Effectiveness of prompted voiding in treating urinary incontinence in cognitively impaired homebound older adults. Failure of Internet-based audit and feedback to improve quality of care delivered by primary care residents. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. A randomized trial of a computer-based intervention to reduce utilization of redundant laboratory tests. Use of a time series design to test effectiveness of a theory-based intervention targeting adherence of health professionals to a clinical guideline. Randomised controlled trial of a theoretically grounded tailored intervention to diffuse evidence-based public health practice [ISRCTN23257060]. Prompted voiding treatment of urinary incontinence in nursing home patients. A behavior management approach for nursing home staff. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. A randomized trial of "corollary orders" to prevent errors of omission.
The objective of this study was to examine the short-term effectiveness of prompted voiding (PV) in cognitively impaired homebound older adults.
                This was a prospective, controlled exploratory study with a cross-over design where usual care controls crossed-over to the intervention following an 8-week observation period.
                Adults aged 60 years and older with urinary incontinence and who met Center for Medicare and Medicaid Services criteria for being homebound were referred to the study by home care nurses from 2 large Medicare-approved home health agencies in a large metropolitan county in southwestern Pennsylvania. Nineteen cognitively impaired older adults were randomly assigned to either the PV intervention or a usual care attention control group.
                Measures used included structured continence and medical histories. Older American Research and Service Physical and Instrumental Activities of Daily Living scales, Folstein Mini Mental State Examination, Clock Drawing Test, Geriatric Depression Scale, Performance-Based Toileting Assessment, bladder diaries, and physical examination.
                Nineteen subjects were randomly assigned to a PV (n = 9) or delayed attention-control group (n = 10). Treatment subjects with complete pretreatment and posttreatment data (n = 6) experienced a mean 60% reduction in daytime incontinent episodes compared with a mean 37% reduction among control subjects (n = 10). Following the control phase, subjects crossed over to the treatment protocol. A total of 15 subjects completed the PV protocol. Among all subjects completing the treatment protocol, there was a 22% reduction in daytime incontinent episodes compared with true baseline (immediately following the control phase for those crossing over from the control group).
                The PV intervention resulted in clinically significant reductions in urinary incontinence for many of the participants, which may be achievable for many cognitively impaired homebound older adults. To determine the effectiveness of Internet-based audit and feedback to physicians to improve care for diabetes and hypertension.
                Time-series analysis of an intervention.
                The study setting was Harvard Vanguard Medical Associates, a 14-site multispecialty group in greater Boston. The study period was July 1997-June 1999.
                were 12 primary care internal medicine residents who provided care to adult patients with diabetes (n = 76 pre-intervention and n = 88 post-intervention), hypertension (n = 329 pre-intervention and n = 338 post-intervention), or both (n = 62 pre-intervention and n = 71 post-intervention). We determined the proportion of each resident's patients whose care fulfilled national guidelines for quality (i.e. diabetes patients had hemoglobin testing in the previous 6 months or hypertension patients received a beta-blocker or diuretic in the same time period). After meeting individually with each resident to obtain informed consent and to encourage participation, we sent each resident information for accessing his or her practice profile on a secure website. The main outcome measures were (i) the proportion of resident physicians who accessed their profiles and (ii) change following the intervention in the proportion of patients whose care followed national guidelines.
                Over a 1-year period, only four of the 12 residents accessed their websites. One of the residents visited her site three times, while the other three residents visited their sites once each. In interrupted time-series analyses, the intervention had no discernible effect on adherence to practice guidelines for diabetes or hypertension.
                The lack of participation in this Internet-based intervention may have important implications for the development of future programs that require physicians to interact with technology to improve quality of care. To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects.
                An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects.
                Meta-analyses from the Cochrane Pregnancy and Childbirth Database.
                The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding.
                Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%.
                This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials. To determine the impact of giving physicians computerized reminders about apparently redundant clinical laboratory tests.
                We performed a prospective randomized controlled trial that included all inpatients at a large teaching hospital during a 15-week period. The intervention consisted of computerized reminders at the time a test was ordered that appeared to be redundant. Main outcome measures were the proportions of clinical laboratory orders that were canceled and the proportion of the tests that were actually performed.
                During the study period, there were 939 apparently redundant laboratory tests among the 77,609 study tests that were ordered among the intervention (n = 5,700 patients) and control (n = 5,886 patients) groups. In the intervention group, 69% (300 of 437) of tests were canceled in response to reminders. Of 137 overrides, 41% appeared to be justified based on chart review. In the control group, 51% of ordered redundant tests were performed, whereas in the intervention group only 27% of ordered redundant tests were performed (P <0.001). However, the estimated annual savings in laboratory charges was only $35,000. This occurred because only 44% of redundant tests performed had computer orders, because only half the computer orders were screened for redundancy, and because almost one-third of the reminders were overridden.
                Reminders about orders for apparently redundant laboratory tests were effective when delivered. However, the overall effect was limited because many tests were performed without corresponding computer orders, and many orders were not screened for redundancy. The aim of this study was to test the effectiveness of a theory of planned behaviour intervention to increase adherence of community mental health professionals to a national suicide prevention guideline.
                Routinely collected audit adherence data from an intervention and control site were collected and analysed using time series analysis to test whether the intervention significantly increased adherence. The effects of a local and national event on adherence were also examined.
                A Theory of Planned Behaviour (TPB) questionnaire, developed from interview findings, was administered to the health professionals. Subjective norms were found to be the most significant predictor of intention to adhere to the guideline, and were targeted with an interactive educational intervention. Time series analysis applied to routinely collected audit adherence data was used to test intervention effectiveness.
                The TPB accounted for 58% of the variance in intention to adhere, with subjective norms the only significant predictor. The intervention did not significantly increase adherence; however, the national and local events were found to have significantly increased adherence.
                The TPB was a useful framework for exploring barriers to adherence; however, this did not translate into an effective intervention. Future research should seek collaboration with local experts, and use this information in combination with the TPB, to develop interventions. Collaborative research with experts in pedagogy may also help to develop more effective interventions, particularly education-based interventions that require adult learning. Previous studies have shown that Norwegian public health physicians do not systematically and explicitly use scientific evidence in their practice. They work in an environment that does not encourage the integration of this information in decision-making. In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence-based public health practice increases the physicians' use of research information.
                148 self-selected public health physicians were randomised to an intervention group (n = 73) and a control group (n = 75). The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services. Baseline assessments before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted. The intervention was theoretically based and consisted of a workshop in evidence-based public health, a newsletter, access to a specially designed information service, to relevant databases, and to an electronic discussion list. The main outcome measure was behaviour as measured by the use of research in different documents.
                The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes. We found, however, a statistical significant difference between the two groups for both knowledge scores: Mean difference of 0.4 (95% CI: 0.2-0.6) in the score for knowledge about EBM-resources and mean difference of 0.2 (95% CI: 0.0-0.3) in the score for conceptual knowledge of importance for critical appraisal. There were no statistical significant differences in attitude-, self-efficacy-, decision-to-adopt- or job-satisfaction scales. There were no significant differences in Cochrane library searching after controlling for baseline values and characteristics.
                Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour. This study evaluated a treatment procedure in which 126 incontinent nursing home patients were checked on an hourly basis, asked if they needed toileting assistance (prompted), and socially reinforced for appropriate toileting. Urodynamic analysis (including cystometrogram), provocative stress test, and behavioral assessment revealed that the nursing home patients were severely debilitated, with 65% demonstrating bladder abnormalities, 87% incapable of independent toileting, and 25% failing to score on the Mini-Mental Status Exam (average score, 8.0). The treatment procedures were evaluated with a multiple baseline design in which subjects were randomly divided into immediate or delayed treatment groups after a baseline observation period. During treatment, the frequency of incontinence per 12 hours changed from a baseline average of 3.85 to a treatment average of 1.91. Three behavioral measures that can be easily collected by nursing staff significantly predicted continence levels during treatment (multiple R, 0.79) and change in incontinence during treatment (multiple R, 0.64). These prognostic criteria offer nursing staff a cost-effective method for selecting the most responsive patients for prompted-voiding treatment. To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses.
                Meta-analyses of randomized trials that included at least one large trial (>/=1000 participants) were included, regardless of the therapeutic area. Eligible meta-analyses were identified through electronic searches and bibliographies of relevant articles.
                Full-length randomized trials.
                Methodologic quality was assessed according to reported randomization, double blinding, and follow-up as separate components and by using the Jadad composite scale.
                Fourteen meta-analyses involving 190 randomized trials from eight therapeutic areas were included. Compared with large trials, intervention effects were exaggerated in small trials with inadequate allocation sequence generation (ratio of odds ratios, 0.46 [95% CI, 0.25 to 0.83]; P = 0.011), inadequate allocation concealment (ratio of odds ratios, 0.49 [CI, 0.27 to 0.86]; P = 0.014), and no double blinding (ratio of odds ratios, 0.52 [CI, 0.28 to 0.96]; P = 0.01). Large trials did not differ significantly from small trials with adequate generation of the allocation sequence, adequate allocation concealment, or adequate double blinding. No association was seen between reported follow-up and intervention effects. The Jadad scale provided no additional information because the scale and the quality components overlapped substantially.
                Inadequate generation of the allocation sequence, allocation concealment, and double blinding lead to exaggerated estimates of intervention benefit and may contribute to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses. Errors of omission are a common cause of systems failures. Physicians often fail to order tests or treatments needed to monitor/ameliorate the effects of other tests or treatments. The authors hypothesized that automated, guideline-based reminders to physicians, provided as they wrote orders, could reduce these omissions.
                The study was performed on the inpatient general medicine ward of a public teaching hospital. Faculty and housestaff from the Indiana University School of Medicine, who used computer workstations to write orders, were randomized to intervention and control groups. As intervention physicians wrote orders for 1 of 87 selected tests or treatments, the computer suggested corollary orders needed to detect or ameliorate adverse reactions to the trigger orders. The physicians could accept or reject these suggestions.
                During the 6-month trial, reminders about corollary orders were presented to 48 intervention physicians and withheld from 41 control physicians. Intervention physicians ordered the suggested corollary orders in 46.3% of instances when they received a reminder, compared with 21.9% compliance by control physicians (p < 0.0001). Physicians discriminated in their acceptance of suggested orders, readily accepting some while rejecting others. There were one third fewer interventions initiated by pharmacists with physicians in the intervention than control groups.
                This study demonstrates that physician workstations, linked to a comprehensive electronic medical record, can be an efficient means for decreasing errors of omissions and improving adherence to practice guidelines.
The data were too few and of insufficient quality to provide empirical support for or against the intervention of timed voiding.