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PubMed1983

UCLA hospice evaluation study. Methodology and instrumentation.

An unbiased evaluation of hospice effectiveness requires a randomized controlled trial (RCT), but the implementation of such a design is difficult. This paper describes the methods of the only RCT to date and reports on the validity and reliability of scales selected or developed to assess attainment of hospice goals. The patients involved are those in a VA hospital in Los Angeles who have cancer and a prognosis of about 6 months and who consent. They and their significant others are interviewed periodically until the patient's death to measure such hospice variables as pain, depression, anxiety, satisfaction with care and the environment, activities of daily living, and bereavement effects. Many of the scales, including McGill Pain, CES-D Depression, and Satisfaction with Care scales, have been validated in other studies with similar samples. The authors' test-retest reliability analyses show that these scales are reliable with advanced cancer patients and their significant others with coefficients ranging from 0.77 to 0.97.

California↗
PubMedDate not supplied

The Consolidated Standards of Reporting Trials (CONSORT): Guidelines for reporting randomized trials.

BACKGROUND: The rules for reporting the results of randomized controlled trials (RCTs) in published manuscripts have been elusive, and many nurse scientists have learned to write research reports by trial and error. APPROACH: New comprehensive guidelines for reporting RCTs are now available to authors, editors, and readers, a development that is likely to improve the quality of published reports. The Consolidated Standards of Reporting Trials (CONSORT) guidelines consist of two parts, a 22-item checklist and a flowchart template, that track the flow of all participants through the RCT. Currently, some journals, including Nursing Research, have adopted CONSORT and suggest or require its use in submitted manuscripts, but other journals do not. RESULTS: The CONSORT has potential to be useful beyond writing manuscripts. Because CONSORT is a comprehensive guide to essential elements of an RCT report, it also provides a useful guide for designing RCTs and writing funding proposals that include all the essential elements of a trial. It also could be a useful synopsis of important concepts when teaching research design to doctoral students. DISCUSSION: Reports of RCTs that use CONSORT are easier to read, interpret, and evaluate for relevancy to clinical practice. In addition, excellent reports of research increase the visibility of nursing research beyond our discipline. The CONSORT adds value to nursing research because researchers and readers alike will benefit if it is used more often.

Nursing Research↗
PubMedDate not supplied

Quantifying smoking cessation outcomes: from The Women's Initiative for Nonsmoking Study (X): methodological implications.

BACKGROUND: Classification of smoking status has a major impact on the conclusions drawn from smoking cessation intervention research, yet few studies have addressed this critical issue. OBJECTIVES: The aim of this study was to compare three classifications (naïve, optimistic, and pessimistic) of smoking cessation outcomes or smoking status from the Women's Initiative for Nonsmoking Study (WINS). METHODS: This is a longitudinal prospective study nested within a randomized clinical trial (RCT) design of WINS, an RCT of 277 women over the age of 18 years who reported smoking cigarettes continuously for 1 month prior to a cardiovascular event requiring hospital admission. Women were randomized to either the usual care group (UC) or the intervention group (IG). Recruitment for WINS occurred between October 1996 and December 1998 in 10 hospitals in the San Francisco Bay area. Follow-up data on smoking status was obtained from the UC and the IG using a structured telephone interview at 6 and 12 months from baseline and was confirmed by family members and salivary cotinine levels. RESULTS: Seven-day point prevalence(self-report of not smoking in the past 7 days; "not even a puff") using the naïve (the most liberal) classification yields a greater number of nonsmokers than the pessimistic or most conservative classification (cotinine level verification of smoking status). The classification of smoking status also affects time to continuous smoking. The pessimistic classification results in the shortest time to continuous smoking, whereas the opposite is observed with the naïve classification. DISCUSSION: It is important to critically evaluate the underlying assumptions made by study investigators when measuring and reporting smoking status. The classification of smoking status and the selection of analysis, meaning point prevalence versus survival analysis, affect study results and contribute to the variability observed in the research findings of smoking cessation intervention trials and the challenges faced in making appropriate comparisons across studies.

Adult↗
PubMed1999

Teaching telephone management skills to pediatric residents in a pilot program using a standardized patient.

BACKGROUND: Pediatricians spend a significant amount of time on the telephone but receive little formal training in telephone management skills. We found only two previous reports in the literature using a randomized controlled trial (RCT) that documented the effectiveness of a telephone management program for residents. METHODS: The goals of this pilot study were (1) to provide second year pediatric residents (PL-2s) an experimental telephone management educational program, using a standardized patient (SP); (2) to assess the PL-2s' affective skills and ability to address relevant content on a series of simulated telephone calls; and (3) to determine whether feedback to the experimental group would improve their telephone management skills. RESULTS: In this small pilot RCT using an SP intervention, no improvement was found in PL-2s' short-term or long-term telephone management skills. CONCLUSION: Further studies involving larger number of residents and revised study design are needed in planning effective approaches to teaching these important skills to pediatric residents in our training program.

Data Collection↗
PubMed2001

A randomized controlled trial to prevent patient lift and transfer injuries of health care workers.

STUDY DESIGN: Randomized controlled trial (RCT). OBJECTIVES: To compare the effectiveness of training and equipment to reduce musculoskeletal injuries, increase comfort, and reduce physical demands on staff performing patient lifts and transfers at a large acute care hospital. SUMMARY OF BACKGROUND DATA: Back injury to nursing staff during patient handling tasks is a major issue in health care. The value of mechanical assistive devices in reducing injuries to these workers is unclear. METHODS: This three-armed RCT consisted of a "control arm," a "safe lifting" arm, and a "no strenuous lifting" arm. A medical, surgical, and rehabilitation ward were each randomly assigned to each arm. Both intervention arms received intensive training in back care, patient assessment, and handling techniques. Hence, the "safe lifting" arm used improved patient handling techniques using manual equipment, whereas the "no strenuous lifting" arm aimed to eliminate manual patient handling through use of additional mechanical and other assistive equipment. RESULTS: Frequency of manual patient handling tasks was significantly decreased on the "no strenuous lifting" arm. Self-perceived work fatigue, back and shoulder pain, safety, and frequency and intensity of physical discomfort associated with patient handling tasks were improved on both intervention arms, but staff on the mechanical equipment arm showed greater improvements. Musculoskeletal injury rates were not significantly altered. CONCLUSIONS: The "no strenuous lifting" program, which combined training with assured availability of mechanical and other assistive patient handling equipment, most effectively improved comfort with patient handling, decreased staff fatigue, and decreased physical demands. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators.

Back Injuries↗
PubMedDate not supplied

The one-person randomized controlled trial.

Currently, the gold standard for collection of clinical evidence is the randomized controlled trial (RCT), preferably with large, multicenter samples of subjects. Although this approach provides valuable information, many clinicians find it difficult to translate RCT results to the individual patient level. In this report, a statistical approach called Design of Experiments (DOE) is described as a method of applying the principles of RCTs one person at a time. An overview of the method, with a simple clinical example, is presented. As shown, DOE is a more efficient method than the sequential approach often taken by clinicians and their patients when evaluating various treatment choices. Further, the effect of multiple interventions can be assessed, alone or in combination with each other. In this way, DOE can be an important addition to the field of evidence-based medicine, although further studies are needed.

Data Interpretation, Statistical↗
PubMed2005

Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols.

OBJECTIVE: Applicability of randomized controlled clinical trial (RCT) results to 'real world' situations is dependent on the comparability of trial participants to general patient populations. A full disclosure of criteria employed for trial enrollment is necessary for clinicians to assess generalizability. We sought to assess both the impact on generalizability and the disclosure rate of enrollment criteria for 32 major HIV RCTs in the AIDS Clinical Trial Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) trial networks. DESIGN AND METHODS: Eligibility criteria were compared in complete protocols to criteria listed in publications from these 32 NIH-funded HIV RCTs. We then applied these criteria to the Women's Interagency HIV Study (WIHS), the largest cohort study of HIV-infected women in the US. RESULTS: When applied to WIHS, eligibility criteria from protocols excluded 0-67.6% (median 42%) of WIHS participants (50.6% excluded from ACTG trials). Eligibility criteria in publications excluded 0-62% (median 19.6%) of WIHS (21.2% excluded from ACTG trials). The number of women in WIHS seemingly ineligible for trial participation per enrollment criteria listed in publications averaged only 60% of those actually excluded based on the protocols. CONCLUSIONS: We found that HIV RCT eligibility criteria excluded a large proportion of a representative cohort of HIV-infected women from trial participation. Furthermore, trial publications are not fully reflective of protocols in terms of disclosing eligibility criteria. Standardization and full disclosure of trial methodology will allow clinicians and researchers to more fully assess the generalizability of findings to their patient populations.

Clinical Protocols↗
PubMed2005

Transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) in the management of chronic LBP. SUMMARY OF BACKGROUND DATA: Chronic low back pain (LBP) affects a significant proportion of the population. TENS was introduced more than 30 years ago as an adjunct to pharmacologic pain management. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. METHODS: We searched MEDLINE, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials (Issue 2, 2005), up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. RESULTS: Two RCTs (175 patients) were included. They differed with respect to study design, methodologic quality, inclusion and exclusion criteria, characteristics of TENS application, treatment schedule, cointerventions, and measured outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Preplanned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations, and baseline patient characteristics were not possible because of the small number of included trials. CONCLUSIONS: Evidence for the efficacy of TENS as an isolated intervention in the management of chronic LBP is limited and inconsistent. Larger, multicenter, RCTs are needed to better resolve its role in this condition. Increased attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low back pain.

Chronic Disease↗
PubMed2007

Acupuncture for neck disorders.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the effects of acupuncture for individuals with neck pain. SUMMARY OF BACKGROUND DATA: Neck pain is one of the 3 most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are the perceptions of benefits. METHODS.: We searched CENTRAL (2006, issue 1) and MEDLINE, EMBASE, MANTIS, Cumulative Index to Nursing and Allied Health Literature from their beginning to February 2006. We searched reference lists and the acupuncture database TCMLARS in China. Any published trials using randomized (RCT) or quasi-randomized (quasi-RCT) assignment to the intervention groups, either in full text or abstract form, were included. RESULTS: We found 10 trials that examined acupuncture treatments for chronic neck pain. Overall, methodologic quality had a mean of 2.3 of 5 on the Jadad scale. For chronic mechanical neck disorders, there was moderate evidence that acupuncture was more effective for pain relief than some types of sham controls, measured immediately posttreatment. There was moderate evidence that acupuncture was more effective than inactive, sham treatments measured immediately posttreatment, and at short-term follow-up (pooled standardized mean difference, -0.37; 95% confidence interval, -0.61 to -0.12). There was limited evidence that acupuncture was more effective than massage at short-term follow-up. For chronic neck disorders with radicular symptoms, there was moderate evidence that acupuncture was more effective than a wait-list control at short-term follow-up. CONCLUSIONS: There is moderate evidence that acupuncture relieves pain better than some sham treatments, measured at the end of the treatment. There is moderate evidence that those who received acupuncture reported less pain at short-term follow-up than those on a waiting list. There is also moderate evidence that acupuncture is more effective than inactive treatments for relieving pain posttreatment, and this is maintained at short-term follow-up.

Acupuncture Therapy↗
PubMed2006

Testing effectiveness of a community-based aggression management program for children 7 to 11 years old and their families.

OBJECTIVE: There are few well-evaluated uncomplicated community-based interventions for childhood aggression. The authors assess the impact of a community-based anger management group on child aggressive behaviors, using a randomized, controlled trial (RCT). METHOD: Families with children 7 to 11 years old were recruited through advertisements and randomized (N = 123). Inclusion required parent concern about anger/aggressive behavior, RCT agreement, and a telephone behavior screen. Intervention participants were offered three parent education/skill-building group sessions, 10 weekly child group sessions, and three in-home family practice sessions. Nine groups ran from August 2002 to August 2004. Interviewers naïve to randomization collected data on all participants pre- and postgroup. Outcomes included child-rated anger and parent-rated child aggressive behavior, externalizing behavior and hostility, parent-child relationship, and parenting stress. Intent-to-treat analyses were done. RESULTS: Pre/postoutcome comparisons indicated no significant differences between intervention versus control, with small effect sizes for most outcomes (0.27-0.29). Although not significant, the magnitude of improvement favored intervention families on all parent-rated measures. CONCLUSIONS: Overall, there was no differential impact of participating in a community-based anger management group versus control on child aggressive behaviors and other associated measures. The impact of regression to the mean, effect, and sample size estimates; child comorbidity; and programmatic and methodological issues are discussed.

Aggression↗
PubMed2003

Cost utility analysis of first-line hormonal therapy in advanced breast cancer: comparison of two aromatase inhibitors to tamoxifen.

Recent randomized clinical trials (RCT) comparing anastrozole (Arimidex) and letrozole (Femara) to tamoxifen in the first-line treatment of postmenopausal women with advanced hormone-sensitive breast cancer have demonstrated that both agents were at least as effective as tamoxifen. In addition, one RCT has revealed significant superiority of letrozole to tamoxifen with regard to tumor response rate and time to progression. Based on the efficacy and toxicity data, anastrozole or letrozole may replace tamoxifen. A cost effectiveness analysis was undertaken to determine whether the new agents are economically acceptable alternatives to tamoxifen. In the absence of a randomized three-arm trial, a decision model was developed to simulate and compare the most common therapeutic outcomes. The clinical data were obtained from a meta analysis of modern (i.e., post-1990) randomized trials. Clinical outcomes data from the various trials were statistically pooled using a random effects model to provide point estimates and 95% confidence intervals. Total hospital resource consumption was collected from the charts of 87 patients with advanced disease who had failed tamoxifen therapy. The model suggested a comparable duration of quality-adjusted progression-free survival between letrozole and anastrozole, both being superior to tamoxifen (179 days vs. 172 days vs. 161 days). Letrozole and anastrozole had overall costs of Can2,883 dollars and 2,847 dollars per patient, respectively, which were marginally higher than tamoxifen at Can2,258 dollars per patient. When the costs and benefits were combined, the data generated an incremental cost per quality-adjusted progression-free year of 12,500 dollars and 19,600 dollars for letrozole and anastrozole, respectively, relative to tamoxifen. Letrozole and anastrozole are both economically acceptable alternatives to tamoxifen in the first-line treatment setting. However, when efficacy and cost effectiveness are considered together, letrozole could be preferentially considered.

Anastrozole↗
PubMed2002

A randomized controlled trial of early kangaroo care for preterm infants: effects on temperature, weight, behavior, and acuity.

Kangaroo care (KC) has been the intervention for preterm infants in numerous published studies. However, most well designed studies to date have used a one-group repeated measure design. This methodology is not as definitive as an experimental design. Because of the absence of a comparable control group, change between pretest and posttest may be due to any other environmental variables or normal variation of subjects (Kirk, 1995). This randomized controlled trial (RCT) was done to test the hypotheses that KC infants would have higher mean tympanic temperatures, less weight loss, more optimal behavioral states, and lower acuity (length of stay). Thirty-four eligible mother-infant dyads were randomly assigned to the KC or the control group by computerized minimization on the day following birth. Stratification variables included infant gender, birth weight, delivery method, and parity. KC infants compared to control infants had higher mean tympanic temperature (37.3 degrees C vs. 37.0 degrees C), more quiet sleep (62% vs. 22%), and less crying (2% vs. 6%) all at p=.000. No significant difference was found for weight loss and acuity (length of stay). These findings can be used for evidence-based nursing practice in Taiwan. With the knowledge attained from this RCT, nurses can educate and motivate mothers to keep their stable preterm infants warm by skin-to- skin contact inside their clothing, thereby encouraging self-regulatory feeding.

Adult↗
PubMed2006

Recent randomized controlled trials in pancreaticoduodenectomy.

OBJECTIVES: To analyze and summarize the recent randomized controlled trials (RCTs) investigating pancreaticoduodenectomy (PD). METHODS: A MEDLINE search was performed to identify prospective RCTs on PD published during the last decade. Eligible RCTs were analyzed using the following items: publication year, geographical area, study theme, sample size, and multicenter study. Moreover, the quality of each RCT was evaluated. RESULTS: Thirty-four articles were eligible for review. One to 6 RCTs have been carried out annually during the recent 10 years. Geographically, 15 trials were performed in Europe, 10 trials in North America, and 9 in Asia. Studies concerning postoperative complications in the early postoperative period such as pancreatic fistula and delayed gastric emptying have been most frequent. Randomized controlled trials comparing anastomotic procedures for the remnant pancreas, standard PD versus PD with extended lymphadenectomy, and PD versus pylorus-preserving PD follow in descending order. The average sample size has been 117, and 10 RCTs had sample size less than 50. The rate of multicenter studies among all RCTs is 21%, with the rate in the most recent 5 years having increased 2-fold compared with that in the earlier period. Concerning the quality of RCTs, calculation of sample size was described in only 14 RCTs and intention to treat analysis was performed in 26 RCTs. CONCLUSIONS: This study reviewed 34 RCTs on PD performed all over the world. Although the quality of every RCT was not satisfactory, high-grade evidence obtained by these RCTs should be applied in clinical settings to improve surgical quality and quality of life for each patient.

Evidence-Based Medicine↗
PubMed2006

N-of-1 trials: innovative methods to evaluate complementary and alternative medicines in pediatric cancer.

N-of-1 randomized controlled trials (RCTs) are randomized trials conducted within individuals and may be an attractive methodology for conducting studies of complementary and alternative medicine (CAM) in pediatric oncology. These trials may be used to determine the efficacy of an intervention in an individual, or multiple N-of-1 RCTs may be combined to estimate a population effect. There are many potential advantages to the use of N-of-1 RCTs with CAM in pediatric cancer. These advantages include the ability to determine whether CAM is effective in a specific child. In addition, the N-of-1 RCT allows parents and children to voice preferences about treatment options and allows them to directly participate in balancing adverse events and therapeutic benefits. Also, in estimation of population effects, combining multiple N-of-1 RCTs tends to require smaller sample sizes than do traditional parallel-group designs. However, there also may be several challenges to the conduct of such a trial. The use of N-of-1 RCTs may be very beneficial in evaluating CAM therapies in pediatric cancer. However, careful consideration of the advantages and disadvantages of such a design should be undertaken prior to initiating an N-of-1 RCT.

Child↗
PubMed2006

Modified directly observed therapy to facilitate highly active antiretroviral therapy adherence in Beira, Mozambique. Development and implementation.

As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention's success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants' work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients.

Adult↗
PubMed2001

Partial and random covering times in one dimension.

We study the recently introduced random walk problems of partial covering time (PCT) and random covering time (RCT). We generalize the concept of first-passage time to a given set of m sites by considering the probability of visiting all m sites for the first time on the tth step. For the one-dimensional case we derive an explicit result for the mean time needed to visit m sites for the first time. Using this result we are able to solve the PCT and RCT problems exactly in one dimension.

Journal Article↗
PubMed2005

The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines.

PURPOSE: To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation. DESIGN/METHODOLOGY/APPROACH: Interventional "before-after" study in 51 units (38 surgical and 13 anaesthetic) in nine hospitals participating in a RCT in the greater Copenhagen area; 27 of the units also underwent international accreditation. FINDINGS: The proportion of units with guidelines increased from 24/51 (47 percent) units before to 38/51 (75 percent) units after the trial. Among the 27 units without guidelines before the trial, significantly more accredited units compared to non-accredited units had a guideline after the trial (9/10 (90 percent) compared to 5/17 (29 percent). The quality of the systematic development scale and the clinical scales improved significantly after the trial in both accredited units (both p < 0.001) and in non-accredited units (both p < 0.02). The improvement of the systematic development scale was significantly higher in accredited than in non-accredited units (p < 0.01). ORIGINALITY/VALUE: The combination of conducting both the DIPOM Trial and international accreditation led to a significant improvement of both dissemination and quality of guidelines on perioperative diabetic care.

Accreditation↗
PubMed2002

Update on intrapartum fetal pulse oximetry.

This article examines the current status of fetal pulse oximetry (FPO) as a means of intrapartum assessment of fetal wellbeing. FPO has been developed to a stage where it is a safe and accurate indicator of intrapartum fetal oxygenation. In general, sliding the FPO sensor along the examiner's fingers and through the cervix, to lie alongside the fetal cheek or temple is easy The recent publication of a randomised controlled trial (RCT) of FPO versus conventional intrapartum monitoring has validated its use to reduce caesarean section rates for nonreassuring fetal status. An Australian multicentre RCT is currently underway. Maternal satisfaction rates with FPO are high. FPO may be used during labour when the electronic fetal heart rate trace is nonreassuring or when conventional monitoring is unreliable, such as with fetal arrhythmias. If the fetal oxygen saturation (FSpO2) values are < 30%, prompt obstetric intervention is indicated, such as fetal scalp blood sampling or delivery FSpO2 monitoring should not form the sole basis of intrapartum fetal welfare assessment. Rather, the whole clinical picture should be considered.

Female↗