PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (1332961)

Clipboard (0)
None

Related Articles

1.  Why don't physicians adhere to guideline recommendations in practice? An analysis of barriers among Dutch general practitioners 
Background
Despite wide distribution and promotion of clinical practice guidelines, adherence among Dutch general practitioners (GPs) is not optimal. To improve adherence to guidelines, an analysis of barriers to implementation is advocated. Because different recommendations within a guideline can have different barriers, in this study we focus on key recommendations rather than guidelines as a whole, and explore the barriers to implementation perceived by Dutch GPs.
Methods
A qualitative study using six focus groups was conducted, in which 30 GPs participated, with an average of seven per session. Fifty-six key recommendations were derived from twelve national guidelines. In each focus group, barriers to the implementation of the key recommendations of two clinical practice guidelines were discussed. Focus group discussions were audiotaped and transcribed verbatim. Data was analysed by using an existing framework of barriers.
Results
The barriers varied largely within guidelines, with each key recommendation having a unique pattern of barriers. The most perceived barriers were lack of agreement with the recommendations due to lack of applicability or lack of evidence (68% of key recommendations), environmental factors such as organisational constraints (52%), lack of knowledge regarding the guideline recommendations (46%), and guideline factors such as unclear or ambiguous guideline recommendations (43%).
Conclusion
Our study findings suggest a broad range of barriers. As the barriers largely differ within guidelines, tailored and barrier-driven implementation strategies focusing on key recommendations are needed to improve adherence in practice. In addition, guidelines should be more transparent concerning the underlying evidence and applicability, and further efforts are needed to address complex issues such as comorbidity in guidelines. Finally, it might be useful to include focus groups in continuing medical education as an innovative medium for guideline education and implementation.
doi:10.1186/1748-5908-4-54
PMCID: PMC2734568  PMID: 19674440
2.  Barriers to adherence to chronic obstructive pulmonary disease guidelines by primary care physicians 
Purpose:
Even with the dissemination of several clinical guidelines, chronic obstructive pulmonary disease (COPD) remains underdiagnosed and mismanaged by many primary care physicians (PCPs). The objective of this study was to elucidate barriers to consistent implementation of COPD guidelines.
Patients and methods:
A cross-sectional study implemented in July 2008 was designed to assess attitudes and barriers to COPD guideline usage.
Results:
Five hundred US PCPs (309 family medicine physicians, 191 internists) were included in the analysis. Overall, 23.6% of the surveyed PCPs reported adherence to spirometry guidelines over 90% of the time; 25.8% reported adherence to guidelines related to long-acting bronchodilator (LABD) use in COPD patients. In general, physicians were only somewhat familiar with COPD guidelines, and internal medicine physicians were significantly more familiar than family physicians (P < 0.05). In a multivariate model controlling for demographics and barriers to guideline adherence, we found significant associations with two tested guideline components. Adherence to spirometry guidelines was associated with agreement with guidelines, confidence in interpreting data, ambivalence to outcome expectancy, and ability to incorporate spirometry into patient flow. Adherence to LABD therapy guidelines was associated with agreement with guidelines and confidence in gauging pharmacologic response.
Conclusions:
Adherence to guideline recommendations of spirometry use was predicted by agreement with the recommendations, self-efficacy, perceived outcome expectancy if recommendations were adhered to, and resource availability. Adherence to recommendations of LABD use was predicted by agreement with guideline recommendations and self-efficacy. Increasing guideline familiarity alone may have limited patient outcomes, as other barriers, such as low confidence and outcome expectancy, are more likely to impact guideline adherence.
doi:10.2147/COPD.S16396
PMCID: PMC3064423  PMID: 21468169
COPD; primary care; barriers; guideline adoption
3.  Guidelines on uncomplicated urinary tract infections are difficult to follow: perceived barriers and suggested interventions 
BMC Family Practice  2010;11:51.
Background
Urinary tract infections (UTI) are among the most common health problems seen in general practice. Evidence-based guidelines on UTI are available, but adherence to these guidelines varies widely among practitioners for reasons not well understood. The aim of this study was to identify the barriers to the implementation of a guideline on UTI perceived by Dutch general practitioners (GPs) and to explore interventions to overcome these barriers.
Methods
A focus group study, including 13 GPs working in general practices in the Netherlands, was conducted. Key recommendations on diagnosis and treatment of uncomplicated UTI were selected from the guideline. Barriers to guideline adherence and possible interventions to address these barriers were discussed. The focus group session was audio-taped and transcribed verbatim. Barriers were classified according to an existing framework.
Results
Lack of agreement with the recommendations, unavailable and inconvenient materials (i.e. dipslides), and organisational constraints were perceived as barriers for the diagnostic recommendations. Barriers to implementing the treatment recommendations were lack of applicability and organisational constraints related to the availability of drugs in pharmacies. Suggested interventions were to provide small group education to GPs and practice staff members, to improve organisation and coordination of care in out of hour services, to improve the availability of preferred dosages of drugs, and to pilot-test guidelines regionally.
Conclusions
Despite sufficient knowledge of the recommendations on UTI, attitudinal and external barriers made it difficult to follow them in practice. The care concerning UTI could be optimized if these barriers are adequately addressed in implementation strategies. The feasibility and success of these strategies could be improved by involving the target group of the guideline in selecting useful interventions to address the barriers to implementation.
doi:10.1186/1471-2296-11-51
PMCID: PMC2908068  PMID: 20584276
4.  Labour intensity of guidelines may have a greater effect on adherence than GPs' workload 
BMC Family Practice  2009;10:74.
Background
Physicians' heavy workload is often thought to jeopardise the quality of care and to be a barrier to improving quality. The relationship between these has, however, rarely been investigated. In this study quality of care is defined as care 'in accordance with professional guidelines'. In this study we investigated whether GPs with a higher workload adhere less to guidelines than those with a lower workload and whether guideline recommendations that require a greater time investment are less adhered to than those that can save time.
Methods
Data were used from the Second Dutch National survey of General Practice (DNSGP-2). This nationwide study was carried out between April 2000 and January 2002.
A multilevel logistic-regression analysis was conducted of 170,677 decisions made by GPs, referring to 41 Guideline Adherence Indicators (GAIs), which were derived from 32 different guidelines. Data were used from 130 GPs, working in 83 practices with 98,577 patients. GP-characteristics as well as guideline characteristics were used as independent variables. Measures include workload (number of contacts), hours spent on continuing medical education, satisfaction with available time, practice characteristics and patient characteristics. Outcome measure is an indicator score, which is 1 when a decision is in accordance with professional guidelines or 0 when the decision deviates from guidelines.
Results
On average, 66% of the decisions GPs made were in accordance with guidelines. No relationship was found between the objective workload of GPs and their adherence to guidelines. Subjective workload (measured on a five point scale) was negatively related to guideline adherence (OR = 0.95). After controlling for all other variables, the variation between GPs in adherence to guideline recommendations showed a range of less than 10%.
84% of the variation in guideline adherence was located at the GAI-level. Which means that the differences in adherence levels between guidelines are much larger than differences between GPs. Guideline recommendations that require an extra time investment during the same consultation are significantly less adhered to: (OR = 0.46), while those that can save time have much higher adherence levels: OR = 1.55). Recommendations that reduce the likelihood of a follow-up consultation for the same problem are also more often adhered to compared to those that have no influence on this (OR = 3.13).
Conclusion
No significant relationship was found between the objective workload of GPs and adherence to guidelines. However, guideline recommendations that require an extra time investment are significantly less well adhered to while those that can save time are significantly more often adhered to.
doi:10.1186/1471-2296-10-74
PMCID: PMC2791751  PMID: 19943953
5.  Adherence to the European Society of Cardiology (ESC) guidelines for chronic heart failure - A national survey of the cardiologists in Pakistan 
Background
The aims of this study were to evaluate the awareness of and attitudes towards the 2005 European Society of Cardiology (ESC) guidelines for Heart Failure (HF) of the cardiologists in Pakistan and assess barriers to adherence to guidelines.
Methods
A cross-sectional survey was conducted in person from March to July 2009 to all cardiologists practicing in 4 major cities in Pakistan (Karachi, Lahore, Quetta and Peshawar). A validated, semi-structured questionnaire assessing ESC 2005 Guidelines for HF was used to obtain information from cardiologists. It included questions about awareness and relevance of HF guidelines (See Additional File 1). Respondents' management choices were compared with those of an expert panel based on the guidelines for three fictitious patient cases. Cardiologists were also asked about major barriers to adherence to guidelines.
Results
A total of 372 cardiologists were approached; 305 consented to participate (overall response rate, 82.0%). The survey showed a very high awareness of CHF guidelines; 97.4% aware of any guideline. About 13.8% considered ESC guidelines as relevant or very relevant for guiding treatment decisions while 92.8% chose AHA guidelines in relevance. 87.2% of respondents perceived that they adhered to the HF guidelines. For the patient cases, the proportions of respondents who made recommendations that completely matched those of the guidelines were 7% (Scenario 1), 0% (Scenario 2) and 20% (Scenario 3). Respondents considered patient compliance (59%) and cost/health economics (50%) as major barriers to guideline implementation.
Conclusion
We found important self reported departures from recommended HF management guidelines among cardiologists of Pakistan.
doi:10.1186/1471-2261-11-68
PMCID: PMC3250933  PMID: 22093082
Heart failure; cardiologist; guidelines; awareness
6.  Barriers and facilitators to the implementation of clinical practice guidelines: A cross-sectional survey among physicians in Estonia 
Background
In an era when an increasing amount of clinical information is available to health care professionals, the effective implementation of clinical practice guidelines requires the development of strategies to facilitate the use of these guidelines. The objective of this study was to assess attitudes towards clinical practice guidelines, as well as the barriers and facilitators to their use, among Estonian physicians. The study was conducted to inform the revision of the clinical practice guideline development process and can provide inspiration to other countries considering the increasing use of evidence-based medicine.
Methods
We conducted an online survey of physicians to assess resource, system, and attitudinal barriers. We also asked a set of questions related to improving the use of clinical practice guidelines and collected free-text comments. We hypothesized that attitudes concerning guidelines may differ by gender, years of experience and practice setting. The study population consisted of physicians from the database of the Department of Continuing Medical Education of the University of Tartu. Differences between groups were analyzed using the Kruskal-Wallis non-parametric test.
Results
41% (497/1212) of physicians in the database completed the questionnaire, comprising more than 10% of physicians in the country. Most respondents (79%) used treatment guidelines in their daily clinical practice. Lack of time was the barrier identified by the most physicians (42%), followed by lack of medical resources for implementation (32%). The majority of physicians disagreed with the statement that guidelines were not accessible (73%) or too complicated (70%). Physicians practicing in outpatient settings or for more than 25 years were the most likely to experience difficulties in guideline use. 95% of respondents agreed that an easy-to-find online database of guidelines would facilitate use.
Conclusions
Use of updated evidence-based guidelines is a prerequisite for the high-quality management of diseases, and recognizing the factors that affect guideline compliance makes it possible to work towards improving guideline adherence in clinical practice. In our study, physicians with long-term clinical experience and doctors in outpatient settings perceived more barriers, which should be taken into account when planning strategies in improving the use of guidelines. Informed by the results of the survey, leading health authorities are making an effort to develop specially designed interventions to implement clinical practice guidelines, including an easily accessible online database.
doi:10.1186/1472-6963-12-455
PMCID: PMC3532376  PMID: 23234504
Clinical practice guidelines; Implementation; Estonia; World health organization; Barriers; Facilitators
7.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
8.  Patient Adherence to Tuberculosis Treatment: A Systematic Review of Qualitative Research 
PLoS Medicine  2007;4(7):e238.
Background
Tuberculosis (TB) is a major contributor to the global burden of disease and has received considerable attention in recent years, particularly in low- and middle-income countries where it is closely associated with HIV/AIDS. Poor adherence to treatment is common despite various interventions aimed at improving treatment completion. Lack of a comprehensive and holistic understanding of barriers to and facilitators of, treatment adherence is currently a major obstacle to finding effective solutions. The aim of this systematic review of qualitative studies was to understand the factors considered important by patients, caregivers and health care providers in contributing to TB medication adherence.
Methods and Findings
We searched 19 electronic databases (1966–February 2005) for qualitative studies on patients', caregivers', or health care providers' perceptions of adherence to preventive or curative TB treatment with the free text terms “Tuberculosis AND (adherence OR compliance OR concordance)”. We supplemented our search with citation searches and by consulting experts. For included studies, study quality was assessed using a predetermined checklist and data were extracted independently onto a standard form. We then followed Noblit and Hare's method of meta-ethnography to synthesize the findings, using both reciprocal translation and line-of-argument synthesis. We screened 7,814 citations and selected 44 articles that met the prespecified inclusion criteria. The synthesis offers an overview of qualitative evidence derived from these multiple international studies. We identified eight major themes across the studies: organisation of treatment and care; interpretations of illness and wellness; the financial burden of treatment; knowledge, attitudes, and beliefs about treatment; law and immigration; personal characteristics and adherence behaviour; side effects; and family, community, and household support. Our interpretation of the themes across all studies produced a line-of-argument synthesis describing how four major factors interact to affect adherence to TB treatment: structural factors, including poverty and gender discrimination; the social context; health service factors; and personal factors. The findings of this study are limited by the quality and foci of the included studies.
Conclusions
Adherence to the long course of TB treatment is a complex, dynamic phenomenon with a wide range of factors impacting on treatment-taking behaviour. Patients' adherence to their medication regimens was influenced by the interaction of a number of these factors. The findings of our review could help inform the development of patient-centred interventions and of interventions to address structural barriers to treatment adherence.
From a systematic review of qualitative research, Munro and coauthors found that a range of interacting factors can lead to patients deciding not to complete their course of tuberculosis treatment.
Editors' Summary
Background.
Every year nearly nine million people develop tuberculosis—a contagious infection, usually of the lungs—and about two million people die from the disease. Tuberculosis is caused by Mycobacterium tuberculosis, bacteria that are spread in airborne droplets when people with active tuberculosis sneeze or cough. Tuberculosis can be cured by taking several strong antibiotics daily for at least six months but many patients fail to complete this treatment because the drugs have unpleasant side-effects and the treatment is complicated. In addition, people often feel better soon after starting treatment so they stop taking their tablets before all the bacteria in their body are dead. Poor treatment adherence (poor compliance) means that people remain infectious for longer and are more likely to relapse and die. It also contributes to the emergence of drug-resistant tuberculosis. To help people complete their treatment, the World Health Organization recommends a strategy known as DOTS (directly observed treatment, short course). As part of this strategy, a health worker or a tuberculosis treatment supporter—a person nominated by the health worker and the patient—watches the patient take his/her antibiotics.
Why Was This Study Done?
Although DOTS has contributed to improved tuberculosis control, better patient compliance is needed to halt the global tuberculosis epidemic. Treatment adherence is a complex behavioral issue and improving treatment outcomes for tuberculosis (and for other diseases) requires a full understanding of the factors that prevent people taking medicines correctly and those that help them complete their treatment. In this study, the researchers have done a systematic review (a study in which the medical literature is surveyed and appraised using defined methods to reach a consensus view on a specific question) of qualitative studies that asked patients, carers, and health workers which factors contributed to adherence to tuberculosis treatment. Qualitative studies collect non-quantitative data so, for example, a qualitative study on tuberculosis treatment might ask people how the treatment made them feel whereas a quantitative study might count bacteria in patient samples.
What Did the Researchers Do and Find?
The researchers searched electronic databases and reference lists for qualitative studies on adherence to tuberculosis treatments and also consulted experts on tuberculosis treatment. They carefully read the 44 published papers that met their predefined inclusion criteria and then used a method called “meta-ethnography” to compare the factors (themes) associated with good or bad adherence in the different studies and to synthesize (reach) a consensus view of which factors influence adherence to tuberculosis treatment. The researchers identified eight major factors associated with adherence to treatment. These included: health service factors such as the organization of treatment and care; social context (family, community and household influences); and the financial burden of treatment. Finally, the researchers interpreted the themes that emerged from the studies to build a simple model that proposes that adherence to tuberculosis treatment is influenced by four interacting sets of factors—structural factors (including poverty and gender discrimination), social context factors, health service factors, and personal factors (including attitudes towards treatment and illness).
What Do These Findings Mean?
The findings of this systematic review of qualitative research on patient adherence to tuberculosis treatment are inevitably limited by the quality and scope of the original research. Consequently, further studies into patients' understanding of tuberculosis and its treatment are needed. Nevertheless, the findings and the model proposed by the researchers indicate that patients often take their tuberculosis medications under very difficult conditions and that they cannot control many of the factors that prevent them taking their drugs. So, although current efforts to improve adherence to tuberculosis treatments emphasize instilling a willingness to take their medications into patients, this systematic review suggests that more must be done to address how factors such as poverty and gender affect treatment adherence and to tailor support systems to patients' needs. Most importantly, it indicates that future interventions should involve patients more in the decisions made about their treatment.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040238.
MedlinePlus has an encyclopedia page on tuberculosis (in English and Spanish)
See the US National Institute of Allergy and Infectious Disease fact sheet on tuberculosis
US Centers for Disease Control and Prevention provide a variety of fact sheets and other information resources on tuberculosis
World Health Organization has produced the 2007 Global Tuberculosis Control report (in English with key findings in French and Spanish), information on DOTS (in English, Spanish, French, Russian, Arabic and Chinese), and A Guide for Tuberculosis Treatment Supporters
See the brief guide to systematic reviews, published by the British Medical Journal
doi:10.1371/journal.pmed.0040238
PMCID: PMC1925126  PMID: 17676945
9.  Rational Prescribing in Primary Care (RaPP): A Cluster Randomized Trial of a Tailored Intervention 
PLoS Medicine  2006;3(6):e134.
Background
A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.
Methods and Findings
We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals.
The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49–2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
Conclusions
Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.
Editors' Summary
Background.
An important issue in health care is “getting research into practice,” in other words, making sure that, when evidence from research has established the best way to treat a disease, doctors actually use that approach with their patients. In reality, there is often a gap between evidence and practice.
  An example concerns the treatment of people who have high blood pressure (hypertension) and/or high cholesterol. These are common conditions, and both increase the risk of having a heart attack or a stroke. Research has shown that the risks can be lowered if patients with these conditions are given drugs that lower blood pressure (antihypertensives) and drugs that lower cholesterol. There are many types of these drugs now available. In many countries, the health authorities want family doctors (general practitioners) to make better use of these drugs. They want doctors to prescribe them to everyone who would benefit, using the type of drugs found to be most effective. When there is a choice of drugs that are equally effective, they want doctors to use the cheapest type. (In the case of antihypertensives, an older type, known as thiazides, is very effective and also very cheap, but many doctors prefer to give their patients newer, more expensive alternatives.) Health authorities have issued guidelines to doctors that address these issues. However, it is not easy to change prescribing practices, and research in several countries has shown that issuing guidelines has only limited effects.
Why Was This Study Done?
The researchers wanted—in two parts of Norway—to compare the effects on prescribing practices of what they called the “passive dissemination of guidelines” with a more active approach, where the use of the guidelines was strongly promoted and encouraged.
What Did the Researchers Do and Find?
They worked with 146 general practices. In half of them the guidelines were actively promoted. The remaining were regarded as a control group; they were given the guidelines but no special efforts were made to encourage their use. It was decided at random which practices would be in which group; this approach is called a randomized controlled trial. The methods used to actively promote use of the guidelines included personal visits to the practices by pharmacists and use of a computerized reminder system. Information was then collected on the number of patients who, when first treated for hypertension, were prescribed a thiazide. Other information collected included whether patients had been properly assessed for their level of risk (for strokes and heart attacks) before antihypertensive or cholesterol-lowering drugs were given. In addition, the researchers recorded whether the recommended targets for improvement in blood pressure and cholesterol level had been reached.
Only 11% of those patients visiting the control group of practices who should have been prescribed thiazides, according to the guidelines, actually received them. Of those seen by doctors in the practices where the guidelines were actively promoted, 17% received thiazides. According to statistical analysis, the increase achieved by active promotion is significant. Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
What Do These Findings Mean?
Even in the active promotion group, the great majority of patients (83%) were still not receiving treatment according to the guidelines. However, active promotion of guidelines is more effective than simply issuing the guidelines by themselves. The study also demonstrates that it is very hard to change prescribing practices. The efforts made here to encourage the doctors to change were considerable, and although the results were significant, they were still disappointing. Also disappointing is the fact that achievement of treatment goals was no better in the active-promotion group. These issues are discussed further in a Perspective about this study (DOI: 10.1371/journal.pmed.0030229).
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030134.
• The Web site of the American Academy of Family Physicians has a page on heart disease
• The MedlinePlus Medical Encyclopedia's pages on heart diseases and vascular diseases
• Information from NHS Direct (UK National Health Service) about heart attack and stroke
• Another PLoS Medicine article has also addressed trends in thiazide prescribing
Passive dissemination of management guidelines for hypertension and hypercholesterolaemia was compared with active promotion. Active promotion led to significant improvement in antihypertensive prescribing but not other aspects of management.
doi:10.1371/journal.pmed.0030134
PMCID: PMC1472695  PMID: 16737346
10.  Experiences and barriers to implementation of clinical practice guideline for depression in Korea 
BMC Psychiatry  2013;13:150.
Background
Clinical guidelines can improve health-care delivery, but there are a number of challenges in adopting and implementing the current practice guidelines for depression. The aim of this study was to determine clinical experiences and perceived barriers to the implementation of these guidelines in psychiatric care.
Methods
A web-based survey was conducted with 386 psychiatric specialists to inquire about experiences and attitudes related to the depression guidelines and barriers influencing the use of the guidelines. Quantitative data were analyzed, and qualitative data were transcribed and coded manually.
Results
Almost three quarters of the psychiatrists (74.6%) were aware of the clinical guidelines for depression, and over half of participants (55.7%) had had clinical experiences with the guidelines in practice. The main reported advantages of the guidelines were that they helped in clinical decision making and provided informative resources for the patients and their caregivers. Despite this, some psychiatrists were making treatment decisions that were not in accordance with the depression guidelines. Lack of knowledge was the main obstacle to the implementation of guidelines assessed by the psychiatrists. Other complaints addressed difficulties in accessing the guidelines, lack of support for mental health services, and general attitudes toward guideline necessity. Overall, the responses suggested that adding a summary booklet, providing teaching sessions, and improving guidance delivery systems could be effective tools for increasing depression guideline usage.
Conclusion
Individual barriers, such as lack of awareness and lack of familiarity, and external barriers, such as the supplying system, can affect whether physicians’ implement the guidelines for the treatment of depression in Korea. These findings suggest that further medical education to disseminate guidelines contents could improve public health for depression.
doi:10.1186/1471-244X-13-150
PMCID: PMC3681685  PMID: 23705908
Depressive disorder; Practice guidelines; Health care surveys; Questionnaires
11.  BARRIERS TO ADHERENCE TO COPD GUIDELINES AMONG PRIMARY CARE PROVIDERS 
Respiratory Medicine  2011;106(3):374-381.
Background
Despite efforts to disseminate guidelines for managing chronic obstructive pulmonary disease (COPD), adherence to COPD guidelines remains suboptimal. Barriers to adhering to guidelines remain poorly understood.
Methods
Clinicians from two general medicine practices in New York City were surveyed to identify barriers to implementing seven recommendations from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. Barriers assessed included unfamiliarity, disagreement, low perceived benefit, low self-efficacy, and time constraints. Exact conditional regression was used to identify barriers independently associated with non-adherence.
Results
The survey was completed by 154 clinicians. Adherence was lowest to referring patients with a forced expiratory volume in one second (FEV1) <80% predicted to pulmonary rehabilitation (5%); using FEV1 to guide management (12%); and ordering pulmonary function tests (PFTs) in smokers (17%). Adherence was intermediate to prescribing inhaled corticosteroids when FEV1 <50% predicted (41%) and long-acting bronchodilators when FEV1 <80% predicted (54%). Adherence was highest for influenza vaccination (90%) and smoking cessation counseling (91%). In unadjusted analyses, low familiarity with the guidelines, low self-efficacy, and time constraints were significantly associated with non-adherence to ≥2 recommendations. In adjusted analyses, low self-efficacy was associated with less adherence to prescribing inhaled corticosteroids (OR: 0.28; 95% CI: 0.10, 0.74) and time constraints were associated with less adherence to ordering PFTs in smokers (OR: 0.31; 95% CI: 0.08, 0.99).
Conclusions
Poor familiarity with recommendations, low self-efficacy, and time constraints are important barriers to adherence to COPD guidelines. This information can be used to develop tailored interventions to improve guideline adherence.
doi:10.1016/j.rmed.2011.09.010
PMCID: PMC3377746  PMID: 22000501
COPD; guidelines; adherence; primary care
12.  General practitioners' use of guidelines in the consultation and their attitudes to them. 
BACKGROUND: There is concern about the apparent lack of uptake of management and referral guideline information by general practitioners (GPs) in their day-to-day consultations with patients. Little is understood about the barriers to the uptake of guidelines as perceived by GPs. AIMS: To explore how GPs gain access to and use guidelines, including computer-based guidelines, in day-to-day consultations with their patients; and to identify the perceived problems and barriers to the use of guidelines in such situations. METHOD: Postal questionnaires enquiring about the practices and attitudes towards the use of guidelines in general practice were completed by 391 of 600 randomly selected GPs in the South and West NHS region. RESULTS: GPs found guidelines a useful method of accessing expert information. Key factors in their uptake were brevity, an authoritative and unbiased source of evidence, and resonance with the GP's usual practices; they also needed to be flexible enough to incorporate individual viewpoints. Guidelines were perceived as being valuable to enable safe delegation of care to other health professionals and for sharing decision-making with patients. Dissemination of guidelines through the medium of computers was acceptable to the majority of GPs. Virtually all (93%) responders reported adapting guidelines to the needs of individual patients. Older GPs from non-fundholding practices were least likely to show a positive attitude towards guidelines. CONCLUSION: In principle, there is a very positive attitude towards the use of guidelines in general practice. However, those developing guidelines for use by GPs in the consulting room need to be aware of the factors that facilitate their use in practice. Educational strategies aimed at increasing the use of guidelines need to take into account the significant proportion who show negative attitudes towards guidelines, whose characteristics have been identified in this study.
PMCID: PMC1313310  PMID: 10622009
13.  How Evidence-Based Are the Recommendations in Evidence-Based Guidelines? 
PLoS Medicine  2007;4(8):e250.
Background
Treatment recommendations for the same condition from different guideline bodies often disagree, even when the same randomized controlled trial (RCT) evidence is cited. Guideline appraisal tools focus on methodology and quality of reporting, but not on the nature of the supporting evidence. This study was done to evaluate the quality of the evidence (based on consideration of its internal validity, clinical relevance, and applicability) underlying therapy recommendations in evidence-based clinical practice guidelines.
Methods and Findings
A cross-sectional analysis of cardiovascular risk management recommendations was performed for three different conditions (diabetes mellitus, dyslipidemia, and hypertension) from three pan-national guideline panels (from the United States, Canada, and Europe). Of the 338 treatment recommendations in these nine guidelines, 231 (68%) cited RCT evidence but only 105 (45%) of these RCT-based recommendations were based on high-quality evidence. RCT-based evidence was downgraded most often because of reservations about the applicability of the RCT to the populations specified in the guideline recommendation (64/126 cases, 51%) or because the RCT reported surrogate outcomes (59/126 cases, 47%).
Conclusions
The results of internally valid RCTs may not be applicable to the populations, interventions, or outcomes specified in a guideline recommendation and therefore should not always be assumed to provide high-quality evidence for therapy recommendations.
From an analysis of cardiovascular risk-management recommendations in guidelines produced by pan-national panels, McAlister and colleagues concluded that fewer than half were based on high-quality evidence.
Editors' Summary
Background.
Until recently, doctors largely relied on their own experience to choose the best treatment for their patients. Faced with a patient with high blood pressure (hypertension), for example, the doctor had to decide whether to recommend lifestyle changes or to prescribe drugs to reduce the blood pressure. If he or she chose the latter, he or she then had to decide which drug to prescribe, set a target blood pressure, and decide how long to wait before changing the prescription if this target was not reached. But, over the past decade, numerous clinical practice guidelines have been produced by governmental bodies and medical associations to help doctors make treatment decisions like these. For each guideline, experts have searched the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluated the quality of that evidence, and then made recommendations based on the best evidence available.
Why Was This Study Done?
The recommendations made in different clinical practice guidelines vary, in part because they are based on evidence of varying quality. To help clinicians decide which recommendations to follow, some guidelines indicate the strength of their recommendations by grading them, based on the methods used to collect the underlying evidence. Thus, a randomized clinical trial (RCT)—one in which patients are randomly allocated to different treatments without the patient or clinician knowing the allocation—provides higher-quality evidence than a nonrandomized trial. Similarly, internally valid trials—in which the differences between patient groups are solely due to their different treatments and not to other aspects of the trial—provide high-quality evidence. However, grading schemes rarely consider the size of studies and whether they have focused on clinical or so-called “surrogate” measures. (For example, an RCT of a treatment to reduce heart or circulation [“cardiovascular”] problems caused by high blood pressure might have death rate as a clinical measure; a surrogate endpoint would be blood pressure reduction.) Most guidelines also do not consider how generalizable (applicable) the results of a trial are to the populations, interventions, and outcomes specified in the guideline recommendation. In this study, the researchers have investigated the quality of the evidence underlying recommendations for cardiovascular risk management in nine evidence-based clinical practice guides using these additional criteria.
What Did the Researchers Do and Find?
The researchers extracted the recommendations for managing cardiovascular risk from the current US, Canadian, and European guidelines for the management of diabetes, abnormal blood lipid levels (dyslipidemia), and hypertension. They graded the quality of evidence for each recommendation using the Canadian Hypertension Education Program (CHEP) grading scheme, which considers the type of study, its internal validity, its clinical relevance, and how generally applicable the evidence is considered to be. Of 338 evidence-based recommendations, two-thirds were based on evidence collected in internally valid RCTs, but only half of these RCT-based recommendations were based on high-quality evidence. The evidence underlying 64 of the guideline recommendations failed to achieve a high CHEP grade because the RCT data were collected in a population of people with different characteristics to those covered by the guideline. For example, a recommendation to use spironolactone to reduce blood pressure in people with hypertension was based on an RCT in which the participants initially had congestive heart failure with normal blood pressure. Another 59 recommendations were downgraded because they were based on evidence from RCTs that had not focused on clinical measures of effectiveness.
What Do These Findings Mean?
These findings indicate that although most of the recommendations for cardiovascular risk management therapies in the selected guidelines were based on evidence collected in internally valid RCTs, less than one-third were based on high-quality evidence applicable to the populations, treatments, and outcomes specified in guideline recommendations. A limitation of this study is that it analyzed a subset of recommendations in only a few guidelines. Nevertheless, the findings serve to warn clinicians that evidence-based guidelines are not necessarily based on high-quality evidence. In addition, they emphasize the need to make the evidence base underlying guideline recommendations more transparent by using an extended grading system like the CHEP scheme. If this were done, the researchers suggest, it would help clinicians apply guideline recommendations appropriately to their individual patients.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040250.
• Wikipedia contains pages on evidence-based medicine and on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
• The National Guideline Clearinghouse provides information on US national guidelines
• The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
• Information is available on the Canadian Hypertension Education Program (CHEP) (in French and English)
• See information on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group, an organization that has developed an grading scheme similar to the CHEP scheme (in English, Spanish, French, German, and Italian)
doi:10.1371/journal.pmed.0040250
PMCID: PMC1939859  PMID: 17683197
14.  Influence of patient age and comorbid burden on clinician attitudes toward heart failure guidelines 
Background
Clinical practice guidelines have been criticized for paying insufficient attention to the unique needs of patients with advanced age and multiple comorbid conditions. However, little empiric research is available to inform this topic.
Methods
We conducted telephone interviews with staff physicians and nurse practitioners in 4 VA health care systems. Respondents were asked to rate the usefulness of national heart failure guidelines for patients of different ages and levels of comorbid burden on a five point scale and to comment on the reasons for their ratings.
Results
Among 139 clinicians contacted, 65 (47%) completed the interview. Half (49%) were women and 48 (74%) were general internists or family practitioners. On a five-point scale assessing the usefulness of clinical practice guidelines for heart failure, the mean response ranged from 4.4 (+/− 0.7) for patients age <65 years with few comorbidities to 3.5 (+/− 1.2) for patients age >80 years with multiple comorbidities (P<.001). The difference in perceived usefulness varied more by patient age than by the degree of comorbidity (P=.02). Four major concepts underlay the perceived utility of guidelines across different patient types: (a) harms of treatment and patients’ clinical and pharmacologic complexity; (b) expected benefits of treatment; (c) patient preferences and abilities; and (d) confidence in the validity of guideline recommendations.
Conclusions
Clinicians perceive heart failure guidelines to be substantially less useful for patients with older age and greater comorbid burden. Concerns about the clinical and pharmacologic complexity of these patients and the expected benefits of drug therapy were commonly invoked as reasons for this skepticism.
doi:10.1016/j.amjopharm.2012.04.003
PMCID: PMC3369693  PMID: 22579695
clinical practice guidelines; physician attitudes; aged; geriatrics; comorbidity
15.  Routine HIV Testing in Botswana: A Population-Based Study on Attitudes, Practices, and Human Rights Concerns 
PLoS Medicine  2006;3(7):e261.
Background
The Botswana government recently implemented a policy of routine or “opt-out” HIV testing in response to the high prevalence of HIV infection, estimated at 37% of adults.
Methods and Findings
We conducted a cross-sectional, population-based study of 1,268 adults from five districts in Botswana to assess knowledge of and attitudes toward routine testing, correlates of HIV testing, and barriers and facilitators to testing, 11 months after the introduction of this policy. Most participants (81%) reported being extremely or very much in favor of routine testing. The majority believed that this policy would decrease barriers to testing (89%), HIV-related stigma (60%), and violence toward women (55%), and would increase access to antiretroviral treatment (93%). At the same time, 43% of participants believed that routine testing would lead people to avoid going to the doctor for fear of testing, and 14% believed that this policy could increase gender-based violence related to testing. The prevalence of self-reported HIV testing was 48%. Adjusted correlates of testing included female gender (AOR = 1.5, 95% CI = 1.1–1.9), higher education (AOR = 2.0, 95% CI = 1.5–2.7), more frequent healthcare visits (AOR = 1.9, 95% CI = 1.3–2.7), perceived access to HIV testing (AOR = 1.6, 95% CI = 1.1–2.5), and inconsistent condom use (AOR = 1.6, 95% CI = 1.2–2.1). Individuals with stigmatizing attitudes toward people living with HIV and AIDS were less likely to have been tested for HIV/AIDS (AOR = 0.7, 95% CI = 0.5–0.9) or to have heard of routine testing (AOR = 0.59, 95% CI = 0.45–0.76). While experiences with voluntary and routine testing overall were positive, 68% felt that they could not refuse the HIV test. Key barriers to testing included fear of learning one's status (49%), lack of perceived HIV risk (43%), and fear of having to change sexual practices with a positive HIV test (33%).
Conclusions
Routine testing appears to be widely supported and may reduce barriers to testing in Botswana. As routine testing is adopted elsewhere, measures should be implemented to assure true informed consent and human rights safeguards, including protection from HIV-related discrimination and protection of women against partner violence related to testing.
Editors' Summary
Background.
In 2005, there were 5 million new infections with the human immunodeficiency virus (HIV), and the disease it causes—acquired immunodeficiency syndrome (AIDS)—killed three million people. Despite the increased availability of drugs that can fight HIV (antiretrovirals), the AIDS epidemic continues to grow, particularly in sub-Saharan Africa. To halt it, more needs to be done to prevent the spread of HIV. Education about safe sex can help—HIV is most commonly spread through unprotected sex with an infected partner—but increasing HIV testing is of paramount importance. Unfortunately, the uptake of voluntary counseling and testing in sub-Saharan Africa is worryingly low. Fear of being stigmatized—socially disgraced—and discriminated against, fears about the positive result itself, and worries about access to antiretroviral drugs are all putting people off being tested.
Why Was This Study Done?
In Botswana, one in three adults is infected with HIV. Since 2002, antiretroviral drugs have been freely available but enrollment in the Botswana National Treatment Program during its first two years was slow, in part due to inadequate uptake of voluntary HIV testing. Consequently, in early 2004, the government introduced a policy of routine HIV testing in which all patients are tested for HIV when they visit their doctor unless they opt out. A major aim of this approach to HIV testing, which was formally recommended in June 2004 by UNAIDS and the World Health Organization, is to increase uptake of HIV testing and treatment, and to reduce HIV-related stigma by treating the HIV test like any other routine medical procedure. However, there are fears that the policy could back-fire—people might not visit their doctors, for example, because they are afraid of being tested and think that they will not be able to refuse the test. In this study, the researchers investigated knowledge of and attitudes to routine testing in Botswana to understand better the consequences of a routine testing policy.
What Did the Researchers Do and Find?
The researchers interviewed adults throughout Botswana about their knowledge of and attitudes to routine HIV testing 11 months after introduction of the policy. Only half of the participants had heard of routine testing before being interviewed but nearly all were in favor of routine testing. More than half thought it would reduce HIV-related stigma and the violence toward women that is associated with an HIV-positive status. However, almost half believed that routine testing might prevent people from going to the doctor because of fear of testing and a few thought the policy would increase violence against women. Nearly half of the interviewees had had an HIV test and the researchers found, for example, that women were more likely to have been tested than men and that people with stigmatizing attitudes toward people living with HIV and AIDS were less likely to be tested. Fear of learning one's HIV status, lack of perceived risk, and fear of having to change sexual practices if positive all stopped people taking the test. Finally, although experiences with testing were generally positive, approximately two-thirds of interviewees who had been tested felt that it would have been difficult to refuse the test.
What Do These Findings Mean?
These results show that there is widespread support for routine HIV testing in Botswana, a finding supported by recent increases in treatment uptake. Routine testing, write the researchers, holds significant promise for the prevention and treatment of HIV/AIDS in Botswana and elsewhere. In particular, increasing the number of people tested for HIV may reduce HIV-related stigma, which should further increase testing and hopefully slow the spread of HIV. But the results of this study also highlight some areas of concern. Whenever HIV testing policies are implemented, human rights must be protected by ensuring that patients have all the information necessary to make an informed and free decision about being tested, by providing protection for women against violence related to HIV status, and by ensuring total confidentiality. Careful monitoring of Botswana's program and similar programs will be needed to ensure that these human rights are fully met, conclude the researchers.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030261
• US National Institute of Allergy and Infectious Diseases factsheet on HIV infection and AIDS
• US Department of Health and Human Services information on AIDS
• US Centers for Disease Control and Prevention information on HIV/AIDS
• UNAIDS and World Health Organization 2004 policy statement on HIV testing
• AVERT, a UK-based charity, provides information about HIV and AIDS in Botswana
A cross-sectional, population-based study of 1,268 adults from five districts in Botswana showed that routine HIV testing appears to be widely supported and may reduce barriers to HIV testing.
doi:10.1371/journal.pmed.0030261
PMCID: PMC1502152  PMID: 16834458
16.  Acceptance and perceived barriers of implementing a guideline for managing low back in general practice 
Background
Implementation of guidelines in clinical practice is difficult. In 2003, the German College of General Practitioners and Family Physicians (DEGAM) released an evidence-based guideline for the management of low back pain (LBP) in primary care. The objective of this study is to explore the acceptance of guideline content and perceived barriers to implementation.
Methods
Seventy-two general practitioners (GPs) participating in quality circles within the framework of an educational intervention study for guideline implementation evaluated the LBP-guideline and its practicability with a standardised questionnaire. In addition, statements of group discussions were recorded using the metaplan technique and were incorporated in the discussion.
Results
Most GPs agree with the guideline content but believe that guideline stipulations are not congruent with patient wishes. Non-adherence to the guideline and contradictory information for patients by other professionals (e.g., GPs, orthopaedic surgeons, physiotherapists) are important barriers to guideline adherence. Almost half of the GPs have no access to recommended multimodal pain programs for patients with chronic LBP.
Conclusion
Promoting adherence to the LBP guideline requires more than enhancing knowledge about evidence-based management of LBP. Public education and an interdisciplinary consensus are important requirements for successful guideline implementation into daily practice. Guideline recommendations need to be adapted to the infrastructure of the health care system.
Trial registration
BMBF Grant Nr. 01EM0113. FORIS (database for research projects in social science) Reg #: 20040116 [25].
doi:10.1186/1748-5908-3-7
PMCID: PMC2275295  PMID: 18257923
17.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Background
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Conclusions
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001498.
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
doi:10.1371/journal.pmed.1001498
PMCID: PMC3742442  PMID: 23966839
18.  Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments 
PLoS Medicine  2013;10(7):e1001489.
Background
The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address.
Methods and Findings
We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria—most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation.
Conclusions
By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The development process for new drugs is lengthy and complex. It begins in the laboratory, where scientists investigate the causes of diseases and identify potential new treatments. Next, promising interventions undergo preclinical research in cells and in animals (in vivo animal experiments) to test whether the intervention has the expected effect and to support the generalization (extension) of this treatment–effect relationship to patients. Drugs that pass these tests then enter clinical trials, where their safety and efficacy is tested in selected groups of patients under strictly controlled conditions. Finally, the government bodies responsible for drug approval review the results of the clinical trials, and successful drugs receive a marketing license, usually a decade or more after the initial laboratory work. Notably, only 11% of agents that enter clinical testing (investigational drugs) are ultimately licensed.
Why Was This Study Done?
The frequent failure of investigational drugs during clinical translation is potentially harmful to trial participants. Moreover, the costs of these failures are passed onto healthcare systems in the form of higher drug prices. It would be good, therefore, to reduce the attrition rate of investigational drugs. One possible explanation for the dismal success rate of clinical translation is that preclinical research, the key resource for justifying clinical development, is flawed. To address this possibility, several groups of preclinical researchers have issued guidelines intended to improve the design and execution of in vivo animal studies. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the authors identify the experimental practices that are commonly recommended in these guidelines and organize these recommendations according to the type of threat to validity (internal, construct, or external) that they address. Internal threats to validity are factors that confound reliable inferences about treatment–effect relationships in preclinical research. For example, experimenter expectation may bias outcome assessment. Construct threats to validity arise when researchers mischaracterize the relationship between an experimental system and the clinical disease it is intended to represent. For example, researchers may use an animal model for a complex multifaceted clinical disease that only includes one characteristic of the disease. External threats to validity are unseen factors that frustrate the transfer of treatment–effect relationships from animal models to patients.
What Did the Researchers Do and Find?
The researchers identified 26 preclinical guidelines that met their predefined eligibility criteria. Twelve guidelines addressed preclinical research for neurological and cerebrovascular drug development; other disorders covered by guidelines included cardiac and circulatory disorders, sepsis, pain, and arthritis. Together, the guidelines offered 55 different recommendations for the design and execution of preclinical in vivo animal studies. Nineteen recommendations addressed threats to internal validity. The most commonly included recommendations of this type called for the use of power calculations to ensure that sample sizes are large enough to yield statistically meaningful results, random allocation of animals to treatment groups, and “blinding” of researchers who assess outcomes to treatment allocation. Among the 25 recommendations that addressed threats to construct validity, the most commonly included recommendations called for characterization of the properties of the animal model before experimentation and matching of the animal model to the human manifestation of the disease. Finally, six recommendations addressed threats to external validity. The most commonly included of these recommendations suggested that preclinical research should be replicated in different models of the same disease and in different species, and should also be replicated independently.
What Do These Findings Mean?
This systematic review identifies a range of investigational recommendations that preclinical researchers believe address threats to the validity of preclinical efficacy studies. Many of these recommendations are not widely implemented in preclinical research at present. Whether the failure to implement them explains the frequent discordance between the results on drug safety and efficacy obtained in preclinical research and in clinical trials is currently unclear. These findings provide a starting point, however, for the improvement of existing preclinical research guidelines for specific diseases, and for the development of similar guidelines for other diseases. They also provide an evidence-based platform for the analysis of preclinical evidence and for the study and evaluation of preclinical research practice. These findings should, therefore, be considered by investigators, institutional review bodies, journals, and funding agents when designing, evaluating, and sponsoring translational research.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001489.
The US Food and Drug Administration provides information about drug approval in the US for consumers and for health professionals; its Patient Network provides a step-by-step description of the drug development process that includes information on preclinical research
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) provides information about all aspects of the scientific evaluation and approval of new medicines in the UK; its My Medicine: From Laboratory to Pharmacy Shelf web pages describe the drug development process from scientific discovery, through preclinical and clinical research, to licensing and ongoing monitoring
The STREAM website provides ongoing information about policy, ethics, and practices used in clinical translation of new drugs
The CAMARADES collaboration offers a “supporting framework for groups involved in the systematic review of animal studies” in stroke and other neurological diseases
doi:10.1371/journal.pmed.1001489
PMCID: PMC3720257  PMID: 23935460
19.  Barriers to optimal antibiotic use for community‐acquired pneumonia at hospitals: a qualitative study 
Quality & Safety in Health Care  2007;16(2):143-149.
Background
Physician adherence to key recommendations of guidelines for community‐acquired pneumonia (CAP) is often not optimal. A better understanding of factors influencing optimal performance is needed to plan effective change.
Methods
The authors used semistructured interviews with care providers in three Dutch medium‐sized hospitals to qualitatively study and understand barriers to appropriate antibiotic use in patients with CAP. They discussed recommendations about the prescription of empirical antibiotic therapy that adheres to the guidelines, timely administration of antibiotics, adjusting antibiotic dosage to accommodate decreased renal function, switching and streamlining therapy, and blood and sputum culturing. The authors then classified the barriers each recommendation faced into categories using a conceptual framework (Cabana).
Results
Eighteen interviews were performed with residents and specialists in pulmonology and internal medicine, with medical microbiologists and a clinical pharmacist. Two additional multidisciplinary small group interviews which included nurses were performed. Each guideline recommendation elicited a different type of barrier. Regarding the choice of guideline‐adherent empirical therapy, treating physicians said that they worried about patient outcome when prescribing narrow‐spectrum antibiotic therapy. Regarding the timeliness of antibiotic administration, barriers such as conflicting guidelines and organisational factors (for example, delayed laboratory results, antibiotics not directly available, lack of time) were reported. Not streamlining therapy after culture results became available was thought to be due to the physicians' attitude of “never change a winning team”.
Conclusions
Efforts to improve the use of antibiotics for patients with CAP should consider the range of barriers that care providers face. Each recommendation meets its own barriers. Interventions to improve adherence should be tailored to these factors.
doi:10.1136/qshc.2005.017327
PMCID: PMC2653154  PMID: 17403764
20.  Developing a computer delivered, theory based intervention for guideline implementation in general practice 
BMC Family Practice  2010;11:90.
Background
Non-adherence to clinical guidelines has been identified as a consistent finding in general practice. The purpose of this study was to develop theory-informed, computer-delivered interventions to promote the implementation of guidelines in general practice. Specifically, our aim was to develop computer-delivered prompts to promote guideline adherence for antibiotic prescribing in respiratory tract infections (RTIs), and adherence to recommendations for secondary stroke prevention.
Methods
A qualitative design was used involving 33 face-to-face interviews with general practitioners (GPs). The prompts used in the interventions were initially developed using aspects of social cognitive theory, drawing on nationally recommended standards for clinical content. The prompts were then presented to GPs during interviews, and iteratively modified and refined based on interview feedback. Inductive thematic analysis was employed to identify responses to the prompts and factors involved in the decision to use them.
Results
GPs reported being more likely to use the prompts if they were perceived as offering support and choice, but less likely to use them if they were perceived as being a method of enforcement. Attitudes towards using the prompts were also related to anticipated patient outcomes, individual prescriber differences, accessibility and presentation of prompts and acceptability of guidelines. Comments on the prompts were largely positive after modifying them based on participant feedback.
Conclusions
Acceptability and satisfaction with computer-delivered prompts to follow guidelines may be increased by working with practitioners to ensure that the prompts will be perceived as valuable tools that can support GPs' practice.
doi:10.1186/1471-2296-11-90
PMCID: PMC2995485  PMID: 21087469
21.  Determinants of implementation of maternal health guidelines in Kosovo: mixed methods study 
Background
One of the challenges to implementing clinical practice guidelines is the need to adapt guidelines to the local context and identify barriers to their uptake. Several models of framework are available to consider for use in guideline adaptation.
Methods
We completed a multiphase study to explore the implementation of maternal health guidelines in Kosovo, focusing on determinants of uptake and methods to contextualize for local use. The study involved a survey, individual interviews, focus groups, and a consensus meeting with relevant stakeholders, including clinicians (obstetricians, midwives), managers, researchers, and policy makers from the national Ministry of Health and the World Health Organization office in Pristina, Kosovo.
Results
Participants identified several important barriers to implementation. First, lack of communication between clinicians and ministry representatives was seen as leading to duplication of effort in creating or adapting guidelines, as well as substantial mistrust between clinicians and policy makers. Second, there was a lack of communication across clinical groups that provide obstetric care and a lack of integration across the entire healthcare system, including rural and urban centers. This fragmentation was thought to have directly resulted from the war in 1998 – 1999. Third, the conflict substantially and adversely affected the healthcare infrastructure in Kosovo, which has resulted in an inability to monitor quality of care across the country. Furthermore, the impact on infrastructure has affected the ability to access required medications consistently and to smoothly transfer patients from rural to urban centers. Another issue raised during this project was the appropriateness of including guideline recommendations perceived to be ‘aspirational’.
Conclusions
Implementing clinical practice guidelines in low- and middle-income countries (LMICs) requires consideration of several specific barriers. Particularly pertinent to this study were the effects of recent conflict and the resulting fragmentation of healthcare and communication strategies among relevant stakeholders. However, as Kosovo rebuilds and invests in infrastructure after the conflict, there is a tremendous opportunity to create comprehensive, thoughtful strategies to monitor and improve quality of care. To avoid duplication of effort, it may be beneficial for LMICs to share information on assessing barriers as well as on guideline implementation strategies.
doi:10.1186/1748-5908-8-108
PMCID: PMC3846581  PMID: 24016149
Guideline implementation; Determinants of evidence uptake
22.  Physicians Report Barriers to Deliver Best Practice Care for Asplenic Patients: A Cross-Sectional Survey 
PLoS ONE  2011;6(3):e17302.
Background
Current management of asplenic patients is not in compliance with best practice standards, such as defined by the British Committee for Standards in Haematology. To improve quality of care, factors inhibiting best practice care delivery need to be identified first. With this study, we aimed to identify and quantify physicians' barriers to adhere to best practice management of asplenic patients in the Netherlands.
Methods and Principal Findings
A cross-sectional survey, preceded by multiple focus group discussions, was performed among Dutch physicians responsible for prevention of infections in asplenic patients, including specialists (of Internal medicine and Surgery) and general practitioners (GPs). Forty seven GPs and seventy three hospital specialists returned the questionnaire, yielding response rates of 47% and 36,5% respectively. Physicians reported several barriers to deliver best practice. For both GPs and specialists, the most frequently listed barriers were: poor patient knowledge (>80% of hospital specialists and GPs) and lack of clarity about which physician is responsible for the management of asplenic patients (50% of Internists, 46% of Surgeons, 55% of GPs). Both GPs and hospital specialists expressed to experience a lack of mutual trust: specialists were uncertain whether the GP would follow their advice given on patient discharge (33–59%), whereas half of GPs was not convinced that specialists' discharge letters contained the correct recommendations. Almost all physicians (>90%) indicated that availability of a national guideline would improve adherence to best practice, especially if accessible online.
Conclusion
This study showed that, in accordance with reports on international performance, care delivery for asplenic patients in the Netherlands is suboptimal. We identified and quantified perceived barriers by physicians that prevent adherence to post-splenectomy guidelines for the first time. Better transmural collaboration and better informed patients are likely to improve the quality of care of the asplenic patient population. A national, online-available guideline is urgently required.
doi:10.1371/journal.pone.0017302
PMCID: PMC3053367  PMID: 21423748
23.  An Evaluation of Web-Based Clinical Practice Guidelines for Managing Problems Associated with Cannabis Use 
Background
Cannabis is the most widely used illicit substance, and multiple treatment options and avenues exist for managing its use. There has been an increase in the development of clinical practice guidelines (CPGs) to improve standards of care in this area, many of which are disseminated online. However, little is known about the quality and accessibility of these online CPGs.
Objective
The purpose of study 1 was to determine the extent to which cannabis-related CPGs disseminated online adhere to established methodological standards. The purpose of study 2 was to determine if treatment providers are familiar with these guidelines and to assess their perceived quality of these guidelines.
Methods
Study 1 involved a systematic search using the Google Scholar search engine and the National Drugs Sector Information Service (NDSIS) website of the Alcohol and Other Drugs Council of Australia (ADCA) to identify CPGs disseminated online. To be included in the current study, CPGs needed to be free of charge and provide guidance on psychological interventions for reducing cannabis use. Four trained reviewers independently assessed the quality of the 7 identified guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Study 2 assessed 166 Australian cannabis-use treatment providers’ (mean age = 45.47 years, SD 12.14) familiarity with and opinions of these 7 guidelines using an online survey. Treatment providers were recruited using online advertisements that directed volunteers to a link to complete the survey, which was posted online for 6 months (January to June 2012). Primary study outcomes included quality scores and rates of guideline familiarity, guideline use, and discovery methods.
Results
Based on the AGREE II, the quality of CPGs varied considerably. Across different reporting domains, adherence to methodological standards ranged from 0% to 92%. Quality was lowest in the domains of rigor of development (50%), applicability (46%), and editorial independence (30%). Although examination of AGREE II domain scores demonstrated that the quality of the 7 guidelines could be divided into 3 categories (high quality, acceptable to low quality, and very low quality), review of treatment providers’ quality perceptions indicated all guidelines fell into 1 category (acceptable quality). Based on treatment providers’ familiarity with and usage rates of the CPGs, a combination of peer/colleagues, senior professionals, workshops, and Internet dissemination was deemed to be most effective for promoting cannabis use CPGs. Lack of time, guideline length, conflicts with theoretical orientation, and prior content knowledge were identified as barriers to guideline uptake.
Conclusions
Developers of CPGs should improve their reporting of development processes, conflicts of interest, and CPGs’ applicability to practice, while remaining cognizant that long guidelines may deter implementation. Treatment providers need to be aware that the quality of cannabis-related CPGs varies substantially.
doi:10.2196/jmir.2319
PMCID: PMC3799569  PMID: 23249447
Cannabis; Marijuana Abuse; Addiction; Psychotherapy; Standards; Information Dissemination; Health Plan Implementation; Internet
24.  Barriers and facilitators to implement shared decision making in multidisciplinary sciatica care: a qualitative study 
Background
The Dutch multidisciplinary sciatica guideline recommends that the team of professionals involved in sciatica care and the patient together decide on surgical or prolonged conservative treatment (shared decision making [SDM]). Despite this recommendation, SDM is not yet integrated in sciatica care. Existing literature concerning barriers and facilitators to SDM implementation mainly focuses on one discipline only, whereas multidisciplinary care may involve other barriers and facilitators, or make these more complex for both professionals and patients. Therefore, this qualitative study aims to identify barriers and facilitators perceived by patients and professionals for SDM implementation in multidisciplinary sciatica care.
Methods
We conducted 40 semi-structured interviews with professionals involved in sciatica care (general practitioners, physical therapists, neurologists, neurosurgeons, and orthopedic surgeons) and three focus groups among patients (six to eight per group). The interviews and focus groups were audiotaped and transcribed in full. Reported barriers and facilitators were classified according to the framework of Grol and Wensing. The software package Atlas.ti 7.0 was used for analysis.
Results
Professionals reported 53 barriers and 5 facilitators, and patients 35 barriers and 18 facilitators for SDM in sciatica care. Professionals perceived most barriers at the level of the organizational context, and facilitators at the level of the individual professional. Patients reported most barriers and facilitators at the level of the individual professional. Several barriers and facilitators correspond with barriers and facilitators found in the literature (e.g., lack of time, motivation) but also new barriers and facilitators were identified. Many of these new barriers mentioned by both professionals and patients were related to the multidisciplinary setting, such as lack of visibility, lack of trust in expertise of other disciplines, and lack of communication between disciplines.
Conclusions
This study identified barriers and facilitators for SDM in the multidisciplinary sciatica setting, by both professionals and patients. It is clear that more barriers than facilitators are perceived for implementation of SDM in sciatica care. Newly identified barriers and facilitators are related to the multidisciplinary care setting. Therefore, an effective implementation strategy of SDM in a multidisciplinary setting such as in sciatica care should focus on these barriers and facilitators.
doi:10.1186/1748-5908-8-95
PMCID: PMC3765956  PMID: 23968140
Sciatica; Lumbar radicular syndrome; Implementation strategy; Shared decision making; Barriers and facilitators; Multidisciplinary; Patients; Professionals; Providers
25.  Adherence to HAART: A Systematic Review of Developed and Developing Nation Patient-Reported Barriers and Facilitators 
PLoS Medicine  2006;3(11):e438.
Background
Adherence to highly active antiretroviral therapy (HAART) medication is the greatest patient-enabled predictor of treatment success and mortality for those who have access to drugs. We systematically reviewed the literature to determine patient-reported barriers and facilitators to adhering to antiretroviral therapy.
Methods and Findings
We examined both developed and developing nations. We searched the following databases: AMED (inception to June 2005), Campbell Collaboration (inception to June 2005), CinAhl (inception to June 2005), Cochrane Library (inception to June 2005), Embase (inception to June 2005), ERIC (inception to June 2005), MedLine (inception to June 2005), and NHS EED (inception to June 2005). We retrieved studies conducted in both developed and developing nation settings that examined barriers and facilitators addressing adherence. Both qualitative and quantitative studies were included. We independently, in duplicate, extracted data reported in qualitative studies addressing adherence. We then examined all quantitative studies addressing barriers and facilitators noted from the qualitative studies. In order to place the findings of the qualitative studies in a generalizable context, we meta-analyzed the surveys to determine a best estimate of the overall prevalence of issues. We included 37 qualitative studies and 47 studies using a quantitative methodology (surveys). Seventy-two studies (35 qualitative) were conducted in developed nations, while the remaining 12 (two qualitative) were conducted in developing nations. Important barriers reported in both economic settings included fear of disclosure, concomitant substance abuse, forgetfulness, suspicions of treatment, regimens that are too complicated, number of pills required, decreased quality of life, work and family responsibilities, falling asleep, and access to medication. Important facilitators reported by patients in developed nation settings included having a sense of self-worth, seeing positive effects of antiretrovirals, accepting their seropositivity, understanding the need for strict adherence, making use of reminder tools, and having a simple regimen. Among 37 separate meta-analyses examining the generalizability of these findings, we found large heterogeneity.
Conclusions
We found that important barriers to adherence are consistent across multiple settings and countries. Research is urgently needed to determine patient-important factors for adherence in developing world settings. Clinicians should use this information to engage in open discussion with patients to promote adherence and identify barriers and facilitators within their own populations.
An analysis of qualitative and quantitative studies found consistent barriers to adherence to HIV therapy across multiple settings and countries, ranging from access to medication to problems with complicated regimens.
Editors' Summary
Background.
The World Health Organization has estimated that in 2005, about 38 million people worldwide were living with HIV/AIDS; the mortality caused by HIV/AIDS is very high. Antiretroviral drugs are effective at controlling the disease and extending life span. However, it is important for people to stick to the drug regimens exactly in order to keep levels of HIV low, prevent it from becoming resistant to drugs, and stop the illness from progressing. However, many people find it very difficult to take antiretroviral drugs precisely as they should. There is already some evidence from research studies on the reasons why this is the case. There are two different research approaches taken by these studies: “qualitative” methods, which try to find out about attitudes and behaviors using focus groups, interviews, or other techniques; and “quantitative” methods, which try to find out about peoples' opinions and experience using surveys with set questions for the participants to answer, and then count the different responses.
Why Was This Study Done?
The investigators wanted to put together all of the available evidence from published research studies (called doing a “systematic review”) on which factors affected people's adherence to antiretroviral drugs. They wanted to do a systematic review because it is thought to be a very rigorous way of appraising all the available evidence (although there is considerable debate about the value of using such a method to analyze the results of qualitative research).
What Did the Researchers Do and Find?
The study team searched biomedical literature databases as well as conference abstracts and research registries using a defined set of search queries. They screened all the scientific papers they found; those reporting results of original research into factors affecting antiretroviral adherence were then analyzed in more detail. 84 relevant studies were identified, of which 37 used “qualitative” methods (focus groups, interviews, open-ended questioning) and 47 used “quantitative” methods (surveys). Most of these studies had been carried out in the developed world. Then, the researchers extracted the factors affecting adherence from the original studies, which could be either “positive” factors (helping adherence) or “negative” ones (making adherence more difficult). They classified the factors into four key themes: “patient related” (e.g., seeing positive results, fear of disclosure, being depressed); “beliefs about medication” (e.g., faith in how well the drugs worked, side effects); “daily schedules” (e.g., using reminder tools, disruptions to routine); and “interpersonal relationships” (e.g., trusting relations with health-care provider; social isolation).
  Many barriers to adherence were common to both developed and developing settings. Some factors were unique to the studies conducted in the developing world, such as financial constraints and problems with traveling to get access to treatment. Fear of disclosure was an important barrier identified in many of the studies.
What Do These Findings Mean?
The researchers combined the results of many different studies and identified factors that help or obstruct adherence to antiretroviral treatment. By identifying influences common to the different settings, greater weight can be placed on the factors that were identified. Only 12 of the studies included in this research were from the developing world, where the majority of HIV/AIDS patients live; hence more work is needed to examine and address the factors influencing antiretroviral adherence in these parts of the world. This study provides researchers and health policy makers with a starting point for changes that might help to ensure greater adherence to antiretroviral treatment.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030438.
Medline Plus information on AIDS medicines (Medline Plus is a service of the US National Library of Medicine and the National Institutes of Health)
Joint United Nations Programme on HIV/AIDS has information about the state of the HIV/AIDS epidemic worldwide
The World Health Organization has an HIV/AIDS program site providing comprehensive information on the HIV/AIDS epidemic worldwide
The World Health Organization pages on antiretroviral therapy
doi:10.1371/journal.pmed.0030438
PMCID: PMC1637123  PMID: 17121449

Results 1-25 (1332961)