A randomized controlled trial comparing quantitative informed consent formats

Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.     

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.     

Brief intervention on maternal smoking: a randomized controlled trial

OBJECTIVES: To determine if mothers receiving a smoking cessation intervention emphasizing health risks of environmental tobacco smoke (ETS) for their children have a higher quit rate than mothers who received routine smoking cessation advice, which focused on their own health, or a control group of mothers. SETTING: Tertiary referral centre. METHODS: Randomized control trial. A total of 363 mothers were randomly assigned to a smoking cessation intervention either aimed at their children's health (n = 111) or their own health (n = 131), or to a control group receiving no smoking cessation advice (n = 121). RESULTS: Provision to mothers of both groups of health risks of tobacco smoke resulted in significantly higher rate of cessation of smoking and smoking location change than those of the control group, with child intervention group having significantly higher rate of cessation of smoking and smoking location change than those of the maternal intervention group (P < 0.05). Post-intervention knowledge scores differed significantly for all groups; however, child intervention group was the only significantly better group than the others (P < 0.05). According to the multivariate analysis results, intervention grouping and presence of smoking friends were independent factors determining smoking cessation (P < 0.05). Intervention grouping, post-intervention knowledge, presence of other household members who smoked and family income were independent factors determining smoking location change (P < 0.05). Family income, intervention grouping and presence of smoking friends were significant independent factors influencing post-intervention knowledge (P < 0.05). CONCLUSION: Discussion during short paediatric visits on effects of smoking on child's or maternal health may result in a significant smoking cessation, smoking location change rate or knowledge change. Those who cannot give up smoking usually change their location of smoking. Provision of information on effects of smoking on child's health, rather than maternal, may result in more significant changes in behaviour or knowledge. Maternal education on smoking should include information on effects of smoking on both child's and maternal health, but should be especially focused on child's health.     

Assessing recall and understanding of informed consent in a contraceptive clinical trial

Recall and understanding of information provided to contraceptive study participants in four sites were assessed. Analysis was completed of data for 70 women who were asked about their recollection of information and understanding of participation. Most women understood the purpose of the study. Their reasons for agreeing to participate varied by site and included wanting to try a new method, wanting to help others, and wishing to avoid pregnancy. Most women recalled correctly the burden of participation—number and frequency of visits, tests, and examinations. Most understood that they could withdraw from the study without jeopardizing their care. The women were also asked to recall the risks and benefits of the contraceptive they were testing. Only 23 percent recalled the pregnancy risk correctly; 40 percent underestimated and 19 percent overestimated it. Few women interpreted rates of risk correctly; some perceived high rates as low ones and the rates of the spermicide being studied as better than those of other contraceptives. This study confirms that risk is better recalled than understood. The participants surveyed remembered the information they were questioned about better than did participants in some other studies, a finding that supports earlier research results showing that younger, healthier patients (such as contraceptive users) recall better than older, less healthy ones.     

Behavioral mediators of colorectal cancer screening in a randomized controlled intervention trial

Background

Understanding mediators for behavioral change is important for the optimization of intervention strategies. This report examines mediators of change in the context of a randomized controlled intervention trial (Los Angeles, 2004-2009) that successfully increased colorectal cancer (CRC) screening among Filipino Americans.

Methods

The intervention, based on the Health Behavior Framework, targeted knowledge/awareness of CRC screening, communication with health care provider, health beliefs, social support and barriers to CRC screening. Health Behavior Framework variables were assessed at baseline and 6-month follow-up (N = 432). Variables targeted for change were tested as potential mediators of the primary outcome, self-reported receipt of CRC screening during the follow-up period, which was previously found to have increased significantly among intervention participants.

Results

Consistent with the Health Behavior Framework, knowledge/awareness of CRC screening and patient-provider communication mediated receipt of screening. Increase in knowledge/awareness of CRC screening accounted for 13% (95% confidence interval 2%-24%) of the total intervention effect size, while patient-provider communication accounted for 20% (5%-36%). Combined, these two variables accounted for 28% (10%-46%) of the total effect size.

Conclusion

Examining the roles of potential mediators in intervention trials may help identify constructs to target in order to enhance the effectiveness of interventions to increase screening.     

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial

ObjectiveTo assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia.MethodsAdults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants’ comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups.FindingsOn day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12–0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13–0.82). There was no significant independent association with educational level. The risk that a participant’s comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16–0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand.ConclusionA multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.     

Worksite intervention effects on physical health: a randomized controlled trial

Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure. Well-designed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors. This randomized controlled trial was conducted at one of Australia's casinos in 2002-2003, to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness. Only 6.4% of the workforce expressed interest in being study participants. Seventy-three employees (aged 32 +/- 8 years, 51% overweight/obese, 73% shift workers and 52% women) were recruited and randomized to treatment or wait-list control groups for 24 weeks, 44 of whom completed the intervention. Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic (at least 20 min duration 3 days/week) and weight-training (for an estimated 30 min completed 2-3 days/week), and dietary/health education (delivered via group seminars, one-on-one counselling and literature through the provision of a worksite manual). ANCOVA, by intention-to-treat and of study completers, found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake (VO2max), favouring the intervention, but effects were concentrated in one subject. For study completers, between-group differences in the mean waist circumference (82.3 +/- 9.2 versus 90.5 +/- 17.8 cm, p = 0.01) and predicted VO2max (47 versus 41 ml/kg/min, p < 0.001) remained significant without the outlier, favouring the intervention. Higher intervention compliance predicted greater improvements in physical fitness. No significant effects on body mass or body mass index were found. This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees, most of whom were shift workers. Worksite interventions have the potential to counter the increasing burden of overweight and obesity, particularly visceral adiposity, as well as physical inactivity; however, substantial barriers to adoption/adherence need to be overcome for greater feasibility and impact on employee physical health.     

Testing a workplace physical activity intervention: a cluster randomized controlled trial

Background  

Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels.     

Reducing occupational psychological distress: a randomized controlled trial of a mailed intervention

There are increasing levels of psychological distress among general practitioners (GPs). The purpose of this study is to evaluate the effectiveness of a mailed intervention to reduce distress among 'at-risk' GPs. A questionnaire was sent to 1356 GPs from eight Divisions of General Practice. Out of 819 (60%) who responded, 233 GPs were recruited with scores indicative of psychological distress. These GPs were randomized to intervention (n = 120) or control (n = 113). The intervention consisted of a simple letter feeding back and interpreting the psychological score together with a self-help sheet. During the study, an educational program was offered to GPs by Divisions of General Practice. The main outcome measure used was changes in psychological distress (General Health Questionnaire 12) score after 3 months. Significance was set at P < 0.05. Initial analysis of the data showed borderline significance (P = 0.05). However, analysis of the data post hoc excluding GPs who participated in the educational program showed a significant reduction in psychological distress (P = 0.03). It appears that there may have been a dilution of the intervention effect. Mailed interventions are a cost-effective way of reaching at-risk GPs and may contribute to a reduction in psychological morbidity.     

A client-centred ADL intervention: three-month follow-up of a randomized controlled trial

Abstract

Objective: The aim was to study a client-centred activities of daily living (ADL) intervention (CADL) compared with the usual ADL intervention (UADL) in people with stroke regarding: independence in ADL, perceived participation, life satisfaction, use of home-help service, and satisfaction with training and, in their significant others, regarding: caregiver burden, life satisfaction, and informal care. Methods: In this multicentre study, 16 rehabilitation units were randomly assigned to deliver CADL or UADL. The occupational therapists who provided the CADL were specifically trained. Eligible for inclusion were people with stroke treated in a stroke unit ≤3 months after stroke, dependent in ≥two ADL, not diagnosed with dementia, and able to understand instructions. Data were collected at inclusion and three months thereafter. To detect a significant difference between the groups in the Stroke Impact Scale (SIS) domain “participation”, 280 participants were required. Intention-to-treat analysis was applied. Results: At three months, there was no difference in the outcomes between the CADL group (n = 129) and the UADL group (n = 151), or their significant others (n = 87/n = 93) except in the SIS domain “emotion” in favour of CADL (p = 0.04). Conclusion: The CADL does not appear to bring about short-term differences in outcomes and longer follow-ups are required.     

An analysis of factors that predict patient consent to take part in a randomized controlled trial

BACKGROUND: Recruitment targets of patients to multi-centre primary care-based randomized controlled trials (RCT) are often not met. A critical step in the pathway is whether an eligible patient will give consent. OBJECTIVE: To assess whether patient, practice or practitioner characteristics are associated with a patient's likelihood of giving consent to participation in a large primary care-based RCT. METHODS: A cross-sectional study of patients from 260 practices in England and Wales who met the eligibility criteria for an RCT of aspirin versus warfarin for stroke prevention and attended an appointment with their GP to consider trial participation. Logistic regression analysis was used to determine which patient and practitioner factors independently predicted whether or not a patient would give consent to take part in the trial. RESULTS: Of the 1740 patients, 973 (55.9%) gave consent. On multivariable analysis, patient factors associated with increased likelihood of giving consent were younger age, current use of warfarin and year of recruitment to the trial. Patients with a history of transient ischaemic attack, angina or valve disease were less likely to give consent. Practice/practitioner factors that were associated with increased likelihood of consent were smaller practice size (practices with greater than eight GPs as compared with those with one to two GPs, odds ratio 0.40, 95% confidence interval 0.21-0.75) and older GPs. CONCLUSIONS: The strong association of consent with year of recruitment may be due to changes in trial procedures and investigator training. If so, this has important implications for the conduct of future trials.     

A school nurse-delivered adolescent smoking cessation intervention: a randomized controlled trial

BACKGROUND: The aim of the present study was to evaluate the efficacy of a school nurse-delivered smoking cessation intervention to improve abstinence rates among adolescents interested in quitting. METHODS: Seventy-one high schools in Massachusetts were randomized to either a four-session one-on-one school nurse-delivered smoking cessation intervention (37 schools, n = 571) or usual smoking cessation care control condition (34 schools, n = 577). Adolescents in grades 9-12 who smoked in the past 30 days completed surveys at baseline, 6 weeks and 3 months. The study was conducted during the 2002-2003 school year. RESULTS: Thirty-day self-reported abstinence rates were significantly greater in students in the intervention compared to control condition at 6 weeks (18% vs. 2%, respectively) and 3 months (24% vs. 5%, respectively). After adjusting for school and potential confounders, students in the intervention schools had odds of quitting 8 times greater than students in the control schools at 6 weeks (OR = 8.4; 95% CI 3.7, 20.6) and 6 times greater at 3 months (OR = 6.4; 95% CI 3.4, 11.4). School nurses delivered intervention with a high degree of fidelity. CONCLUSIONS: A four-session smoking cessation intervention can feasibly be delivered by school nurses and increase self-reported short-term abstinence rates among students interested in quitting smoking.     

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

ABSTRACT: BACKGROUND: Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. METHODS: Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0-6-12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient's nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. DISCUSSION: The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers' education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number: Clinical Trial Registration-URL: www.clinicaltrials.gov. Unique identifier: NCT01360775.     

Community Mothers Programme--seven year follow-up of a randomized controlled trial of non-professional intervention in parenting

BACKGROUND: The Community Mothers Programme aims at using experienced volunteer mothers in disadvantaged areas to give support to first-time parents in rearing their children up to 1 year of age. The programme was evaluated by randomized controlled trial in 1990. METHODS: Seven years later, trial participants were interviewed about child health, nutrition, cognitive stimulation, parenting skills, and maternal self-esteem. The aim of this study was to see whether the demonstrated benefits at 1 year of age of this programme could be sustained at age 8. RESULTS: One-third of the original group (38 intervention, 38 control), were contacted and interviewed. The risk for having an accident requiring a hospital visit was lower in the intervention group: relative risk (RR) 0.59, 95 per cent confidence interval (CI) 0.31-1.11. Intervention children were more likely to visit the library weekly: RR 1.58, 95 per cent CI 1.10-2.26. Intervention mothers were more likely to check homework every night: RR 1.23, 95 per cent CI 1.05-1.43 (p=0.006); and to disagree with the statement 'children should be smacked for persistently bad behaviour': RR 2.11, 95 per cent CI 1.10-4.06. They were more likely to disagree with the statement 'I do not have much to be proud of': RR 1.24, 95 per cent CI 1.04-1.40; and to make a positive statement about motherhood than controls: RR 1.53, 95 per cent CI 1.06-2.20. Subsequent children of intervention mothers were more likely to have completed Haemophilus influenzae b: RR 1.26, 95 per cent CI 1.06-1.51; and polio immunization: RR 1.19, 95 per cent CI 1.02-1.40. CONCLUSIONS: The Community Mothers programme had sustained beneficial effects on parenting skills and maternal self-esteem 7 years later with benefit extending to subsequent children.     

Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia

ObjectiveTo assess the effect of a mobile phone-based intervention (mHealth) on post-abortion contraception use by women in Cambodia.MethodsThe Mobile Technology for Improved Family Planning (MOTIF) study involved women who sought safe abortion services at four Marie Stopes International clinics in Cambodia. We randomly allocated 249 women to a mobile phone-based intervention, which comprised six automated, interactive voice messages with counsellor phone support, as required, whereas 251 women were allocated to a control group receiving standard care. The primary outcome was the self-reported use of an effective contraceptive method, 4 and 12 months after an abortion.FindingsData on effective contraceptive use were available for 431 (86%) participants at 4 months and 328 (66%) at 12 months. Significantly more women in the intervention than the control group reported effective contraception use at 4 months (64% versus 46%, respectively; relative risk, RR: 1.39; 95% confidence interval, CI: 1.17–1.66) but not at 12 months (50% versus 43%, respectively; RR: 1.16; 95% CI: 0.92–1.47). However, significantly more women in the intervention group reported using a long-acting contraceptive method at both follow-up times. There was no significant difference between the groups in repeat pregnancies or abortions at 4 or 12 months.ConclusionAdding a mobile phone-based intervention to abortion care services in Cambodia had a short-term effect on the overall use of any effective contraception, while the use of long-acting contraceptive methods lasted throughout the study period.