Telemedicine for new neurological outpatients: putting a randomized controlled trial in the context of everyday practice

In a retrospective review, the telemedical management of 65 outpatients from a randomized controlled trial (RCT) of telemedicine for non-urgent referrals to a consultant neurologist was compared with the management of 76 patients seen face to face in the same trial, with that of 150 outpatients seen in the neurology clinics of district general hospitals and with that of 102 neurological outpatients seen by general physicians. Outcome measures were the numbers of investigations and of patient reviews. The telemedicine group did not differ significantly from the 150 patients seen face to face by neurologists in hospital clinics in terms of either the number of investigations or the number of reviews they received. Patients from the RCT seen face to face had significantly fewer investigations but a similar number of reviews to the other 150 patients seen face to face by neurologists (the disparity in the number of investigations may explain the negative result for telemedicine in that RCT). Patients with neurological symptoms assessed by general physicians had significantly more investigations and were reviewed significantly more often than all the other groups. Patients from the RCT seen by telemedicine were not managed significantly differently from those seen face to face by neurologists in hospital clinics but had significantly fewer investigations and follow-ups than those patients managed by general physicians. The results suggest that management of new neurological outpatients by neurologists using telemedicine is similar to that by neurologists using a face-to-face consultation, and is more efficient than management by general physicians.     

Effects of nurse follow-up on emergency room revisits: a randomized controlled trial

The emergency room (ER) is the gatekeeper of the hospital. It receives clients seeking help from the health care system, then refers them for necessary further care or, discharges them back into the community. A 1-year randomized control trial was conducted in an acute general hospital in Hong Kong to see if post-ER nurse follow-up helped to change health outcome and health care utilization. The intervention group received two follow-up calls from an experienced ER nurse, within 1-2 days and 3-5 days after ER discharge. The calls' content and the management options decisions were protocol driven. A total of 795 patients (intervention group=395, control group=400) completed the study. Bivariate analysis shows two significantly different variables between the intervention and control groups, improvement of the condition and ER revisit within 30 days. When other factors are controlled in a multivariate analysis using logistic regression, the effect of the intervention on re-visits to ER within 30 days is reversed. Gender, times of attending general practitioner after ER visits, and not considering other doctors are risks factors related to a higher chance of re-visiting ER within 30 days. Those who have an improved health condition and higher number of times attending general outpatient after ER visits are associated with a lower 30-day ER revisit rate. Nurse telephone follow-ups might have sensitized subjects to health care needs. Some subjects tended to use the ER as a primary care setting and some were doctor-shoppers. A more structured ER transitional model that incoporates nurse telephone follow-up and better interfacing between private and public health care sector, primary and tertiary care might help to decrease inappropriate ER use.     

Social intervention and the elderly: a randomized controlled trial.

A randomized controlled trial was set up in 1985 to test the effect of social intervention over 3 years among elderly people, aged 75 and above, living alone. The sampling frame was the age/sex register of a large group practice of 12 general practitioners serving the town of Melton Mowbray, Leicestershire, England, with a list size of approximately 32,000 patients. A total of 523 elderly people living alone in 1985 were identified, interviewed, and randomized into experimental and control groups. A lay worker offered the experimental group (n = 261) individual packages of support that aimed at enhanced social contacts. The outcome measures, approximately 3 years later in 1988, were mortality; changes in physical status; demand for medical, paramedical, social, and voluntary services; and changes in a number of subjective variables (morale, loneliness, and self-perceived health). No significant differences were found for any of the variables with the exception of self-perceived health status, where the experimental group showed significantly greater improvements than did the control group. More importantly, half the elderly in this sample declined several offers of help.     

Preventing alcohol-exposed pregnancies: a randomized controlled trial

BACKGROUND: Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. DESIGN: A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. SETTING/PARTICIPANTS: A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). INTERVENTIONS: Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. MAIN OUTCOME MEASURES: Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. RESULTS: Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. CONCLUSIONS: A brief motivational intervention can reduce the risk of an AEP.     

Aerobic exercise in the adjunctive treatment of depression: a randomized controlled trial.

Two clinical trials have been conducted in a sample of depressed patients to determine whether the addition of an aerobic exercise programme to their usual treatment improved outcome after 12 weeks. In the first trial, an aerobic exercise group had a superior outcome compared with a control group in terms of trait anxiety and a standard psychiatric interview. A second trial was then conducted to compare an aerobic exercise programme with low intensity exercise. Both groups showed improvement but there were no significant differences between the groups. In neither trial was there any correlation between the extent of change in the subjects' physical fitness due to aerobic exercise and the extent of the improvement of psychiatric scores.     

Nurse-led adherence support in hypertension: a randomized controlled trial

BACKGROUND: Lack of medication adherence is a common reason for poor control of blood pressure in the community, increasing the risk of heart attacks and strokes. OBJECTIVE: To evaluate the effect of nurse-led adherence support for people with uncontrolled high blood pressure compared with usual care. METHODS: We recruited 245 women and men with uncontrolled hypertension (> or = 150/90 mmHg) from 21 general practices in Bristol, UK. Participants were randomized to receive nurse-led adherence support or usual care alone. Main outcome measures were adherence to medication ('timing compliance') and blood pressure. RESULTS: Mean baseline timing compliance (+/- SD) was high in both the intervention (90.8 +/- 15.6%) and the control group (94.5 +/- 7.6%). There was no evidence of an effect of the intervention on timing compliance at follow-up (adjusted difference in means -1.0%; 95% confidence interval (CI) -5.1 to 3.1). There was also no difference at follow-up between the groups with regard to systolic blood pressure (-2.7 mmHg; 95% CI -7.2 to 1.8) or diastolic blood pressure (0.2 mmHg; 95% CI -1.9 to 2.3). Projected costs for the primary care sector per consultation were 6.60 pound sterling for the intervention compared with 5.08 pound sterling for usual care. CONCLUSION: In this study, adherence to blood pressure medication was much higher than previously reported. There was no evidence of an effect of nurse-led adherence support on medication adherence or blood pressure compared with usual care. Nurse-led adherence support was also more expensive from a primary care perspective.     

Web-based tailored nutrition education: results of a randomized controlled trial.

There is ample evidence that printed, computer-tailored nutrition education is a more effective tool for motivating people to change to healthier diets than general nutrition education. New technology is now providing more advanced ways of delivering tailored messages, e.g. via the World Wide Web (WWW). Before disseminating a tailored intervention via the web, it is important to investigate the potential of web-based tailored nutrition education. The present study investigated the immediate impact of web-based computer-tailored nutrition education on personal awareness and intentions related to intake of fat, fruit and vegetables. A randomized controlled trial, with a pre-test-post-test control group design was conducted. Significant differences in awareness and intention to change were found between the intervention and control group at post-test. The tailored intervention was appreciated better, was rated as more personally relevant, and had more subjective impact on opinion and intentions to change than the general nutrition information. Computer literacy had no effect on these ratings. The results indicate that interactive, web-based computer-tailored nutrition education can lead to changes in determinants of behavior. Future research should be aimed at longer-term (behavioral) effects and the practicability of distributing tailored interventions via the WWW.     

Maintenance of internet-based prevention: a randomized controlled trial

OBJECTIVE: Excessive weight or shape concerns and dieting are among the most important and well-established risk factors for the development of symptoms of disordered eating or full-syndrome eating disorders. Prevention programs should therefore target these factors in order to reduce the likelihood of developing an eating disorder. The aims of this study were to determine the short-term and maintenance effects of an internet-based prevention program for eating disorders. METHOD: One hundred female students at two German universities were randomly assigned to either an 8-week intervention or a waiting-list control condition and assessed at preintervention, postintervention, and 3-month follow-up. RESULTS: Compared with the control group, the intervention produced significant and sustained effects for high-risk women. CONCLUSION: Internet-based prevention is effective and can be successfully adapted to a different culture.     

Alcohol and high-density-lipoprotein cholesterol: a randomized controlled trial

1. A randomized controlled trial of cross-over design was set up to examine the effect of alcohol on blood lipids and certain haematological variates relevant to ischaemic heart disease. 2. One hundred subjects drank some alcohol for 4 weeks (mean intake 18.4 g/d) and abstained totally for 4 weeks, the order of these periods being randomized. 3. Alcohol appeared to produce a rise of 7% in serum high-density-lipoprotein (HDL) cholesterol, probably due to a rise in the HDL2 subfraction. 4. No significant change was detected in plasma fibrinogen or the other haematological indices. 5. These results are consistent with the hypothesis that a moderate intake of alcohol confers some protection against heart disease.     

耳穴贴压疗法治疗失眠症的随机对照研究

目的 探讨耳穴贴压疗法及特定穴位治疗失眠症的有效性.方法 选择符合纳入标准的失眠症患者125例,随机分为真穴治疗组63例和伪穴对照组62例.真穴组选取神门、皮质下、心、肾、肝、脾、枕等穴位,伪穴组选上述穴位旁开2～3mm处,疗程1个月.每组治疗前后均采用匹兹堡睡眠质量指数量表(PSQI)评价疗效.结果 (1)两组治疗前后PSQI各因子评分差及总分差均有统计学意义(P＜0.01);(2)两组间治疗后各因子评分及总分的比较显示,两组在睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍和日间功能障碍6项的差异有统计学意义(P＜0.01);两组治疗前后其评分差值的比较也有统计学意义;(3)对两组各因子治疗前后的等级差值进行秩次分析,其差异均有统计学意义(P＜0.01).结论 耳穴贴压疗法近期内能有效改善睡眠质量,缩短入睡时间,延长睡眠时间,提高睡眠效率.     

Neighborhood effects in a behavioral randomized controlled trial

Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation.     

A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study

Background

The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity.

Study Design

We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms.

Results

Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20-1.60; p=.23).

Conclusions

A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies.     

Placebo effects and the common cold: a randomized controlled trial

PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all.METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later.RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, −4.47 to −0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (−97.0, 95% CI, −249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group.CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.