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PubMed2005

Multi-center randomized clinical trials in oral and maxillofacial surgery: modeling of fixed and random effects.

The multi-center randomized clinical trial (MCCT) is an important tool to evaluate treatment of rare diseases. An important and challenging analytic consideration is how to model the variability of the set of clinical centers composing an MCCT. The purpose of this paper was to demonstrate how changing the assumptions regarding the variability (fixed effect versus random effect) of the set of clinical centers may alter the results. The data for this paper were derived from a recently completed MCCT. The MCCT was designed as a prospective, randomized clinical trial comparing the stability of two techniques, i.e., wire versus rigid internal fixation (RIF), for stabilizing the mandible after bilateral sagittal split ramus osteotomy (BSSO) for patients requiring mandibular advancement. Three treatment centers were involved. The key outcome variable was change in mandibular position (B-point) over time. We developed two different analytic models by varying the underlying statistical assumptions regarding the variability of the clinical treatment centers, i.e., random or fixed effects. Analyses based on the random-effects model demonstrated no significant difference between treatment groups in terms of relapse (P=0.13). With the fixed-effects model, however, wire fixation had significantly more relapse at B-point over time than RIF (P=0.02). The results from these two sets of analyses demonstrate how changing assumptions regarding the variability of the set of clinical centers can alter the interpretation of the treatment effect. The choice of statistical modeling of the set of clinical centers is an important consideration when performing analyses of MCCTs and it is a decision that should be made prior to initiating the study.

Analysis of Variance↗

PubMed1995

Selecting the optimum therapeutic dose of serotonin reuptake inhibitors: studies with citalopram.

Establishing the optimum therapeutic dose of a putative antidepressant is important to avoid unnecessarily high doses, which may be associated with increased frequency of severity of unwanted side effects, or too low a dose which may not achieve the best therapeutic effect. Flexible dose regimes that are often used in clinical trial programmes may lead to the use of too high a dose because of the attribution of response in depression to the higher dose used later in the study rather than being identified as a delayed response to a lower dose used earlier. Fixed dose studies provide a more reliable view of the dose response relationship and, where differences between doses are small, metanalysis of large databases may provide a useful tool for the establishing of the minimum therapeutic dose. Metanalysis of the placebo controlled results with citalopram demonstrated that the dose-response curves based on log odds ratios showed a very flat curve across the 20-60 mg range and that 20 mg appeared therefore to be the minimum effective dose. There was evidence that in some subgroups of depressed patients a better response may be seen with a higher dose. For example in patients with severe depression citalopram was effective compared with placebo in doses of both 20 mg and 40 mg. However there was a more pronounced therapeutic effect with the higher dose. Similar results have been reported with other selective serotonin reuptake inhibitors.

Citalopram↗

PubMed2002

Behaviors changed by intervention are associated with reduced STD recurrence: the importance of context in measurement.

BACKGROUND: Evaluations of STD/HIV interventions incorporating behavioral and biologic outcomes have not reported strong correspondence. GOAL: The goal of the study was to demonstrate that behaviors, measured comprehensively, are associated with infection and to delineate the behaviors responsible for reduced infection rates in Project SAFE (Sexual Awareness For Everyone). STUDY DESIGN: Follow-up data from an intervention trial were analyzed to determine: (1) study versus control differences in complex risk behaviors and (2) the overall relationship between these behaviors and infection status (chlamydia and/or gonorrhea), with use of multiple logistic regression. RESULTS: Lower infection rates among 249 women who received intervention (compared with 228 controls) were explained by reduced-risk status in 5 modifiable behaviors. The 0 to 12-month logistic regression model (including sex with untreated partner [OR = 5.6], lack of mutual monogamy [OR = 2.4], unsafe sex [OR = 1.9], rapid partner turnover [OR = 2.7], and douching after sex [OR = 1.9]) correctly predicted infection status for 75.3% of participants (71.8% of infected, 76.2% of uninfected). Women in nonmutually monogamous unions who had sex with partners who were untreated or incompletely treated were 13 times more likely to be infected than those who were monogamous and avoided sex with an untreated/incompletely treated partner. CONCLUSION: This intervention reduced infection rates by maintaining low-risk behaviors and changing high-risk behaviors. We elucidated the complex relationship between behavior and infection by incorporating context into variable conceptualization and considering several behaviors simultaneously.

Adolescent↗

PubMed1999

Implication of evidence-based medicine in prescription guidelines taught to French medical students: current status in the cardiovascular field.

OBJECTIVES: To study how satisfactory the contents of introductory courses in cardiovascular therapeutics, given to medical students in France, are with respect to the concepts of evidence-based medicine. METHODS: Medical school lecturers were asked to provide written course material used as part of medical school courses. Best-available evidence was classified as existent (including two therapeutic subclasses: indicated and contraindicated), and nonexistent. Four scores (from 0 to 10) were given, according to conformity with best-available evidence, and citation of randomized clinical trials (RCT), meta-analyses and therapeutic objectives. RESULTS: Thirty-four written documents were obtained from 43 faculties. Although the score (mean +/- SEM) of conformity with best-available evidence was 5.43 +/- 0.28 for the existent best-available evidence class, the corresponding scores for the citation of RCT, meta-analyses, and therapeutic objectives were, respectively, 1 +/- 0.2, 0.16 +/- 0.07, and 2.7 +/- 0.3. The four scores were highest when the best-available evidence belonged to the indicated class, intermediate when best-available evidence was nonexistent, and lowest for the contraindicated class (P < .05). These scores were significantly higher when the printed material was intended for specialists. CONCLUSION: Despite some limitations, the extent of agreement with the best-available evidence is only moderate. Pathophysiologic reasoning is largely preferred to justify the choice of therapeutics recommended to medical students.

Analysis of Variance↗

PubMed2004

Social support in diabetes: a systematic review of controlled intervention studies.

Systematic, computerized search in Medline, the Cochrane Library, Eric, PsychINFO and Embase files, 1980-2003, selecting descriptions of prospective intervention trials with good methodological design, testing effects of social support interventions on health outcomes in primary and outpatient care for type 2 diabetes. Six controlled trials were reviewed. They defined, modified, and measured social support in various ways, and scored outcomes with varying measures. Gender differences and the right amount of support seem important. Promising new forms of social support: group consultations (better HbA1c and lifestyle), Internet or telephone-based peer support (improved perceived support, increased physical activity, respectively), and social support groups (improved knowledge and psychosocial functioning). No improved diabetes control by classic forms of support, e.g. from spouse (but weight loss in women) and family and friends (no differences). It is tentatively concluded that this review supports the hypothesis that specific social support interventions affect patient self-care and diabetes outcomes. New forms of social support may be discussed and incorporated in the work of diabetes teams, and offered to patients as new possibilities to help them adjust to a life with (type 2) diabetes and make information-based decisions. Only in the group consultations study, diabetes control was protected. More well-designed research testing the effects of specific social support interventions on patient self-care, lifestyle adaptations, and outcomes of diabetes care, is warranted.

Counseling↗

PubMed2005

Duloxetine for the treatment of major depressive disorder: a closer look at efficacy and safety data across the approved dose range.

OBJECTIVE: This analysis focuses on efficacy and safety data obtained from studies of duloxetine for the treatment of major depressive disorder (MDD) within the approved dose range of 40-60 mg/day. METHOD: Efficacy and safety data were obtained from the acute phase portions of four randomized, double-blind, placebo-controlled clinical trials in patients meeting DSM-IV criteria for MDD. In Studies 1 and 2, patients were randomized to duloxetine 60 mg once daily (QD) (n=123 [Study 1]; n=128 [Study 2]) or placebo (n=122 [Study 1]; n=139 [Study 2]) for 9 weeks. In Studies 3 and 4, patients were randomized to duloxetine 20 mg twice daily (BID) (n=91 [Study 3]; n=86 [Study 4]) or placebo (n=90 [Study 3]; n=89 [Study 4]) for 8 weeks. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAMD17) total score (primary outcome), HAMD17 subscales, the Clinical Global Impression of Severity (CGI-S) and Patient Global Impression of Improvement (PGI-I) scales, and Visual Analog Scales (VAS) for pain. Safety assessments included rates of discontinuation due to adverse events, spontaneously reported treatment-emergent adverse events, and changes in vital signs. RESULTS: In both studies of duloxetine 60 mg QD, mean change in HAMD17 total score was significantly greater in duloxetine-treated patients compared with placebo (Study 1, p<.001; Study 2, p=.024). At a dose of 20 mg BID, duloxetine demonstrated significant superiority over placebo on the HAMD17 total score in one of the two studies (Study 4, p=.034). Probabilities of remission among patients receiving duloxetine 60 mg QD were 44.2% in Study 1 (p<.001 vs. placebo) and 43.0% in Study 2 (NS), while for patients receiving duloxetine 20 mg BID the probabilities of remission were 27.2% in Study 3 (NS) and 36.1% in Study 4 (NS). Across the six assessed VAS measures of pain severity and interference, the main effect of treatment for duloxetine 60 mg QD was significantly superior to placebo on 7 of the 12 outcomes in Studies 1 and 2, while duloxetine 20 mg BID was not superior to placebo on any of the 12 outcomes in Studies 3 and 4. The rate of discontinuation due to adverse events was 13.1% among patients receiving duloxetine 60 mg QD, and 11.9% at a dose of 20 mg BID. The most frequently reported treatment-emergent adverse events at both doses included nausea, headache, dry mouth, dizziness, and insomnia. The incidence of treatment-emergent nausea among patients receiving duloxetine 60 mg QD was 37.8%, compared with 16.4% among patients receiving 20 mg BID. CONCLUSION: Duloxetine provides safe and effective acute phase treatment of MDD at doses of 40-60 mg/day. Compared with placebo, the 60 mg QD dose was more consistently effective than the 20 mg BID dose. However, the incidence of certain treatment-emergent adverse events is likely to be lower at the 40 mg dose.

Adolescent↗

PubMed2003

Oral anticoagulants vs. aspirin for stroke prevention in patients with non-valvular atrial fibrillation: the verdict is in.

There is an increased risk of stroke and other cardiovascular events in patients with atrial fibrillation (AF). Three meta-analyses of randomized clinical trials (RCTs) comparing oral anticoagulants (OAC) with aspirin (ASA) arrived at different conclusions regarding the relative efficacy of these agents to prevent ischemic stroke in AF patients. This article summarizes a recently published individual patient meta-analysis of all published RCTs comparing OAC and ASA in AF. In total, 4052 patients randomized to OAC or ASA were similar regarding important prognostic factors. Patients receiving OAC had a significantly lower risk of any stroke (hazard ratio [HR] 0.54 [95% CI 0.43-0.71]), ischemic stroke (HR 0.48 [0.37-0.63]), or cardiovascular events (HR 0.71 [0.59-0.85]). Patients receiving OAC were more likely to experience major bleeding (HR 1.71 [1.21-2.41]). The benefit of OAC was most prominent in patients at a high risk of stroke and other cardiovascular events, such as patients with hypertension, diabetes, or previous cerebrovascular events. Overall, OAC improves outcomes for cardiovascular events in AF patients but modestly increases the absolute risk of major bleeding. Since high-risk AF patients appear to benefit most from OAC, determining stroke risk in AF patients is very important.

Administration, Oral↗

PubMed2006

Cause of death with bare metal and sirolimus-eluting stents.

AIMS: Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents. METHODS AND RESULTS: An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently. CONCLUSION: At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.

Aged↗

PubMed1993

[Randomized clinical trials in the Nederlands Tijdschrift voor Geneeskunde].

OBJECTIVE: To collect all randomized clinical trials (RCT) published in the Nederlands Tijdschrift voor Geneeskunde (Ned Tijdschr Geneeskd) in order to present them to the Cochrane Centre, Oxford, United Kingdom, to be included in the international database of RCT's, which will be used to perform meta-analyses. DESIGN: Retrospective bibliometric study. SETTING: Editorial office of Ned Tijdschr Geneeskd. METHOD: All original papers (OP), published between the May 1st, 1948 and May 1st, 1993 were studied. Papers were selected that met the criteria for RCT: randomization or the similar assignment of patients to different treatment groups. RESULTS: Of 6820 OP 259 (3.8%) were selected. In 69 (26.6%) randomization seemed to be performed correctly and in 20 (7.7%) randomization was not correct; in 170 (65.6%) there was no randomization. In the period May 1st, 1948 till May 1st, 1968 24 RCT's were published, in the period May 1st, 1973 till May 1st, 1993 60. Most RCT's (78%) describe the effects of pharmaceutical treatment. CONCLUSION: RCT's as such were difficult to recognize in Ned Tijdschr Geneeskd. Over the years there was an increase in the number of published RCT's. The problems we found with the design of RCT's and randomization are still current. An international register of published and/or planned RCT's, as envisaged by the Cochrane Centre, will make it easier to carry out meta-analyses.

Humans↗

PubMed2000

Design and statistical issues of the hemodialysis (HEMO) study.

The Hemodialysis Study is a multicenter clinical trial of hemodialysis prescriptions for patients with end stage renal disease. Participants from over 65 dialysis facilities associated with 15 clinical centers in the United States are randomized in a 2 x 2 factorial design to dialysis prescriptions targeted to a standard dose or a high dose, and to either low or high flux membranes. The primary outcome variable is mortality; major secondary outcomes are defined based on hospitalizations due to cardiovascular or infectious complications, and on the decline of serum albumin. The Outcome Committee, consisting of study investigators, uses a blinded review system to classify causes of death and hospitalizations related to the major secondary outcomes. The dialysis dose intervention is directed by the Data Coordinating Center using urea kinetic modeling programs that analyze results from dialysis treatments to monitor adherence to the study targets, adjust suggested dialysis prescriptions, and assist in trouble-shooting problems with the delivery of dialysis. The study design has adequate power to detect reductions in mortality rate equal to 25% of the projected baseline mortality rate for both of the interventions.

Humans↗

PubMed2003

[Controversies in the conduction and evaluation of clinical trials results for the treatment in vasovagal syncope].

The vasovagal syncope is a reflex reaction to various stimuli leading to the marked hypotension with or without bradycardia with loss of consciousness and fall of postural muscle tone. The vast majority of the patients recover spontaneously but if the syncope occurs frequently and causes injury of the patients body it worsens the quality of life and needs appropriate treatment. The injuries requiring hospitalization occur approximately in 10% of the patients with vasovagal syncope. The aim of the therapy of affected patients is to diminish the syncope prevalence, to brake the neurocardiogenic reaction on an early stage or to prolong the duration of the presyncope phase to enable the patient prevention of the injury. The lack of clear diagnostic criteria and difficulties with estimation the efficacy of any particular therapeutic intervention in many clinical studies of different authors, inclusion to the studies patients with different clinical presentation stages of the disease contribute to different conclusions, which automatic use in the clinical practice is inappropriate. There is an urgent need to clear the methodological discrepancies and to conduct good planed, large, randomized, multicentre studies to assess the efficacy of different therapeutic methods in the treatment of vasovagal syncope.

Evaluation Studies as Topic↗

PubMed1993

Brodimoprim: therapeutic efficacy and safety in the treatment of bacterial infections.

The clinical efficacy and safety of brodimoprim has been studied by numerous investigators. In the trials reviewed 2291 cases were entered. Of these 2214 were evaluable for efficacy and 2277 for safety. Brodimoprim has been found to exhibit good therapeutic efficacy in upper and lower respiratory tract infections, in bacterial gastroenteritis and in typhoid fever. Response rates in the above indications were reported to be in the range of 85-100% for upper respiratory tract infections, 84-92% for lower respiratory tract infections, 97-100% for bacterial gastroenteritis and 95-100% for enteric fever. In controlled studies these response rates were in the same range as those obtained with standard drugs (ampicillin, amoxicillin, cephalosporins, erythromycin, doxycycline, chloramphenicol). Of the 2277 patients assessable for safety 1429 had received brodimoprim and 848 received a comparative agent. In the brodimoprim group, the overall incidence of clinical adverse events occurring in patients during treatment was 12.7%. The majority of adverse events reported were nausea and vomiting, skin reactions, and CNS reactions. The incidence and pattern of adverse events caused by comparative drugs was similar to those caused by brodimoprim, with the exception of doxycycline which generated fewer clinical adverse events than the other regimens. Brodimoprim in single daily doses may be considered as a highly efficacious and well tolerated antibacterial agent against a broad range of bacterial infections.

Adult↗

PubMed2005

Physical activity, cardiorespiratory fitness, and their relationship to cardiovascular risk factors in African Americans and non-African Americans with above-optimal blood pressure.

This report describes cross-sectional associations among physical activity, cardiorespiratory fitness, dietary habits, and cardiovascular disease (CVD) risk factors in a large sample (n = 810) of African Americans (n = 279) and non-African Americans (n = 531) with above-optimal blood pressure. Participants in PREMIER, a clinical trial for blood pressure control through lifestyle approaches, underwent baseline assessments to determine physical activity level, cardiorespiratory fitness category, dietary intake, and CVD risk factors. Mean levels of body mass index (BMI), total cholesterol, LDL cholesterol, HDL cholesterol, daily percent calories from fat and saturated fat, daily servings of fruits and vegetables, and daily fiber intake were examined across three physical activity levels and two fitness categories. Hypertension status was also assessed. Data were stratified by sex and ethnicity. For all participants, those in the low fitness category had higher BMI levels. Total cholesterol was lower in African American women in the high fitness category. Mean values of more than five daily servings of fruits and vegetables were reported by non-African American women and African American men in the high activity category. Higher intake of dietary fiber was found for non-African American women at the high activity level, with a similar trend observed for African American women. Future work examining these associations prospectively should include sufficient minority representation to enhance generalizability to all population groups and determine the beneficial effects from increased physical activity and improved cardiorespiratory fitness.

Adult↗

PubMed2005

Systematic review of the diagnosis and management of malignant extradural spinal cord compression: the Cancer Care Ontario Practice Guidelines Initiative's Neuro-Oncology Disease Site Group.

PURPOSE: This systematic review describes the diagnosis and management of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression (MSCC). METHODS: MEDLINE, CANCERLIT, and the Cochrane Library databases were searched to January 2004 using the following terms: spinal cord compression, nerve compression syndromes, spinal cord neoplasms, clinical trial, meta-analysis, and systematic review. RESULTS: Symptoms for MSCC include sensory changes, autonomic dysfunction, and back pain; however, back pain was not predictive of MSCC. The sensitivity and specificity for magnetic resonance imaging (MRI) range from 0.44 to 0.93 and 0.90 to 0.98, respectively, in the diagnosis of MSCC. The sensitivity and specificity for myelography range from 0.71 to 0.97 and 0.88 to 1.00, respectively. A randomized study detected higher ambulation rates in patients with MSCC who received high-dose dexamethasone before radiotherapy (RT) compared with patients who did not receive corticosteroids before RT (81% v 63% at 3 months, respectively; P = .046). There is no direct evidence that supports or refutes the type of surgery patients should have for the treatment of MSCC, whether surgical salvage should be attempted if patient is progressing on or shortly after RT, and whether patients with spinal instability should be treated with surgery. CONCLUSION: Patients with symptoms of MSCC should be managed to minimize treatment delay. MRI is the preferred imaging technique. Treatment for patients with MSCC should consider pretreatment ambulatory status, comorbidities, technical surgical factors, the presence of bony compression and spinal instability, potential surgical complications, potential RT reactions, and patient preferences.

Adrenal Cortex Hormones↗

PubMed2005

Evaluating the quality of informed consent.

CONTEXT: Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process. OBJECTIVE: To develop and test a practical and general means of evaluating the quality of informed consent for clinical research. Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP. RESULTS: 632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0-10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0-5, with 5 a perfect score. CONCLUSIONS: The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.

Consent Forms↗

PubMed1999

Reliability of echocardiographic assessment of left ventricular structure and function: the PRESERVE study. Prospective Randomized Study Evaluating Regression of Ventricular Enlargement.

OBJECTIVES: The study was done to evaluate reliability of echocardiographic left ventricular (LV) mass. BACKGROUND: Echocardiographic estimation of LV mass is affected by several sources of variability. METHODS: We assessed intrapatient reliability of LV mass measurements in 183 hypertensive patients (68% men, 65 +/- 9 years) enrolled in the Prospective Randomized Enalapril Study Evaluating Regression of Ventricular Enlargement (PRESERVE) trial after a screening echocardiogram (ECHO) showed LV hypertrophy. A second ECHO was repeated at randomization (45 +/- 25 days later). Two-dimensional (2D)-guided M-mode or 2D linear measurements of LV cavity and wall dimensions were verified by one experienced reader. RESULTS: Mean LV mass was similar at first and second ECHO (243 +/- 53 vs. 241 +/- 54 g) and showed high reliability as estimated by intraclass correlation coefficient (RHO) = 0.93. Within-patient 5th, 10th, 90th and 95th percentiles of between-study difference in LV mass were -32 g, -28 g, +25 g and +35 g. Mean LV mass fell less from the first to the second ECHO than expected from a formula to predict regression to the mean (2 +/- 19 vs. 17 +/- 12 g, p < 0.001). Reliability was also high for LV internal diameter (RHO = 0.87), septal (RHO = 0.85) and posterior wall thickness (RHO = 0.83). Substantial or moderate reliability was observed for measures of LV systolic function and diastolic filling (RHO from 0.71 to 0.57). CONCLUSIONS: Left ventricular mass had high reliability and little regression to the mean; between-study LV mass change of +/-35 g or +/-17 g had > or = 95% or > or = 80% likelihood of being true change.

Aged↗

PubMed2002

Return-to-work interventions for low back pain: a descriptive review of contents and concepts of working mechanisms.

Low back pain is a major medical and social problem associated with disability, work absenteeism and high costs. Given the impact of the problem, there is a need for effective treatment interventions in occupational healthcare that aim at the prevention of chronic disability and the realisation of return to work. These so-called return-to-work (RTW) interventions are becoming increasingly popular. As well as questions concerning the effectiveness of RTW interventions, there are also important questions on the actual content and underlying concepts of these multifactorial intervention strategies. The purpose of this review is to examine the literature on the content and underlying concepts of RTW interventions for low back pain. A systematic literature search identified 14 randomised controlled trials (RCTs) evaluating the effects of 19 RTW interventions. The content and concepts of these RTW interventions are described, compared and discussed in this review. Further, the contents of the RTW interventions are classified by the use of predefined components (physical exercises, education, behavioural treatments and ergonomic measures). The identified RTW interventions varied with respect to the disciplines involved, the target population and the number and duration of sessions. The classification showed that physical exercises were a component of most of the selected interventions, followed by education, behavioural treatments and ergonomic measures. The most prevalent combination of components was the combination of physical exercises, behavioural treatment and education. However, the types of physical exercises, behavioural treatment and education varied widely among the RTW interventions. The described concepts for the physical exercises were an increase of muscle strength, coordination, range of motion of the spine and cardiovascular fitness, and a decrease of muscle tension. Education as a part of RTW interventions is believed to increase the understanding of patients regarding their disorder and treatment. Behavioural treatments were mainly based on the gate control theory of pain (psychophysiological processes are involved in pain perception) and/or the operant conditioning hypothesis (pain behaviour is determined by its consequences). No concepts were described for ergonomic measures. Finally, the plausibility of the described concepts is discussed. Future RCTs on this topic should evaluate the underlying concepts of the RTW intervention in addition to its effectiveness.

Absenteeism↗

PubMed1997

[The insulin analog, Humalog, in discontinuous: from pharmacology to clinical use].

Humalog is the first analog of human insulin to be evaluated on a large scale in clinical conditions by discontinuous subcutaneous administration. Eight international multicentric studies have investigated the efficacy and tolerance of Humalog in protocols with 3 daily insulin injections (3 preprandial injections of Humalog associated with 1 or 2 injections of Umuline NPH or Umuline Zinc). A total of 2834 patients participated in these studies, including 2,277 who used Humalog. In addition to these trials, more than 5,000 patients had used Humalog by 1996, in some cases for more than 3 years. In insulin-dependent diabetes (IDDM), glycaemic control at the time of inclusion of patients in these protocols, as evaluated by HbA1C, was generally moderate (8 to 9%) despite 3 daily injections. This did not constitute intensive care since basal insulin for half of these patients was ensured by only a single daily injection. In these conditions, the results obtained showing significant postprandial improvement in glycaemic control and a significant reduction of the number of hypoglycaemic episodes, particularly at night, are important even though HbA1C levels were not significantly decreased. In a more recent crossover study (1996), 199 well-controlled IDDM patients (HbA1C = 7.3%) were treated intensively by multiple injections. The number of severe hypoglycaemic episodes with coma was only one-fifth that of the group treated by Humalog (equivalent to a reduction of 26 comas per 100 patients/year) in the absence of any significant modification of HbA1C. No differences were noted for lipids, adverse side effects or severe events (except hypoglycaemic episodes) and immunogenicity. In non-insulin-dependent diabetes, the results were similar but less impressive concerning the improvement in postprandial glycaemic control and the reduction in hypoglycaemic episodes. In addition to the significant results obtained in these studies, Humalog was favoured by the vast majority of patients. It is likely that Humalog will allow intensified treatment of diabetes in very favourable conditions, and that more patients will achieve the difficult goal of normalising glycaemia. However, a single injection of NPH or prolonged insulin is not sufficient for that purpose. Two daily injections will generally be necessary.

Diabetes Mellitus, Type 1↗