peer reviewed journals or funded by industry have serious methodological flaws that limit their value to guide decisions. Cochrane reviews are more rigorous and better reported than those published in peer reviewed journals.

Improving clinical practice guidelines for the 21st century. Attitudinal barriers and not technology are the main challenges.

Through the use of three scenarios, this paper presents the challenges for clinical practice guidelines in the 21st century. Such challenges relate to technological developments to improve the efficiency and pace of the development process, to ensure that clinical practice guidelines are kept up to date, and to facilitate implementation of guidelines in the clinical setting. To improve and ensure the validity of the content of clinical practice guidelines, we need to address the important problem of publication bias, for which researchers, granting agencies, industry, and journal editors share responsibility. This means insisting on registration of trials at their inception, and incentives backed up by rules for funding and peer review publication that would promote behaviors to avoid publication bias. The more difficult challenges for clinical practice guidelines relate to what are referred to as attitudinal factors. To achieve optimal efficiencies in development and maintenance of clinical practice guidelines, we need to promote cooperation among various information resource providers internationally and to stress partnership over leadership. Finally, there need to be reconciliation of the different stakeholder perspectives of the value and purpose of clinical practice guidelines so that they are used appropriately as aids to decision making and are not abused as tools for controlling clinical practice.

Essence of evidence-based medicine: A case report.

PURPOSE: To illustrate the complexities of the evidence-based approach in clinical oncology practice and the implications for guidelines and evaluation of processes of care. PATIENT AND METHODS: A case report is presented in which a limited systematic review of the literature was used to address a specific clinical problem in an individual patient. Experts' opinions were also sought. RESULTS: A reasonable clinical decision was made by a participating patient based on indirect evidence of benefit that would be insufficient to support the same decision as a health policy in some jurisdictions. CONCLUSION: The practice of evidence-based oncology requires clinical judgment about the validity and applicability of research evidence. The factors that influence an evidence-based decision in the clinical context differ from those in the broader policy context, which could lead to legitimate differences in recommendations based on the same information. Used properly, the individual case report can be a powerful tool to illustrate complex clinical decision phenomena.

Development of clinical practice guidelines: surgical perspective.

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. The implications of this definition are that: the methodologic perspective and operations for systematic development must be specified, a strategy is needed to account for the patient's perspective in the CPG development process and the clinical decision, and a mechanism is required to determine how appropriateness ought to be conceptualized and defined. Addressing these issues, we review models of CPG development, outline challenges to evidence-based approaches to CPG development, address unique factors relevant to the development of guidelines for the surgical community, introduce an Ontario practice guidelines strategy that uses complementary methods of CPG development, and summarize the feedback provided by the surgical community regarding the practice guidelines produced in Ontario's cancer system.

Evidence-based paradigms and opinions in clinical management and cancer research.

Clinical management involves values, the recognition of a patient's unique circumstances, and information. Given strong biases in the way we all process experience, clinical decision making must acknowledge the results of formal research. Evidence-based clinical management requires that we take account of the whole body of available evidence, not a potentially biased "biopsy" of it. Systematic literature review is therefore a central element. Such an approach is time consuming and requires skills in literature search and data evaluation, which physicians frequently have not been taught. Computing and library facilities are an important aid, as is the development of evidence-based resources such as the Cochrane Library Collection. Practice guidelines can prove useful and acceptable to clinicians if they are both evidence- and practice-based. The largest single obstacle to evidence-based clinical management is the bias against the reporting of studies with negative findings. This can be overcome by compulsory trial registration.

Health care professionals' familiarity with non-pharmacological strategies for managing cancer pain.

Many studies have confirmed unnecessary suffering among cancer patients, due to the inadequate use of analgesic medication and other effective interventions. While pharmacological treatments are appropriately the central component of cancer pain management, the under-utilization of effective nonpharmacological strategies (NPS) may contribute to the problem of pain and suffering among cancer patients. The purpose of this study was to determine health care professionals' familiarity with, and perceptions regarding, NPS for managing cancer pain, and to assess their interest in learning more about NPS as adjuncts to pharmacological analgesics. Two-hundred and fourteen health care professionals were surveyed at two cancer treatment centres in Ontario, Canada. The self-report questionnaire included questions regarding 11 psychological strategies (e.g. imagery) and eight other NPS (e.g. acupuncture). The response rate was 67% (141/214). Subjects were found to be the least familiar with autogenic training, operant conditioning, and cognitive therapy. Other than radiation and surgery, subjects most commonly reported recommending support groups (67%), imagery (54%), music or art therapy (49%) and meditation (43%) for managing cancer pain. Participants were most interested in learning more about acupuncture, massage therapy, therapeutic touch, hypnosis, and biofeedback. Participants were somewhat familiar with most of the 19 NPS presented; however, they use or recommend few NPS for managing cancer pain. Health professionals' interest in NPS has important implications for the supportive care of cancer patients.