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Results for “randomized controlled trial (RCT)”

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PubMed1995

Unbiased research and the human spirit: the challenges of randomized controlled trials.

Research by Klein and associates provides useful information on the relation between episiotomy and outcomes such as perineal trauma, but the methodologic implications of their work are especially fascinating. Physicians who participated in their randomized controlled trial (RCT) were supposed to adhere to a policy of either liberal or restrictive use of episiotomy according to the study arm to which each patient was assigned. However, some used the procedure for approximately 90% of patients regardless of allocation. Klein and associates' post-hoc study (see pages 769 to 779 of this issue) sheds light on the relation between physician attitudes and the practice of episiotomy. The author contends that the noncompliance encountered by Klein and associates reflects the fact that randomized trials are anathema to the human spirit. He offers suggestions for making RCTs more meaningful and stresses that, although RCTs are indispensible to the advancement of medical knowledge, they necessitate assiduous attention to matters of design and implementation.

Attitude of Health Personnel↗

PubMed2005

Investigation of staff and patients' opinions of a proposed trial of elective single embryo transfer.

BACKGROUND: In the context of mounting concern about the risks of twin pregnancies resulting from IVF, this study aimed to assess staff and patients' attitudes towards a proposed randomized controlled trial (RCT) of elective single embryo transfer (SET) in a Scottish fertility centre. METHODS: The views of 10 members of IVF clinic staff were assessed by means of a focus group and those of 12 couples by semi-structured interviews. RESULTS: Staff were aware of the risks of twin pregnancies to mothers and babies and the need for evidence of success in SET, but had reservations about the proposed RCT. The need to subject patients to unpopular scientific procedures such as randomization and blinding conflicted with their perceived caring role. They felt it would be hard to recruit and onerous to patients but nevertheless discussed how it could be successfully mounted if necessary. They debated how to ensure that consent was fully informed, and when, and how, to randomize. Patients accepted the possibility of twins but were largely unaware of risks inherent in twin pregnancies. They saw no need for a trial and found the idea of randomization unacceptable except in younger women. They would accept SET if it became unit policy and appeared unaffected by financial considerations. CONCLUSIONS: Involving affected staff at the design stage may make it easier to conduct a SET trial in their clinics. IVF patients whose ultimate goal is pregnancy are less likely to support a trial which aims to minimize twin pregnancies.

Adult↗

PubMed2003

Efficacy of massage therapy in chronic pain: a pragmatic randomized trial.

BACKGROUND: Although classic massage is used widely in Germany and elsewhere for treating chronic pain conditions, there are no randomized controlled trials (RCT). DESIGN: Pragmatic RCT of classic massage compared to standard medical care (SMC) in chronic pain conditions of back, neck, shoulders, head and limbs. OUTCOME MEASURE: Pain rating (nine-point Likert-scale; predefined main outcome criterion) at pretreatment, post-treatment, and 3 month follow-up, as well as pain adjective list, depression, anxiety, mood, and body concept. RESULTS: Because of political and organizational problems, only 29 patients were randomized, 19 to receive massage, 10 to SMC. Pain improved significantly in both groups, but only in the massage group was it still significantly improved at follow-up. Depression and anxiety were improved significantly by both treatments, yet only in the massage group maintained at follow-up. CONCLUSION: Despite its limitation resulting from problems with numbers and randomization this study shows that massage can be at least as effective as SMC in chronic pain syndromes. Relative changes are equal, but tend to last longer and to generalize more into psychologic domains. Because this is a pilot study, the results need replication, but our experiences might be useful for other researchers.

Adult↗

PubMed1999

An international network for evaluating neuroprotective therapy after severe birth asphyxia.

Animal studies have shown great promise in their applicability to potentially neuroprotective therapies for severe birth asphyxia in human babies. It is now necessary to consider a strategy to evaluate some or all of these techniques within the context of human neonatal randomized control trials (RCT). We have set up a pilot study for an international RCT of mature babies with severe asphyxia (defined by an Apgar score of 5 or less at 10 minutes) and have shown that we can recruit from 120 centers in 17 countries an average of three babies a week, which is the required number to undertake a study over a 2-year period with sufficient power to show a significant improvement in outcome. Particular attention must be given in future studies to the size of improvement in outcome required, generalizability of entry criteria, and the appropriate measure of functional outcome in treated babies.

Animals↗

PubMed2006

[Psychotherapy for anxiety disorders in childhood and adolescence--what is evidence-based?].

Anxiety disorders are the most frequent mental disorders in children and adolescents. They are also an important risk factor for psychological disturbances in adulthood and require adequate treatment. The effectiveness of psychotherapy in the treatment of anxiety disorders today can no longer be questioned. However, a meta-analysis of treatment studies shows that so far, only cognitive-behavior therapy has proved, on the basis of randomized, controlled trials (RCT), to be successful in the treatment of anxiety disorders in children and adolescents. Regardless of whether the cognitive behavior therapy took place individually or in a group, or whether it was carried out with the child alone or with the inclusion of the family, no differences in the effectiveness were found. The follow-up data show that the therapy success persisted for several years and that it was not limited only to the symptoms of anxiety. Although for many psychotherapeutic interventions there is still no empirical basis, initial RCT prove the short-term effectiveness of psychopharmacological treatment (SSRI). The central, empirically validated psychotherapeutic interventions include psychoeducation, cognitive treatment of dysfunctional thoughts, and systematic exposure to the situation triggering anxiety. These interventions will be presented briefly and open questions in psychotherapy research will be discussed in the conclusion.

Adolescent↗

PubMed2005

Implementation of new medical techniques: experience from the Swedish randomized controlled trial on fetal ECG during labor.

BACKGROUND: In a large Swedish multicenter randomized controlled trial (RCT) on intra partum fetal monitoring with automatic analysis of fetal ECG waveform (STAN) in combination with cardiotocography (CTG) (4966 parturients, 300 obstetricians and midwives managing the patients), interim analysis revealed protocol violations. By a post hoc analysis of the results over time, factors affecting the acceptance of the new technique were analyzed. METHODS: The rates of primary and secondary outcome measures (fetal outcome, operative deliveries) were compared in the two study groups (CTG + ST and CTG only). Changes over time were statistically evaluated using a test for homogeneity between the two periods. RESULTS: After retraining, the CTG + ST group showed the lowest rates of operative delivery for fetal distress, fetal blood sampling and admissions to neonatal intensive care unit. Operative deliveries (p = 0.02) and the number of fetal blood sampling decreased significantly over time (p = 0.001). CONCLUSIONS: Training and education probably predisposed the clinicians to a change and reinforced it when it occurred as a result of increased personal experience. The audit and feedback together with the influence of opinion leaders and inter-collegial interactions seem to have been of importance for the successively increasing acceptance of the new method during the RCT.

Cardiotocography↗

PubMed2001

The double-blind, randomized, placebo-controlled trial: gold standard or golden calf?

The double-blind randomized controlled trial (RCT) is accepted by medicine as objective scientific methodology that, when ideally performed, produces knowledge untainted by bias. The validity of the RCT rests not just on theoretical arguments, but also on the discrepancy between the RCT and less rigorous evidence (the difference is sometimes considered an objective measure of bias). A brief overview of historical and recent developments in "the discrepancy argument" is presented. The article then examines the possibility that some of this "deviation from truth" may be the result of artifacts introduced by the masked RCT itself. Can an "unbiased" method produce bias? Among the experiments examined are those that augment the methodological stringency of a normal RCT in order to render the experiment less susceptible to subversion by the mind. This methodology, a hypothetical "platinum" standard, can be used to judge the "gold" standard. The concealment in a placebo-controlled RCT seems capable of generating a "masking bias." Other potential biases, such as "investigator self-selection," "preference," and "consent" are also briefly discussed. Such potential distortions indicate that the double-blind RCT may not be objective in the realist sense, but rather is objective in a "softer" disciplinary sense. Some "facts" may not exist independent of the apparatus of their production.

Bias↗

PubMed1998

A systematic review of compression therapy for venous leg ulcers.

The aim of the study was to determine the relative effectiveness of compression therapies used in the treatment of venous leg ulcers. Randomized controlled trials (RCT) were sought using a search strategy that aimed to identify relevant RCT by searching eight electronic databases (including Medline, Embase and CINHAL), conference proceedings and hand searching key journals. In addition, citations within papers were scrutinized to identify any relevant studies. Suitability for inclusion in this review was determined by a critical appraisal of key determinants of the quality of the trials. Trials that included patients of mixed ulcer aetiology were excluded unless the results of patients with venous disease were reported separately. Data was extracted independently by two reviewers and synthesized quantitatively and qualitatively. Losses to follow-up/withdrawals were assumed to be failures of treatment. A total of 132 articles were identified, and of these eight fulfilled the inclusion criteria. The remaining 126 trials were excluded due to trial design flaws, the inclusion of mixed/arterial aetiology ulcers or because they were non-RCT. Meta-analysis using a random-effects model showed the benefits of multi-layer and elastic compression bandages. It was concluded that more high-quality trials are required and that more emphasis should be placed on economic and quality of life data to try to ascertain the cost-effectiveness and utility of the treatment options available.

Bandages↗

PubMed2005

[A systematic evaluation of randomized controlled trials for acupuncture and moxibustion treatment of insomnia].

OBJECTIVE: To assess the therapeutic effect of acupuncture on insomnia. METHODS: A systematic evaluation of all relevant randomized controlled trials (RCT) about acupuncture and moxibustion treatment of insomnia was carried out. The data were statistically analyzed with a special software RevMan 4.1. RESULTS: Six papers of RCT including 585 patients met the enrolled criteria. All of the trials were of lower in methodological quality without using blind method; Meta-analysis indicated that odds ratio was 3.55, 95% confidence interval [2.50, 5.05], P < 0.0001, as acupuncture group compared with drug group. CONCLUSION: Acupuncture is possibly effective for insomnia. However, because of lower methodological quality of all the trials, this conclusion has no enough evidence.

Acupuncture↗

PubMed1998

Subcortical vascular dementia: survey of treatment patterns and research considerations.

BACKGROUND: Since few studies have examined the effectiveness of therapies for subcortical vascular dementia, treatment guidelines are not available. Current patterns in the treatment of such dementias have not been studied. OBJECTIVE: To determine the practice patterns of Canadian specialists for the treatment of subcortical vascular dementia, and to survey their opinions regarding issues which are important in the design of a randomized controlled trial (RCT) in this field. DESIGN: National survey of all specialists certified in Neurology or Geriatric Medicine. RESULTS: Of responding physicians (78%) prescribed antithrombotic therapy for patients with vascular dementia. Most begin treatment with aspirin 325 mg daily (64%). The next three most common initial treatments were; no pharmacotherapy (12%), aspirin 650 mg daily (11%), and aspirin 1300 mg daily (11%). If the dementia continued to progress despite initial therapy, the treatment options were more varied. Most specialists (69%) believed that an RCT to assess the efficacy of aspirin in vascular dementia is warranted. The majority (69%) also felt that serial neuroimaging would be required for participants in such a trial, with magnetic resonance imaging being cited most frequently (41%). The majority of specialists considered three years as the minimum duration for such a trial. CONCLUSIONS: Specialist physician practice patterns vary significantly for the treatment of patients with subcortical vascular dementia. Most physicians believe that an RCT testing the efficacy of aspirin in this condition is required. However, before such a trial can be conducted, many methodological difficulties need to be addressed.

Aspirin↗

PubMedDate not supplied

Taking an evidence-based model of depression care from research to practice: making lemonade out of depression.

OBJECTIVE: The Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) trial [randomized controlled trial (RCT)] found that collaborative care management of depression in older primary care patients was significantly more effective than the usual care. We examined how an adapted version of IMPACT is working in the "real-world" setting of an HMO 3 years after the conclusion of the trial. METHOD: Two hundred ninety-seven adults treated according to IMPACT protocol "poststudy" (PS) at a large group model HMO were compared to the 141 participants (historical control) in the intervention arm of the RCT at the same site. The Patient Health Questionnaire (PHQ-9) was used to compare depression severity at baseline and 6 months. We also compared treatment contacts, use of antidepressants and psychotherapy and total health care costs. RESULTS: The RCT and PS groups were equivalent regarding baseline depression scores (14.5 vs. 14.2, P=.72), 6-month scores (5.6 vs. 6.3, P=.28) and percent experiencing 50% improvement in depression (68% vs. 70%, P=.83). Antidepressant use was similar (85% and 90%, P=.57). Treatment contacts were fewer in PS than RCT (14 vs. 20, P<.001). CONCLUSIONS: An adapted version of the IMPACT program implemented at a large HMO achieved similar clinical improvements in depression as the clinical trial despite a lower number of intervention contacts.

Aged↗

PubMed2004

Pharmacotherapy of bipolar II disorder: a critical review of current evidence.

OBJECTIVES: There is much controversy surrounding the diagnosis and treatment of patients with bipolar II disorder (BP II). To address the growing need to find effective treatment strategies for patients with BP II, this article identifies and summarizes available published evidence specific to the pharmacotherapy of BP II. METHODS: Using the keywords, 'bipolar disorder', 'type II' or 'type 2', 'bipolar II', 'hypomania', and 'bipolar spectrum', a search of the databases Medline (via PubMed), the Cochrane Central Register of Controlled Trials (via Ovid), and PsychInfo was conducted for the period January 1994 to January 2003. Articles deemed directly relevant to the treatment of BP II were selected. Studies that included both BP I and II patients were excluded if results for BP II patients were not analyzed and reported separately. RESULTS: Fourteen articles were selected for the review period. There are no double blind, randomized controlled trials (RCT) involving only BP II patients. Most studies investigating the pharmacotherapy of BP II are methodologically limited, having observational or retrospective designs and small samples. For long-term treatment, lamotrigine has the strongest quality of evidence (double blind RCT), while lithium is the best studied. With regard to short-term treatment, there is some limited support for the use of risperidone in hypomania, and for divalproex, fluoxetine and venlafaxine in treating depression. CONCLUSIONS: There is a paucity of sound evidence to help guide clinicians treating BP II patients. Decisions about pharmacotherapy should be made on a case-by-case basis; overall, broad recommendations that are based on available evidence cannot be adequately made. More quality research is needed to delineate effective treatment strategies.

Anticonvulsants↗

PubMed2003

Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560].

BACKGROUND: To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2-8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back pain management. METHODS DESIGN: An RCT and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain. Interventions used are 1. Communication between general practitioner and occupational physician plus Participative Ergonomics protocol performed by an ergonomist. 2. Graded Activity based on cognitive behavioural principles by a physiotherapist. 3. Usual care, provided by an occupational physician according to the Dutch guidelines for the occupational health management of workers with low back pain. The primary outcome measure is return to work. Secondary outcome measures are pain intensity, functional status and general improvement. Intermediate variables are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs due to low back pain. The outcome measures are assessed before randomization (after 2-6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave. DISCUSSION: The combination of these interventions has been subject of earlier research in Canada. The results of the current RCT will: 1. crossvalidate the Canadian findings in an different sociocultural environment; 2. add to the cost-effectiveness on treatment options for workers in the sub acute phase of low back pain. Results might lead to alterations of existing (inter)national guidelines.

Cost-Benefit Analysis↗

PubMed2004

Levels of evidence for the outcome of endodontic retreatment.

The purpose of this investigation was 2-fold: (a) to complete a thorough search of published literature related to clinical studies on the success and failure of nonsurgical retreatment, and (b) to assign levels of evidence to these publications. Clinical studies related to success and failure of retreatment since 1970 were identified using both electronic and manual literature searches. After identification of pertinent literature, each article received a level of evidence (LOE) from one (high) to five (low). Thirty-one clinical studies and six review articles related to this subject were identified. There was no LOE 1 Randomized Control Trials (RCT). There were three LOE 2 RCTs, one LOE 2 Cohort, and two LOE 3 Case Control Studies. Thirteen Case Series (LOE 4), which comprise the most highly quoted success and failure data, were found. Twelve Case Reports (LOE 5) and six review articles (LOE 5) were found. Based on these findings, it appears that few high level studies have been published in the past 34 yr related to the success and failure of endodontic retreatment.

Dental Restoration Failure↗

PubMed1997

Advancing the standards of clinical research: the urgent need for new methods and better data.

Some of the weaknesses of the randomized controlled trial (RCT) are pointed out, among them unavoidable biases, the possibility of coming to erroneous conclusions by the 'luck of the draw' and the fact that most such experiments lack a doctor/patient relationship and are of little assistance in clinical decision making. An exaggerated propensity on the part of the medical profession to regard the RCT as the only 'scientific' method for research into therapeutics is noted. The potential advantages of post-marketing surveillance of new interventions in a physician-centred manner are outlined. Such a data base could ultimately be expanded into a data base that records all activity in a given practice. The PACE strategy, employed by haematologists in the north of England, and the sentinel practice primary care research networks used by family doctors contain elements of the system proposed here. However, each possesses disadvantages that limit its applicability to special cases. Random choice of practices for any particular observational study of a new intervention could lend it some of the features of an experiment.

Bias↗

PubMed2006

Spinal-injured neuropathic bladder antisepsis (SINBA) trial.

OBJECTIVE: To determine whether Methenamine Hippurate (MH) or cranberry tablets prevent urinary tract infections (UTI) in people with neuropathic bladder following spinal cord injury (SCI). STUDY DESIGN: Double-blind factorial-design randomized controlled trial (RCT) with 2 year recruitment period from November 2000 and 6 month follow-up. SETTING: In total, 543 eligible predominantly community dwelling patients were invited to participate in the study, of whom 305 (56%) agreed. METHODS: Eligible participants were people with SCI with neurogenic bladder and stable bladder management. All regimens were indistinguishable in appearance and taste. The dose of MH used was 1 g twice-daily. The dose of cranberry used was 800 mg twice-daily. The main outcome measure was the time to occurrence of a symptomatic UTI. RESULTS: Multivariate analysis revealed that patients randomized to MH did not have a significantly longer UTI-free period compared to placebo (HR 0.96, 95% CI: 0.68-1.35, P=0.75). Patients randomized to cranberry likewise did not have significantly longer UTI-free period compared to placebo (HR 0.93, 95% CI: 0.67-1.31, P=0.70). CONCLUSION: There is no benefit in the prevention of UTI from the addition of MH or cranberry tablets to the usual regimen of patients with neuropathic bladder following SCI.

Adolescent↗

PubMed2005

Treatment of Guillain-Barré syndrome and CIDP.

Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating poly-(radiculo)neuropathy (CIDP) are immune-mediated disorders with a variable duration of progression and a range in severity of weakness. Infections can trigger GBS and exacerbate CIDP. Anti-ganglioside antibodies are important, but there is debate on the role of genetic factors in the pathogenesis of these disorders. Randomized controlled trials (RCT) have shown that intravenous immunoglobulin (IVIg) and plasma exchange (PE) are effective in both GBS and CIDP. Most CIDP patients also improve after steroid therapy. Despite current treatment options, many patients have residual deficits or need to be treated for a long period of time. Therefore, new treatment trials are highly indicated. This review focuses on the current and possible new treatment options that could be guided by recent results from laboratory experiments.

Animals↗

PubMedDate not supplied

The one-person randomized controlled trial.

Currently, the gold standard for collection of clinical evidence is the randomized controlled trial (RCT), preferably with large, multicenter samples of subjects. Although this approach provides valuable information, many clinicians find it difficult to translate RCT results to the individual patient level. In this report, a statistical approach called Design of Experiments (DOE) is described as a method of applying the principles of RCTs one person at a time. An overview of the method, with a simple clinical example, is presented. As shown, DOE is a more efficient method than the sequential approach often taken by clinicians and their patients when evaluating various treatment choices. Further, the effect of multiple interventions can be assessed, alone or in combination with each other. In this way, DOE can be an important addition to the field of evidence-based medicine, although further studies are needed.

Data Interpretation, Statistical↗