Does a deadline improve men's participation in self-administered health surveys? A randomized controlled trial in general practice

BACKGROUND: Self-administered questionnaires are commonly used in experimental studies to elicit quality of life or other outcomes. Hence, achieving an acceptable level of follow-up from patients is critical to minimizing bias. Many methods for maximizing follow-up remain untested. It is also unclear what level of follow-up is required to prevent bias being introduced. METHODS: We recruited 246 men from general practice surgeries in Sydney, Australia. These 246 men were randomized to receive a covering letter with their follow-up questionnaire either advising of a deadline to reply (Deadline, n = 126) or a standard letter without a deadline (No Deadline, n = 120). Four standardized reminder prompts subsequently were administered. We calculated interim response rates and the final proportion of follow-up questionnaires received according to group. We also compared scores on two main outcomes, namely, knowledge and decisional conflict at each time when reminder prompts were administered. RESULTS: One hundred and twelve (88.9%) men in the Deadline group returned their follow-up questionnaires compared with 102 (85.0%) men in the No Deadline group. This difference was not statistically significant [odds ratio = 1.41, 95% confidence interval (CI) = 0.67-2.99; p = 0.36]. Time to response also was not significantly affected by cover letter received (hazard ratio = 0.96; 95% CI = 0.73-1.25; p = 0.76). Results of the original RCT were similar in terms of direction and effect size at all times irrespective of when reminder prompts were administered. CONCLUSION: The addition of a deadline adds no further impact in improving response rates from male patients compared with an unspecified letter. Despite the accepted wisdom that higher response protects against bias, differences in outcomes were consistent throughout the post-test data collection period.     

Does amoxicillin improve outcomes in patients with purulent rhinorrhea? A pragmatic randomized double-blind controlled trial in family practice

OBJECTIVE: To compare the efficacy of amoxicillin vs placebo in patients with an acute upper respiratory tract infection and purulent rhinorrhea. STUDY DESIGN: Double-blind randomized placebo-controlled trial. POPULATION: The 416 patients included from 69 family practices were 12 years or older, presenting with acute upper respiratory complaints, and having a history of purulent rhinorrhea and no signs of complications of sinusitis. OUTCOMES MEASURED: Therapy success (disappearance of symptoms that most greatly affected the patient's health) at day 10 and duration of general illness, pain, and purulent rhinorrhea. RESULTS: Therapy was successful in 35% of patients with amoxicillin and in 29% of patients with placebo (relative risk [RR] 1.14, 95% confidence interval [CI], 0.92-1.42). There was no effect on duration of general illness or pain. Duration of purulent rhinorrhea was shortened by amoxicillin (9 days vs 14 for clearing of purulent rhinorrhea in 75% of patients; P =.007). Diarrhea was more frequent with amoxicillin (29% vs 19%, RR 1.28, 95% CI, 1.05-1.57). No complications were reported. One patient (0.5%) receiving amoxicillin and 7 (3.4%) receiving placebo discontinued trial therapy because of exacerbation of symptoms (RR 0.25, 95% CI 0.04-1.56, P =.07). All 8 patients recovered with antibiotic therapy. CONCLUSIONS: Amoxicillin has a beneficial effect on purulent rhinorrhea caused by an acute infection of the nose or sinuses but not on general recovery. The practical implication is that all such patients, whatever the suspected diagnosis, can be safely treated with symptomatic therapy and instructed to return if symptoms worsen.     

Does the school fruit and vegetable scheme improve children's diet? A non-randomised controlled trial

OBJECTIVE: Evaluation of the impact on diet of the school fruit and vegetable scheme (SFVS). DESIGN: Non-randomised controlled trial. SETTING: Infant and primary schools in the north of England. PARTICIPANTS: 3,703 children aged four to six years (reception, year 1, and year 2). INTERVENTION: One portion of fruit or vegetable provided per child on each school day between February and December 2004. MAIN OUTCOME MEASURES: Fruit and vegetables consumed and intake of nutrients. RESULTS: The SFVS was associated with an increase in fruit intake across reception and year 1 pupils of 0.4 portions (95% confidence interval, 0.2 to 0.5) and 0.6 portions (0.4 to 0.9), respectively, at three months, which fell to 0.2 (0.1 to 0.4) and 0.3 (0.1 to 0.6) at seven months. In year 2 it was associated with an increase of 0.5 portions (0.2 to 0.7) of fruit at three months, which fell to baseline values at seven months when these children were no longer eligible for the scheme. Overall, at seven months there were no changes in vegetable consumption, no associations between the SFVS and energy, fat, or salt intake, and small changes in carotene and vitamin C intake. CONCLUSIONS: The SFVS promoted an increase in fruit intake after three months. At seven months the effect remained significant but reduced, and it returned to baseline in year 2 when pupils were no longer part of the scheme. There was a small impact on the intake of some nutrients across the children surveyed.     

Does patient feedback improve the consultation skills of general practice trainees? A controlled trial

Medical Education 2010: 44 : 156–164 Context This study aimed to assess if an additional patient feedback training programme leads to better consultation skills in general practice trainees (GPTs) than regular communication skills training, and whether process measurements (intensity of participation in the programme) predict the effect of the intervention. Methods We carried out a controlled trial in which two sub‐cohorts of GPTs were allocated to an intervention group (n = 23) or a control group (n = 30), respectively. In 2006, allocated first‐year GPTs in the VU University Medical Centre attended a patient feedback training programme in addition to the regular communication skills training. The control group attended only regular communication skills training. Trainees were assessed by simulated patients who visited the practices and videotaped the consultations at baseline and after 3 months. The videotapes were randomly assigned to eight trained staff members. The MAAS‐Global Instrument (range 0–6) was used to assess (a change in) trainee consultation skills. Results were analysed using a multi‐level, linear mixed‐model analysis. Results Data on 50 GPTs were available for the follow‐up analysis. Both intervention group and control group GPTs improved their consultation skills: mean MAAS‐Global scores for all participants were 3.29 (standard deviation [SD] 0.75) at baseline and 3.54 (SD 0.66) at follow‐up (P = 0.047). The improvement in MAAS‐Global scores in the intervention group did not differ significantly from the improvement in the control group. The analysis showed a trend for intensity of participation in the patient feedback programme to predict greater improvement in MAAS‐Global scores. Discussion Although the baseline scores were already in the high range, consultation skills in both groups improved significantly. This is reassuring for current teaching methods. The patient feedback programme did not improve consultation skills more than regular communication skills training. However, a subgroup of GPTs who participated intensively in the programme did improve their consultation skills further in comparison with the less motivated subgroup.     

Can a brief video intervention improve breast cancer clinical trial knowledge and beliefs?

A total of 262 women in the USA (161 breast cancer survivors and 101 controls) were exposed to a video vignette using modeling in which a physician discussed the concept of a clinical trial (CT) with a woman who was in the process of making a treatment decision. A pretest-post-test design was used and improvements in clinical trial knowledge and beliefs were assessed. Results indicate that video modeling is a powerful tool for increasing CT knowledge (pretest mean=41.5% correct, post-test mean=77.5% correct) but not for improving CT beliefs. Increased clinical trial knowledge, as measured by change scores, was associated with white race, lower levels of education and pretest breast cancer knowledge, more negative pretest CT beliefs, and a higher estimate of the lifetime probability that a woman will have breast cancer. When pretest CT knowledge was added to the analysis using hierarchical multiple regression, all variables except white race became nonsignificant; an increase in CT knowledge was associated with having lower pretest CT knowledge. Results indicate that the effects of low education, low breast cancer knowledge, and biased probability assessment were mediated through the pretest score. An increase in post-test positive CT beliefs was associated with older age, thinking about breast cancer less often, and having lower pretest CT knowledge in the total sample. When pretest CT beliefs was added to the analysis using hierarchical multiple regression, all other variables became nonsignificant; an increase in CT beliefs was associated with having lower pretest CT beliefs, again indicating mediation of the effects of other variables.     

Does work-site physical activity improve self-reported psychosocial workplace factors and job satisfaction? A randomized controlled intervention study

Purpose

To investigate whether a work-site strength-training program has a positive effect on self-reported psychosocial workplace factors and job satisfaction.

Methods

We conducted a randomized controlled trial among laboratory technicians implementing neck and shoulder exercises for pain relief, with 199 participants in the training group and 228 in the control group. Influence at work, sense of community, time pressure, and job satisfaction were measured with the Copenhagen Psychosocial Questionnaire at baseline and post-intervention after 20 weeks.

Results

There was no statistically significant change in any of the four variables in the training group from baseline to follow-up (all p ≥ 0.39). When we used MANOVA to test for between-group effects over time, we did not find any statistically significant result (all p > 0.14).

Conclusions

This study does not provide evidence for an effect of a work-site strength-training program on self-reported psychosocial workplace factors and job satisfaction.     

Learning with computerized guidelines in general practice?: A randomized controlled trial

BACKGROUND: Evidence-based guidelines are seen as an important instrument to transfer scientifically generated knowledge into daily clinical practice and to ensure high standards of clinical care. Despite wide promulgation, clinical guidelines so far have a limited impact on individual professional learning and on changing daily medical practice. OBJECTIVES: Our aims were (i) to study a potential knowledge increase among German GPs after implementation of web- and evidence-based guidelines and (ii) to identify and analyse potential barriers to individual professional learning with computerized guidelines. METHODS: A prospective, randomized controlled trial was conducted including 72 GPs (21% female, 79% male). The intervention group (n = 38) had access to clinical guidelines via the Internet or CD-ROM, the control group had not (n = 34). Both groups received a standardized two-part questionnaire. An increase of knowledge was measured with 25 multiple choice questions related to four different medical topics. In addition, reasons for using or not using computerized guidelines were analysed after access to guidelines was open to all participating physicians. RESULTS: There was no significant knowledge increase in the intervention group (P = 0.69). Twenty-two (58%) GPs of the intervention group had used the guidelines. Unspecified curiosity (76%) and a specific medical question (38%) were predominant motives for usage among physicians who had used the guidelines. Among 'non-users', 78% stated 'lack of time' as the main reason for not using guidelines. CONCLUSION: An efficient knowledge transfer through computerized guidelines was not achieved. Usage, individual learning and potential implementation depend on adequate incentives and pragmatic aspects of clinical practice: easy and quick access.     

Are distinctive ethical principles required for cluster randomized controlled trials?

Cluster randomized trials are increasingly used in research into health care and health services. Ethics of individual patient randomized trials have been elucidated in a number of different codes, but less attention has been given to the ethical issues raised by cluster randomized trials. I assess the challenges raised by cluster randomized controlled trials by considering three questions: What are the essential elements of ethical medical research, particularly experiments on people? What are the features which distinguish cluster randomized controlled trials from ordinary RCTs? Do the distinctive features of cluster randomized trials entail new ethical principles, or careful application of existing principles? I conclude that cluster randomized controlled trials raise new issues on the nature and practice of informed consent, because of the levels at which consent can be sought, and for which it can be sought. In addition, careful consideration of the principles relating to the quality of the scientific design and analysis, balance of risk and benefit, liberty to leave a trial, early stopping of a trial and the power to exclude people from potential benefits is required.     

Does primary care referral to an exercise programme increase physical activity one year later? A randomized controlled trial

OBJECTIVE: To assess the effectiveness of a primary care referral scheme on increasing physical activity at 1 year from referral. Design Two-group randomized controlled trial recruiting primary care referrals to a borough-based exercise scheme. Setting A local authority borough in the north-west of England. Participants 545 patients defined as sedentary by a primary care practitioner. Intervention Referral to a local-authority exercise referral scheme and written information compared with written information only. Main outcome measures Meeting physical activity target at 12 months following referral, with a secondary outcome measured at 6 months from referral. RESULTS: At 12 months, a non-significant increase of 5 per cent was observed in the intervention compared with control group, for participation in at least 90 minutes of moderate/vigorous activity per week (25.8 versus 20.4 per cent, OR 1.45, 0.84 to 2.50, p = 0.18). At 6 months, a 10 per cent treatment effect was observed which was significant (22.6 versus 13.6 per cent, OR 1.67, 1.08 to 2.60, p = 0.05). The intervention increased satisfaction with information but this did not influence adherence with physical activity. CONCLUSION: Community-based physical activity referral schemes have some impact on reducing sedentary behaviour in the short-term, but which is unlikely to be sustained and lead to benefits in terms of health.     

Can distance learning improve smoking cessation advice in family practice? A randomized trial

INTRODUCTION: Family physicians (FPs) underuse opportunities to provide smoking cessation advice during routine consultations with patients who smoke. Distance learning is a promising approach to continuing medical education, particularly for FPs practicing in rural and remote areas. We developed a distance learning module, conducting a randomized trial to assess its educational impact on knowledge, attitudes and skills ("competence"), self-rated competence, confidence, and readiness to change. METHODS: Volunteer FPs were randomly allocated to receive either a distance learning module or a preventive care guideline. Self-administered questionnaires were completed at baseline and post-test. RESULTS: Fifty-three FPs enrolled in the study. There were no changes in knowledge or attitudes. Change in skills was limited to a reduction in use of one ineffective technique, namely "nicotine fading." Change in self-rated competence between baseline and post-test was significantly greater for the intervention than for the control group, however (p = .03). Although self-ratings of confidence increased significantly between baseline and post-test in both groups, the magnitude of change was no greater in the intervention than the control group (p = .3). Both groups demonstrated only nonsignificant shifts in readiness to change. DISCUSSION: These modest changes are of uncertain educational value, inviting caution before recommending distance learning approaches to promote smoking cessation advice in family practice.     

Are antibiotics beneficial for patients with sinusitis complaints? A randomized double-blind clinical trial

BACKGROUND: Sinusitis is the fifth most common reason for patients to visit primary care physicians, yet clinical outcomes relevant to patients are seldom studied. OBJECTIVE: To determine whether patients with purulent rhinitis, "sinusitis-type symptoms," improved with antibiotics. Second, to examine a clinical prediction rule to provide preliminary validation data. METHODS: Prospective clinical trial, with double-blinded placebo controlled randomization. The setting was a suburb of Washington, DC, from Oct 1, 2001, to March 31, 2003. All participants were 18 years or older, presenting to a family practice clinic with a complaint of sinusitis and with pus in the nasal cavity, facial pressure, or nasal discharge lasting longer than 7 days. The main outcome measures were resolution of symptoms within a 14-day follow-up period and the time to improvement (days). RESULTS: After exclusion criteria, 135 patients were randomized to either placebo (n=68) or amoxicillin (n=67) for 10 days. Intention-to-treat analyses showed that 32 (48%) of the amoxicillin group vs 25 (37%) of the placebo group (P=.26) showed complete improvement by the end of the 2-week follow-up period (relative risk=1.3; 95% confidence interval [CI], 0.87-1.94]). Although the rates of improvement were not statistically significantly different at the end of 2 weeks, the amoxicillin group improved significantly earlier, in the course of treatment, a median of 8 vs 12 days, than did the placebo group (P=.039). CONCLUSION: For most patients with sinusitis-type complaints, no improvement was seen with anti-biotics over placebo. For those who did improve, data suggested there is a subgroup of patients who may benefit from antibiotics.