Practice Guideline Initiative Research Articles

A Clinical Practice Guideline on the Timing of Surgical Decompression and Hemodynamic Management of Acute Spinal Cord Injury and the Prevention, Diagnosis, and Management of Intraoperative Spinal Cord Injury: Introduction, Rationale, and Scope.

Protocol for the development of clinical practice guidelines following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) standards. Acute SCI or intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. The treatment of SCI has dramatically evolved over the last century as a result of preclinical and clinical research that has addressed important knowledge gaps, including injury mechanisms, disease pathophysiology, medical management, and the role of surgery. In an acute setting, clinicians are faced with critical decisions on how to optimize neurological recovery in patients with SCI that include the role and timing of surgical decompression and the best strategies for hemodynamic management. The lack of consensus surrounding these treatments has prevented standardization of care across centers and has created uncertainty with respect to how to best manage patients with SCI. ISCI is a feared complication that can occur in the best of hands. Unfortunately, there are no systematic reviews or clinical practice guidelines to assist spine surgeons in the assessment and management of ISCI in adult patients undergoing spinal surgery. Given these limitations, it is the objective of this initiative to develop evidence-based recommendations that will inform the management of both SCI and ISCI. This protocol describes the rationale for developing clinical practice guidelines on (i) the timing of surgical decompression in acute SCI; (ii) the hemodynamic management of acute SCI; and (iii) the prevention, identification, and management of ISCI in patients undergoing surgery for spine-related pathology. Systematic reviews were conducted according to PRISMA standards in order to summarize the current body of evidence and inform the guideline development process. The guideline development process followed the approach proposed by the GRADE working group. Separate multidisciplinary, international groups were created to perform the systematic reviews and formulate the guidelines. All potential conflicts of interest were vetted in advance. The sponsors exerted no influence over the editorial process or the development of the guidelines. This process resulted in both systematic reviews and clinical practice guidelines/care pathways related to the role and timing of surgery in acute SCI; the optimal hemodynamic management of acute SCI; and the prevention, diagnosis and management of ISCI. The ultimate goal of this clinical practice guideline initiative was to develop evidence-based recommendations for important areas of controversy in SCI and ISCI in hopes of improving neurological outcomes, reducing morbidity, and standardizing care across settings. Throughout this process, critical knowledge gaps and future directions were also defined.

CEO’s Message

The death of professional societies and not-for-profit associations has been greatly exaggerated, to paraphrase Mark Twain. Professional societies, like your Association for Vascular Access (AVA), have proven to be the invaluable resource to their members during this time of COVID-19 crisis. Clinicians, healthcare administrators, stakeholders, and others have turned to their trusted professional homes to seek reliable, accurate, pertinent, and distilled information. Like our members, AVA has used this horrific pandemic to learn lessons and come back stronger and nimbler. Here are some of the projects the Board of Directors, committees, special interest groups, and staff have been working on.After more than a year in development, the Vascular Access Education partnership, featuring the Fundamentals of Peripheral Intravenous Vascular Access™ curriculum, has moved into the pilot stage and prepares for a full launch in Fall 2021. The Vascular Access Education Program is open to all current, prelicensure nursing, medical, and allied healthcare students and the faculty that teach them. The package includes a 1-year complimentary student or faculty AVA membership as well as access to 3 semesters of peripheral intravascular curriculum.The 3-course comprehensive curriculum was developed by vascular access subject matter experts in the United States and internationally without influence from B. Braun, which partnered with AVA on this important project. The curriculum will provide vascular access knowledge acquisition through online courses designed to increase the ability of healthcare professionals to insert, care for, and maintain peripheral venous catheters. The curriculum is offered free of charge to prelicensure associate or baccalaureate academic programs in nursing, medicine, advanced practice, respiratory therapy, and other allied health professions. The curriculum was designed to fill a gap in knowledge on the placement, care, and maintenance of peripheral venous catheters.The curriculum includes 3 courses: AVA101, Fundamentals of Peripheral Vascular AccessAVA201, PIV Insertion and Intermediate ConceptsAVA301, Advanced Topics in Peripheral Vascular AccessThe curriculum includes 3 pretests and posttests, student and instructor access to AVA’s learning management platform, periodic reports on student performance to instructor, and student certificate of completion. After passing all 3 courses, students will receive the AVA Certificate of Completion of Fundamentals of Peripheral Intravenous Vascular Access™ Certificate. AVA believes this certificate of added qualification will be in demand by employers. For more information, please contact avaed@avainfo.org.The AVA staff is excited to be working with a tremendous group of subject matter experts from around the world for the development of AVA’s first evidence-based Clinical Practice Guidelines. This initiative is a result of growing interest over the past decade for a standardized framework for healthcare professionals inserting and caring for vascular access devices.The Clinical Practice Guidelines initiative is expected to be a multi-year project with most of the work occurring in the first year. Six teams will meet regularly to discuss and draft the guidelines, align statements with current evidence and research, and decide where a consensus agreement needs to be applied. The project will include all aspects of vascular access devices intended for infusion or phlebotomy, excluding devices intended for monitoring of biomedical therapies, starting with the assessment of the patient and ending with the removal of the device.Last July and March, AVA held special meetings for network leaders to celebrate moving into 2021 and, hopefully, the soon-to-be post-COVID-19 era. The network representatives and AVA staff discussed how to strengthen their partnerships to attract and provide added value to members and nonmembers. AVA national is increasing focus on including more multidisciplinary members. Other discussions included how to work together to deliver continuing education hours for virtual events. “AVA on the Road,” a new program for industry partners, is offered to networks. This traveling webinar allows industry partners to rebroadcast a previously presented webinar at a network meeting. Please contact avainfo@avainfo.org for more information.Dr Amy Bardin, EdD, MSc, RRT, VA-BC™, became president of the AVA Foundation in May. The board expressed its sincere gratitude for the service and dedication of: Marcia Ryder, PhD, MS, RN, FNAP, outgoing president; and board directors Gregory Schears, MD, Reid Nishikawa, PharmD, Marshall Kerr, and Matthew Ostroff. “The Foundation is an important organization that advocates for improving patient safety through promotion of vascular access education and scholarship awards that focus on both research and education. I appreciate the opportunity and look forward to working with the dedicated individuals who serve on the Board of Directors,” Bardin said. “The Board and I are committed to the growth and development of the Foundation.”

The relationship between symptoms and blood pressure during maintenance hemodialysis.

Intradialytic hypotension (IDH) is a detrimental complication of maintenance hemodialysis, but how it is defined and reported varies widely in the literature. European Best Practice Guideline and Kidney Disease Outcomes Quality Initiative guidelines require symptoms and a mitigating intervention to fulfill the diagnosis, but morbidity and mortality outcomes are largely based on blood pressure alone. Furthermore, little is known about the incidence of asymptomatic hypotension, which may be an important cause of hypoperfusion injury and impaired outcome. Seventy-seven patients were studied over 456 dialysis sessions. Blood pressure was measured at 15-minute intervals throughout the session and compared with post-dialysis symptom questionnaire results using mixed modeling to adjust for repeated measures in the same patient. The frequency of asymptomatic hypotension was estimated by logistic regression using a variety of commonly cited blood pressure metrics that describe IDH. In 113 sessions (25%) where symptoms were recorded on the questionnaire, these appear not to have been reported to dialysis staff. When symptoms were reported (293 sessions [64%]), an intervention invariably followed. Dizziness and cramp were strongly associated with changes in systolic blood pressure (SBP), but not diastolic blood pressure. Nausea occurred more frequently in younger patients but was not associated with falls in blood pressure. Thresholds that maximized the probability of an intervention rather than a session remaining asymptomatic were SBP <100 mmHg or a 20% reduction in SBP from baseline. The probability of SBP falling to <100 mmHg in an asymptomatic session was 0.23. Symptoms are frequently not reported by patients who are hypotensive during hemodialysis, which leads to an underestimation of IDH if symptom-based definitions are used. A revised definition of IDH excluding patient-reported symptoms would be in line with literature reporting morbidity and mortality outcomes and include sessions in which potentially detrimental asymptomatic hypotension occurs.

Canadian Society of Nephrology Commentary on the 2009 KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of CKD–Mineral and Bone Disorder (CKD-MBD)

Canadian Society of Nephrology Commentary on the 2009 KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of CKD–Mineral and Bone Disorder (CKD-MBD)

Oncological and Functional Outcome of Radical Cystectomy in Patients With Bladder Cancer and Obstructive Uropathy

We present our experience with the perioperative, functional and oncological outcomes of radical cystectomy in patients with bladder cancer and obstructive uremia. From 1998 to June 2006, 58 patients with bladder cancer, and concomitant obstructive uropathy and azotemia presented to our institution. Mean +/- SD serum creatinine at presentation was 9.2 +/- 4.5 mg% (range 2.4 to 16.5). Radical cystectomy, bilateral pelvic lymphadenectomy and urinary diversion were performed after stabilizing renal function with and without percutaneous nephrostomy in 28 and 8 patients, respectively. Various preoperative variables were evaluated for predicting long-term treatment failure and renal deterioration. Mean followup was 34 months. Mean serum creatinine at surgery was 1.85 mg%. An ileal conduit was used in 32 patients and cutaneous ureterostomy was used in 4. One patient died of chest infection in the perioperative period. All patients had muscle invasive disease, while 15 had positive lymph nodes. At the mean followup 15 patients (41.6%) were free of disease and 21 had treatment failure. Of the factors evaluated pathological tumor stage, grade and lymph node involvement predicted the long-term oncological outcome, while serum creatinine greater than 2.5 mg% at surgery and ileal conduit diversion predicted long-term renal deterioration. Patients with bladder cancer who have obstructive uremia usually present with locally advanced disease. Radical cystectomy is not associated with additional morbidity, provided that patients are adequately prepared before surgery by optimizing renal function. An adequate number of these patients achieve long-term disease-free survival after radical cystectomy. As the urinary diversion of choice, an ileal conduit appears to be safe in patients with serum creatinine less than 2.5 mg% at surgery.

Baseline radiological staging in primary breast cancer: impact of educational interventions on adherence to published guidelines

The purpose of baseline radiological staging in newly diagnosed breast cancer patients is to rule out overt metastatic disease. We have previously compared the use of radiological staging at our institution with the recommendations of the Cancer Care Ontario Practice Guidelines Initiative (CCOPGI). Our results demonstrated that between January 2000 to December 2002, a high proportion of our cohort (n = 135) of patients underwent unnecessary investigations. To implement and assess an educational intervention to encourage staging guideline utilization in a cohort of early breast cancer patients. In January 2003, multidisciplinary educational rounds were held, highlighting the CCOPGI guidelines, and reporting results of the audit of staging investigations. The staging guidelines were then included in the Clinical Practice Guidelines of the Breast Disease Site Group, Toronto-Sunnybrook Regional Cancer Centre. A retrospective chart review was completed that assessed staging investigations from a random sample of a similar group of patients (n = 134) from January 2003 to April 2005, to explore the effects of these educational interventions on clinical practice. For patients with Stage I breast cancer, there was a significant decrease (P < 0.004) in each type of investigation: a twofold decrease in chest X-rays; 2.5-fold decrease bone scans and fourfold decrease in the number of abdominal ultrasounds. For patients in Stage II, there was no significant change in the proportion of patients undergoing radiological investigations. There was a non-significant trend towards appropriately receiving all three investigations for patients with Stage III disease. Our results demonstrate that prior to the educational intervention, many patients with early breast cancer were undergoing inappropriate radiological staging. Since 2003 however, for Stage I patients there has been a significant improvement in adherence with the guidelines. We hypothesize that our educational intervention had a positive impact on improving the utilization of baseline radiological staging in patients with primary breast cancer.

Ontario doctors’ attitudes toward and use of clinical practice guidelines in oncology

Clinical practice guidelines are intended to improve patient care and outcomes. Controversy exists about the utility of guidelines and doctors' attitudes toward them. The purpose of the survey was to determine Ontario doctors' attitudes toward practice guidelines in general, awareness of, and attitudes about, Cancer Care Ontario's Practice Guideline Initiative and the evidence-based guidelines it produces, self-reported use of guidelines and, factors related to guideline use. We conducted a cross-sectional, self-administered postal survey of 1034 Ontario doctors who treat cancer. Main outcome measures were attitudes toward practice guidelines in general, attitudes towards those developed by Cancer Care Ontario's Practice Guideline Initiative, and self-reported use of practice guidelines. A total of 520 doctors responded producing a 57% survey response rate. Ontario doctors are quite positive about practice guidelines in general and those developed by Cancer Care Ontario. Forty-four per cent reported using guidelines routinely or most of the time. Positive attitudes towards guidelines in general and the Ontario cancer guidelines specifically were related to more frequent reported use of guidelines. Other factors related to frequent reported use of guidelines included being a medical oncologist, treating gynaecological cancers and not other types of cancers. Ontario doctors have positive attitudes toward practice guidelines and report frequent use of them. By understanding the relationship between doctors' perceptions of specific guidelines and their subsequent adherence to them, guideline developers will be better positioned to produce quality evidence-based guidelines that doctors will find acceptable, and therefore, be more predisposed to use.

Systematic Review of the Diagnosis and Management of Malignant Extradural Spine Cord Compression: The Cancer Care Ontario Practice Guidelines Initiative's Neuro-Oncology Disease Site Group

Purpose This systematic review describes the diagnosis and management of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression (MSCC). Methods MEDLINE, CANCERLIT, and the Cochrane Library databases were searched to January 2004 using the following terms: spinal cord compression, nerve compression syndromes, spinal cord neoplasms, clinical trial, meta-analysis, and systematic review. Results Symptoms for MSCC include sensory changes, autonomic dysfunction, and back pain; however, back pain was not predictive of MSCC. The sensitivity and specificity for magnetic resonance imaging (MRI) range from 0.44 to 0.93 and 0.90 to 0.98, respectively, in the diagnosis of MSCC. The sensitivity and specificity for myelography range from 0.71 to 0.97 and 0.88 to 1.00, respectively. A randomized study detected higher ambulation rates in patients with MSCC who received high-dose dexamethasone before radiotherapy (RT) compared with patients who did not receive corticosteroids...

Should 5-Hydroxytryptamine-3 Receptor Antagonists Be Administered Beyond 24 Hours After Chemotherapy to Prevent Delayed Emesis? Systematic Re-Evaluation of Clinical Evidence and Drug Cost Implications

5-Hydroxytryptamine-3 receptor antagonists (5-HT(3) antagonists) are effective for preventing acute chemotherapy-induced emesis but the benefits of continuing administration of these agents beyond 24 hours after chemotherapy (delayed emesis) remain unclear. The purpose of this study was to provide estimates of clinical efficacy and drug acquisition cost associated with administering 5-HT(3) antagonists beyond 24 hours, as monotherapy or as added to dexamethasone. This analysis is based on the Cancer Care Ontario Practice Guidelines Initiative meta-analysis of the efficacy of 5-HT(3) antagonists. Results from the clinical trials covered in that meta-analysis were reanalyzed to provide estimates of absolute risk reductions (ARR) and numbers needed to treat (NNT) for 5-HT(3) antagonists, as monotherapy or as adjunct treatment. Numbers of 5-HT(3) antagonist unit doses per successfully treated patient were also calculated. Five studies (comprising 1,716 assessable patients) compared a 5-HT(3) antagonist with placebo; five studies (2,240 patients) compared a combination of a 5-HT(3) antagonist and dexamethasone with dexamethasone monotherapy. ARR for monotherapy was only 8.2% (95% CI, 3.0% to 13.4%). On average, 74 5-HT(3) antagonist doses must be administered to 12 patients (NNT, 12.2; 95% CI, 7.5 to 33.4) not receiving dexamethasone to protect one patient from delayed emesis. In those patients receiving dexamethasone as standard antiemetic treatment in the delayed phase, the addition of a 5-HT(3) antagonist did not significantly improve control of delayed emesis as compared with dexamethasone monotherapy (ARR, 2.6%; 95% CI, -0.6% to 5.8%). Neither clinical evidence nor considerations of cost effectiveness justify using 5-HT(3) antagonists beyond 24 hours after chemotherapy for prevention of delayed emesis.

Errata

BJU InternationalVolume 94, Issue 4 p. 700-700 Free Access Errata First published: 25 August 2004 https://doi.org/10.1111/j.1464-410X.2004.05124.xAboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat In [1], the following errors were published on pages 1179 and 1181. Figure 3 legend Fig. 3. Overall survival data as HRs for combination therapy compared with castration alone from published meta-analyses. Figure reproduced with permission from [4]. Derived from information in [3]; †Relative risks using data from [3]; CPA, cyproterone acetate; FLUT, flutamide; NILUT, nilutamide; NSAA, nonsteroidal antiandrogen; NSAA(LH), relative risks (log HR) from P-values; NSAA(PH), relative risks (proportional hazards) from discrete proportional hazards model. The text was incorrect and should have read: Figure 3 and legend Fig. 3. Overall survival data as HRs for combination therapy compared with castration alone from published meta-analyses. Figure reproduced with permission from [14]. Derived from information in [3]; †Relative risks using data from [3]; CPA, cyproterone acetate; FLUT, flutamide; NILUT, nilutamide; NSAA, nonsteroidal antiandrogen; NSAA(LH), relative risks (log HR) from P-values; NSAA(PH), relative risks (proportional hazards) from discrete proportional hazards model. Figure 1Open in figure viewerPowerPoint The references 15–18 which are alluded to in this figure were omitted from the published paper; they are given below. 15 Caubet J-F, Tosteson TD, Dong EW et al. Maximum androgen blockade in advanced prostate cancer: a meta-analysis of published randomized controlled trials using nonsteroidal antiandrogens. Urology 1997; 49: 71– 8 CrossrefCASPubMedWeb of Science®Google Scholar 16 Klotz LH, Newman T and the Ontario Practice Guidelines Initiative. Total androgen blockade for metastatic prostate cancer: history and analysis of the PCTCG overview. Can J Urol 1996; 3 (Suppl 1): 102– 5 Google Scholar 17 Debruyne FMJ, De Géry A, Hucher M, Godfroid N. Maximum androgen blockade with nilutamide combined with orchidectomy in advanced prostate cancer: an updated metaanalysis of 7 randomised, placebo-controlled trials (1191 patients). Eur Urol 1996; 30 (Suppl 2): 264 Google Scholar 18 Bennett CL, Tosteson TD, Schmitt B, Weinberg PD, Ernstoff MS, Ross SD. Maximum androgen-blockade with medical or surgical castration in advanced prostate cancer: a meta-analysis on nine published randomised controlled trials and 4128 patients using flutamide. Prostate Cancer PD 1999; 2: 4– 8 CrossrefCASPubMedWeb of Science®Google Scholar We apologize for these errors. REFERENCE 1 Klotz L, Schellhammer P, Carroll K. A re-assessment of the role of combined androgen blockade for advanced prostate cancer. BJU Int 2004; 93: 1177– 82 Wiley Online LibraryCASPubMedWeb of Science®Google Scholar Volume94, Issue4September 2004Pages 700-700 FiguresReferencesRelatedInformation

American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer.

To address whether all medically fit patients with curatively resected stage II colon cancer should be offered adjuvant chemotherapy as part of routine clinical practice, to identify patients with poor prognosis characteristics, and to describe strategies for oncologists to use to discuss adjuvant chemotherapy in practice. An American Society of Clinical Oncology Panel, in collaboration with the Cancer Care Ontario Practice Guideline Initiative, reviewed pertinent information from the literature through May 2003. A literature-based meta-analysis found no evidence of a statistically significant survival benefit of adjuvant chemotherapy for stage II patients. Recommendations The routine use of adjuvant chemotherapy for medically fit patients with stage II colon cancer is not recommended. However, there are populations of patients with stage II disease that could be considered for adjuvant therapy, including patients with inadequately sampled nodes, T4 lesions, perforation, or poorly differentiated histology. Direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer. Patients and oncologists who accept the relative benefit in stage III disease as adequate indirect evidence of benefit for stage II disease are justified in considering the use of adjuvant chemotherapy, particularly for those patients with high-risk stage II disease. The ultimate clinical decision should be based on discussions with the patient about the nature of the evidence supporting treatment, the anticipated morbidity of treatment, the presence of high-risk prognostic features on individual prognosis, and patient preferences. Patients with stage II disease should be encouraged to participate in randomized trials.

Atherosclerotic Vascular Disease Conference: Writing Group IV: imaging.

The goals of the imaging writing group were to define the role of imaging and to recommend important programmatic research and advocacy initiatives in atherosclerotic peripheral vascular disease for the American Heart Association. It should be noted that this is not a practice guideline initiative; therefore, the writing group purposely avoided recommending imaging modalities for specific circulatory beds. This report discusses the following imaging modalities: duplex ultrasound, MRI and MR angiography (MRA), CT imaging and angiography (CTA), and digital intra-arterial angiography. The requirements for proficiency in all of these modalities include physician oversight, quality assurance programs, and standardization for acquisition of images, interpretation of the study, postprocessing procedures, workstations, and reporting. The roles of imaging for each modality such as screening for subclinical disease, diagnosis, and treatment planning as an adjunct to invasive therapies (interventional MR and CT) and follow-up and monitoring are reviewed.

Systematic review of management of colorectal cancer in elderly patients.

This study is designed to clarify the benefits and risks of chemotherapy and radiation therapy in elderly patients with colorectal cancer through a systematic review of the literature. Searches of the Medline, Embase, and Cochrane Library databases; PDQ Cancer Information Summaries, American Society of Clinical Oncology Guidelines, Cancer Care Ontario Practice Guideline Initiative, Interprovincial Drug Strategies and Guidelines Group, and OncoLink Web sites; and manual searches of meeting proceedings and bibliographies were performed. Additional studies known to the authors were also identified. Randomized controlled trials, reviews, and guidelines evaluating the impact of age on overall survival and/or toxicity with adjuvant and palliative therapies for colorectal adenocarcinoma were selected. A preset study selection form was applied to all identified studies. All selected studies underwent a preset study appraisal. Analyses of the effect of age on overall survival benefits and/or toxicity of therapy were extracted. A qualitative synthesis and narrative review was undertaken. There is good evidence to support that patients = 80 years of age have similar overall survival benefits with adjuvant 5-fluorouracil (5-FU)-based chemotherapy for colon cancer and with palliative first-line monotherapy for metastatic colorectal cancer, as do younger patients. Data are limited with regard to toxicity of therapy in older patients in these settings. An increase in toxicity with bolus 5-FU chemotherapy regimens is evident. There is a paucity of data regarding adjuvant treatment of older patients with rectal cancer. More elderly patients need to be enrolled in clinical trials in order to fully evaluate the outcomes of colorectal cancer therapy in this population. Further studies are warranted.

Single fraction radiotherapy is as effective as multiple fractions for palliating painful bone metastases: Abstracted from: Wu JSY, Wong R, Johnston M et al. on behalf of the Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Rad Oncol Biol Phys 2003; 55: 594–605.

Single fraction radiotherapy is as effective as multiple fractions for palliating painful bone metastases: Abstracted from: Wu JSY, Wong R, Johnston M et al. on behalf of the Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Rad Oncol Biol Phys 2003; 55: 594–605.

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

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. 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. 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. 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.

Foreword

Foreword

Progress of clinical oncology guidelines development using the Practice Guidelines Development Cycle: the role of practitioner feedback.

To present an update on the development of oncology practice guidelines (PGs) using the Practice Guidelines Development Cycle (Cycle), and to present the results of surveys of oncologists on the first 10 guidelines from the Cancer Care Ontario Practice Guidelines Initiative. Practitioners' opinions about guidelines in development were sought using a mail survey method with systematic follow-up. Practitioners were identified by cancer center representatives. Survey packages included evidence-based recommendations (EBRs) and a one-page, nine-item feedback questionnaire. Data were collected between February 1995 and February 1996. Nine hundred fourteen surveys that pertained to 10 guidelines were mailed to 423 practitioners in Ontario. Practitioners included 112 medical oncologists/hematologists, 34 radiation oncologists, 195 surgeons, and 82 practitioners from other medical specialities. One hundred practitioners were located in cancer centers and 323 had community-based practices. The overall response rate by practitioner was 72% and by survey questionnaire, 70%. For the five questionnaire items that assessed guideline quality, approval ratings ranged from 86% to 92%. For the 10 recommendations, 77% ( 63% to 82%) of respondents agreed that the EBR could be approved as a PG. Response and approval rates were consistent across medical specialities and locations of practice. The process of obtaining practitioner feedback in the development of PGs is both feasible and useful. The high response rates to the survey indicate that it is possible to obtain broad participation in evidence-based guidelines development throughout Ontario. The changes made to the EBRs in response to feedback suggest that practitioners' opinions can be valuable in shaping evidence-based guidelines.

Chemotherapy benefit and cost-effectiveness of treatment for advanced lung cancer

Chemotherapy benefit and cost-effectiveness of treatment for advanced lung cancer

The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation.

To develop a conceptual tool for the systematic development of cancer treatment practice guidelines. The guidelines development tool, the Practice Guidelines Development Cycle, was derived from observing an evidence-based practice guidelines initiative at a comprehensive cancer center in Ontario, Canada, and from a literature review that uncovered barriers to guidelines development and implementation. Based on the literature findings and direct observations of how clinicians struggled with evidence-based guidelines development, we evolved a framework to incorporate clinical and administrative factors (eg, costs) into evidence-based guidelines. Use of the Practice Guidelines Development Cycle is illustrated with a clinical example (the use of adjuvant systemic therapy in good-risk, node-negative premenopausal breast cancer patients). The result is the Practice Guidelines Development Cycle, which consists of eight sequential steps, from topic selection to policy formulation. Independent validation of guidelines is included. The cycle products are the evidence-based recommendation, the practice guideline, and the practice policy. The main features of the cycle are emphasis on scientific evidence, acknowledgment of the roles of clinical experience and nonclinical (administrative) factors through consensus, and explicit separation of clinical and cost considerations in guidelines development. Twenty guidelines are currently in development. Attention to the barriers of guidelines development and the sociocultural nature of clinical practice, and respect for clinical experience, can lead to improved strategies for guidelines development.

Improved management of gangrene of the foot: Bowers, Warner F., and Kennedy, John C.: Am. J. Surg. 50: 573, 1940

Improved management of gangrene of the foot: Bowers, Warner F., and Kennedy, John C.: Am. J. Surg. 50: 573, 1940