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1.  Implementing clinical guidelines in psychiatry: a qualitative study of perceived facilitators and barriers 
BMC Psychiatry  2010;10:8.
Background
Translating scientific evidence into daily practice is complex. Clinical guidelines can improve health care delivery, but there are a number of challenges in guideline adoption and implementation. Factors influencing the effective implementation of guidelines remain poorly understood. Understanding of barriers and facilitators is important for development of effective implementation strategies. The aim of this study was to determine perceived facilitators and barriers to guideline implementation and clinical compliance to guidelines for depression in psychiatric care.
Methods
This qualitative study was conducted at two psychiatric clinics in Stockholm, Sweden. The implementation activities at one of the clinics included local implementation teams, seminars, regular feedback and academic detailing. The other clinic served as a control and only received guidelines by post. Data were collected from three focus groups and 28 individual, semi-structured interviews. Content analysis was used to identify themes emerging from the interview data.
Results
The identified barriers to, and facilitators of, the implementation of guidelines could be classified into three major categories: (1) organizational resources, (2) health care professionals' individual characteristics and (3) perception of guidelines and implementation strategies. The practitioners in the implementation team and at control clinics differed in three main areas: (1) concerns about control over professional practice, (2) beliefs about evidence-based practice and (3) suspicions about financial motives for guideline introduction.
Conclusions
Identifying the barriers to, and facilitators of, the adoption of recommendations is an important way of achieving efficient implementation strategies. The findings of this study suggest that the adoption of guidelines may be improved if local health professionals actively participate in an ongoing implementation process and identify efficient strategies to overcome barriers on an organizational and individual level. Getting evidence into practice and implementing clinical guidelines are dependent upon more than practitioners' motivation. There are factors in the local context, e.g. culture and leadership, evaluation, feedback on performance and facilitation, -that are likely to be equally influential.
doi:10.1186/1471-244X-10-8
PMCID: PMC2822755  PMID: 20089141
2.  Mono-disciplinary or multidisciplinary back pain guidelines? How can we achieve a common message in primary care? 
European Spine Journal  2005;15(5):641-647.
Description of a workshop entitled “Sharing Guidelines for Low Back Pain Between Primary Health Care Providers: Toward a Common Message in Primary Care” that was held at the Fifth International Forum on Low Back Pain in Primary Care in Canada in May 2002. Despite a considerable degree of acceptance of current evidence-based guidelines, in practice, primary health care providers still do not share a common message. The objective of the workshop was to describe the outcomes of a workshop on the sharing of guidelines in primary care. The Fifth International Forum on Low Back Pain Research in Primary Care focused on relations between stakeholders in the primary care management of back pain. Participants in this workshop contributed to an open discussion on “how and why” evidence-based guidelines about back pain do or do not work in practice. Ways to minimise the factors that inhibit implementation were discussed in the light of whether guidelines are mono-disciplinary or multidisciplinary. Examples of potential issues for debate were contained in introductory presentations. The prospects for improving implementation and reducing barriers, and the priorities for future research, were then considered by an international group of researchers. This paper summarises the conclusions of three researcher subgroups that focused on the sharing of guidelines under the headings of: (1) the content, (2) the development process, and (3) implementation. How to share the evidence and make it meaningful to practice stakeholders is the main challenge of guideline implementation. There is a need to consider the balance between the strength of evidence in multidisciplinary guidelines and the utility/feasibility of mono-disciplinary guidelines. The usefulness of both mono-disciplinary and multidisciplinary guidelines was agreed on. However, in order to achieve consistent messages, mono-disciplinary guidelines should have a multidisciplinary parent. In other words, guidelines should be developed and monitored by a multidisciplinary team, but may be transferred to practice by mono-disciplinary messengers. Despite general agreement that multi-faceted interventions are most effective for implementing guidelines, the feasibility of doing this in busy clinical settings is questioned. Research is needed from local implementation pilots and quality monitoring studies to understand how to develop and deliver the contextual understanding required. This relates to processes of care as well as outcomes, and to social factors and policymaking as well as health care interventions. We commend these considerations to all who are interested in the challenges of achieving better-integrated, evidence-based care for people with back pain.
doi:10.1007/s00586-005-0883-9
PMCID: PMC3489332  PMID: 15931509
Back pain; Guidelines; Primary Care; Implementation
3.  Addressing implementation challenges during guideline development – a case study of Swedish national guidelines for methods of preventing disease 
Background
Many of the world’s life threatening diseases (e.g. cancer, heart disease, stroke) could be prevented by eliminating life-style habits such as tobacco use, unhealthy diet, physical inactivity and excessive alcohol use. Incorporating evidence-based research on methods to change unhealthy lifestyle habits in clinical practice would be equally valuable. However gaps between guideline development and implementation are well documented, with implications for health care quality, safety and effectiveness. The development phase of guidelines has been shown to be important both for the quality in guideline content and for the success of implementation. There are, however, indications that guidelines related to general disease prevention methods encounter specific barriers compared to guidelines that are diagnosis-specific. In 2011 the Swedish National board for Health and Welfare launched guidelines with a preventive scope. The aim of this study was to investigate how implementation challenges were addressed during the development process of these disease preventive guidelines.
Methods
Seven semi-structured interviews were conducted with members of the guideline development management group. Archival data detailing the guideline development process were also collected and used in the analysis. Qualitative data were analysed using content analysis as the analytical framework.
Results
The study identified several strategies and approaches that were used to address implementation challenges during guideline development. Four themes emerged from the analysis: broad agreements and consensus about scope and purpose; a formalized and structured development procedure; systematic and active involvement of stakeholders; and openness and transparency in the specific guideline development procedure. Additional factors concerning the scope of prevention and the work environment of guideline developers were perceived to influence the possibilities to address implementation issues.
Conclusions
This case study provides examples of how guideline developers perceive and approach the issue of implementation during the development and early launch of prevention guidelines. Models for guideline development could benefit from an initial assessment of how the guideline topic, its target context and stakeholders will affect the upcoming implementation.
doi:10.1186/s12913-014-0672-4
PMCID: PMC4308005  PMID: 25608684
Clinical practice guidelines; Development process; Evidence-based public health; Implementation; Disease prevention; Lifestyle change
4.  How can we improve guideline use? A conceptual framework of implementability 
Background
Guidelines continue to be underutilized, and a variety of strategies to improve their use have been suboptimal. Modifying guideline features represents an alternative, but untested way to promote their use. The purpose of this study was to identify and define features that facilitate guideline use, and examine whether and how they are included in current guidelines.
Methods
A guideline implementability framework was developed by reviewing the implementation science literature. We then examined whether guidelines included these, or additional implementability elements. Data were extracted from publicly available high quality guidelines reflecting primary and institutional care, reviewed independently by two individuals, who through discussion resolved conflicts, then by the research team.
Results
The final implementability framework included 22 elements organized in the domains of adaptability, usability, validity, applicability, communicability, accommodation, implementation, and evaluation. Data were extracted from 20 guidelines on the management of diabetes, hypertension, leg ulcer, and heart failure. Most contained a large volume of graded, narrative evidence, and tables featuring complementary clinical information. Few contained additional features that could improve guideline use. These included alternate versions for different users and purposes, summaries of evidence and recommendations, information to facilitate interaction with and involvement of patients, details of resource implications, and instructions on how to locally promote and monitor guideline use. There were no consistent trends by guideline topic.
Conclusions
Numerous opportunities were identified by which guidelines could be modified to support various types of decision making by different users. New governance structures may be required to accommodate development of guidelines with these features. Further research is needed to validate the proposed framework of guideline implementability, develop methods for preparing this information, and evaluate how inclusion of this information influences guideline use.
doi:10.1186/1748-5908-6-26
PMCID: PMC3072935  PMID: 21426574
5.  The guideline implementability research and application network (GIRAnet): an international collaborative to support knowledge exchange: study protocol 
Background
Modifying the format and content of guidelines may facilitate their use and lead to improved quality of care. We reviewed the medical literature to identify features desired by different users and associated with guideline use to develop a framework of implementability and found that most guidelines do not contain these elements. Further research is needed to develop and evaluate implementability tools.
Methods
We are launching the Guideline Implementability Research and Application Network (GIRAnet) to enable the development and testing of implementability tools in three domains: Resource Implications, Implementation, and Evaluation. Partners include the Guidelines International Network (G-I-N) and its member guideline developers, implementers, and researchers. In phase one, international guidelines will be examined to identify and describe exemplar tools. Indication-specific and generic tools will populate a searchable repository. In phase two, qualitative analysis of cognitive interviews will be used to understand how developers can best integrate implementability tools in guidelines and how health professionals use them for interpreting and applying guidelines. In phase three, a small-scale pilot test will assess the impact of implementability tools based on quantitative analysis of chart-based behavioural outcomes and qualitative analysis of interviews with participants. The findings will be used to plan a more comprehensive future evaluation of implementability tools.
Discussion
Infrastructure funding to establish GIRAnet will be leveraged with the in-kind contributions of collaborating national and international guideline developers to advance our knowledge of implementation practice and science. Needs assessment and evaluation of GIRAnet will provide a greater understanding of how to develop and sustain such knowledge-exchange networks. Ultimately, by facilitating use of guidelines, this research may lead to improved delivery and outcomes of patient care.
doi:10.1186/1748-5908-7-26
PMCID: PMC3338081  PMID: 22471937
Guidelines; Guideline development; Guideline implementation; Research networks; Knowledge exchange
6.  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
7.  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
8.  Hypertension guidelines and their effects on the health system 
Introduction
Hypertension guidelines, which have existed for many years and primarily used in the USA, Canada and Great Britain, are now becoming an issue in Germany. Strong efforts are presently underway for a German version comparable to the guidelines developed for the mentioned countries. The development of guidelines is a part of the implementation system of guidelines in Germany. It covers the mode of operation of the AWMF (work community of the scientific medical subject companies) with the clearinghouse for guidelines (CLA) and the cooperation with the centre for medical quality (ÄZQ).
In the HTA report the real use of the hypertension guidelines shall be investigated for Germany from the development trends and further possibilities of use according to a medical applicability. Economic issues and an optimisation of use are also discussed.
Question
The following questions shall be answered in particular:
How much are the guidelines used concerning hypertension? Can effects (or their influence) be established on the medical procedures? Are there statements available about costs and cost effectiveness? Are there recommendations for further use?
Methodology
To answer these questions, a comprehensive literature search was done. No empirical investigation was carried out. From this enquiry 206 articles were checked in detail but not all of them were available in full text.
Only those publications which directly dealt with high blood pressure guidelines or articles with a direct reference to the topic have been considered in the HTA report.
Publications concerning screening or methods of prevention, medical studies of the hypertension syndrome without a direct reference to guidelines and publications concerned with putting guidelines into action were excluded.
Results
After an analysis of the selected literature addressing the topic of hypertension guidelines, it was evident that the use of these guidelines cannot be gathered from existing literature at the present time. One can assume from international studies with analogical reasoning that these are confessed and have a high level of acceptance in the medical community. Unfortunately the actual usage is not represented satisfactorily in the scientific literature.
The effects of the guidelines on the medical procedures seem to be very strongly individual and the analyses to the compliance show at least an observable effect within the last few years. No publications could be found for the cost effectiveness of the guidelines.
The actual compliance with guidelines seems to be in relation with the duration of the professional practice. It seems the shorter the professional practice takes place, the stronger the guidelines are adhered.
Discussion
At present, there are only a few notes for the German health service regarding the actual effect of the hypertonus guidelines. However, the reason is not that the effect would not be possibly strong but at the methodical challenge to evaluate the sustaining effects of the application of the hypertonus guidelines. For this reason the literature is very rare regarding this topic.
For Germany it can be derived by analogical reasoning from foreign studies that guidelines will facilitate a more and more essential contribution to the design of the health system. Considering that primarily younger physicians accepted guidelines mode, the further construction, update and implementation of guidelines are essential, particularly with regard to the quality assurance. Straight guidelines can express a standard of the quality of a health system as a benchmark. The existence of guidelines or the lack thereof is considered also as a quality indicator of a health system at the organisation for economic cooperation and development (OECD).
Conclusion
Guidelines should be evaluated - especially the hypertonus guideline. Also further development and implementation should be emphasised. Methodically oriented work to the approach is pretty recent.
It is undeniable that guidelines represent a very essential and important contribution for the successful dealing with significant morbidity problems in a health system.
The fact that primarily younger doctors more frequently adopt, employ and adhere to guidelines leads to the assumption that expected sustainability for practical use will increase. Furthermore intensified use of guidelines can be considered in the "mainstream" of the development of the public health system also in an international perspective.
Not one single publication contradicts that a further acquirement, update and distribution of guidelines for the use of practices is necessary. The importance of the guideline is also not questioned in any article.
PMCID: PMC3011314  PMID: 21289932
9.  "What lies beneath it all?" – an interview study of GPs' attitudes to the use of guidelines 
Background
General practitioners (GPs) adopt clinical practice guidelines to varying degrees. Several factors have been found to influence application of guidelines in practice and the GP is apparently the key actor. Studies are needed to increase our understanding of how GPs' attitudes influence their use of guidelines. In this study we explored GPs' attitudes to guidelines.
Methods
In 2007 we conducted six semi-structured group interviews with a purposive sample of 27 Norwegian GPs. The participants were encouraged to discuss guidelines they were familiar with, the evidence base of guidelines, professional autonomy and doctor-patient relations. We used thematic content analysis to extract central themes and arguments.
Results
When deciding whether tfollow guideline recommendations, GPs consider whether guidelines are trustworthy, whether they suit patients and whether the recommended action is feasible. There were two important findings. First, the GP's were concerned that guidelines may be more heavily influenced by economic considerations than clinical ones. Second, in contrast to earlier findings, changes in recommendations and disagreement between experts were mostly viewed positively.
Conclusion
This study underscores the need for transparency in the process of development and implementation of guidelines. To enhance the use of guidelines, primary care physicians should be involved in the process of developing guidelines and the process should be transparent and explicit regarding the evidence base and economic considerations.
doi:10.1186/1472-6963-8-218
PMCID: PMC2577651  PMID: 18945360
10.  A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial 
PLoS Medicine  2011;8(4):e1001018.
Philip Ayieko and colleagues report the outcomes of a cluster-randomized trial carried out in eight Kenyan district hospitals evaluating the effects of a complex intervention involving improved training and supervision for clinicians. They found a higher performance of hospitals assigned to the complex intervention on a variety of process of care measures, as compared to those receiving the control intervention.
Background
In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.
Methods and Findings
This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n = 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n = 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline.
In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean = 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05–0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%–26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [−3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%–48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; −6.5% [−12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; −6.8% [−11.9% to −1.6%]).
Conclusions
Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.
Trial registration
Current Controlled Trials ISRCTN42996612
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2008, nearly 10 million children died in early childhood. Nearly all these deaths were in low- and middle-income countries—half were in Africa. In Kenya, for example, 74 out every 1,000 children born died before they reached their fifth birthday. About half of all childhood (pediatric) deaths in developing countries are caused by pneumonia, diarrhea, and malaria. Deaths from these common diseases could be prevented if all sick children had access to quality health care in the community (“primary” health care provided by health centers, pharmacists, family doctors, and traditional healers) and in district hospitals (“secondary” health care). Unfortunately, primary health care facilities in developing countries often lack essential diagnostic capabilities and drugs, and pediatric hospital care is frequently inadequate with many deaths occurring soon after admission. Consequently, in 1996, as part of global efforts to reduce childhood illnesses and deaths, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) introduced the Integrated Management of Childhood Illnesses (IMCI) strategy. This approach to child health focuses on the well-being of the whole child and aims to improve the case management skills of health care staff at all levels, health systems, and family and community health practices.
Why Was This Study Done?
The implementation of IMCI has been evaluated at the primary health care level, but its implementation in district hospitals has not been evaluated. So, for example, interventions designed to encourage the routine use of WHO disease-specific guidelines in rural pediatric hospitals have not been tested. In this cluster randomized trial, the researchers develop and test a multifaceted intervention designed to improve the implementation of treatment guidelines and admission pediatric care in district hospitals in Kenya. In a cluster randomized trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions and the outcomes in different “clusters” of patients are compared. In this trial, each cluster is a district hospital.
What Did the Researchers Do and Find?
The researchers randomly assigned eight Kenyan district hospitals to the “full” or “control” intervention, interventions that differed in intensity but that both included more strategies to promote implementation of best practice than are usually applied in Kenyan rural hospitals. The full intervention included provision of clinical practice guidelines and training in their use, six-monthly survey-based hospital assessments followed by face-to-face feedback of survey findings, 5.5 days training for health care workers, provision of job aids such as structured pediatric admission records, external supervision, and the identification of a local facilitator to promote guideline use and to provide on-site problem solving. The control intervention included the provision of clinical practice guidelines (without training in their use) and job aids, six-monthly surveys with written feedback, and a 1.5-day lecture-based seminar to explain the guidelines. The researchers compared the implementation of various processes of care (activities of patients and doctors undertaken to ensure delivery of care) in the intervention and control hospitals at baseline and 18 months later. The performance of both groups of hospitals improved during the trial but more markedly in the intervention hospitals than in the control hospitals. At 18 months, the completion of admission assessment tasks and the uptake of guideline-recommended clinical practices were both higher in the intervention hospitals than in the control hospitals. Moreover, a lower proportion of children received inappropriate doses of drugs such as quinine for malaria in the intervention hospitals than in the control hospitals.
What Do These Findings Mean?
These findings show that specific efforts are needed to improve pediatric care in rural Kenya and suggest that interventions that include more approaches to changing clinical practice may be more effective than interventions that include fewer approaches. These findings are limited by certain aspects of the trial design, such as the small number of participating hospitals, and may not be generalizable to other hospitals in Kenya or to hospitals in other developing countries. Thus, although these findings seem to suggest that efforts to implement and scale up improved secondary pediatric health care will need to include more than the production and dissemination of printed materials, further research including trials or evaluation of test programs are necessary before widespread adoption of any multifaceted approach (which will need to be tailored to local conditions and available resources) can be contemplated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001018.
WHO provides information on efforts to reduce global child mortality and on Integrated Management of Childhood Illness (IMCI); the WHO pocket book “Hospital care for children contains guidelines for the management of common illnesses with limited resources (available in several languages)
UNICEF also provides information on efforts to reduce child mortality and detailed statistics on child mortality
The iDOC Africa Web site, which is dedicated to improving the delivery of hospital care for children and newborns in Africa, provides links to the clinical guidelines and other resources used in this study
doi:10.1371/journal.pmed.1001018
PMCID: PMC3071366  PMID: 21483712
11.  The development of a guideline implementability tool (GUIDE-IT): a qualitative study of family physician perspectives 
BMC Family Practice  2014;15:19.
Background
The potential of clinical practice guidelines has not been realized due to inconsistent adoption in clinical practice. Optimising intrinsic characteristics of guidelines (e.g., its wording and format) that are associated with uptake (as perceived by their end users) may have potential. Using findings from a realist review on guideline uptake and consultation with experts in guideline development, we designed a conceptual version of a future tool called Guideline Implementability Tool (GUIDE-IT). The tool will aim to involve family physicians in the guideline development process by providing a process to assess draft guideline recommendations. This feedback will then be given back to developers to consider when finalizing the recommendations. As guideline characteristics are best assessed by end-users, the objectives of the current study were to explore how family physicians perceive guideline implementability, and to determine what components should comprise the final GUIDE-IT prototype.
Methods
We conducted a qualitative study with family physicians inToronto, Ontario. Two experienced investigators conducted one-hour interviews with family physicians using a semi-structured interview guide to 1) elicit feedback on perceptions on guideline implementability; 2) to generate a discussion in response to three draft recommendations; and 3) to provide feedback on the conceptual GUIDE-IT. Sessions were audio taped and transcribed verbatim. Data collection and analysis were guided by content analyses.
Results
20 family physicians participated. They perceived guideline uptake according to facilitators and barriers across 6 categories of guideline implementability (format, content, language, usability, development, and the practice environment). Participants’ feedback on 3 draft guideline recommendations were grouped according to guideline perception, cognition, and agreement. When asked to comment on GUIDE-IT, most respondents believed that the tool would be useful, but urged to involve “regular” or community family physicians in the process, and suggested that an online system would be the most efficient way to deliver it.
Conclusions
Our study identified facilitators and barriers of guideline implementability from the perspective of community and academic family physicians that will be used to build our GUIDE-IT prototype. Our findings build on current knowledge by showing that family physicians perceive guideline uptake mostly according to factors that are in the control of guideline developers.
doi:10.1186/1471-2296-15-19
PMCID: PMC4016596  PMID: 24476491
Guideline implementability; Family practice; Knowledge translation; Qualitative
12.  Effect of an Educational Toolkit on Quality of Care: A Pragmatic Cluster Randomized Trial 
PLoS Medicine  2014;11(2):e1001588.
In a pragmatic cluster-randomized trial, Baiju Shah and colleagues evaluated the effectiveness of printed educational materials for clinician education focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Please see later in the article for the Editors' Summary
Background
Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Methods and Findings
All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.
Conclusions
The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.
Trial Registration
http://www.ClinicalTrials.gov NCT01411865 and NCT01026688
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Clinical practice guidelines help health care providers deliver the best care to patients by combining all the evidence on disease management into specific recommendations for care. However, the implementation of evidence-based guidelines is often far from perfect. Take the example of diabetes. This common chronic disease, which is characterized by high levels of sugar (glucose) in the blood, impairs the quality of life of patients and shortens life expectancy by increasing the risk of cardiovascular diseases (conditions that affect the heart and circulation) and other life-threatening conditions. Patients need complex care to manage the multiple risk factors (high blood sugar, high blood pressure, high levels of fat in the blood) that are associated with the long-term complications of diabetes, and they need to be regularly screened and treated for these complications. Clinical practice guidelines for diabetes provide recommendations on screening and diagnosis, drug treatment, and cardiovascular disease risk reduction, and on helping patients self-manage their disease. Unfortunately, the care delivered to patients with diabetes frequently fails to meet the standards laid down in these guidelines.
Why Was This Study Done?
How can guideline adherence and the quality of care provided to patients be improved? A common approach is to send printed educational materials to clinicians. For example, when the Canadian Diabetes Association (CDA) updated its clinical practice guidelines in 2008, it mailed educational toolkits that contained brochures and other printed materials targeting key themes from the guidelines to family physicians. In this pragmatic cluster randomized trial, the researchers investigate the effect of the CDA educational toolkit that targeted cardiovascular disease screening and treatment on the quality of care of people with diabetes. A pragmatic trial asks whether an intervention works under real-life conditions and whether it works in terms that matter to the patient; a cluster randomized trial randomly assigns groups of people to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers randomly assigned family practices in Ontario, Canada to receive the educational toolkit in June 2009 (intervention group) or in May 2010 (control group). They examined outcomes between July 2009 and April 2010 in all patients with diabetes in Ontario aged over 40 years (933,789 people) using population-level administrative data. In Canada, administrative databases record the personal details of people registered with provincial health plans, information on hospital visits and prescriptions, and physician service claims for consultations, assessments, and diagnostic and therapeutic procedures. They also examined clinical outcome data from a random sample of 1,592 patients at high risk of cardiovascular complications. In the administrative data study, death or non-fatal heart attack (the primary outcome) occurred in about 11,500 patients in both the intervention and control group. In the clinical data study, the primary outcome―use of a statin to lower blood fat levels―occurred in about 700 patients in both study groups. Secondary outcomes, including other clinical events, processes of care, and measures of risk factor control were also not improved by the intervention. Indeed, in the administrative data study, some processes of care outcomes related to screening for heart disease were statistically significantly worse in the intervention group than in the control group, and in the clinical data study, fewer patients in the intervention group reached blood pressure targets than in the control group.
What Do These Findings Mean?
These findings suggest that the CDA cardiovascular diseases educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Indeed, the toolkit may have led to worsening in some secondary outcomes although, because numerous secondary outcomes were examined, this may be a chance finding. Limitations of the study include its length, which may have been too short to see an effect of the intervention on clinical outcomes, and the possibility of a ceiling effect—the control group in the clinical data study generally had good care, which left little room for improvement of the quality of care in the intervention group. Overall, however, these findings suggest that printed educational materials may not be an effective way to improve the quality of care for patients with diabetes and other complex conditions and highlight the need for a rigorous, scientific approach to the development, dissemination, and evaluation of quality improvement interventions.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001588.
The US National Diabetes Information Clearinghouse provides information about diabetes for patients, health care professionals, and the general public (in English and Spanish)
The UK National Health Service Choices website provides information (including some personal stories) for patients and carers about type 2 diabetes, the commonest form of diabetes
The Canadian Diabetes Association also provides information about diabetes for patients (including some personal stories about living with diabetes) and health care professionals; its latest clinical practice guidelines are available on its website
The UK National Institute for Health and Care Excellence provides general information about clinical guidelines and about health care quality standards in the UK
The US Agency for Healthcare Research and Quality aims to improve the quality, safety, efficiency, and effectiveness of health care for all Americans (information in English and Spanish); the US National Guideline Clearinghouse is a searchable database of clinical practice guidelines
The International Diabetes Federation provides information about diabetes for patients and health care professionals, along with international statistics on the burden of diabetes
doi:10.1371/journal.pmed.1001588
PMCID: PMC3913553  PMID: 24505216
13.  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
14.  Health professionals’ perceptions about the adoption of existing guidelines for the diagnosis of fetal alcohol spectrum disorders in Australia 
BMC Pediatrics  2012;12:69.
Background
Despite the availability of five guidelines for the diagnosis of fetal alcohol spectrum disorders (FASD), there is no national endorsement for their use in diagnosis in Australia. In this study we aimed to describe health professionals’ perceptions about the adoption of existing guidelines for the diagnosis of FASD in Australia and identify implications for the development of national guidelines.
Methods
We surveyed 130 Australian and 9 international health professionals with expertise or involvement in the screening or diagnosis of FASD. An online questionnaire was used to evaluate participants’ familiarity with and use of five existing diagnostic guidelines for FASD, and to assess their perceptions about the adoption of these guidelines in Australia.
Results
Of the 139 participants surveyed, 84 Australian and 8 international health professionals (66.2%) responded to the questions on existing diagnostic guidelines. Participants most frequently reported using the University of Washington 4-Digit Diagnostic Code (27.2%) and the Canadian guidelines (18.5%) for diagnosis. These two guidelines were also most frequently recommended for adoption in Australia: 32.5% of the 40 participants who were familiar with the University of Washington 4-Digit Diagnostic Code recommended adoption of this guideline in Australia, and 30.8% of the 26 participants who were familiar with the Canadian guidelines recommended adoption of this guideline in Australia. However, for the majority of guidelines examined, most participants were unsure whether they should be adopted in Australia. The adoption of existing guidelines in Australia was perceived to be limited by: their lack of evidence base, including the appropriateness of established reference standards for the Australian population; their complexity; the need for training and support to use the guidelines; and the lack of an interdisciplinary and interagency model to support service delivery in Australia.
Conclusions
Participants indicated some support for the adoption of the University of Washington or Canadian guidelines for FASD diagnosis; however, concerns were raised about the adoption of these diagnostic guidelines in their current form. Australian diagnostic guidelines will require evaluation to establish their validity in the Australian context, and a comprehensive implementation model is needed to facilitate improved diagnostic capacity in Australia.
doi:10.1186/1471-2431-12-69
PMCID: PMC3416706  PMID: 22697051
15.  Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility 
BMC Family Practice  2011;12:128.
Background
Most guidelines concentrate on investigations, treatment, and monitoring instead of patient history and clinical examination. We developed a guideline that dealt with the different aetiologies of chest pain by emphasizing the patient's history and physical signs. The objective of this study was to evaluate the guideline's acceptance and feasibility in the context of a practice test.
Methods
The evaluation study was nested in a diagnostic cross-sectional study with 56 General Practitioners (GPs) and 862 consecutively recruited patients with chest pain. The evaluation of the guideline was conducted in a mixed method design on a sub-sample of 17 GPs and 282 patients. Physicians' evaluation of the guideline was assessed via standardized questionnaires and case record forms. Additionally, practice nursing staff and selected patients were asked for their evaluation of specific guideline modules. Quantitative data was analyzed descriptively for frequencies, means, and standard deviations. In addition, two focus groups with a total of 10 GPs were held to gain further insights in the guideline implementation process. The data analysis and interpretation followed the standards of the qualitative content analysis.
Results
The overall evaluation of the GPs participating in the evaluation study regarding the recommendations made in the chest pain guideline was positive. A total of 14 GPs were convinced that there was a need for this kind of guideline and perceived the guideline recommendations as useful. While the long version was partially criticized for a perceived lack of clarity, the short version of the chest pain guideline and the heart score were especially appreciated by the GPs. However, change of clinical behaviour as consequence of the guideline was inconsistent. While on a concrete patient related level, GPs indicated to have behaved as the guideline recommended, the feedback on a more general level was heterogeneous. Several suggestions to improve guideline implementation were made by participating physicians. Due to the small number of practice nursing staff evaluating the flowchart and patients remembering the patient leaflet, no valid results regarding the flowchart and patient leaflet modules could be reported.
Conclusions
Overall, the participating GPs perceived the guideline recommendations as useful to increase awareness and to reflect on diagnostic issues. Although behaviour change in consequence of the guideline was not reported on a general level, guidelines on history taking and the clinical examination may serve an important conservative and practical function in a technology driven environment. Further research to increase the implementation success of the guideline should be undertaken.
doi:10.1186/1471-2296-12-128
PMCID: PMC3267789  PMID: 22103603
16.  Guidelines, Editors, Pharma And The Biological Paradigm Shift 
Mens Sana Monographs  2007;5(1):27-30.
Private investment in biomedical research has increased over the last few decades. At most places it has been welcomed as the next best thing to technology itself. Much of the intellectual talent from academic institutions is getting absorbed in lucrative positions in industry. Applied research finds willing collaborators in venture capital funded industry, so a symbiotic growth is ensured for both.
There are significant costs involved too. As academia interacts with industry, major areas of conflict of interest especially applicable to biomedical research have arisen. They are related to disputes over patents and royalty, hostile encounters between academia and industry, as also between public and private enterprise, legal tangles, research misconduct of various types, antagonistic press and patient-advocate lobbies and a general atmosphere in which commercial interest get precedence over patient welfare.
Pharma image stinks because of a number of errors of omission and commission. A recent example is suppression of negative findings about Bayer's Trasylol (Aprotinin) and the marketing maneuvers of Eli Lilly's Xigris (rhAPC). Whenever there is a conflict between patient vulnerability and profit motives, pharma often tends to tilt towards the latter. Moreover there are documents that bring to light how companies frequently cross the line between patient welfare and profit seeking behaviour.
A voluntary moratorium over pharma spending to pamper drug prescribers is necessary. A code of conduct adopted recently by OPPI in India to limit pharma company expenses over junkets and trinkets is a welcome step.
Clinical practice guidelines (CPG) are considered important as they guide the diagnostic/therapeutic regimen of a large number of medical professionals and hospitals and provide recommendations on drugs, their dosages and criteria for selection. Along with clinical trials, they are another area of growing influence by the pharmaceutical industry. For example, in a relatively recent survey of 2002, it was found that about 60% of 192 authors of clinical practice guidelines reported they had financial connections with the companies whose drugs were under consideration. There is a strong case for making CPGs based not just on effectivity but cost effectivity. The various ramifications of this need to be spelt out. Work of bodies like the Appraisal of Guidelines Research and Evaluation (AGREE) Collaboration and Guidelines Advisory Committee (GAC) are also worth a close look.
Even the actions of Foundations that work for disease amelioration have come under scrutiny. The process of setting up ‘Best Practices’ Guidelines for interactions between the pharmaceutical industry and clinicians has already begun and can have important consequences for patient care. Similarly, Good Publication Practice (GPP) for pharmaceutical companies have also been set up aimed at improving the behaviour of drug companies while reporting drug trials
The rapidly increasing trend toward influence and control by industry has become a concern for many. It is of such importance that the Association of American Medical Colleges has issued two relatively new documents - one, in 2001, on how to deal with individual conflicts of interest; and the other, in 2002, on how to deal with institutional conflicts of interest in the conduct of clinical research. Academic Medical Centers (AMCs), as also medical education and research institutions at other places, have to adopt means that minimize their conflicts of interest.
Both medical associations and research journal editors are getting concerned with individual and institutional conflicts of interest in the conduct of clinical research and documents are now available which address these issues. The 2001 ICMJE revision calls for full disclosure of the sponsor's role in research, as well as assurance that the investigators are independent of the sponsor, are fully accountable for the design and conduct of the trial, have independent access to all trial data and control all editorial and publication decisions. However the findings of a 2002 study suggest that academic institutions routinely participate in clinical research that does not adhere to ICMJE standards of accountability, access to data and control of publication.
There is an inevitable slant to produce not necessarily useful but marketable products which ensure the profitability of industry and research grants outflow to academia. Industry supports new, not traditional, therapies, irrespective of what is effective. Whatever traditional therapy is supported is most probably because the company concerned has a product with a big stake there, which has remained a ‘gold standard’ or which that player thinks has still some ‘juice’ left.
Industry sponsorship is mainly for potential medications, not for trying to determine whether there may be non-pharmacological interventions that may be equally good, if not better. In the paradigm shift towards biological psychiatry, the role of industry sponsorship is not overt but probably more pervasive than many have realised, or the right thinking may consider good, for the health of the branch in the long run.
An issue of major concern is protection of the interests of research subjects. Patients agree to become research subjects not only for personal medical benefit but, as an extension, to benefit the rest of the patient population and also advance medical research.
We all accept that industry profits have to be made, and investment in research and development by the pharma industry is massive. However, we must also accept there is a fundamental difference between marketing strategies for other entities and those for drugs.
The ultimate barometer is patient welfare and no drug that compromises it can stand the test of time. So, how does it make even commercial sense in the long term to market substandard products? The greatest mistake long-term players in industry may make is try to adopt the shady techniques of the upstart new entrant. Secrecy of marketing/sales tactics, of the process of manufacture, of other strategies and plans of business expansion, of strategies to tackle competition are fine business tactics. But it is critical that secrecy as a tactic not extend to reporting of research findings, especially those contrary to one's product.
Pharma has no option but to make a quality product, do comprehensive adverse reaction profiles, and market it only if it passes both tests.
Why does pharma adopt questionable tactics? The reasons are essentially two:
What with all the constraints, a drug comes to the pharmacy after huge investments. There are crippling overheads and infrastructure costs to be recovered. And there are massive profit margins to be maintained. If these were to be dependent only on genuine drug discoveries, that would be taking too great a risk.Industry players have to strike the right balance between profit making and credibility. In profit making, the marketing champions play their role. In credibility ratings, researchers and paid spokes-persons play their role. All is hunky dory till marketing is based on credibility. When there is nothing available to make for credibility, something is projected as one and marketing carried out, in the calculated hope that profits can accrue, since profit making must continue endlessly. That is what makes pharma adopt even questionable means to make profits.
Essentially, there are four types of drugs. First, drugs that work and have minimal side-effects; second, drugs which work but have serious side-effects; third, drugs that do not work and have minimal side-effects; and fourth, drugs which work minimally but have serious side-effects. It is the second and fourth types that create major hassles for industry. Often, industry may try to project the fourth type as the second to escape censure.
The major cat and mouse game being played by conscientious researchers is in exposing the third and fourth for what they are and not allowing industry to palm them off as the first and second type respectively. The other major game is in preventing the second type from being projected as the first. The third type are essentially harmless, so they attract censure all right and some merriment at the antics to market them. But they escape anything more than a light rap on the knuckles, except when they are projected as the first type.
What is necessary for industry captains and long-term players is to realise:
Their major propelling force can only be producing the first type. 2. They accept the second type only till they can lay their hands on the first. 3. The third type can be occasionally played around with to shore up profits, but never by projecting them as the first type. 4. The fourth type are the laggards, real threat to credibility and therefore do not deserve any market hype or promotion.
In finding out why most pharma indulges in questionable tactics, we are lead to some interesting solutions to prevent such tactics with the least amount of hassles for all concerned, even as both profits and credibility are kept intact.
doi:10.4103/0973-1229.32176
PMCID: PMC3192391  PMID: 22058616
Academia; Pharmaceutical Industry; Clinical Practice Guidelines; Best Practice Guidelines; Academic Medical Centers; Medical Associations; Research Journals; Clinical Research; Public Welfare; Pharma Image; Corporate Welfare; Biological Psychiatry; Law Suits Against Industry
17.  Adopting and implementing nutrition guidelines in recreational facilities: Public and private sector roles. A multiple case study 
BMC Public Health  2012;12:376.
Background
Recreational facilities are an important community resource for health promotion because they provide access to affordable physical activities. However, despite their health mandate, many have unhealthy food environments that may paradoxically increase the risk of childhood obesity. The Alberta Nutrition Guidelines for Children and Youth (ANGCY) are government-initiated, voluntary guidelines intended to facilitate children’s access to healthy food and beverage choices in schools, childcare and recreational facilities, however few recreational facilities are using them.
Methods
We used mixed methods within an exploratory multiple case study to examine factors that influenced adoption and implementation of the ANGCY and the nature of the food environment within three cases: an adopter, a semi-adopter and a non-adopter of the ANGCY. Diffusion of Innovations theory provided the theoretical platform for the study. Qualitative data were generated through interviews, observations, and document reviews, and were analysed using directed content analysis. Set theoretic logic was used to identify factors that differentiated adopters from the non-adopter. Quantitative sales data were also collected, and the quality of the food environment was scored using four complementary tools.
Results
The keys to adoption and implementation of nutrition guidelines in recreational facilities related to the managers’ nutrition-related knowledge, beliefs and perceptions, as these shaped his decisions and actions. The manager, however, could not accomplish adoption and implementation alone. Intersectoral linkages with schools and formal, health promoting partnerships with industry were also important for adoption and implementation to occur. The food environment in facilities that had adopted the ANGCY did not appear to be superior to the food environment in facilities that had not adopted the ANGCY.
Conclusions
ANGCY uptake may continue to falter under the current voluntary approach, as the environmental supports for voluntary action are poor. Where ANGCY uptake does occur, changes to the food environment may be relatively minor. Stronger government measures may be needed to require recreational facilities to improve their food environments and to limit availability of unhealthy foods.
doi:10.1186/1471-2458-12-376
PMCID: PMC3490726  PMID: 22632384
Childhood obesity; Food environment; Recreational facility; Diffusion of Innovations; Mixed methods; Case study; Nutrition guidelines; Adoption; Implementation
18.  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
19.  Thou shalt versus thou shalt not: a meta-synthesis of GPs' attitudes to clinical practice guidelines 
Background
GPs' adherence to clinical practice guidelines is variable. Barriers to guideline implementation have been identified but qualitative studies have not been synthesised to explore what underpins these attitudes.
Aim
To explore and synthesise qualitative research on GPs' attitudes to and experiences with clinical practice guidelines.
Design of study
Systematic review and meta-synthesis of qualitative studies.
Method
PubMed, CINAHL, EMBASE, Social Science Citation Index, and Science Citation Index were used as data sources, and independent data extraction was carried out. Discrepancies were resolved by consensus. Initial thematic analysis was conducted, followed by interpretative synthesis.
Results
Seventeen studies met the inclusion criteria. Five were excluded following quality appraisal. Twelve papers were synthesised which reported research in the UK, US, Canada, and the Netherlands, and covered different clinical guideline topics. Six themes were identified: questioning the guidelines, GPs' experience, preserving the doctor–patient relationship, professional responsibility, practical issues, and guideline format. Comparative analysis and synthesis revealed that GPs' reasons for not following guidelines differed according to whether the guideline in question was prescriptive, in that it encouraged a certain type of behaviour or treatment, or proscriptive, in that it discouraged certain treatments or behaviours.
Conclusion
Previous analyses of guidelines have focused on professional attitudes and organisational barriers to adherence. This synthesis suggests that the purpose of the guideline, whether its aims are prescriptive or proscriptive, may influence if and how guidelines are received and implemented.
PMCID: PMC2084137  PMID: 18252073
attitudes of health personnel; general practice; guideline adherence; guidelines; meta-synthesis; qualitative research
20.  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
21.  Guideline adaptation and implementation planning: a prospective observational study 
Background
Adaptation of high-quality practice guidelines for local use has been advanced as an efficient means to improve acceptability and applicability of evidence-informed care. In a pan-Canadian study, we examined how cancer care groups adapted pre-existing guidelines to their unique context and began implementation planning.
Methods
Using a mixed-methods, case-study design, five cases were purposefully sampled from self-identified groups and followed as they used a structured method and resources for guideline adaptation. Cases received the ADAPTE Collaboration toolkit, facilitation, methodological and logistical support, resources and assistance as required. Documentary and primary data collection methods captured individual case experience, including monthly summaries of meeting and field notes, email/telephone correspondence, and project records. Site visits, process audits, interviews, and a final evaluation forum with all cases contributed to a comprehensive account of participant experience.
Results
Study cases took 12 to >24 months to complete guideline adaptation. Although participants appreciated the structure, most found the ADAPTE method complex and lacking practical aspects. They needed assistance establishing individual guideline mandate and infrastructure, articulating health questions, executing search strategies, appraising evidence, and achieving consensus. Facilitation was described as a multi-faceted process, a team effort, and an essential ingredient for guideline adaptation. While front-line care providers implicitly identified implementation issues during adaptation, they identified a need to add an explicit implementation planning component.
Conclusions
Guideline adaptation is a positive initial step toward evidence-informed care, but adaptation (vs. ‘de novo’ development) did not meet expectations for reducing time or resource commitments. Undertaking adaptation is as much about the process (engagement and capacity building) as it is about the product (adapted guideline). To adequately address local concerns, cases found it necessary to also search and appraise primary studies, resulting in hybrid (adaptation plus de novo) guideline development strategies that required advanced methodological skills.
Adaptation was found to be an action element in the knowledge translation continuum that required integration of an implementation perspective. Accordingly, the adaptation methodology and resources were reformulated and substantially augmented to provide practical assistance to groups not supported by a dedicated guideline panel and to provide more implementation planning support. The resulting framework is called CAN-IMPLEMENT.
doi:10.1186/1748-5908-8-49
PMCID: PMC3668213  PMID: 23656884
Knowledge to action; Practice guidelines; Evidence-informed practice; Knowledge activation; Guideline adaptation; Implementation planning
22.  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
23.  Promoting best gynecologic oncology practice: a role for the Society of Gynecologic Oncologists of Canada 
Current Oncology  2006;13(3):94-98.
During March 30–April 1, 2005, the Society of Gynecologic Oncologists of Canada (goc) and the Canadian Strategy for Cancer Control (cscc) Clinical Practice Guidelines Action Group (cpg-ag) met to
determine how goc would like to influence practice in the care of women with gynecologic cancer.explore a collaborative model for developing and implementing evidence-based practice guidelines.investigate the utility of the cpg evaluation and adaptation cycle as a tool for selecting, adapting, and adopting guidelines.
At the workshop meeting, 21 members of the goc and the cpg-ag heard presentations from various Canadian guideline initiatives. As an example of adaptation and adoption processes, the agree (Appraisal of Guidelines for Research and Evaluation) tool was applied to guidelines in recurrent ovarian cancer, and the group explored their opportunity to use knowledge translation to influence the care of women with gynecologic cancer.
The themes influencing practice are consistent with goc’s mandate. The future is expected to involve partnering with other groups to maximize scarce resources. Resources should be directed to facilitating implementation of existing guidelines rather than to developing new documents. The full spectrum of cancer care includes prevention, screening, diagnosis, primary treatment, follow-up, treatment of recurrent disease, and palliation. High-quality evidence is available in some areas, but gaps exist where guideline panels could provide guidance. Development of a pan-Canadian gynecologic oncology process could provide an opportunity to influence access to care at the political and policy levels.
The goc will develop linkages such that the toolbox available through cscc-cpg-ag can be incorporated into future collaboration.
PMCID: PMC1891179  PMID: 17576448
Practice guidelines; gynecologic oncology
24.  Improving the use of research evidence in guideline development: 1. Guidelines for guidelines 
Background
The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the first of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this.
Objectives
We reviewed the literature on guidelines for the development of guidelines.
Methods
We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments.
Key questions and answers
We found no experimental research that compared different formats of guidelines for guidelines or studies that compared different components of guidelines for guidelines. However, there are many examples, surveys and other observational studies that compared the impact of different guideline development documents on guideline quality.
What have other organizations done to develop guidelines for guidelines from which WHO can learn?
• Establish a credible, independent committee that evaluates existing methods for developing guidelines or that updates existing ones.
• Obtain feedback and approval from various stakeholders during the development process of guidelines for guidelines.
• Develop a detailed source document (manual) that guideline developers can use as reference material.
What should be the key components of WHO guidelines for guidelines?
• Guidelines for guidelines should include information and instructions about the following components: 1) Priority setting; 2) Group composition and consultations; 3) Declaration and avoidance of conflicts of interest; 4) Group processes; 5) Identification of important outcomes; 6) Explicit definition of the questions and eligibility criteria ; 7) Type of study designs for different questions; 8) Identification of evidence; 9) Synthesis and presentation of evidence; 10) Specification and integration of values; 11) Making judgments about desirable and undesirable effects; 12) Taking account of equity; 13) Grading evidence and recommendations; 14) Taking account of costs; 15) Adaptation, applicability, transferability of guidelines; 16) Structure of reports; 17) Methods of peer review; 18) Planned methods of dissemination & implementation; 19) Evaluation of the guidelines.
What have other organizations done to implement guidelines for guidelines from which WHO can learn?
• Obtain buy-in from regions and country level representatives for guidelines for guidelines before dissemination of a revised version.
• Disseminate the guidelines for guidelines widely and make them available (e.g. on the Internet).
• Develop examples of guidelines that guideline developers can use as models when applying the guidelines for guidelines.
• Ensure training sessions for those responsible for developing guidelines.
• Continue to monitor the methodological literature on guideline development.
doi:10.1186/1478-4505-4-13
PMCID: PMC1665445  PMID: 17118181
25.  The European Society of Human Reproduction and Embryology guideline for the diagnosis and treatment of endometriosis: an electronic guideline implementability appraisal 
Background
Clinical guidelines are intended to improve healthcare. However, even if guidelines are excellent, their implementation is not assured. In subfertility care, the European Society of Human Reproduction and Embryology (ESHRE) guidelines have been inventoried, and their methodological quality has been assessed. To improve the impact of the ESHRE guidelines and to improve European subfertility care, it is important to optimise the implementability of guidelines. We therefore investigated the implementation barriers of the ESHRE guideline with the best methodological quality and evaluated the used instrument for usability and feasibility.
Methods
We reviewed the ESHRE guideline for the diagnosis and treatment of endometriosis to assess its implementability. We used an electronic version of the guideline implementability appraisal (eGLIA) instrument. This eGLIA tool consists of 31 questions grouped into 10 dimensions. Seven items address the guideline as a whole, and 24 items assess the individual recommendations in the guideline. The eGLIA instrument identifies factors that influence the implementability of the guideline recommendations. These factors can be divided into facilitators that promote implementation and barriers that oppose implementation. A panel of 10 experts from three European countries appraised all 36 recommendations of the guideline. They discussed discrepancies in a teleconference and completed a questionnaire to evaluate the ease of use and overall utility of the eGLIA instrument.
Results
Two of the 36 guideline recommendations were straightforward to implement. Five recommendations were considered simply statements because they contained no actions. The remaining 29 recommendations were implementable with some adjustments. We found facilitators of the guideline implementability in the quality of decidability, presentation and formatting, apparent validity, and novelty or innovation of the recommendations. Vaguely defined actions, lack of facilities, immeasurable outcomes, and inflexibility within the recommendations formed barriers to implementation. The eGLIA instrument was generally useful and easy to use. However, assessment with the eGLIA instrument is very time-consuming.
Conclusions
The ESHRE guideline for the diagnosis and treatment of endometriosis could be improved to facilitate its implementation in daily practice. The eGLIA instrument is a helpful tool for identifying obstacles to implementation of a guideline. However, we recommend a concise version of this instrument.
doi:10.1186/1748-5908-6-7
PMCID: PMC3034686  PMID: 21247418

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