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Results for “randomized controlled trial (RCT)”

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At least 91 records · Page 5Linked to original sources

PubMed1992

Does episiotomy prevent perineal trauma and pelvic floor relaxation?

OBJECTIVE: To compare the outcomes of the current practice of liberally or routinely employing episiotomy to prevent perineal tears and pelvic floor relaxation (control group) to a policy of restricting episiotomy use to specific fetal and maternal indications (experimental group). DESIGN: A randomized controlled trial (RCT). SETTING: Three university hospitals in Montreal. SUBJECTS: Seven hundred three low-risk women enrolled at 30 to 34 weeks of gestation were randomized late in labor to the designated trial arm, by parity, and followed up to 3 months postpartum. MAIN OUTCOME MEASURES: Antepartum and postpartum information on perineal trauma and pain, pelvic floor symptoms (urinary incontinence), and sexual activity was collected through the use of standard questionnaires; pelvic floor function was measured by electromyographic (EMG) perineometry. RESULTS: Restricting episiotomy use in primiparous women was associated with similar sutured perineal trauma to the liberal or routine approach. Multiparous women in the restricted episiotomy group more often gave birth with an intact perineum (31% compared with 19%, odds ratio (OR) = 1.85, 95% confidence interval (CI) = 1.09 to 3.16). All but one 3rd/4th-degree perineal tear was associated with median episiotomy (46 of 47 in primiparous women and 6 of 6 among multiparous women). No difference between trial groups was found in postpartum perineal pain, antepartum and 3-month postpartum EMG perineometry, and urinary and pelvic floor symptoms. CONCLUSIONS: We found no evidence that liberal or routine use of episiotomy prevents perineal trauma or pelvic floor relaxation. Virtually all severe perineal trauma was associated with median episiotomy. Restriction of episiotomy use among multiparous women resulted in significantly more intact perineums and less perineal suturing.

Adult↗

PubMedDate not supplied

Three-year data from a randomizd, controlled study of early loading of single-stage dental implants supporting maxillary full-arch prostheses.

PURPOSE: The aim of this 3-year randomized controlled trial (RCT) was to compare biologic and technical treatment outcomes and patient satisfaction after early (< or = 14 days postimplantation) loaded implants with those of implants loaded after a healing period of 3 to 4 months in the edentulous maxilla. MATERIALS AND METHODS: Twenty-four patients with completely edentulous maxillae were randomized into a test group (n = 16) and a control group (n = 8). All patients received 5 or 6 solid screw-type titanium implants with sandblasted, large-grit, acid-etched (SLA) surfaces. In total, 142 implants were placed and 139 implants were loaded with full-arch prostheses. Clinical assessments were obtained at loading and after 3, 6, 12, 24, and 36 months. Radiographs of implants and existing teeth were taken at loading; after 6, 12, 24, and 36 months; and at 12, 24, and 36 months, respectively. RESULTS: The cumulative implant success rate 3 years after loading was 100%. At the 3-year examination the mean (P < or = .005), distal (P < or = .005), and mesial (P > .05) crestal bone levels were better in the test group. No significant differences between the test and control groups were noted for any other outcome measure. The most common adverse event in both groups was tooth-crown fracture. DISCUSSION: A review of the literature, both printed and electronic, revealed no study fulfilling the criteria of an RCT dealing with the early loading of maxillary full-arch prostheses. This study fulfills those criteria. CONCLUSION: In this study population it has been concluded that the early (approximately 2 weeks) loading protocol is a viable alternative to the standard (3 to 4 months) protocol in the rehabilitation of a completely edentulous maxilla with a complete implant-supported fixed prosthesis.

Adult↗

PubMed2003

Reporting of clinical details in randomized controlled trials of acupuncture for the treatment of migraine/headaches and nausea/vomiting.

OBJECTIVES: The main purpose of this study was to investigate the degree of reporting of clinical details in a selected sample of 30 randomized control trials (RCT) on acupuncture efficacy for the treatment of migraine/headaches (n = 11) and for nausea/vomiting (n = 19). Additional goals included the assessment of the quality of randomization of the trials, and the assessment of the degree of reporting of information about the outcome measures used in each trial. METHODS: A checklist of 50 clinical details selected on the basis of a previous survey was used to evaluate the degree of reporting of information about patients, practitioners, diagnosis, and acupuncture treatments presented in each RCT. The likelihood of bias in the randomization process was assessed using a previously validated scale. Information about reliability/validity and clinical significance of the outcome measures used in each trial was assessed in terms of fully, partially, or not reported, with no attempt to evaluate their quality or appropriateness. RESULTS: In this sample of RCTs an average of 38.7% of important clinical details per trial were either fully or partially reported by researchers, the lowest being 26.4% for the migraine/headaches group. Studies with better quality of randomization were not more likely to report important clinical details. Only five studies (16.7%) provided information about reliability and validity of the outcome measures used, and only four studies (13.3%), all from the migraines/headache group, discussed the clinical significance of the outcome measures selected. CONCLUSIONS: In this sample of 30 RCTs of acupuncture efficacy for the treatment of migraines/headache and nausea/vomiting, researchers neglected to report adequately on important clinical details, and often did not discuss the reliability, validity, and clinical significance of the outcome measures used in the trials, thus rendering potential readers of the articles unable to critically appraise them from a clinical standpoint. In addition, the fact that the quality of randomization of the trials was totally unrelated to the degree of reporting of clinical details renders potential reviewers of these studies unable to establish valid conclusions about acupuncture efficacy based on the general quality of the methodological design. In the future, all areas of clinical acupuncture research need to be reviewed in a similar manner, and recommendations about proper reporting of important clinical details and proper discussion of the validity, reliability, and clinical significance of the outcome measures used in each trial should be made. Only then could this research be used to generate meaningful evidence-based recommendations for the contemporary practice of acupuncture.

Acupuncture Therapy↗

PubMed2003

Effectiveness of pelvic floor muscle exercise therapy supplemented with a health education program to promote long-term adherence among women with urinary incontinence.

AIMS: A longitudinal randomized controlled trial (RCT) was conducted to evaluate the effectiveness of physiotherapeutic pelvic floor muscle exercise (PFME) therapy supplemented with a health education program to promote long-term adherence among women with stress, mixed, and urge urinary incontinence (UI). METHODS: Women (n = 129) were evaluated by their general practitioner (GP) and randomized in either the control group (PFME therapy alone) or one of the three experimental groups (PFME therapy with one of the three health education program versions). Therapy consisted of 9-18 individual 30 min sessions with a specialized physiotherapist, over 14-22 weeks. Outcome measures were weekly frequency of wet episodes and adherence behavior. Women were assessed up to 1 year after therapy. RESULTS: The health education program had no additional impact to individual contact during PFME therapy on treatment outcome, nor on adherence. However, the individual physiotherapeutic treatment protocol was very effective in reducing weekly frequency of wet episodes from 23 to 8 times a week immediately after therapy, and effects were maintained during the 1-year follow-up period. Adherence was very high; most women followed the behavioral advice on average 6 days/week at posttest and still 4-5 days 1 year after therapy. Results were not different between incontinence types. Women who had relatively frequent wet episodes before and 1 year after therapy had higher adherence levels compared to women who had fewer weekly losses. CONCLUSIONS: Results suggest that a standardized protocol checklist for physiotherapists covering all treatment aspects of PFME therapy, may optimize long-term treatment outcome and adherence behavior among patients, and outshines the addition of a health education program.

Adult↗

PubMed1996

Randomization is important in studies with pain outcomes: systematic review of transcutaneous electrical nerve stimulation in acute postoperative pain.

We set out to examine the evidence for the importance of randomization of transcutaneous electrical nerve stimulation (TENS) in acute postoperative pain. Controlled studies were sought; randomization and analgesic and adverse effect outcomes were summarized. Forty-six reports were identified by searching strategies. Seventeen reports with 786 patients could be regarded unequivocally as randomized controlled trials (RCT) in acute postoperative pain. No meta-analysis was possible. In 15 of 17 RCT, we judged there to be no benefit of TENS compared with placebo. Of the 29 excluded trials, 19 had pain outcomes but were not RCT; in 17 of these 19 TENS studies, the authors concluded that TENS had a positive analgesic effect. No adverse effects were reported. Non-randomized studies overestimated treatment effects.

Acute Disease↗

PubMed2006

Can pelvic floor muscle training prevent and treat pelvic organ prolapse?

BACKGROUND AND METHODS: Pelvic floor muscle dysfunction may cause urinary and fecal incontinence, pelvic organ prolapse (POP), pain, and sexual disturbances. The aim of the present study is to review the literature on the effectiveness of pelvic floor muscle training (PFMT) to prevent and treat POP, and the possible theories and mechanisms on how PFMT could prevent or reverse prolapse. RESULTS: No studies were found on prevention of POP. One uncontrolled study and one low-quality RCT were found in the treatment of prolapse. The results showed a positive effect of PFMT in severe, but not in mild prolapse. A review is presented of the main hypothesis of mechanisms on how PFMT may be effective. The two mechanisms are morphological changes occurring after strength training and use of a conscious contraction during increase in abdominal pressure in daily activities. CONCLUSIONS: In addition to the theory of functional anatomy and exercise science, one randomized controlled trial (RCT) is supportive for a positive effect of PFMT in the treatment of POP. There is an urgent need for more RCT with high methodological quality, use of valid and reproducible methods to assess degree of prolapse, and appropriate training protocols to evaluate the effect of PFMT in the prevention and treatment of POP.

Exercise Therapy↗

PubMed2005

Randomization, informed consent and physicians' communication skills in pediatric oncology: a delicate balance.

Parents asked to consent to a child's randomization in a pediatric cancer clinical trial are often unprepared to grasp the implications of this scientifically crucial but seemingly unfair process. Physicians must adopt specific communication skills to engage families in open dialogue from the outset in order to elicit truly shared informed consent. Starting from the case of a family with an only child affected by disseminated neuroblastoma, we wish to comment on the problems surfacing in the informed consent process for treatment and research in pediatric oncology that implicate an understanding of bioethical issues and psychological principles. Although the outcome of childhood cancer has improved dramatically over the last 30 years, with overall survival rates now exceeding 70%, there are regretfully still types and stages of cancer carrying a very high risk of death that urgently require new clinical strategies. The response to this need has been the design of experimental protocols that often entail randomized controlled trials (RCT). A large number of these trials concern stage IV neuroblastoma, acute leukemia, rhabdomyosarcoma, and other types of childhood cancers presenting great heterogeneity both in terms of localization and responsiveness to therapy. Most trials for disease relapses also include one or more randomizations. The scientific motivation justifying an RCT is the need to compare and evaluate an innovative protocol (or part thereof) with reference treatment modalities. Nevertheless, the process brings to bear the ethical dilemma of having to weigh the needs of the single afflicted child against the benefit which may ensue for a much larger patient community.

Child, Preschool↗

PubMed2006

Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials.

OBJECTIVE: To systematically review published randomized controlled trials (RCT) evaluating a new topical diclofenac solution (Pennsaid) in patients with osteoarthritis (OA) of the knee. METHODS: RCT were identified by searching electronic data sources as well as by contact with the manufacturer of Pennsaid. Details of study demographics, methodology, quality, and outcomes were analyzed. A metaanalysis evaluating the efficacy and safety of Pennsaid in OA of the knee was performed. RESULTS: Four RCT were analyzed in this systematic review (3 published reports and one published abstract). Mean trial duration was 8.5 weeks. Generally, these RCT were of excellent quality. The mean Jadad quality score was 4.5 out of 5. Many indicators of high quality in a RCT were found in these RCT, including adequate descriptions of the methods used for randomization, blinding, and allocation concealment. In comparison to a vehicle control placebo (VCP), the standardized mean differences (SMD) for the WOMAC pain, stiffness, and physical function subscales, as well as for patient global assessment, were all statistically significant in favor of Pennsaid, with SMD ranging from 0.30 to 0.39. Pennsaid was as safe as VCP, with the only exception that it was more likely to result in minor skin dryness at the site of application (relative risk 1.7). In a 12 week equivalence trial that used the WOMAC subscales to compare treatment response, Pennsaid was as effective as oral diclofenac, but was much better tolerated. CONCLUSION: Pennsaid is an effective topical NSAID in patients with OA of the knee. Apart from minor localized skin reactions, Pennsaid was as safe as VCP. It is not known whether the favorable results of Pennsaid can be extrapolated to other topical NSAID preparations. Pennsaid deserves further consideration when the existing treatment guidelines for OA of the knee are updated.

Administration, Topical↗

PubMed1999

Effects of mailed advice on stress reduction among employees in Japan: a randomized controlled trial.

We conducted a randomized controlled trial (RCT) to examine the effects of mailed advice on reducing psychological distress, blood pressure, serum lipids, and sick leave of workers employed in a manufacturing plant in Japan. Those who indicated higher psychological distress (defined as having GHQ scores of three or greater) in the baseline questionnaire survey (n = 226) were randomly assigned to an intervention group or a control group. Individualized letters were sent to the subjects of the intervention group, informing them of their stress levels and recommending an improvement in daily habits and other behaviors to reduce stress. Eighty-one and 77 subjects in the intervention and control groups, respectively, responded to the one-year follow-up survey. No significant intervention effect was observed for the GHQ scores, blood pressure, serum lipids, or sick leave (p > 0.05). The intervention effect was marginally significant for changes in regular breakfasts and daily alcohol consumption (p = 0.09). The intervention effect was marginally significant for the GHQ scores among those who initially did not eat breakfast regularly (p = 0.06). The study suggests that only sending mailed advice is not an effective measure for worksite stress reduction. Mailed advice which focuses on a particular subgroup (e.g., those who do not eat breakfast regularly) may be more effective.

Absenteeism↗

PubMedDate not supplied

Teaching staff to respond effectively to cognitively impaired residents who display self-protective behaviors.

A randomized controlled trial (RCT) was implemented to evaluate the effectiveness of a 7 1/2 hour educational program designed to provide staff with the knowledge, skill, and confidence to manage physical self-protective behaviors of cognitively impaired long-term care residents. This RCT using a pretest/post-test design was conducted using consenting staff members (n = 40) who were randomly allocated to either a control or experimental group. The main outcome measure was a skills lab that evaluated participants 'responses to simulated patients. Both groups participated in the skills lab prior to training, and six weeks after the experimental group completed the program. Pre- and post-training and skills lab observational field notes were subjected to thematic content analysis. Twenty-eight staff members completed both pre- and post-training assessment measurements. Descriptive statistics and paired t-test analyses yielded statistically significant differences in change scores for performance indicators in three simulation scenarios. Analysis of the qualitative data support the finding that, once trained, staff felt better prepared to manage self-protective behaviors. The results suggest that an initiative to educate staff will enhance knowledge, improve performance, and provide the confidence necessary for staff to respond positively to overt physical behaviors in cognitively impaired elders.

Adolescent↗

PubMed2004

Randomized controlled trial of hip protectors among women living in the community.

OBJECTIVE: To assess whether hip protectors used among women living in the community in the United Kingdom and at high risk of hip fracture, lead to a reduction in hip fracture. DESIGN: Pragmatic randomized controlled trial (RCT). SETTING: Primary care with participants being recruited largely from general practitioners' patient lists. PARTICIPANTS: Women aged 70 years and over with one or more risk factors for hip fracture (i.e., low body weight, current smoker, a prior fracture, family history of hip fracture). INTERVENTION: Three pairs of hip protectors of the "shell" type mailed to participants with instructions on how to use them. MAIN OUTCOME MEASURE: Reduction in hip fractures. RESULTS: 1,388 and 2,781 women aged 70 years or over were randomized to be given three pairs of hip protectors or act as controls, respectively. We followed up both groups of women for a minimum of 24 months (maximum 42 months, median 28). Compliance was poor with only 31% of participants reporting that they wore the hip protectors on a daily basis at 12 months. Intention-to-treat analysis showed that there was no statistically significant difference in the unadjusted odds ratios (ORs) of sustaining a hip fracture between the groups (OR = 1.19; 95% confidence interval, 0.80 to 1.78, p = 0.40). Adjustment for important covariates did not materially change these findings (OR = 1.17; 95% CI, 0.78 to 1.75). Comparing the rate of hip fracture between those women who regularly wore the devices and the control group yielded an OR of 1.12 (95% CI, 0.58 to 2.03; p = 0.83). CONCLUSION: This study is the largest RCT of hip protectors to date and provides no evidence of an effect of hip protectors among women living independently and at high risk of fracture.

Accidental Falls↗

PubMed2005

In unselected patients, elective single embryo transfer prevents all multiples, but results in significantly lower pregnancy rates compared with double embryo transfer: a randomized controlled trial.

BACKGROUND: Elective single embryo transfer (eSET) in a selected group of patients (i.e. young patients with at least one good quality embryo) reduces the number of multiple pregnancies in an IVF programme. However, the reduced overall multiple pregnancy rate (PR) is still unacceptably high. Therefore, a randomized controlled trial (RCT) was conducted comparing eSET and double embryo transfer (DET) in an unselected group of patients (i.e. irrespective of the woman's age or embryo quality). METHODS: Consenting unselected patients were randomized between eSET (RCT-eSET) (n = 154) or DET (RCT-DET) (n = 154). Randomization was performed just prior to the first embryo transfer, provided that at least two 2PN zygotes were available. Non-participants received our standard transfer policy [SP-eSET in a selected group of patients (n = 100), otherwise SP-DET (n = 122)]. RESULTS: The ongoing PR after RCT-eSET was significantly lower as compared with RCT-DET (21.4 versus 40.3%) and the twin PR was reduced from 21.0% after RCT-DET to 0% after RCT-eSET. The ongoing PRs after SP-eSET and SP-DET did not differ significantly (33.0 versus 30.3%), with an overall twin PR of 12.9%. CONCLUSION: To avoid twin pregnancies resulting from an IVF treatment, eSET should be applied in all patients. The consequence would be a halving of the ongoing PR as compared with applying a DET policy in all patients. The transfer of one embryo in a selected group of good prognosis patients leads to a less drastic reduction in PR but maintains a twin PR of 12.9%.

Adult↗

PubMedDate not supplied

Turning theory into practice: rationale, feasibility and external validity of an exploratory randomized controlled trial of training family practitioners in reattribution to manage patients with medically unexplained symptoms (the MUST).

BACKGROUND: The evidence for the effectiveness of reattribution training are limited, and optimal service delivery is not yet established. OBJECTIVES: The objectives of this study were to establish the feasibility and to optimize the service delivery and design of a definitive randomized controlled trial (RCT) of reattribution training for patients with medically unexplained symptoms (MUSs) in routine primary care. METHODOLOGY: The study was of a cluster RCT design with the practice as the unit of randomization. Health facilitator (HF)-delivered reattribution training was compared with no reattribution training. The primary outcome measure used is doctor-patient communication in the consultation. Quantitative and qualitative methods identify barriers to effectiveness. The acceptability and feasibility of the intervention were established by attendance rates and postal survey after completion of training. RESULTS: Sixteen practices and 70 family practitioners (FPs) were recruited with representative practice and FP characteristics. Six hours of HF reattribution training to FPs in the workplace proved feasible and acceptable with all 35 FPs completing the training. Feedback from 27 (77%) FPs who received training indicated that 25 (93%) FPs believed that specific and relevant learning achievements were made, 22 (82%) felt more confident and 21 (77%) thought the training was useful. CONCLUSION: HF-delivered reattribution training to whole practices is feasible and acceptable, and its effectiveness is measurable in routine primary care.

Adult↗

PubMed2006

Simulation of the Syst-Eur randomized control trial using a primary care electronic medical record was feasible.

OBJECTIVE: To determine the validity of outcome research using a primary care practice database by comparing a randomized controlled trial (RCT) with a simulated one. STUDY DESIGN AND SETTING: A cohort from the United Kingdom General Practice Research Database (GPRD) was used to simulate the Systolic Hypertension in Europe (Syst-Eur) trial, a study of antihypertensive therapy of isolated systolic hypertension, by replicating all aspects of that RCT (selection criteria, study time frame, treatment, and outcomes) except randomization. RESULTS: The exposed and unexposed groups in the GPRD study exhibited similar baseline characteristics. Stroke, the primary RCT outcome, decreased significantly in both the RCT (incidence rate ratio IRR = 0.58) and the GPRD study (IRR = 0.68). Myocardial infarction decreased nonsignificantly but similarly in both studies (RCT IRR = 0.70; GPRD IRR = 0.74). With the GPRD study extended for 3 years more, myocardial infarction decreased significantly, comparable to findings from the Systolic Hypertension in the Elderly Program (SHEP), another RCT similar to Syst-Eur. CONCLUSIONS: The findings support the potential value of clinical databases to investigate treatment effectiveness. RCT simulation using the GPRD may be the most feasible way to assess observational study validity in comparison to RCTs. The extended GPRD study shows the feasibility of using a simulated study to supplement the results of an RCT of limited duration.

Computer Simulation↗

PubMed2006

[Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

BACKGROUND: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. AIM: To determine methodological quality and internal and external validity of the Macdonald study. MATERIAL AND METHOD: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. RESULTS: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. CONCLUSION: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

Antineoplastic Combined Chemotherapy Protocols↗

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↗

PubMedDate not supplied

Grading the evidence for diabetes performance measures.

CONTEXT: Grading scientific evidence is a critical step in developing practice guidelines and quality performance measures. GENERAL QUESTION: What is the most useful way to grade evidence? SPECIFIC QUESTION: How should we grade the recommended clinical practices for patients with diabetes? STANDARD APPROACH: Hierarchical grading systems (e.g., grades I, II, and III), such as that used by the U.S. Preventive Services Task Force, have traditionally been used to rank the research designs of studies that support a particular clinical practice. POTENTIAL DIFFICULTIES: Many studies that support the clinical practices of diabetes care do not clearly conform to the categories traditionally used in hierarchical grading systems. As a result, there is a tendency to inaccurately characterize the level of evidence, leading to the phenomenon of evidence inflation or evidence deflation. To avoid exaggerating the evidence, important sources of information may be excluded, resulting in an understatement of the available supporting evidence. ALTERNATE APPROACH: This paper offers a more descriptive typologic system that uses the study design and an explanatory modifier to grade the evidence supporting the clinical practices of diabetes care. The study grades are randomized, controlled trial (RCT); RCT-embedded component; RCT-treatment only; RCT-different population; observational study-risk factor; and expert opinion. Using this grading system, the authors were able to more accurately describe the best available evidence supporting the clinical practices of diabetes care.

Diabetes Mellitus↗

PubMed2006

Redefining the randomized controlled trial in the context of acupuncture research.

BACKGROUND: The randomized controlled trial (RCT) is considered the 'gold standard' methodology for evaluating efficacy of an intervention. It has been argued that RCTs cannot be used to examine the effectiveness of acupuncture. PURPOSE: The purpose of this paper is to examine the applicability of an RCT study design for acupuncture research. FINDINGS: RCTs would be more effective in studying acupuncture if study participants were randomized to groups based on the acupuncture diagnosis and not solely on the Western diagnostic criteria. Treatments must also be standardized somewhat to ensure replicability of the study and the information it provides. Blinding is not absolutely necessary for a good-quality RCT; however, if used, control groups need to be standardized and sham techniques evaluated to ensure accurate interpretation of results. CONCLUSIONS: With these factors combined, it is possible to greatly increase internal and external validity in acupuncture RCTs.

Acupuncture Therapy↗