Hematologic toxicities of cancer chemotherapy are common and often limit the ability to provide treatment in a timely and dose-intensive manner. These limitations may be of utmost importance in the adjuvant and curative intent settings. Hematologic toxicities may result in febrile neutropenia, infections, fatigue, and bleeding, all of which may lead to additional complications and prolonged hospitalization. The older cancer patient and patients with significant comorbidities may be at highest risk of neutropenic complications. Colony-stimulating factors (csfs) such as filgrastim and pegfilgrastim can effectively attenuate most of the neutropenic consequences of chemotherapy, improve the ability to continue chemotherapy on the planned schedule, and minimize the risk of febrile neutropenia and infectious morbidity and mortality. The present consensus statement reviews the use of csfs in the management of neutropenia in patients with cancer and sets out specific recommendations based on published international guidelines tailored to the specifics of the Canadian practice landscape. We review existing international guidelines, the indications for primary and secondary prophylaxis, the importance of maintaining dose intensity, and the use of csfs in leukemia, stem-cell transplantation, and radiotherapy. Specific disease-related recommendations are provided related to breast cancer, non-Hodgkin lymphoma, lung cancer, and gastrointestinal cancer. Finally, csf dosing and schedules, duration of therapy, and associated acute and potential chronic toxicities are examined.
Canadian recommendations; neutropenia; febrile neutropenia; supportive care; colony-stimulating factors; chemotherapy-induced neutropenia; safety
Background: Heterogeneity in aspects of development, structure and context of oncology guidelines was not evaluated. We analysed and critically examined its implications.
Materials and methods: Nine cancer clinical practice guidelines were selected on the basis of popularity among oncologists. The relevant Web sites and publications on three tumours were examined and characteristics grouped in the data domains: producing organisation, methodology, guideline structure and content, implementation and evaluation and scientific agreement.
Results: ASCO, ESMO, NICE, SIGN, START, NHMRC, NCI, NCCN and CCO guidelines were examined. Development was initiated by stakeholders or authorised bodies, run by task forces with varying degrees of multidisciplinarity, with rare endorsement of external guidelines. Recommendation formulation was on the basis of evidence, shaped via interactive processes of expert review and public consultation-based modifications. Guidelines varied in comprehensiveness per tumour type, number, size, format, grading of evidence, update and legal issues. Orientation for clinic use or as reference document, end-users and binding or elective nature also varied. Standard dissemination strategies were used, though evaluation of adoption and of impact on health outcomes was implemented with considerable heterogeneity.
Conclusions: Heterogeneity in development, structure, user and end points of guidelines is evident, though necessary in order to meet divergent demands. Crucial for their effectiveness are adherence to methodological standards, a clear definition of what the guideline intends to do for whom and a systematic evaluation of their impact on health care.
cancer; clinical practice; guidelines; oncology
Myelosuppressive chemotherapy can lead to dose-limiting febrile neutropenia. Prophylactic use of recombinant human G-CSF such as daily filgrastim and once-per-cycle pegfilgrastim may reduce the incidence of febrile neutropenia. This comparative study examined the effect of pegfilgrastim versus daily filgrastim on the risk of hospitalization.
This retrospective United States claims analysis utilized 2004–2009 data for filgrastim- and pegfilgrastim-treated patients receiving chemotherapy for non-Hodgkin’s lymphoma (NHL) or breast, lung, ovarian, or colorectal cancers. Cycles in which pegfilgrastim or filgrastim was administered within 5 days from initiation of chemotherapy (considered to represent prophylaxis) were pooled for analysis. Neutropenia-related hospitalization and other healthcare encounters were defined with a “narrow” criterion for claims with an ICD-9 code for neutropenia and with a “broad” criterion for claims with an ICD-9 code for neutropenia, fever, or infection. Odds ratios (OR) for hospitalization and 95% confidence intervals (CI) were estimated by generalized estimating equation (GEE) models and adjusted for patient, tumor, and treatment characteristics. Per-cycle healthcare utilization and costs were examined for cycles with pegfilgrastim or filgrastim prophylaxis.
We identified 3,535 patients receiving G-CSF prophylaxis, representing 12,056 chemotherapy cycles (11,683 pegfilgrastim, 373 filgrastim). The mean duration of filgrastim prophylaxis in the sample was 4.8 days. The mean duration of pegfilgrastim prophylaxis in the sample was 1.0 day, consistent with the recommended dosage of pegfilgrastim - a single injection once per chemotherapy cycle. Cycles with prophylactic pegfilgrastim were associated with a decreased risk of neutropenia-related hospitalization (narrow definition: OR = 0.43, 95% CI: 0.16–1.13; broad definition: OR = 0.38, 95% CI: 0.24–0.59) and all-cause hospitalization (OR = 0.50, 95% CI: 0.35–0.72) versus cycles with prophylactic filgrastim. For neutropenia-related utilization by setting of care, there were more ambulatory visits and hospitalizations per cycle associated with filgrastim prophylaxis than with pegfilgrastim prophylaxis. Mean per-cycle neutropenia-related costs were also higher with prophylactic filgrastim than with prophylactic pegfilgrastim.
In this comparative effectiveness study, pegfilgrastim prophylaxis was associated with a reduced risk of neutropenia-related or all-cause hospitalization relative to filgrastim prophylaxis.
The authors' analysis of this data set produced benchmarks from which medical oncologists can monitor, measure, and improve on common areas of billing fraud, waste, or abuse in their practices.
The frequency and sophistication of health care reimbursement auditing has progressed rapidly in recent years, leaving many oncologists wondering whether their private practices would survive a full-scale Office of the Inspector General (OIG) investigation. The Medicare Part B claims database provides a rich source of information for physicians seeking to understand how their billing practices measure up to their peers, both locally and nationally. This database was dissected by a team of cancer specialists to uncover important benchmarks related to targeted auditing. All critical Medicare charges, payments, denials, and service ratios in this article were derived from the full 2010 Medicare Part B claims database. Relevant claims were limited by using Medicare provider specialty codes 83 (hematology/oncology) and 90 (medical oncology), with an emphasis on claims filed from the physician office place of service (11). All charges, denials, and payments were summarized at the Current Procedural Terminology code level to drive practice benchmarking standards. A careful analysis of this data set, combined with the published audit priorities of the OIG, produced germane benchmarks from which medical oncologists can monitor, measure and improve on common areas of billing fraud, waste or abuse in their practices. Part II of this series and analysis will focus on information pertinent to radiation oncologists.
The National Comprehensive Cancer Network clinical practice guidelines in oncology-gastric cancer guidelines have been widely used to provide appropriate recommendations for the treatment of patients with gastric cancer. The aim of this study was to examine the adherence of surgical oncologists, medical oncologists, and radiation oncologists' to the recommended guidelines.
A questionnaire asking the treatment options for gastric cancer cases was sent to 394 Chinese oncology specialists, including surgical oncologists, medical oncologists, and radiation oncologists working in hospitals joined in The Western Cooperative Gastrointestinal Oncology Group of China. The questionnaire involved a series of clinical scenarios regarding the interpretation of surgery, neoadjuvant, adjuvant, and advanced treatment planning of gastric cancer.
Analysis of 358 respondents (91%) showed variations between each specialization and from the recommended guidelines in the management approaches to specific clinical scenarios. The majority of specialists admitted that less than 50% of patients received multidisciplinary evaluation before treatment. The participants gave different responses to questions involving adjuvant, neoadjuvant, and advanced settings, compared to the recommended guidelines.
These results highlight the heterogeneity of the treatment of gastric cancer. Surgical oncologists, medical oncologists, and radiation oncologists are not adhering to the recommended guidelines.
This multicenter, randomized, open-label study evaluated the efficacy, safety, and pharmacokinetics of a single subcutaneous pegfilgrastim injection with daily subcutaneous filgrastim administration in pediatric patients receiving myelosuppressive chemotherapy for sarcoma.
Patients and Methods
Forty-four patients with previously untreated, biopsy-proven sarcoma stratified into three age groups (0-5, 6-11, and 12-21 years) were randomly assigned in a 6:1 randomization ratio to receive a single pegfilgrastim dose of 100 μg/kg (n = 38) or daily filgrastim doses of 5 μg/kg (n = 6) after chemotherapy (cycles 1 and 3: vincristine-doxorubicin-cyclophosphamide; cycles 2 and 4: ifosfamide-etoposide). The duration of grade 4 neutropenia, time to neutrophil recovery, incidence of febrile neutropenia, and adverse events were recorded.
Pegfilgrastim and filgrastim were similar for all efficacy and safety end points, and their pharmacokinetic profiles were consistent with those in adults. Younger children experienced more protracted neutropenia and had higher median pegfilgrastim exposure than older children.
A single dose of pegfilgrastim at 100 μg/kg administered once per chemotherapy cycle is comparable to daily injections of filgrastim at 5 μg/kg for pediatric sarcoma patients receiving myelosuppressive chemotherapy.
The Florida Initiative for Quality Cancer Care has identified how multiple aspects of breast cancer care can be improved.
The Florida Initiative for Quality Cancer Care (FIQCC) comprises 11 Florida practice sites that participate in comprehensive reviews of quality of care specific to patients with cancer. Here, we examined site adherence to performance indicators to assess quality of care for patients with breast cancer (BC).
Quality indicators were scripted on the basis of accepted guidelines from the Quality Oncology Practice Initiative, National Comprehensive Cancer Network, American College of Surgeons, and site-specific expert panel consensus. Comprehensive chart reviews, including both medical and surgical oncology quality measures, were conducted for patients with BC first seen in 2006 by a medical oncologist at one of the sites. Statistical comparisons were made by the Pearson χ2 exact test, using Monte Carlo estimation.
Charts of 622 patients were reviewed. Of the 34 indicators, seven for medical oncology and four for surgical oncology fell below the 85% level of adherence. A statistically significant difference (P < .001) in variation of performance across the sites was found for the following medical and surgical oncology indicators: documentation of menopausal status, family history, informed consent, planned chemotherapy regimen and flow sheet, American Joint Committee on Cancer staging, HER2/neu status, reporting of margin orientation and inking of the margins, histological grade, having a sentinel lymph node biopsy for invasive BC, and obtaining a mammogram within 14 months of definitive surgery.
The FIQCC has identified how multiple aspects of BC care can be improved. Findings are being used at the participating institutions to guide quality improvement efforts.
OBJECTIVE--To review the use of the domiciliary consultation service in modern clinical practice in the Northern region. DESIGN--Retrospective study of data on domiciliary consultations from claim forms for payment submitted to the regional health authority by consultants during 1984-5 and prospective study during 1985-9. Peer review of patterns of practice by consultants. SETTING--15 Of the 16 health districts in the Northern region, comprising a mixed urban and rural population of about 2.8 million. PARTICIPANTS--760 Consultants in 28 specialties and 1666 general practitioners who were eligible to perform or request domiciliary consultations. MAIN OUTCOME MEASURES--Numbers of domiciliary consultations, general practitioners' requests for consultations, and consultants performing consultations and expenditure on the service by the region. RESULTS--Use of the domiciliary consultation service in the Northern region declined by 53% between 1984-5 and 1988-9, considerably in excess of the national rate of decline of 27%, and expenditure on the service was reduced, after allowing for inflation, by 604,000 pounds, or 38%, in real terms. Most consultants and general practitioners used the service sparingly whereas a small proportion used it heavily; a few specific consultants and general practitioners were responsible for a relatively high rate of domiciliary consultations. Contrary to the original definition of domiciliary consultation, the general practitioner accompanied the consultant on only one occasion in 17 and, in one specialty examined (paediatrics) patients who received domiciliary consultations seemed to have minor medical problems. CONCLUSIONS--Peer review examination of the pattern of practice in the domiciliary consultation service proved effective in rationalising use of the service, although a substantial minority of consultants and general practitioners continued to use the service heavily. The place of the service in modern clinical practice would benefit from a national review.
In 2005, draft guidelines were published for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. This article contains the full revised version of the guidelines, which the authors refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). This paper also describes the consensus process, which included informal feedback from authors, editors and peer reviewers who used the guidelines; formal written commentaries; input from a group of publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programmes; a two-day meeting of stakeholders for critical discussion and debate of the guidelines’ content and wording; and commentary on sequential versions of the guidelines from an expert consultant group. Finally, the authors consider the major differences between SQUIRE and the initial draft guidelines; limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions that are under development; and plans for dissemination, testing and further development of SQUIRE.
Under Medicare, one of the federally required objectives of peer review organizations is to reduce inappropriate and unnecessary admissions. We reevaluated 32 admissions approved and 32 denied by the Arizona peer review organization, Health Services Advisory Group (HSAG), in a "blind" manner to determine whether practicing physicians in the community agree with the local peer review organization. Overall, physicians at the Scottsdale Memorial Hospital (SMH) approved 72% of HSAG-approved and denied 61% of HSAG-denied admissions. Of the 64 admissions, 3 or 4 of 4 reviewers (2 physicians and 2 nurses) agreed with the HSAG decision in 38 (59%), but 2 or more reviewers disagreed in the other 26 (41%). Disagreement between the 2 physicians occurred in 48% of the cases and disagreement between the 2 nurses in 33%. Even among admissions denied by SMH physician reviewers, the physicians would have admitted 23% of those patients under similar circumstances. In 28% of the HSAG-denied admissions, the reviewing physicians thought that the patients' health care would have been compromised if the admissions had not taken place. Despite well-defined criteria for the appropriateness of hospital admissions, the review process remains subjective, with much disagreement between peer review organizations and practicing physicians.
BACKGROUND: The production of clinical guidelines is increasing and will continue to do so with the introduction of clinical governance. In 1997, the British Orthopaedic Association (BOA) and the British Association of Plastic Surgeons (BAPS) published joint guidelines on the management of open tibial fractures. It is not known whether these guidelines reached their target audience, or indeed influenced clinical practice. METHODS: We determined the effectiveness of these guidelines by sending a postal questionnaire survey to 172 orthopaedic surgeons. RESULTS: Only 57% of consultants were aware of the guidelines, 70% of registrars and 25% of staff grades. Less than 29% of orthopaedic consultants would choose to consult the plastic surgical team pre-operatively in the management of an open tibial fracture and only 43% would seek plastic surgical involvement at all. The primary aim of increasing multidisciplinary communication has not been achieved. CONCLUSIONS: The awareness of, and adherence to, these guidelines is sub-optimal. This clearly has implications for both the future management of open tibial fractures and the further production of guidelines.
Although ‘best practice’ guidelines for dyspepsia management have been disseminated, it remains unclear whether providers adhere to these guidelines.
To compare adherence to ‘best practice’ guidelines among dyspepsia experts, community gastroenterologists and primary-care providers (PCPs).
We administered a vignette survey to elicit knowledge and beliefs about dyspepsia including a set of 16 best practices, to three groups: (i) dyspepsia experts; (ii) community gastroenterologists and (iii) PCPs.
The expert, community gastroenterologist and PCP groups endorsed 75%, 73% and 57% of best practices respectively. Gastroenterologists were more likely to adhere with guidelines than PCPs (P < 0.0001). PCPs were more likely to define dyspepsia incorrectly, overuse radiographic testing, delay endoscopy, treat empirically for Helciobacter pylori without confirmatory testing and avoid first-line proton pump inhibitors (PPIs). PCPs had more concerns about adverse events with PPIs [e.g. osteoporosis (P = 0.04), community-acquired pneumonia (P = 0.01)] and higher level of concern predicted lower guideline adherence (P = 0.04).
Gastroenterologists are more likely than PCPs to comply with best practices in dyspepsia, although compliance remains incomplete in both groups. PCPs harbour more concerns regarding long-term PPI use and these concerns may affect therapeutic decision making. This suggests that best practices have not been uniformly adopted and persistent guideline-practice disconnects should be addressed.
Implementation of health research findings is important for medicine to be evidence-based. Previous studies have found variation in the information sources thought to be of greatest importance to clinicians but publication in peer-reviewed journals is the traditional route for dissemination of research findings. There is debate about whether the impact made on clinicians should be considered as part of the evaluation of research outputs. We aimed to determine first which information sources are generally most consulted by paediatricians to inform their clinical practice, and which sources they considered most important, and second, how many and which peer-reviewed journals they read.
We enquired, by questionnaire survey, about the information sources and academic journals that UK medical paediatric specialists generally consulted, attended or read and considered important to their clinical practice.
The same three information sources – professional meetings & conferences, peer-reviewed journals and medical colleagues – were, overall, the most consulted or attended and ranked the most important. No one information source was found to be of greatest importance to all groups of paediatricians. Journals were widely read by all groups, but the proportion ranking them first in importance as an information source ranged from 10% to 46%. The number of journals read varied between the groups, but Archives of Disease in Childhood and BMJ were the most read journals in all groups. Six out of the seven journals previously identified as containing best paediatric evidence are the most widely read overall by UK paediatricians, however, only the two most prominent are widely read by those based in the community.
No one information source is dominant, therefore a variety of approaches to Continuing Professional Development and the dissemination of research findings to paediatricians should be used. Journals are an important information source. A small number of key ones can be identified and such analysis could provide valuable additional input into the evaluation of clinical research outputs.
The use of guidelines in general practice is not optimal. Although evidence-based methods to improve guideline adherence are available, variation in physician adherence to general practice guidelines remains relatively high. The objective for this study is to transfer a quality improvement strategy based on audit, feedback, educational materials, and peer group discussion moderated by local opinion leaders to the field. The research questions are: is the multifaceted strategy implemented on a large scale as planned?; what is the effect on general practitioners' (GPs) test ordering and prescribing behaviour?; and what are the costs of implementing the strategy?
In order to evaluate the effects, costs and feasibility of this new strategy we plan a multi-centre cluster randomized controlled trial (RCT) with a balanced incomplete block design. Local GP groups in the south of the Netherlands already taking part in pharmacotherapeutic audit meeting groups, will be recruited by regional health officers. Approximately 50 groups of GPs will be randomly allocated to two arms. These GPs will be offered two different balanced sets of clinical topics. Each GP within a group will receive comparative feedback on test ordering and prescribing performance. The feedback will be discussed in the group and working agreements will be created after discussion of the guidelines and barriers to change. The data for the feedback will be collected from existing and newly formed databases, both at baseline and after one year.
We are not aware of published studies on successes and failures of attempts to transfer to the stakeholders in the field a multifaceted strategy aimed at GPs' test ordering and prescribing behaviour. This pragmatic study will focus on compatibility with existing infrastructure, while permitting a certain degree of adaptation to local needs and routines.
Nederlands Trial Register ISRCTN40008171
Background—It is difficult to put research findings into clinical practice by either guidelines or prescription feedback.
Aim—To study the effect on the quality of prescribing by a combined intervention of providing individual feedback and deriving quality criteria using guideline recommendations in peer review groups.
Methods—199 general practitioners in 32 groups were randomised to participate in peer review meetings related to either asthma or urinary tract infections. The dispensing by the participating doctors of antiasthmatic drugs and antibiotics during the year before the intervention period provided the basis for prescription feedback. The intervention feedback was designed to describe the treatment given in relation to recommendations in the national guidelines. In each group the doctors agreed on quality criteria for their own treatment of the corresponding diseases based on these recommendations. Comparison of their prescription feedback with their own quality criteria gave each doctor the proportion of acceptable and unacceptable treatments.
Main outcome measure—Difference in the prescribing behaviour between the year before and the year after the intervention.
Results—Before intervention the mean proportions of acceptably treated asthma patients in the asthma group and urinary tract infection (control) group were 28% and 27%, respectively. The mean proportion of acceptably treated patients in the asthma group was increased by 6% relative to the control group; this difference was statistically significant. The mean proportions of acceptable treatments of urinary tract infection before intervention in the urinary tract infection group and asthma (control) group were 12% for both groups which increased by 13% in the urinary tract infection group relative to the control group. Relative to the mean pre-intervention values this represented an improvement in treatment of 21% in the asthma group and 108% in the urinary tract infection group.
Conclusions—Deriving quality criteria of prescribing by discussing guideline recommendations gave the doctors a basis for judging their treatment of individual patients as acceptable or unacceptable. Presented with feedback on their own prescribing, they learned what they did right and wrong. This provided a foundation for improvement and the process thus instigated resulted in the doctors providing better quality patient care.
Key Words: quality assessment; quality improvement; prescription feedback; continuing medical education; asthma; urinary tract infection
Pegylated granulocyte colony-stimulating factor (G-CSF; pegfilgrastim) is a longer-acting form of G-CSF, whose effects on dendritic cell (DC) and regulatory T cell (Treg) mobilization, and on the in vivo and ex vivo release of immune modulating cytokines remain unexplored.
Twelve patients with gynecological cancers received carboplatin/paclitaxel chemotherapy and single-dose pegfilgrastim as prophylaxis of febrile neutropenia. Peripheral blood was collected prior to pegfilgrastim administration (day 0) and on days +7, +11 and +21, to quantify immunoregulatory cytokines and to assess type 1 DC (DC1), type 2 DC (DC2) and Treg cell mobilization. In vitro-differentiated, monocyte-derived DC were used to investigate endocytic activity, expression of DC maturation antigens and ability to activate allogeneic T-cell proliferation.
Pegfilgrastim increased the frequency of circulating DC1 and DC2 precursors. In contrast, CD4+FoxP3+ bona fide Treg cells were unchanged compared with baseline. Serum levels of hepatocyte growth factor and interleukin (IL)-12p40, but not transforming growth factor-β1 or immune suppressive kynurenines, significantly increased after pegfilgrastim administration. Interestingly, pegfilgrastim fostered in vitro monocytic secretion of IL-12p40 and IL-12p70 when compared with unconjugated G-CSF. Finally, DC populations differentiated in vitro after clinical provision of pegfilgrastim were phenotypically mature, possessed low endocytic activity, and incited a robust T-cell proliferative response.
Pegfilgrastim induced significant changes in immune cell number and function. The enhancement of monocytic IL-12 secretion portends favorable implications for pegfilgrastim administration to patients with cancer, a clinical context where the induction of immune deviation would be highly undesirable.
OBJECTIVE--To measure the effect on hospital radiology referral practice of introducing a strategy for change involving guidelines of good practice, monitoring, and peer review. DESIGN--Prospective data collection over a continuous 21-24 month period at each centre some time between January 1987 and December 1990. SETTING--Five district general hospitals and one district health authority. SUBJECTS--314,663 inpatient discharges, deaths, and day cases and 1,706,781 outpatient attendances under the care of 722 consultants from 25 clinical specialties. MAIN OUTCOME MEASURES--Number of referrals for x ray examination per 100 inpatient discharges, deaths, and day cases and per 100 new outpatient attenders. RESULTS--Most doctors were prepared to accept standards of clinical practice set by peers and also the monitoring and review of their practice with respect to these standards by local colleagues. 18% of firms were identified before guidelines were instituted as having persistently high referral rates. Appreciable, and often dramatic reductions in referral rates for individual x ray examinations were recorded by a substantial number of firms in every centre and in every specialty after guidelines were instituted. The major part of this reduction was achieved by some of the firms whose initial practice did not meet "high referral" criteria. Important variations in compliance with agreed standards of good practice were observed. CONCLUSIONS--The study offers strong experimental evidence to support a recent suggestion that at least a fifth of radiological examinations carried out in NHS hospitals are clinically unhelpful. The problem of how to assure compliance with agreed standards of practice needs to be resolved. Until this happens medical audit alone is unlikely to translate good practice into common practice.
Patients with acute myeloid leukemia (AML) are often neutropenic as a result of their disease. Furthermore, these patients typically experience profound neutropenia following induction and/or consolidation chemotherapy and this may result in serious, potentially life-threatening, infection. This randomized, double-blind, phase 2 clinical trial compared the efficacy and tolerability of pegfilgrastim with filgrastim for assisting neutrophil recovery following induction and consolidation chemotherapy for de novo AML in patients with low-to-intermediate risk cytogenetics.
Patients (n = 84) received one or two courses of standard induction chemotherapy (idarubicin + cytarabine), followed by one course of consolidation therapy (high-dose cytarabine) if complete remission was achieved. They were randomized to receive either single-dose pegfilgrastim 6 mg or daily filgrastim 5 μg/kg, beginning 24 hours after induction and consolidation chemotherapy.
The median time to recovery from severe neutropenia was 22.0 days for both pegfilgrastim (n = 42) and filgrastim (n = 41) groups during Induction 1 (difference 0.0 days; 95% CI: -1.9 to 1.9). During Consolidation, recovery occurred after a median of 17.0 days for pegfilgrastim versus 16.5 days for filgrastim (difference 0.5 days; 95% CI: -1.1 to 2.1). Therapeutic pegfilgrastim serum concentrations were maintained throughout neutropenia. Pegfilgrastim was well tolerated, with an adverse event profile similar to that of filgrastim.
These data suggest no clinically meaningful difference between a single dose of pegfilgrastim and multiple daily doses of filgrastim for shortening the duration of severe neutropenia following chemotherapy in de novo AML patients with low-to-intermediate risk cytogenetics.
To investigate whether pharmacy students' anonymous peer assessment of a medication management review (MMR) was constructive, consistent with the feedback provided by an expert tutor, and enhanced the students' learning experience.
Fourth-year undergraduate pharmacy students were randomly and anonymously assigned to a partner and participated in an online peer assessment of their partner's MMR.
An independent expert graded a randomly selected sample of the MMR's using a schedule developed for the study. A second expert evaluated the quality of the peer and expert feedback. Students also completed a questionnaire and participated in a focus group interview. Student peers gave significantly higher marks than an expert for the same MMR; however, no significant difference between the quality of written feedback between the students and expert was detected. The majority of students agreed that this activity was a useful learning experience.
Anonymous peer assessment is an effective means of providing additional constructive feedback on student performance on the medication review process. Exposure to other students' work and the giving and receiving of peer feedback were perceived as valuable by students.
peer assessment; medication therapy management; assessment
Remarkable technological advances of fibreoptic endoscopy in the past two decades have produced important improvements in diagnosis and treatment of gastrointestinal and hepatobiliary disorders. These advances must be kept in perspective; continuing, critical assessment of their contribution to the management of patients is desirable. Endoscopy can have adverse effects on the total performance of departments of gastroenterology, on gastroenterology as a discipline, and even on the status of the medical profession in the community. Gastroenterologists need to show proficiency of performance and integrity of practice. Control may be achieved by certification delineation of privileges, peer review, public accountability, and realistic financial returns for procedures. Records of a department of gastroenterology indicate that some control may be achieved by insistence on a consultation before decision on endoscopy. This may be a desirable alternative to endoscopy on demand. Undue emphasis on technology runs some risk of destroying the proper practice of consultant medicine.
Pegfilgrastim-induced bone pain is a significant clinical problem that may result in discontinuation of pegfilgrastim and lead to less effective chemotherapy dosing. Interventions for pegfilgrastim-induced bone pain are needed.
Patients and Methods
The University of Rochester Cancer Center Clinical Community Oncology Program Research Base randomly assigned 510 patients at 17 sites to receive either naproxen (500 mg two times per day) or placebo on the day of pegfilgrastim administration, continuing for 5 to 8 days after pegfilgrastim. Patients recorded pain severity (using a scale of 0 to 10) and duration in daily diaries. The primary outcome measure was the area under the curve (AUC) for pain for days 1 through 5. Secondary outcome measures included the identification of risk factors for the development of pain and response to naproxen.
Patients' mean age was 55.6 years and 86% were female. Sixty-eight percent of patients had breast cancer and 10% had lung cancer. Pain reached its peak at 3 days for both groups. The mean AUC for pain was 7.71 for the placebo group and 6.04 for the naproxen group (P = .037). Naproxen reduced maximum pain from 3.40 to 2.59 (P = .005). Naproxen also reduced overall pain incidence from 71.3% to 61.1% (P = .020) and duration from 2.40 to 1.92 days (P = .009). The reduction in severe pain (> 5 on a scale of 1 to 10) from 27.0% to 19.2% was also significant (P = .048). Risk factors could not be identified to predict incidence, severity, or ability to prevent pegfilgrastim-induced bone pain.
Our phase III randomized placebo-controlled clinical trial demonstrated that naproxen at a dose of 500 mg twice per day is effective in reducing the incidence and severity of pegfilgrastim-induced bone pain.
Febrile neutropenia (FN) occurs following myelosuppressive chemotherapy and is associated with morbidity, mortality, costs, and chemotherapy reductions and delays. Granulocyte colony-stimulating factors (G-CSFs) stimulate neutrophil production and may reduce FN incidence when given prophylactically following chemotherapy.
A systematic review and meta-analysis assessed the effectiveness of G-CSFs (pegfilgrastim, filgrastim or lenograstim) in reducing FN incidence in adults undergoing chemotherapy for solid tumours or lymphoma. G-CSFs were compared with no primary G-CSF prophylaxis and with one another. Nine databases were searched in December 2009. Meta-analysis used a random effects model due to heterogeneity.
Twenty studies compared primary G-CSF prophylaxis with no primary G-CSF prophylaxis: five studies of pegfilgrastim; ten of filgrastim; and five of lenograstim. All three G-CSFs significantly reduced FN incidence, with relative risks of 0.30 (95% CI: 0.14 to 0.65) for pegfilgrastim, 0.57 (95% CI: 0.48 to 0.69) for filgrastim, and 0.62 (95% CI: 0.44 to 0.88) for lenograstim. Overall, the relative risk of FN for any primary G-CSF prophylaxis versus no primary G-CSF prophylaxis was 0.51 (95% CI: 0.41 to 0.62). In terms of comparisons between different G-CSFs, five studies compared pegfilgrastim with filgrastim. FN incidence was significantly lower for pegfilgrastim than filgrastim, with a relative risk of 0.66 (95% CI: 0.44 to 0.98).
Primary prophylaxis with G-CSFs significantly reduces FN incidence in adults undergoing chemotherapy for solid tumours or lymphoma. Pegfilgrastim reduces FN incidence to a significantly greater extent than filgrastim.
Clinical Practice Guidelines (CPGs) have been published on a number of topics in spinal cord injury (SCI) medicine. Research in the general medical literature shows that the distribution of CPGs has a minimal effect on physician practice without targeted implementation strategies. The purpose of this study was to determine (a) whether dissemination of an SCI CPG improved the likelihood that patients would receive CPG recommended care and (b) whether adherence to CPG recommendations could be improved through a targeted implementation strategy. Specifically, this study addressed the “Neurogenic Bowel Management in Adults with Spinal Cord Injury” Clinical Practice Guideline published in March 1998 by the Consortium for Spinal Cord Medicine
CPG adherence was determined from medical record review at 6 Veterans Affairs SCI centers for 3 time periods: before guideline publication (T1), after guideline publication but before CPG implementation (T2), and after targeted CPG implementation (T3). Specific implementation strategies to enhance guideline adherence were chosen to address the barriers identified by SCI providers in focus groups before the intervention.
Overall adherence to recommendations related to neurogenic bowel did not change between T1 and T2 (P = not significant) but increased significantly between T2 and T3 (P < 0.001) for 3 of 6 guideline recommendations. For the other 3 guideline recommendations, adherence rates were noted to be high at T1.
While publication of the CPG alone did not alter rates of provider adherence, the use of a targeted implementation plan resulted in increases in adherence rates with some (3 of 6) CPG recommendations for neurogenic bowel management.
Spinal cord injuries; Neurogenic bowel; Practice guidelines; Consensus guidelines; Patient education
To explore the “how” and “why” of care decision making by frontline providers of maternal and newborn services in the Greater Accra region of Ghana and determine appropriate interventions needed to support its quality and related maternal and neonatal outcomes.
A cross sectional and descriptive mixed method study involving a desk review of maternal and newborn care protocols and guidelines availability, focus group discussions and administration of a structured questionnaire and observational checklist to frontline providers of maternal and newborn care.
Tacit knowledge or ‘mind lines’ was an important primary approach to care decision making. When available, protocols and guidelines were used as decision making aids, especially when they were simple handy tools and in situations where providers were not sure what their next step in management had to be. Expert opinion and peer consultation were also used through face to face discussions, phone calls, text messages, and occasional emails depending on the urgency and communication medium access. Health system constraints such as availability of staff, essential medicines, supplies and equipment; management issues (including leadership and interpersonal relations among staff), and barriers to referral were important influences in decision making. Frontline health providers welcomed the idea of interventions to support clinical decision making and made several proposals towards the development of such an intervention. They felt such an intervention ought to be multi-faceted to impact the multiple influences simultaneously. Effective interventions would also need to address immediate challenges as well as more long-term challenges influencing decision-making.
Supporting frontline worker clinical decision making for maternal and newborn services is an important but neglected aspect of improved quality of care towards attainment of MDG 4 & 5. A multi-faceted intervention is probably the best way to make a difference given the multiple inter-related issues.
International interest in peer-teaching and peer-assisted learning (PAL) during undergraduate medical programs has grown in recent years, reflected both in literature and in practice. There, remains however, a distinct lack of objective clarity and consensus on the true effectiveness of peer-teaching and its short- and long-term impacts on learning outcomes and clinical practice.
To summarize and critically appraise evidence presented on peer-teaching effectiveness and its impact on objective learning outcomes of medical students.
A literature search was conducted in four electronic databases. Titles and abstracts were screened and selection was based on strict eligibility criteria after examining full-texts. Two reviewers used a standard review and analysis framework to independently extract data from each study. Discrepancies in opinions were resolved by discussion in consultation with other reviewers. Adapted models of “Kirkpatrick’s Levels of Learning” were used to grade the impact size of study outcomes.
From 127 potential titles, 41 were obtained as full-texts, and 19 selected after close examination and group deliberation. Fifteen studies focused on student-learner outcomes and four on student-teacher learning outcomes. Ten studies utilized randomized allocation and the majority of study participants were self-selected volunteers. Written examinations and observed clinical evaluations were common study outcome assessments. Eleven studies provided student-teachers with formal teacher training. Overall, results suggest that peer-teaching, in highly selective contexts, achieves short-term learner outcomes that are comparable with those produced by faculty-based teaching. Furthermore, peer-teaching has beneficial effects on student-teacher learning outcomes.
Peer-teaching in undergraduate medical programs is comparable to conventional teaching when utilized in selected contexts. There is evidence to suggest that participating student-teachers benefit academically and professionally. Long-term effects of peer-teaching during medical school remain poorly understood and future research should aim to address this.
peer-teaching; peer-assisted learning; near-peer teaching; medical student; medical school