Quality of Data Entry Using Single Entry, Double Entry and Automated Forms Processing–An Example Based on a Study of Patient-Reported Outcomes

Background: The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated forms processing may be an alternative, but further validation is warranted. Methods: 200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level. Results: Manual double-key data entry (error proportion per 1000 fields = 0.046 (95 % CI: 0.001–0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95 % CI: 0.160–0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95 % CI: 0.001–0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95 % CI: 0.817–24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95 % CI: 0.085–18.616)), (p = 0.319))

Consistent superiority of selective serotonin reuptake inhibitors over placebo in reducing depressed mood in patients with major depression.

The recent questioning of the antidepressant effect of selective serotonin reuptake inhibitors (SSRIs) is partly based on the observation that approximately half of company-sponsored trials have failed to reveal a significant difference between active drug and placebo. Most of these have applied the Hamilton depression rating scale to assess symptom severity, the sum score for its 17 items (HDRS-17-sum) serving as effect parameter. In this study, we examined whether the negative outcomes of many SSRI trials may be partly caused by the use of this frequently questioned measure of response. We undertook patient-level post-hoc analyses of 18 industry-sponsored placebo-controlled trials regarding paroxetine, citalopram, sertraline or fluoxetine, and including in total 6669 adults with major depression, the aim being to assess what the outcome would have been if the single item depressed mood (rated 0-4) had been used as a measure of efficacy. In total, 32 drug-placebo comparisons were reassessed. While 18 out of 32 comparisons (56%) failed to separate active drug from placebo at week 6 with respect to reduction in HDRS-17-sum, only 3 out of 32 comparisons (9%) were negative when depressed mood was used as an effect parameter (

Developmental and evolutionary assumptions in a study about the impact of premature birth and low income on mother–infant interaction

In order to study the impact of premature birth and low income on mother–infant interaction, four Portuguese samples were gathered: full-term, middle-class (n=99); premature, middle-class (n=63); full-term, low income (n=22); and premature, low income (n=21). Infants were filmed in a free play situation with their mothers, and the results were scored using the CARE Index. By means of multinomial regression analysis, social economic status (SES) was found to be the best predictor of maternal sensitivity and infant cooperative behavior within a set of medical and social factors. Contrary to the expectations of the cumulative risk perspective, two factors of risk (premature birth together with low SES) were as negative for mother–infant interaction as low SES solely. In this study, as previous studies have shown, maternal sensitivity and infant cooperative behavior were highly correlated, as was maternal control with infant compliance. Our results further indicate that, when maternal lack of responsiveness is high, the infant displays passive behavior, whereas when the maternal lack of responsiveness is medium, the infant displays difficult behavior. Indeed, our findings suggest that, in these cases, the link between types of maternal and infant interactive behavior is more dependent on the degree of maternal lack of responsiveness than it is on birth status or SES. The results will be discussed under a developmental and evolutionary reasonin

Interactive voice response technology for symptom monitoring and as an adjunct to the treatment of chronic pain

Chronic pain is a medical condition that severely decreases the quality of life for those who struggle to cope with it. Interactive voice response (IVR) technology has the ability to track symptoms and disease progression, to investigate the relationships between symptom patterns and clinical outcomes, to assess the efficacy of ongoing treatments, and to directly serve as an adjunct to therapeutic treatment for chronic pain. While many approaches exist toward the management of chronic pain, all have their pitfalls and none work universally. Cognitive behavioral therapy (CBT) is one approach that has been shown to be fairly effective, and therapeutic interactive voice response technology provides a convenient and easy-to-use means of extending the therapeutic gains of CBT long after patients have discontinued clinical visitations. This review summarizes the advantages and disadvantages of IVR technology, provides evidence for the efficacy of the method in monitoring and managing chronic pain, and addresses potential future directions that the technology may take as a therapeutic intervention in its own right

Exposure-in-vivo containing interventions to improve work functioning of workers with anxiety disorder: a systematic review

<p>Abstract</p> <p>Background</p> <p>Anxiety disorders are associated with functional disability, sickness absence, and decreased productivity. Effective treatments of anxiety disorders can result in remission of symptoms. However the effects on work related outcomes are largely unknown. Exposure in vivo is potentially well fit to improve work-related outcomes. This study systematically reviews the effectiveness of exposure-in-vivo containing interventions in reducing work-related adverse outcomes in workers with anxiety disorders.</p> <p>Methods</p> <p>A systematic study search was conducted in Medline, Cinahl, Embase and Psycinfo. Two reviewers independently extracted data and from each study assessed the quality of evidence by using the GRADE approach. We performed a meta-analysis if data showed sufficient clinical homogeneity.</p> <p>Results</p> <p>Seven studies containing 11 exposure-in-vivo interventions were included. Four studies were focused on Obsessive Compulsive Disorder (OCD), two on Post Traumatic Stress Disorder (PTSD), and one on a mixed group of OCD and severe phobias. The studies were grouped according to type of anxiety disorder and subsequently according to type of comparisons. For OCD, exposure-in-vivo containing interventions can yield better work-related outcomes compared to medication (SSRIs) and relaxation but not better compared to response prevention. The results on anxiety outcomes were similar. The net contribution of exposure in vivo in two OCD intervention programs is also presented as a meta-analysis and shows significant positive results on work role limitations. The calculated pooled effect size with 95% confidence interval was 0.72 (0.28, 1.15). For PTSD, exposure-in-vivo containing interventions can yield better work-related and anxiety-related outcomes compared to a waiting-list but not better compared to imaginal exposure.</p> <p>Conclusions</p> <p>Exposure in vivo as part of an anxiety treatment can reduce work-related adverse outcomes in workers with OCD and PTSD better than various other anxiety treatments or a waiting-list. We recommend that it should be studied how the results of these studies can be transferred to the practice of occupational health professionals and how clinicians can make better use of them to improve work-related outcomes. In future research, priority should be given to high-quality randomised controlled trials (RCTs) in which exposure-in-vivo containing interventions are applied to a variety of anxiety disorders and compared with other clinical anxiety treatments such as SSRIs. Work-related outcomes, in particular work functioning and sickness absence, need to be assessed with reliable and valid measures.</p

On the Effects of Serotonin Reuptake Inhibitors in Major Depression

This thesis focuses on the antidepressant effects of selective serotonin reuptake inhibitors (SSRIs) and how these are reflected by the Hamilton Depression Rating Scale (HDRS). To this end, we have assembled a large data set of placebo-controlled SSRI trials in major depression, and used this for a series of post-hoc patient-level analyses. Thus, in a population of 8 262 patients treated with either of four SSRIs (citalopram, fluoxetine, paroxetine, or sertraline) or placebo, we have assessed (1) to what extent the various symptoms included in the HDRS separate between active treatment and placebo, and contrasted this to the sum-score of all HDRS items, which has been the conventional effect parameter, (2) whether the effects of SSRIs are dose-dependent, (3) whether side effects are necessary for SSRIs to outperform placebo, (4) if SSRIs increase or decrease suicidal ideation, and (5) whether only patients with high baseline depression severity respond to treatment with SSRIs. We found that the influence of drug treatment on individual HDRS items differs vastly with regard to both the size and direction of effect. While depressed mood and other core symptoms of depression are consistently improved by SSRI treatment, HDRS items that may reflect typical SSRI side effects, such as e.g., gastrointestinal symptoms and sexual symptoms, respond, on average, negatively. The HDRS sum-score thus represents an aggregate of beneficial effects on core depression symptoms and detrimental effects on possible side-effect related items. Further, we suggest that the balance between these domains vary with time under treatment, with side-effects being relatively more influential early in treatment, thereby obfuscating significant positive effects otherwise evident as early as after one week of treatment. We also found evidence for a dose-response relationship, i.e., very low SSRI doses were more effective than placebo, but less effective than higher doses; this relation plateaued at the low to mid-range of currently recommended doses. We did not find any evidence in support of the hypothesis that side effects be an indispensable prerequisite for antidepressant efficacy, or that side effect severity moderates response. We could replicate previous studies showing SSRIs to decrease suicidal ideation in subjects ≥ 25 years of age, but could not detect a significant influence of SSRIs in either direction in young adults (18 ≤ age < 25). We found baseline symptom severity to be positively associated with SSRI efficacy when measured by the HDRS sum-score. This was however not the case for core depression symptoms where instead patients improved equally regardless of baseline severity. We suggest this to be partly due to non-core symptoms being absent in low-severity patients, thus leaving less room for improvement and more room for worsening on side-effect related items. Most of these observations were replicated in a population of 3575 patients from studies of the serotonin and noradrenaline reuptake inhibitor duloxetine. We conclude i) that the sum-score of the HDRS rating scale is an insufficient and insensitive measure of antidepressant efficacy, ii) that the use of this outcome parameter has led to an underestimation of the true efficacy of SSRIs and SNRIs, particularly at the early phase of treatment and in subjects with relatively mild depression, iii) that normal doses of antidepressants are superior to low doses but not inferior to high doses, iv) that antidepressant effects are not, as has been suggested, secondary to side effects breaking the blind, and v) that the net effect of antidepressants on suicidality is beneficial, at least in subjects ≥ 25 years of age. In conjunction, the results rebut many of the claims that have been put forward by those questioning the usefulness of antidepressants