Conflict of interest in clinical practice guideline development: a systematic review

Background

There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.

Methodology/Principal Findings

We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6–80%); research support (4–78%); equity/stock ownership (2–17%); or any COI (56–87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.

Conclusions/Significance

There are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias.     

Applying psychological theories to evidence-based clinical practice: identifying factors predictive of lumbar spine x-ray for low back pain in UK primary care practice

Background

Effectiveness of combined physician and patient-level interventions for blood pressure (BP) control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH) Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC) in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs).

Methods

Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (e.g., BP, anti-hypertensive medications), psychosocial (e.g., depression, medication adherence, self-efficacy), and behavioral (e.g., exercise, diet) characteristics were gathered through direct observation, chart review, and interview.

Results

The sample was primarily female (71.6%), middle-aged (mean age = 56.9 ± 12.1 years), high school educated (62.4%), low-income (72.4% reporting less than $20,000/year income), and received Medicaid (35.9%) or Medicare (12.6%). Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs). One-quarter (25.6%) of the sample had resistant hypertension; one-half (55.7%) reported medication non-adherence. Most (79.7%) reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes mellitus was common (35.8%), and moderate/severe depression was present in 16% of participants. Participants were sedentary (835.3 ± 1,644.2 Kcal burned per week), obese (59.7%), and had poor global physical health, poor eating habits, high health literacy, and good overall mental health.

Conclusions

A majority of patients in the CAATCH trial exhibited adverse lifestyle behaviors, and had significant medical and psychosocial barriers to adequate BP control. Trial outcomes will shed light on the effectiveness of evidence-based interventions for BP control when implemented in real-world medical settings that serve high numbers of low-income hypertensive African-Americans with multiple co-morbidity and significant barriers to behavior change.     

Audit and feedback and clinical practice guideline adherence: Making feedback actionable

Background

Effective interventions prepare patients for making values-sensitive health decisions by helping them become informed and clarifying their values for each of the options. However, patient decision support interventions have not been widely implemented and little is known about effective models for delivering them to patients. The purpose of this study was to describe call centre nurses' adoption of a decision support protocol into practice following exposure to an implementation intervention and to identify factors influencing sustainable nursing practice changes.

Methods

Exploratory case study at a Canadian province-wide call centre guided by the Ottawa Model of Research Use. Data sources included a survey of nurses who participated in an implementation intervention (n = 31), 2 focus groups with nurses, interviews with 4 administrators, and a document review.

Results

Twenty-five of 31 nurses responded to the survey measuring adoption of decision support in practice. Of the 25 nurses, 11 had used the decision support protocol in their practice within one month of the intervention. Twenty-two of the 25 intended to use it within the next three months. Although some nurses found it challenging to begin using the protocol, most nurses reported that it: a) helped them recognize callers needing decision support; b) changed their approach to handling these calls; and c) was a positive enhancement to their practice. Strategies identified to promote sustainability of practice changes included integration of the decision support protocol in the call centre database, streamlining the patient decision aids for easier use via telephone, clarifying the administrative direction for the call centre's program, creating a call length guideline specific for these calls, incorporating decision support training in the staff development plan, and informing the public of this enhanced service.

Conclusion

Although most nurses adopted the decision support protocol for coaching callers facing values-sensitive decisions, to sustain practice changes, interventions are required to manage barriers in the practice environment and integrate decision support into the organization's policies, resources, and routine activities.     

Adapting HIV prevention evidence-based interventions in practice settings: an interview study

Background

A knowledge broker (KB) is a popular knowledge translation and exchange (KTE) strategy emerging in Canada to promote interaction between researchers and end users, as well as to develop capacity for evidence-informed decision making. A KB provides a link between research producers and end users by developing a mutual understanding of goals and cultures, collaborates with end users to identify issues and problems for which solutions are required, and facilitates the identification, access, assessment, interpretation, and translation of research evidence into local policy and practice. Knowledge-brokering can be carried out by individuals, groups and/or organizations, as well as entire countries. In each case, the KB is linked with a group of end users and focuses on promoting the integration of the best available evidence into policy and practice-related decisions.

Methods

A KB intervention comprised one of three KTE interventions evaluated in a randomized controlled trial.

Results

KB activities were classified into the following categories: initial and ongoing needs assessments; scanning the horizon; knowledge management; KTE; network development, maintenance, and facilitation; facilitation of individual capacity development in evidence informed decision making; and g) facilitation of and support for organizational change.

Conclusion

As the KB role developed during this study, central themes that emerged as particularly important included relationship development, ongoing support, customized approaches, and opportunities for individual and organizational capacity development. The novelty of the KB role in public health provides a unique opportunity to assess the need for and reaction to the role and its associated activities. Future research should include studies to evaluate the effectiveness of KBs in different settings and among different health care professionals, and to explore the optimal preparation and training of KBs, as well as the identification of the personality characteristics most closely associated with KB effectiveness. Studies should also seek to better understand which combination of KB activities are associated with optimal evidence-informed decision making outcomes, and whether the combination changes in different settings and among different health care decision makers.     

Biomarkers for cardiovascular risk prediction: from pioneering to evidence-based use in clinical practice

Netherlands Heart Journal -     

Institutionalizing evidence-based practice: an organizational case study using a model of strategic change

Background

There is a general expectation within healthcare that organizations should use evidence-based practice (EBP) as an approach to improving the quality of care. However, challenges exist regarding how to make EBP a reality, particularly at an organizational level and as a routine, sustained aspect of professional practice.

Methods

A mixed method explanatory case study was conducted to study context; i.e., in terms of the presence or absence of multiple, inter-related contextual elements and associated strategic approaches required for integrated, routine use of EBP ('institutionalization'). The Pettigrew et al. Content, Context, and Process model was used as the theoretical framework. Two sites in the US were purposively sampled to provide contrasting cases: i.e., a 'role model' site, widely recognized as demonstrating capacity to successfully implement and sustain EBP to a greater degree than others; and a 'beginner' site, self-perceived as early in the journey towards institutionalization.

Results

The two sites were clearly different in terms of their organizational context, level of EBP activity, and degree of institutionalization. For example, the role model site had a pervasive, integrated presence of EBP versus a sporadic, isolated presence in the beginner site. Within the inner context of the role model site, there was also a combination of the Pettigrew and colleagues' receptive elements that, together, appeared to enhance its ability to effectively implement EBP-related change at multiple levels. In contrast, the beginner site, which had been involved for a few years in EBP-related efforts, had primarily non-receptive conditions in several contextual elements and a fairly low overall level of EBP receptivity. The beginner site thus appeared, at the time of data collection, to lack an integrated context to either support or facilitate the institutionalization of EBP.

Conclusion

Our findings provide evidence of some of the key contextual elements that may require attention if institutionalization of EBP is to be realized. They also suggest the need for an integrated set of receptive contextual elements to achieve EBP institutionalization; and they further support the importance of specific interactions among these elements, including ways in which leadership affects other contextual elements positively or negatively.     

Hepatitis B in China： from Guideline to Practice

Chronic hepatitis B infection is a very important health problem in China, which is carrying an enormous economic and social burdens. The major routs of chronic hepatitis B infection in China are mother-infant vertical transmission and early childhood horizontal transmission. After more than 10 years implementation of universal vaccination against hepatitis B in newborns and safety injection in health care settings, the prevalence of HBsAg in general population has decreased from 9.75% to around 7%. In China, patients with hepatitis are cared by either hepatologists or physicians of infectious diseases. The Chinese Society of Hepatology, and Chinese Society of Infectious Diseases jointly issued an evidence-based guideline on the prevention and treatment of chronic hepatitis B in 2005. This guideline concisely describes the virology, epidemiology, natural history and prevention, as well as diagnosis and management of chronic hepatitis B. It also highlights the importance of active viral replication in disease progression in chronic HBV infection and explicitly states the necessity of antiviral therapy in patient care. The cornerstone of anti-hepatitis B therapy is optimal use of interferons or nucleos(t)ide analogs in those patients with active viral replication and elevated serum transaminase levels. Through an independent continue medical educational agency, a panel of selected speakers were trained to give well-formatted talks on the key points of the guideline in over 60 major cities across China. This educational campaign among health care providers has greatly improved the awareness and the stand of care for antiviral therapy.     

Designing an automated clinical decision support system to match clinical practice guidelines for opioid therapy for chronic pain

Background

Opioid prescribing for chronic pain is common and controversial, but recommended clinical practices are followed inconsistently in many clinical settings. Strategies for increasing adherence to clinical practice guideline recommendations are needed to increase effectiveness and reduce negative consequences of opioid prescribing in chronic pain patients.

Methods

Here we describe the process and outcomes of a project to operationalize the 2003 VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Non-Cancer Pain into a computerized decision support system (DSS) to encourage good opioid prescribing practices during primary care visits. We based the DSS on the existing ATHENA-DSS. We used an iterative process of design, testing, and revision of the DSS by a diverse team including guideline authors, medical informatics experts, clinical content experts, and end-users to convert the written clinical practice guideline into a computable algorithm to generate patient-specific recommendations for care based upon existing information in the electronic medical record (EMR), and a set of clinical tools.

Results

The iterative revision process identified numerous and varied problems with the initially designed system despite diverse expert participation in the design process. The process of operationalizing the guideline identified areas in which the guideline was vague, left decisions to clinical judgment, or required clarification of detail to insure safe clinical implementation. The revisions led to workable solutions to problems, defined the limits of the DSS and its utility in clinical practice, improved integration into clinical workflow, and improved the clarity and accuracy of system recommendations and tools.

Conclusions

Use of this iterative process led to development of a multifunctional DSS that met the approval of the clinical practice guideline authors, content experts, and clinicians involved in testing. The process and experiences described provide a model for development of other DSSs that translate written guidelines into actionable, real-time clinical recommendations.