Sidney Klawansky

Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials.

OBJECTIVE To assess the efficacy of functional electrical stimulation (FES) in the rehabilitation of hemiparesis in stroke. DESIGN A meta-analysis combined the reported randomized controlled trials of FES in stroke, using the effect size method of Glass, and the DerSimonian-Laird Random Effects Method for pooling studies. SETTING The included studies were published between 1978 and 1992. They were conducted in academic rehabilitation medicine settings. PATIENTS In all included studies, patients were in poststroke rehabilitation. The mean time after stroke varied from 1.5 to 29.2 months. INTERVENTION FES applied to a muscle or associated nerve in a hemiparetic extremity was compared to No FES. MAIN OUTCOME MEASURE Change in paretic muscle force of contraction following FES was compared to change without FES. RESULTS For the four included studies, the mean effect size was .63 (95% CI: .29, .98). This result was statistically significant (p < .05). CONCLUSION Pooling from randomized trials supports FES as promoting recovery of muscle strength after stroke. This effect is statistically significant. There is a reasonable likelihood of clinical significance as well.

Biofeedback therapy in poststroke rehabilitation: A meta-analysis of the randomized controlled trials

OBJECTIVE To assess the efficacy of biofeedback therapy in poststroke rehabilitation. DESIGN A meta-analysis of the reported randomized control trials of biofeedback therapy in poststroke rehabilitation was performed. Data were analyzed using the effect size method and pooled using the Der Simonian-Laird Random Effects Model. Study quality was assessed according to the method of Chalmers. SETTING All included studies were conducted in academically based rehabilitation settings. PATIENTS Patients were in the rehabilitative phase of their illness. The timing of the intervention from the acute event did vary greatly between and within studies. INTERVENTION Biofeedback therapy was applied to a paretic limb of patients in the study group. Both treatment and control groups received standard physical therapy. MAIN OUTCOME MEASURE Change in range of motion of a joint of a paretic limb as a result of treatment was examined. This measure was chosen after the eligible studies were evaluated for combinable end points. RESULTS A total of eight studies were included in the analysis. The mean effect size for change in lower extremity range of motion as a result of biofeedback therapy was 1.50 (95% confidence interval [CI]: -0.59, 3.59). For the upper extremity the effect size was 2.30 (95% CI: -1.06, 5.66). Both results were not significant at the p < .05 level. Statistical tests showed significant heterogeneity among studies, validating the use of the Random Effects Model. CONCLUSION Results of pooling available randomized control trials do not support the efficacy of biofeedback in restoring the range of motion of hemiparetic joints. Nevertheless, because the calculated mean effect sizes were large, with associated wide confidence intervals, the possibility of a type II error masking an important clinical benefit needs to be considered in evaluating this result.

Meta-analysis of randomized controlled trials of cranial electrostimulation : efficacy in treating selected psychological and physiological conditions

To clarify the diverse published results of cranial electrostimulation (CES) efficacy, we conducted an extensive literature review that identified 18 of the most carefully conducted randomized controlled trials of CES versus sham treatment. For the 14 trials that had sufficient data, we used the techniques of meta-analysis to pool the published results of treating each of four conditions: anxiety (eight trials), brain dysfunction (two trials), headache (two trials), and insomnia (two trials). Because studies utilized different outcome measures, we used an effect size method to normalize measures which we then pooled across studies within each condition. The meta-analysis of anxiety showed CES to be significantly more effective than sham treatment (p < .05). Pooling did not affect results that were individually positive (headache and pain under anesthesia) or negative (brain dysfunction and insomnia). Most studies failed to report all data necessary for meta-analysis. Moreover, in all but two trials, the therapist was not blinded and knew which patients were receiving CES or sham treatment. We strongly recommend that future trials of CES report complete data and incorporate therapist blinding to avoid possible bias.

Biofeedback therapy in stroke rehabilitation: a review.

The history of biofeedback therapy in neuromuscular rehabilitation began with the discovery in 1830 that electrical events emanated from the surface of a muscle during its contraction1. The prototype forerunner of the current electromyogram (EMG) appeared in 19282. Reports of the application of biofeedback (BFB) techniques for the treatment of various neuromuscular disorders began to appear in the late 1950s and early 1960s3-5. In the next three decades, enthusiastic case series, and later randomized controlled trials, were published. The results of the latter more rigorous trials were mixed in their appraisal of its efficacy68. Finally over the last three years, quantitative literature overviews, or meta-analyses, have been published in an attempt to elucidate the potential role of this modality more adequately9-11. Although the various reports have described its use in a wide variety of neuromuscular disorders including spinal cord injury12, spastic torticollis and other dystonias13, cerebral palsy and peripheral nerve damage14, by far the greatest area of investigation and concomitant utilization has been post-stroke rehabilitation. This paper will describe some of the basic physiological constructs of BFB, and the functional aspects of applying it in the clinical setting. The special problems related to research in stroke rehabilitation will be reviewed with special reference to BFB. However, the main focus and purpose of this work will be to provide the reader with an assessment of the overall efficacy of this modality in stroke rehabilitation.

Methadone vs. L-alpha-acetylmethadol (LAAM) in the Treatment of Opiate Addiction: A Meta-Analysis of the Randomized, Controlled TriaIs

The authors conducted a meta-analysis of the reported randomized, controlled trials comparing methadone to I.-alpha-acetylmethadol (LAAM) to assess the efficacy of LAAM relative to methadone in the treatment of opiate addiction. All studies were conducted in standard outpatient opiate addiction treatment clinics. Most patients were men from lower socioeconomic strata. A statistically significant risk difference favoring methadone was detected for retention-in-treatment and discontinuation of treatment because of side effects. The risk difference for illicit drug use favored LAAM, but was not significant. A small treatment difference in favor of methadone was noted. LAAM does appear to be a relatively effective alternative in the treatment of opiate addiction, more so in certain select situations. (Am J Addict 1997; 6:339–349)

A growth rate distribution model for the age dependence of human cancer incidence: A proposed role for promotion in cancer of the lung and breast*

A biological model is proposed to account for the steep rise of human cancer incidence with age. The model casts in mathematical terms the assumptions that each clone destined to give rise to a detectable tumor displays a characteristic net growth rate and that the assembly of such clones displays a distribution of growth rates. Incidence is introduced as the rate of appearance of clones whose size permits detection. While the cancer formation process may involve a series of stages, we assume that the overall kinetics of tumor detection reflect one stage of development whose duration spans the major portion of the latent period between initial cell alteration and final detection. We further assume that the net growth rates of tumor-forming clones increase in the presence of promotors and resume their original growth rates when the promoting substance is removed. Assuming that cigarette smoke has promoting activity, we show how the model could account for the abrupt impact of cessation of smoking on subsequent lung cancer incidence. If we assume that clones destined to be detected as breast cancers experience promotional activity during the period of a womans fertility, the model predicts that as a consequence of the slowing down of the clones a discontinuous decline in incidence would follow menopause. Since women experience menopause over a range of ages, we show how aggregating the contributions from these menopausal ages results in an overall age dependence of incidence with no discontinuities and with the observed change in the incidence rate for breast cancer near the age range of menopause.

Use of the Seer Cancer Registry for Technology Assessment

The Surveillance, Epidemiology, and End Results (SEER) cancer registry contributed to technology assessment by providing population-based samples for detailed case-control studies, by serving as the control group in comparisons with various experimental groups, by allowing an assessment of selection bias in clinical trials, and by facilitating evaluations of classification and coding systems.

Introduction: Using Medical Registries and Data Sets for Technology Assessment

The rising costs of health care and interest in the evaluation of health services and systems have sparked an increased need for technology assessment. A variety of available methods of assessment are described in the Institute of Medicines book Assessing Medical Technologies (1). Although such methods as the randomized controlled trial (RCT) are widely accepted and used, obtaining information by such methods often takes a considerable amount of time, expense, and sophistication in study design. These costs suggest that a broader range of methods for collecting information about health care technologies should be considered. A vast resource of data collected on patients, ranging from a providers practice records to national data sets, might be useful for technology assessment if it could be properly appraised.

Interruption of cell transformation and cancer formation

A review of the results of X‐ray and chemical carcinogen induction of transformation of mouse cells supports a two‐step epigenetic model of transformation. According to this model, exposure induces an epigenetic regulatory alteration that makes the cells hypermutable so that when the cell population inheriting this alteration becomes sufficiently large, the second step, a mutation to the transformant phenotype, becomes increasingly likely. The epigenetic alteration in X‐ray‐exposed mouse cells has been demonstrated to be reversible by brief exposure to certain protease inhibitors. If the rodent cell experiments constitute a valid system for studying human cancer, then this two‐step model may herald rich opportunities for preventing and perhaps even treating cancer in humans.—Fox, M. S., Klawansky, S. Interruption of cell transformation and cancer formation. FASEB J. 20, 2209–2213 (2006)

Survival from localized breast cancer: variability across trials and registries

Age-specific (< 50, 50-69 years) 10-year survival proportions in four European trials for node-negative, Stage I and II breast cancer patients differ significantly. These patients, identified as having the same stage as localized-breast cancer patients in the End Results Registry of the U.S. National Cancer Institute, had pooled survival proportions for the two age groups (0.713, 0.579) close to those of the registry (0.713, 0.607).