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PubMed2006

Adjuvant chemotherapy with folinic acid and 5-fluorouracil in patients with locally advanced rectal cancer previously treated by preoperative radiochemotherapy and curative tumor resection.

BACKGROUND AND AIMS: The role of postoperative adjuvant chemotherapy in patients with rectal cancer pretreated by preoperative radiochemotherapy (RCT) and curative surgery is still poorly investigated. PATIENTS AND METHODS: We pooled data from both arms of a phase III trial in which patients with locally advanced (T3/4) rectal cancer were randomized to preoperative RCT alone or combined with pelvic radio-frequency hyperthermia. After surgery, R0-resected patients were scheduled to adjuvant chemotherapy with four monthly courses of 50 mg folinic acid (FA) and gradually escalated 5-fluorouracil (5-FU, 350-500 mg/m2, days 1-5). Reasons preventing initiation of chemotherapy and treatment-related toxicities were evaluated. Patients' characteristics and survival parameters were compared between the treated and untreated patient groups. RESULTS: Out of 93 patients, 73 (79%) started adjuvant chemotherapy, whereas 19 (21%) did not, mostly due to perioperative complications and refusal. Chemotherapy-related toxicities were mild to moderate in most cases, but--together with protracted postoperative complications--prevented the intended dose escalation of 5-FU in 71% of patients. Distant-failure-free (p=0.03) and overall survival (p=0.03) were improved in the chemotherapy group, although there was a negative selection of patients with unfavourable characteristics into the untreated patient group. INTERPRETATION/CONCLUSION: Adjuvant chemotherapy using FA and 5-FU can be safely applied to the majority of patients with rectal cancer pretreated by RCT and surgery. Survival data are not suitable to allow far-reaching conclusions, but are in line with suggestions of a favourable effect of adjuvant chemotherapy in these patients.

Adolescent↗

PubMed2003

Overall and differentiated ratings of perceived exertion at the respiratory compensation threshold: effects of gender and mode.

Research on gender differences in ratings of perceived exertion (RPE) has been equivocal with few studies comparing exercise modes and differentiated RPE. The current study examined gender differences in overall and differentiated RPE at the respiratory compensation threshold (RCT) during cycling and treadmill exercise. Each minute during a maximal treadmill and maximal cycling test, men (n=18) and women (n=16) estimated RPE corresponding to overall (RPE-O), legs (RPE-L), and breathing/chest (RPE-C) exertion. A 2 (gender) x 2 (mode) x 3 (RPE-O, RPE-L, RPE-C) repeated measures MANOVA revealed no significant mode x gender or RPE x gender interactions. The exercise mode x RPE interaction approached significance (P=0.055) when cycling [mean (SD) 14.8 (2.9)] and treadmill exercise [12.8 (2.9)] were compared. No main effects for gender [men: 13.7 (2.6), women: 13.4 (2.6)] were detected. Main effects for mode showed RPE to be significantly greater during cycling [14.4 (2.8)] versus treadmill exercise [12.7 (2.9)]. Main effects for differentiated RPE showed RPE-L [13.8 (2.6)] to be significantly greater than RPE-O [13.5 (2.6)] and RPE-C [13.3 (2.6)]. Results suggest that overall and differentiated RPE at the RCT are not significantly different between genders during cycling or treadmill exercise. While RPE-L was statistically greater than RPE-O and RPE-C, the magnitude of the differences makes this result of little practical significance. The marginal interaction suggests greater RPE-L values might be expected at the RCT during cycling versus treadmill exercise. However, results suggest that minimal RPE differences exist between men and women during cycling and treadmill exercise.

Adaptation, Physiological↗

PubMed2004

Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence?

BACKGROUND: The need to administer antibiotic prophylaxis (ABP) during laparoscopic cholecystectomy (LC) is still a matter of significant controversy. The purpose of this study was to resolve this issue by performing a meta-analysis of the available randomized controlled trials (RCT) on this topic. METHODS: Papers identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. The outcome measures were the rates of all perioperative infections, the rates of surgical site infections, and the rates of infections at other sites. Results were examined for 974 patients randomized to ABP or placebo prior to LC in six RCT published from 1997 to 2001. RESULTS: The cumulative rates of all infections were 2.8% in the ABP group and 4.4% in the placebo group. The pooled odds ratio (OR) (95% confidence interval [CI]) was 0.69 (0.34-1.43; p = 0.32). The cumulative rates of surgical site infections were 2.1% in the ABP group and 2.9% in the placebo group. The pooled OR (95% CI) was 0.82 (0.36-1.86; p = 0.63). The cumulative rates of infections at other sites were 0.7% in the ABP group and 1.5% in the placebo group. Pooled OR (95% CI) was 0.82 (0.18-1.90; p = 0.37). No significant heterogeneity was found in any data pooling. CONCLUSIONS: Based on the available evidence, there appears to be no need to administer routine ABP to low-risk patients during LC. However, the number of patients enrolled to date into RCT is insufficient to avoid a type II error. A large and well-designed trial is urgently needed to find a conclusive answer to this question.

Antibiotic Prophylaxis↗

PubMed2003

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

To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here 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 this 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 shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done 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.

Humans↗

PubMed2026

Application of SPI-guided analgesia in laparoscopic gynecologic surgery: a randomized controlled trial evaluating the remifentanil-sparing effect and predictive value of time-weighted SPI.

This study aimed to achieve two primary objectives: (1) to evaluate the opioid-sparing effect of Surgical Pleth Index (SPI)-directed analgesia during surgery via a randomized controlled trial (RCT), and (2) to propose and preliminarily assess a novel dynamic metric, Threshold-based Time-Weighted SPI (Tb-TW-SPI), which integrates stimulus intensity and duration, for its predictive efficacy regarding postoperative moderate-to-severe pain. Employing an RCT combined with exploratory analysis, 61 patients undergoing elective laparoscopic gynecologic surgery were randomized into an SPI-directed analgesia group or a conventional analgesia group. The primary outcome was total intraoperative remifentanil consumption. Postoperatively, an exploratory analysis of the control group data evaluated the correlation between Tb-TW-SPI and Numeric Rating Scale (NRS) pain scores in the post-anesthesia care unit (PACU), calculating its predictive value for moderate-to-severe pain (NRS ≥ 4). Results: The SPI-directed group required significantly less intraoperative remifentanil than the conventional group [median (IQR): 5.84(5.02,6.62)vs. 6.96(5.81,8.19)µg/kg/h; P = 0.016]. Postoperative pain scores did not differ significantly between groups (P > 0.05). Exploratory analysis of the conventional analgesia group revealed that Tb-TW-SPI values were significantly higher in patients with moderate-to-severe postoperative pain (NRS ≥ 4) compared to those without (P = 0.0417).The area under the ROC curve for Tb-TW-SPI predicting this pain was 0.74 (95% CI: 0.52-0.96), with 67% sensitivity and 76% specificity at an optimal cutoff of 1210. This RCT suggests that SPI-directed analgesia can safely and moderately reduce intraoperative remifentanil consumption. Furthermore, the proposed Tb-TW-SPI metric, in this exploratory analysis, suggests potential for predicting postoperative pain, though this finding requires validation in larger cohorts with higher-frequency SPI sampling, offering a new direction for SPI interpretation. Large-scale, multicenter trials are warranted to validate the predictive utility of Tb-TW-SPI. Clinical Trial Registration, China Clinical Trial Registry: ChiCTR2400088444.

Humans↗

PubMed2007

The Personality Disorders Institute/Borderline Personality Disorder Research Foundation Randomized Control Trial for Borderline Personality Disorder: reliability of Axis I and II diagnoses.

The Personality Disorder Institute/Borderline Personality Disorder Research Foundation randomized control trial (PDI/BPDRF RCT) is a randomized control trial comparing three treatments for borderline personality disorder (BPD). An important issue for any RCT is diagnostic reliability, demonstration of which is necessary to evaluate claims of a treatment's efficacy for a given population. The present paper examines the interrater reliability of Axis I and II disorders in the context of a high base rate of BPD features for participants referred for inclusion in the RCT. Our results indicate good to excellent levels of interrater reliability for all Axis I and II disorders in this context. Assessors were able to reliably diagnose BPD, exclusionary criteria, and comorbid diagnoses. This data is important for comparing findings and sample composition across different studies using similar sampling strategies, especially as treatments are increasingly being developed and tested for BPD.

Adult↗

PubMed2026

Robot-assisted versus manual percutaneous vascular interventions across vascular territories: a systematic review and meta-analysis.

Robot-assisted percutaneous vascular intervention (R-PVI) has expanded beyond coronary procedures, but previous reviews were largely coronary-focused and observational. Recent randomized controlled trials (RCTs) warrant broader reassessment of R-PVI versus manual percutaneous vascular intervention (M-PVI) across vascular territories. PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials were searched from database inception to January 31, 2026, following PRISMA guidelines. RCTs and observational studies including ≥10 adult patients in total were eligible. Comparative studies informed primary analyses, while single-arm studies provided supportive evidence. Primary outcomes were clinical success rate and major adverse cardiovascular/cerebrovascular events (MACE) rate. Secondary outcomes included mortality rate, technical success rate, procedural time metrics, contrast volume, and radiation exposure. Random-effects models were used. Forty studies were included: 3 RCTs, 10 comparative observational studies, and 27 single-arm observational studies, comprising 3,870 patients undergoing R-PVI and 1,142 undergoing M-PVI. Comparative analyses showed similar clinical success rates (RR 1.00, P = 0.46), MACE rates (RR 0.72, P = 0.43), and mortality. Single-arm pooled estimates for clinical and technical success were 98.76% and 96.09%, respectively. R-PVI prolonged total procedure time overall (MD 15.92 min, P = 0.01), with consistent increases in the neurovascular, RCT, and non-RCT subgroups. Fluoroscopy time was also longer (MD 1.91 min, P = 0.04), mainly in the RCT subgroup (MD 2.83 min, P = 0.001). In contrast, intravascular intervention time was unchanged overall and in RCTs, but was prolonged in non-RCTs (MD 8.72 min, P = 0.006). Operator radiation exposure was markedly reduced (MD -33.97 μSv, P < 0.001), whereas patient radiation exposure and contrast volume were similar. R-PVI appears feasible and safe across selected vascular procedures. Its clearest benefit is reduced operator radiation exposure, whereas lower whole-procedure efficiency remains its main limitation.

Humans↗

PubMed2005

The effect of alpha-linolenic acid and linoleic acid on the growth and development of formula-fed infants: a systematic review and meta-analysis of randomized controlled trials.

This systematic review and meta-analysis aimed to evaluate the effect of modifying 18-carbon PUFA [18-C PUFA: alpha-linolenic acid (ALA, 18:3n-3) and linoleic acid (LA, 18:2n-6)] in the diets of term and preterm infants on DHA (22:6n-3) status, growth, and developmental outcomes. Only randomized controlled trials (RCT) involving formula-fed term and preterm infants, in which the 18-C PUFA composition of the formula was changed and growth or developmental outcomes were measured, were included. Differences were presented as control (standard formula) and treatment (18-C PUFA-supplemented formula). Primary analyses for term infants were 4 and 12 mon and for preterm infants 37-42 and 57 wk postmenstrual age. Five RCT involving term infants and three RCT involving preterm infants were included in the systematic review. Infants fed ALA-supplemented formula had significantly higher plasma and erythrocyte phospholipid DHA levels than control infants. There was no effect of ALA supplementation on the growth of preterm infants. In term infants, ALA supplementation was associated with increased weight and length at 12 mon, which was at least 4 mon after the end of dietary intervention. Developmental indices of term infants did not differ between groups. There was a transient improvement in the retinal function of preterm infants fed ALA-supplemented diets compared with controls. The findings suggest that ALA-supplemented diets improve the DHA status of infants. Further studies are needed to provide convincing evidence regarding the effects of ALA supplementation of formula on infant growth and development.

Body Size↗

PubMed1999

Polyunsaturated fatty acids and infant visual development: a critical appraisal of randomized clinical trials.

At the Consensus and Controversies Conference held in Barcelona in November 1996, one of the sessions focused on an evaluation of the effects of dietary polyunsaturated fatty acids (PUFA) on infant visual development. The intervention trials in preterm and term infants were reviewed and discussed in detail. Results of these trials, particularly those in term infants, were inconsistent; much discussion occurred concerning the causes of these diverse results. We attempt to reflect, rather than report exactly, the discussion relating to these issues and address the clinical trials according to recently published guidelines for conduct and reporting of randomized clinical trials (RCT). Compared with these recent guidelines, the published papers of RCT involving PUFA and visual function are often incomplete, making it difficult to assess if we can have a high degree of confidence in the reported effects (or lack of effects). Despite this, valuable data relating to the effect of diet on the visual development of infants were obtained. Our evaluation of the trials to date suggests that the definitive answer to the degree to which dietary long-chain PUFA is likely to influence visual development may only be resolved with impeccably conducted RCT.

Fatty Acids, Unsaturated↗

PubMed1983

Pituitary immunoreactive calcitonin-like material: lack of evidence for cross-reactivity with pro-opiomelanocortin.

In mammals, calcitonin (CT) is synthesized, stored, and secreted by intrathyroidal C cells. Several reports have suggested the presence of immunoreactive CT in the pituitary gland. We have studied the rat pituitary gland using a radioimmunoassay for CT and have also found immunoreactive CT-like material. Assay of extracts of whole rat pituitary glands was performed using a radioimmunoassay for human CT, which gave identical dilution curves with synthetic human CT (hCT), synthetic rat CT (rCT), and mouse and rat thyroid extracts, but not with a variety of other pituitary and hypothalamic peptides. Immunoreactive CT (iCT) content of extracts of whole pituitary glands ranged from 6 to 72 pg/mg wet weight of tissue (60-840 pg/whole pituitary gland), whereas iCT was not measureable (less than 5 pg/mg tissue) in similar extracts of hypothalamus and cerebral cortex. Gel filtration studies of pituitary extracts showed a peak of iCT, which eluted with 125I-rCT and diluted in parallel with rCT. To investigate whether the pituitary iCT was related to pro-opiomelanocortin, extracts of ACTH-producing AtT20/D16 cells from mice, which contain the ACTH precursor in large quantities, were examined and no iCT was found. Immunohistochemical studies of rat pituitary glands with peroxidase-antiperoxidase and immunofluorescent techniques showed positive staining for CT in cells in the pars anterior, but not in the pars intermedia of pars nervosa; this staining was not eliminated when the antiserum was absorbed with CT under conditions that completely obliterated staining of rat thyroid glands. Double staining demonstrated essentially two distinct populations of cells, one positive for CT and another positive for ACTH, with less than 1% of the cells positive for both ACTH and CT. Immunoreactive CT-like material was present in the pituitary glands of rats thyroparathyroidectomized 18 days before they were killed, but was diminished. Biosynthetic labeling in vitro of rat pituitary glands with 3H-leucine showed incorporation into prolactin; there was no incorporation into CT. No in vitro secretion of iCT by whole rat pituitary glands either basally or after high K+ stimulation was observed. We conclude that: (1) a substance that has certain immunologic and size characteristics of CT is present in minute amounts in the pituitary gland of rats; (2) this material is not a part of the ACTH precursor; and (3) positive immunohistochemical staining in pituitary glands may not be specific for authentic CT.

Animals↗

PubMed1993

Increased reverse cholesterol transport in athletes.

Proposed mechanisms for the cardioprotective benefits of exercise include decreased lipid deposition and increased reverse cholesterol transport (RCT). RCT involves the efflux of tissue free cholesterol into high-density lipoprotein (HDL) particles, esterification by lecithin:cholesterol acyltransferase (LCAT), transfer to other lipoproteins by cholesterol ester transfer proteins (CETP), and liver excretion. We tested the hypothesis that RCT is enhanced in athletes and that this can occur without large increases in plasma HDL cholesterol (HDL-C) mass levels. Fasting venous blood was drawn from 13 sedentary men and 11 athletes exercising at the rate of 5,185 +/- 501 kcal/wk. Compared with controls, athletes had similar age, body mass index (BMI), HDL-C (P > .1) and apolipoprotein (apo) A-1 (P > .5) levels, and lower low-density lipoprotein cholesterol (LDL-C) (P < .05) and apo B (P < .03) levels. The net mass of free cholesterol transported (NMCT) out of cultured human fibroblasts into the athletes' serum was greater than that for controls (25.5 +/- 8.0 v 7.1 +/- 2.6 micrograms/mL/h, P = .048). The efflux component of this transport correlated with HDL-C and apo A-1 levels and was similar between groups (P = .24), suggesting that athletes' antiatherogenic NMCT findings were due to decreased cholesterol influx into the cells. Athletes had increased plasma LCAT (20.3 +/- 2.1 v 13.9 +/- 1.5 micrograms/mL/h, P = .028) and CETP activities (69.7 +/- 4.5 v 21.5 +/- 4.8%/mL/h, P < .001). The NMCT positively correlated with CETP and LCAT activities and inversely with apo B levels and the cardiac risk ratio apo B/A-1.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1986

An infectious cDNA clone of the poliovirus Sabin strain could be used as a stable repository and inoculum for the oral polio live vaccine.

Viruses were recovered from HeLa S3 cells and African green monkey kidney (AGMK) cells transfected with an infectious cDNA clone of poliovirus vaccine Sabin 1 strain. The viruses recovered from the different DNA-transfected cells were tested for the biological characteristics of temperature sensitivity (rct marker), plaque size, and bicarbonate concentration dependency (d marker). The results revealed that the above properties were similar to those obtained from tests on the Sabin 1 vaccine reference strain. The recovered viruses and the vaccine reference virus were passaged in AGMK cells at an elevated temperature of 37.5 degrees, and the passaged isolates were tested for the rct marker. The virus recovered from AGMK cells had the most stable rct phenotype while the virus from HeLa S3 cells had a similar stability to that of the reference virus, suggesting that the virus from AGMK cells would be more suitable as a vaccine strain than the other two viruses. Furthermore, an infectious cDNA clone of high specific infectivity, constructed by introducing SV40 large T antigen into the plasmid, was used for production of high titers of virus after transfection. The results of in vitro biological tests on the recovered virus suggested that virus produced in the transfected AGMK cells also had the high quality that is desirable in vaccine stocks. Monkey neurovirulence tests performed with these recovered viruses revealed that the recovered viruses were weakly neurovirulent, similar to the vaccine reference virus. The infectious cDNA clone of the poliovirus vaccine strain could therefore be used to generate a possible inoculum of the oral polio live vaccine. Our findings strongly suggest that an infectious cDNA clone of poliovirus RNA may be used to preserve the constancy and quality of the present seed viruses of the Sabin 1 vaccine strain.

Animals↗

PubMed1984

Prognostic significance of residual cancer tissue after diagnostic biopsy in breast carcinoma. Three-year short-term results.

Among 3264 cases of breast carcinoma undergoing diagnostic biopsy and frozen section followed by one-stage mastectomy, the occurrence of residual cancer tissue (RCT) was evaluated as part of a prospective, nationwide trial in Denmark. RCT was defined by the presence of cancer left in relation to the biopsy cavity in the mastectomy specimen. A significantly higher cumulative recurrence rate within 3 yr was found in cases with residual cancer compared to cases without this finding. The difference was most pronounced in the premenopausal high-risk group. Therefore, RCT in the wall of the biopsy cavity is considered a prognostic hazard by itself.

Biopsy↗

PubMed1989

Stage-shift cancer screening model.

A stage-shift cancer screening model is developed in the context of a randomized controlled trial (RCT) of cancer screening. In the model, detection by screening causes the time of diagnosis of the cancer to be advanced so that either the stage at diagnosis is shifted from one stage to the next lower one or the stage of diagnosis is unchanged but the cancer is diagnosed earlier in the stage. These are called external and internal stage shifts, respectively. At each stage the extent of the external and internal shifts and any associated mortality benefits are estimated. Further, the model allows the interrelationships of these benefits within and between stages to be delineated. This then allows us to better understand the results of the RCT. Data from a completed breast cancer screening RCT are used to illustrate the application of the model and its value in improving our understanding of the trial's results.

Adult↗

PubMed2005

Enteral nutritional support in prevention and treatment of pressure ulcers: a systematic review and meta-analysis.

BACKGROUND: There have been few systematic reviews and no meta-analyses of the clinical benefits of nutritional support in patients with, or at risk of developing, pressure ulcers. Therefore, this systematic review and meta-analysis was undertaken to address the impact of enteral nutritional support on pressure ulcer incidence and healing and a range of other clinically relevant outcome measures in this group. METHODS: Fifteen studies (including eight randomised controlled trials (RCTs)) of oral nutritional supplements (ONS) or enteral tube feeding (ETF), identified using electronic databases (including Pub Med and Cochrane) and bibliography searches, were included in the systematic review. Outcomes including pressure ulcer incidence, pressure ulcer healing, quality of life, complications, mortality, anthropometry and dietary intake were recorded, with the aim of comparing nutritional support versus routine care (e.g. usual diet and pressure ulcer care) and nutritional formulas of different composition. Of these 15 studies, 5 RCTs comparing ONS (4 RCTs) and ETF (1 RCT) with routine care could be included in a meta-analysis of pressure ulcer incidence. RESULTS: Meta-analysis showed that ONS (250-500 kcal, 2-26 weeks) were associated with a significantly lower incidence of pressure ulcer development in at-risk patients compared to routine care (odds ratio 0.75, 95% CI 0.62-0.89, 4 RCTs, n=1224, elderly, post-surgical, chronically hospitalised patients). Similar results were obtained when a combined meta-analysis of ONS (4 RCT) and ETF (1 RCT) trials was performed (OR 0.74, 95% CI 0.62-0.88, 5 RCTs, n=1325). Individual studies showed a trend towards improved healing of existing pressure ulcers with disease-specific (including high protein) versus standard formulas, although robust RCTs are required to confirm this. Although some studies indicate that total nutritional intake is improved, data on other outcome measures (quality of life) are lacking. CONCLUSIONS: This systematic review shows enteral nutritional support, particularly high protein ONS, can significantly reduce the risk of developing pressure ulcers (by 25%). Although studies suggest ONS and ETF may improve healing of PU, further research to confirm this trend is required.

Aged↗

PubMed2005

Size of treatment effects and their importance to clinical research and practice.

In randomized clinical trails (RCTs), effect sizes seen in earlier studies guide both the choice of the effect size that sets the appropriate threshold of clinical significance and the rationale to believe that the true effect size is above that threshold worth pursuing in an RCT. That threshold is used to determine the necessary sample size for the proposed RCT. Once the RCT is done, the data generated are used to estimate the true effect size and its confidence interval. Clinical significance is assessed by comparing the true effect size to the threshold effect size. In subsequent meta-analysis, this effect size is combined with others, ultimately to determine whether treatment (T) is clinically significantly better than control (C). Thus, effect sizes play an important role both in designing RCTs and in interpreting their results; but specifically which effect size? We review the principles of statistical significance, power, and meta-analysis, and commonly used effect sizes. The commonly used effect sizes are limited in conveying clinical significance. We recommend three equivalent effect sizes: number needed to treat, area under the receiver operating characteristic curve comparing T and C responses, and success rate difference, chosen specifically to convey clinical significance.

Area Under Curve↗

PubMed2005

Factors associated with patients' loss to follow-up after finishing randomized clinical trial participation.

OBJECTIVES: To study patient's follow-up after finishing participation in randomized clinical trials (RCTs), and to identify factors associated with loss to follow-up (FU). PATIENTS AND METHODS: Medical charts of 212 rheumatoid arthritis (RA) and osteoarthritis (OA) patients from a rheumatological out-patient center were analyzed. Loss to FU was considered when patients did not return to their regular appointments within the first year after finishing their participation in an RCT assessing anti-cyclooxygenase-2 non-steroidal anti-inflammatory drugs (anti-COX-2 NSAIDs). Mann-Whitney U-test, chi2 test and Wilcoxon test were performed as appropriate. Logistic regression was performed to identify factors which might be related to loss to FU. A survey was conducted to obtain lost to FU patients' opinions. p values less than 0.05 were considered significant. RESULTS: The mean frequency of patients' visits in the year before enrollment in an RCT was 3.73 SD 2.06, and during the year after participation was 2.6 SD 1.96 (p<0.0001). Fifty patients (23.6%) did not return to their usual rheumatologic visit. On multivariate analysis, the number of daily tablets of study medication (odds ratio (OR)=2.64, 95% confidence interval (CI) 1.1 to 6.3) and the frequency of clinical visits (OR=0.56, 95% CI 0.37 to 0.85) were associated with loss to FU (p<0.008). Lost to FU patients' opinions did not support these findings. CONCLUSIONS: After participating in a RCT assessing anti-COX-2 NSAIDs, many patients return with less frequency, or do not return at all to their regular rheumatologic visit. Although a high number of tablets of the investigational drug and a low frequency of protocol visits may be contributors to patient loss to FU, investigators should consider that personal situations not related to the RCTs may also influence patients' return to consultation in the private setting.

Arthritis, Rheumatoid↗

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↗