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PubMed2004

Outcomes and lessons from a pilot RCT of a community-based HIV prevention multi-session group intervention for gay men.

This paper presents the first outcome evaluation of multi-session groupwork for HIV prevention among gay men in the UK. This community-based RCT recruited 50 men, of whom 42% were HIV-positive or untested, and 32% reported status unknown or serodiscordant UAI in the previous 12 months. No knowledge, skills, attitudinal or behavioural differences were detected between intervention and control at baseline. At eight weeks, those attending the group reported significant gains over their control in making sexual choices, physical safety, HIV and STI transmission knowledge, and sexual negotiation skills. At 20 weeks, significant differences remained for HIV and STI transmission knowledge and comfort with sexual choices. Although no behavioural differences were detected, the aims of the National Prevention Strategy were met. This pilot RCT is appraised in the light of modest sample size and attrition, and recommendations for establishing behavioural outcomes are presented. This study has demonstrated that high-risk community samples can be recruited to multi-session interventions, and has provided feasibility data for future rigorous evaluation designs.

Adult↗

PubMed2005

Are randomized controlled trials (RCTs) redundant for testing the efficacy of homeopathy? A critique of RCT methodology based on entanglement theory.

INTRODUCTION: Randomized controlled trials (RCTs) have yet to deliver unequivocal results demonstrating the efficacy (or otherwise) of homeopathic remedies and individualized homeopathic prescribing. This could be caused by an implicit assumption inherent in RCT methodology that specific effects of a remedy and any nonspecific effects of consultation are independent of each other. Reported here is a theoretical investigation of the consequences arising from this assumption proving to be false. METHODS: A previously developed theoretical model of entanglement in homeopathy between patient, practitioner, and remedy (called PPR entanglement) was used in this investigation. RESULTS: The adherence to RCT methodology could result in such trials completely disrupting the formation or survival of any three-way PPR entangled state. CONCLUSIONS: Assuming the PPR entangled state is a necessary condition for therapeutic interaction, alternatives to RCTs are urgently required that can take into account possible entangled specific and nonspecific effects during trials of homeopathy. That RCTs sometimes deliver positive results for the use of homeopathic remedies may be caused by residual entanglement arising from homeopathic remedy manufacture.

Homeopathy↗

PubMed2002

Educational strategies to promote evidence-based community pharmacy practice: a cluster randomized controlled trial (RCT).

BACKGROUND: Community pharmacists have increasing involvement in the self-management of minor illness as a result of the availability of a wider range of over-the-counter (OTC) medicines. We undertook a randomized controlled trial (RCT) to assess the effectiveness and efficiency of educational strategies to implement evidence-based guidelines for the sale of OTC anti-fungals in the community pharmacy setting. OBJECTIVE: The aim of the study was to compare the effectiveness and efficiency of two guideline dissemination strategies in community pharmacy settings. METHODS: A 2 x 2 factorial, cluster RCT was conducted with 60 community pharmacies in the Grampian region of Scotland. The interventions included dissemination of an evidence-based guideline for OTC management of vulvovaginal candidiasis (thrush) by postal dissemination (control), educational outreach visit or attendance at a continuing professional education session. Pre- and post-intervention simulated patient visits were made to participating pharmacies. The simulated patients completed assessment forms following each visit. The primary outcome was the appropriateness (based upon the guidelines) of sale or no sale of OTC anti-fungals. RESULTS: There were no significant differences in the proportion of appropriate outcomes following educational outreach [odds ratio (OR) = 1.1; 95% confidence interval (CI) 0.52 to 2.45] or continuing professional education (OR = 0.88; 95% CI 0.41 to 1.91). CONCLUSIONS: Neither strategy was effective in improving the appropriateness of OTC management of vulvovaginal candidiasis by community pharmacy staff. Further research is needed to identify barriers to guideline implementation and evidence-based practice in this setting.

Antifungal Agents↗

PubMedDate not supplied

Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.

BACKGROUND: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. METHODS: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). RESULTS: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). CONCLUSION: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.

Adolescent↗

PubMed1990

Leukemia inhibitory factor binds with high affinity to preosteoblastic RCT-1 cells and potentiates the retinoic acid induction of alkaline phosphatase.

This study examines the effect of leukemia inhibitory factor (LIF) on preosteoblastic rat calvaria (RCT-1) cells, which acquire osteoblastic properties when treated with retinoic acid (RA). LIF potentiated the increase in alkaline phosphatase (AP) activity produced by RA. The LIF effect was time and dose dependent (EC50, approximately 1 pM). The earliest effects on AP activity were detected at 48 h, and maximal effects were observed after 72 h. RA increased AP mRNA about 2-fold at 3 h and 6-fold at 6 and 12 h. LIF further increased AP mRNA to 18-fold at 12 h. After RA treatment AP mRNA returned to control levels at 24 h, but in the presence of LIF, AP mRNA remained elevated at 24 and 72 h of treatment. When given alone, LIF had no effect on either AP activity or mRNA levels. Tumor necrosis factor-alpha and 1,25-dihydroxyvitamin D3 also potentiated the RA induction of AP, and interleukin-6 had a small effect, whereas granulocyte macrophage colony-stimulating factor had no effect. LIF alone had a small inhibitory effect on type 1 collagen mRNA, but did not oppose the stimulatory effect of RA. Consistent with these biological actions, LIF receptors were demonstrated on these cells. [125I]LIF bound to RCT-1 cells at 0 C with an apparent dissociation constant of 20 pM, and it was found that these cells express an average of 300 receptors/cell. Scatchard analyses showed a single class of high affinity binding site. LIF was internalized with an endocytic rate constant for occupied receptors of 0.03 min-1, and the apparent equilibrium dissociation constant at 37 C was 358 pM. These findings suggest that osteoblast precursor cells are among the target cells of LIF.

Adenylyl Cyclases↗

PubMed2004

An exploration of participants' treatment preferences in a partial RCT.

The partial RCT is a modified design meant to account for participants' treatment preferences. Little is known about the factors that influence such preferences. This study investigated the extent to which participants are willing to be randomized and the factors that affect their treatment preferences. The quantitative and qualitative data collected as part of a partial RCT evaluating 2 behavioural interventions for insomnia were analyzed. Of the participants, 75% were unwilling to be randomly allocated to a treatment group. This figure increased to 90% after information on the 2 interventions was provided. Participants' knowledge of the treatment, its suitability, and their perceived ability to adhere to it influenced their treatment preference. A few participants who had no strong preference and who required treatment were willing to be randomized. The findings raise questions about the impact of treatment preference and allocation procedures on the validity of study conclusions.

Adult↗

PubMed1991

A pyrrhic victory over the RCT?

Where does the moral authority reside to determine what shall be the norms of conduct within a profession? Key documents in nursing, especially "A Social Policy Statement," are analyzed. From this literature it is apparent that nursing is committed to the philosophy that society "owns" the profession. Consequently, moral authority is rooted in the general public. Examining nursing reactions to the registered care technician (RCT) with this philosophy for consistency, we conclude that in this case nursing did not clearly acknowledge the moral authority of society. The public record of the debate suggests that nursing, like medicine, is guilty of a form of paternalism (i.e., nursing is in the best position to decide what is best for society). Nursing needs to evaluate its level of awareness with regard to stated social policy philosophy and the extent to which this philosophy is consciously used to focus discussion about such issues as are raised by the RCT. Most important, if nursing sincerely believes in the moral authority of society, the profession has an obligation to devise creative means of involving society in more direct ways in decision making about health care priorities.

Allied Health Personnel↗

PubMed1987

Inhibition of experimental and spontaneous pulmonary metastasis of murine RCT (+) sarcoma by beta-cyclodextrin-benzaldehyde.

The effect of beta-cyclodextrin-benzaldehyde (CDBA) on pulmonary metastasis in C3H/He mice was examined. In experimental metastasis that was induced by iv injection of 1 X 10(6) RCT (+) cells, the highest inhibition was observed in the mice that were treated daily with CDBA (5 mg/day) for 1 week before tumor cell inoculation and further treated for 3 weeks after inoculation, when compared with those in other experimental groups that were given only pretreatment or posttreatment. The inhibitory effect was dose-dependent. In spontaneous metastasis that was induced by sc injection of 3 X 10(6) RCT (+) cells, the inhibition of metastasis was also observed in the mice treated with CDBA (5 mg/day) in the same manner as described above. However, the development of the primary tumor was not inhibited. CDBA-treated tumor-bearing mice showed almost as much NK activity as normal mice. Furthermore, although injection of 5-fluorouracil suppressed this activity to about 50% of that in normal mice, the combined treatment with CDBA could maintain the NK cell activity at the normal level. The results suggested that the inhibition of pulmonary metastasis might be induced by a combined effect of CDBA; that is, the direct inhibition of tumors and the maintenance of NK cell activity.

Animals↗

PubMed2004

An RCT of early intervention in psychosis: Croydon Outreach and Assertive Support Team (COAST).

BACKGROUND: Despite considerable interest in early intervention in psychosis, the evidence base for its effectiveness is sparse. We aimed to evaluate a new service in South London, UK, Croydon Outreach and Assertive Support Team (COAST) using a randomised controlled trial (RCT) during its first year. METHOD: Referrals were taken from local adult community mental health teams of those with documented first service contact in the last 5 years and a diagnosis of any functional psychosis. Those who consented (N = 59) were randomised to COAST or treatment as usual (TAU). COAST offered a range of interventions, including optimum atypical medication, psychological interventions (individual cognitive behavioural therapy and family intervention if appropriate) and a range of vocational and welfare help according to need. Whole team training was used to be able to offer these kinds of interventions. RESULTS: Outcomes were evaluated at baseline, 6 months and 9 months on a range of standardised clinical and social measures. Overall both COAST and TAU clients improved over time, but there were no significant improvements for COAST clients; a lack of significant results in the time x treatment interaction. There was a trend for COAST carers' quality of life to increase. Bed days were also less in COAST, but not significantly so. CONCLUSIONS: The lack of clearly demonstrated improvements for COAST is consistent with the published literature so far. The fact that both groups improved in symptoms and functioning over the year suggests that while access to early intervention is helpful, community adult mental health teams should aim to offer high quality input at any stage of psychosis in order to meet client and carer needs.

Adult↗

PubMed2005

Bayes' theorem: a negative example of a RCT on grommets in children with glue ear.

Bayesian inference presupposes that practitioners' belief in the effectiveness of medical intervention is the product of prior belief and recent evidence from studies. Although increasingly used, up to now the posterior belief calculated according to the theorem has not been compared with an empirically measured posterior belief. We conducted a RCT, which was preceded by elicitation of prior beliefs among ENT-surgeons, and which was followed by elicitation of posterior beliefs among ENT-surgeons, 1 year after completion of the trial. We compared the posterior beliefs of ENT-surgeons about the effect of grommets in children with glue ears, as predicted by Bayes' theorem with actual measured posterior beliefs. The distribution of the measured posterior beliefs was not in line with the calculated posterior, but almost identical to the distribution of the measured prior beliefs. The results showed that our trial had little or no impact on the beliefs of the ENT-surgeons, i.e. they did not adjust their belief to the extent that was expected according to Bayes' theorem.

Bayes Theorem↗

PubMed2006

The effect of a "training on work readiness" program for workers with musculoskeletal injuries: a randomized control trial (RCT) study.

BACKGROUND: This is a clinical randomized trail (RCT) to investigate the effects of a three-week training program on work readiness designed for musculoskeletal injured workers with long-term sick leave who had difficulties resuming their work role. The program was planned to help injured workers overcome the psychological and psychosocial problems and to facilitate their Work Readiness on Return to Work (RTW) based on the Employment readiness model. METHODOLOGY: A total of 64 injured workers were recruited and randomly assigned into the training (T) and control (C) groups. Observations were blinded between service providers and evaluators. A three-week intensive training on work readiness program was given to the T group while subjects in the C group were given advice on job placement by social workers in a community work health center. The training program was comprised of individual vocational counseling and group therapy using cognitive behavioral approach to alleviate symptoms of stress, pain and anxiety. The Chinese Lam Assessment of Stages of Employment Readiness (C-LASER), the Chinese State Trait and Anxiety Inventory (C-STAI) and the Short form of Health Survey (SF-36) were used to evaluate all subjects' psychological health status and behavioral changes on job readiness before and after the intervention. RESULTS: Subjects in the T group showed significant improvement in their work readiness (p < 0.05), level of anxiety (p < 0.05) and their self perception of health status measured by SF-36 (p < 0.02) when compared with subjects in the C group. Control of chronic pain, negative motivation, and anxiety level were some of the key behavioral changes found from the study. CONCLUSION: The TWR program appeared to improve injured workers' motivation and employment readiness. Further study on the employment outcomes of subjects is recommended.

Adult↗

PubMed1982

A potpourri of RCT topics.

(1. Randomization of the first patient. At least six examples are known to the author, and there are undoubtedly others. (2. Factorially structured treatments. The advantages of conducting two trials in the same patients when there is no suggestion of interaction, and documenting interaction if it exists must be weighed against the potential loss of power and the inconvenience of missing values. (3. RCT control groups as a source of unnatural history. Such a small percentage of apparently suitable patients are actually randomized in most clinical trials that be control group can never the considered representative of that disease seen by practicing physicians. (4. Bias in random and nonrandom treatment assignments. Differences in risk factors documented before randomization can be as much responsible for differences in outcome as the treatments under study. (5. Time lags between innovation, RCTs, and practice. These have varied from a very few years (coronary bypass operations) to 154 years (treatment of scurvy).

Clinical Trials as Topic↗

PubMed1985

A failed RCT to determine the best method of delivery for very low birth weight infants.

An RCT to determine the optimum method of delivery for very low birth weight (VLBW) infants was canceled after it had been in progress for only 5 months when it was discovered that more than 40% of eligible patients were being withdrawn from the trial before randomization. A review of hospital births before the trial began suggested that the trial was held too late: that a critical shift in obstetric practice towards abdominal delivery of VLBW infants had already occurred. Obtaining patient consent to participation, which had been the main predicted problem, was not difficult.

Cesarean Section↗

PubMed2005

Follow-up of abnormal or inadequate cervical smears using two guidance systems: RCT on effectiveness.

BACKGROUND: To improve follow-up compliance after an initial inadequate or abnormal cervical smear, two follow-up guidance systems were tested for effectiveness. A comprehensive system (cytopathology laboratory monitored the follow-up of all abnormal and inadequate smears) was compared to a selective system (monitoring was left to the smear taker; laboratory acted as a safety net). METHODS: In an RCT on all family practices (N = 171) in the catchment areas of two cytopathology laboratories (Nijmegen region, The Netherlands, 1998-2000), practices were allocated at random to one of the follow-up guidance systems. All women included were registered at the practices, invited to the national screening program and had abnormal or inadequate smears. Measurements comprised of (1) follow-up compliance at baseline and 1 year after the initial smear and (2) diagnostic outcome of the follow-up smear. RESULTS: During the study period, 132 practices sent their cervical smears to the laboratories. The comprehensive system covered 1226 women, the selective 1034. In the comprehensive system, the increase in follow-up compliance for initial inadequate and slightly abnormal smears was significantly higher (8.9%) than in the selective one, which implied an extra detection of eleven, more serious, abnormalities per 1000 women. CONCLUSION: The comprehensive system was more effective than the selective and is suitable for use on a larger scale.

Female↗

PubMed2026

Effects of Digital Mental Health Screening Alone and With the Online MINDBODYSTRONG CBT-Based Program on Burnout, Depression, Anxiety, Healthy Behaviors, and Suicidal Ideation in at-Risk Nurses at 3- and 6-Months Post-Intervention: An RCT.

BACKGROUND: Burnout and mental distress among nurses are global public health epidemics that adversely affect nurse well-being and healthcare quality. Evidence-based, scalable mental health interventions are urgently needed. AIMS: To evaluate the 3- and 6-month outcomes of a randomized controlled trial (RCT) comparing a psychologically safe, digital mental health screening and referral program alone versus the same screening and referral program combined with the video-based online MINDBODYSTRONG (MBS) cognitive behavioral therapy (CBT)-based skills-building program among nurses at risk for mental distress. METHODS: 501 nurses were recruited from professional organizations and healthcare systems across the United States by email and randomized to either mental health screening and referral (standard care) or standard care plus the MBS cognitive behavioral skills-building intervention (the intervention). All study activities were conducted remotely. Follow-up surveys administered at 3- and 6-months assessed anxiety, depression, suicidal ideation, burnout, healthy lifestyle beliefs, and healthy lifestyle behaviors using valid and reliable scales. RESULTS: Compared with the screening and referral only group, participants in the intervention group had greater reductions in anxiety and depression and significantly greater increases in healthy lifestyle beliefs and behaviors at 3 and 6 months post-intervention. After controlling baseline risk, the intervention group had a lower risk of suicidal ideation than the screening and referral group at 3 months (relative risk ratio [RRR] = 0.717; 95% CI: 0.320-1.606) and 6 months (RRR = 0.329; 95% CI: 0.101-1.072). The intervention group also had a significantly lower risk of burnout at 6 months (RRR: 0.698, 95% CI: 0.528, 0.929, p = 0.012). Nurses who completed more MBS sessions had less suicidal ideation at 6 months and those who completed more MBS skills-building activities had less burnout at 3 and 6 months. LINKING ACTION TO EVIDENCE: Integrating psychologically safe mental health screening combined with the scalable online CBT-based intervention, MBS, can produce sustained improvements in burnout, mental health symptoms, including suicidality, and healthy lifestyle beliefs and behaviors among nurses experiencing mental distress.

Humans↗

PubMed2005

Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of an RCT [ISRCTN71777817].

BACKGROUND: About half of all newly presented episodes of shoulder complaints (SC) in general practice are reported to last for at least six months. Early interventions aimed at the psychological and social determinants of SC are not common in general practice, although such interventions might prevent the development of chronic SC. The Education and Activation Programme (EAP) consists of an educational part and a time-contingent activation part. The aim of the EAP is to provide patients with the proper cognitions by means of education, and to stimulate adequate behaviour through advice on activities of daily living. DESIGN: The article describes the design of a randomised clinical trial (RCT) to evaluate the effectiveness and cost-effectiveness of an EAP in addition to usual care, compared to usual care only, in the prevention of chronic SC after six months. It also describes the analysis of the cost and effect balance. Patients suffering from SC for less than three months are recruited in general practice and through open recruitment. A trained general practitioner or a trained therapist administers the EAP.Primary outcome measures are patient-perceived recovery, measured by self-assessment on a seven-point scale, and functional limitations in activities of daily living. Questionnaires are used to study baseline measures, prognostic measures, process measures and outcome measures. DISCUSSION: The inclusion of patients in the study lasted until December 31st 2003. Data collection is to end in June 2004.

Activities of Daily Living↗

PubMed2004

A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389].

BACKGROUND: A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus)- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. METHODS: Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples. We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples. RESULTS: We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early. CONCLUSIONS: In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics) with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.

Journal Article↗

PubMedDate not supplied

RCT of a care manager intervention for major depression in primary care: 2-year costs for patients with physical vs psychological complaints.

PURPOSE: Depression care management for primary care patients results in sustained improvement in clinical outcomes with diminishing costs over time. Clinical benefits, however, are concentrated primarily in patients who report to their primary care clinicians psychological rather than exclusively physical symptoms. This study proposes to determine whether the intervention affects outpatient costs differentially when comparing patients who have psychological with patients who have physical complaints. METHODS: We undertook a group-randomized controlled trial (RCT) of depression comparing intervention with usual care in 12 primary care practices. Intervention practices encouraged depressed patients to engage in active treatment, using nurses to provide regularly scheduled care management for 24 months. The study sample included 200 adults beginning a new depression treatment episode where patient presentation style could be identified. Outpatient costs were defined as intervention plus outpatient treatment costs for the 2 years. Cost-offset analysis used general linear mixed models, 2-part models, and bootstrapping to test hypotheses regarding a differential intervention effect by patients' style, and to obtain 95% confidence intervals for costs. RESULTS: Intervention effects on outpatient costs over time differed by patient style (P <.05), resulting in a $980 cost decrease for depressed patients who complain of psychological symptoms and a 1,378 dollars cost increase for depressed patients who complain of physical symptoms only. CONCLUSIONS: Depression intervention for a 2-year period produced observable clinical benefit with decreased outpatient costs for depressed patients who complain of psychological symptoms. It produced limited clinical benefit with increased costs, however, for depressed patients who complain exclusively of physical symptoms, suggesting the need for developing new intervention approaches for this group.

Adult↗