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PubMed2001

[The roles of pharmacists on prior review of clinical trials].

A prior review system for clinical trials was introduced into The University of Tokyo Hospital in March 1999, for the purpose of supporting the Institutional Review Board (IRB). In this study, we investigated the effect of this system on IRB, and evaluated roles of pharmacists involved in utilizing this prior review system. An average period from the acceptance of regular application of each protocol to the approval of IRB was 1.7 months, and the period was significantly shorter than that before the introduction of this system (2.3 months). On the other hand, the number of instructions given to applicants increased to be 2.8 times before the introduction of this system, suggesting the improvement of the quality of this prior review system. In the prior review, the number of instructions pointed out from pharmacists concerning pharmacokinetics, pharmacodynamics, drug-interactions, adverse reactions, and the other matters related to investigational drugs was greater than that from doctors or nurses. According to the results of the surveys for doctors, nurses, and other clerical employees, pharmacists were indicated to review from a pharmaceutical point of view and their review was found to be very important. In conclusion, the prior review system was considered to be useful for the rational practice of clinical trials and pharmacists were recognized to be indispensable as reviewers on the prior review.

Clinical Trials as Topic↗
PubMed2002

The reliability of medical record review for estimating adverse event rates.

BACKGROUND: The data used by the U.S. Institute of Medicine to estimate deaths from medical errors come from a study that relied on nurse and physician reviews of medical records to detect the errors. OBJECTIVE: To measure the reliability of medical record review for detecting adverse events and negligent adverse events. DESIGN: Medical record review. SETTING: Hospitalizations in Utah and Colorado in 1992. MEASUREMENTS: After three independent reviews of 500 medical records, the following were measured: reliability and the effect of varying criteria for reviewer confidence in and reviewer agreement about the presence of adverse events. RESULTS: For agreements in judgments of adverse events among the three sets of reviews, the kappa statistics ranged from 0.40 to 0.41 (95% CIs ranged from 0.30 to 0.51) for adverse events and from 0.19 to 0.23 (CIs, 0.05 to 0.37) for negligent adverse events. Rates for adverse events and for negligent adverse events varied substantially depending on the degree of agreement and the level of confidence that was required among reviewers. CONCLUSION: Estimates of adverse event rates from medical record review, including those reported by the Institute of Medicine in its 2000 report on medical errors, are highly sensitive to the degree of consensus and confidence among reviewers.

Colorado↗
PubMed2003

Developing primary care review criteria from evidence-based guidelines: coronary heart disease as a model.

BACKGROUND: National Health Service (NHS) initiatives such as Clinical Governance, National Service Frameworks and the National Institute of Clinical Excellence (NICE) clinical guidelines programme create demand for tools to enable performance review by healthcare professionals. Ideally such tools should enable clinical teams to assess quality of care and highlight areas of good practice or where improvement is needed. They should also be able to be used to demonstrate progress towards goals and promote quality, while not unnecessarily increasing demand on limited resources or weakening professional control. AIM: To formulate and evaluate a method for developing, from clinical guidelines, evidence-based review criteria that are proritised, useful and relevant to general practices assessing quality of care for the primary care management of coronary heart disease (CHD). DESIGN OF STUDY: A two-stage study comprising, first, a review of available evidence-based guidelines for CHD and, second, the definition and prioritization of associated review criteria from the most highly rated guidelines. SETTING: Primary healthcare teams in England. METHODS: Using structured methods, evidence-based clinical guidelines for CHD were identified and appraised to ensure their suitability as the basis for developing review criteria. Recommendations common to a number of guidelines were priortszid by a panel of general practitioners to develop review criteria suitable for use in primary care. RESULTS: A standardised method has been developed for constructing evidence-based review criteria from clinical guidelines. A limited, prioritized set of review criteria was developed for the primary care management of CHD. This was distributed around the NHS through the Royal College of General Practitioners for use by primary care teams across the United Kingdom. CONCLUSION: Developing useful, evidence-based review criteria is not a straightforward process, partly because of a lack of consistency and clarity in guidelines currently available. A method was developed which accommodated these limitations and which can be applied to the development and evaluation of review criteria from guidelines for other conditions.

Coronary Disease↗
PubMed2005

Cost-effectiveness of telephone or surgery asthma reviews: economic analysis of a randomised controlled trial.

BACKGROUND: Only about a third of people with asthma attend an annual review. Clinicians need to identify cost-effective ways to improve access and ensure regular review. AIM: To compare the cost-effectiveness of nurse-led telephone with face-to-face asthma reviews. DESIGN OF STUDY: Cost-effectiveness analysis based on a 3-month randomised controlled trial. SETTING: Four general practices in England. METHOD: Adults due an asthma review were randomised to telephone or face-to-face consultations. Trial nurses recorded proportion reviewed, duration of consultation, and abortive calls/missed appointments. Data on use of healthcare resources were extracted from GP records. Cost-effectiveness was assessed from the health service perspective; sensitivity analyses were based on proportion reviewed and duration of consultation. RESULTS: A total of 278 people with asthma were randomised to surgery (n = 141) or telephone (n = 137) review. Onehundred-and-one (74%) of those with asthma in the telephone group were reviewed versus 68 (48%) in the surgery group (P <0.001). Telephone consultations were significantly shorter (mean duration telephone = 11.19 minutes [standard deviation {SD} = 4.79] versus surgery = 21.87 minutes [SD = 6.85], P <0.001). Total respiratory healthcare costs per patient over 3 months were similar (telephone = pounds sterling 64.49 [SD = 73.33] versus surgery = pounds sterling 59.48 [SD = 66.02], P = 0.55). Total costs of providing 101 telephone versus 68 face-to-face asthma reviews were also similar (telephone = pounds sterling 725.84 versus surgery = pounds sterling 755.70), but mean cost per consultation achieved was lower in the telephone arm (telephone = pounds sterling 7.19 [SD = 2.49] versus surgery = pounds sterling 11.11 [SD = 3.50]; mean difference = - pounds sterling 3.92 [95% confidence interval = - pounds sterling 4.84 to pounds sterling 3.01], P <0.001). CONCLUSIONS: Telephone consultations enable a greater proportion of asthma patients to be reviewed at no additional cost to the health service. This mode of delivering care improves access and reduces cost per consultation achieved.

Asthma↗
PubMedDate not supplied

Peer review organization payment denials: comparative analysis of emergency department and non-emergency-department admissions.

The Health Care Financing Administration has contracted with regional peer review organizations to review Medicare admissions and to deny payment for hospital admissions that fail to meet peer review organization criteria. The purpose of this study was to compare emergency department admissions with non-emergency-department admissions with respect to rates of peer review organization denial and the reasons for those denials. All hospital Medicare admissions between January 1984 and April 1987 were retrospectively reviewed. Patients were excluded if they received peer review organization pre-authorization prior to admission. The rest were classified by 1) source of admission (emergency department or non-emergency department), 2) peer review organization decision, 3) reason for peer review organization denial, 4) whether the denial was appealed, 5) the results of appeal. Chi-square or Fisher's Exact Test analysis was performed, and P less than 0.05 was considered to be significant. During the 40-month study period, there were 19,847 emergency department Medicare admissions and 19,752 non-emergency-department Medicare admissions. Of the non-emergency-department admissions, 7887 received pre-authorization. None of the emergency department admissions received pre-authorization. Of the 19,847 emergency department admissions, 433 (2.23%) were denied. Of these denials, 269 (60.7%) were appealed by the hospital; 136 (50.5%) successfully. Of the 11,865 non-emergency department, non-pre-authorized admissions, 333 (2.81%) were denied. Of these denials, 174 (52.2%) were appealed, 76 (43.6%) successfully. Overall, emergency department admissions were significantly less likely to receive peer review organization denial than non-emergency-department, non-pre-authorized admissions (P less than 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2004

The use of systematic reviews and meta-analyses in infection control and hospital epidemiology.

Systematic review is a type of research that attempts to identify and summarize all of the evidence related to a specific research question. It can be thought of as a "pause" in the process of conducting research in a particular area, in which the following questions are asked: Based on all of the available evidence, what do we know about this specific question so far, and what future studies should be conducted to clarify areas of uncertainty? The systematic review arose as an alternative to the traditional narrative review-which allows authors to pick and choose the studies they discuss and the depth at which they discuss them-a process prone to bias. By adhering to a prospectively defined protocol that specifies how studies should be identified, evaluated, and statistically combined (the statistical process is a component of systematic review and is called "meta-analysis"), systematic reviews reduce the bias inherent to traditional narrative reviews. Systematic reviews are an increasingly common form of published research, and several of the approximately 1000 such studies that are published annually focus on topics important to infection control professionals. Consequently, it is essential that infection control professionals and hospital epidemiologists be able to understand and evaluate the quality of this useful research design. This article discusses the essential elements of a systematic review, provides a framework for evaluating the quality of such an article, and will help the infection control professional and hospital epidemiologist in determining whether the results of such reviews should change clinical practice.

Cross Infection↗
PubMedDate not supplied

Inter- and intrarater reliability of retrospective drug utilization reviewers.

OBJECTIVE: To assess inter- and intrarater reliability among 23 pharmacist and physician retrospective drug utilization reviewers and to assess interrater reliability after a reviewer training session. DESIGN: Exploratory study. SETTING: Maryland Medicaid's retrospective drug utilization review (DUR) program. PARTICIPANTS: 23 physician and pharmacist retrospective drug utilization reviewers. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Profiles rated as "intervention indicated" or "intervention not indicated." Cochran's Q test, overall percent agreement, and the unweighted kappa statistic were used in the analysis of review consistency. RESULTS: Intrarater reliability showed substantial consistency among the 23 reviewers; the percent agreement was 82.9% with kappa = 0.66. Interrater reliability, however, was poor, with an overall agreement of 69.6% and kappa = 0.16. Interrater reliability was also poor after a one-hour reviewer training session (agreement 81.8%, kappa = -0.19). CONCLUSION: The implicit review process used in the retrospective DUR program that we evaluated was unreliable. Since reliability is a necessary but not sufficient condition for validity of an indicator of inappropriate drug use, the validity of the DUR implicit review process is in question.

Data Interpretation, Statistical↗
PubMed2006

Pitfalls in systematic reviews.

PURPOSE OF REVIEW: The term 'evidence-based medicine' means integrating individual clinical expertise with the best available external clinical evidence from systematic research. An important source for those who wish to practise evidence-based medicine is the systematic review. Systematic reviews, however, are not without their pitfalls. This review will consider the problems and challenges for researchers and users of systematic reviews. RECENT FINDINGS: Failure to adequately assess study quality, funding bias, publication bias, reliance on outcomes that provide no help in clinical decision-making, analysis errors and the incorrect use of evidence statements are all common pitfalls in systematic reviews. SUMMARY: There are several steps in completing a systematic review. These include developing the clinical question, searching for all available literature, study selection, assessment of study quality, data extraction, data analysis, interpreting the results, implications for practice and further research, and finally updating the review in a timely manner. Authors of systematic reviews need to be aware of these problems and attempt to address them so that research evidence may be of clinical value to both providers and consumers of healthcare.

Evidence-Based Medicine↗
PubMed1996

Manuscript reviewing: too long a concealed form of scholarship?

Reviewing manuscripts prior to publication is an increasingly time consuming activity for many professionals. This paper proposes that reviewing is a significant form of scholarship that deserves more overt attention, and an increased level of sharing among reviewers on their unique approach to the task. A review of relevant literature reveals a range of reviewing procedures and practices among journals, some of which are relatively novel within nursing. Research is reportedly scant on the topic, and the research that has been undertaken shows that the best reviewers are not necessarily the most senior; indeed the more senior and busy the reviewer, the more likely the review shall be superficial and hasty. Within this paper I include a personal approach to reviewing that draws upon the thinking of Richard Bernstein and promotes a "conversational'-as apposed to an "adversarial'-style.

Humans↗
PubMed2004

A process for systematically reviewing the literature: providing the research evidence for public health nursing interventions.

BACKGROUND: Several groups have outlined methodologies for systematic literature reviews of the effectiveness of interventions. The Effective Public Health Practice Project (EPHPP) began in 1998. Its mandate is to provide research evidence to guide and support the Ontario Ministry of Health in outlining minimum requirements for public health services in the province. Also, the project is expected to disseminate the results provincially, nationally, and internationally. Most of the reviews are relevant to public health nursing practice. AIMS: This article describes four issues related to the systematic literature reviews of the effectiveness of public health nursing interventions: (1) the process of systematically reviewing the literature, (2) the development of a quality assessment instrument, (3) the results of the EPHPP to date, and (4) some results of the dissemination strategies used. METHODS: The eight steps of the systematic review process including question formulation, searching and retrieving the literature, establishing relevance criteria, assessing studies for relevance, assessing relevant studies for methodological quality, data extraction and synthesis, writing the report, and dissemination are outlined. Also, the development and assessment of content and construct validity and intrarater reliability of the quality assessment questionnaire used in the process are described. RESULTS: More than 20 systematic reviews have been completed. Content validity was ascertained by the use of a number of experts to review the questionnaire during its development. Construct validity was demonstrated through comparisons with another highly rated instrument. Intrarater reliability was established using Cohen's Kappa. Dissemination strategies used appear to be effective in that professionals report being aware of the reviews and using them in program planning/policymaking decisions. CONCLUSIONS: The EPHPP has demonstrated the ability to adapt the most current methods of systematic literature reviews of effectiveness to questions related to public health nursing. Other positive outcomes from the process include the development of a critical mass of public health researchers and practitioners who can actively participate in the process, and the work on dissemination has been successful in attracting external funds. A program of research in this area is being developed.

Confounding Factors, Epidemiologic↗
PubMed2001

What is evidence-based medicine and the role of the systematic review: the revolution coming your way.

The practice of evidence-based medicine involves the critical application of current best evidence to the care of individual patients. This process requires clinicians to be able to efficiently locate, critically appraise and appropriately apply the best available evidence to particular clinical scenarios. The current volume of medical and scientific literature is unmanageable and traditional approaches to continuing education cannot fully address the information needs of practicing clinicians in the era of evidence-based medicine. Review articles are useful resources but traditional narrative reviews often include a selective summary of research findings mixed with personal opinion. Systematic reviews have many advantages over traditional narrative reviews; importantly, the use of systematic and explicit methods mean that bias in identifying, selecting and summarizing the evidence is minimized. For systematic reviews where meta-analysis can be performed, the quantitative synthesis of data from different studies can provide additional information. Systematic reviews are retrospective studies and like all research may be susceptible to bias. Furthermore some methodological issues related to meta-analysis have yet to be resolved. The strengths and limitations of systematic reviews are discussed in this article and useful resources for locating high quality systematic reviews are outlined. Clinical judgement and experience have a pivotal role in the practice of evidence-based medicine and clinicians must rely on this judgement when deciding how and when to apply the results of systematic reviews to particular patients.

Clinical Competence↗
PubMed2002

Reading systematic reviews.

BACKGROUND: While systematic reviews should be of assistance in decision making, currently many reviews are unreliable, poorly reported or not clinically useful. It is therefore important that they are read critically. OBJECTIVES: The objective is to provide a logical way to appraise systematic reviews. Particular objectives are to demonstrate how to use a validated general guide for appraising systematic reviews; amend the guide so that it can be used to appraise systematic reviews of controlled trials, prognostic studies and studies evaluating diagnostic tests; choose between discordant reviews and assess the usefulness of good systematic reviews. DISCUSSION: Guidelines for undertaking and reporting systematic reviews should eventually improve their quality and usefulness. In the meantime, reviews must be appraised critically, particularly those outside the Cochrane Library.

Data Interpretation, Statistical↗
PubMed1995

Comprehensiveness and bias in reporting clinical trials. Study of reviews of pneumococcal vaccine effectiveness.

PURPOSE: To assess the extent to which relevant controlled clinical trials are cited and summarized in review articles, and to determine whether citation of relevant clinical trails is biased as to study results. DATA SOURCES: Articles were identified by searching MEDLINE and EMBASE databases. STUDY SELECTION: Review articles published between 1986 and 1988 on the clinical effectiveness of pneumococcal vaccine. DATA EXTRACTION: Proportion of relevant clinical trials cited and whether citation is biased by study results. DATA SYNTHESIS: The proportion of relevant primary studies cited per review article ranged from 0% to 36% (mean 9%). The number of trials cited per review ranged from zero to six (mean 1.2). In nine of 17 reviews, no clinical trials were cited. Study populations and outcome(s) were specified and results presented quantitatively for 0 to 27% of relevant trials per review (mean 6%). Unsupportive trials were almost twice as likely to be cited as supportive trials. CONCLUSIONS: Reporting of the results of relevant clinical trials in reviews of pneumococcal vaccine effectiveness is incomplete. Our findings suggest a need for greater scientific rigour in preparing, reviewing, and editing review articles.

Bacterial Vaccines↗
PubMed1998

The Cochrane Skin Group. Preparing, maintaining, and disseminating systematic reviews of clinical interventions in dermatology.

In 1979, Prof Archie Cochrane challenged the medical profession to produce a critical summary of randomized controlled clinical trials according to specialty, which should be updated periodically. The Cochrane Collaboration, an international voluntary group of reviewers and researchers from a range of professional backgrounds dedicated to producing systematic reviews, was established in 1992 in response to Cochrane's challenge. Systematic reviews produced by the Cochrane Collaboration start with individuals who formulate questions that are important to the care of patients. Every effort is then made to locate published and unpublished evidence to answer the question, and explicit criteria are used to select studies for inclusion in the review and to assess their quality. If appropriate, meta-analysis is used to combine results from several smaller studies to produce an overall result. Reviews are published in the Cochrane Library, an electronic publication (CD-ROM or diskette form), and the reviews are updated quarterly. In December 1997, a Cochrane Skin Group was registered with the Cochrane Collaboration to prepare, maintain, and disseminate reviews on the effects of health care for people with dermatological conditions. Currently, 25 titles and 9 review protocols have been registered with the Cochrane Skin Group, and the first set of dermatological reviews will be available before the end of 1999. The Cochrane Skin Group aims to become the best source of unbiased external evidence for summarizing the effects of dermatological care.

Dermatology↗
PubMed1993

The attitudes of family physicians toward the peer review process.

We conducted a study to determine family physicians' attitudes and perceptions toward current peer review practices, and to discover if family physicians, general surgeons, and hospital-based physicians view the process differently. A survey instrument measured perceptions of physicians on the following four areas of the peer review process: (1) how peer reviews are administered, (2) the educational value of peer reviews, (3) the performance of peer review committees, and (4) the effect of the peer review process on physician morale. The survey was mailed to all 3528 practicing physicians who were members of a state medical society. A subgroup of 1695 family physicians, general surgeons, and hospital-based physicians was used for this study, of whom 774 (46%) responded to the questionnaire. Over one half of the family physicians responded negatively toward the peer review process on all items of the survey, with over 70% dissatisfied on five of the 17 items. Family physicians, general surgeons, and hospital-based physicians viewed the peer review process differently in the four areas measured. We found statistically significant differences of opinions regarding present peer review practices among the specialties cited. However, the overall dissatisfaction of the specialty groups studied may suggest that the concern resides more with the profession at large than with any one medical specialty group.

Analysis of Variance↗
PubMed2002

Prevalence of honorary and ghost authorship in Cochrane reviews.

CONTEXT: To determine the prevalence of honorary and ghost authorship in Cochrane reviews, how authorship is assigned, and the ways in which authors and Cochrane editorial teams contribute. METHODS: Using a Web-based, self-administered survey, corresponding authors for 577 reviews published in issues 1 and 2 from 1999 of The Cochrane Library were invited to report on the prevalence of honorary and ghost authors, contributions by authors listed in the byline and members of Cochrane editorial teams, and identification of methods of assigning authorship. Responses were received for 362 reviews (63% response rate), which contained 913 authors. RESULTS: One hundred forty-one reviews (39%) had evidence of honorary authors, 32 (9%) had evidence of ghost authors (most commonly a member of the Cochrane editorial team), and 9 (2%) had evidence of both honorary and ghost authors. The editorial teams contributed in a wide variety of ways to 301 reviews (83%). Authorship was decided by the group of authors (31%) or lead author (25%) in most reviews. Authorship order was assigned according to contribution in most reviews (76%). The 3 functions contributed to most by those listed in the byline were assessing the quality of included studies (83%), interpreting data (82%), and abstracting data from included studies (77%). CONCLUSIONS: A substantial proportion of reviews had evidence of honorary and ghost authorship. The Cochrane editorial teams contributed to most Cochrane reviews.

Authorship↗
PubMed2002

Prodding tardy reviewers: a randomized comparison of telephone, fax, and e-mail.

CONTEXT: To compare telephone, fax, and e-mail methods of prodding tardy reviewers. METHODS: Randomized trial conducted January 1998 through June 1999 at the main editorial office of Obstetrics & Gynecology. Reviewers who had failed to file reviews by 28 days after being sent manuscripts (7 days after deadline) were sent identical messages in oral (telephone) or written (fax and e-mail) form inquiring as to the status of review, asking for its completion as soon as possible, and requesting it be sent by fax or e-mail. RESULTS: Of 378 reviewers, proportions returning reviews within 7 days were essentially identical: telephone, 85 (68%) of 125; fax, 86 (67%) of 129; and e-mail, 84 (67%) of 124 (P =.59). In the two thirds who responded, the mean time to return reviews did not differ among the 3 groups. CONCLUSION: Contacting tardy reviewers resulted in a review being received within 7 days in about two thirds of cases, and it made no difference if the contact was made by telephone, fax, or e-mail.

Computer Communication Networks↗
PubMed2002

Identifying manuscript reviewers: randomized comparison of asking first or just sending.

CONTEXT: Some journals routinely query potential referees before sending manuscripts ("askfirst"), whereas others just send manuscripts and allow referees to opt out ("justsend"). It is not known which protocol results in more completed reviews or shorter review time. METHODS: Trial to assess proportion of referee turndowns and length of review process, conducted at editorial office of Obstetrics & Gynecology and involving 283 consecutive qualifying manuscripts. For each, a referee was randomly assigned to askfirst (manuscript sent only after affirmative response within 3 days) and another to justsend (manuscript sent with request to review; could opt out). RESULTS: Only 64% of askfirst referees assented initially (15% declined [vs 8% for justsend, P =.008] and 21% failed to respond within 3 working days, necessitating a replacement). But once manuscript was mailed, mean time to file a review was significantly shorter for askfirst (21.0 vs 25.0 days, P<.001); thus, overall time to receipt of review did not differ significantly (24.7 vs 25.9 days, P =.19), nor did review quality (P =.39). CONCLUSION: Askfirst led to a higher rate of referee turndown than did justsend, but assenting askfirst referees completed reviews faster. The overall time for the review process did not differ between the 2 protocols.

Manuscripts, Medical as Topic↗