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Biomedical subjects

D Reitman

Publications and source records attributed to D Reitman.

At least 19 recordsLinked to original sources

The real and imagined harmful effects of rewards: implications for clinical practice.

In recent years, a number of researchers and social critics have cautioned against the widespread application of behavioral interventions on the grounds that the philosophy of behaviorism is fundamentally manipulative and damaging to creative and intrinsically motivated behavior. Most central to their arguments are concerns about the harmful effects of "extrinsic" rewards. Though concerns about the allegedly harmful effects of "rewards" on intrinsically motivated actions may have been partially allayed by a recent meta-analysis, proponents of the view that intrinsic interest is eroded by the delivery of contingent rewards will likely continue to attest to the dangers of operant conditioning and its application to human behavior. The present manuscript addresses the content of claims about the harmful effects of extrinsic rewards. While consideration is given to the existing behavior therapy literature and its treatment of "natural" versus "arbitrary" rewards, some surprising convergences between the views of self-determination theorists and behavioral practitioners are noted.

Behavior Therapy

A review of methods and instruments for assessing externalizing disorders: theoretical and practical considerations in rendering a diagnosis.

This review addresses the most current and widely used methods of assessing childhood and adolescent externalizing disorders. Interviews, rating scales, and self-report instruments are described, and their strengths and weaknesses are discussed. Direct observational techniques in naturalistic and analogue settings are also reviewed. Throughout the article, commentary is offered regarding the psychometric adequacy and clinical validity of these instruments. It is suggested that, although the instruments presently used to assist in diagnosing externalizing disorders generally possess adequate reliability and representational validity, evidence of elaborative validity is lacking. Clinicians and researchers are encouraged to adopt a broader conceptualization of the diagnostic process, to question existing standards for establishing validity, and to consider alternative means of demonstrating diagnostic utility.

Adolescent

Factors influencing condom use among African American women: implications for risk reduction interventions.

Examined factors associated with condom use in a community-based sample of 423 sexually active African American women. Measures were selected to reflect the components in prevailing models of health behavior. Condom users were higher on AIDS health priority, prevention attitudes, stage of change, behavioral intentions, reported more frequent and comfortable sexual communication with partners, perceived greater partner and peer approval for condom use, and reported that peers also used condoms. Women in exclusive relationships evidenced earlier stage of change, lower intentions to use condoms, fewer peers who engaged in preventive behaviors, perceived themselves to have lower risk, and had lower rates of condom use, higher education, and family income. Women in fluid relationships were at particularly high risk, with lower rates of condom use relative to women not in a relationship and greater sexual risk for HIV. Implications for HIV-risk reduction interventions with African American women are discussed.

Adolescent

Course and outcome of chronic fatigue in children and adolescents.

PURPOSE: To describe the epidemiology, symptoms, and psychosocial characteristics of children and adolescents evaluated in a chronic fatigue program and determine the course and outcome of the syndrome in these patients. METHODS: During the summer of 1994, chart review was performed for the 58 patients evaluated between 1990 and 1994 and a telephone follow-up was conducted with 42 of the 58 families. Patients were predominantly female (71%) and white (94%), with 50% between the ages of 7 and 14 years and 50% between the ages of 15 and 21 years (mean age 14.6 years). RESULTS: At time of presentation, 50% of patients had been fatigued for 1 to 6 months and 50% had been fatigued for 7 to 36 months. Sixty percent indicated the fatigue had begun with an acute illness and 60% had a history of allergies. Most commonly reported symptoms were fatigue (100%), headache (74%), sore throat (59%), abdominal pain (48%), fever (36%), and difficulties with concentration and/or memory (33%). Most patients had a worsening of school performance and a decrease in social activities. On follow-up, there was significant improvement in many patients during the summer after the first visit, with continued improvement in most patients during the second and third years. At time of the follow-up telephone call, 43% of families considered their child "cured" and 52% considered their child "improved," whereas only 5% considered their child to be "the same." Statistical analyses demonstrated no demographic or clinical factors that distinguished between those who did or did not participate in the follow-up study, or between those who did or did not do well on follow-up. CONCLUSIONS: These data demonstrate that children and adolescents with chronic fatigue have a syndrome that is similar to that described in adults, but that the syndrome differs in several ways, most specifically, presentation earlier in the course of the illness and a more optimistic outcome.

Adolescent

Predictors of African American adolescents' condom use and HIV risk behavior.

This study evaluated predictors of risky and safer behavior in a sample of low-income African American adolescents, assessed their perceptions of the risk associated with their sexual behavior, and examined differences between adolescents who used condoms consistently, inconsistently, or engaged only in unprotected intercourse. African American adolescents (N = 312) completed measures related to AIDS knowledge, frequency of condom use, attitudes toward condoms, and sexual behavior over the preceding 2 months. Multiple regression analyses for the sexually active youths (N = 114) revealed that lower self-efficacy, higher perceived risk, and male gender were associated with high-risk behavior. Positive attitudes toward condoms and younger age had the strongest association with condom use. Consistent condom users were more knowledgeable and held more positive attitudes toward condoms, and nonusers were older. Regardless of their behavior, the adolescents generally did not perceive themselves to be a risk for HIV infection. The findings suggest that precautionary practices (condom use) and high-risk behavior (unprotected sex with multiple partners) may have different correlates. In addition, the data indicate that theoretical models developed with homosexual male populations may also be generalizable to African American adolescents' sexual behavior.

Adolescent

Drug treatment of hypertension in the elderly: a meta-analysis.

PURPOSE: A meta-analysis of the effect of antihypertensive drug treatment on mortality and morbidity in elderly patients. DATA SOURCES: A literature search of published articles from January 1980 to February 1992. STUDY SELECTION: Randomized controlled trials of drug treatment of hypertension with end points for elderly patients reported separately. DATA EXTRACTION: Mortality or morbidity end points or both in patients older than 59 years were pooled by determination of typical odds ratio. A meta-regression was used to study heterogeneity. RESULTS: Nine major trials with 15,559 patients older than 59 years were identified. Death rates in the control group varied between 2.7% and 77.2%; stroke and coronary mortality increased with the severity-of-illness rank (P < 0.001). Overall, treated patients had an approximately 12% reduction in all-cause mortality (odds ratio, 0.88; 95% CI, 0.80 to 0.97; 953 events compared with 1069 events, P = 0.009). There was a 36% reduction in stroke mortality (odds ratio, 0.64; CI, 0.49 to 0.82; 94 events compared with 149 events, P < 0.001) and a 25% reduction in coronary heart disease mortality (odds ratio, 0.75; CI, 0.64 to 0.88; 263 events compared with 350 events, P < 0.001). Coronary morbidity was reduced 15% (odds ratio, 0.85; CI, 0.73 to 0.99; 325 events compared with 379 events, P = 0.036), and stroke morbidity was reduced 35% (odds ratio, 0.65; CI, 0.55 to 0.76; 247 events compared with 382 events, P < 0.001). CONCLUSION: Overall, treatment of hypertension in elderly patients produces a significant benefit in total mortality and cardiovascular morbidity and mortality. However, this benefit may be reduced in the oldest age groups.

Aged

Minimizing the three stages of publication bias.

Publication bias can be considered to have three stages: (1) Prepublication bias occurs in the performance of research, caused by ignorance, sloth, greed, or the double standard applied to clinical trials but not to clinical practice. (2) Publication bias refers to basing acceptance or rejection of a manuscript on whether it supports the treatment tested. Potentially biased reviewers are of equal concern. (3) Postpublication bias occurs in publishing interpretations, reviews, and meta-analyses of published clinical trials. Bias can be minimized by (1) insisting on high-quality research and thorough literature reviews, (2) eliminating the double standard concerning peer review and informed consent applied to clinical research and practice, (3) publishing legitimate trials regardless of their results, (4) requiring peer reviewers to acknowledge conflicts of interest, (5) replacing ordinary review articles with meta-analyses, and (6) requiring the authors of reviews to acknowledge possible conflicts of interest.

Clinical Trials as Topic

Selection and evaluation of empirical research in technology assessment.

Technology assessment involves application of the scientific method to the practice of medicine. Finding all of the assessment reports in a given field is not an easy task. Proper evaluation of those assessments requires the conduct of a prospective experiment in which the sources and results are blinded when the choice is made of papers to exclude and to include, and the process should be carried out in duplicate. There are several available data bases for carrying out the search, but because of indexing problems they should be supplemented by reference to the bibliographies of pertinent published articles. Clinical trials included in meta-analyses should be graded by quality and thus facilitate sensitivity analyses. Attention must be paid to the possibility of publication bias. Finally, the advent of meta-analysis makes it desirable to begin randomized controlled trials in areas of uncertainty, even when there is no possibility that individual investigators will encounter enough patients to draw valid conclusions.

Clinical Trials as Topic

Meta-analysis of randomized controlled trials as a method of estimating rare complications of non-steroidal anti-inflammatory drug therapy.

The design of randomized controlled trials to assess the efficacy of pharmacological measures for the prevention of the gastrointestinal side-effects of anti-inflammatory drugs requires an accurate estimate of excess risk under controlled conditions. Photocopies of 952 randomized controlled trial publications were obtained after scanning titles and abstracts of a MEDLINE computer search, 427 were excluded for obvious reasons, and 525 were again photocopied after obliterating source and results. Selection criteria were: the presence of a non-anti-inflammatory drug control group; at least 4 days of therapy; at least 3 days without anti-inflammatory drugs before randomization; no complicating background drugs; mention of side-effects; and a clear differentiation of gastrointestinal complications. Observer error, with two independent readings, for inclusion suitability in the study was 19% for Methods and 9% for Results. For the 44 aspirin trials, the mean therapy duration was 357 days; the unweighted rate difference between therapy and control groups ( +/- 1 S.E.M.) for ulcer was 0.006 +/- 0.003, for gross haemorrhage 0.006 +/- 0.002 and for unspecified gastric symptoms 0.03 +/- 0.01. In 123 non-aspirin non-steroidal anti-inflammatory drug (NA-NSAID) trials, the mean duration was 67 days; the unweighted rate difference for ulcer was 0.0005 +/- 0.0003, for gross haemorrhage 0.007 +/- 0.004 and for unspecified gastric symptoms 0.02 +/- 0.005. Risk differences were also pooled using the DerSimonian and Laird method, which weights studies inversely according to variance. Using this method, only the unspecified gastric symptoms for non-aspirin non-steroidal anti-inflammatory drugs (NA-NSAIDs) and the haemorrhage for aspirin were found to be statistically significant. Longer studies have higher risk differences. Randomized control trials to determine prophylactic efficacy against haemorrhage (that is, to demonstrate a reduction of ulcer rate in the therapy group to the rate of controls) would require 190 patients in each group for NA-NSAIDs in studies of 2-6 months; 950 subjects would be needed to detect a 50% reduction. Randomized control trials to determine a reduction in ulcer rate to that of controls in patients on aspirin for more than 6 months would require 700 subjects in each group; 3346 subjects would be needed to detect a 50% reduction. Such studies are feasible.

Anti-Inflammatory Agents, Non-Steroidal

Antiplatelet agents in the secondary prevention of stroke: meta-analysis of the randomized control trials.

Randomized control trials of antiplatelet agents in the prevention of stroke following transient ischemic attacks have had conflicting results. The decision to employ aspirin instead of placebo as the control regimen in trials testing newer antiplatelet agents emphasizes the need for an accurate estimate of the efficacy of older drugs. A meta-analysis of seven randomized control trials comparing aspirin and/or sulfinpyrazone or dipyridamole with placebo was performed. For aspirin compared with placebo, a nonsignificant reduction in stroke of 15% (odds ratio 0.85, 95% confidence interval 0.60-1.19; chi 2 = 0.78, p greater than 0.30) was found. For aspirin combined with sulfinpyrazone or dipyridamole compared with placebo, a 39% reduction in stroke was observed (odds ratio 0.61, 95% confidence interval 0.39-0.95; chi 2 = 4.22, p less than 0.05); at the same time a 350% increase in gastrointestinal hemorrhage or peptic ulcer was noted (odds ratio 3.5, 95% confidence interval 1.26-9.75; chi 2 = 4.61, p less than 0.05). A trend in reduction of strokes for men was observed (odds ratio 0.58, 95% confidence interval 0.32-1.07; chi 2 = 2.52, p less than 0.15) for any regimen containing aspirin. The significant benefit of aspirin-combination therapy on stroke must be interpreted cautiously because of a number of possible biases. It is still conceivable that aspirin alone may decrease the incidence of stroke by as much as 40%, but a sample of greater than 13,000 patients would be needed to confirm the benefit observed in our analysis.

Aspirin

Meta-analyses of randomized controlled trials.

A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.

Clinical Trials as Topic

Loss of patients in clinical trials that measure long-term survival following myocardial infarction.

Loss of patients from clinical trials can nullify adequate randomization if the loss is unequally distributed among treatment groups. This study was designed to assess the magnitude of the problem in randomized control trials evaluating long-term therapy for survivors of myocardial infarction (MI). Only 19 of 52 trials reported having an explicit policy on withdrawals in the design stage; only 2 reported blinding the decision for withdrawal and only 7 reported accounting for withdrawals in sizing. In addition, only 16 gave the reader enough information to calculate the effect of withdrawals on trial results. In 2 of these 16 trials a p less than 0.05 result obtained by including withdrawals (intention to treat method) was reduced to p less than 0.05 when withdrawals were excluded. It is evident that many long-term trials do not contain adequate data on withdrawals. Readers of published trials are seldom able to judge whether or not withdrawals might affect the final results.

Clinical Trials as Topic

Peer review using a paired-comparison technique.

A paired-comparison technique is used to enable surgical residents and attending surgeons to make peer judgments of each other. Comparative peer judgments were made in three areas: the ability of the surgeon to make a diagnosis and to decide on a plan of active medical care, the operating ability of the surgeon, and the postoperative care of the patient. This method of peer judgment ensures the confidentiality of those making the judgments, and the analysis results in a final ranking of the surgeons and surgical residents with indicated significant differences (P less than 0.05) among them. The technique also includes an assessment of how consistent each judge is in making comparisons of fellow surgeons.

Clinical Competence

Association of adrenocorticosteroid therapy and peptic-ulcer disease.

We reexamined the association between corticosteroid therapy and subsequent peptic ulceration or gastrointestinal hemorrhage by pooling data from 71 controlled clinical trials in which patients were randomized to systemic corticosteroids (or ACTH) or to nonsteroid therapy. Of 3064 steroid-treated patients evaluated for peptic ulcer, 55 (1.8 per cent) had ulcers, as compared with 23 of 2897 controls (0.8 per cent) (relative risk, 2.3; 95 per cent confidence interval, 1.4 to 3.7). Of 3135 steroid-treated patients evaluated for gastrointestinal hemorrhage, 78 (2.5 per cent) had bleeding, as compared with 48 of 2976 controls (1.6 per cent) (relative risk, 1.5; 95 per cent confidence interval, 1.1 to 2.2). The incidence of ulcers varied directly with the dosage of steroids. When separate analyses were performed for studies that were double-blind, used only oral steroids, used only parenteral steroids, or excluded patients with a history of ulcer, the trend remained consistent but did not always reach statistical significance. This study strongly suggests that corticosteroids do increase the risk of peptic ulcers and gastrointestinal hemorrhage.

Adrenal Cortex Hormones

A method for assessing the quality of a randomized control trial.

A system has been constructed to evaluate the design, implementation, and analysis of randomized control trials (RCT). The degree of quadruple blinding (the randomization process, the physicians and patients as to therapy, and the physicians as to ongoing results) is considered to be the most important aspect of any trial. The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies. Description of the patient and treatment materials and the measurement of various controls of quality have less weight. An index of quality of a RCT is proposed with its pros and cons. If published papers were to approximate these principles, there would be a marked improvement in the quality of randomized control trials. Finally, a reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.

Clinical Trials as Topic

Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials.

Meta-analysis is an important method of bridging the gap between undersized randomized control trials and the treatment of patients. However, as in any retrospective study, the opportunities for bias to distort the results are widespread. Attempts must be made to introduce the controls found in prospective studies by blinding the selection of papers and extraction of data and making blinded duplicate determinations. Informal and personalized methods of obtaining data are probably more liable to error and bias than employing only published data. Publication bias is a serious problem requiring further research. There also need to be more comparisons of meta-analysed small studies with large co-operative trials.

Adrenergic beta-Antagonists

Meta-analysis of clinical trials as a scientific discipline. II: Replicate variability and comparison of studies that agree and disagree.

The replicate variability of meta-analyses of controlled clinical trials has been assessed as a measure of scientific precision. 46 of 91 known meta-analysis papers were divided into 20 cohorts of studies of the same therapies. Ten cohorts contained meta-analyses with different statistical conclusions; 14 contained differing clinical conclusions with a wider spread than the statistically differing studies. Possible causes of variability, such as different trials included, different policies regarding the inclusion of non-randomized and unpublished trials, and different statistical methodologies, were not obvious causes of differing conclusions. Further work in this area should include multivariate analyses in order to explore possible interactions in the factors accounting for the variability found in replicate meta-analyses.

Clinical Trials as Topic