Variability in adherence to clinical practice guidelines and recommendations in COPD outpatients: a multi-level,cross-sectional analysis of the EPOCONSUL study

Background

Clinical audits have reported considerable variability in COPD medical care and frequent inconsistencies with recommendations. The objectives of this study were to identify factors associated with a better adherence to clinical practice guidelines and to explore determinants of this variability at the the hospital level.

Methods

EPOCONSUL is a Spanish nationwide clinical audit that evaluates the outpatient management of COPD. Multilevel logistic regression with two levels was performed to assess the relationships between individual and disease-related factors, as well as hospital characteristics.

Results

A total of 4508 clinical records of COPD patients from 59 Spanish hospitals were evaluated. High variability was observed among hospitals in terms of medical care. Some of the patient’s characteristics (airflow obstruction, degree of dyspnea, exacerbation risk, presence of comorbidities), the hospital factors (size and respiratory nurses available) and treatment at a specialized COPD outpatient clinic were identified as factors associated with a better adherence to recommendations, although this only explains a small proportion of the total variance.

Conclusion

To be treated at a specialized COPD outpatient clinic and some intrinsic patient characteristics were factors associated with a better adherence to guideline recommendations, although these variables were only explaining part of the high variability observed among hospitals in terms of COPD medical care.

     

Challenges of disseminating clinical practice guidelines in a weak health system: the case of HIV and infant feeding recommendations in Tanzania

Background

Clinical guidelines aim to improve patient outcomes by providing recommendations on appropriate healthcare for specific clinical conditions. Scientific evidence produced over time leads to change in clinical guidelines, and a serious challenge may emerge in the process of communicating the changes to healthcare practitioners and getting new practices adopted. There is very little information on the major barriers to implementing clinical guidelines in low-income settings. Looking at how continual updates to clinical guidelines within a particular health intervention are communicated may shed light on the processes at work. The aim of this paper is to explore how the content of a series of diverging infant feeding guidelines have been communicated to managers in the Prevention of Mother to Child Transmission of HIV Programme (PMTCT) with the aim of generating knowledge about both barriers and facilitating factors in the dissemination of new and updated knowledge in clinical guidelines in the context of weak healthcare systems.

Methods

A total of 22 in-depth interviews and two focus group discussions were conducted in 2011. All informants were linked to the PMTCT programme in Tanzania. The informants included managers at regional and district levels and health workers at health facility level.

Results

The informants demonstrated partial and incomplete knowledge about the recommendations. There was lack of scientific reasoning behind various infant feeding recommendations. The greatest challenges to the successful communication of the infant feeding guidelines were related to slowness of communication, inaccessible jargon-ridden English language in the manuals, lack of summaries, lack of supportive supervision to make the guidelines comprehensible, and the absence of a reading culture.

Conclusion

The study encountered substantial gaps in knowledge about the diverse HIV and infant feeding policies. These gaps were partly related to the challenges of communicating the clinical guidelines. There is a need for caution in assuming that important changes in guidelines for clinical practice can easily be translated to and implemented in local programme settings, not least in the context of weak healthcare systems.

     

European guidelines for quality assurance in cervical cancer screening: recommendations for clinical management of abnormal cervical cytology, part 1

The current paper presents the first part of Chapter 6 of the second edition of the European Guidelines for Quality Assurance in Cervical Cancer Screening. It provides guidance on how to manage women with abnormal cervical cytology. Throughout this article the Bethesda system is used for cervical cytology terminology, as the European guidelines have recommended that all systems should at least be translated into that terminology while cervical intraepithelial neoplasia (CIN) is used for histological biopsies (Cytopathology 2007; 18 :213–9). A woman with a high‐grade cytological lesion, a repeated low‐grade lesion or with an equivocal cytology result and a positive human papillomavirus (HPV) test should be referred for colposcopy. The role of the colposcopist is to identify the source of the abnormal cells and to make an informed decision as to whether or not any treatment is required. If a patient requires treatment the colposcopist will decide which is the most appropriate method of treatment for each individual woman. The colposcopist should also organize appropriate follow‐up for each woman seen. Reflex testing for high‐risk HPV types of women with atypical squamous cells (ASC) of undetermined significance with referral for colposcopy of women who test positive is a first option. Repeat cytology is a second possibility. Direct referral to a gynaecologist should be restricted to special circumstances. Follow‐up of low‐grade squamous intraepithelial lesion is more difficult because currently there is no evidence to support any method of management as being optimal; repeat cytology and colposcopy are options, but HPV testing is not sufficiently selective, unless for older women. Women with high‐grade squamous intraepithelial lesion (HSIL) or atypical squamous cells, cannot exclude HSIL (ASC‐H) should be referred without triage. Women with glandular lesions require particular attention. In a subsequent issue of Cytopathology, the second part of Chapter 6 will be presented, with recommendations for management and treatment of histologically confirmed intraepithelial neoplasia and guidance for follow‐up of special cases such as women who are pregnant, postmenopausal or immunocompromised.     

The Barrier inventory: a validity study

The Barrier (B) inventory is a 37 item test based on the MMPI and measuring the B personality trait as conceived by Fisher. The validity of the inventory was tested by having the subjects (N = 94) complete it and answer a series of inkblot reproductions. In fact, according to Fisher, inkblot test responses are a useful means to assess the B trait. Correlation between the results of the two tests was high (.74).     

The effects of clinical practice guidelines on patient outcomes in primary care: a systematic review

OBJECTIVE: To assess the evidence for the effectiveness of clinical practice guidelines (CPGs) in improving patient outcomes in primary care. DATA SOURCES: A search of the MEDLINE, HEALTHPLAN, CINAHL and FAMLI databases was conducted to identify studies published between Jan. 1, 1980, and Dec. 31, 1995, concerning the use of guidelines in primary medical care. The keywords used in the search were "clinical guidelines," "primary care," "clinical care," "intervention," "randomized controlled trial" and "effectiveness." STUDY SELECTION: Studies of the use of CPGs were selected if they involved a randomized experimental or quasi-experimental method, concerned primary care, were related to clinical care and examined patient outcomes. Of 91 trials of CPGs identified through the search, 13 met the criteria for inclusion in the critical appraisal. DATA EXTRACTION: The following data were extracted, when possible, from the 13 trials: country and setting, number of physicians, number of patients (and the proportion followed to completion), length of follow-up, study method (including random assignment method), type of intervention, medical condition treated and effect on patient outcomes (including clinical and statistical significance, with confidence intervals). DATA SYNTHESIS: The most common conditions studied were hypertension (7 studies), asthma (2 studies) and cigarette smoking (2 studies). Four of the studies followed nationally developed guidelines, and 9 used locally developed guidelines. Six studies involved computerized or automated reminder systems, whereas the others relied on small-group workshops and education sessions. Only 5 of the 13 trials (38%) produced statistically significant results. CONCLUSION: There is very little evidence that the use of CPGs improves patient outcomes in primary medical care, but most studies published to date have used older guidelines and methods, which may have been insensitive to small changes in outcomes. Research is needed to determine whether the newer, evidence-based CPGs have an effect on patient outcomes.     

Postoperative use of radioiodine (131-I): review of recommendations and guidelines

In the management of large number of patients with differentiated thyroid cancer, the radioactive iodine (131-I) administration plays an important role. The guidelines of numerous international and national medical societies regarding the issue of postoperative 131-I administration have been published and updated in the last few years. The guidelines differ in the shape and content, and contain some specific features. The different methods for evaluation and analysis of clinical evidence level and resulting grades of recommendations have been used in line with the very guidelines. The postoperative 131-I administration refers to the radioiodine ablation as a form of adjuvant treatment and radioiodine therapy in the management of patients with recurrent cancer, persistent disease and regional or distant metastases. According to the indications for the postoperative 131-I administration, the patients could be divided into the three risk groups: the very low risk group in which there is no indication for the postoperative 131-I administration, the low risk group in which the indication could be considered, and the high risk group in which there is a clear indication for the 131-I administration. The different criteria for distribution of patients into these three groups are expressed in a certain guidelines. There are different opinions about the necessary dosage of 131-I for the efficient ablation in the low risk group. Moreover, the opinions are also divided regarding the conduction of postoperative (preablative or pretherapeutic) scintigraphy with 131-I. As regards the instructions on preparation of patients for the radioiodine ablation and therapy, all the guidelines recommend the low iodine diet and endogenous or exogenous stimulation of TSH. The endogenous stimulation is accomplished by the withdrawal of thyroid hormones, whereas the recombinant human TSH (rhTSH) is used for exogenous stimulation. For conducting the therapy with 131-I the level of TSH has to be > 25-30 mU/L.     

Pediatric terrorism preparedness national guidelines and recommendations: findings of an evidenced-based consensus process

A cadre of experts and stakeholders from government agencies, professional organizations, emergency medicine and response, pediatrics, mental health, and disaster preparedness were gathered to review and summarize the existing data on the needs of children in the planning, preparation, and response to disasters or terrorism. This review was followed by development of evidence-based consensus guidelines and recommendations on the needs of children in disasters, including chemical, biological, and radiological terrorism. An evidence-based consensus process was used in conjunction with a modified Delphi approach for selection of topic areas and discussion points. These recommendations and guidelines represent the first national evidence-based standards for pediatric disaster and terrorism preparedness.     

Evaluation of evidence-based literature and formulation of recommendations for the clinical preventive guidelines for immigrants and refugees in Canada

Background:

This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee.

Methods:

The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada.

Results:

A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada.

Interpretation:

This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition.Primary care practitioners who care for recently arrived immigrants and refugees have raised concerns over the lack of evidence-based guidelines for clinical prevention, noting that it is not always clear whether current recommendations made for the general population in Canada can be generalized to this population. In 2006, the Canadian Collaboration for Immigrant and Refugee Health (CCIRH) Guideline Committee was formed to address this issue by first identifying the top-priority health conditions for this population. The group of 20 health conditions identified was very diverse ranging from infectious disease to chronic conditions including depression. The challenge was creating a rigorous interdisciplinary process and then to generate pragmatic recommendations. This document outlines the systematic approach designed to produce the evidence reviews.A variety of methods is used for developing clinical guidelines and practice recommendations.¹ We used the recently developed approach of moving away from recommendations classified by letters and numbers to the simplified classification system recommended by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group² and applied this to clinical preventive actions. Our guideline development process followed the Appraisal of Guidelines Research & Evaluation (AGREE) instrument (www.agreetrust.org), which is recognized internationally as providing best-practice criteria for evidence-based guideline development.We developed the recommendations on the basis of a pre-specified process overseen by the CCIRH Guideline Committee. Defining a methods process ensured that each guideline was developed in a systematic, reproducible manner and was based on the best evidence available. This process was based on existing guidelines including the Canadian Medical Association Journal handbook on developing clinical practice guidelines¹ and the ADAPTE framework for adapting existing guidelines.³ Our process emphasized identifying immigrant- and refugee-specific evidence on efficacy and population characteristics from guidelines, systematic reviews and primary studies. When immigrant- and refugee-specific evidence was unavailable, we used specific criteria, adapted from the Cochrane Handbook,⁴ to judge how this evidence applied to our intended target population.Conditions considered most important by practitioners caring for immigrants and refugees in Canada were assigned to groups of content experts to develop evidence reviews with clinical conclusions for recent immigrants and refugees to Canada using a logic model and following a structured 14-step process. The guidelines focus on clinical care gaps¹ during the “health settlement period,” which we define as the first five years of residence in a new country for an immigrant or refugee. This is the time in which health practitioners are likely to have initial contact with this population and the time during which stressors from one’s country of origin and country of settlement are most likely to manifest. Immigrants and refugees are thus grouped together by this organizing period of resettlement; however, the heterogeneity, complexities, and differences between and within these groups were recognized throughout the process.In our process, we emphasized making clinically relevant recommendations and establishing an extension to existing guidelines rather than a replacement or revision.     

SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study

Background

Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives).

Methods

An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs.

Discussion

This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child.

Trial registration

http://www.clinicaltrials.gov: NCT01261676     

Completeness and validity in a national clinical thyroid cancer database: DATHYRCA

BackgroundAlthough a prospective national clinical thyroid cancer database (DATHYRCA) has been active in Denmark since January 1, 1996, no assessment of data quality has been performed. The purpose of the study was to evaluate completeness and data validity in the Danish national clinical thyroid cancer database: DATHYRCA.Study design and settingNational prospective cohort. Denmark; population 5.5 million. Completeness of case ascertainment was estimated by the independent case ascertainment method using three governmental registries as a reference. The reabstracted record method was used to appraise the validity. For validity assessment 100 cases were randomly selected from the DATHYRCA database; medical records were used as a reference.ResultThe database held 1934 cases of thyroid carcinoma and completeness of case ascertainment was estimated to 90.9%. Completeness of registration was around or above 90% in most instances. Perfect agreement on the diagnosis of thyroid carcinoma was found, both inter- and intra-observer, and κ values of selected variables showed overall good to excellent agreement.ConclusionIn a setup with public health insurance, personal identity numbers and extended governmental databases, it is possible to establish national clinical cancer databases with a satisfactory completeness and validity. The DATHYRCA database is considered reliable in terms of describing thyroid carcinoma at a national level.     

Current guidelines have limited applicability to patients with comorbid conditions: a systematic analysis of evidence-based guidelines

Background

Guidelines traditionally focus on the diagnosis and treatment of single diseases. As almost half of the patients with a chronic disease have more than one disease, the applicability of guidelines may be limited. The aim of this study was to assess the extent that guidelines address comorbidity and to assess the supporting evidence of recommendations related to comorbidity.

Methodology/Principal Findings

We conducted a systematic analysis of evidence-based guidelines focusing on four highly prevalent chronic conditions with a high impact on quality of life: chronic obstructive pulmonary disease, depressive disorder, diabetes mellitus type 2, and osteoarthritis. Data were abstracted from each guideline on the extent that comorbidity was addressed (general comments, specific recommendations), the type of comorbidity discussed (concordant, discordant), and the supporting evidence of the comorbidity-related recommendations (level of evidence, translation of evidence). Of the 20 guidelines, 17 (85%) addressed the issue of comorbidity and 14 (70%) provided specific recommendations on comorbidity. In general, the guidelines included few recommendations on patients with comorbidity (mean 3 recommendations per guideline, range 0 to 26). Of the 59 comorbidity-related recommendations provided, 46 (78%) addressed concordant comorbidities, 8 (14%) discordant comorbidities, and for 5 (8%) the type of comorbidity was not specified. The strength of the supporting evidence was moderate for 25% (15/59) and low for 37% (22/59) of the recommendations. In addition, for 73% (43/59) of the recommendations the evidence was not adequately translated into the guidelines.

Conclusions/Significance

Our study showed that the applicability of current evidence-based guidelines to patients with comorbid conditions is limited. Most guidelines do not provide explicit guidance on treatment of patients with comorbidity, particularly for discordant combinations. Guidelines should be more explicit about the applicability of their recommendations to patients with comorbidity. Future clinical trials should also include patients with the most prevalent combinations of chronic conditions.