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Medical malpractice: a case study in medical and legal decision making.
The conference was organized in part to dispel some of the misinformation that interferes with cooperative efforts of attorneys and physicians to redress the malpractice situation. During discussion of the hypothetical case, participants identified how medical decision-making responsibilities were allocated among health care providers caring for the patient. Panel members suggested ways in which medical decision making might be affected by non-medical factors such as third-party reimbursement (e.g., selection of inpatient or outpatient setting, the opportunity to discuss issues related to informed consent prior to the day of a procedure) and potential malpractice litigation (e.g., documentation in charts, use of diagnostic procedures). The characterization of decision-making roles and responsibilities differed somewhat for purposes of malpractice litigation; that is, which caregivers might be named as defendants. Panel members reconstructed the development of the medical incident into a legal case. Plaintiff's attorney commented that it is often a hospital employee who advises the family to consult an attorney and described some of the constraints on information gathering (e.g., the rule of "discovery" requiring that suit be filed before defendants can be forced to give statements about what happened, insurance contract provisions prohibiting physicians from talking without legal counsel present to persons who indicate that they plan to file suit). He also briefly explained the rationale for the contingency fee arrangement in these cases. Describing the role of the medical expert witness and the need to review the medical record, he outlined the process of deciding whether to pursue a malpractice case. In making this decision, plaintiff's attorney evaluates the facts to identify issues in the case, to determine if there are deviations from the standard of care, and to try to predict jury reaction. If a suit is filed, defense attorneys employed by the hospital, insurance company, or individual defendants will decide, based on facts including coverage limits, possible publicity, and likelihood of successful prosecution, whether the case should be settled and for what amount. Interests represented by the defense attorneys differ and may affect settlement strategies. Physician feelings of concern for the patient/family or desire for vindication will, to varying degrees, be factors in the decision to try or settle a case. Panel members explored several important policy issues. Among these were the effect of malpractice cases on doctor-patient communications and ethical issues concerning expert witnesses.(ABSTRACT TRUNCATED AT 400 WORDS)
Requirements for clinical trials.
Significant progress and valuable contributions have been made by pioneers in the field of dental implantology during the past 20 years. The feasibility of clinical application of dental implants for specific prosthodontic conditions has been demonstrated by several reports based upon retrospective data or surveys of clinical experiences. However, there is a lack of reliable scientific information to determine the clinical efficacy of implant-supported prostheses or the physiological merits of the two types of implant-bone interface. Similarly, there are no known studies that have tested the relative efficacy of different implant systems. The claims of success rates for different implants can only be substantiated when controlled, independent studies are made, following research protocols that meet the requirements of clinical trials in terms of delineation of hypothesis, definition of treatment, entry and treatment allocations, exclusions and withdrawals, sample size, and a coordinated plan for the statistical analysis of data and interpretation of results. The study design of the VA Cooperative Study has followed the essential requirements of clinical trials in comparing the efficacies of the two treatment modalities--traditional removable partial dentures versus fixed partial dentures supported by implants.
A randomized, controlled clinical trial of a geriatric consultation team. Compliance with recommendations.
As part of a prospective, randomized, controlled study of the effectiveness of a geriatric consultation team, we examined compliance by the house staff with recommendations made by the team. Recommendations were formulated for 185 patients, aged 75 years or older, who were randomized into intervention (n = 92) and control (n = 93) groups. In the control group, only 27.1% of the actions that would have been recommended by the team were implemented independently by the house staff. Problems commonly neglected included polypharmacy, sensory impairment, confusion, and depression. In the intervention group, overall compliance was 71.7%. Highest compliance occurred for recommendations addressing instability and falls (95.0%) and discharge planning (94.3%). We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients. Furthermore, relatively high compliance can be achieved with recommendations made by a geriatric consultation team, thereby overcoming the first barrier to the establishment of such a service.
The conduct of a cooperative clinical trial.
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Second International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-threatening Illnesses.
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Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.
BACKGROUND: Transarterial chemoembolisation (TACE), a standard treatment for embolisation-eligible hepatocellular carcinoma (HCC), induces tumour immune responses. Single tremelimumab regular interval durvalumab (STRIDE) is a standard treatment in advanced HCC. In this phase 3 trial, we assessed the efficacy and safety of STRIDE, with or without lenvatinib, plus TACE, in participants with embolisation-eligible HCC. METHODS: EMERALD-3 is a phase 3, randomised, open-label, sponsor-blinded study, conducted at 177 medical sites in 21 countries. Eligible participants were 18 years or older (aged ≥21 years in Egypt or Singapore) at screening and had confirmed HCC (by imaging or histopathologically from biopsy specimen, surgery, or both) not amenable to curative surgery, curative ablation, or transplantation but amenable to TACE. Participants had Child-Pugh class A liver function, an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable target intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours. Participants were randomly allocated in a 1:1:1 ratio to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE until each group reached its preplanned enrolment target of 175 participants. After the STRIDE plus TACE group reached its enrolment target, randomisation was adjusted to continue in a 1:1 ratio between the STRIDE plus lenvatinib plus TACE group and TACE group until approximately 275 participants were enrolled in each of these two groups. Randomisation used a centrally assigned interactive response technology system, stratified by region, baseline tumour burden, and previous palliative embolisation. In the STRIDE plus lenvatinib plus TACE group, on the first day, participants were given 300 mg tremelimumab intravenously, followed by 1500 mg durvalumab plus oral lenvatinib (8 mg for <60 kg bodyweight or 12 mg for ≥60 kg bodyweight); participants then received 1500 mg durvalumab every 4 weeks plus once-daily lenvatinib for up to 36 cycles. In the STRIDE plus TACE group, participants were given 300 mg tremelimumab and 1500 mg durvalumab intravenously on the first day, followed by 1500 mg durvalumab every 4 weeks. The technique and number of TACE procedures were at the investigators' discretion, with the first procedure administered at least 7 days after the first dose of durvalumab in the two investigation treatment groups and within 7 days of random allocation in the TACE group. The primary endpoint was progression-free survival for STRIDE plus lenvatinib plus TACE versus TACE. Key secondary endpoints were overall survival for STRIDE plus lenvatinib plus TACE versus TACE and progression-free survival and overall survival for STRIDE plus TACE versus TACE. This study was registered with ClinicalTrials.gov (NCT05301842), with enrolment completed. FINDINGS: From March 28, 2022, to Nov 20, 2024, 1124 participants were screened. The full analysis set comprised 760 participants, who were randomly allocated to STRIDE plus lenvatinib plus TACE (n=293), STRIDE plus TACE (n=175), or TACE (n=292). 633 (83%) participants were male and 127 (17%) were female; 548 (72%) were Asian. At the first data cutoff (Sept 2, 2025); the overall median follow-up for progression-free survival was 10·0 months (IQR 4·6-17·2); median follow-up for progression-free survival was 11·0 months (IQR 4·8-18·4) for STRIDE plus lenvatinib plus TACE and 8·3 months (4·1-15·5) for TACE. Median progression-free survival was 13·0 months (95% CI 12·2-16·7) for STRIDE plus lenvatinib plus TACE versus 9·8 months (8·0-11·4) for TACE (HR 0·70 [95% CI 0·57-0·86]; p=0·0007). At the second data cutoff (Feb 23, 2026) and a median follow-up for overall survival of 24·6 months (IQR 16·5-31·5) for STRIDE plus lenvatinib plus TACE and 22·9 months (14·9-30·2) for TACE, median overall survival was 39·5 months (95% CI 34·1-not reached) for STRIDE plus lenvatinib plus TACE and 34·7 months (28·8-not reached) for TACE (HR 0·84 [95% CI 0·65-1·09]; p=0·18). At this data cutoff, median progression-free survival was 12·9 months (95% CI 10·2-15·9) for STRIDE plus TACE and 8·1 months (6·5-10·2) for the first 175 participants randomised to TACE (HR 0·71 [95% CI 0·56-0·91]), with median follow-up of 10·3 months (IQR 4·6-23·7) for STRIDE plus TACE and 7·7 months (3·0-18·5) for the first 175 participants randomly allocated to TACE. The most common adverse events of maximum grade 3 or 4 were hypertension (34 [12%] of 287) for STRIDE plus lenvatinib plus TACE, post-embolisation syndrome and anaemia (ten [6%] of 175 each) for STRIDE plus TACE, and post-embolisation (17 [6%] of 290) for TACE. 184 (64%) participants receiving STRIDE plus lenvatinib plus TACE, 89 (51%) receiving STRIDE plus TACE, and 68 (23%) receiving TACE had serious adverse events. Treatment-related adverse events with an outcome of death during the treatment-emergent period occurred in seven (2%) of 287 participants who received STRIDE plus lenvatinib plus TACE (two for myocarditis; and one each for hepatic failure, haemophagocytic lymphohistiocytosis, septic shock, cardiac failure, and unknown cause), none of 175 participants who received STRIDE plus TACE, and two (1%) of 290 participants who received TACE (one each for acute myocardial infarction and unknown cause). INTERPRETATION: STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups. FUNDING: AstraZeneca.
Treatment of polycythaemia vera by radiophosphorus or busulphan: a randomized trial. "Leukemia and Hematosarcoma" Cooperative Group, European Organization for Research on Treatment of Cancer (E.O.R.T.C.).
Between 1967 and 1978 a Phase III cooperative study was performed in polycythaemia vera (PCV) patients who had not been treated previously with any specific therapy other than phlebotomy. 293 patients were included and allocated at random for either radiophosphorus therapy (146) or busulphan treatment (147). Additional phlebotomies were indicated in both groups, to keep the haematocrit at 42-47%. 285 patients were evaluable after the study was completed, of whom 50% have an 8-year follow-up. Both groups were comparable with respect to age, clinical symptoms and haematological parameters immediately before randomization. The duration of the first remission and the overall survival were significantly better in the busulphan group. This difference remains significant after correction for differences between the two groups with respect to sex-ratio and phlebotomy before and the start of therapy. Busulphan induced a longer first remission (P less than 0.001) and a longer overall survival (P less than 0.02).
From individual control to majority rule: extending transactional models of reproductive skew in animal societies.
Transactional concession models of social evolution explain the reproductive skew within groups by assuming that a dominant individual completely controls the allocation of reproduction to other group members. The models predict when the dominant will benefit from donating parcels of reproduction to other members in return for peaceful cooperation. Using linear programming methods, we present a 'majority-rules' model in which the summed actions of all society members, each with equal power, completely determine the reproductive share of any single member. The majority-rules model predicts that, despite the diffusion of power, a 'virtual dominant' (a dominant lacking special behavioural power) will emerge and that the reproductive skew will be exactly that predicted if the virtual dominant were to control completely the group's reproductive partitioning. The virtual dominant is the individual to which group members have the maximum average genetic relatedness. This result greatly broadens the applicability of transactional models of reproductive skew to social groups of any size, such as large-colony eusocial insects, and explains why queens in such colonies can achieve reproductive domination without any behavioural enforcement. Moreover, the majority-rules model unifies transactional-skew theory with models of worker policing and even generates a new theory for the cooperation among somatic cells in a multicellular organism.
Synchronization of decentralized multiple-model systems by market-based optimization.
Market-based optimization is a new optimization method for large decentralized systems where the distributed resource allocation of an economic system is adopted. Market-based algorithms can be interpreted as multi-agent scenarios where producer and consumer agents both compete and cooperate on a market of specified commodities. The market-based approach is applied to the synchronization of a set of local multiple-model systems. The method is extended to the case where each of the subsystems is represented by a Takagi-Sugeno (TS) fuzzy system. Although all local systems are provided with the same control input, the behaviors of the local systems are, in general, different because of different parameters in the subsystems. The task of the market-based optimization is to find an appropriate composition of subsystems so that all local systems exhibit a similar dynamical behavior. Examples show that even systems with potentially unstable local systems can be synchronized if there exists a stable combination of weighted subsystems.
Health services management manpower and educational needs with American health reform.
This paper argues that our previous health services management (HSM) manpower projections may be overly optimistic as the health networks, managed care, capitated payment, and eventually global budgetary targets become the dominant themes to implement cost restraints, universal access, and social equity. HSM programs should, therefore, focus more on their educational pursuits to produce leaders for clinical management teams, who are able to allocate scarce clinical resources. A sensible strategy for HSM programs is to develop closer ties with the schools of medicine, public health, nursing, or allied health. These cooperative efforts would be particularly beneficial in teaching 'clinical-fiscal performance methodologies' to familiarize students with such concepts as clinical benchmarking, managing quality, resource management, and continuous quality improvement (CQI).
Professionalism reconsidered: physician payment from a health plan perspective.
Traditional fee-for-service health insurance rested on the assumption that doctors have primary responsibility for decisions about care. Those who long for unrestrained autonomy in an environment that is characterized by "information overload" and that continually demonstrates lapses in safety and quality fail to grasp the importance of physician and patient decision support systems and the key role that a health plan may play in dealing with these issues. The unbalanced allocation of resources between and among physician specialties is a contributing factor that must be addressed.
Double blind comparative study of omeprazole and ranitidine in patients with duodenal or gastric ulcer: a multicentre trial. Cooperative study group.
We studied omeprazole and ranitidine in promoting duodenal ulcer healing in a multicentre trial by comparing the proportion of healed ulcers after two, four, and eight weeks of treatment. Altogether, 194 patients (143 men) were randomly allocated according to a prearranged treatment schedule to either drug and were treated double blind. Each received 40 mg omeprazole in the morning and a ranitidine placebo morning and evening or 150 mg ranitidine morning and evening with an omeprazole placebo in the morning. A total of 188 patients (94 taking omeprazole, 94 taking ranitidine) completed the trial. Sixty four (68%) omeprazole treated and 45 (48%) ranitidine treated patients had healed ulcers at two weeks, 91 (99%) omeprazole treated and 79 (88%) ranitidine treated had healed ulcers by four weeks, and 91 (100%) omeprazole treated and 86 (97%) ranitidine treated patients had healed ulcers by eight weeks. The overall difference in healing rates was significant (p = 0.0008, Mantel-Haenszel test). The differences were significant also at two weeks (20%, 95% confidence interval 5.6 to 34.4, p less than 0.01) and at four weeks (11%, 95% CI 3.7 to 17.3, p less than 0.01), but not at eight weeks (3%, 95% CI -0.5 to + 7.3, p = 0.25), using the chi 2 statistic, the study having a power to detect a 20% difference on 90% of occasions. After two weeks of treatment complete symptom relief was observed in 70 (74%) patients receiving omeprazole and in 58 (62%) receiving ranitidine. Diary cards showed a significantly lower percentage of days with pain in the omeprazole treated group (7.4% v 21.4%, p < 0.02) when assessed over either the first two weeks or over weeks three and four treatment. A total of 144 patients with healed duodenal ulcer were followed up, with no treatment, for six months. At the end of this period 19 (26%) of 74 patients healed with omeprazole and 17 (24%) of 70 patients healed with ranitidine were still in remission. A similar protocol was used for 46 patients (25 men) with gastric ulcer who were randomly allocated to treatment with omeprazole or ranitidine as described above. Forty patients (16 omeprazole, 24 ranitidine) completed trial. Thirteen (81%) omeprazole treated and 14 (58%) ranitidine treated patients had healed ulcers at four weeks; at eight weeks 14 (93%) omeprazole treated and 20 (87%) ranitidine treated patients had healed ulcers. These differences were not significant at four weeks (p = 0.25) or eight weeks (p = 0.96). Twenty seven gastric ulcer patients were followed up for six months and seven (58%) of the 12 omeprazole healed and five (33%) of the 15 ranitidine healed patients were in remission at six months. Unwanted adverse events were trivial except for one fatality in a 67 year old women, who died from bronchopneumonia and myocardial ischaemia while receiving treatment with omeprazole, which was judged to be unrelated to her death.
Economic analyses in clinical trials for cooperative groups: operational considerations.
Clinical trials have served as valuable tools for evaluating new therapeutic strategies in the treatment of cancer. Traditionally, new pharmaceuticals and procedures have been appraised on the basis of effectiveness, efficacy, and safety. Recently, economic concerns have become increasingly important when considering treatment strategies for cancer patients. The national emphasis on assessing the costs of health care has focused primarily on the cost-effectiveness of resource allocation. Policy makers are exhibiting greater interest in economic data to supplement clinical data of new procedures and pharmaceutical agents before the approval and widespread application of such methodologies. Clinical trials have increasingly become viewed as a proper setting for such economic analyses. In this paper, we review operational details for carrying out economic analyses of clinical trials being conducted in the cancer cooperative group setting.
Reaction of mock jurors to testimony of a court appointed expert.
A study was conducted to assess the impact of court appointed experts on the judgments of mock jurors. A civil proceeding was adopted for the experiment. Mock jurors heard testimony about a plaintiff's injury in an automobile accident. In some conditions, medical testimony for the plaintiff and defendant was provided by experts hired by each side. In other conditions, a medical expert appointed by the court testified in addition to the two adversarial experts. In one of these conditions, the court expert sided with the plaintiff; in another, the expert sided with the defendant. The plaintiff in the case was always an individual. The defendant was sometimes a corporation and sometimes an individual. The results showed that mock jurors sided with the court appointed expert in every condition except when the expert favored a corporate defendant. The results were discussed in terms of heuristic processing of persuasive information.
Study duration for group sequential clinical trials with censored survival data adjusting for stratification.
The study duration in a clinical trial with censored survival data is the sum of the accrual duration, which determines the sample size in a traditional sense, and the follow-up duration, which more or less controls the number of events to be observed. We propose a design procedure for determining the study duration or for calculating the power in a group sequential clinical trial with censored survival data and possibly unequal patient allocation between treatments, adjusting for stratified randomization. The group sequential method is based on the use function approach. We describe a clinical trial recently activated by the Eastern Cooperative Oncology Group for an illustration of the proposed procedure.
Interpersonal tactics and communicative strategies of Anglo-American and Mexican-American mildly mentally retarded and nonretarded students.
In this investigation, we compared the preferred interpersonal tactics of mildly mentally retarded Mexican-American and Anglo-American children in an experimental social problem-solving situation. Sixty subjects were divided into four equal groups based upon ethnicity (Mexican-American or Anglo-American) and educational status (mildly mentally retarded or nonretarded). Results indicated that although there were no ethnic group differences, differences in preferred problem solving strategies were demonstrated by mentally retarded and nonretarded children. Overall, nonretarded children tended to utilize strategies such as cooperation and temporary withdrawal more often than mentally retarded children.
Ethics and economics of intensive care: the way forward.
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