Handheld vs. Laptop Computers for Electronic Data Collection in Clinical Research: A Crossover Randomized Trial

AbstractObjective To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers. Design The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment. Measurements The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard. Results The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p < 0.001). Data accuracy also improved. There were 5.8 typing errors per 1,000 entries with the laptop compared to 8.4 per 1,000 with the handheld computer (p < 0.001). The difference was even more important for missing data which decreased from 22.8 to 2.9 per 1,000 entries when a laptop was used (p < 0.001). Users found the laptop easier, faster and more satisfying to use than the handheld computer. Conclusions Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare workers, unfamiliar with Computer Technologies, for self-reporting or research data collection processe

Effect of magnesium therapy on nocturnal leg cramps: a systematic review of randomized controlled trials with meta-analysis using simulations

Background and objective. Nocturnal leg cramps (NLC) are common in primary care and may cause severe pain and sleep disturbance. We systematically reviewed the effectiveness of magnesium in treating NLC and the side-effect profile of magnesium compared to placebo. Methods. We searched Medline, Embase, Cochrane Library, ClinicalTrials.gov, the International Standard Randomised Controlled Trial Number and the International Clinical Trials Registry Platform registries until August 2012. All randomized controlled trials (RCTs) comparing magnesium therapy for NLC in adults with any other comparator were eligible. Two investigators independently selected, extracted data from and rated the risk of bias of relevant studies. To compensate for the heterogeneity in outcome measures, simulations were used to summarize the data. Results. Seven RCTs were included in the review (n = 361), all comparing magnesium to placebo. Three of these trials included only pregnant women. The difference in the median number of leg cramps per week between the placebo and the intervention groups was 0.345 (quantile 2.5%: −0.133, quantile 97.5%: 0.875). This difference was 0.807 (quantile 2.5%: 0.015, quantile 97.5%: 1.207) in the three studies involving only pregnant women and 0.362 (quantile 2.5%: −0.386, quantile 97.5%: 1.148) in the others. Overall gastrointestinal side effects were slightly more common with magnesium therapy than with placebo. The strength of this evidence was weak, mainly due to small study sizes and short follow-up. Conclusions. Magnesium therapy does not appear to be effective in the treatment of NLC in the general population, but may have a small effect in pregnant women. Further research using better designed RCTs is necessar

Text message communication in primary care research: a randomized controlled trial

Background. Text message communication is increasingly used in clinical practice but rarely in research. Particularly in young people, this method of participation in primary care research appears both feasible and acceptable. However, previous experience shows that text messaging for research may lead to lower response rates. Aim. To test the hypothesis that text message communication in primary care research does not lead to lower response rates compared to a paper-based method. Methods. This randomized controlled trial took place in 26 randomly selected practices in Victoria, Australia. Consecutive patients aged 16-24 years attending general practice appointments were recruited as part of a larger study on patients' perspectives. Patients owning a mobile phone were randomized to receive a question about satisfaction with the consultation either by text message or on a card completed before leaving the practice. Logistic regression was used to estimate the effect on the response rate of using text message rather than the card method, adjusting for clustering within practices and for differences in baseline characteristics among participants. Results. In total, 402 of 409 eligible young people agreed to participate and were randomized to either receive a text message (n = 193) or a card enquiry (n = 209). The response rate was 80.2% [95% confidence interval (CI): 73.3-87.1%] with text message and 85.6% (95% CI: 79.6-91.7%) with the card. The adjusted odds of responding (odds ratio: 0.62; 95% CI: 0.30-1.27) were not significantly lower in the group using text messaging compared to the group using the card response method. Conclusion. These findings offer new perspectives for use of text message communication to gather information from patients in primary care researc

Excessive substance use among young people consulting family doctors: a cross-sectional study

Background. Family doctors can only play a role in the prevention of excessive substance use in young people if those affected are seen in the practice. Objective. To describe the prevalence of excessive substance use among young people consulting family doctors in a European context. Methods. As part of a trial of an intervention addressing substance use we collected data from young people consulting 32 family doctors in the French-speaking part of Switzerland. Before the consultation, consecutive patients aged 15-24 years completed a self-administered questionnaire on their general health and substance use. Outcomes were excessive alcohol (defined as ≥1 episode of binge drinking), excessive cannabis (use ≥1/week), regular tobacco (≥1 cigarettes a day) and/or any other substance use in the past 30 days. Prevalence data were computed with 95% confidence intervals (CIs) adjusted for clustering within practices, stratified by age and gender. Results. Between February 2009 and November 2010, 636 patients were eligible. Participation rate was 93.4% (n = 594, 53% female). The prevalence of excessive use in the past 30 days was alcohol 44.9% (95% CI: 37.8-52.1), cannabis 11.1% (95% CI: 8.0-14.1), tobacco 23.4% (95% CI: 19.0-28.1) and any other drug 2.6 (95% CI: 1.4-4.2). Excessive use was higher in males than in females. Except for tobacco prevalence of excessive use was only slightly higher in young adults compared to adolescents. Conclusion. Excessive substance use is frequent among young people consulting family doctors in a European context. Future research should provide guidance about how to best seize this window of opportunity for prevention and early interventio

Multimorbidity and patterns of chronic conditions in a primary care population in Switzerland: a cross-sectional study

To characterise in details a random sample of multimorbid patients in Switzerland and to evaluate the clustering of chronic conditions in that sample. 100 general practitioners (GPs) each enrolled 10 randomly selected multimorbid patients aged ≥18 years old and suffering from at least three chronic conditions. The prevalence of 75 separate chronic conditions from the International Classification of Primary Care-2 (ICPC-2) was evaluated in these patients. Clusters of chronic conditions were studied in parallel. The final database included 888 patients. Mean (SD) patient age was 73.0 (12.0) years old. They suffered from 5.5 (2.2) chronic conditions and were prescribed 7.7 (3.5) drugs; 25.7% suffered from depression. Psychological conditions were more prevalent among younger individuals (≤66 years old). Cluster analysis of chronic conditions with a prevalence ≥5% in the sample revealed four main groups of conditions: (1) cardiovascular risk factors and conditions, (2) general age-related and metabolic conditions, (3) tobacco and alcohol dependencies, and (4) pain, musculoskeletal and psychological conditions. Given the emerging epidemic of multimorbidity in industrialised countries, accurately depicting the multiple expressions of multimorbidity in family practices' patients is a high priority. Indeed, even in a setting where patients have direct access to medical specialists, GPs nevertheless retain a key role as coordinators and often as the sole medical reference for multimorbid patients

Determinants associated with deprivation in multimorbid patients in primary care-A cross-sectional study in Switzerland

Deprivation usually encompasses material, social, and health components. It has been shown to be associated with greater risks of developing chronic health conditions and of worse outcome in multimorbidity. The DipCare questionnaire, an instrument developed and validated in Switzerland for use in primary care, identifies patients subject to potentially higher levels of deprivation. To identifying determinants of the material, social, and health profiles associated with deprivation in a sample of multimorbid, primary care patients, and thus set priorities in screening for deprivation in this population. Secondary analysis from a nationwide cross-sectional study in Switzerland. A random sample of 886 adult patients suffering from at least three chronic health conditions. The outcomes of interest were the patients' levels of deprivation as measured using the DipCare questionnaire. Classification And Regression Tree analysis identified the independent variables that separated the examined population into groups with increasing deprivation scores. Finally, a sensitivity analysis (multivariate regression) confirmed the robustness of our results. Being aged under 64 years old was associated with higher overall, material, and health deprivation; being aged over 77 years old was associated with higher social deprivation. Other variables associated with deprivation were the level of education, marital status, and the presence of depression or chronic pain. Specific profiles, such as being younger, were associated with higher levels of overall, material, and health deprivation in multimorbid patients. In contrast, patients over 77 years old reported higher levels of social deprivation. Furthermore, chronic pain and depression added to the score for health deprivation. It is important that GPs consider the possibility of deprivation in these multimorbid patients and are able to identify it, both in order to encourage treatment adherence and limit any forgoing of care for financial reasons