Re Thomas

Toward Evidence-Based Quality Improvement

OBJECTIVES: To determine effectiveness and costs of different guideline dissemination and implementation strategies. DATA SOURCES: MEDLINE (1966 to 1998), HEALTH-STAR (1975 to 1998), Cochrane Controlled Trial Register (4th edn 1998), EMBASE (1980 to 1998), SIGLE (1980 to 1988), and the specialized register of the Cochrane Effective Practice and Organisation of Care group. REVIEW METHODS: INCLUSION CRITERIA: Randomized-controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series evaluating guideline dissemination and implementation strategies targeting medically qualified health care professionals that reported objective measures of provider behavior and/or patient outcome. Two reviewers independently abstracted data on the methodologic quality of the studies, characteristics of study setting, participants, targeted behaviors, and interventions. We derived single estimates of dichotomous process variables (e.g., proportion of patients receiving appropriate treatment) for each study comparison and reported the median and range of effect sizes observed by study group and other quality criteria. RESULTS: We included 309 comparisons derived from 235 studies. The overall quality of the studies was poor. Seventy-three percent of comparisons evaluated multi-faceted interventions. Overall, the majority of comparisons (86.6%) observed improvements in care; for example, the median absolute improvement in performance across interventions ranged from 14.1% in 14 cluster-randomized comparisons of reminders, 8.1% in 4 cluster-randomized comparisons of dissemination of educational materials, 7.0% in 5 cluster-randomized comparisons of audit and feedback, and 6.0% in 13 cluster-randomized comparisons of multifaceted interventions involving educational outreach. We found no relationship between the number of components and the effects of multifaceted interventions. Only 29.4% of comparisons reported any economic data. CONCLUSIONS: Current guideline dissemination and implementation strategies can lead to improvements in care within the context of rigorous evaluative studies. However, there is an imperfect evidence base to support decisions about which guideline dissemination and implementation strategies are likely to be efficient under different circumstances. Decision makers need to use considerable judgment about how best to use the limited resources they have for quality improvement activities.

Effectiveness and efficiency of guideline dissemination and implementation strategies

Objectives: A systematic review of the effectiveness and costs of different guideline development, dissemination, and implementation strategies wasundertaken. The resource implications of these strategies was estimated, and a framework for deciding when it is efficient to develop and introduce clinical guidelines was developed.

Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial

BACKGROUND Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. METHODS For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18-65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 μg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. FINDINGS Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI -5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [-5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). INTERPRETATION Tamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.

Mothers and daughters menopausal ages: is there a link?

OBJECTIVE To confirm whether there is a familial association in menopausal age between mothers and daughters. DESIGN questionnaire survey of women attending an osteoporosis screening programme. SUBJECTS 551 women who fulfilled the study inclusion criteria out of a random population sample of 2399 women aged between 45 to 54 living within 32 km of Aberdeen who were selected from the community health index. RESULTS 1758 women attended screening and completed the questionnaire. Of these only 1081 women were eligible being neither hormone replacement therapy users, nor had they had a hysterectomy. However, only 551 (51%) knew their mothers menopausal age. Women with premature (< 40 years) and early menopause (< 45 years) reported significantly lower maternal menopausal ages than women with normal menopausal ages (43.81, 45.40 and 48.38 for premature, early and normal women respectively p < 0.0001). The odds of a woman having an early or premature menopause if their mother had experienced an early menopause was 6.02 (95% confidence interval 3.39 to 10.66). CONCLUSION There seems to be a strong relationship between mothers and daughters menopausal age.

Validity of open-ended and payment scale approaches to eliciting willingness to pay

The open-ended and payment scale approaches to eliciting willingness to pay (WTP) valuations are compared. Use of the payment scale led to a higher response rate, a higher rate of completion of the WTP question, higher mean and median WTP values, a stronger association between WTP and ability to pay and a higher R2 in regression analysis of WTP on several independent variables. Taking these results in combination, it can be inferred that the payment scale technique leads to more valid WTP values than use of the open-ended approach.

The relationship between organisational characteristics and the effects of clinical guidelines on medical performance in hospitals, a meta-analysis

ObjectiveTo measure the effectiveness of strategies to implement clinical guidelines andthe influence of organisational characteristics on hospital care.MethodsSystematic review and meta regression analysis including randomisedcontrolled trials, controlled clinical trials and controlled before-and-after studies.Results53 studies were identified, including 81 comparisons. The total effect of allintervention strategies appeared to be Odds ratio 2.13 (SD 1.72-2.65). Interventionstrategies (such as educational material, reminders, feedback) and other professionalinterventions that mostly comprised revisions of professional roles were found to berelatively strong components of multi faceted interventions. Outcomes of organisationaleffect modifiers were better in a learning environment in inpatient studies than inoutpatient studies. Interventions developed outside hospitals yielded better outcomes; OR4.62 (SD 2.82-7.57) versus OR 1.78 (SD 1.36-2.23).ConclusionBoth single and multifaceted interventions seemed to be effective in hospitalsettings. Evidence for the effects of organisational determinants remained limited.

Alcohol consumption and age of maternal menopause are associated with menopause onset

OBJECTIVES To examine whether a number of nutritional and familial factors were associated with menopausal development. METHODS A prospective postal survey amongst a random sample of 1227 women aged 47 to 51 who were premenopausal in a cross-sectional survey 2 years previously. Women were classed into three groups; premenopause (regular menstruation); irregular menstruation; postmenopausal (absence of menstrual cycle for at least 6 months). Proportional odds regression was used to identify those factors which were independently predictive of subsequent menopausal development. RESULTS There was an 80% (n = 983) survey response rate. After exclusion of current HRT users (n = 178); 150 (19%) women were postmenopausal, 277 (34%) had erratic menstruation and 378 (47%) were premenopause. There were significant univariate associations between menopausal status and age (P < 0.001), age of maternal menopause (P = 0.006), alcohol consumption (P = 0.005) and social class (P = 0.03). Maternal age and alcohol consumption were significantly correlated with estradiol levels (r = 0.45, P = 0.02, and r = 0.61, P = 0.02 for maternal age and alcohol consumption, respectively). In proportional odds regression analyses, age, maternal menopausal age, alcohol consumption and smoking were independently associated with menopausal status. CONCLUSIONS These results suggest that, (1) there is a strong familial association in menopausal age, and (2) moderate consumption of alcohol is associated with delayed menopausal development.

Effect of enhanced feedback and brief educational reminder messages on laboratory test requesting in primary care: a cluster randomised trial

BACKGROUND Laboratory services play an important part in screening, diagnosis, and management of patients within primary care. However, unnecessary use of laboratory tests is increasing. Our aim was to assess the effect of two interventions on the number of laboratory tests requested by primary-care physicians. METHODS We did a cluster randomised controlled trial using a 2x2 factorial design, involving 85 primary-care practices (370 family practitioners) that request all laboratory tests from one regional centre. The interventions were quarterly feedback of practice requesting rates for nine laboratory tests, enhanced with educational messages, and brief educational reminder messages added to the test result reports for nine laboratory tests. The primary outcome was the number of targeted tests requested by primary-care practices during the 12 months of the intervention. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN06490422. FINDINGS Practices that received either or both the enhanced feedback and the reminder messages were significantly less likely than the control group to request the targeted tests in total (enhanced feedback odds ratio 0.87, 95% CI 0.81-0.94; reminder messages 0.89, 0.83-0.93). The effect of the interventions varied across the targeted tests individually, although the number of tests requested for both interventions was generally reduced. Neither intervention was consistently better than the other. INTERPRETATION Enhanced feedback of requesting rates and brief educational reminder messages, alone and in combination, are effective strategies for reducing test requesting in primary care. Both strategies are feasible within most laboratory settings.

Systematic review of economic evaluations and cost analyses of guideline implementation strategies

To appraise the quality of economic studies undertaken as part of evaluations of guideline implementation strategies, we conducted a systematic review of such studies published between 1966 and 1998. Studies were assessed against BMJ economic evaluations guidelines for each stage (guideline development, implementation and treatment). Of 235 studies identified, 63 reported some information on cost. Only 3 studies provided evidence that their guideline was effective and efficient, 38 reported treatment costs only, 12 implementation and treatment costs, 11 implementation costs alone, and 2 guideline development, implementation and treatment costs. No study gave reasonably complete information on costs. Thus, very few satisfactory economic evaluations of guideline implementation strategies have been performed. Current evaluations have numerous methodological defects and rarely consider all relevant costs and benefits. Future evaluations should focus on evaluating the implementation of evidence-based guidelines.

Explaining clinical behaviors using multiple theoretical models

BackgroundIn the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change.MethodsThese were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior.ResultsResponse rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior.ConclusionsWe operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.