[Treatment of primary pulmonary hypertension: one hundred years of search and disappointments].
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Anticoagulants↗
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Redefining the real problem in psychedelic trials: Why fighting the Lessebo matters more than blinding integrity.
Imperfect blinding is not specific to psychedelic trials. In randomized trials, treatment allocation is frequently correctly guessed, yet blinding integrity is rarely assessed outside of psychedelic research and is generally not considered a barrier in regulatory evaluation. The intense debate in psychedelics may reflect a broader double standard affecting mental health research, when uncertainties arising from imperfect blinding are confounded by those linked to patient-reported outcome measures. Indeed, people living with mental disorders are often viewed as unreliable reporters, despite well-documented limitations of clinician-rated scales and the absence of robust biological markers of symptomatic change. Importantly, it is the maintenance of reasonable doubt of treatment allocation that sustains internal validity and ethical feasibility of placebo-controlled designs, rather than perfect blinding. Concerns about expectancy bias in psychedelic trials are closely tied to blinding debates. When allocation is inferred, expectations may cluster in the arm perceived as active or in stereotyped experiences and influence outcomes differently in active and control arms, leading to a risk of lessebo, a negative placebo effect due to the negative expectation related to receiving a placebo. However, we argue that an underrecognized mechanism of lessebo is disappointment. This risk may reflect insufficient clinical management of disappointment rather than pre-treatment expectation alone. We therefore propose shifting the emphasis from preserving inevitably imperfect blinding towards mitigating disappointment in both arms. Establishing non-stereotyped expectations prior to treatment through structured psychoeducation, strengthened therapeutic alliance, and realistic preparation would help avoid lessebo effects. Such strategies would enhance ethical rigor, interpretability, and the clinical usefulness of psychedelic trials.
Humans↗
Obese patients' perceptions of treatment outcomes and the factors that influence them.
BACKGROUND: Despite considerable professional consensus that modest weight losses of 5% to 10% are successful for reducing the comorbid conditions associated with obesity, obese patients often desire weight losses 2 to 3 times greater than this. Examining ways to reduce the disparities between treatment expectations and subsequent outcomes, this study evaluated the role of physical characteristics, treatment setting, and mood in patients' evaluations of treatment outcomes. METHODS: This study was conducted in a university outpatient weight loss clinic with a sample of 397 obese individuals seeking weight loss by a variety of modalities. Before treatment, participants' heights and weights were measured, and the Beck Depression Inventory and the Goals and Relative Weight Questionnaire were administered. RESULTS: Outcome evaluations ranged from 64.4 +/- 11.1 kg (mean +/- SD) for dream weight to 90.1 +/- 19.1 kg for disappointed weight. Initial body weight was the strongest predictor of disappointed, acceptable, and happy weights (beta =.90,.76, and.57, respectively). Sex (beta = -.37) and height (beta =.37) were the strongest determinants of dream weight. Heavier participants chose higher absolute weights, but the weight loss required to reach each of the outcomes was greater for heavier than for lighter patients. CONCLUSIONS: These data signal a therapeutic dilemma in which the amount of weight loss produced by the best behavioral and/or pharmacologic treatments is viewed as even less than disappointing. Patients with the highest pretreatment weights are likely to have the most unrealistic expectations for success.
Adult↗
Reconsidering the Relation between Regret and Responsibility.
Recently Connolly, Ordóñez, and Coughlan challenged the view that regret is partly determined by perceived responsibility for the regretted outcome [Connolly, T. Ordóñez, L. D., & Coughlan, R. (1997). Regret and responsibility in the evaluation of decision outcomes. Organizational Behavior and Human Decision Processes, 70, 73-85]. In a series of experiments they manipulated whether actors arrived at an outcome through their own decision or through a "computer assignment" over which they had no influence. This decision agency manipulation did not affect their "regret measure." We show in two experiments that this null-effect is due to the fact that regret was measured by means of a general happiness assessment. In the present research we replicated the basic design of their experiments and also found no effects of decision agency on the happiness assessment. However, the results showed the predicted effects of decision agency when regret was directly measured. Moreover, a measure of disappointment seemed to indicate the opposite effect: People are more disappointed when a negative outcome is caused by a computer assignment than when caused by their own choice. The role of regret and disappointment in decision making is discussed. Copyright 1998 Academic Press.
Journal Article↗
Emotional competence and aggressive behavior in school-age children.
Examined emotional competence in 87 children, aged 7-10 years, who varied with respect to reports of aggressive behavior to determine whether individual differences in emotional competence characterize children with higher levels of aggressive behavior. Emotional competence was assessed during a 1-hr lab visit that included (a) an observational period consisting of a modified disappointment paradigm, (b) assessment of cognitive and language abilities, and (c) 2 structured emotion interviews. Children with higher levels of aggressive behavior exhibited more intense and frequent expressions of anger, both as reported by mothers and as observed during the disappointment paradigm. Less sophisticated ability to identify the causes of emotion also characterized children with higher levels of aggressive behavior. Gender moderated the relation between aggressive behavior and type of emotion identified such that reports of happiness (in response to receiving a disappointing prize) were associated with lower levels of reported aggressive behavior for boys. The value of assessing children's emotional competence in the context of an emotionally arousing situation is suggested by these findings.
Adaptation, Psychological↗
What is a reasonable weight loss? Patients' expectations and evaluations of obesity treatment outcomes.
Expert panels and governmental guidelines now recommend that obese persons seek modest (i.e., "reasonable") reductions in body weight rather than striving for "ideal" weights. Little is known, however, about patients' views of what is a "reasonable" weight loss. This study assessed patients' goals, expectations, and evaluations of various outcomes before, during, and after 48 weeks of treatment. Before treatment, 60 obese women (99.1 +/- 12.3 kg; body mass index of 36.3 +/- 4.3 kg/ m2) defined their goal weight and 4 other weights: "dream weight"; "happy weight"; "acceptable weight"; and "disappointed weight." Goal weight averaged a 32% reduction in body weight. A 17-kg weight loss was defined as disappointed; a 25-kg loss, was acceptable. After 48 weeks of treatment and a 16-kg weight loss, 47% of patients did not achieve even a disappointed weight. These data illustrate the dramatic disparity between patients' expectations and professional recommendations and the need to help patients accept more modest weight loss outcomes.
Adult↗
Emotion self-regulation in preschool-aged children with and without orofacial clefts.
Emotion self-regulation is an important developmental task in the preschool period that is related to children's emotional and behavioral adjustment in early childhood. Emotion self-regulation and its relation to later adjustment has not been studied in children born with orofacial clefts, despite their risk for externalizing and internalizing behavior problems. Eighty-three 5-year-old children with cleft lip and palate, isolated cleft palate, or no cleft condition were videotaped during a laboratory disappointment situation. Results showed that children in the cleft group expressed less disappointment than children in the comparison group. Longitudinal analyses revealed that parenting stress measured when the children were 2 years of age predicted Expressed Disappointment at age 5 years, which, in turn, predicted severity of behavior problems at age 7 years. Although tentative, results indicate that control over mild negative affect may be a protective factor for children with clefts, buffering the effects of early stress on the development of later behavioral and emotional problems. Thus, interventions that reduce parenting stress and enhance children's emotion regulation strategies may decrease the risk for later psychological problems in this population.
Child↗
[Posterosuperior impingement of the shoulder in the athlete: results of arthroscopic debridement in 75 patients].
PURPOSE OF THE STUDY: The painful shoulder is a well-recognized clinical entity in throwers although the pathogenic mechanisms involved are still debated. In 1991 Walch then Jobe developed the concept of posterosuperior impingement to explain lesions observed arthroscopically. This impingement between the deep aspect of the supraspinatus tendon and the glenoid occurs during loaded arm movements. The purpose of this work was to study the different types of lesions observed arthroscopically and to analyse outcome after arthroscopic debridement. MATERIAL AND METHOD: Our series included 75 thrower athletes who had shoulder pain for loaded arm movements. Pain was situated in the dominant shoulder in all cases. Clinically, the Jobe manipulation provoked pain in 52 patents, expression of a supraspinous disorder. After failure of conservative treatment, the patients underwent arthroscopy for assessment and debridement. At the time of arthroscopy, the patients had suffered pain for two years (mean 22.3 months). All 75 patients were seen for clinical and radiological assessment at least two years after arthroscopy. RESULTS: Among the 75 arthroscopies, there were 67 (89%) partial tears involving the deep aspect of the cuff, associated in 90% of the cases with a labral lesion. Tears involved the supraspinatus in 40 cases, the supraspinatus and the infraspinatus in 24 and the infraspinatus alone in three. Eight patients were free of tendon lesions at arthroscopy. There were no full thickness tears. The labrum had a meniscal (45%) or non-meniscal aspect (55%) and appeared normal (18%), fringed (38%) or fissured (52%). The very large majority of the labral fissures were found behind the biceps insertion. Fissures of the labrum were found in front of the biceps insertion in only three cases (slap lesion). Arthroscopy demonstrated glenoid damage (soft cartilage, fissure, abrasion, wear). The humeral head also exhibited lesions of the cartilage facing the insertion of the infraspinatus. At last follow-up (minimum > 2 years), eight patients were very satisfied, 22 were satisfied and 45 were disappointed. Twelve patients had resumed their sports activities at their former level with loaded arm movement and one patient had interrupted all sports activities. At last follow-up, 22 patient had undergone another surgical procedure: 20 derotation osteotomies of the humerus, one anterior stabilization, one acromioplasty. DISCUSSION: The notion of posterosuperior impingement is increasingly recognized as the cause of pain in thrower athletes. Loaded arm movements produce a physiological contact between the posteriorsuperior edge of the glenoid cavity and the deep aspect of the rotator cuff. Injury results from repeated loaded arm movements in throwers. In our series, all the patients had at least one lesion, either involving the cuff or the labrum. According to the Snyder classification, 80% of the supraspinatus lesions were grade 1 or grade 2. We did not have any full thickness tears. All patients with a normal cuff were found to have a lesion of the posterosuperior labrum. At arthroscopy, dynamic assessment evidenced an impingement between the supraspinatus (or the infraspinatus) and the labrum or the bony edge of the glenoid cavity. Only three patients had a labral lesion anterior to the biceps insertion that could be considered a type 1 or 2 slap lesion. Unlike earlier reports by others, we had disappointing results after debridement: 60% of the patients were disappointed after the procedure and only 40% were satisfied (22 patients) or very satisfied (8 patients). Patient satisfaction depended greatly on the level of sports activity attained after arthroscopy, the eight very satisfied patients had resumed their former level. None of the professional athletes or those competing at the international level were very satisfied with arthroscopic debridement. There was an inverse relationship between level of competition and patient satisfaction after debridement.
Adult↗
Spontaneous expressive control in blind and sighted children.
The effect of blindness on the spontaneous expressive control of negative emotion was examined in a study comparing 12 congenitally blind children with 12 sighted children who were matched by age, sex, and school. Blind children engaged in as much positive facial display as sighted children when receiving a disappointing prize, although they were less likely to refer spontaneously to their expressive control in explaining whether the examiner knew of their disappointment. Blind children were more likely to engage in neutral remarks when receiving the disappointing prize, and older blind children referred to verbal control of emotion communication. The data suggest that blindness does not preclude the spontaneous expressive control of negative emotion.
Affect↗
[Surgical therapy in chronic pancreatitis].
In patients with chronic pancreatitis, surgical treatment is required when conservative approaches are unsuccessful in treating symptoms and complications of the disease. The indications for surgery are 1) recurrent abdominal pain which does not respond to analgesics and 2) duodenal, common bile duct and/or main pancreatic duct obstruction or stenosis. In addition, obstruction of the retropancreatic vessels with subsequent portal hypertension is an indication to operate. Over the last decades the surgical standards in the treatment of chronic pancreatitis have changed. Due to disappointing long-term results, pancreatic left resection and drainage procedures of the main pancreatic duct are limited only to a small number of patients. In a number of patients with chronic pancreatitis, inflammatory enlargement of the pancreatic head causes complications which require surgical treatment. In the past, the classical Whipple resection has served as the standard operation in these patients. However, the classical Whipple resection was initially inaugurated for pancreatic head malignancies, and in addition to resection of the pancreatic head it includes resection of the complete duodenum, the extra hepatic bile system and 2/3 of the stomach. The Whipple procedure's disappointing long-term results and especially its disappointing quality of life have led to the development of newer organ-preserving procedures designed to treat complications caused by chronic pancreatitis. The pylorus-preserving Whipple resection is a modification of the classical Whipple resection which avoids the resection of the stomach. Since its initial publication by Watson in 1945 and Traverso and Longmire in 1978, pylorus preserving Whipple resection has been performed by many surgeons for the treatment of chronic pancreatitis. However, the high incidence of postoperative diabetes mellitus following this operation is a major drawback that has limited its use. The duodenum-preserving pancreatic head resection was developed to selectively remove the pancreatic head subtotally by preserving the body and tail of the pancreas as well as the pylorus, the duodenum, and the extrahepatic biliary tract. With this organ-preserving operation all the pancreatic head-related complications of chronic pancreatitis can be abolished without inducing diabetes mellitus. Excellent short- and long-term follow-up results prove the superiority of the duodenum-preserving pancreatic head resection over the classical and the pylorus-preserving Whipple resections in patients with chronic pancreatitis. Therefore, the duodenum-preserving pancreatic head resection should be adopted as a new standard operation in patients with chronic pancreatitis and pancreatic head-related complications.
Chronic Disease↗
Conceptualization and treatment of rage in self psychology.
This article presents a self-psychological understanding and treatment of anger. Angry reactions are based on various types of injury to self-esteem, and on disappointments in those one holds in special esteem-such as early caretakers and later important others. When these injuries and disappointments are massive--traumatic--the ensuing angry reaction is especially intense and often destructive. Treatment addresses the patient's vulnerability, the soil on which all these forms of anger arise, through an empathic entry into the subjective inner world of the angry or enraged individual rather than through direct confrontations. Empathic entry leads the therapist to the sources of anger, often precipitated by inadvertent, unempathic responses in the therapeutic encounter. Accepting nonjudgmentally, understanding uncritically, and explaining patiently the meaning and origin of the anger may lead to the amelioration of the vulnerability that gives rise to the anger.
Adult↗
Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures.
BACKGROUND: Hip fracture patients have a high risk of thromboembolic complications following surgical management. OBJECTIVES: To examine the effects of heparin (unfractionated (U), and low molecular weight (LMW) heparins), and physical methods (compression stockings, calf or foot pumps) for prevention of deep venous thrombosis (DVT) and pulmonary embolism after surgery for hip fracture in the elderly. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline, Embase, and reference lists of published papers and books. We contacted trialists and other workers in the field. Date of most recent search: September 1996. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating the use of heparins and physical agents for prevention of DVT and pulmonary embolism in patients undergoing surgery for hip fracture. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. Trials were grouped into four categories (heparin versus control, mechanical versus control, LMW heparin versus U heparin, and miscellaneous) and results pooled where possible. MAIN RESULTS: The 26 included trials involved 2600 predominantly female and elderly patients. Overall, trial quality was disappointing. Ten trials involving 826 patients which compared U heparin with control, and four trials of 471 patients which compared LMW heparin with control, showed a reduction in the incidence of lower limb DVT (121/511 (24%) versus 203/519 (39%); Peto odds ratio 0.41; 95% confidence interval 0.31 to 0.55). There were insufficient data to confirm the efficacy of either agent in the prevention of pulmonary embolism. There was a non significant increase in overall mortality in the heparin group (46/420 (11%) versus 35/423 (8%); Peto odds ratio 1.39; 95% confidence interval 0. 86 to 2.23). Data were inadequate for all other outcomes including wound complications. There is insufficient evidence from five trials, involving 644 patients, to establish if LMW heparin was superior to U heparin. Most trials evaluating heparins had methodological defects. Four trials, involving 442 patients, testing mechanical pumping devices were also methodologically flawed, and so pooled results need to be viewed cautiously. Mechanical pumping devices may protect against DVT (12/202 (6%) versus 42/212 (19%); Peto odds ratio 0.24; 95% confidence interval 0.13 to 0.44). Although the limited data indicated a potential benefit, they were inadequate to establish any effect on the incidence of pulmonary embolism and overall mortality. Problems with skin abrasion and compliance were reported. REVIEWER'S CONCLUSIONS: U and LMW heparins protect against lower limb DVT. There is insufficient evidence to confirm either protection against pulmonary embolism or overall benefit, or to distinguish between various applications of heparin. Foot and calf pumping devices appear to prevent DVT, may protect against pulmonary embolism, and reduce mortality, but compliance remains a problem. Good quality trials of mechanical methods as well as direct comparisons with heparin should be considered.
Anticoagulants↗
Prospective randomized study of radical versus four piles haemorrhoidectomy for symptomatic large circumferential prolapsed piles.
Twenty-eight patients (14 men, 14 women) with circumferential prolapsed piles were prospectively randomized to undergo either modified radical haemorrhoidectomy (group 1; 14 patients) or four piles haemorrhoidectomy (group 2; 14). The median duration of surgery was 30 and 10 min respectively in groups 1 and 2. After operation all patients in group 1 were continent compared with 12 of 14 in group 2. Two patients in group 2 developed an anal stricture requiring manual dilatation. Five patients in group 1 had wound dehiscence requiring secondary suture; three of these developed an anal stricture: two needed anal dilatation and one required anoplasty. Two patients in group 1 had residual anal skin tags, compared with nine in group 2. Two patients in group 2 had symptomatic residual piles, whereas none in group 1 had this problem. At 6 months, six patients in group 2 considered the results to be excellent, seven acceptable and one was disappointed. In group 1 two considered the operation to be excellent, ten acceptable and two were disappointed.
Adult↗
Is there a role for consolidation or salvage radiotherapy after chemotherapy in advanced epithelial ovarian cancer?
Cure rates following surgery and platinum-containing chemotherapy in advanced epithelial ovarian cancer are only 20-30%. Relapse rates even after complete chemotherapy responses or those leaving only microscopic residual disease are disappointingly high at 30 to 80%. Strategies to improve outcome, consolidate the results of surgery and chemotherapy, or salvage those with residual disease include whole-abdominopelvic irradiation. This paper reviews its usage to date in 28 trials. The results of sequential therapy are generally disappointing, possibly because of inappropriate patient selection, toxic regimens, underlying biological factors, and difficulties interpreting the uncontrolled studies. Tumor residuum appears to be one factor predictive of survival: no residuum, 76%; microscopic or < 5 mm, 49%; macroscopic, 17%. Other factors may be tumor grade and patient age. Appropriate selection of patients for controlled studies of sequential radiotherapy after surgery and chemotherapy include those with negative second-look laparotomy who had large residual Stage III presentations prechemotherapy, are over 50 years of age, or who have grade 3 tumors. Others are those with microscopic residual disease, grade 1 or 2. If therapy is to be successfully completed with minimal morbidity, abdominal radiotherapy should be limited to < or = 25 Gy, initial chemotherapy to six courses, and surgery to initial debulking and second-look laparotomy.
Carcinoma↗
Long-term outcome of the use of OKT3 to treat steroid-resistant acute renal allograft rejection.
OKT3 was used to treat steroid-resistant acute renal allograft rejection in 30 of 496 adult patients transplanted over a 6-year period. Rejection was reversed (defined as a fall in serum creatinine by 50% or more within 30 days of treatment with OKT3) in 40% of cases. Successful reversal was significantly more likely when rejection occurred shortly after transplantation (t ratio -2.53; P = 0.019). The long-term outcome was disappointing; the actuarial graft survival at 1 year from the start of treatment with OKT3 was 42%, and no grafts have thus far survived longer than 3 years. Graft survival was shorter in older patients (coefficient/standard error 2.226; P < 0.05), and no other predictor of long-term outcome was identified. Patient survival at 3 years was 88%. Serious infection occurred in 33% of patients, with two deaths. Our experience suggests that treatment with OKT3 is unlikely to reverse acute renal allograft rejection in more than half of patients where rejection is resistant to steroids. Although long-term graft survival occurred in a few cases, the overall long-term outcome was disappointing, particularly in older patients. Finally, our analysis indicates the difficulty of predicting which patients will derive long-term benefit when OKT3 is used to treat steroid-resistant rejection.
Acute Disease↗
New agents in the treatment of primary brain tumors.
A review of single agent trials of cytotoxic agents in adults with high grade gliomas is presented. The rationale for testing these agents in patients with brain tumors was variable and is discussed. The criteria to evaluate responses were also variable ranging from subjective evaluation of clinical improvement with a stable radiographic assessment to the same objective response criteria utilized for solid tumors. Trials of agents specifically designed for brain tumors such as AZQ and spiromustine have been disappointing. There are encouraging results being seen in early trials of newer agents which await confirmation in larger trials but which hold promise for improving the disappointing results seen so far with chemotherapy in primary brain tumors.
Antineoplastic Agents↗
Local excision of carcinoma of the rectum: indications.
To discuss indications for local excision of adenocarcinoma of the low rectum, two different series of patients were analysed. Series I consisted of 60 patients treated by local excision from 1969 to 1985 in whom local recurrence developed. Series II consisted of 59 patients who underwent resection for non high grade tumors less than or equal to 3.5 cm from 1980 to 1990 in whom lymph node spread was studied. A distinction is made between tumors which are obvious cancers and malignant polyps, and the discussion of indications for local excision is orientated to the former. The results of local excision have been disappointing but a number of compromise selections for local excision have been necessary. Endorectal ultrasound has emerged as the most important method of assessing the depth of invasion of the tumor. Stratifying the depth of the tumor is at present the most important prognostic indicator for lymph node metastasis and local recurrence in non high grade tumors. If the muscle layer is invaded by tumor, local metastasis will occur in 17% of patients. It is likely that only tumors involving superficial layers of muscle are suitable for local excision, but this needs further study. Mucinous carcinomas and the presence of lymphatic invasion are contra-indications to local excision. The shape and size of tumors are not independent prognostic indicators. The techniques available for local excision alter the indications. Salvage operations for recurrence after local excision have proved disappointing.
Adenocarcinoma↗
Audit of a one-stop breast clinic--revisited.
BACKGROUND: A one-stop diagnostic service has been available for women with symptomatic breast disease at St Bartholomew's Hospital for 5 years and was originally audited in May 1993. In re-auditing the one-stop service our aim was to see if our practice had improved following the original audit and to look at the impact which these changes in practice had made to the service offered to the patient. METHODS: A prospective audit of 4 consecutive clinics was undertaken in November 1997. A total of 300 patients (59 new and 241 follow up) were seen in clinic in this time. The primary outcome measure concerned the completeness of triple assessment in the 40 patients who required one stop investigations, including mammography, ultrasonography and fine-needle aspiration cytology. In addition, mean time to initial consultation and level of awareness of the one-stop facility and its attendant time delay were measured. RESULTS: Of the 300 clinic attendees 40 (38 new, 2 follow-up) had one-stop investigations. As a result of the one-stop service being in practice, 36 patients (90%) had a definitive management decision made at their first outpatient visit. Of these 2 were symptomatic cancers, forming 5% of the workload. A total of 86% of the workload was benign. Four patients (10%) had equivocal results. The mean waiting time from designated appointment until surgical consultation was 36.7 minutes and was disappointingly unchanged from that of the previous audit. However this does not take into account the significant reduction in staffing levels which has occurred between the two periods of assessment. CONCLUSIONS: The initial audit identified a significant problem with time constraints, necessitating that a large number of patients with carcinomas return at a later date for further investigations. Booking only new patients at the beginning of clinic has provided a solution. Disappointingly, our figures do not show a significant improvement in mean waiting time compared with the previous audit, despite allowing GPs greater access of referral. Encouragingly, we have been able to maintain a similar standard of provision of care despite lower staffing levels and to implement the changes suggested by the original audit (thereby closing the audit loop).
Adolescent↗