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PubMedDate not supplied

Equipoise and the ethics of the Canadian Lung Volume Reduction Surgery Trial study: should there be a randomized, controlled trial to evaluate lung volume reduction surgery?

The physical improvement is so great following lung volume reduction surgery that there is growing opinion that a randomized, controlled trial is unnecessary. A randomized, controlled trial, it is argued, would deprive those patients randomly assigned to the nonsurgical treatment arm the 'benefit' of lung volume reduction surgery. Entering a trial in which one arm leads to a surgical intervention and the other to best medical management also poses a variety of ethical difficulties. If one is to be offered surgery, there must be perceived benefit because the physician has an obligation to offer the best possible treatment for his or her patient. If a patient agrees to have surgery, the expectation is that surgery would help. Thus, a patient randomly assigned to the medical arm of a trial may easily believe that he or she is being deprived of surgery that may help them. This paper illustrates this dilemma using the Canadian Lung Volume Reduction Surgery Trial. The authors discuss the concept of 'equipoise' in three dimensions, adding community equipoise to theoretical equipoise and clinical equipoise earlier described by Freedman. The paper concludes that the Canadian Lung Volume Reduction Surgery Trial needs to continue because of the clinical equipoise that drives it.

Attitude of Health Personnel↗
PubMedDate not supplied

Comparison of dietary protein with an oral, branched chain-enriched amino acid supplement in chronic portal-systemic encephalopathy: a randomized controlled trial.

A randomized study was conducted in 37 hospitalized patients at six cooperating hospitals in which protein-intolerant cirrhotic patients were fed increasing amounts of either dietary protein or a branched-chain enriched amino acid solution (BCAA) until they attained an intake of 80 gm protein per day or equivalent or until they developed stage 2 encephalopathy. All patients initially received 20 gm of dietary protein for 1 week, after which 20 gm of protein or BCAA were added weekly. Nitrogen balance improved from negative to positive in all patients in whom it was measured and increased equally in both groups. Seven of the 20 patients in the protein group and 1 of 17 in the BCAA group developed encephalopathy of stage 2 or greater (p less than 0.05). Changes in each component of the portal-systemic encephalopathy syndrome were compared, and differences were statistically significant for mental status grade (p less than 0.01), asterixis (p less than 0.05), Portal-systemic encephalopathy index (p less than 0.01), but insignificant for Number Connection Test, EEG or ammonia. Plasma amino acid profiles showed an increase in BCAA in the study group. Thus, oral BCAA supplements appear to induce positive nitrogen balance to approximately the same degree as an equivalent amount of dietary protein without inducing encephalopathy as frequently.

Adult↗
PubMed2002

Efficacy of continuous versus intermittent morphine administration after major surgery in 0-3-year-old infants; a double-blind randomized controlled trial.

A randomized double-blind clinical trial compared the efficacy of 10 microg/kg/h morphine continuous intravenous infusion (CM) with that of 30 microg/kg morphine (IM) every 3h after major abdominal or thoracic surgery, in 181 infants aged 0-3 years. Efficacy was assessed by the caregiving nurses with the COMFORT 'behavior' and a visual analogue scale (VAS) for pain, every 3h in the first 24h after surgery. Random regression modeling was used to simultaneously estimate the effect of randomized group assignment, actual morphine dose (protocol dosage plus extra morphine when required), age category, surgical stress, and the time-varying covariate mechanical ventilation on COMFORT 'behavior' and the observational VAS rated pain, respectively. Overall, no statistical differences were found between CM and IM morphine administration in reducing postoperative pain. A significant interaction effect of condition with age category showed that the CM assignment was favorable for the oldest age category (1-3 years old). The greatest differences in pain response and actual morphine dose were between neonates and infants aged 1-6 months, with lower pain response in neonates who were on average satisfied with the protocol dosage of 10 microg/kg/h. Surgical stress and mechanical ventilation were not related to postoperative pain or morphine doses, leaving the inter-individual differences in pain response and morphine requirement largely unexplained.

Age Factors↗
PubMed2004

The design of randomized controlled trials of veterinary vaccines.

Randomized controlled trials of veterinary vaccines are essential if we are to have a reasonable understanding of how those vaccines can be expected to perform when used in the field. This manuscript reviews a few (but certainly not all) of the key elements that need to be considered in the design of veterinary vaccine trials. The first step in the design of such a trial is to have a clear statement of the objective of the trial that reflects what is expected of the vaccine (e.g. should it minimize clinical disease or does it need to prevent infection?). Because domestic animals are often managed in groups, the 'unit of concern' used in a vaccine trial becomes of great importance. Whether the trial should be carried out at the individual or group level will depend on the objectives of the trial and the extent of concern about 'group effects' affecting the trial. Sample sizes will also be influenced heavily by the choice of unit of concern and the nature of the primary outcome being assessed. Finally, while there is no easy solution (except to conduct group-level trials, which may be logistically impossible), the potential for group effects to influence the trial outcome must be considered.

Animals↗
PubMedDate not supplied

Treatment of patients with superficial bladder cancer by intravesical instillation of anticancer drugs plus oral chemotherapy following TUR-Bt: a randomized controlled trial.

We conducted a randomized controlled trial to compare local recurrence rate after transurethral resection of superficial bladder cancer treated by either intravesical instillation of an anticancer drug alone (method A) and the intravesical instillation plus oral chemotherapy (doxifluridine, 5'-DFUR, an intermediate metabolite of capecitabine) (method B). Results between groups showed no difference in recurrence-free survival curves in 196 patients subjected to primary analysis. However, patients subjected to secondary analysis (method B, over 3 months administration of 5'-DFUR) showed a significantly better prognosis than method A (p=0.0244, Wilcoxon). Regarding correlation between thymidine phosphorylase (TP, an enzyme to convert 5'-DFUR to 5-fluorouracil) level and prognosis, method A patients showed poorer prognosis in higher TP level cases than in lower TP levels. However, there was no significant difference in prognosis between those with higher and lower TP levels. In method B patients, there was no difference in prognosis between those with higher and lower TP levels. Method A patients tended to show a slightly better prognosis than those with lower TP levels, while method B patients tended to have a slightly better prognosis with higher TP levels, but no significant difference was observed. These findings suggested 5'-DFUR showed a mild efficacy in patients with higher TP levels and that patients with higher TP levels resulted in poorer prognosis.

Administration, Intravesical↗
PubMed2006

Aftertreatment of malleolar fractures following ORIF -- functional compared to protected functional in a vacuum-stabilized orthesis: a randomized controlled trial.

In a monocenter randomized controlled trial, 45 patients with isolated malleolar fracture type OTA/AO 44 A1-B2 undergoing ORIF were allocated randomly to a postoperative treatment either with a vacuum-stabilized orthesis with prescribed full weight bearing after the second week (23 patients) (orthesis group -- OG) or with functional aftertreatment with partial weight bearing of 15 kg for 6 weeks (22 patients) (control group -- CG). Outcomes were compared at 6- and 10-week follow-up examinations. The Olerud and Molander ankle (OMA) score, ankle swelling, usage of crutches, range of motion, Short Form 12, patient-reported visual analogue scales (VAS) (pain, comfort, walking confidence) and time to return to work were evaluated. All patients of OG showed reduced swelling at discharge. The median OMA scores after 6 weeks were 42 and 42.5 (p = 0.46) and after 10 weeks 69 and 72 (p = 0.55) in the OG and CG, respectively. The time to achieve secure walking capacity was reduced by 1 day (p = 0.03) in the OG. After ORIF of simple malleolar fractures, patients with a vacuum-stabilized orthesis can bear full weight 2 weeks postoperatively. This group experienced no adverse events. Postoperative swelling was significantly reduced and of the ability to walk on stairs confidently was shorter as compared to a functional aftertreatment without any external stabilization of the ankle.

Adolescent↗
PubMedDate not supplied

The need for randomized controlled trials in podiatric medical research.

The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research.

Adult↗
PubMed2007

Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. METHODS: Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. RESULTS: Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. CONCLUSIONS: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.

Aged↗
PubMed2006

Routine use of hysterosalpingography prior to laparoscopy in the fertility workup: a multicentre randomized controlled trial.

BACKGROUND: A multicentre randomized controlled trial with or without hysterosalpingography (HSG) was conducted to assess the usefulness of HSG as a routine investigation in the fertility workup prior to laparoscopy and dye. METHODS: From 1 April 1997 to 1 April 2002, subfertile women were allocated by a computer-based 1 : 1 ratio randomization procedure, either for an HSG followed by laparoscopy and dye (the intervention group) of for laparoscopy and dye only (the control group) as a part of their fertility workup. Cumulative pregnancy rate (CPR) within 18 months after randomization was the primary outcome of interest. RESULTS: 344 women were randomized to the intervention group (n = 169) and the control group (n = 175). There was no significant difference in CPR at 18 months in the intervention group (49.1%) [95% confidence interval (CI) 41.6 to 56.6] and the control group (50.3%) (95% CI 42.8 to 57.8), a difference of -1.2% (95% CI -11.8% to 9.5%). CONCLUSION: The routine use of HSG at an early stage in the fertility workup prior to laparoscopy and dye does not influence CPR, compared with the routine use of laparoscopy and dye without HSG.

Adult↗
PubMed2002

Unique methodological issues facing randomized controlled trials of endourologic procedures.

Randomized controlled trials provide the optimal design for evaluating the effectiveness of treatment but have not been widely accepted by surgical investigators. Although there are several methodological and ethical difficulties, none is insurmountable. In the United Kingdom, a regulatory agency has been established to supervise the introduction of new medical procedures, and something similar might be seen in the United States, particularly given the pressure from the government and third-party payors for proof of efficacy and cost effectiveness. Endourologists have responded to similar challenges in the past and must continue to do so.

Cost-Benefit Analysis↗
PubMed2005

Randomized controlled trials in knee surgery.

Randomized controlled trials are complex, require great effort and attention to detail by the investigator, and are expensive. This research methodology is important to allow us to base our decision-making for patients on solid evidence to ultimately improve patient care.

Humans↗
PubMed2006

Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial, prestest-posttest design, with a 3-, 6-, and 12-month follow-up. OBJECTIVES: To investigate the efficacy of a therapeutic exercise approach in a population with chronic low back pain (LBP). BACKGROUND: Therapeutic approaches developed from the Pilates method are becoming increasingly popular; however, there have been no reports on their efficacy. METHODS AND MEASURES: Thirty-nine physically active subjects between 20 and 55 years old with chronic LBP were randomly assigned to 1 of 2 groups. The specific-exercise-training group participated in a 4-week program consisting of training on specialized (Pilates) exercise equipment, while the control group received the usual care, defined as consultation with a physician and other specialists and healthcare professionals, as necessary. Treatment sessions were designed to train the activation of specific muscles thought to stabilize the lumbar-pelvic region. Functional disability outcomes were measured with The Roland Morris Disability Questionnaire (RMQ/RMDQ-HK) and average pain intensity using a 101-point numerical rating scale. RESULTS: There was a significantly lower level of functional disability (P = .023) and average pain intensity (P = .002) in the specific-exercise-training group than in the control group following the treatment intervention period. The posttest adjusted mean in functional disability level in the specific-exercise-training group was 2.0 (95% CI, 1.3 to 2.7) RMQ/RMDQ-HK points compared to a posttest adjusted mean in the control group of 3.2 (95% CI, 2.5 to 4.0) RMQ/RMDQ-HK points. The posttest adjusted mean in pain intensity in the specific-exercise-training group was 18.3 (95% CI, 11.8 to 24.8), as compared to 33.9 (95% CI, 26.9 to 41.0) in the control group. Improved disability scores in the specific-exercise-training group were maintained for up to 12 months following treatment intervention. CONCLUSIONS: The individuals in the specific-exercise-training group reported a significant decrease in LBP and disability, which was maintained over a 12-month follow-up period. Treatment with a modified Pilates-based approach was more efficacious than usual care in a population with chronic, unresolved LBP.

Adult↗
PubMed2007

Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate the effectiveness and cost of usual care plus patient choice of acupuncture, chiropractic, or massage therapy (choice) compared with usual care alone in patients with acute low back pain (LBP). SUMMARY OF BACKGROUND DATA: Few studies have evaluated care models with facilitated access to and financial coverage for adjunctive complementary and alternative medicine therapies. METHODS: A total of 444 patients with acute LBP (<21 days) were recruited from 4 clinical sites and randomized into 2 groups: usual care or choice. Outcomes included symptoms (bothersomeness), functional status (Roland), and satisfaction between baseline and 5 weeks, and cost of medical care in the 12 weeks after randomization. RESULTS: After 5 weeks, providing patients with a choice did not yield clinically important reductions in symptoms (median -4, [interquartile range -7, -2] for usual care, and -5 [-7, -3] for choice; P = 0.002) or improvements in functional status (-8 [-13, -2] for usual care, and -9 [-15, -4] for choice; P = 0.15). Although there was a significantly greater satisfaction with care in the choice group, this came at a net increase in costs of 244 dollars per patient. This consisted of a 99 dollars reduction in the average cost to the insurer for medical care but an additional cost of 343 dollars, for an average of 6.0 complementary and alternative medicine treatments per patient. CONCLUSIONS: A model of care that offered access to a choice of complementary and alternative medicine therapies for acute LBP did not result in clinically significant improvements in symptom relief or functional restoration. This model was associated with greater patient satisfaction but increased total costs. Future evaluations of this choice model should focus on patients with chronic conditions (including chronic back pain) for which conventional medical care is often costly and of limited benefit.

Acupuncture Therapy↗
PubMed2005

Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial.

STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to guideline recommendations. SUMMARY OF BACKGROUND DATA: Guidelines for the management of low back pain in primary care have been developed in various countries, but little is known about the optimal implementation strategy. A multifaceted implementation strategy was developed to overcome identified barriers to the implementation of the Dutch low back pain guideline for general practitioners. METHODS: General practitioners were randomized to an intervention or a control group. The general practitioners in the intervention group (n = 21) received tailored interventions consisting of the Dutch low back pain guideline for general practitioners, a 2-hour educational and clinical practice workshop; two scientific articles on low back pain management; the guideline for occupational physicians; a tool for patient education; and a tool for reaching agreement on low back care with physical, exercise, and manual therapists. The control group (n = 20) received no intervention. The participating general practitioners were asked to recruit consecutive patients with a new episode of low back pain as the main reason for consultation. General practitioners completed registration forms of each individual consultation with regard to the main outcome measures: advice and information, referral to other health-care providers, and prescription of medication. RESULTS: Forty-one of the 67 randomized general practitioners reported on a total of 616 consultations for 531 patients with nonspecific low back pain. The advice and explanation provided by the general practitioners, the prescription of paracetamol or nonsteroidal anti-inflammatory drugs, and prescription of pain medication on atime contingent or a pain contingent basis showed no statistically significant differences between the intervention and control groups. There were also no differences in overall referral rate. However, in follow-up consultations fewer patients were referred to a physical or exercise therapist by the general practitioners in the intervention group than in the control group. CONCLUSIONS: The multifaceted intervention strategy modestly improved implementation (for parts of the recommendations in) the Dutch low back pain guideline by general practitioners and produced small concomitant changes in patient management. The implementation strategy produced fewer referrals to therapists during follow-up consultations.

Adolescent↗
PubMed1989

On randomized controlled trials and lifestyle interventions.

Randomized controlled trials (RCT) are viewed as the ultimate method for evaluation. The author claims that RCT do not enable full evaluation of lifestyle interventions in particular. Lifestyle interventions usually affect several diseases not measured by RCTs and the people who have undergone these interventions also have an impact on the lifestyle in their immediate environment. These potential biases indicate that RCTs underestimate the value of lifestyle interventions.

Bias↗
PubMed1996

Omitting nitrous oxide in general anaesthesia: meta-analysis of intraoperative awareness and postoperative emesis in randomized controlled trials.

We have reviewed randomized controlled trials to assess the effectiveness and safety of anaesthetics which omitted nitrous oxide (N2O) to prevent postoperative nausea and vomiting (PONV). Early and late PONV (6 and 48 h after operation, respectively), and adverse effects were evaluated using the numbers-needed-to-treat (NNT) method. In 24 reports with information on 2478 patients, the mean incidence of early and late vomiting with N2O (control) was 17% and 30%, respectively. Omitting N2O significantly reduced vomiting compared with a N2O regimen; the combined NNT to prevent both early and late vomiting with a N2O-free regimen was about 13 (95% confidence intervals (CI) 9, 30). The magnitude of the effect depended on the incidence of vomiting in controls. In studies with a baseline risk higher than the mean of all reports, the NNT to prevent both early and late vomiting with a N2O-free anaesthetic was 5 (95% CI 4, 10). When the baseline risk was lower than the mean, omitting N2O did not improve outcome. Omitting N2O had no effect on complete control of emesis or nausea. The NNT for intraoperative awareness with a N2O-free anaesthetic was 46 compared with anaesthetics where N2O was used. This clinically important risk of major harm reduces the usefulness of omitting N2O to prevent postoperative emesis.

Anesthesia, General↗
PubMed2026

Effectiveness of Embedded Social Media Content on E-cigarette Attitudes and Behaviors: Results from a Randomized Control Trial.

BACKGROUND: This longitudinal randomized controlled trial examined the effects of anti-vaping social media content on e-cigarette attitudes and intentions among U.S. young adults (ages 18-24; n=3,400). METHODS: Targeted content was embedded directly into participants' social media feeds, with varying levels of impressions. RESULTS: Results indicate that increased exposure to anti-vaping messages significantly elevated perceived risk of harm (&#x3b2;=0.11, 95% CI: 0.03-0.20, p < .01) and social unacceptability of e-cigarette use (&#x3b2;=0.10, 95% CI: 0.03-0.18, p < .01), while decreasing intentions to vape (RRR = 0.59, 95% CI: 0.36-0.97, p < .05). Notably, these attitudinal shifts occurred even with relatively low ad exposure and over an extended intervention period, while controlling for the e-cigarette use status (never, former, or current) of participants. Discussion These findings support the effectiveness of digital media campaigns in influencing health-related behaviors and attitudes among young adults. Specifically, embedding anti e-cigarette content directly in the feed of young adults is shown to be effective in shifting attitudes in a space where these young adults are already engaged. Limitations include limited ad impressions and minimal change in ad awareness recall, suggesting future research should explore longer interventions and broader nicotine product messaging.

Humans↗