Decisions around what care to provide at the population  level are particularly complex, involving considerations such as feasibility, cost, and population needs in addition to scientific evidence. One example of decision-making at this "population-policy" level involves what screening questions and intervention guides to include on standardized provincial prenatal records. As mandatory medical reporting forms, prenatal records are potentially powerful vehicles for promoting population-wide evidence-based care. However, the extent to which Canadian prenatal records reflect best-practice recommendations for the assessment of well-known risk factors such as maternal smoking and alcohol consumption varies markedly across Canadian provinces and territories. The goal of this study is to better understand the interaction of contextual factors and research evidence on decision-making at the population-policy level, by examining the processes by which provincial prenatal records are reviewed and revised.There is a significant gap in the knowledge translation literature related to Guided by Dobrow et al.'s (2004) conceptual model for context-based evidence-based decision-making, this study will use a multiple case study design with embedded units of analysis to examine contextual factors influencing the prenatal record revision process in different Canadian provinces and territories. Data will be collected using multiple methods to construct detailed case descriptions for each province/territory. Using qualitative data analysis techniques, decision-making processes involving prenatal record content specifically related to maternal smoking and alcohol use will be compared both within and across each case, to identify key contextual factors influencing the uptake and application of research evidence by prenatal record review committees. All study participants will be required to give written informed consent prior to participating in data collection.This study will advance knowledge in the field of evidence-based decision-making by illustrating the complex interaction of contextual factors and evidence on health policy decision-making by provincial-level committees. By increasing the transparency of decision-making within provincial prenatal record committees, this study will help inform more effective strategies for enhancing the integration of best-practice evidence into prenatal records. Decision-making -4. As man-making , beggingn-making ; these mn-making .To gain an in-depth understanding of the influence of contextual factors on evidence use by provincial/territorial prenatal record review committees, this study will focus on two specific exemplars: the uptake of research evidence related to maternal smoking, and alcohol consumption during pregnancy. The scientific evidence identifying smoking and alcohol use as risk factors for adverse obstetrical outcomes is well-documented and long-standing ,9 meriti1) Describe and compare how provincial prenatal records are reviewed and updated across selected Canadian provinces;2) Identify specific contextual factors in the decision-making environment that impede or facilitate the use of research evidence during the prenatal record revision process, as well as alternative sources of evidence contributing to decision-making within provincial prenatal record committees; and3) Explore the relative impact of internal versus external contextual factors on the integration of research evidence in provincial practice policies such as the prenatal record.Four main research questions underlie these study objectives:What are the processes and who are the actors involved in developing and revising provincial prenatal records?How are decisions made about the content of provincial prenatal records related specifically to maternal smoking and prenatal alcohol?What key contextual factors influence the uptake of research evidence during the prenatal record revision process?What other factors in the decision-making environment at the provincial level may account for variations in the evidence base of prenatal records across provinces?Standardized provincial prenatal assessment forms are universally used in most provinces and territories in Canada to serve as a written health record which may be transferred from one part of the health care system to another  and provide data for routine surveillance of perinatal risk factors. The government prenatal records for each province and territory typically include a comprehensive health history form completed by health care providers at the first prenatal visit, as well as additional forms for documentation of on-going prenatal care at each subsequent encounter. By providing health care practitioners with reminders and prompts, provincial prenatal records outline the content of routine prenatal care and play a key role in guiding health professionals in what to assess and how to intervene with pregnant women. Physician reminders and prompts have been identified as one of the most effective mechanisms for transferring evidence into routine practice in preventative care . As stanDespite the potential for manipulating prenatal records to mandate evidence-based clinical care, literature examining and comparing the content and quality of Canadian prenatal records is virtually non-existent. A recent examination of Canadian prenatal records for their content related to maternal smoking found marked variation in the application of available research evidence across provinces . In the A central focus of the study of knowledge utilization in health care is to better understand why available research evidence is not readily adopted. Few studies, however, have explored precisely how research evidence is evaluated and integrated into provincial-level practice policies. This specific area of inquiry is uniquely situated between two more extensively-researched bodies of literature in the field of evidence-based decision-making: 1) the development and implementation of clinical practice guidelines (CPGs), and 2) evidence-based health policymaking. The following text addresses each of these topics in further detail.Evidence-based CPGs are increasingly viewed as important decision-making tools in the quest to improve the quality and effectiveness of health care -18. GrowThe important question of when and how CPGs should be modified and updated following their development and dissemination has received considerably less attention, although such formal practice guidelines are expected to be as evidence-based as feasible ,27. The Whereas standardized provincial prenatal records serve in essence as clinical practice guidelines, their mandatory use as part of the patient record and additional role in health surveillance adds complexity to decision-making around their content. However findings from the field of CPG development and maintenance suggest that various issues may influence decision-making around provincial prenatal content, such as the composition and dynamics of the committee responsible for reviewing and updating the prenatal records; the different sources and types of evidence considered in the decision-making process; and situational factors such as time and resources allocated to the review process.health policy is used variably in the evidence-based decision-making literature to refer to broad political actions taken by governments and other decision makers to improve the health of populations , as well as more specific clinical practice directives aimed at the population level . Our study focus falls more closely within the latter definition, which views evidence-based health policy  as the application of best current knowledge to the health needs and values of populations rather than individual patients [The second topic, evidence-based health policymaking, has been implicated in decision-making in health care. Growing demand for a return from investments in health services research has increased the need for transparency and rationalization of health policy decision-making . The terpatients .To date, studies in the area of evidence-based health care policymaking have focused largely on increasing research uptake in the policy setting by means of strengthening relationships between policy makers and researchers . Few stuFindings from the field of evidence-based health policy point to the decision-making environment at the provincial level as an important influence on what types and sources of evidence are considered in decisions around prenatal record content. An important gap that remains in the literature is the relative influence of different types or levels of contextual factors on the uptake and application of evidence in health policy decision-making. By closely examining how provincial prenatal records are reviewed and revised, this study aims to identify key contextual influences on evidence-based decision-making that can help inform strategies to increase research uptake at the population-policy level. The development of standardized provincial prenatal records offers an intriguing example of health policy decision-making, particularly as the forms function as both national practice guidelines and as a mandatory clinical documentation system. Prenatal records also address a broad scope of clinical parameters, allowing comparison of evidence integration across different content areas. To more closely examine decision-making processes within provincial prenatal record review committees, this study will focus specifically on the uptake and application of research evidence related to the prenatal assessment of maternal smoking and alcohol use.The Canadian Guide to Clinical Preventive Health Care advocates routine prenatal screening and counseling for the behavioral risk factors of both maternal smoking and alcohol use . AccordiMaternal smoking remains an important modifiable risk factor for adverse perinatal outcomes as well as for as longer-term mother and child health problems -39. HealDespite the availability of research evidence related to effective screening and interventions to reduce maternal smoking, current Canadian prenatal records vary markedly in the extent to which they incorporate these best-practice recommendations. A recent comparison of provincial and territorial prenatal records from all Canadian provinces and territories found that all the prenatal record forms included at least one question assessing maternal tobacco use at the first prenatal visit, but only two of the forms provided prompts for on-going monitoring of maternal smoking throughout the rest of pregnancy and only two included a prompt to refer smokers for specialized smoking cessation support . SeveralThe other behavioral risk factor of this study's interest is maternal alcohol use. Alcohol use during pregnancy is a significant and preventable public health issue that can result in a lifelong burden of psychological, emotional, and financial costs to the affected individuals and families -53. Preninternal decision-making context refers to the environment in which decisions are made and includes the purpose of the decision-making activity, participants' roles in the decision-making process, and the strategies used to arrive at the decision outcome . The individual participants on the prenatal record revision committees may influence the decision-making process through personal characteristics or relationships they bring to the table, as demonstrated in the previously-mentioned studies [external decision-making context refers to the provincial environment in which the decisions are applied, and involves more fixed, uncontrollable factors such as patterns of service delivery and dynamics among health professional organizations; as well as economic, regulatory and other sociopolitical features that may influence policy alternatives. Dobrow et al.'s model traces how internal and external contextual factors impact three main stages of evidence utilization: 1) introduction of evidence, that is, how evidence is identified and brought to the decision-making table; 2) interpretation of evidence, which refers to how the internal and external validity of the evidence is evaluated; and 3) application of evidence .This study of evidence-based decision-making by provincial prenatal record review committees will be guided by Dobrow et al.'s 2004) conceptual framework for "context-based evidence-based decision-making" [004 conce studies ,24 of hoThis framework for evidence-based decision-making is particularly useful for understanding why best-practice recommendations related to maternal smoking and alcohol consumption may have been differentially applied by provincial prenatal record review committees, as it explicitly moves the focus of inquiry beyond "the evidence" to specific contextual features within the broader policy environment. Dobrow et al.'s model suggests numerous propositions that may explain why some prenatal records have more detailed and evidence-based questioning of risk factors than others. For example, political pressure from provincial medical associations to minimize government control over medical practice  may act to decrease the number and specificity of prenatal record assessment questions and prompts. Conversely, provinces with more time and money allocated to the prenatal record revision process and/or greater capacity of committee members to assess the available research evidence  would be expected to have more evidenced-base prenatal records. An important question to address is how factors from both these different decision-making contexts are collectively weighed to justify health policy decisions. Because we are examining the integration of two areas of research evidence  in the prenatal record forms, our methods will allow us to decipher the relative influence of the internal and external decision-making contexts both within and across provincial prenatal record review committees, helping to identify key contextual factors influencing decision-making at the population-policy level.literal replication of findings (obtaining the same results across similar cases) and theoretical replication (obtaining different results but for predictable reasons), allowing exploration of the study's theoretical underpinnings [A multiple case study with embedded units of analysis will be used to examine and compare decision-making processes within and across provincial prenatal record review committees. The case study approach using mixed-methods is most valuable when the questions being posed require investigation of a real-life event in detail; where the focus is on "how" and "why" questions; when boundaries between phenomena and their context are not clear; and when the investigators have little control over events ,61. The pinnings . Study cpinnings .across these six provinces, in addition to comparing contextual influences on decision-making around maternal smoking vs. alcohol use questions and prompts within each of the case provinces. Other important dimensions of comparison across the selected case provinces may come to light as our case study unfolds, such as size of the province and type of organizational body responsible for maintaining the prenatal records.We purposefully selected six Canadian provinces that varied in the extent to which their prenatal record content related to maternal smoking and alcohol use was evidence-based, as reflected by questions and intervention prompts included on current prenatal records from each province and territory in Canada. We considered the extent to which the prenatal forms integrated available research evidence related to maternal smoking questions as "weak" if the prenatal record simply inquired about current smoking status, and "strong" if there were additional questions addressing issues such as previous smoking history and exposure to environmental tobacco smoke, and if the prenatal record provided for ongoing monitoring and/or prompted referral of smokers to specialized smoking cessation resources. Similarly, we considered the extent to which prenatal record content related to alcohol consumption was evidence-based to be "weak" if questions simply inquired about present alcohol use, and "strong" if the T-ACE scale also was included as part of routine prenatal assessment. Of the six provinces chosen for comparison, two had prenatal records with strong screening questions for both smoking and alcohol use; two had weak questioning related to both smoking and alcohol use; one had strong smoking questions but weaker alcohol-related questions; and one had weak assessment of maternal smoking but stronger questions related to alcohol use. The study's embedded design thus allowed for the examination of 12 separate decision-making events Multiple sources of data will be used to explore internal and external contextual factors at play during the prenatal record revision process . The priPertinent documents  will be examined  during a site visit to the provincial organizations responsible for the prenatal record review process in each of the six case provinces. When permitted, documents and records will be copied to include as part of the case study data base. The purpose of the site visits are to interview key informants, collect additional corroborating documentary data, gain a first-hand sense of the myriad actors and organizations involved in the prenatal record review process, and seek potential opportunities to directly observe decision-making processes in provinces currently engaged in prenatal record review. Due to the large volume of data to be collected and the variety of organizational settings that may need to be visited per province, each site visit will be conducted by the research associate accompanied by at least one of the study investigators. Each site visit will be scheduled over two days. Those conducting each site visit will be asked to prepare a brief report including their field notes recording their impressions and observations of the visit. This report will be shared with provincial prenatal record committee members to verify that we have provided an accurate record of decision-making processes. The research associate will be responsible for organizing a case study database for each case province, and for maintaining additional field diaries throughout the study to record observations and track events that may be of relevance to findings and analysis.Transcription of interviews and data analysis will proceed concurrently to permit follow-up of issues that might emerge from the data. Data will be transcribed and analyzed in their source language . The content of interview transcripts, documents and observations will first be analyzed descriptively to characterize the prenatal record review process for each case province, and to develop a detailed narrative of how and why decisions around prenatal record content related specifically to maternal smoking and alcohol use were arrived at. The data will then be examined using a number of qualitative data analysis techniques and the analytic categories suggested by Dobrow et al.'s conceptual model, while also building on new insights that may arise from close familiarity with the data. For example, content analysis of the data will be conducted to identify different evidentiary sources weighed in the decision-making process, as well as contextual features of the decision-making environments. Contextual factors will be coded and categorized according to their type  as well as point of impact on individual sources of evidence . New or more refined categories may be developed as needed. Data will be ordered and displayed using category matrices, graphics and frequency tables . The anaThe four tests commonly used to ensure rigor in case study designs are construct validity, internal reliability, external validity and reliability . ConstruThis study addresses an important gap in the field of evidence-based decision-making by seeking to illustrate the complex influence of contextual factors on decision-making processes within provincial-level committees. It will build on Dobrow et al.'s framework, generating knowledge about specific contextual factors that maximize the uptake of evidence in population-policy decision-making. Specifically, this study will increase the transparency of decision-making within provincial prenatal record committees and will thus help to identify effective strategies for promoting the integration of research evidence into the mandatory and widely used prenatal records. More broadly, study findings will contribute to a model of evidence-based decision-making that can be adapted to the broader contextual features of policy environments, helping inform avenues for promoting research utilization for other types of committees developing provincial tools and programs. Examples include the development of mandatory core program guidelines in Ontario ; and the development of surveillance tools for use across clinical practice settings such as injury surveillance, and patient safety monitoring tools.This proposed research directly meets the Canadian Institutes of Health Research's knowledge translation strategic direction of advancing research in the use of health-related knowledge across the various levels of decision-making in the health system. Therefore, the study results should advance our understanding of internal and external contextual factors that influence population-policy decision-making. As such, results are expected to be of interest to scientists working in the fields of knowledge translation, public and population health, and health services research.CPGs: Clinical Practice Guidelines; FASD: Fetal Alcohol Spectrum DisordersThe authors declare that they have no competing interests.All authors contributed to the conception and design of the study protocol. SS and NE drafted the protocol, with further input from all other authors. This manuscript was prepared by PM and SS. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:Ethics approval Ottawa additional file 1.  Ethics approval to study protocol from the University of Ottawa research ethics boardClick here for fileEthics approval Laurentian additional file 2.  Ethics approval to study from University of Laurentian research ethics boardClick here for fileEthics approval McGill additional file 3.  Ethics approval to study protocol from McGill University research ethics boardClick here for fileEthics approval Alberta additional file 4. Ethics approval to study protocol from University of Alberta research ethics boardClick here for fileEthics approval Calgary additional file 5.  Ethics approval to study protocol from University of Calgary research ethics boardClick here for file


Colorectal cancer is the third most commonly diagnosed cancer and third leading cause of cancer death in the United States. The extent to which Comprehensive Cancer Control (CCC) programs in states, tribal governments and organizations, territories, and Pacific Island jurisdictions address evidence-based recommendations and interventions for colorectal cancer in their CCC plans is largely unknown.We downloaded CCC plans posted on the Cancer Control PLANET Web site for review. We searched the plans for key terms, identifying potential evidence-based content surrounding colorectal cancer prevention and early detection. Content was abstracted for further review and classification.Guide toCommunity Preventive Services. Few programs mentioned Research Tested Intervention Programs (n = 1), National Cancer Institute's Physician Data Query (n = 4), Cochrane Reviews (n = 2), or Put Prevention Into Practice (n = 2) in reference to evidence-based interventions for colorectal cancer prevention.Of 55 plans reviewed, 54 (98%) referred to evidence-based recommendations or interventions for colorectal cancer or indicated they intended to refer to the evidence base when developing programs. More than 57% (n = 31) of programs referred to the American Cancer Society guidelines, 41% (n = 22) referred to the United States Preventive Services Task Force, and 11% (n = 6) referred to the Most CCC programs discussed either evidence-based screening guidelines or interventions in their cancer plans, although many mentioned this information exclusively as background information. We recommend that program planners be trained to locate evidence-based interventions and use consistent common language to describe them in their plans. CCC program planners should be encouraged to conduct and publish intervention studies. Colorectal cancer (CRC) is one of the most commonly diagnosed cancers in the United States. In 2004, more than 145,000 people — approximately 74,000 men and approximately 71,000 women — were diagnosed with CRC, making it the third most common cancer in men and women .Regular screening for CRC can reduce incidence by 76% to 90%  and deatwww.cdc.gov/Cancer/ncccp/). Health agencies use the funding to establish broad-based CCC coalitions, assess the burden of cancer, and develop and implement CCC plans. These plans include interventions to reduce cancer incidence and mortality  provided funding to 5 states and 1 tribal health board that had existing CCC plans . Since 1ortality .The Future of the Public's Health in the 21st Century . This Web site contains all published CCC plans and is regularly updated as new plans are disseminated. A list of search terms to identify evidence-based content was compiled on the basis of a content review of topics in CCC plans  posted on the Cancer Control PLANET Web site  to search each cancer plan for colorectal or colon cancer content. The paragraph related to the term was reviewed for specific key terms to potentially identify evidence-based content . An abstbest practice(s), effective/effectiveness, established, evaluated intervention trial, evidence-base(d)/evidence base(d), evolving science, guideline(s), proven, research into practice, research-tested, science-based, scientific evidence, translation of research, and tested. The following organizations and sources of evidence-based recommendations and interventions (documents and Web sites) were included as key terms: American Cancer Society (ACS), Cochrane Reviews, the Task Force on Community Preventive Services' Guide to Community Preventive Services (Community Guide), the National Cancer Institute's Physician Data Query (NCI's PDQ), the Agency for Healthcare Research and Quality (AHRQ), Put Prevention into Practice (PPIP), NCI's and Substance Abuse and Mental Health Services Administration's (SAMHSA) Research Tested Intervention Programs (RTIPs), and United States Preventive Services Task Force (USPSTF) recommendations — Guide to Clinical Preventive Services. If multiple key terms identified the same content, each additional key term was also recorded.Key terms included the following exact phrases or words: Community Guide, Cochrane Reviews, NCI's PDQ, USPSTF, ACS, PPIP, and RTIPs. The year that the cancer plan was published , Cochrane Reviews, NCI's PDQ, USPSTF, ACS, PPIP, and RTIPs. The year that the cancer plan was published  was recorded. In the absence of a publication date, the first year of implementation of the cancer plan was used. The evidence-based content in the CCC plans was further evaluated and categorized according to whether it referred to 1) select evidence-based screening/early detection guidelines  or 2) an evidence-based program or intervention in the community. The second category included interventions that were being proposed, planned, developed, adapted; were currently in use; or had been used. Some evidence-based content appeared as background or reference material only and was categorized as such. CCC plans could have content in all categories.The context of each key term was evaluated for whether it appeared in background information; a goal, objective, or strategy; an activity outside of a goal, objective, or strategy; a recommendation that will be promoted; or other. The section or chapter of the cancer plan where the term was located was categorized according to the following sections along the cancer control continuum: primary prevention, secondary prevention or early detection, treatment, palliation or end-of-life care, and survivorship. Other categories were based on where the content was found in the plan, including executive summary, introduction, conclusion, health disparities, and other. If recorded as "other," the specific title of the section or chapter was recorded. Because not all cancer plans were organized along the cancer control continuum, the "other" category often included chapters specifically addressing CRC. Direct mention of the following evidence-based cancer prevention recommendations and sources were noted and categorized as follows: Two separate analyses were conducted. The first analysis examined the evidence-based content itself to describe the type of content that appeared in the CCC plans, and the second was a program-level analysis to identify the number of programs referring to specific types of evidence-based interventions or screening guidelines. The latter analysis was conducted to identify gaps in addressing evidence-based interventions in current CCC plans. All descriptive analyses were conducted using SAS version 9  after importing the abstracted and coded content from Excel.Fifty-four CCC plans (98%) had content that mentioned an evidence-based recommendation or intervention surrounding CRC prevention and early detection or indicated they intended to use an evidence base when developing programs and activities. The 1 CCC plan that did not include identifiable evidence-based content was excluded from further analysis. Therefore, the denominator for all program analyses was 54.Plans were released between 2000 and 2007. Release years could not be identified for 2 states. Of 52 CCC plans with evidence-based content and a known publication or release date, 2005 was the most common publication or release year (n = 19). Sixty-five percent (n = 34) of the 52 CCC plans had a publication or release date of 2005 or later.Overall, we abstracted 186 evidence-based content items related to CRC prevention and early detection from 54 CCC plans. Nearly 54% (n = 100) of content items were found in sections of the plans with titles specific to secondary prevention or early detection (data not shown), 20% (n = 37) were found in sections with titles specific to CRC, 1.6% (n = 3) were found in primary prevention, and the remaining 25% of content (n = 46) were found in sections such as the executive summary, health disparities, appendices, or plan-specific categories.evaluated intervention trial, evolving science, research into practice, research-tested, tested, and translation of research — did not yield any evidence-based content for prevention and early detection of CRC  for CRC, 30 used the term guidelines, 22 used the term evidence-based, 22 referred to the USPSTF, and 18 used the term effective or effectiveness (Six key terms — n of CRC . Multipltiveness .Community Guide. Few programs mentioned RTIPs (n = 1), NCI's PDQ (n = 4), Cochrane Reviews (n = 2), or PPIP (n = 2) in reference to evidence-based interventions for CRC prevention.Nearly 65% (n = 35) of CCC programs had evidence-based content appearing in a goal, objective, or strategy, while approximately 76% (n = 41) had content that appeared as background information in a chapter or section . Nearly Nearly 53% of identified content (98 of 186) referred to evidence-based screening guidelines for CRC . Approximately 30% (n = 56) described an evidence-based intervention or program intended for use or that had been used in the community, and approximately 17% (n = 32) referred to evidence-based interventions as background information or reference material . Nearly For nearly all CCC plans, the evidence-based content included at least 1 reference to CRC prevention and early detection. We encountered varying degrees of levels of evidence during this content analysis, ranging from plans with the most objective evidence (evidence-based guidelines and systematic reviews) to those with more subjective evidence  . Nearly Community Guide, compared with breast cancer screening, CRC screening has fewer recommended interventions and more interventions with "insufficient evidence" (Unlike breast cancer screening, which has established interventions to increase screening, few published evidence-based interventions exist for the prevention and early detection of CRC ,27. Accovidence" . Researcvidence"  and are Community Guide.Another challenge programs face when they search for evidence-based interventions is finding interventions that will work in their locales . PracticCommunity Guide (Community Guide when discussing interventions. These findings may indicate a need for training on how to find and select culturally sensitive evidence-based interventions and an efficient mechanism to share information on evidence-based interventions with practitioners (Even though CCC programs frequently referred to evidence-based CRC interventions in their plans, specific information regarding the identification and implementation of interventions was not obvious in the content. For example, interventions recommended by the ty Guide , such asitioners .One major limitation of this content analysis was that some CCC plans grouped "screenable" cancers together, most often breast, colorectal, and cervical cancers. This grouping made identifying content related specifically to CRC difficult and required entire sections on all "screenable" cancers to be read to find evidence-based content.guidelines and effective/effectiveness, did not always yield evidence-based content related to CRC. This content was either not abstracted or was removed after later determination.Another limitation was that evidence-based content items that did not specifically include the key terms were not identified in this analysis. Because it was not always clear from the content in the CCC plans whether a program or intervention was evidence-based, some items may have been included that do not fall into this context. This determination was left to the judgment of a single reviewer. CCC programs were not contacted to verify their evidence-based content. Content analyses are subjective and are vulnerable to reviewer bias and coding inconsistencies when manually coded. Other documents, such as work plans, which may describe evidence-based intervention activities being conducted or implemented, were not reviewed as part of this study. Furthermore, some key terms used, such as Lack of common terminology surrounding dissemination and implementation may have contributed to the lack of consistent nomenclature in the plans. Rabin et al reported that, because research regarding program dissemination and implementation has origins in multiple disciplines, there are inconsistencies in the use and definitions of terms and concepts . The gloSubstantial illness and death from CRC still exist even though screening is effective. As public health professionals, we need to find better ways to disseminate and apply cost-effective, culturally sensitive interventions that promote CRC screening. In some cases, there may be a need to convince communities to accept evidence-based interventions and abandon ineffective practices. In situations where the evidence base is lacking, we need to evaluate existing programs or build on promising practices to assist in developing the evidence base. To help CCC programs reduce the burden of CRC among the populations they serve, we recommend the following: train programs to locate culturally sensitive, evidence-based interventions ,32; enco


Liver function tests and other biochemical investigations were within normal limits. Color Doppler sonography revealed multiple collateral channels replacing the portal vein  and massive splenomegaly. Furthermore, it demonstrated multiple, small foci of echogenic nodules with no acoustic shadowing in the spleen. Non-enhanced CT divulged massive splenomagaly with a pressure effect on the ipsilateral kidney and multiple, discrete, millimetric hyperdense spots in the spleen . Laboratory tests revealed a hemoglobin of 85 g/L, a total leucocyte count of 4.2×10e spleen . A contrHaemophilus influenzae vaccines were given and the patient underwent a modified Suguira procedure consisting of extensive esophagogastric devascularization combined with esophageal transaction, reanastomosis and splenectomy. The postoperative hospital period was uneventful and the patient was discharged on the tenth postoperative day. Histopathological examination of the spleen disclosed an abnormality.Pneumococcal and What is the preoperative diagnosis of the splenic lesions?What is the differential diagnosis of small, discrete, hyperdense splenic lesions?This patient had ultrasound evidence of splenomegaly with discrete, multiple, small echogenic foci in the splenic parenchyma. Both color Doppler and CT splenoportovenography revealed evidence of extrahepatic portal hypertension. In addition, CT confirmed the presence of multiple hyperdense foci in the splenic parenchyma . In thisPneumocystitis carinii infection.The differential diagnosis of small, discrete, hyperdense splenic lesions apart from GGB would also include sarcoidosis, miliary tuberculosis, histoplasmosis and Microscopic examination of the splenic lesions revealed typical spheroid, bamboo-shaped fibers resembling mycelial structures , 3. TherGamna-Gandy bodies (GGB), also known as siderotic nodules or tobacco flecks, are minute, firm nodules of fibrous tissue impregnated with iron pigments (hemosiderin) and calcium salts. They occur as a result of focal hemorrhages and necrosis followed by accumulation of hemosiderin. The most common cause of GGB in the spleen is portal hypertension; it is observed in 9% to 12% of these patients.1Rarely GGB may be seen in extrasplenic sites like in cardiac myxoma,Pneumocystitis carinii infection.18In portal hypertension these lesions should be distinguished from sclerotic venous branches within the spleen, which shows the presence of blood flow within them on Doppler imaging. On sonography, multiple hyperechoic foci within the spleen may also be seen in sarcoidosis,Pneumocystitis carinii infections. This report also provides a correlation of various imaging modalities with histopathological diagnosis.Thus in patients of portal hypertension, detection of such lesions on various imaging modalities not only strengthens the diagnosis of portal hypertension, but also excludes other causes like miliary tuberculosis, histoplasmosis and disseminated


In the contemporary scientific environment, practice draws heavily upon evidence. This is particularly so in case of medicine, which has a strong scientific tradition, although the tradition of paternalistic decision-making by experienced senior clinicians has been no less strong. In the traditional model of practice of medicine , the science base or the evidence was expected to yield to the wise and considered, even if intuitive, opinion of the treating clinician. This traditional model has been in transformation during the twentieth century, in a variety of ways, and from many directions and forces. Systematic efforts of ‘research to practice’ and expert or consensus guidelines, and clinical practice guidelines (CPGs), have been attempts at translating scientific evidence to clinical practice. The more recent and influential movement of evidence-based medicine (EBM) and evidence-based practice (EBP) takes a decisive position against the traditional model of practice, wherein the individual opinion or wisdom of a clinician is expected to yield to, or at least consider significantly, the available current scientific evidence. Indeed, it moves beyond this reversal to incorporate the principle of medical practice and healthcare being patient-centred, i.e. in terms of individualizing the evidence and encouraging personal choices. It has been said that ‘EBM assumes that patient preferences, expressed as informed choices, always outweigh the scientific evidence’!1The four fundamental principles of EBM have been outlined as (i) use the best available scientific evidence, (ii) individualize the evidence, (iii) incorporate patient preferences, and (iv) expand clinical expertise. The traditional model did not and does not equip the clinicians with adequate expertise to be able to follow these principles and the need to expand the clinical expertise to a wide variety of skills required has also been emphasized.1EBM is about the use of the four fundamental principles to individual treatment decisions in each case. EBPs refer to the forms of healthcare interventions, and the capacity to provide interventions that have been shown to be effective. In other words, EBP is about the extent to which individual practitioners, teams and departments/hospitals, follow and practice the principles of EBM. Further, evidence-based healthcare (EBHC) is about the optimal availability of national/provincial healthcare systems and thus refers to macro policy decisions for creating healthcare systems which are governed by the principles of EBM.The application of the four fundamental principles are required to guide the decision-making at various levels by individual clinicians/teams in each case for EBM, by departments/institutions as a standard practice for EBP, and by health systems of state or country for EBHC. In a short time, the movement has found wide acceptance and stability in medicine and healthcare. The Institute of Medicine's reportThe principle of using the best available scientific evidence is not entirely new to the field of mental health. Parallel to, and sometimes independently ahead of medicine, the field of mental health has generated and documented ‘evidence’ through controlled studies, including the gold standard evidence of randomized controlled trials (RCTs). Such studies have been possible only with well-defined clinical conditions, and not for a wide variety of mental health problems. In the hierarchy of ‘evidence’ in EBM, below the gold standard of RCTs, in that order, are quasi-experimental studies, open clinical trials, systematic observations and unsystematic observations. A large part of the current practice in clinical psychiatry or mental health is based on the type of evidence considered lower in the hierarchy of EBM. This is particularly so for psychological and psychosocial therapies, except for a few elegant studies in those treatment modalities. On the other hand, there are treatment methods with proven efficacy, which do not seem to have reached clinical practice. The task of bridging the gap from ‘research to practice’ was enormous, and seems to have enlarged itself to EBM by incorporating the issues of patient preference and participation.The task of choosing the best available evidence, and making it easily accessible to clinicians has been attempted by many groups, including the Cochrane collaboration, Schizophrenia Patient Outcome Research Team and Texas Medication Algorithm Project. The task of finding and evaluating the evidence is not easy at all, and the common errors are of confusing CPGs as evidence, or believing that continuing medical education (CME) programmes or accreditation based on CME credits can help clinicians in evaluating evidence. In the more rigorous field of medicine, these myths have been exploded. It is well established and seen in the larger, more vigorous field of medicine that the CPGs developed by professional societies are unsatisfactory, and are often developed to justify their members' practices,78The relevance of RCT as the gold standard has also been debated. Although it has been argued that in contemporary science, RCTs would form the highest level of evidence, there are concerns of how the evidence may be influenced by the funding support for such studies by the pharmaceutical industry. In a systematic review of RCTs published between 1966 and 2002, it was concluded that ‘systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated, and publication bias.’The second fundamental principle of individualizing the evidence involves the limits of generalizability of evidence to each patient depending on clinical issues of the subtype of the disorder or the comorbidities; as well as of background variables from the age, gender, socioeconomic status, urban domicile to the culture and subculture. It is fascinating to consider how the principle of individualizing evidence to each patient will be applied to the multi-axial system of classifications.The third fundamental principle of incorporating patient preferences has been a result of the patient-centred medicine/healthcare, and the consumer movement in healthcare, and makes a process of shared decision-making essential. This process, which encourages patients to take more responsibility for making informed choices and adhering to the treatment, makes many clinicians distinctly uncomfortable, if not apprehensive, particularly in mental health.The fourth fundamental principle of expanding clinical expertise is crucial since it refers to the need for equipping individual clinicians and health systems to be able to effectively deliver the services based on the first three principles. Traditional skills of individual clinicians and clinical teams need to be diversified and enlarged considerably to include the analysis of scientific evidence, apply that to individual's sociocultural context, and lead the entire process of dialogue with the patient and the family with effective bilateral communication and interpersonal skills.On the other hand, the evolving social, economic and legal trends in developing countries, which are similar to the trends in developed countries, are likely to make the movement for EBM and EBP unavoidable and inescapable. The scientific feasibility and the ethical correctness of the movement needs to be recognized as an emerging reality. It would seem that the need for a genuine attempt at all levels for moving towards the implementation of the principles of EBP, to the extent feasible, is a sociopolitical imperative. Indeed, the seemingly distant dream of EBM, EBP and EBHC can be meaningfully synthesized with the emerging reality of this imperative, so that the dream is fulfilled! The EBP orientation and a pervasive liberal flavouring of mental healthcare services with the principles of EBP can be the first step towards making the dream into a reality. The field of mental health in the developing world would do well to be able to start with this effectively. The attitudinal paradigm shifts and modification of behaviour patterns required across service providers, policy-makers, consumers and their family members, as well as activists, for turning the emerging reality of EBP into a dream which can be meaningfully realized, are huge, and it will be prudent not to expect too much too soon or permit complacence for it not to happen. It is for the service providers and the consumers and their families to work together, to turn the challenge into an opportunity.


The PARiHS framework  has proved to be a useful practical and conceptual heuristic for many researchers and practitioners in framing their research or knowledge translation endeavours. However, as a conceptual framework it still remains untested and therefore its contribution to the overall development and testing of theory in the field of implementation science is largely unquantified.This being the case, the paper provides an integrated summary of our conceptual and theoretical thinking so far and introduces a typology  used to distinguish between the terms conceptual framework, theory and model – important definitional and conceptual issues in trying to refine theoretical and methodological approaches to knowledge translation.Secondly, the paper describes the next phase of our work, in particular concentrating on the conceptual thinking and mapping that has led to the generation of the hypothesis that the PARiHS framework is best utilised as a two-stage process: as a preliminary  measure of the elements and sub-elements of evidence (E) and context (C), and then using the aggregated data from these measures to determine the most appropriate facilitation method. The exact nature of the intervention is thus determined by the specific actors in the specific context at a specific time and place.In the process of refining this next phase of our work, we have had to consider the wider issues around the use of theories to inform and shape our research activity; the ongoing challenges of developing robust and sensitive measures; facilitation as an intervention for getting research into practice; and finally to note how the current debates around evidence into practice are adopting wider notions that fit innovations more generally.The paper concludes by suggesting that the future direction of the work on the PARiHS framework is to develop a two-stage diagnostic and evaluative approach, where the intervention is shaped and moulded by the information gathered about the specific situation and from participating stakeholders. In order to expedite the generation of new evidence and testing of emerging theories, we suggest the formation of an international research implementation science collaborative that can systematically collect and analyse experiences of using and testing the PARiHS framework and similar conceptual and theoretical approaches.We also recommend further refinement of the definitions around conceptual framework, theory, and model, suggesting a wider discussion that embraces multiple epistemological and ontological perspectives. The spread of best practice and the use of best evidence remain sporadic. There continues to be a tension between policy imperatives and the ability to successfully support and enable local developments. Arguably the debate about how to implement evidence effectively reflects a lack of a true appreciation or understanding of the multiple factors involved. However, there has been a shift away from the traditional notion that getting evidence into practice is straightforward. Until relatively recently the spread of evidence was seen as a linear and technical process at the level of the individual, and was described as changes in clinicians' behaviour in line with evidence-based guidelines . Now theThe PARiHS framework represents the complexities of implementing evidence into practice. Previous papers have reported on the development of the framework over time -9. OtherWithin the PARiHS framework, successful implementation (SI) is represented as a function (f) of the nature and type of evidence (E), the qualities of the context (C) in which the evidence is being introduced, and the way the process is facilitated (F); SI = f . Detailed descriptions exist in the literature on the development and empirical evaluation of the PARiHS framework -9. The fThe main features and assumptions of the framework are:1. Evidence encompasses codified and non-codified sources of knowledge, including research evidence, clinical experience including professional craft knowledge, patient preferences and experiences, and local information.2. Melding and implementing such evidence in practice involves negotiation and developing a shared understanding about the benefits, disbenefits, risks, and advantages of the new over the old. This is a dialectical process that requires careful management and choreography, and one that is not done in isolation; in other words, it is a team effort.3. Some contexts are more conducive to the successful implementation of evidence into practice than others – these include contexts that have transformational leaders, features of learning organisations, and appropriate monitoring, evaluative, and feedback mechanisms.4. There is an emphasis on the need for appropriate facilitation to improve the likelihood of success. The type of facilitation, and the role and skill of the facilitator that is required is determined by the "state of preparedness" of an individual or team, in terms of their acceptance and understanding of evidence, the receptivity of their place of work or context in terms of the resources, culture and values, leadership style, and evaluation activity. Facilitators work with individuals and teams to enhance the process of implementation.The objective of the current phase of our work is to build on the concept analysis and clarification undertaken in phases one and two, and to evaluate the current framework through the development and testing of diagnostic and evaluative instruments to assist in the process of knowledge translation. Whilst conducting this phase, a number of challenges have arisen, which, whilst reflecting the particular complexities of the PARiHS framework's development, are also relevant to current debates in the field of knowledge translation. These include:1. Understanding how the conceptual framework relates to, and informs the development of, integrated theoretical positions that are practically useful and theoretically robust.2. Engaging in the challenges measurement presents and particularly within a theoretical position which argues that the intervention (a precise and tailor-made type of facilitation constructed by a skilled facilitator and those involved in the implementation process) is contingent upon the diagnosis of the evidence and context elements and clarifying facilitation as an intervention.These issues will be considered in turn.There is a growing interest in the literature around clarification of terminology used in implementation science and also around the use of such mental devices as conceptual frameworks, theories, and models . Howeveret al.'s synthesis of the literature on diffusion of innovations has also produced a conceptual map [Greenhalgh tual map . Describet al. have offered their own conceptual framework to help elucidate what they believe to be the key elements of the knowledge-to-action process [et al. [In contrast, Graham  process . Essenti [et al. .) The fr [et al.  and haveThe PARiHS framework shares similar characteristics to the above conceptual frameworks – the identification of elements and relationships, embedded (either explicit or implicit) theoretical positions, and a way of trying to explain a complex set of phenomena that enable action to be taken. What distinguishes the PARiHS conceptual framework from the others is that as well as mapping the interrelationships, PARiHS has the potential to be used as a practical and pragmatic tool by practitioners and researchers at the local level. This is the claim, and it is also the hypothesis that we are continually testing.et al.'s description illustrates the vast array of theories that could be used to determine or explain the process of implementation, and also demonstrates the lack of agreement on terms – models, frameworks, and theories are used interchangeably [et al.'s transtheoretical model of health behaviour change [In addition to the literature on conceptual frameworks, there is an emerging debate about theory use and development in knowledge translation work -22. Theoangeably . What seangeably . The useangeably -27 to mor change . Howeverr change .Therefore, one important question is whether it matters what we call these mental devices. Is there a difference between conceptual frameworks, theories, and models, and, if so, what and how would such differentiations help our understanding of the complex world of research implementation or knowledge translation? Identical questions have been posed in the discipline of public policy analysis and implementation, as well as theory development . The pol"...given the need for multiple disciplinary languages and given the multiple levels of analysis involved in studying configural relationships between rules, relevant aspects of the world and cultural phenomena, the study of institutions does depend on theoretical work undertaken at three levels, namely frameworks, theories and models"Both Sabatier  and OstrFor Ostrom , a conceWhilst the PARiHS framework has been subject to an ongoing development process, questions about it remain, including:1. How do the elements  and sub-elements interrelate and interact with each other and across the different layers of the organisation?2. Do the elements and sub-elements have equal weighting in getting evidence into practice?3. Is the content of the framework comprehensive?For the framework to usefully inform the development and testing of current and emerging theories, these questions need to be answered. Arguably, work to date has provided evidence of the framework's content and construct validity -8,11; thAccording to Ostrom , key que1. Does the framework provide a coherent language for identifying universal elements of theories attempting to explain an important range of phenomena?2. Does the framework help scholars to identify similarities or differences of diverse theories as well as to analyse the relative strengths and weaknesses of theories in explaining particular types of phenomena?3. Does the framework stimulate new theoretical developments?Questions used to test the usefulness of any conceptual framework in empirical research include:1. Does the framework help organise empirical research in those areas where well-specified theories are not yet formulated?2. Does empirical research drawing in the framework lead to new discoveries and better explanation of important phenomena?3. Can the framework be applied to multiple levels of analysis in empirical research?And finally, in relation to conceptual frameworks, Ostrom's typology includes questions about the ease by which the framework aids the better understanding and dialogue across disciplinary boundaries:1. Does the framework encourage integration across other disciplines?2. Is the framework consistent with other frameworks initially developed to focus on a particular level of analysis?3. Does the framework perform better than others in a similar stage of application?et al.'s [et al.'s [These questions are helpful because they enable an assessment to be made of the PARiHS framework's stage of development and provide an agenda for further work. For example, there is evidence to indicate that PARiHS does help organise empirical research where theories are yet to be formulated ,34, and et al.'s  Knowledget al.'s  conceptuFurther consideration of these issues forms the basis of the next phase of work/development of PARiHS and in particular attempts to answer the key questions raised by Ostrom. These include whether the framework can provide a coherent language for identifying universal elements of theories attempting to explain an important range of phenomena, or indeed whether PARiHS can be applied to multiple levels of analysis – such as individual, team, unit, and organisational-wide level?i.e. the conceptual framework.How does this analysis help to guide users in successfully implementing evidence into practice? We could use the analogy that the PARiHS framework is like a chess game. There is a defined set of rules and an agreed number of chess players. The pawns, knights, king, queen, bishops, etc. each have a set of rules to follow. Each chess piece has its own provenance or theoretical background that would explain the reason why different pieces move in certain ways. Equally, in each game the unique configuration of the chess pieces creates an almost infinite number of moves that can test the boundaries of movement of each piece, and equally test the boundaries of the higher rules of the game (framework) itself. Each new game could be like a model that will test the theories of the chess pieces within the boundaries of the chess game, a priori position is consistent to Kuhn's notion that all good scientific endeavours are about the business of empirically falsifying propositions within a theoretical framework [However, unlike the chess game, we still do not know the rules (should there be any) of the knowledge translation game and the movements of the different pieces are yet to be fully understood. Of course, this analogy only works if we accept the prior assumption that implementation processes are predictable, and that there are certain causes and effects at work. The converse position is to assume that all interactions are random, and that there is no predictive capacity because of the complexity involved in working with so many variables. Given that we do not know which of these positions is the more accurate, and it is largely dependent on one's world view of how these issues should be studied, we argue that it is legitimate to proceed with the "chess game analogy" until there is sufficient evidence amassed to disprove it. Taking such an ramework .Thus, to conceptualise the process of introducing evidence into practice, we are suggesting that to use the PARiHS framework, practitioners and researchers contemplate the interplay of evidence, context, and facilitation, as well as their sub-elements. Each element and sub-element has a conceptual and theoretical order that determines its intrinsic properties; the interaction of these elements is conditional on their state, maturity, context, and many other factors. The modelling or experimentation that can be constructed is a way of tracking the nature of the different elements and beginning to map the processes by which change occurs through the interaction of these elements.Table How researchers and practitioners "make sense" of the bigger conceptual framework is a fundamental question and an on-going challenge reflecting the complexities involved. The choice of theoretical perspective will necessarily put a boundary around the area of investigation. For example, if we want to investigate the impact of opinion leaders on research implementation using transformational leadership theory, then we will still be left with the job of integrating these findings into the bigger conceptual picture of how research findings get into practice. Holding one piece of the conceptual jigsaw without negating the possible impact of other factors is very important but very difficult to manage. The proposed links are hypothetical and illustrate the conceptual challenges of any nascent discipline.Such an approach to framework and theory use and development requires researchers to be flexible and holistic. To date, the knowledge translation literature describes theory use and development as a linear and discrete process in line with more traditional scientific thinking and the search for understanding causation ,22. LookAn additional set of definitional challenges that Sabatier and Ostrom's typology raises is their definition of models. Ostrom describes models as precise assumptions about a limited set of parameters and variables . Logic, So, for example, in this typology, we could set up an experiment that would test the model of audit and feedback as a precise intervention. The theoretical underpinning of the model could be decision theory or learning organisation theory, both embedded within the bigger conceptual framework of evidence, context, and facilitation. The challenge then is to draw sufficiently cogent paradigmatic boundaries around the framework so that it does not become a catchall of ideas and conjectures. How we do this is where the real scientific discipline comes into focus and where logical coherence and consistency of terms and relationships are set out for scrutiny, and it is where causal processes seek to explain how certain patterns of phenomena have come about. And, of course, this requires the ability to measure the variables under scrutiny. Our deliberations over the years as to how we move the PARiHS framework from a conceptual artefact to becoming a measure of knowledge translation has led us down the path of whether we have to disaggregate the elements because there is no conceptual coherence or whether we dissect the elements in different ways. The notion that the framework becomes a diagnostic and evaluative measure on the evidence and context axes and informs the facilitation or intervention process has been an important development.et al. have outlined the challenges of measuring knowledge utilisation in health care [Estabrooks lth care . These ilth care . These mlth care -14. GivePARiHS Framework: stages of refinement – [See Additional File To this end, a briefing summary – The PARiHS diagnostic and evaluative grid. At this stage, the location on the grid enables an assessment of the type of facilitation support that would most effectively lead to the successful implementation of evidence, likely requiring changes in behaviour and working patterns. The diagnosis identifies the position of the team. The trajectories in Figure We suggest one way of testing this state of readiness is to aggregate responses to the questions, and then translate them onto a grid that plots the position the team judges themselves to be in before they embark upon the implementation process. An example of this is presented in Figure 1 = facilitation method for transforming weak context and strong evidence into a highly receptive context1. F2 = facilitation method to manage weak context and weak evidence situation – most challenging and possibly involves issues of safety, basic competence needs to be managed2. F3 = facilitation method to manage strong context and weak evidence situation – issues of routine and power involved3. Fe.g., project management, resource identification) to more enabling processes . The role of the facilitator then is concerned with assessment of the situation, assessment of individual, team and workplace readiness, development of change and evaluation strategies, support of the implementation process, and coaching and mentoring the team though the change.Whilst it is likely that many sources of information will be required to decide on an appropriate course of action, the diagnostic score may provide an indication of the starting point. Facilitation, as the intervention, can then combine a range of approaches ranging from task focused  carrying out the role with the appropriate skills, personal attributes, and knowledge2. The purpose of facilitation varies from providing help and support to achieve a goal to enabling individuals and teams to analyse, reflect, and change their own attitudes, behaviours, and ways of working.3. A "facilitation continuum" has been described, which distinguishes between a "doing for others" role  on the one side to an "enabling and empowering" role which is more developmental, seeking to mentor, guide and support the staff within the system to take control of their own learning and change processes.4. Facilitation skills are developed through experiential learning , and mor5. Facilitation as a discrete intervention has been described in the practice development movement in nursing -44 and iAs a key dimension of the PARiHS framework, facilitation needs to be further refined and tested. Our deliberations have led us to propose that facilitation will be more effective following a diagnosis of the context (C) into which the new knowledge is being introduced and an assessment of practitioners' understanding of and acceptance of the evidence/new knowledge itself (E). The diagnostic should provide data to determine the most appropriate facilitation approach – which, consistent with the evidence, should lead to a multi-faceted, flexible, tailor-made intervention being constructed. Information on individual and teams' understanding of and receptiveness to the new evidence will help determine how much new learning and change is needed. An assessment of the readiness for change from a contextual perspective will cover the PARiHS framework sub- elements of context, culture, leadership, and evaluation ,14.The role of the appropriately prepared facilitator, along with the team(s) they are working with, is to construct a programme of change that meets the individual and team's learning needs. The actual ingredients making up this intervention could draw from a whole range of methods – from very task based, planned change programme approaches to much more experiential, action learning approaches.et al. recommend much greater involvement of practitioners in determining the nature of interventions at local level [What we are proposing is consistent with the early observations of Havelock and colleagues, where they argued for greater alignment or linkage between those who generate and implement new evidence and those who are expected to be involved in its application . Equallyal level , a perspal level . In thisWhat are the next practical steps for developing a series of studies that would begin to test the hypotheses outlined above? First obvious steps are to refine the diagnostic process and associated measures, and the second step is to agree the content of a facilitation training programme that would equip appropriately (and consistently) trained facilitators to work with a number of practice areas wishing to engage in knowledge translation activities.We argue that more careful theoretical work, modelling, and testing of the concept of facilitation is required because it is the process by which individuals and teams first interact and engage with evidence  and then try to negotiate its adoption/acceptance into their organisation.These conclusions would lead one to surmise that the future direction of travel will be around the development of much more complex and bespoke interventions that fit local contexts. Whether this is different from what the PARiHS framework terms "facilitation" is an appropriate question to ask.There is a small, but growing body of evidence from research and practice that shows the PARiHS framework has conceptual integrity, face and concept validity.However, there are major challenges ahead if the framework is to help in the systematic exploration of these complexities around the art and science of implementation.The three challenges outlined include the need to integrate theoretical perspectives into the framework in a way that enables us to make sense of the complexities and to construct appropriate models to explore what works in knowledge translation. PARiHS was developed inductively, which points to an interpretive lens on theory application and development. However, using Ostrom's helpful analytical approach it may be more helpful to begin to see the framework as being populated by various theoretical positions, which some would view as strength, some as a weakness. These issues have yet to be debated in the knowledge translation literature generally, and in relation to the PARiHS framework specifically.A second area of investigation is the development and testing of diagnostic and evaluative methodologies and associated instruments based on the elements and sub-elements of the PARiHS framework. What seems to be emerging is the need for a high level set of principles  that can help people on the ground understand what they can do. The principles can offer a framework within which a number of approaches or attempts at implementation and evaluation of the effectiveness of the intervention can be made by both the players on the ground and any researchers involved with them.Thus, it would seem that the current knowledge base around successful implementation of innovations into practice emphasises processes of engaging local practitioners as well as outlining a set of key principles that help guide the activity.et al.'s work [Whilst there are some studies underway , to date.'s work , where t.'s work . We also.'s work  who had,i.e. the particular interventions, to see what happens. Our research endeavours will, if we are lucky, be able to produce guiding principles for the moves that practitioners can use to successfully implement research into practice. However, we acknowledge the significant work that practitioners will always have to do to transform the principles into effective actions in their own workplaces.Lastly, we suggested the analogy of a chess game as a way of trying to understand the task in hand. We have a board in front of us  with game pieces (PARiHS elements and sub-elements) whose moves we need to test. Once we know what these pieces do, we can set up the games, 1. The PARiHS framework is a useful practical and conceptual heuristic for research implementation but it remains largely untested, hence there is not an evidence base to discount or refine it.2. The paper summarises the conceptual and theoretical thinking around the use of the framework, inviting colleagues who have or are using it to comment on its utility and effectiveness.3. The first stages of developing diagnostic and evaluative methodologies based on the framework are presented.4. Alternative perspectives for thinking about theory use and development are offered.An implementation science collaborative, working on various elements of the framework is proposed to accelerate the production and testing of its evidence base.The author(s) declare that they have no competing interests.ALK is the lead author and co-ordinator of the paper. JR-M co-wrote and re-drafted the paper. GH, BM, KS, and AT offered ideas contained within the paper, commenting on drafts, reading and approving the final draft of the manuscript. All authors have contributed to the development of the PARiHS Framework, refined the different stages of its development and are responsible for the further refining and testing of the framework.PARiHS Framework: Stages of Refinement. A table outlining the development of the diagnostic and evaluative measuresClick here for file


Patients with knee osteoarthritis [OA] are commonly treated by physiotherapists in primary care. Measuring physiotherapy performance is important before developing strategies to improve quality. The purpose of this study was to measure physiotherapy performance in patients with knee OA by comparing clinical practice to evidence from systematic reviews.We developed a data-collection form and invited all private practitioners in Norway [n = 2798] to prospectively collect data on the management of one patient with knee OA through 12 treatment session. Actual practice was compared to findings from an overview of systematic reviews summarising the effect of physiotherapy interventions for knee OA.A total of 297 physiotherapists reported their management for patients with knee OA. Exercise was the most common treatment used, provided by 98% of the physiotherapists. There is evidence of high quality that exercise reduces pain and improves function in patients with knee OA. Thirty-five percent of physiotherapists used acupuncture, low-level laser therapy or transcutaneous electrical nerve stimulation. There is evidence of moderate quality that these treatments reduce pain in knee OA. Patient education, supported by moderate quality evidence for improving psychological outcomes, was provided by 68%. Physiotherapists used a median of four different treatment modalities for each patient. They offered many treatment modalities based on evidence of low quality or without evidence from systematic reviews, e.g. traction and mobilisation, massage and stretching.Exercise was used in almost all treatment sessions in the management of knee OA. This practice is desirable since it is supported by high quality evidence. Physiotherapists also provide several other treatment modalities based on evidence of moderate or low quality, or no evidence from systematic reviews. Ways to promote high quality evidence into physiotherapy practice should be identified and evaluated. Osteoarthritis [OA] is the most common condition affecting synovial joints . The numImproving the quality of care is a major issue for all health care systems, and measuring performance is essential for the planning and evaluation of quality improvement strategies -5. MeasuThe aim of this study was to measure physiotherapy performance in patients with knee OA by comparing actual clinical practice to evidence from systematic reviews.The study was conducted among private physiotherapy practitioners in Norway, who are integrated into primary health care. The National Committees for Research Ethics in Norway approved the protocol for the study.For the purpose of this study, we developed a paper-based data-collection form to register actual clinical practice for patients with knee OA. We started the development by visiting several practices, observing physiotherapists treating patients with knee OA. In two one-day meetings, ten clinicians invited through The Norwegian Physiotherapy Association developed, piloted and revised the data-collection form in collaboration with the researchers. We piloted the form among 10 physiotherapists and assessed the reliability of the form using 15 independent observations of treatment sessions. We evaluated the relationship between data entered independently by the observer, who was an experienced physiotherapist, and data entered by the treating physiotherapists and calculated kappa scores.The final form was in three parts  reported various reasons for not completing, e.g. no patient referred during the study period (n = 109), not working in clinical practice (n = 41) or specialist in other areas such as neurology, child or mental health (n = 46).When assessing the reliability of the data-collection form we found that the different items had a kappa score that varied from 0.8 to 1.0. For some types of exercise, e.g exercise aimed at increasing strength, coordination and stability, the score was lower.The mean age of the physiotherapists was 47 years SD = 11]. Almost half [47%] were women , followed by increasing muscle strength [85%].Exercise was used by all but six physiotherapists 2%], and 86% used exercise in almost all sessions; 11% of physiotherapists provided exercise as the only treatment at all 12 sessions. As described in Table %, and 86There is evidence of moderate quality that transcutaneous electrical nerve stimulation [TENS], low-level laser therapy and acupuncture reduce pain. Each of these modalities were used by less than 25% of the therapists [Table The physiotherapists applied a median number of four [range 1–10] different treatment modalities for each patient throughout the sessions. Massage, traction/mobilisation and stretching were the next most common modalities after exercise, and were applied in approximately half of patients Table . There iThere is evidence of moderate quality that psychoeducation, including patient education and self-management programmes improve psychological outcomes, e.g., scales of psychological disability, mental functioning, self-efficacy or depressive symptoms. Sixty eight percent used interventions that were classified as psychoeducation, such as education about OA and coping with the disease. Almost all physiotherapists [90%] provided information and guidance about physical activity, and 76% prescribed a home exercise programme.The physiotherapists provided advice and information about weight reduction to 59 [58%] of the 102 patients that they considered overweight. On the other hand, almost all patients that the physiotherapist assessed to need more physical activity [n = 101] received advice and support for increasing activity level [n = 92].To our knowledge, this is the first study of physiotherapy performance for patients with knee OA. The study describes clinical practice in terms of individual patients, as recorded prospectively by therapists during every treatment session. We compared the treatment to findings from an overview of systematic reviews. Quality of care includes many elements. We have studied one important factor that contributes to quality, – the factor of clinical effectiveness.Almost all therapists in this study used exercise in all treatment sessions. This current practice is desirable, since it is supported by evidence of high quality. Less than 35% of physiotherapists used acupuncture, low-level laser therapy or TENS which have moderate-quality evidence for reducing pain. In addition, physiotherapists used many treatment modalities with low-quality evidence or no evidence from systematic reviews, e.g., traction, massage and stretching.The physiotherapists provided different types of exercises. Because there is no evidence from systematic reviews to support one specific type or dose , we mergOnly 58% of the patients that the physiotherapists categorized as overweight were given information and advice about weight reduction. The therapists rated subjectively if the patient was overweight. This method might be prone to bias because we do not know how this measure compares with body mass index, which is commonly used to identify overweight. However, clinical judgement and experience might be as important as body mass index for offering patients advice about weight reduction. There are many plausible explanations why many physiotherapists did not focus on weight reduction, e.g., they do not have enough knowledge and/or skills on how to address the problem, the topic is too intimate or they provide advice on physical activity instead. Still we think that physiotherapists might contribute to the positive outcomes of weight reduction by supervision and guidance, perhaps in cooperation with a dietician.Our findings are comparable to studies of physiotherapy performance for low back pain which demonstrate that adherence to guidelines varies across different treatment modalities ,9,13. TrThere are some limitations to this study. The response rate was low, and this might be a threat to the validity of the data of physiotherapy performance because the therapists that responded might have different practice pattern than the study population. We feared that a low response rate might be a problem, and we tried to develop a strategy to get a large and unbiased sample of responses from Norwegian physiotherapists. We invited all private practitioners in Norway to the study. We used finding from a systematic review on how to increase response rate . We contThe physiotherapists who participated were comparable to private practitioners in Norway regarding age [mean age reported by the Norwegian Physiotherapists Association is 48], although a higher proportion of men responded to our study. We have no additional information about the non-responding physiotherapists. Surprisingly many physiotherapists reported that they did not treat a patient with knee OA during the study period. This might also be the case for many of the non-responders.Other studies of physiotherapy performance in primary care that have used a prospective design have experienced the same lack of participation ,16. WhenAnother potential source of bias is the self-selection of patients, because the therapists might choose patients that are not representative to patients normally treated in private practice. We asked the physiotherapists to report the management of the first patient with knee OA. The characteristics of the patients in the study are comparable to patients included in 36 trials in a systematic review on physical interventions for patients with OA . The meaWe collected data by self-report from the therapist. Self-report of practice might represent a threat to validity because some therapists might report treatments that they do not perform. Some might also adopt new practice pattern because they think it is expected. This might mean that self-reported adherence rates to guidelines could exceed the rate measured by medical records or observation . There mWe measured performance by comparing practice to findings from systematic reviews. For some interventions we lack evidence because we did not identify any systematic reviews. Evidence of high quality from primary studies not included in systematic reviews might be available for such interventions. This is clearly a limitation to our approach. Secondly, some reviews needed updating. Inclusion of new primary studies might change the estimates of effect and the quality of evidence. Finally, it is crucial to remember that "no evidence from systematic reviews" does not imply "evidence of no effect".It is difficult to measure physiotherapy performance because physiotherapy practice is complex. Treatment can differ both within and across sessions. Type, dose and frequency vary and the interaction and communication between patient and therapist are important parts of the therapy. In the present study we assessed performance for one measurable part of physiotherapy practice, but we excluded interpersonal communication, structural aspects of care, organisational culture, teamwork and access. These are other important parts of high quality physiotherapy care. Multiple data collection methods might be used to get a more comprehensive picture of actual physiotherapy practice.Despite clear limitations in our methods, this study contributes to the knowledge about physiotherapy performance in patients with knee OA. We need research to develop valid and reliable methods to measure physiotherapy performance in primary care, as well as research on how to bridge research and clinical practice. Specifically, we should identify effective ways to promote interventions supported by high quality evidence. Finally, in order to be able to measure performance in physiotherapy, we need more research and more systematic reviews on the effects of physiotherapy interventions for patients with knee OA. Because physiotherapists use exercise regularly for patients with knee OA, and there are different opinions about optimal exercise regimen, studies should compare different types, settings, intensities and volumes of exercise. Interventions that are frequently used by physiotherapists without evidence from systematic reviews, e.g., traction, massage and stretching for patients with knee OA, should be tested in rigorous trials and summarised in reviews.This study provides information about physiotherapy performance in patients with knee OA. Exercise is the most common treatment and this is supported by high quality evidence. Physiotherapists also provide several treatment modalities based on moderate and low quality evidence of benefit, or without evidence from systematic reviews. We need more research to develop and identify the best methods to measure physiotherapy performance in primary care.OA: osteoarthritis; SD: standard deviation: TENS: transcutaneous electrical nerve stimulation; VAS: visual analogue scale.The authors declare that they have no competing interests.GJ wrote the protocol and designed the study, developed the data-collecting instrument, performed the analysis and drafted the first version of the manuscript. KTD contributed to designing the study, piloted the instrument, entered data into SPSS and revised drafts of the manuscript. IH and SF contributed to the idea of the project and to design and analysis and revised drafts of the manuscript. All authors approved the final manuscriptThe pre-publication history for this paper can be accessed here:Variable list.Click here for fileData collection form.Click here for file


Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program.Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program.Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update.Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria.Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved.As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program. Development and implementation of evidence-based clinical guidelines are the main focus of health care policy in many countries. Clinical guidelines are 'systematically developed statements designed to help practitioners and patients to make decisions about appropriate health care for specific circumstances' . Also inAn important reason for updating the development process was the publication of the AGREE Instrument which provides a framework, including 23 criteria, to assess the quality of clinical practice guidelines . The insOne of the key issues in the debate is to formulate criteria for inclusion of considerations beyond the evidence from literature reviews -17.The aim of this study is to compare a selection of different guideline development programs in detail and to use these findings to review the previous KNGF guideline program in the Netherlands. The results are used to update the KNGF guideline program.Burgers  defined The 23 criteria of the AGREE instrument  were useWe further compared the different guideline programs in detail based on the guideline structure by Shekelle . It inclCompliance with the AGREE criteria in the descriptions of the guideline development process was high. Four organizations  complied with 22 out of 23 criteria. The other two organizations  complied with 20 criteria.The criterion least met was 'The guideline has been piloted among target users'. In the handbooks of four organizations  piloting of the guideline was not specifically described or recommended. Table To evaluate the previous Dutch guideline program in physical therapy we also used the AGREE criteria. Identification of weaknesses could then subsequently be used to update the program. In Table Table Two organizations collect topics through an open procedure . Any group or individual may propose a guideline topic to SIGN. USPSTF solicits new topics for consideration from the field through a periodic notice and solicitation of professional liaison organizations. All programs describe criteria for selecting topics. These include: clinical relevance, the number of patients affected, undesired variation in healthcare practice, no existing guidelines available, available evidence to support the guidelines, acceptability of a guideline to potential users. NZGG uses a suitability screen to assess the potential success of a guideline in a particular clinical area. Their key criterion is the ability to demonstrate significant positive changes in outcomes, based on valid scientific studies.USPSTF prioritizes topics using two specific criteria: the public health importance of the condition to be prevented, and the potential for the USPSTF to affect clinical practice.The actual development of a guideline can be divided into four steps: refining subject area and defining questions; identifying the evidence available; assessing and synthesizing the evidence; and translating evidence into recommendations.Three programs  use the scope of the guideline as a framework to refine the subject area and to formulate or refine research questions. NZGG develops a series of key questions using PECOT (Patient-Exposure-Comparison-Outcome-Time).Identification of the evidence is done by systematic literature search. All programs stress the importance of a well-defined search strategy as part of a systematic review to be performed. Medline, Cinahl, Embase, Cochrane, PEDro are examples of databases used for searching relevant literature.The details in assessing the literature vary among the programs, although the approach is similar. All programs perform systematic literature reviews, in which the outcomes of relevant studies are described in evidence tables and related to the methodological quality of the study. The strength of the evidence is classified in levels of evidence, but the classification varies. Four programs explicitly mention the inclusion of qualitative studies in the literature review .The evidence from the studies is used to formulate recommendations, and recommendations are linked to the evidence by grading the recommendations in different levels. Beyond the evidence, other factors are considered in all programs, although USPSTF refrains from making recommendations if they cannot be supported by evidence. SIGN uses the concept of 'considered judgment' to cover these factors. A specific form is used to define specific recommendations considering changes to current practice, predicted impact on changes to current practice and economic issues and implications. NHMRC requires balancing of benefits and harms, to assist in formulating recommendations. Table All programs organize an external review of draft guidelines by experts and stakeholders. Only two organizations  publish draft guidelines on their website for comments.All programs publish the full guidelines on their websites. NZGG is the only organization that publishes separate patient versions of the guideline.All programs describe the need for evaluation and revision of guidelines, but the steps of the updating process are not described in detail. Five programs provide a date for review in the guideline document. Length of update time varies depending on the topic and likelihood of new evidence. SIGN recommends assessment after two years, while CBO uses a five-year period.CBO describes the concept of 'living guidelines', which follows a yearly cycle of reviewing the scope and clinical questions, performing an updated literature search identifying new evidence, and considering new factors and barriers in practice.The main purpose of this study was to compare different guideline programs and review the previous KNGF program for guideline development in physical therapy, based on an evidence-based approach. We collected information from handbooks and websites from six organizations that published guideline programs. We did not perform a random search for guideline programs, but based the selection on a previous survey by Burgers .Comparing methodology for guideline development from handbooks, using the AGREE criteria, does not imply that the clinical guidelines themselves actually meet the AGREE criteria as well. Comparison of the published clinical guidelines was beyond the scope of this study.All programs showed high compliance with the AGREE criteria, by means of addressing the criteria in the handbooks that describe the development process. Four of the six programs  also explicitly mention the AGREE criteria as basis for their development process. The somewhat lower CSP score can be explained by their choice not to include steps for implementation in the handbook. The other lower score by USPSTF can be explained by their explicit choice to formulate recommendations strictly based on evidence, and not specifically involving the views of professionals and patients in the recommendations. Considerations beyond scientific evidence are not included in the scope of the reviews by USPSTF.The previous Dutch program for guideline development in physical therapy complied only with 13 of the 23 AGREE criteria. These findings supported the need for updating the Dutch program. The lack of compliance with the AGREE criteria can partly be explained by the publication date in 1998, which was prior to publication of the AGREE instrument. Some changes were made in the development process, but were not yet published in an update of the handbook.et al.[Our study confirms the findings of Burgers et al. that guiet al.. The difet al.. The finet al.,32.All programs describe a procedure for weighing the evidence and grading recommendations using a hierarchy of levels of evidence. However, a large debate about the use of hierarchy levels is ongoing in the international guideline community ,34. DiffThe update of the Dutch guideline program for physical therapy was based on evaluation of the current procedure and new insights. The framework of the updated Dutch program is shown in Table In the Dutch guideline program for physical therapy patients and other disciplines are included in the external review group. This approach allows the development group to focus primarily on the physiotherapy process, while specific input from patients and other disciplines is ensured in the external review. As a result, the updated procedure complied with 22 AGREE criteria Table .As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development processes in the different guideline programs. We learned that prioritizing topics, defining the scope of the guideline and the formulation of recommendations can be more clearly described. In particular, the process of translation of evidence into practice recommendations can be improved. The previous KNGF program for guideline development in physical therapy lacked compliance with the AGREE criteria. Detailed comparison of the different guideline programs was used for updating the KNGF guideline program, which reflects international consensus and describes explicit choices in those issues lacking consensus. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program.The author(s) declare that they have no competing interests.PW and EH collected data and analyzed the guideline programs. PW, EH and JC updated the Dutch program for guideline development. JD, RB and JB critically revised the manuscript and contributed to the international perspective of the study. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here: