PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “list randomization”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,225 records · Page 68Linked to original sources

The effectiveness of self-management training for individuals with HIV/AIDS.

This study tested the effects of a 7-week individual self-management and coping skills training program on various measures of health and well-being of persons with HIV/AIDS. Forty men and women were randomly assigned to the treatment or wait-list control group. Treated participants showed significant posttreatment changes on all four major measures of mood, coping, and health attitudes. Treatment significantly improved coping strategies as measured by the use and effective measures of the Jalowiec Coping Scale and several of its subscales, including decreases in use of emotive, fatalistic, and palliative coping styles. Psychological mood was improved, as measured by the Profile of Moods Total Mood Disturbance (POMS TMD) score and specific subscales of the POMS, which were targeted in the intervention (e.g., Anger). Treated participants also showed significant increases on the Internal subscale of the Health Attribution Test.

Adaptation, Psychological↗

Survey of nursing practice related to decanting intravenous solutions.

A survey instrument was mailed to a stratified random sample of 1000 nurses from the membership list of the American Association of Critical-Care Nurses to determine whether there are generally accepted standards for decanting intravenous (IV) solutions before the addition of medication. Four hundred seventy-eight surveys were returned from 47 states and the District of Columbia. Of those, 475 were usable. Seventy-one percent of the respondents did not decant. Of those who did decant (29%), 79% used a needle and syringe to withdraw a volume equal to that of the medication to be added. The results of this study indicate that no generally accepted standards of practice exist for the preparation of IV solutions. Patients may not, therefore, be receiving the dose prescribed by the physician. Nurses need to develop standards for accurate administration of IV solutions.

Critical Care↗

Inner speech as a retrieval aid for task goals: the effects of cue type and articulatory suppression in the random task cuing paradigm.

Articulatory suppression has been shown to increase switch costs in the list paradigm (e.g., [J. Exp. Psychol.: General 130 (2001) 641, J Memory Language 48 (2003) 148]). The present dual-task study examined whether this effect generalizes to the random task cuing paradigm. Participants performed color or shape judgments according to explicit word cues (COLOR or SHAPE) or less transparent letter cues ( C for the color task and S for the shape task). In the word cue condition, the switch cost was equivalent for the articulatory suppression and the control (no dual-task) conditions, but, in the letter cue condition, the switch cost was significantly greater for the articulatory suppression condition than for the control condition. These results suggest that inner speech may be recruited as a tool for retrieving and activating the relevant task goal when the task cue is not transparent and hence imposes nonnegligible retrieval demand.

Analysis of Variance↗

Testing the validity of the Euroqol and comparing it with the SF-36 health survey questionnaire.

There is an interest in the consequences of deriving a single index measure of health for validity and sensitivity. This paper presents the results of testing a recent example of a general health measure designed to derive a single index, the Euroqol (EQ), and presents a comparison with a new, influential profile measure, the Short Form 36 (SF-36) Health Survey Instrument. The EQ and an anglicised version of the SF-36 health survey, both designed for self-completion, were included in a postal survey of a random sample of 1980 patients from two practice lists in Sheffield, UK. The response rate for the EQ questionnaire was 83%, and the rate of completion over 95%. Evidence was found for the construct validity of the EQ dimension responses and the derived total EQ health score in terms of distinguishing between groups with expected health differences. Considerable agreement was found between EQ responses and the total EQ score, and the UK SF-36 profile scores. There was substantial evidence of EQ being less sensitive at the ceiling (i.e. low levels of perceived ill-health) and throughout the range of health states. A recent restructuring of the EQ, may help overcome some of the problems with the physical dimensions by reducing their skewness.

Activities of Daily Living↗

A behavioral group treatment program for menopausal hot flashes: results of a pilot study.

In the present study, we tested the effectiveness of a cognitive-behavioral group treatment (CBGT) for hot flashes in menopausal women. Treatment was administered over 8, 90 min weekly sessions and consisted of education, relaxation training and cognitive restructuring. Nineteen women meeting STRAW staging criteria for the menopause transition (stages -1 to +1) were randomly assigned to immediate or delayed treatment (wait list) and were asked to monitor their hot flashes and night sweats prospectively. They also completed questionnaires, including the Women's Health Questionnaire and the Menopause Specific Quality of Life Questionnaire to determine psychosocial benefits of treatment. Results suggested that the CBGT was moderately successful in reducing the frequency of total vasomotor symptoms [F (1, 17) = 6.16, p < .01], as measured by daily symptom diaries. While there were arithmetic improvements in psychosocial functioning in this sample, these results were not significant. Despite the limitations of small sample size and possible placebo effect, this pilot study supports the notion that cognitive-behavioral interventions aimed at reducing vasomotor symptoms may be of value for menopausal hot flashes when administered in a small-group format.

Cognitive Behavioral Therapy↗

A randomized trial of yoga for adolescents with irritable bowel syndrome.

BACKGROUND: Adolescents with irritable bowel syndrome (IBS) frequently experience interference with everyday activities. Mind-body approaches such as yoga have been recommended as interventions for patients with IBS. Despite promising results among adult samples, there have been limited studies exploring the efficacy of yoga with pediatric patients. OBJECTIVE: To conduct a preliminary randomized study of yoga as treatment for adolescents with IBS. METHODS: Twenty-five adolescents aged 11 to 18 years with IBS were randomly assigned to either a yoga or wait list control group. Before the intervention, both groups completed questionnaires assessing gastrointestinal symptoms, pain, functional disability, coping, anxiety and depression. The yoga intervention consisted of a 1 h instructional session, demonstration and practice, followed by four weeks of daily home practice guided by a video. After four weeks, adolescents repeated the baseline questionnaires. The wait list control group then received the yoga intervention and four weeks later completed an additional set of questionnaires. RESULTS: Adolescents in the yoga group reported lower levels of functional disability, less use of emotion-focused avoidance and lower anxiety following the intervention than adolescents in the control group. When the pre- and postintervention data for the two groups were combined, adolescents had significantly lower scores for gastrointestinal symptoms and emotion-focused avoidance following the yoga intervention. Adolescents found the yoga to be helpful and indicated they would continue to use it to manage their IBS. CONCLUSIONS: Yoga holds promise as an intervention for adolescents with IBS.

Adolescent↗

Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit.

BACKGROUND: The need for sedation for neonates undergoing uncomfortable procedures in the neonatal intensive care unit (NICU) has often been overlooked. Proper sedation may reduce stress and avoid complications during procedures such as mechanical ventilation. Midazolam is a short acting benzodiazepine that has been increasingly used in the NICU. However, the effectiveness of intravenous midazolam as a sedative in neonates has not been systematically evaluated. OBJECTIVES: To determine whether intravenous midazolam infusion is an effective sedative, as evaluated by behavioural and/or physiologic measurements, for critically ill neonates undergoing intensive care, and to assess clinically significant short and long term adverse effects associated with its use. SEARCH STRATEGY: Literature search according to the Cochrane Neonatal Collaborative Review Group search strategy. Randomized and quasi-randomized controlled trials of intravenous midazolam use in neonates were identified by searching MEDLINE, EMBASE, the Cochrane Controlled Trials Register, reference lists of published studies, personal files, and abstracts published in Pediatric Research from 1990-1999. SELECTION CRITERIA: Randomized controlled trials of intravenous midazolam infusion in infants </= 28 days of age for sedation during mechanical ventilation or radiologic investigations were selected for review. Studies on midazolam use as an anesthetic or an anticonvulsant were excluded. Studies involving neonates and older infants and children were excluded if data for neonates could not be extracted. DATA COLLECTION AND ANALYSIS: Data regarding the primary outcome of level of sedation (as evaluated by behavioural scales or physiologic parameters) were abstracted. Secondary outcomes including intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), death within 28 days of age, adverse effects associated with midazolam (hemodynamic and neurologic), days of ventilation, days of supplemental oxygen use, pneumothorax, length of NICU stay, and long term neurodevelopmental outcome were assessed. When appropriate, meta-analyses were performed using relative risk (RR), risk difference (RD), along with their 95% confidence intervals (95% CI) for categorical variables and weighted mean difference (WMD) for continuous variables. MAIN RESULTS: Two trials were eligible for inclusion in the review. Data on level of sedation from the two trials could not be combined because of differences in tools used to measure sedation levels. One study (Jacqz-Aigrain 1994) showed statistically a significant higher level of sedation in the midazolam group compared to the placebo group. The other study (Anand 1999) comparing midazolam to morphine and placebo found no statistically significant difference in sedation level among the three groups, but statistically significantly higher level of sedation was found in the midazolam group compared with the placebo group during the treatment infusion. However, since the sedation scales used in both studies have not been validated in preterm infants, the effectiveness of midazolam as a sedative in this population could not be ascertained based on the findings of these two studies. In the study by Jacqz-Aigrain (1994), blood pressures were statistically significantly lower in the midazolam group than in the placebo group on days 1 and 2, although there was no statistically significant difference in the incidence of hypotension requiring albumin or vasoactive drugs between groups. The study by Anand (1999) showed a statistically significant higher incidence of adverse neurologic events (death, grade III-IV IVH, PVL) in the midazolam group compared with the other groups. In addition, the midazolam group had a statistically significantly longer duration of NICU stay compared to the placebo group (WMD 5.4 days, 95%CI 0.4, 10.5). (ABSTRACT TRUNCATED)

Humans↗

The effect of systemic metronidazole after non-surgical treatment in moderate and advanced periodontitis in young adults.

The effect of adjunctive systemic metronidazole was studied in patients with moderate and advanced periodontitis recalcitrant to comprehensive non-surgical treatment. The material originated from a randomly selected part of the population aged 31 to 40 years. After non-surgical treatment of 149 patients, 98 with persisting pathological pockets greater than or equal to 5 mm (52 men and 46 women) became the subjects for the study. Clinical parameters were registered and pocket contents subjected to laboratory analysis. The subjects were randomized into two groups according to a code list known only by the manufacturer and the statistician. The test group took three 400 mg metronidazole tablets daily for 1 week and the control group took placebo tablets. Reassessment 6 months later showed statistically significant clinical improvement, with a reduction in the number of sites greater than or equal to 5 mm in both test and control groups. Complete healing, with no pockets greater than or equal to 5 mm, was noted in 30% of the test group and 9% of the control group. The difference is statistically significant and shows the supplementary effect of adjunctive metronidazole in non-surgical treatment of moderate and advanced periodontitis.

Adult↗

Untreated short-term course of major depression: a meta-analysis of outcomes from studies using wait-list control groups.

INTRODUCTION: While the short-term response rates to antidepressant medication and placebo are well established, very little is known about the short-term course of untreated depression. Knowledge of the course of untreated depression can serve as a benchmark for assessing the true benefits of active treatment. METHOD: A meta-analysis was performed analyzing the outcomes of all psychotherapy studies that randomized adult outpatients with major depressive disorder to a wait-list control group. RESULTS: Nineteen studies involving 221 subjects were reviewed. The mean decrease in Hamilton Rating Scale for Depression scores over 2-20 weeks was 11.9%, while the mean decrease in Beck Depression Inventory scores was 15.7%. Using a subsample of studies that reported individual outcomes, we estimated that 15 of 76 subjects (19.7%) improved to a degree comparable to what would be considered a positive response in antidepressant trials. CONCLUSIONS: In the short-term, depressive symptomatology can be expected to decrease by about 10-15% on average without treatment. As many as 20% of subjects who participate in a short-term antidepressant trial may experience a spontaneous remission.

Adult↗

Efficacy of citalopram in anorexia nervosa: a pilot study.

INTRODUCTION: Anorexia nervosa (AN) still lacks a defined treatment. Since fluoxetine proved effective in weight-restored anorexics, this pilot study evaluates the efficacy of another SSRI, citalopram, in restricting-type AN. EXPERIMENTAL PROCEDURES: Fifty-two female anorectic outpatients were randomized in the citalopram (n=26) and waiting list (n=26) as a control group. Efficacy was assessed using Eating Disorder Inventory-2, Eating Disorder Inventory-Symptom Checklist, State-Trait Anger Expression Inventory, Beck Depression Inventory, Symptom Checklist-90 and Structured Clinical Interview for DSM-IV Axis II Disorders. RESULTS: Thirteen patients dropped-out, thus 19 patients received citalopram and 20 remained in the control group. After 3 months of treatment, the citalopram group showed a decrease on BDI and SCL-90 Depression subscale and an improvement of baseline obsessive compulsive features on SCL-90, EDI-2 impulsiveness and Trait-anger on STAXI. Weight gain was similar in the two groups. DISCUSSION: These preliminary results support the efficacy of citalopram in anorectics. Citalopram seems to improve depression, obsessive-compulsive symptoms, impulsiveness and Trait-anger.

Adolescent↗

Drug information sources used by community pharmacists in Louisiana: a preliminary study.

OBJECTIVE: There is a paucity of information in the literature regarding the type of reference sources that are used by community pharmacists to answer drug information questions. This survey was conducted to determine the frequency of use of selected drug information references by independent and chain pharmacists in Louisiana. DESIGN: A study population of 15% of registered pharmacists was obtained by random stratification of all pharmacists on the mailing list of the Louisiana Board of Pharmacy on the basis of zip code and gender. These pharmacists were mailed an uncoded, pretested questionnaire and were asked to complete and return it if they were employed by an independent or chain pharmacy; nonchain and independent pharmacists were asked to return their questionnaires uncompleted. No follow-up was performed. PARTICIPANTS: Ninety-one independent pharmacists (mean age=45 y; mean years of experience=21) and 71 chain pharmacists (mean age=40 y; mean years of experience=16). OUTCOME MEASURES: The frequency of use of selected drug information reference sources by independent and chain pharmacists and the type of drug information questions received by pharmacists were determined. A Statistical Analysis System software program was used to analyze the data. Spearman's rank test was used to determine statistical differences between independent and chain pharmacists. The a priori level of significance was p less than or equal to 0.05. RESULTS: A 54% response rate was obtained.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

Factors that influence cancer patients' anxiety following a medical consultation: impact of a communication skills training programme for physicians.

BACKGROUND: No study has yet assessed the impact of physicians' skills acquisition after a communication skills training programme on the evolution of patients' anxiety following a medical consultation. This study aimed to compare the impact, on patients' anxiety, of a basic communication skills training programme (BT) and the same programme consolidated by consolidation workshops (CW), and to investigate physicians' communication variables associated with patients' anxiety. PATIENTS AND METHODS: Physicians, after attending the BT, were randomly assigned to CW or to a waiting list. The control group was not a non-intervention group. Consultations with a cancer patient were recorded. Patients' anxiety was assessed with the State Trait Anxiety Inventory before and after a consultation. Communication skills were analysed according to the Cancer Research Campaign Workshop Evaluation Manual. RESULTS: No statistically significant change over time and between groups was observed. Mixed-effects modelling showed that a decrease in patients' anxiety was linked with screening questions (P = 0.045), physicians' satisfaction about support given (P = 0.004) and with patients' distress (P < 0.001). An increase in anxiety was linked with breaking bad news (P = 0.050) and with supportive skills (P = 0.013). No impact of the training programme was observed. CONCLUSIONS: This study shows the influence of some communication skills on the evolution of patients' anxiety. Physicians should be aware of these influences.

Adult↗

Applicability and clinical relevance of results in randomized controlled trials: the Cochrane review on exercise therapy for low back pain as an example.

STUDY DESIGN: A critical appraisal of the literature. OBJECTIVES: To increase awareness of the importance of applicability and clinical relevance of the results of randomized controlled trials (RCTs) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs. SUMMARY OF BACKGROUND DATA: In systematic reviews of randomized controlled trials (RCTs), critical appraisal of methodologic quality is considered important. Less attention has been paid to the assessment of the applicability and the clinical relevance of the results. METHODS: RCTs in an update of the Cochrane review on exercise therapy for low back pain were used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients: intervention and setting, outcome, effect size, and benefits related to adverse effects. Item 1 was met by 88% of the trials, but item 2 only by 51%, item 3 by 67%, item 4 by 35%, and item 5 by 0%. Subsequently, a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed. These criteria were pilot tested on the RCTs. After pilot testing and a subsequent consensus meeting, the list of items was drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments. RESULTS: The final list consists of 40 items. The items are ordered on two headings: Does the report enable the assessment of applicability? Are the study results clinically relevant? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed. CONCLUSIONS: Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. The presented list of items may help clinicians reading RCTs and authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance of results.

Humans↗

How to report and monitor the performance of waiting list management.

OBJECTIVES: Potential problems concerning waiting list management are often monitored using mean waiting times based on empirical samples. However, the appropriateness of mean waiting time as an indicator of access can be questioned if a waiting list is not managed well, e.g., if the queue discipline is violated. This study was performed to find out about the queue discipline in waiting lists for elective surgery to reveal potential discrepancies in waiting list management. METHODS: There were 1,774 waiting list patients for hallux valgus or varicose vein surgery or sterilization. The waiting time distributions of patients receiving surgery and of patients still waiting for an operation are presented in column charts. The charts are compared with two model charts. One model chart presents a high queue discipline (first in-first out) and another a poor queue discipline (random) queue. RESULTS: There were significant differences in waiting list management across hospitals and patient categories. Examples of a poor queue discipline were found in queues for hallux valgus and varicose vein operations. CONCLUSIONS: A routine waiting list reporting should be used to guarantee the quality of waiting list management and to pinpoint potential problems in access. It is important to monitor not only the number of patients in the waiting list but also the queue discipline and the balance between demand and supply of surgical services. The purpose for this type of reporting is to ensure that the priority setting made at health policy level also works in practise.

Censuses↗

Pre-incision infiltration of local anesthetic reduces postoperative pain with no effects on bruising and wound cosmesis after thyroid surgery.

Optimizing postoperative pain control is an important aspect in perioperative patient care. The aim of this study was to investigate the efficacy of preincision local anesthetic infiltration in postoperative pain management for thyroid surgery and its relationship to bruising and wound cosmesis. In a randomized single-blinded study, 39 consecutive patients listed for thyroid surgery were assigned into two groups. Group I (n = 19) received subcuticular preincision infiltration with 10 ml of bupivacaine (0.5%) and Group II (n = 20) received no infiltration. Postoperatively, the pain experienced was evaluated by two methods: verbal response scores and linear analogue scores (0-100 mm) at different time intervals following surgery. Bruising and cosmetic effects resulting from surgery were assessed using a linear analogue score at discharge. The two groups were well matched for confounding variables. Pain scores were significantly different at 6 hours post operatively (p = 0.0341) with mean scores Group I = 33 and Group II = 50, but this difference disappeared at 24 hours. No patients (0%) received IV morphine in Group I compared to 5 patients (25%) in Group II. There was no significant difference in the mean bruising scores (p = 0.8864) and mean cosmetic scores (p = 0.3339) at discharge. Preincision infiltration with bupivacaine provides easy and better analgesic control postoperatively in patients following thyroid surgery with no effects on bruising or wound cosmesis.

Acetaminophen↗

Behavioural and cognitive-behavioural interventions for outwardly-directed aggressive behaviour in people with learning disabilities.

BACKGROUND: Outwardly directed aggressive behaviour is a significant part of problem behaviours presented by people with learning disabilities. Prevalence rates between 3.3% to 36% have been reported in the literature. Such behaviours run a long term course and are a major cause of social exclusion OBJECTIVES: To determine the efficacy of behavioural and cognitive behavioural interventions for outwardly-directed aggressive behaviour for people with learning disabilities. SEARCH STRATEGY: The Cochrane Library (CENTRAL), MEDLINE, EMBASE, CINAHL, ERIC and PsycINFO were searched using a strategy combining (Learning or synonyms) and (Disabilities or synonyms) and (Behaviour or synonyms) and (treatment or synonyms) to late 2002. Where appropriate, research filters were used. SELECTION CRITERIA: Studies were selected if more than 4 participants, children or adults, were allocated by random or quasi-random methods to either intervention or standard treatment/wait list. DATA COLLECTION AND ANALYSIS: References identified by electronic searches, examinations of bibliography and personal contacts were screened against inclusion criteria by two independent reviewers. MAIN RESULTS: Three studies based on adult populations with learning disabilities were deemed to be suitable for inclusion but data were only available in a form suitable for meta-analysis in two studies. Direct interventions based on cognitive-behavioural methods (modified relaxation, assertiveness training with problem solving, and anger management) appear to have some impact on reduction of aggressive behaviour at the end of treatment but not at follow up (up to six months) as rated by individuals and their carers. REVIEWERS' CONCLUSIONS: The existing evidence on the efficacy of cognitive behavioural and behavioural interventions on outwards directed aggression in children and adults with ID is scant. There is a paucity of methodologically sound clinical trials. Given the impact of such behaviours on the affected individual, his or her carers and on service providers, effective interventions are essential. It is also important to investigate cost efficacy of treatment models against existing treatments. We recommend that randomised controlled trials of sufficient power are carried out using primary outcomes of reduction in outward directed aggression, improvement in quality of life and cost efficacy as measured by standardised scales.

Aggression↗

Does metabolic syndrome mitigate weight loss in overweight Mexican American women treated for 1-year with orlistat and lifestyle modification?

AIMS: To investigate the effects of a pharmacotherapy (orlistat) plus lifestyle management (OLM) intervention on weight loss in Mexican American women with and without metabolic syndrome (MS). METHODS: One hundred and seven female participants aged 21-65 years and of Mexican origin were randomized to either OLM or a wait-list control group (WLC) for one year. The lifestyle interventions were tailored to exhibit features of the Mexican culture. Within each group, subjects with MS were compared to those without MS to assess whether its presence mitigates weight loss. Risk factors for MS also were assessed. RESULTS: Participants with MS in the OLM group experienced significant decreases in weight and body mass index (BMI) as compared to participants without MS. Participants with MS in the OLM group and who completed the study lost 9.3+/-7.5 kg (20.5+/-16.5 lb) as compared to participants with MS in the WLC group, who only lost 0.2+/-3.1 kg (0.4+/-6.8 lb). Further, participants with MS in the OLM group who completed the study experienced a 3.1+/-3.9 kg/m2 decrease in BMI whereas participants with MS in the WLC group only experienced a 0.1+/-1.2 kg/m2 decrease in BMI. No changes in other MS risk factors were significant. CONCLUSIONS: Patients with MS experienced significant weight loss and decreases in BMI as a result of a lifestyle and pharmacotherapy intervention.

Adult↗

"Block the sun, not the fun": evaluation of a skin cancer prevention program for child care centers.

INTRODUCTION: This paper describes the evaluation of a skin cancer prevention program for preschools and daycare centers. The intervention was targeted primarily at staff of child care centers, with the aim of increasing use of sun protection practices for young children while attending these centers. Secondary target groups included parents and the children themselves. The intervention, which adopted the slogan, "Block the Sun, Not the Fun," included workshops for child care center staff, and information/activity packets for parents. METHODS: Twenty-seven preschools and daycare centers were randomly assigned to an intervention or wait-list control group. The intervention group received the intervention during the spring of 1994; the wait-list control group received the intervention during the spring of 1995. Evaluation consisted of interviews with center directors, observations of practices, and review of written policies before the intervention (in summer, 1993) and after the intervention (in summer, 1994). A survey of 201 parents was conducted during late summer 1994. RESULTS: While the intervention did not appear to change the sun protection attitudes or practices of parents, or use of clothing and shade at child care centers, results suggested significant changes in the sun protection knowledge/attitudes of center directors and the use of sunscreen at child care centers. Additionally, parents with children attending centers in the intervention group were more likely to be satisfied with sun protection practices at their centers. CONCLUSION: This low-intensity intervention appears to be effective at changing sun protection attitudes and sunscreen use at child care centers, and can be easily replicated. However, high staff turnover at child care centers would suggest that "boosters" will be necessary to sustain the impact. More intensive efforts directed at social norms are likely to be necessary to change clothing and outdoor play practices.

Adult↗