Individual Case Review Research Articles

Quality assurance in radiotherapy: from radiation physics to patient- and trial-oriented control procedures

The stepwise process of the EORTC Quality Assurance Programme in Radiotherapy is described in function of two main criteria: the targets of the quality control procedures implemented, in Radiation Physics and clinical research, by the EORTC Radiotherapy Group and the development of both trial- and patient-oriented quality systems. This exhaustive program, which started in 1982, is characterised by three main periods. The first one was fully dedicated to pioneer steps in Radiation Physics measurements, on-site audits and inventories of human resources, staff workload and department infrastructure in institutions participating to EORTC trials. During the second period, which started in the late 1980s, a series of quality systems were implemented to test the compliance of the investigators to follow protocol guidelines, through the use of standard and uniform control procedures like the dummy runs, in order to tackle systematic errors in the participating institutions. Finally, the third period, which took place in the 1990s, was essentially patient-oriented, thanks to large scale individual case reviews, to check the validity of data recording and reporting processes and trace random errors throughout the radiotherapy treatments. Most of the results collected during these two decades allowed the implementation of well codified quality control procedures which, nowadays, can be used outside the field of clinical research, by national societies or bodies willing to improve treatment standards on a large scale.

Outcome survey of early intensive behavioral intervention for young children with autism in a community setting.

This article presents findings from an outcome survey of the effects of early intensive behavioral intervention (EIBI) for young children with autism in a community setting. Results from both individual case reviews and parent questionnaires are presented, with the data failing to support any instances of'recovery' while still yielding a high degree of parental satisfaction with the treatment. Moreover, a follow-up inquiry into the type of services each child was receiving in his or her post-EIBI setting documents continued dependence on extensive educational and related developmental services, suggesting that the promise of future treatment sparing did not materialize. Limitations of the survey in evaluating community-based EIBI services are discussed along with the need for further research designed to document the effectiveness of services provided to young children with ASD in the community.

Vaginal birth after Caesarean section: an Australian multicentre study. VBAC Study Group.

Retrospective analysis of medical records and individual case review was undertaken at 11 major obstetric hospitals for a 5 year period from July 1992 to June 1997 to investigate rates of vaginal birth after Caesarean section (VBAC), the occurrences of uterine rupture, and the outcomes for mother and infant following rupture. Total deliveries were 234,015, of which 21,452 or 9.2% were associated with one or more previous Caesarean sections. Within this scar group, 5419 patients or 25.3% were delivered vaginally. There were 62 cases of significant uterine rupture with no maternal deaths. Perinatal mortality with rupture was 25% and serious maternal complications (usually hysterectomy) occurred in 25% of those with uterine rupture. In women attempting vaginal delivery after a previous lower segment Caesarean section, the uterine rupture rate was estimated at 0.3%, with 0.05% experiencing a perinatal death and 0.05% requiring a hysterectomy. Although VBAC rates in Australia remain lower than many overseas reported series, rates are increasing. While rupture continues to be associated with serious adverse outcomes, the incidence of rupture during trial of labour is low and appears to be associated with a better outcome than rupture of an unscarred uterus.

Serotonin syndrome

Aims and methodTo define serotonin syndrome and its symptoms and to discover which drugs or drug combinations are likely to cause it. A review of literature (including case reports) relating to serotonin syndrome collated from searches of MedLine and Micromedex covering the period January 1991 to July 1998.ResultsMost of the data found were either individual case reports or reviews of case reports. Reports of serotonin syndrome seem to be growing, certainly since the introduction of selective serotonin reuptake inhibitors. Particular combinations seem most likely to induce serotonin syndrome. Awareness of this syndrome as a distinct clinical entity seems to be growing.Clinical implicationsSerotonin syndrome is more likely to occur with drug combinations, especially those involving monoamine oxidase inhibitors. It can also occur when swapping antidepressant therapy, especially If changing from a long acting antidepressant such as fluoxetine. Caution is needed when changing antidepressants and particularly when they are used in combination.

Improving Care for Unstable Angina Patients in a Multiple Hospital Project Sponsored by a Federally Designated Quality Improvement Organization

In 1992, the Health Care Financing Administration (HCFA) implemented a major change in the methodology of the quality of care oversight activities conducted by Medicare Peer Review Organizations. The Health Care Quality Improvement Program (HCQIP) represented a shift in oversight activity direction from identifying and dealing with individual clinical errors to helping providers improve mainstream care. The change in the oversight activities of Peer Review Organizations has been so substantial that the organizations are now commonly referred to as Quality Improvement Organizations (QIOs). Since its introduction, the HCQIP has developed multiple cooperative projects between QIOs and participating hospitals to examine specific processes of care and to ultimately improve the quality of care provided to Medicare patients. This report describes one project in North Carolina focusing on inpatient treatment of patients with a principal diagnosis of unstable angina, one of the most frequent causes of hospital admissions for Medicare patients. Based on the guidelines for treating unstable angina issued by the Agency for Health Care Policy and Research, 5 measures of good medical care for these patients were selected as quality of care indicators. A total of 16 hospitals in North Carolina each provided medical records of approximately 50 Medicare patients discharged with a principal diagnosis of unstable angina. Our findings indicated that guidelines-recommended standard of care were met in only a minority of patients. These indicators of care—including ordering an electrocardiogram within the first hour of admission and admitting high-risk patients to the intensive care unit—all occurred in <50% of the patients. Moreover, use of drugs that improve outcomes in patients with unstable angina was lower than expected. Only 17% of eligible patients with unstable angina were discharged on a lipid-lowering medication. Although there was variation in compliance with the guidelines between types of hospitals, all hospitals had an opportunity to improve in at least one quality of care indicator. The data demonstrate that significant variances exist between published guidelines and actual practices. Given the high rates of readmission for patients with coronary disease, there is opportunity to improve compliance with recommended guidelines of good care. The new oversight activity direction taken by Medicare should ultimately improve care for more patients than could ever be achieved through individual case review.

Drug-related problems in elderly patients admitted to Tayside hospitals, methods for prevention and subsequent reassessment.

although drug-related problems (DRPs) are known to be prevalent in elderly patients, the literature on prevention of iatrogenic disease is sparse. The present study addresses this requirement. to assess the incidence of DRPs in elderly patients admitted to Tayside hospitals before (phase I) and after (phase II) implementation of preventive strategies. all elderly people admitted to hospital were screened by a pharmacist; individual case reviews were prepared for all those with a potential DRP and reviewed by a three-member panel which made a final decision on the presence of a DRP and its contribution to admission. all hospital wards admitting elderly patients in the Tayside region of Scotland. 1011 elderly patient admissions over a 9-month period (phase I); 857 elderly patient admissions over an 8-month period (phase II). incidence of DRPs before and after targeted intervention strategies (information bulletin for general practitioners, patient information leaflet, oral presentation to trainee general practitioners). in phase I, the incidence of DRPs was 144/1011 (14.2%), with 54/1011 (5.3%) of the admissions identified as being definitely or probably drug-related. Non-steroidal anti-inflammatory drugs (NSAIDs) were the main drug group involved, being responsible for 15/54 (28%) of admissions primarily due to a DRP. Over 66% of admissions due to adverse effects of NSAIDs were considered to be definitely preventable. In phase II, after targeted intervention strategies, there was no significant reduction in total incidence of DRPs or incidence of DRPs related to NSAIDs. However, there appeared to be an improvement in the first 4 months, and a significant drop in NSAID prescribing in Tayside compared with the rest of Scotland was observed. DRPs remain a significant problem in elderly patients and NSAIDs are the major contributor. The intervention strategies used in the study were not demonstrably effective, but a continuous programme of education may be necessary to limit NSAID use.

Study design, methodology and statistical analyses in the clinical development of sparfloxacin.

Many publications in the past 10 years have emphasised the difficulties of evaluating anti-infective drugs and the need for well-designed clinical trials in this therapeutic field. The clinical development of sparfloxacin in Europe, involving more than 4000 patients in ten countries, provided the opportunity to implement a methodology for evaluation and statistical analyses which would take into account actual requirements and past insufficiencies. This methodology focused on a rigorous and accurate patient classification for evaluability, subgroups of particular interest, efficacy assessment based on automation (algorithm) and individual case review by expert panel committees. In addition, the statistical analyses did not use significance testing but rather confidence intervals to determine whether sparfloxacin was therapeutically equivalent to the reference comparator antibacterial agents.

Eortc guidelines for writing protocols for clinical trials of radiotherapy

The concept of a Master Protocol for phase III studies was raised at the Steering Committee of the EORTC Radiotherapy Group, in order to make the work of the study coordinators easier, when writing protocols and to give them more homogeneity. The Master Protocol defines and clarifies in a logical order the different steps which must be taken when designing a randomized trial - from the rationale to the references. It pays particular attention to eligibility criteria, volumes of interest defined in agreement with ICRU Report 50 (gross tumor volume, clinical target volume, planning target volume and organs at risk), simulation procedure, treatment technique, normal tissue sparing, dose computation, equipment, dose specification (also in agreement with ICRU Report 50). Last but not least, the different procedures of quality assurance for protocols and patients are also defined (site visits, dummy run procedure, in vivo dosimetry, individual case review) to allow working plans to be made in advance. We are aware that this work is not exhaustive, but hope that the contents will be of help to those who are writing a protocol.

EORTC guidelines for writing protocols for clinical trials of radiotherapy

The concept of a Master Protocol for phase III studies was raised at the Steering Committee of the EORTC Radiotherapy Group, in order to make the work of the study coordinators easier, when writing protocols and to give them more homogeneity. The Master Protocol defines and clarifies in a logical order the different steps which must be taken when designing a randomized trial — from the rationale to the references. It pays particular attention to eligibility criteria, volumes of interest defined in agreement with ICRU Report 50 (gross tumor volume, clinical target volume, planning target volume and organs at risk), simulation procedure, treatment technique, normal tissue sparing, dose computation, equipment, dose specification (also in agreement with ICRU Report 50). Last but not least, the different procedures of quality assurance for protocols and patients are also defined (site visits, dummy run procedure, in vivo dosimetry, individual case review) to allow working plans to be made in advance. We are aware that this work is not exhaustive, but hope that the contents will be of help to those who are writing a protocol.

Hysterectomy, HMOs, and Appropriateness-Reply

In Reply. —We do not agree that individual case review is the criterion standard for making appropriateness determinations. In fact, no criterion standard exists and there are significant problems with the reliability of implicit peer review. 1 One advantage of the RAND/UCLA approach is that the appropriateness criteria are explicit; disagreements with the criteria can be discussed and results analyzed to determine the sensitivity of conclusions to controversial elements. While we know that some cases might be overturned on peer review because of extenuating clinical circumstances not covered by the guidelines or individual patient preferences, we also know this occurs among patients receiving care for both appropriate and inappropriate indications. Because of space limitations we did not mention in our Methods section that all patients whose care was scored as inappropriate were re-reviewed by a physician researcher to ensure that the data on which the ratings are based were accurate.

Hysterectomy, HMOs, and Appropriateness

To the Editor. —Several aspects of the study by Bernstein et al 1 deserve further discussion. In the absence of longitudinal, outcomes-based studies defining which patients benefit from a given intervention, efforts to determine appropriateness of care must rely on the use of expert opinion. Attempts to model the decision-making process of experts and incorporate expert opinion into a series of portable algorithms represent a major advancement in the development of appropriateness criteria. However, it is important to bear in mind the limitations inherent in this approach. Depending on the quality and quantity of scientific information available to them, experts frequently disagree, and even when they agree, experts can be wrong. Despite obvious weaknesses, the current criterion standard for appropriateness determinations is individual case review by experts in the same field. The design of the study by Bernstein et al assumes that the RAND protocols alone, without subsequent peer review

A paradigm shift for ethics committees and case consultation: A modest proposal

In conclusion, the expert-consultation model of ethics consultation is deeply imbedded in modern health care. The paradigm of consultant as expert rather than as community-enabler shapes the expectations and behaviors of healthcare personnel and institutions. This paradigm has also shaped the early stages of HEC development and ethics case consultation. It is time to shift paradigms and adopt one that derives more from the nature of ethics than from the nature of scientific medicine: the role of HECs should be to enable key professionals to carry out the ethical dimensions of patient care. When the HEC does review cases, it should be with the purpose of improving the institution, not of resolving individual cases. One consequence of this is that there will be more individual case reviews than before, but the function, emphasis, agents and locations will shift substantially. A second consequence is that the HEC will function more as an agent of social change by helping to harness the institution's resources. We judge both of these to be a welcome evolution in healthcare ethics.

Identification of Preventable Trauma Deaths

The published evaluation of methods for identifying preventable trauma deaths contains many unstudied confounding factors. To investigate the reliability of methods for identifying such preventable deaths, we compared three consensus systems using separate five-member general review panels assessing 20 non-central nervous system fatalities: panel A, independent judgments; panel B, discussion of all cases preceding individual judgments; and panel C, independent judgments followed by discussion and equivocal case reassignment. The Kappa concordance index was low for all methods (method A, 0.20; methods B and C, 0.40). Of the 11 deaths judged preventable by at least one panel, only one death was judged preventable by all three panels. Consensus agreement (four of five assessors) was 20% for panel A, 45% for panel B, and 10% for panel C (difference between panels B and C, p less than 0.03). In panel C, discussion affected the rate of equivocal case designation from 30% to 5%. Thus different consensus methods yielded different results. We conclude that individual case review can be severely flawed and therefore should not be used to measure institutional quality of patient care. We recommend that assessment of institutional performance should be based on objective evaluation methods, which require the study of patient population outcomes, rather than on subjective methods in which individual cases are reviewed.

The computer as an unbiased medical investigator: Experience on an active surgical service

An adaptable on-line computer system for entry, retrieval, and analysis of medical discharge summaries has been developed and applied in the Trauma Service of a busy city hospital. Each summary occupied 5 to 10 minutes of the physician's time and compared favorably in cost to the standard dictated summary. While the average dictated summary contained 15 ± 7 relevant facts, the machine-generated summaries were found to have 53 ± 20 relevant facts. The summaries are well organized, easily comprehensible, and a duplicate copy can be obtained at any time by using the patient's name or number for identification. To date, 495 discharge summaries have been entered and reside in the memory of the computer. Statistical analysis from the data base is done by the computer, thus eliminating human prejudice. It provides facility for rapid and accurate retrospective studies as well as pattern-of-care and individual case review.

Introducing Institutionalized Retardates to the Community

competence and community acceptance. These impressions from practice have been affirmed in follow-up research. In a com prehensive survey of studies reported on by Windle, Stewart, and Brown, the chief reason for community failure of subnormals released from institutions was given as dif ficulties of interpersonal relationship.1 Gunzburg further substantiates the need to prepare the retardate more adequately in social skills, stating they may need more help in this area than in vocational train ing.2 The impressions at the Johnstone Train ing and Research Center, Borden town, New Jersey, drawn from individual case reviews and surveys of students returning from com munity placement, point up similar needs and difficulties. Cohen reported that for

MULTIPLE SCLEROSIS IN CHILDREN

Reference to textbooks on pediatrics and neurology, individual case reports and review articles on multiple sclerosis showed that multiple sclerosis can occur in childhood in typical form and has been occasionally confirmed by necropsy. During the past year 3 children were seen at the Neurological Institute in New York in whom the diagnosis of multiple sclerosis seemed reasonably certain. Four additional patients are presented in whom that diagnosis was suspected. In the latter group years of observation will be required for confirmation of the diagnosis.