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How conducting a clinical trial affects physicians' guideline adherence and drug preferences.

CONTEXT: General practitioners are frequently involved in clinical trials sponsored by pharmaceutical companies but the effects of participation on their prescribing patterns have not been evaluated. OBJECTIVE: To determine how conducting a company-sponsored clinical trial influenced physicians' adherence to international treatment recommendations and their prescribing of the pharmaceutical company's drugs. DESIGN, SETTING, AND PATIENTS: Observational cohort study in Funen County, Denmark, comparing 10 practices that were conducting a trial on asthma medicine with 165 control (non-trial-conducting) practices. The study population included 5439 patients treated with asthma drugs from the trial-conducting practices and 59,574 patients from the control practices. Practices conducted the trial between April 26, 2001, and October 7, 2002. MAIN OUTCOME MEASURES: Adherence to guidelines measured as use of inhaled corticosteroids among asthma patients. Prevalence of use of the company's drugs and the trial sponsor's share of the total volume of asthma drugs prescribed. RESULTS: The baseline proportion of asthma patients using inhaled corticosteroids was 68.5% in trial-conducting and 69.1% in control practices. Conducting the trial did not influence guideline adherence (odds ratio [OR] after 2 years, 1.00; 95% confidence interval [CI], 0.84-1.19). In trial-conducting practices, the sponsoring company's share of the total prescribed volume of asthma drugs increased compared with control practices (6.7%; 95% CI, 3.0%-11.7%). This could be attributed to a significantly higher preference for the company's inhaled corticosteroids (OR, 1.26; 95% CI, 1.04-1.54) and trends toward increased prescribing of the company's other asthma drugs. CONCLUSION: Conducting a trial sponsored by a pharmaceutical company had no significant impact on physicians' adherence to international treatment recommendations but increased their use of the trial sponsor's drugs.

Anti-Asthmatic Agents↗

Potential for reported needlestick injury prevention among healthcare workers through safety device usage and improvement of guideline adherence: expert panel assessment.

A prospective survey was conducted over six months in order to estimate the proportion of reported occupational needlestick injuries sustained by National Health Service (NHS) Scotland staff that could have been prevented through either safety device introduction, improved guideline adherence, guideline revision or a combination of these. This survey involved the administration of a standard proforma to healthcare workers followed by an expert panel assessment. All acute and primary care NHS Scotland trusts, the Scottish Ambulance Service and the Scottish National Blood Transfusion Service were included. Proforma and expert panel assessment data were available for 64% of injuries (952/1497) reported by healthcare staff. These injuries were all percutaneous. The expert panel concluded that: 56% of all injuries and 80% of venepuncture/injection administration injuries would probably/definitely have been prevented through safety device usage, 52% of all injuries and 56% of venepuncture/injection administration injuries would probably/definitely have been prevented through guideline adherence and 72% of all injuries and 88% of venepuncture/injection administration injuries would probably/definitely have been prevented through either intervention. Multi-factorial analysis indicated that injuries sustained through venepuncture/injection administration were significantly more likely to be prevented through safety device usage [adjusted odds ratio (OR) 5.09, 95% confidence intervals (CI) 3.11-8.31 and adjusted OR 2.70, 95% CI 1.64-4.45, respectively], and significantly less likely to be prevented through guideline adherence (adjusted OR 0.26, 95% CI 0.11-0.60 and adjusted OR 0.31, 95% CI 0.12-0.78, respectively). Injuries sustained after completing procedures were significantly more likely to be prevented through safety device usage and guideline adherence. The study's findings support the need for improvements to staff's adherence to needlestick injury guidelines and appropriate implementation of safety devices for venepuncture and injection administration.

Adolescent↗

Colorectal cancer screening: recommendations and guideline adherence by physicians from digestive endoscopy centers in the Lazio region, Italy.

INTRODUCTION: Endoscopy plays a key role in colorectal cancer screening; at the beginning of a mass screening campaign, it is important for public health officials to assess physicians' attitudes and adherence to guidelines regarding colorectal cancer screening. METHODS: In April 2004, a questionnaire was sent to all 80 digestive endoscopy centers in the Lazio region, identified by the annual census of the Italian Society of Digestive Endoscopy. The results were compared to those from a similar survey of general practitioners (GPs). RESULTS: Seventy-one centers (89%) returned the questionnaire. Only 3% of physicians said they did not recommend any colorectal cancer screening test. Colonoscopy was perceived as the most effective screening test and was the most recommended (80%). Fecal occult blood test was recommended by 61% of physicians and flexosigmoidoscopy by 11%. Endoscopy centers' physicians recommend screening more than GPs (96.9% vs. 78.3%), while they have a similar level of over-recommending (50.8% vs. 47.2%). Almost 95% of endoscopy physicians properly recommended colonoscopy after positive FOBT. CONCLUSIONS: Neither physicians at endoscopy centers nor GPs tend to follow screening guidelines. Screening programmes should not rely on a single medical specialist, but on interdisciplinary management of the disease to strengthen adherence to existing guidelines.

Attitude of Health Personnel↗

Leveraging point-of-care clinician feedback to study barriers to guideline adherence.

Studies of barriers to guideline adherence have generally surveyed clinicians temporally remote from the clinical scenario in which recommendations were delivered, potentially adversely biasing clinician observations. The user interface of ATHENA DSS, a guideline-based decision support system for hypertension, includes a point-of-care feedback window that accepts clinician-user comments during the display of recommendations. Analysis of this feedback has revealed a number of intriguing patient, provider, and technical barriers to adherence collected during real-time system use.

Attitude of Health Personnel↗

Measuring physiotherapists' guideline adherence by means of clinical vignettes: a validation study.

RATIONALE, AIMS AND OBJECTIVES: To assess the criterion validity of paper-and-pencil vignettes to assess guideline adherence by physiotherapists in the Netherlands. The evidence-based physiotherapy practice guideline for low back pain was used as an example. METHODS: Four vignettes were constructed and pre-tested. Three vignettes were found to represent an adequate case-mix. They described one patient with specific low back pain, one with non-specific low back pain and a normal recovery process and one with non-specific low back pain and a delay in the recovery process. Invited to participate were 113 primary care physiotherapists who had joined an randomized controlled trial study 8 months before, in which guideline adherence had been measured by means of semi-structured treatment recording forms. The criterion validity was determined with Spearman's r(s), using Cohen's classification for the behavioural sciences to categorize its effect size. RESULTS: Of the 72 physiotherapists who agreed to participate, 39 completed the questions on the vignettes. In the end, both adherence measures were available for 34 participants, providing 102 vignettes and 268 recording forms. Mean guideline adherence scores were 57% (SD = 17) when measured by vignettes and 74% (SD = 15) when measured by recording forms. Spearman's r(s) was 0.31 (P = 0.036), which, according to Cohen's classification, is a medium effect size. CONCLUSION: Vignettes are of acceptable validity, and are an inexpensive and manageable instrument to measure guideline adherence among large groups of physiotherapists. Further validation studies could benefit from the use of standardized patients as a gold standard, a more diverse case mix to better reflect real physiotherapy practice, and the inclusion of longitudinal vignettes that cover the patients' course of treatment.

Adult↗

Long-term costs of treatment for depression: impact of drug selection and guideline adherence.

OBJECTIVES: This paper examines three processes: SSRI antidepressant choice, adherence to treatment guidelines, and long-term health care expenditures associated with antidepressant treatment for patients with a diagnosis of depression. METHODS: Patient records were abstracted from a medical claims database covering employer-provided health care plans. Treatment episodes required a 6-month antidepressant-free prior period; initial treatment with sertraline, paroxetine or fluoxetine; and data on direct medical costs over the 24 months following the initial prescription. The multivariate model of drug selection, patient adherence to antidepressant use guidelines, and cost was subjected to specification testing to rule out the possibility that nonrandom initial antidepressant selection might lead to sample selection bias. Further tests indicated that the results were free of bias due to a possible correlation between antidepressant selection and use of the medication, or because of the endogeneity of use patterns in the process driving cost. However, there was evidence of unobserved variables correlated with both achieving guideline adherent use and expenditures, which might have led to sample selection bias. RESULTS: Subjects who met the study criteria included 796 initiating therapy with sertraline, 352 with paroxetine, and 882 with fluoxetine. Fluoxetine patients were significantly more likely than sertraline or paroxetine patients to achieve a use pattern that was consistent with guidelines for treating depressive disorder (p < .05). There were no statistically significant differences between the three treatment cohorts in total direct health care expenditures over the 2-year period (p < .05), and depression-related expenditures, other mental health expenditures, and non-mental health care expenditures did not show significant differences across the treatments (p < .05). Natural logged values of antidepressant drug expenditures were predicted to be highest for fluoxetine, followed by sertraline, then paroxetine (p < .01). Predicted log values of mental health expenditures were lower for sertraline relative to fluoxetine. CONCLUSIONS: Fluoxetine patients had the highest likelihood of using antidepressant medication according to treatment guidelines that were developed to assure quality care. This benefit was achieved without incurring greater total health care expenditures.

Adult↗

Prevention of perioperative venous thromboembolism and coronary events: differential responsiveness to an intervention program to improve guidelines adherence.

INTRODUCTION: Prevention of venous thromboembolism and coronary events (with beta-blockers) during and after surgery is at the top of a list of safety practices for hospitalized patients, recommended by the Agency for Health Care Research and Quality (AHRQ). We wished to determine and improve adherence to clinical guidelines for these topics in our institution. PATIENTS, MATERIAL, AND METHODS: A prospective survey was conducted over several weeks on operated patients in a 1200-beds medical center (a teaching, community and referral hospital in Jerusalem, Israel). Eligibility for and actual administration of prophylactic treatment with anticoagulant and beta-blockers were determined. Following an intervention program, which included staff meetings, development of local protocols, and academic detailing by a nurse, the survey was repeated. RESULTS: In general, adherence to recommended anticoagulation prophylaxis was low, found in only 29% [95% confidence interval (CI) = 23-36] of eligible patients. After the intervention, adequate anticoagulation increased to 50% (95% CI = 40-59) of eligible patients (P < 0.001). Initiation of beta-blockers in preventing perioperative cardiac events was very low (0%, 95% CI = 0-5%) and did not increase after intervention. CONCLUSIONS: Adherence to guidelines for prevention of surgical complications was found to be low in our institution. A multifaceted intervention significantly increased use of prophylaxis for venous thromboembolism but not for coronary events. This differential response suggests that the success of a quality improvement project strongly depends on topic content and its phase of acceptance.

Adrenergic beta-Antagonists↗

Evaluation of a computer-based decision support system for treatment of hypertension with drugs: retrospective, nonintervention testing of cost and guideline adherence.

OBJECTIVE: To evaluate a computerized decision support system (DSS) for drug treatment of hypertension, regarding quality, safety, and cost compared to actual antihypertensive drug treatment. DESIGN: The medical profiles of 338 hypertensive patients treated with drugs against hypertension were processed by the DSS. The drug treatment proposed by the system was then compared to actual treatment given by their physician. SETTING: Four health centres in the county of Västerbotten, in Sweden. SUBJECTS: A list of hypertensive patients was extracted from the computerized medical records of each health centre and every fifth patient's medical profile was assessed by the system. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Drug used, drug used in relation to certain major diseases such as diabetes mellitus, asthma, ischaemic heart disease (IHD), and previous myocardial infarction. Adherence to hypertension guidelines, safety, and cost. RESULTS: The DSS suggested significantly more thiazides and significantly fewer calcium antagonists than the physicians had prescribed, with a total cost reduction of 33-40%, depending on doses chosen. The DSS drug profile was more adherent to guidelines in patients with major complicating diseases, suggesting an improvement in treatment quality for these patients by the DSS. CONCLUSION: The DSS which fully implements current guidelines may improve the quality of antihypertensive treatment, concurrently leading to a considerable reduction in drug costs.

Aged↗

Variation in physicians' definitions of the competent parent and other barriers to guideline adherence: the case of pediatric minor head injury management.

A lack of consensus regarding the definition of even an everyday term can affect physician adherence to clinical guidelines using that term. We demonstrate this by taking, as an illustrative case, the American Academy of Pediatrics' minor head injury (MHI) management guidelines, which generally recommend at-home observation by a "competent" parent (or the equivalent). The recommendation assumes consensus among physicians as to what parental competence comprises. We systematically examined this assumption. Physicians associated with Children's Hospital, San Diego were mailed a survey asking them to freely list terms defining parental competence. Independent variables were: physician gender, training, specialty, practice location, patient age mix, years in practice, and number of MHI cases seen per year. Dependent variables were: free-list content and length, ease and style of competence decision-making style (e.g., independent or collaborative), familiarity with the guidelines, and likelihood of ordering a computed tomography (CT) scan. Of 112 respondents, 34 (30%) were "not at all" or only "slightly" familiar with the guidelines; 23% (21/112) "frequently" or "sometimes" ordered CTs when the guidelines did not support this. Surgeons were more likely to order discretionary CTs. Office-based, pediatric-trained, and female physicians each found it significantly easier than their counterparts to determine which parents were, in their opinion, competent. Men reported using "objective" criteria significantly less frequently than women. A total of 64 discrete criteria were listed. Individual lists contained an average of 6.5 items. Surgeon's lists were significantly shorter than those of medical physicians. Seven sub-domains of competence were identified. Parental competence is not a unitary construct interpreted similarly by all physicians. Subgroups with distinct models may exist; training and specialization may be key variables. To decrease MHI management variation, guidelines should specify parental competence factors to be considered; they may need to be tailored to different physician subgroups.

Attitude of Health Personnel↗

Patterns of guideline adherence and care delivery for patients with unstable angina and non-ST-segment elevation myocardial infarction (from the CRUSADE Quality Improvement Initiative).

The Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) initiative is a prospective, rapid-cycle quality-improvement initiative that focuses on improving both the diagnostic evaluation of patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS; defined as ischemic ST-segment changes and/or positive cardiac markers) and the use of treatments recommended by the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for management of NSTE ACS. The ultimate goal of the CRUSADE initiative is to improve the quality of care among high-risk patients with NSTE ACS. At the same time, the CRUSADE initiative provides the unique opportunity to evaluate the pattern of NSTE ACS management in a large-scale, routine practice setting in the United States. Cumulatively, the CRUSADE initiative has collected data from >165,000 patients with NSTE ACS admitted at >400 US hospitals since 2001. This article reviews the major results from the CRUSADE initiative on risk stratification, gaps in guidelines adherence, paradoxical care, and the association of guideline adherence with outcomes.

Angina, Unstable↗

Influence of guideline adherence on outcome in a randomised controlled trial on the efficacy of methotrexate with folate supplementation in rheumatoid arthritis.

OBJECTIVE: To study the influence of rheumatologists' adherence to a methotrexate guideline on efficacy and toxicity in the treatment of rheumatoid arthritis. METHODS: In a 48 week randomised controlled trial of methotrexate, comparing folates with placebo, rheumatologists were advised on methotrexate dosage using a guideline reflecting daily practice. The influence of guideline non-adherence on outcome was analysed using generalised estimating equations and survival analysis. RESULTS: In 51% of the 411 study patients the guidelines were always followed. Non-adherence resulted in lower doses of methotrexate in 25% of cases, and higher doses in 24%. The reduction in the disease activity score was significantly greater (mean -0.4; p = 0.0085) in the adherent group than in the "low dose" group; the "high dose" group did not differ from the adherent group. Dropout caused by severe adverse events did not differ between the three groups. CONCLUSIONS: There is an indication that adherence to guidelines on methotrexate dosage may benefit patients with rheumatoid arthritis by improving disease activity without increasing toxicity. For definite proof, a randomised controlled trial comparing guideline supported dosing with usual care is needed.

Adult↗

Audit and feedback and clinical practice guideline adherence: making feedback actionable.

BACKGROUND: As a strategy for improving clinical practice guideline (CPG) adherence, audit and feedback (A&F) has been found to be variably effective, yet A&F research has not investigated the impact of feedback characteristics on its effectiveness. This paper explores how high performing facilities (HPF) and low performing facilities (LPF) differ in the way they use clinical audit data for feedback purposes. METHOD: Descriptive, qualitative, cross-sectional study of a purposeful sample of six Veterans Affairs Medical Centers (VAMCs) with high and low adherence to six CPGs, as measured by external chart review audits. One-hundred and two employees involved with outpatient CPG implementation across the six facilities participated in one-hour semi-structured interviews where they discussed strategies, facilitators and barriers to implementing CPGs. Interviews were analyzed using techniques from the grounded theory method. RESULTS: High performers provided timely, individualized, non-punitive feedback to providers, whereas low performers were more variable in their timeliness and non-punitiveness and relied on more standardized, facility-level reports. The concept of actionable feedback emerged as the core category from the data, around which timeliness, individualization, non-punitiveness, and customizability can be hierarchically ordered. CONCLUSION: Facilities with a successful record of guideline adherence tend to deliver more timely, individualized and non-punitive feedback to providers about their adherence than facilities with a poor record of guideline adherence. Consistent with findings from organizational research, feedback intervention characteristics may influence the feedback's effectiveness at changing desired behaviors.

Journal Article↗

The influence of risk status on guideline adherence for patients with non-ST-segment elevation acute coronary syndromes.

BACKGROUND: Practice guidelines for patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) recommend targeting evidence-based therapies for the highest-risk patients. We characterized guideline adherence for NSTE ACS by risk status. METHODS: We analyzed inhospital treatments and outcomes for 77760 patients with NSTE ACS (ischemic ST-segment changes and/or positive cardiac markers) included in the CRUSADE initiative from January 2001 to September 2003 at 457 US hospitals. Compliance with the American College of Cardiology/American Heart Association Class guideline recommendations for NSTE ACS was evaluated in subgroups of eligible patients without listed contraindications at increased risk for mortality and among risk categories designated by an adapted version of the PURSUIT risk model designed to predict inhospital mortality. RESULTS: Inhospital mortality was increased in patients with diabetes mellitus (5.8% vs 4.3%), renal insufficiency (10.0% vs 3.9%), signs of congestive heart failure on presentation (10.6% vs 3.1%), and age > or = 75 years (8.6% vs 2.7%), compared with patients without these features. Use of guideline-recommended acute medications, invasive cardiac procedures, and discharge medications and interventions was significantly lower in patients with these high-risk features. Patients designated as high-risk for inhospital mortality were less likely to be treated with guideline-recommended therapies compared with low-risk and moderate-risk patients. CONCLUSIONS: Patients with NSTE ACS with the highest risk of mortality are less likely to receive guideline-recommended therapies and interventions. These findings highlight the need to clarify guideline recommendations for high-risk patients and to develop novel quality improvement approaches that target undertreated subgroups of patients with NSTE ACS.

Acute Disease↗

Improving guideline adherence: a randomized trial evaluating strategies to increase beta-blocker use in heart failure.

BACKGROUND: The dissemination of clinical practice guidelines often has not been accompanied by desired improvements in guideline adherence. This study evaluated interventions for implementing a new practice guideline advocating the use of beta-blockers for heart failure patients. METHODS AND RESULTS: This was a randomized controlled trial involving heart failure patients (n=169) with an ejection fraction < or =45% and no contraindications to beta-blockers. Patients' primary providers were randomized in a stratified design to 1 of 3 interventions: (1) control: provider education; (2) provider and patient notification: computerized provider reminders and patient letters advocating beta-blockers; and (3) nurse facilitator: supervised nurse to initiate and titrate beta-blockers. The primary outcome, the proportion of patients who were initiated or uptitrated and maintained on beta-blockers, analyzed by intention to treat, was achieved in 67% (36 of 54) of patients in the nurse facilitator group compared with 16% (10 of 64) in the provider/patient notification and 27% (14 of 51) in the control groups (P<0.001 for the comparisons between the nurse facilitator group and both other groups). The proportion of patients on target beta-blocker doses at the study end (median follow-up, 12 months) was also highest in the nurse facilitator group (43%) compared with the control (10%) and provider/patient notification groups (2%) (P<0.001). There were no differences in adverse events among groups. CONCLUSIONS: The use of a nurse facilitator was a successful approach for implementing a beta-blocker guideline in heart failure patients. The use of provider education, clinical reminders, and patient education was of limited value in this setting.

Adrenergic beta-Antagonists↗

Guideline adherence for early breast cancer before and after introduction of the sentinel node biopsy.

This population-based study aimed to analyse variations in surgical treatment and guideline compliance with respect to the application of radiotherapy and axillary lymph node dissection (ALND), for early breast cancer, before and after the sentinel node biopsy (SNB) introduction. The study included 13 532 consecutive surgically treated stage I-IIIA breast cancer patients diagnosed in 1989-2002. Hospitals showed large variation in breast-conserving surgery (BCS) rates, ranging between 27 and 72% for T1 and 14 and 42% for T2 tumours. In multivariate analysis marked inter-hospital and time-dependent variation in the BCS rate remained after correction for case-mix. The guideline adherence was markedly lower for elderly patients. In 25.2% of the patients aged > or = 75 years either ALND or radiotherapy were omitted. The proportion of patients with no ALND after an SNB increased from 1.8% in 1999 to 37.8% in 2002. However, in 2002 also 12.2% of the patients with a positive SNB did not have an ALND. Guideline compliance for BCS, with respect to radiotherapy and ALND, fell since the SNB introduction, from 96.1% before 2000 to 91.4% in 2002 (P < 0.001). Noncompliance may however reflect patient-tailored medicine, as for elderly patients with small, radically resected primary tumours. The considerable variation in BCS-rates is more consistent with variations in surgeon preferences than patient's choice.

Aged↗

Barriers to guideline adherence. Based on a presentation by Michael Cabana, MD.

Successful implementation of the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-VI) should improve quality of care by decreasing inappropriate variation and by disseminating new advances to everyday practice. A key component of this process is physician adherence to JNC-VI guidelines. However several reports in the literature show a discrepancy between hypertension guidelines and actual practice. The factors that influence physician behavior change and optimal use of practice guidelines are poorly understood. A combined model that uses the Awareness-to-Adherence Model and Social Cognitive Theory identifies five sequential steps that lead to adherence to a guideline--awareness, agreement, self-efficacy, outcome expectancy, and presence of a cueing mechanism. Barriers to implementation may occur at any of these steps and can be identified with this model. Programs can then be designed to overcome specific barriers. By conceptualizing the underlying issues in physician adherence, the combined model should be useful to guideline developers, practice directors, and health services researchers.

Awareness↗

Guideline adherence in medication management of psychotic disorders: an observational multisite hospital study.

OBJECTIVE: To evaluate guideline adherence in in-patient medication care of psychotic disorders. METHOD: A total of 508 persons with psychotic disorders were included in a naturalistic multisite hospital study. Subjects were assessed weekly on mental state, social functioning, socioeconomic factors and medication prescriptions. RESULTS: In total, 17% of individuals were prescribed antipsychotic dosages above the recommended value. Among those with persistent psychotic symptoms, 73% received insufficient antipsychotic drug management. About 58% of patients with depressive symptoms were not treated according to guidelines, and 53% of patients did not receive adequate management of side-effects from antipsychotic medications. Subjects with more than six previous psychiatric hospitalizations (OR 1.80, CI: 1.05-3.08) and those with a prominent thought disorder (OR 2.28, CI: 1.23-4.23) had a higher likelihood of not being treated according to guidelines. CONCLUSION: Individuals with chronic and thought-disordered psychosis may be at a higher risk of receiving medication care not supported by guidelines.

Adult↗