SEARCH · Search PubMed

Results for “RCT”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

SourceResearch connectionFrom yearThrough year

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 703 records · Page 39Linked to original sources

PubMed2004

Physicians' reasons for not entering their patients in a randomized controlled trial in Japan.

Physicians' not entering their patients can jeopardize the success of a randomized controlled trial (RCT). We used a survey to investigate the possible reasons why physicians who initially agreed to collaborate did not recruit any patients for an RCT being conducted in Japan. A total of 167 questionnaires were sent out and 122 responses were received. Main reasons for not entering patients were: concern about the detrimental effects on the doctor-patient relationship (51.8%), patients' refusal (47.5%), complicated registration and follow-up procedures (34.9%), and not feeling comfortable recruiting their own patients (32.4%). Multivariate logistic regression made it clear that physicians who thought that registering their own patients would damage the doctor-patient relationship and who expected the RCT would fail were more likely to be uncomfortable entering their own patients. Moreover, physicians aged 50 years or older, who felt uncomfortable recruiting their own patients, and saw no advantage in participating in the trial, were more likely to view the enrolment and follow-up procedures as cumbersome. We conclude that training and a manual for obtaining informed consent and a face-to-face demonstration of patient registration/follow-up procedures for the potential participants are prerequisites for increasing physician participation in RCTs in Japan.

Adult↗

PubMed2005

Effects of fish oil supplementation on kidney transplantation: a systematic review and meta-analysis of randomized, controlled trials.

The objective of this study was to assess the effects of omega-3 fatty acid supplementation on various kidney transplant-related outcomes. A systematic review and meta-analysis was performed of published randomized, controlled trials (RCT). There were 16 kidney transplant RCT with a total of 812 patients. All trials evaluated fish oil with dosages that ranged from 1.2 to 5.4 g/d. No consistent benefits were observed for any outcome with the exception of a modest benefit on triglycerides. A meta-analysis of rejection episodes found no significant benefit on either early (<6 mo posttransplantation) or late episodes. The overall relative risk of having at least one rejection episode in those who received fish oil was 0.91 (95% confidence interval 0.74 to 1.10) in four studies with a follow-up of 1 yr. A meta-analysis of eight RCT of graft survival found no significant benefit (relative risk 1.00, 95% confidence interval 0.96 to 1.05). The available data (mostly derived from older studies with important methodologic limitations) do not demonstrate a consistent, clinically important benefit of fish oil in kidney transplantation.

Clinical Trials as Topic↗

PubMed1997

Healing of intrabony defects and its relationship to root canal therapy. A histologic and histometric study in dogs.

The purpose of this study was to evaluate the importance of root canal therapy in the healing process of severe intrabony defects. Four beagle dogs were used and 32 interproximal intrabony defects, up to the apical third, were created. Wire ligatures were placed into these defects for plaque accumulation. Three weeks later, the ligatures were removed and 4 different treatment modalities were employed: group 1) scaling and root planing (SRP); group 2) modified Widman flap (MWF); group 3) modified Widman flap and root canal therapy performed at the same time (RCT/MWF); and group 4) modified Widman flap and root canal therapy performed 3 weeks after the surgical procedure (MWF + RCT). Postoperative oral hygiene was obtained by spraying a 0.12% chlorhexidine solution 3 times a week. The animals were sacrificed 7 weeks after treatment. Blocks were obtained and processed for routine histology. Results were expressed as a percentage of the total defect length (TDL). No differences were observed when SRP was compared to MWF. New bone formation (BF) presented better results for SRP (43.4%) and MWF (53.4%) when compared to RCT/MWF (15.5%). New cementum formation (CF) presented better results for SRP (59.8%) and MWF (64.6%) when compared to RCT/MWF (19.3%) and MWF + RCT (31.5%). Connective tissue repair (CTR) presented better results for SRP (72.4%) and MWF (74.2%) when compared to RCT/MWF (47.5%) and MWF + RCT (44.4%). Results were statistically significant at the level of 0.05. Within the limits of this study, it was concluded that root canal therapy performed simultaneously or 3 weeks after surgery modified the healing of intrabony defects, impairing new bone formation, new cementum formation and new attachment.

Alveolar Bone Loss↗

PubMed2005

Acellular dermal matrix for mucogingival surgery: a meta-analysis.

BACKGROUND: Many clinical studies revealed the effectiveness of acellular dermal matrix (ADM) in the treatment of mucogingival defects. The purpose of this meta-analysis was to compare the efficacy of ADM-based root coverage (RC) and ADM-based increase in keratinized tissues to other commonly used mucogingival surgeries. METHODS: Meta-analysis was limited to randomized clinical trials (RCT). Articles from January 1, 1990 to October 2004 related to ADM were searched utilizing the MEDLINE database from the National Library of Medicine, the Cochrane Oral Health Group Specialized Trials Registry, and through hand searches of reviews and recent journals. Relevant studies were identified, ranked independently, and mean data from each were weighted accordingly. Selected outcomes were analyzed using a meta-analysis software program. The significant estimates of the treatment effects from different trials were assessed by means of Cochrane's test of heterogeneity. RESULTS: 1) Few RCT studies were found to compile the data. In summary, selection identified eight RCT that met the inclusion criteria. There were four studies comparing ADM versus a connective tissue graft for root coverage procedures, two studies comparing ADM versus coronally advanced flap (CAF) for root coverage procedures, and two studies comparing ADM to free gingival graft in augmentation of keratinized tissue. 2) There were no statistically significant differences between groups for any of the outcomes measured (recession coverage, keratinized tissue formation, probing depths, and clinical attachment levels). 3) The majority of the analyses demonstrated moderate to high levels of heterogeneity. 4) Considering the heterogeneity values found among the studies, certain trends could be found: a) three out of four studies favored the ADM-RC group for recession coverage; b) a connective tissue graft tended to increase keratinized tissue compared to ADM (0.52-mm difference; P = 0.11); c) there were trends of increased clinical attachment gains comparing ADM to CAF procedures (0.56-mm difference; P = 0.16). CONCLUSIONS: Differences in study design and lack of data precluded an adequate and complete pooling of data for a more comprehensive analysis. Therefore, considering the trends presented in this study, there is a need for further randomized clinical studies of ADM procedures in comparison to common mucogingival surgical procedures to confirm our findings. It is difficult to draw anything other than tentative conclusions from this meta-analysis of ADM for mucogingival surgery, primarily because of the weakness in the design and reporting of existing trials.

Biocompatible Materials↗

PubMed2003

Low high-density lipoprotein cholesterol: physiological background, clinical importance and drug treatment.

Low high-density lipoprotein (HDL) cholesterol is an important risk factor for coronary heart disease (CHD). In vitro, HDL exerts several potentially anti-atherogenic activities. HDLs mediate the reverse cholesterol transport (RCT) from peripheral cells to the liver, inhibit oxidation of low-density lipoprotein (LDL), adhesion of monocytes to the endothelium, apoptosis of vascular endothelial and smooth muscle cells and platelet activation, and stimulate the endothelial secretion of vasoactive substances as well as smooth muscle cell proliferation. Hence, raising HDL-cholesterol levels has become an interesting target for anti-atherosclerotic drug therapy. Levels of HDL cholesterol and the composition of HDL subclasses in plasma are regulated by apolipoproteins, lipolytic enzymes, lipid transfer proteins, receptors and cellular transporters. The interplay of these factors leads to RCT and determines the composition and, thereby, the anti-atherogenic properties of HDL. Several inborn errors of metabolism, as well as genetic animal models, are characterised by both elevated HDL cholesterol and increased rather than decreased cardiovascular risk. These findings suggest that the mechanism of HDL modification rather than simply increasing HDL cholesterol determine the efficacy of anti-atherosclerotic drug therapy. In several controlled and prospective intervention studies, patients with low HDL cholesterol and additional risk factors benefited from treatment with fibric acid derivatives (fibrates) or HMG-CoA reductase inhibitors (statins). However, only in some trials was prevention of coronary events in patients with low HDL cholesterol and hypertriglyceridaemia related to an increase in HDL cholesterol. We discuss the clinical and metabolic effects of fibrates, statins, nicotinic acid and sex steroids, and present novel therapeutic strategies that show promise in modifying HDL metabolism. In conclusion, HDL-cholesterol levels increase only moderately after treatment with currently available drugs and do not necessarily correlate with the functionality of HDL. Therefore, the anti-atherosclerotic therapy of high-risk cardiovascular patients should currently be focused on the correction of other risk factors present besides low HDL cholesterol. However, modification of HDL metabolism and improvement of RCT remain an attractive target for the development of new regimens of anti-atherogenic drug therapy.

Animals↗

PubMed2005

Pharmacological treatment of ankylosing spondylitis: a systematic review.

The purpose of this study was to review the evidence regarding the efficacy and safety of pharmacological therapies currently available for the treatment of ankylosing spondylitis (AS).A literature search using MEDLINE from 1966 through to April 2005 and a hand search of abstracts from the American College of Rheumatology (ACR) meetings for 2001 through to 2004 were performed. References of articles retrieved were also searched. The MEDLINE search yielded 570 citations and 157 abstracts from ACR were identified. Eighty-four studies were randomised controlled trials (RCTs); 53 fulfilled the inclusion criteria (pharmacological treatment of AS and RCT) and were included in this review. Statistical pooling of data was not performed because of the disparate outcome measures used. Eight RCTs found nonselective NSAIDs and two RCTs found cyclo-oxygenase (COX)-2-selective NSAIDs to be superior to placebo for relief of pain and improvement in physical function. Twenty-nine RCTs showed comparable efficacy and safety between nonselective NSAIDs. One RCT showed no difference between methylprednisolone 1g and 375 mg. Seven RCTs assessing the efficacy of sulfasalazine (sulphasalazine) and two RCTs of methotrexate provided contradictory evidence as to their benefit for treatment of AS. One RCT showed intravenous pamidronate 60 mg to be more effective than 10mg intravenously for the treatment of axial pain. All six RCTs of anti-tumour necrosis factor (TNF)-alpha agents demonstrated superiority to placebo for the treatment of axial and peripheral symptoms. Nonselective as well as COX-2-selective NSAIDs can be used for pain control in patients with AS. Other proven treatment options include sulfasalazine for the treatment of peripheral joint symptoms, while limited evidence supports the use of pamidronate or methotrexate, which require further studies. Anti-TNFalpha agents have been found very effective for the treatment of both peripheral and axial symptoms in patients with AS, but their use is limited by cost and uncertainty over long-term efficacy and safety.

Adrenal Cortex Hormones↗

PubMed2001

Is it possible to prevent sports injuries? Review of controlled clinical trials and recommendations for future work.

Sports injuries are one of the most common injuries in modern western societies. Treating sports injuries is often difficult, expensive and time consuming, and thus, preventive strategies and activities are justified on medical as well as economic grounds. A successful injury surveillance and prevention requires valid pre- and post-intervention data on the extent of the problem. The aetiology, risk factors and exact mechanisms of injuries need to be identified before initiating a measure or programme for preventing sports injuries, and measurement of the outcome (injury) must include a standardised definition of the injury and its severity, as well as a systematic method of collecting the information. Valid and reliable measurement of the exposure includes exact information about the population at risk and exposure time. The true efficacy of a preventive measure or programme can be best evaluated through a well-planned randomised trial. Until now, 16 randomised, controlled trials (RCT) have been published on prevention of sports injuries. According to these RCT, the general injury rate can be reduced by a multifactorial injury prevention programme in soccer (relative risk 0.25, p < 0.001, in the intervention group), or by ankle disk training, combined with a thorough warm-up, in European team handball [odds ratio 0.17; 95% confidence interval (CI) 0.09 to 0.32, p < 0.01]. Ankle sprains can be prevented by ankle supports (i.e. semirigid orthoses or air-cast braces) in high-risk sporting activities, such as soccer and basketball (Peto odds ratio 0.49; 95% CI 0.37 to 0.66), and stress fractures of the lower limb by the use of shock-absorbing insoles in footwear (Peto odds ratio 0.47; 95% CI 0.30 to 0.76). In future studies, it is extremely important for researches to seek consultation with epidemiologists and statisticians to be certain that the study hypothesis is appropriate and that the methodology can lead to reliable and valid information. Further well-designed randomised studies are needed on preventive actions and devices that are in common use, such as preseason medical screenings, warming up, proprioceptive training, stretching, muscle strengthening, taping, protective equipment, rehabilitation programmes and education interventions (such as increasing general injury awareness among a team). The effect of a planned rule change on the injury risk in a particular sport could be tested via a RCT before execution of the change. The most urgent needs are in commonly practised or high-risk sports, such as soccer, American football, rugby, ice hockey, European team handball, karate, floorball, basketball, downhill skiing and motor sports.

Athletic Injuries↗

PubMed1999

Real world designs in economic evaluation. Bridging the gap between clinical research and policy-making.

This paper identifies the information that economic evaluation should provide to adequately inform policy-makers. First, policy-makers need cost-effectiveness information that is both internally and externally valid. The latter aspect is often ignored and refers to the relevance of the results of economic trials to the specific decision-making context of the policy-maker. Second, policy-makers, like purchasers of care, may want assessments of the overall budget and health impacts of adopting an intervention in a disease or treatment area. This requires more of an aggregate analysis than the current approaches to economic evaluation (which are typically individual-orientated). There are 3 main conceptual approaches to economic evaluation: the use of randomised controlled trials (RCTs), observational studies and modelling. The RCT can be considered as the gold standard in economic evaluation because of its high internal validity, but results should be interpreted with caution because of its low external validity. There a number of options to enhance external validity; of these, additional modelling and observational data seem to be the most promising. To address issues at the system level, disease modelling or public health modelling is suggested. A 3-step approach, comprising successive assessment of internal validity, external validity (real world relevance) and net impact at the system level, can enhance the informative value of economic analyses. For example, this approach has been used to assess the informative value to decision-makers of an RCT in benign prostatic hyperplasia. The analysis emphasised the feasibility and importance of additional modelling beyond the results from an RCT-based economic analysis and provided important information of relevance for policy-making. Because of the need to increase the real world relevance of pharmacoeconomic analyses, there is potentially a large role for modelling in economic evaluation; however, in order to enhance its credibility, more attention should be paid to validity aspects.

Cost-Benefit Analysis↗

PubMed2001

Lessons learned: Outcomes and methodology of a coping skills intervention trial comparing individual and group formats for patients with cancer.

OBJECTIVE: Nucare, a short-term psychoeducational coping skills training intervention was evaluated in a randomized controlled clinical trial (RCT) of 225 newly diagnosed breast and colon cancer patients. METHOD: Measures of psychosocial distress, well being and optimism were evaluated every four months during a one-year period. Patients were randomized to one of four arms: Nucare presented in an individual basis; Nucare presented in a group format; a non-directive supportive group; and a no-intervention control. The interventions were provided in five sessions of ninety minutes each. RESULTS: Patients with breast cancer who received Nucare presented in an individual format showed more significant improvements in well-being over time compared to those in the control and group arms. CONCLUSIONS: We were unable to develop functioning groups within the RCT. Partial explanations for the latter finding include the structural limitations of the RCT: the groups were small, difficult to schedule and patients indicated that they would have preferred to choose whether or not to participate in a group. The positive changes in women with breast cancer who received Nucare persisted at 12 months.

Adaptation, Psychological↗

PubMed2025

Duration of Hospitalization is Associated with the Gut Microbiome in Patients Undergoing Hematopoietic Stem Cell Transplantation: Early Results from a Randomized Trial of Home Versus Hospital Transplantation.

Home-based hematopoietic stem cell transplantation (HCT) is an innovative care model with growing interest, but its impact on the gut microbiome remains unexplored in a randomized setting. We present interim results from the first randomized controlled trials (RCT) evaluating the effect of HCT location-home versus hospital-on gut microbial diversity and antimicrobial resistance (AMR) gene carriage. We hypothesize that patients randomized to undergo home HCT would have higher gut taxonomic diversity and lower AMR gene abundance compared to those undergoing standard hospital HCT. We analyzed stool samples from the first 28 patients enrolled in ongoing Phase II RCTs comparing home (n = 16) and hospital (n = 12) HCT at Duke University using shotgun metagenomic sequencing to compare taxa and AMR gene composition between groups. We also performed a secondary analysis comparing patients who received transplants at outpatient infusion clinics versus inpatient standard HCT to evaluate the influence of hospitalization duration. In the primary RCT analysis, taxonomic and AMR gene α- and β-diversity were comparable between home and hospital groups, reflecting similar durations of hospitalization despite group allocation. In contrast, secondary analyses demonstrated that patients transplanted in outpatient infusion clinics who experienced significantly reduced hospitalization had higher gut taxonomic α-diversity and differential β-diversity, although AMR gene diversity remained unchanged. In summary, randomization by transplant location did not impact the gut microbiota to the same extent as the duration of hospitalization, although secondary analyses were heavily confounded. Even when taxonomic differences were observed, AMR genes were similar between groups. This RCT represents a novel investigation into how care setting influences the gut microbiome during HCT. Our findings suggest that hospital duration, rather than randomization allocation alone, is the primary driver of microbial disruption. These results underscore the potential for reducing hospital duration to mitigate microbiome injury, thereby informing future interventions to reduce infection risk and improve patient outcomes.

Microbiome↗

PubMed1989

SV-40 large-T immortalization of embryonic bone cells: establishment of osteoblastic clonal cell lines.

Cells derived from embryonic rat calvariae were immortalized by retroviral delivery of cDNA for the SV-40 large T antigen and the bacterial neomycin resistance gene. After selection with G418, cells were cloned by limiting dilution and screened for expression of osteoblast characteristics. One clone (RCT-3), derived from cells collected during the third period of enzymatic digestion, showed high constitutive expression of alkaline phosphatase (ALP), synthesized type I collagen in the virtual absence of type III and exhibited a parathyroid hormone (PTH)-responsive adenylate cyclase (EC50, 10 nM). Messenger RNAs for osteonectin and osteopontin were present in RCT-3 cells and osteopontin mRNA was enhanced by 1,25 (OH)2 vitamin D3 treatment. The other cell line (RCT-1), derived from cells released during the first 10 min of digestion, expressed osteoblast features only after 3 d treatment with 1 microM retinoic acid (RA). ALP activity increased from 0.003 to 0.25 mumole/min/mg protein, there was a substantial increase in the steady-state level of type I collagen mRNA and a dose-dependent and saturable response to PTH was induced (EC50, 10 nM). Osteopontin mRNA was induced by 1,25 (OH)2D3. This study has provided two new cell lines which may be useful models for studies of differentiation-related gene expression in bone cells.

Animals↗

PubMedDate not supplied

Intra-abdominal desmoplastic small round cell tumor in children: a clinicopathologic study.

Desmoplastic small round cell tumor (RCT) is a relatively newly recognized neoplasm. It has a very distinct morphologic and high-grade polyphenotypic expression with a very poor prognosis. It is commonly seen in adolescent boys. We describe two cases of intra-abdominal desmoplastic small RCT in young girls (5 and 11 years of age). In both cases, the exact origin of tumor in the abdomen could not be established. Histopathologic examination of the biopsy specimens showed distinct desmoplastic stroma and coexpression of various epithelial, neural, and muscle markers. These two patients were treated primarily by debulking surgery followed by adjuvant chemotherapy (RCT II protocol). One of the two had a stable disease while the other had a progressive disease while on treatment. Thus our findings support the diverse histogenesis of this tumor and its poor prognosis.

Abdominal Neoplasms↗

PubMed2005

Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.

OBJECTIVES: To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies. DATA SOURCES: Electronic databases. REVIEW METHODS: The conceptual review was carried out on published papers in the psychology and economics literature concerning concepts of relevance to patient decision-making and preferences, and their measurement. For the systematic review, studies across all medical specialities meeting strict criteria were selected. Data were then extracted, synthesised and analysed. RESULTS: Key elements for a conceptual framework were found to be that preferences are evaluations of an intervention in terms of its desirability and these preferences relate to expectancies and perceived value of the process and outcome of interventions. RCTs differed in the information provided to patients, the complexity of techniques used to provide that information and the degree to which preference elicitation may simply produce pre-existing preferences or actively construct them. Most current RCTs used written information alone. Preference can be measured in many different ways and most RCTs did not provide quantitative measures of preferences, and those that did tended to use very simple measures. The second part of the study, the systematic review included 34 RCTs. The findings gave support to the hypothesis that preferences affect trial recruitment. However, there was less evidence that external validity was seriously compromised. There was some evidence that preferences influenced outcome in a proportion of trials. However, evidence for preference effects was weaker in large trials and after accounting for baseline differences. Preference effects were also inconsistent in direction. There was no evidence that preferences influenced attrition. Therefore, the available evidence does not support the operation of a consistent and important 'preference effect'. Interventions cannot be categorised consistently on degree of participation. Examining differential preference effects based on unreliable categories ran the risk of drawing incorrect conclusions, so this was not carried out. CONCLUSIONS: Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy--value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs (and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.

Attitude of Health Personnel↗

PubMed2004

Does mechanical bowel preparation have a role in preventing postoperative complications in elective colorectal surgery?

BACKGROUND: mechanical bowel preparation (MBP) consists of orthograde fluid preparation to clean the bowel. MBP is considered to prevent postoperative complications. METHODS: meta-analysis of prospective randomised clinical trials (RCT) evaluating MBP versus no MBP. RESULTS: following a medline search we retrieved 15 prospective trials of which only 5 where RCT comparing MBP versus no MBP in elective colorectal surgery. For the randomised studies, there were respectively 186, 179, 149, 267 and 380 patients, including all type of resections. The total number of patients in these 5 studies was 1144 (565 with MBP and 579 with no preparation). All patients received perioperative antibiotic prophylaxis. Only one of these RCT show a significant decrease in anastomotic leak (AL), but among all the patients enrolled, AL is significantly more frequent in the group with MBP (Odds Ratio 1.8). Wound infection, re-operation and intra-abdominal abscess rates were more frequent in the MBP group but the difference did not reach statistical significance and the odds ratios for a 95% confidence interval were extremely large. CONCLUSION: there is limited evidence in the literature to support the use of MBP in patient undergoing elective colorectal surgery. Available data tend to suggest that MBP could be harmful with respect to the incidence of anastomotic leak. Moreover, MBP does not reduce the incidence of other infectious complications. Further RCTs are needed to establish an evidence-based rationale for the use of MBP in elective colorectal surgery.

Anastomosis, Surgical↗

PubMed1991

[The cause-effect relationship between coping and psychological/physical symptoms].

This research was conducted to explore the cause-effect relationship between coping and adaptational outcomes. Cognitive behavior therapy was employed to change coping styles. During a 4-week period, 10 subjects were treated with methods of relaxation as an active-coping skill (RCT) and problem-solving training (PST), while 10 subjects served as a waiting list control. Coping scale scores measured by the revised Ways of Coping Checklist and psychological/physical symptom levels were obtained before and after the treatments, and also after a follow-up period of 14 months. The subjects treated with RCT and PST showed significant reductions in symptoms as well as significant increases in problem-focused coping both after the treatment and at the follow-up measurement. The control group did not show any significant change in symptoms and coping. The results indicate that RCT and PST are effective in changing tangible coping styles and, therefore, in reducing psychological/physical symptoms.

Adaptation, Psychological↗

PubMedDate not supplied

Randomized controlled trials to investigate occupational therapy research questions.

The randomized controlled trial (RCT) has become the most widely accepted research design for testing the efficacy of health care interventions. The purposes of this paper are to (a) introduce the essential elements of RCTs, and (b) discuss some of the special problems faced by occupational therapists in conducting and interpreting RCTs. The CONSORT (Consolidated Standards of Reporting Trials) statement is recommended as an introduction to the components of RCT quality. Problems pertinent to the study of the efficacy of occupational therapy and related interventions include the importance of: theory, background, and rationale; treatment fidelity; theory-based outcomes; management of non-masked (non-blinded) interventionists and participants; and multiplicity of statistical analyses. This paper can help practitioners judge the quality of an RCT, and it can help the profession work toward the development of a cadre of qualified researchers who can adapt the well-established methods of RCTs to the study of occupation-based interventions.

Evidence-Based Medicine↗

PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Con solidated S tandards o f R eporting T rials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Algorithms↗

PubMed2006

Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians.

BACKGROUND: Postoperative pulmonary complications are as frequent and clinically important as cardiac complications in terms of morbidity, mortality, and length of stay. However, there has been much less research and no previous systematic reviews of the evidence of interventions to prevent pulmonary complications. PURPOSE: To systematically review the literature on interventions to prevent postoperative pulmonary complications after noncardiothoracic surgery. DATA SOURCES: MEDLINE English-language literature search, 1 January 1980 through 30 June 2005, plus bibliographies of retrieved publications. STUDY SELECTION: Randomized, controlled trials (RCTs); systematic reviews; or meta-analyses that met predefined inclusion criteria. DATA EXTRACTION: Using standardized forms, the authors abstracted data on study methods, quality, intervention and control groups, patient characteristics, surgery, postoperative pulmonary complications, and adverse events. DATA SYNTHESIS: The authors qualitatively synthesized, without meta-analysis, evidence from eligible studies. Good evidence (2 systematic reviews, 5 additional RCTs) indicates that lung expansion interventions (for example, incentive spirometry, deep breathing exercises, and continuous positive airway pressure) reduce pulmonary risk. Fair evidence suggests that selective, rather than routine, use of nasogastric tubes after abdominal surgery (2 meta-analyses) and short-acting rather than long-acting intraoperative neuromuscular blocking agents (1 RCT) reduce risk. The evidence is conflicting or insufficient for preoperative smoking cessation (1 RCT), epidural anesthesia (2 meta-analyses), epidural analgesia (6 RCTs, 1 meta-analysis), and laparoscopic (vs. open) operations (1 systematic review, 1 meta-analysis, 2 additional RCTs), although laparoscopic operations reduce pain and pulmonary compromise as measured by spirometry. While malnutrition is associated with increased pulmonary risk, routine total enteral or parenteral nutrition does not reduce risk (1 meta-analysis, 3 additional RCTs). Enteral formulations designed to improve immune status (immunonutrition) may prevent postoperative pneumonia (1 meta-analysis, 1 additional RCT). LIMITATIONS: The overall quality of the literature was fair: Ten of 20 RCTs and 6 of 11 systematic reviews were good quality. CONCLUSIONS: Few interventions have been shown to clearly or possibly reduce postoperative pulmonary complications.

Analgesia↗