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At least 1,009 records · Page 56Linked to original sources
PubMed2003

Obstetric technologies: what determines clinical acceptance or rejection of results of randomized controlled trials?

OBJECTIVE: The acceptance or rejection of obstetric technologies in clinical practice is not always based on the results of randomized controlled trials (RCTs). In this study, possible reasons for this discordance are examined. STUDY DESIGN: Eleven technologies introduced over the past 30 years were examined. RCT results were determined from the published literature, with emphasis on meta-analyses and the Cochrane reviews. Results were graded for quality of evidence (I-III) and strength of recommendations (A-E) on the basis of criteria adopted by the United States Preventive Services Task Force. Clinical use was based on data from the literature, or when this was lacking, on an estimate, and graded + to +++ or - to - - -, based on degree of acceptance or rejection. RESULTS: There was concordance of results with midtrimester ultrasound (US) imaging, home uterine activity monitoring (HUAM), Doppler velocimetry in high-risk pregnancy, short-term tocolysis, single-course antenatal corticosteroids (BMZ), thyroid-releasing hormone (TRH), and fetal fibronectin (fFN). There was discordance of results with fetal heart rate monitoring (FHRM), fetal blood sampling (FBS), US imaging in late pregnancy, Doppler velocimetry in low-risk pregnancy, and tocolysis beyond 7 days. In several cases there are published RCTs, but clinical acceptance is still evolving (multiple course BMZ, pulse oximetry, and electrocardiogram ST-segment analysis). CONCLUSION: These observations suggest that technologies which are simple to apply, and have a single endpoint, show concordance between RCT results and clinical use (HUAM, short-term tocolysis, single-course BMZ, TRH, and fFN). Those that are complex to apply (FBS), or interpret (FHRM), and/or do not have a single clear end point (FHRM, Doppler), or have results that are of great personal interest to the patient (FHRM, US imaging, long-term tocolysis), are more likely to show discordance. In several cases despite published RCTs, clinical acceptance or rejection is still evolving (multiple course BMZ, pulse oximetry, and electrocardiogram ST-segment analysis). These inconsistent relationships suggest that the decision-making processes of obstetric providers and patients would be a fruitful area of investigation.

Adrenal Cortex Hormones↗
PubMed2005

Using pilot studies to inform health services.

A pilot study was conducted at the John Hunter Hospital, Newcastle, Australia in 1998-99 to inform a randomised controlled trial (RCT) for a cardiac rehabilitation intervention for patients with congestive heart failure (CHF). Although the RCT did not proceed, the pilot study results raised a number of issues. In this paper, the pilot is used to demonstrate how estimates of population benefit need to take into account patient eligibility, consent and adherence, and also how non-clinical data can inform the planning and development of health service interventions.

Aged↗
PubMed2005

Death, morbidity and economics are the only end points for trials.

In order to determine whether surrogate markers predict clinical outcome, randomized controlled trials (RCT) of nutrition support v. no nutrition support that have reported at least one clinical outcome (mortality, infections, total complications, or duration of hospitalization) and at least one nutritional outcome (energy or protein intake, weight gain, N balance, albumin, prealbumin, transferrin, three anthropometric measures, skin testing, lymphocyte count) were assessed for concordance. If changes in nutritional markers predict clinical outcome, changes in both outcomes should go in the same direction. Concordance is defined as both outcomes changing in the same direction or both outcomes showing no difference. Discordance is defined as one outcome changing and the other not (partial) or both outcomes changing in opposite directions (complete). Ninety-nine RCT were identified, of which most were underpowered to see statistically significant changes, especially in clinical outcomes. Thus, the results were analysed only in relation to the direction of the respective changes in outcomes. Forty-eight comparisons (4 x 12) were made. The rates of concordance were < or =50% in forty-one of forty-eight comparisons; the rate was never >75%. A complete discordance rate of > or =25% was present in forty-three (> or =50% in thirteen) of the forty-eight comparisons. The discordance was usually a result of the nutritional outcome being better than the clinical outcome. Changes in nutritional markers do not predict clinical outcomes. Before adopting any surrogate marker as an end point for a clinical trial, it has to be known that improving it will result in patient benefit.

Biomarkers↗
PubMed2006

Critical review of health effects of soyabean phyto-oestrogens in post-menopausal women.

A consensus view of soyabean phyto-oestrogens in clinical interventions in post-menopausal women is presented that is based on data from the EU-funded project Phytohealth. The phyto-oestrogens, primarily genistein and daidzein, were given as soyabean-protein isolates, whole-soyabean foods or extracts, supplements or pure compounds. A comprehensive literature search was conducted with well-defined inclusion or exclusion criteria. For areas for which substantial research exists only placebo-controlled double-blind randomised controlled trials (RCT) conducted on healthy post-menopausal women were included. For emerging areas all available human studies in post-menopausal women were reviewed. In order to make cross comparisons between studies the doses of isoflavones were calculated as aglycone equivalents. There is a suggestion, but no conclusive evidence, that isoflavones from the sources studied so far have a beneficial effect on bone health. The consumption of whole-soyabean foods and soyabean-protein isolates has some beneficial effects on lipid markers of cardiovascular risk. The consumption of isolated isoflavones does not affect blood lipid levels or blood pressure, although it may improve endothelial function. For menopausal symptoms there is currently limited evidence that soyabean-protein isolates, soyabean foods or red-clover (Trifolium pratense L.) extract are effective but soyabean isoflavone extracts may be effective in reducing hot flushes. There are too few RCT studies to reach conclusions on the effects of isoflavones on breast cancer, colon cancer, diabetes or cognitive function. The health benefits of soyabean phyto-oestrogens in healthy post-menopausal women are subtle and even some well-designed studies do not show protective effects. Future studies should focus on high-risk post-menopausal women, especially in the areas of diabetes, CVD, breast cancer and bone health.

Anticarcinogenic Agents↗
PubMed2004

A systematic review of Swedish research in orthodontics during the past decade.

The aims of this systematic review were to identify the study designs and topics of Swedish orthodontic articles, to elucidate their international position, and to verify in which scientific journals the articles had been published in the past decade. A search of the Medline database for papers published between 1992 and 2002 was made using the Medical Search Heading terms 'orthodontics', 'malocclusion', 'cephalometry', and 'facial bones and growth'. Two independent reviewers selected the articles of Swedish origin and categorized each article according to research design and principal topic. Overall, 15,571 articles in orthodontic research were found, and the Swedish contribution was 1.9% with the majority of these (71.5%) being submitted by universities. Most of the Swedish articles (84.5%) had been published in 10 journals and many high-quality studies with orthodontic interest were published in non-orthodontic journals with higher impact factor scores than the orthodontic journals. Every second study was prospective, and of these, 15 (5.2% of all Swedish articles) were randomized clinical trials (RCTs). It was found that nearly every third study, prospective as well as retrospective, was uncontrolled. The main classification was treatment studies (51.9%), followed by development (18.6%) and diagnostic information (10.7%) studies. Thus, the majority of the articles evaluated therapeutic interventions; however, although the RCT is the preferred study design in evaluation studies, few used this method. In an era focused on evidence-based medicine, studies with an RCT design will be the future challenge for research in the field of orthodontics.

Dental Research↗
PubMed2003

Relevance of abdominal gas analysis and transit study after colorectal cancer surgery.

BACKGROUND: Colon gas volume analysis using abdominal radiographs is an objective and reproducible method for evaluating functional bowel disorders. The aim of this study was to clarify the relevance of colon gas distribution and transit time in rectosigmoid cancer patients after surgery. METHODS: Segmental colon gas volume score was calculated using plain abdominal radiography and evaluated in 40 patients who had undergone sphincter-saving resection. Segmental colonic transit time was analysed using radiopaque markers in the same patients. RESULTS: Transit times in the right colon (RCT) were 15.3 +/- 1.1 h and in the left colon (LCT) 11.2 +/- 1.1 h. Gas volume scores in the RCS and LCS were 1.10 +/- 0.13% and 1.06 +/- 0.14%, respectively. Neither colonic transit time nor colon gas volume score correlated with the operation methods for rectosigmoid colon cancer. A positive correlation of RCS and a negative correlation of LCS/RCS with ageing were noted in male patients but not in female patients. There was no correlation between RCT and RCS (r = 0.028); however, LCT correlated with LCS (r = 0.318, P < 0.05). The ratio of colonic transit time (LCT/RCT) was 0.84 +/- 0.10, while that of colon gas volume score (LCS/RCS) was 1.29 +/- 0.21. There was a significant correlation between LCT/RCT and LCS/RCS (r = 0.541, P < 0.001). CONCLUSIONS: Analysis of colon gas volume is useful for evaluating colonic transit time in rectosigmoid cancer patients after sphincter-saving surgery.

Adult↗
PubMed1999

Acyclovir for treatment of infectious mononucleosis: a meta-analysis.

A meta-analysis of 5 randomized controlled trials (RCT), involving 339 patients with acute infectious mononucleosis (IM) treated with acyclovir (ACV) was performed. ACV was given intravenously in 2 RCTs, which included patients with more severe disease, and orally in the remaining 3 RCTs, which included patients with mild to moderate IM. Both clinical and virological endpoint data available from RCT were evaluated in this study. There was a trend towards clinical effectiveness of ACV treatment, but no statistically significant results were achieved. In contrast, a significant reduction in the rate of oropharyngeal EBV shedding was observed at the end of the therapy (overall OR: 6.62; 95% CI: 3.56-12.29; p < 0.00001). However, no difference in EBV shedding was observed 3 weeks later. There was no significant difference on adverse events in the groups of patients treated with ACV or placebo. In conclusion, clinical data do not support use of ACV for the treatment of acute IM, despite good virological activity of this drug. There is a need for more effective treatment of EBV infection.

Acyclovir↗
PubMed2006

Effects of brief exposure to water, breast-milk substitutes, or other liquids on the success and duration of breastfeeding: a systematic review.

AIM: To systematically evaluate the effect of supplemental fluids or feedings during the first days of life on the overall breastfeeding duration and rate of exclusive breastfeeding among healthy infants. METHODS: Medical subject headings and free-language terms were used to search the following electronic databases for studies relevant to breastfeeding: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Library, and La Leche League. Only randomized, controlled trials (RCT) were considered for study inclusion. RESULTS: Of 56 potentially relevant clinical trials identified, only one RCT (170 infants) met the inclusion criteria for this systematic review. In this study, formula feeding was significantly more frequent at 4 wk in the experimental group in which breastfeeding had been supplemented with 5% glucose ad libitum during the first 3 d of life (n = 83) than in the exclusively breastfed control group (n = 87) (p < 0.05). At 16 wk (5 mo postpartum), the percentage of mothers who continued breastfeeding, either exclusively or partially, was significantly lower in the experimental group than in the control group (p < 0.01). CONCLUSION: There remains considerable uncertainty about the effect of brief exposure to water, breast-milk substitutes, or other liquids on the success and duration of breastfeeding.

Breast Feeding↗
PubMed2006

Predictors of mental health and quality of life in male tortured refugees.

Some of the most frequently reported mental health problems in traumatized refugees are depression, anxiety and post-traumatic stress disorder (PTSD). The aim of this paper is to describe a group of tortured refugees referred to the Rehabilitation and Research Centre for Torture Victims (RCT) and to study the importance of past trauma/torture and post-migratory factors for the present symptoms of PTSD, depression, anxiety and for health-related quality of life. The sample comprises 63 male tortured refugees admitted to a pre-treatment assessment at RCT. Data on personal background, trauma, present situation in Denmark, symptoms of depression, anxiety (Hopkins Symptom Checklist-25, HSCL-25, and Hamilton Depression Scale, HDS), PTSD (Harvard Trauma Questionnaire, HTQ), and on health-related quality of life (WHO Quality of life-Bref, WHOQOL-Bref) were collected through self-administered questionnaires and structured and semi-structured interviews. The scores in the questionnaires measuring emotional distress were high. Previous torture and trauma, lower education, fewer social contacts, no occupation and pain were identified as significant predictors of emotional distress. Few social contacts was a significant predictor of a lower health-related quality of life. Even after many years, past torture is significantly associated with emotional distress. Post-migratory factors are also significantly associated with emotional distress and health-related quality of life, and potentially modifiable factors, such as social relations and occupation, are of special interest.

Adult↗
PubMedDate not supplied

Interventions for infantile nystagmus syndrome: towards a randomized controlled trial?

A PubMed search for papers in the last 10 years on interventions for Infantile Nystagmus Syndrome (INS) reveals 18 papers on surgical or pharmacological interventions and 6 papers describing other interventions. There is only one randomized controlled trial (RCT), with all the other studies being uncontrolled trials/case series. To investigate the importance of RCTs, the data from the one RCT is re-analyzed as if it had been a case series. If only the group receiving the experimental treatment are considered, then the visual acuity was significantly better after than before treatment (paired t-test, p = 0.04). However, the control group who received a placebo treatment improved to a similar degree (p = 0.90). The literature on the placebo effect shows that it can influence objective variables and the outcome of surgical interventions. It is suggested that previous studies on interventions for nystagmus have laid an important foundation for future work in this field, which should involve RCTs.

Evidence-Based Medicine↗
PubMed2004

Recruitment and retention of an online sample for an HIV prevention intervention targeting men who have sex with men: the Smart Sex Quest Project.

There is an increasing interest in developing interventions for HIV and STD prevention that can be delivered on the Internet. However, we know little about what it takes to identify, recruit and retain participants in interventions so that we can test their efficacy and effectiveness. Objectives for this investigation were to evaluate rates of recruitment and retention in an Internet-based randomized controlled trial (RCT) to increase sexually transmitted disease (STD) prevention among men who have sex with men (MSM). The Smart Sex Quest study was a RCT conducted online. Eligible participants were MSM, at least 18 years old and US residents. After completing a baseline risk assessment, participants were exposed to tailored or control messages and asked to return to the site at three months for a follow-up interview. From January 2002 through June 2003, 3,625 persons logged on as potential study participants; of these, 563 were not eligible, while 1,286 left the site without filling out a baseline survey. Complete baseline data were available for 1,776 participants, all of whom were eligible to complete a follow-up. Complete follow-up data were available for 270 (15.2%) participants. While the Internet is a valuable tool for conducting research, conducting this longitudinal research online was severely affected by a loss to follow-up, and analyzing outcome data was hampered by significant differences between those who did and did not complete the study. Alternate ways to recruit for and evaluate online trials must be considered.

Acquired Immunodeficiency Syndrome↗
PubMed2005

A randomized controlled trial to test an HIV-prevention intervention for Latino gay and bisexual men: lessons learned.

At the time of this writing, no randomized controlled trial (RCT) of an intervention to reduce unsafe sex among Latino gay and bisexual men (LGBM) had been published. We report the results of an RCT conducted in New York City in which 180 LGBM were assigned either to an intervention developed specifically for this population or to a wait-list control group. The intervention was based on empowerment theory and used factors identified in prior research as determinants of unsafe sex. By eligibility criteria, all men had engaged in unprotected anal intercourse (UAI) within two months of the baseline assessment. At first (two months) and second (six months later) follow-up assessments, approximately half of the men in the experimental group reported no UAI. Yet, a similar proportion of the control group also reported no UAI. Baseline data indicate that although the men had been the subject of social oppression and sexual prejudice (homophobia), they did not feel disempowered, externally controlled or fatalistic, and they reported self-efficacy and intentionality to enact safer sex. Lessons learned are discussed, as well as notes of caution for future research employing a similar conceptual framework.

Adolescent↗
PubMed2002

Focus groups with pregnant smokers: barriers to cessation, attitudes to nicotine patch use and perceptions of cessation counselling by care providers.

Focus group methodology was used to determine the barriers to smoking cessation for pregnant women prior to the commencement of a randomised controlled smoking cessation trial (RCT), using nicotine patches in the treatment arm. Attitudes to the use of nicotine patches and perceptions of care provider counselling were also explored. Women were identified by researcher interview in the antenatal clinics as current smokers or recent 'quitters' and recruited to one of three focus groups. A number of barriers to achieving smoking cessation were identified. Pregnancy-specific barriers included scepticism about smoking-related harms. Other barriers, such as addiction to nicotine and the smoking behaviour of others, particularly partners, are generic. The latter is magnified in pregnancy by the heightened complexities of familial relationships. Potential use of patches was acceptable to most women, although some high-risk patients expressed doubts about safety and believed continued smoking was preferable. Women recounted that care providers differed in approaches to smoking cessation. Reporting 'cutting down' generally avoided further inquiries about smoking. The knowledge gained of pregnant women's perspectives enhanced the researchers' understanding in these areas. These insights have been incorporated into staff training initiatives, have guided the planning of the RCT, and have continued to inform its conduct.

Administration, Cutaneous↗
PubMed2006

Hair analysis underestimates heroin use in prisoners.

The value of hair analysis in measuring treatment outcome was examined in a randomised controlled trial (RCT) of an Australian state prison-based methadone programme between 1997 and 1998 (n = 382 male prisoners). Hair samples were analysed for morphine using immunoassay techniques. Agreement between hair analysis and self-report was tested using kappa, McNemar's test of symmetry and Pearson's correlation coefficient r. Hair analysis based on immunoassay was inadequate as the primary outcome measure for the RCT but had value in supplementing self-reported heroin use. There was a modest correlation (r = 0.31, p < 0.001) between self-reported frequency of heroin use and morphine concentrations in hair. Sectional hair analysis, a reflection of duration of drug use, was uninformative and generally impractical due to the length of hair sections needed.

Adolescent↗
PubMed2002

The effects of botulinum toxin treatment on associated reactions of the upper limb on hemiplegic gait--a pilot study.

PURPOSE: The involuntary movements of the paretic arm during ambulation and other motor activities are known as associated upper limb reactions (ARs). ARs occur in 80% of stroke patients with spastic hemiplegia and often interfere with balance and safe mobilization. It is hypothesized that the treatment of localized muscle spasticity with botulinum toxin type A (BtxA) would abolish the ARs and improve balance and mobility. METHOD: This hypothesis will need to be tested in a randomized controlled trial (RCT). The aim of the present pilot study is to obtain preliminary data to inform the design of a future RCT. Eight patients received a single injection of 500 units of BtxA (Dysport((R)) Ipsen, Ltd) into the biceps brachii of the paretic arm. The patients' balance and mobility were assessed before and 2, 4 and 6 weeks after treatment using observational gait analysis and other subjective assessment scales. RESULTS: There was a significant reduction of the ARs after treatment but this did not appear to improve the patients' balance or mobility as assessed by the clinicians. Interestingly, seven out of the eight patients reported improvement in their walking. CONCLUSION: The discrepancy between the observed and reported effects of treatment could be due to the poor sensitivity of the outcome measures used in this study.

Adult↗
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↗
PubMed2026

Frontline therapies for adult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia: a systematic literature review.

OBJECTIVES: Philadelphia (Ph) chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL) is the most common ALL in adults. Overall survival (OS) with frontline chemotherapy remains poor. Blinatumomab is currently the only targeted agent approved for frontline treatment. METHODS: We systematically reviewed 96 studies (43 interventional, 53 observational) between 2012-2026 evaluating frontline pharmacologic therapy in adults with Ph- B-ALL. RESULTS: Across chemotherapy studies, nearly half of patients relapsed within 3 years, and only 49%-69% survived beyond 3 years. Blinatumomab demonstrated robust and consistent efficacy in first complete response (CR1), supported by 2 randomized controlled trials (RCT) and 16 single-arm trials (SAT). In one RCT, blinatumomab reduced the risk of death by 59% versus chemotherapy alone (HR 0.41) when added to frontline consolidation in minimal residual disease (MRD) negative patients. Median OS reached 41.2 months in a SAT where blinatumomab monotherapy was administered to patients in MRD-positive CR1. SATs showed consistent efficacy outcomes regardless of age, MRD status, or chemotherapy backbone. DISCUSSION: Additional targeted therapies still under investigation have shown mixed results. CONCLUSION: Frontline inotuzumab (&#xb1;blinatumomab) plus chemotherapy showed promise in older populations, while the efficacy benefit of rituximab was inconclusive. No new safety signals were identified in the frontline setting for targeted therapies.

Humans↗
PubMed2000

Obstacles to a randomised controlled trial of intensive dynamic psychotherapy: an account of the New South Wales Section of Psychotherapy outcomes project.

OBJECTIVE: This paper examines the obstacles to a randomised controlled trial (RCT) of intensive dynamic psychotherapy (IDP) by reference to the fate of the New South Wales Section of Psychotherapy outcomes project. METHOD: Planning was complete and the final research protocol was about to be implemented when funding difficulties led to suspension of the project. The opinions of the research subcommittee regarding the main obstacles to the ultimate success of the project are now analysed in the expectation that better research strategies will follow. RESULTS: With hindsight, six of the eight members of the research subcommittee reported that the project was not feasible. By choice of questionnaire items they identified the greatest threats to a successful trial as: standardisation of the procedures, termination at 24 months, the availability of funding and the choice of treatment procedures. The most frequently volunteered concerns related to the enlistment and cooperation of the trial therapists (5), standardisation of the experimental therapy (3), probable shortfall in trial subjects (3) and the availability of funding (2). CONCLUSIONS: The most powerful general obstacles to success of the project related to the standardisation of procedures and the failure to maintain sufficient cooperation of trial therapists. The protocol required IDP therapists to terminate procedures at 24 months, which contradicted their usual practices and led to some alienation from the project. Amendments to the protocol might improve the possibility of a successful trial. However, one might also conclude that it is premature to attempt a naturalistic RCT of IDP.

Adult↗