Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development

Developing clinical practice guidelines: types of evidence and outcomes; values and economics, synthesis, grading, and presentation and deriving recommendations

Clinical practice guidelines are one of the foundations of efforts to improve healthcare. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearinghouses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this second paper, we discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations

The systematic guideline review: method, rationale, and test on chronic heart failure

Background: Evidence-based guidelines have the potential to improve healthcare. However, their de-novo-development requires substantial resources-especially for complex conditions, and adaptation may be biased by contextually influenced recommendations in source guidelines. In this paper we describe a new approach to guideline development-the systematic guideline review method (SGR), and its application in the development of an evidence-based guideline for family physicians on chronic heart failure (CHF). Methods: A systematic search for guidelines was carried out. Evidence-based guidelines on CHF management in adults in ambulatory care published in English or German between the years 2000 and 2004 were included. Guidelines on acute or right heart failure were excluded. Eligibility was assessed by two reviewers, methodological quality of selected guidelines was appraised using the AGREE instrument, and a framework of relevant clinical questions for diagnostics and treatment was derived. Data were extracted into evidence tables, systematically compared by means of a consistency analysis and synthesized in a preliminary draft. Most relevant primary sources were re-assessed to verify the cited evidence. Evidence and recommendations were summarized in a draft guideline. Results: Of 16 included guidelines five were of good quality. A total of 35 recommendations were systematically compared: 25/35 were consistent, 9/35 inconsistent, and 1/35 un-rateable (derived from a single guideline). Of the 25 consistencies, 14 were based on consensus, seven on evidence and four differed in grading. Major inconsistencies were found in 3/9 of the inconsistent recommendations. We re-evaluated the evidence for 17 recommendations (evidence-based, differing evidence levels and minor inconsistencies) - the majority was congruent. Incongruity was found where the stated evidence could not be verified in the cited primary sources, or where the evaluation in the source guidelines focused on treatment benefits and underestimated the risks. The draft guideline was completed in 8.5 man-months. The main limitation to this study was the lack of a second reviewer. Conclusion: The systematic guideline review including framework development, consistency analysis and validation is an effective, valid, and resource saving-approach to the development of evidence-based guidelines

How physicians evaluate patients with dementia who present with shortness of breath

BackgroundWhether the presence of dementia in patients makes it difficult for physicians to assess the risk such patients might have for serious conditions such as pulmonary embolism (PE) is unknown. Our objective was to examine the differential association of four clinical factors (deep venous thrombosis (DVT)/PE, malignancy, recent surgery, and tachycardia) with PE testing for patients with dementia compared to patients without dementia.MethodsWe performed a cross-sectional study of emergency department (ED) visits to 104 Veterans Affairs (VA) hospitals from 2011 to 2018 by patients aged 60 years and over presenting with shortness of breath (SOB). Our outcomes were PE testing (CT scan and/or D-dimer) and subsequently diagnosed acute PE.ResultsThe sample included 593,001 patient visits for SOB across 7124 ED physicians; 5.6% of the sample had dementia, and 10.6% received PE testing. Three of the four clinical factors examined had a lower association with PE testing for patients with dementia. For example, after taking into account that at baseline, physicians were 0.9 percentage points less likely to test patients with dementia than patients without dementia for PE, physicians were an additional 2.6 percentage points less likely to test patients with dementia who had tachycardia than patients without dementia who had tachycardia. We failed to find evidence that any clinical factor examined had a differentially lower association with a subsequently diagnosed acute PE for patients with dementia.ConclusionsClinical factors known to be predictive of PE risk had a lower association with PE testing for patients with dementia compared to patients without dementia. These results may be consistent with physicians missing these clinical factors more often when evaluating patients with dementia, but also with physicians recognizing such factors but not using them in the decision-making process. Further understanding how physicians evaluate patients with dementia presenting with common acute symptoms may help improve the care delivered to such patients

Why is it difficult to implement e-health initiatives? A qualitative study

<b>Background</b> The use of information and communication technologies in healthcare is seen as essential for high quality and cost-effective healthcare. However, implementation of e-health initiatives has often been problematic, with many failing to demonstrate predicted benefits. This study aimed to explore and understand the experiences of implementers - the senior managers and other staff charged with implementing e-health initiatives and their assessment of factors which promote or inhibit the successful implementation, embedding, and integration of e-health initiatives.<p></p> <b>Methods</b> We used a case study methodology, using semi-structured interviews with implementers for data collection. Case studies were selected to provide a range of healthcare contexts (primary, secondary, community care), e-health initiatives, and degrees of normalization. The initiatives studied were Picture Archiving and Communication System (PACS) in secondary care, a Community Nurse Information System (CNIS) in community care, and Choose and Book (C&B) across the primary-secondary care interface. Implementers were selected to provide a range of seniority, including chief executive officers, middle managers, and staff with 'on the ground' experience. Interview data were analyzed using a framework derived from Normalization Process Theory (NPT).<p></p> <b>Results</b> Twenty-three interviews were completed across the three case studies. There were wide differences in experiences of implementation and embedding across these case studies; these differences were well explained by collective action components of NPT. New technology was most likely to 'normalize' where implementers perceived that it had a positive impact on interactions between professionals and patients and between different professional groups, and fit well with the organisational goals and skill sets of existing staff. However, where implementers perceived problems in one or more of these areas, they also perceived a lower level of normalization.<p></p> <b>Conclusions</b> Implementers had rich understandings of barriers and facilitators to successful implementation of e-health initiatives, and their views should continue to be sought in future research. NPT can be used to explain observed variations in implementation processes, and may be useful in drawing planners' attention to potential problems with a view to addressing them during implementation planning

Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management) : study protocol

Background: Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design: HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific selfmanagement, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guidelineoriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NTproBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion: As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration: Current Controlled Trials ISRCTN30822978

Evidence for Anchoring Bias During Physician Decision-Making

IntroductionCognitive biases are hypothesized to influence physician decision-making, but large-scale evidence consistent with their influence is limited. One such bias is anchoring bias, or the focus on a single-often initial-piece of information when making clinical decisions without sufficiently adjusting to later information.ObjectiveTo examine whether physicians were less likely to test patients with congestive heart failure (CHF) presenting to the emergency department (ED) with shortness of breath (SOB) for pulmonary embolism (PE) when the patient visit reason section, documented in triage before physicians see the patient, mentioned CHF.Design, setting, and participantsIn this cross-sectional study of 2011 to 2018 national Veterans Affairs data, patients with CHF presenting with SOB in Veterans Affairs EDs were included in the analysis. Analyses were performed from July 2019 to January 2023.ExposureThe patient visit reason section, documented in triage before physicians see the patient, mentions CHF.Main outcomes and measuresThe main outcomes were testing for PE (D-dimer, computed tomography scan of the chest with contrast, ventilation/perfusion scan, lower-extremity ultrasonography), time to PE testing (among those tested for PE), B-type natriuretic peptide (BNP) testing, acute PE diagnosed in the ED, and acute PE ultimately diagnosed (within 30 days of ED visit).ResultsThe present sample included 108 019 patients (mean [SD] age, 71.9 [10.8] years; 2.5% female) with CHF presenting with SOB, 4.1% of whom had mention of CHF in the patient visit reason section of the triage documentation. Overall, 13.2% of patients received PE testing, on average within 76 minutes, 71.4% received BNP testing, 0.23% were diagnosed with acute PE in the ED, and 1.1% were ultimately diagnosed with acute PE. In adjusted analyses, mention of CHF was associated with a 4.6 percentage point (pp) reduction (95% CI, -5.7 to -3.5 pp) in PE testing, 15.5 more minutes (95% CI, 5.7-25.3 minutes) to PE testing, and 6.9 pp (95% CI, 4.3-9.4 pp) more BNP testing. Mention of CHF was associated with a 0.15 pp lower (95% CI, -0.23 to -0.08 pp) likelihood of PE diagnosis in the ED, although no significant association between the mention of CHF and ultimately diagnosed PE was observed (0.06 pp difference; 95% CI, -0.23 to 0.36 pp).Conclusions and relevanceIn this cross-sectional study among patients with CHF presenting with SOB, physicians were less likely to test for PE when the patient visit reason that was documented before they saw the patient mentioned CHF. Physicians may anchor on such initial information in decision-making, which in this case was associated with delayed workup and diagnosis of PE

The influence of contextual factors on healthcare quality improvement initiatives:what works, for whom and in what setting? Protocol for a realist review

Background  Context shapes the effectiveness of knowledge implementation and influences health improvement. Successful healthcare quality improvement (QI) initiatives frequently fail to transfer to different settings, with local contextual factors often cited as the cause. Understanding and overcoming contextual barriers is therefore crucial to implementing effective improvement; yet context is still poorly understood. There is a paucity of information on the mechanisms underlyinghowandwhyQI projects succeed or fail in given settings. A realist review of empirical studies of healthcare QI initiatives will be undertaken to examine the influence and impact of contextual factors on quality improvement in healthcare settings and explore whether QI initiatives can work in all contexts.  Methods  The review will explore which contextual factors are important, and how, why, when and for whom they are important, within varied settings. The dynamic nature of context and change over time will be explored by examining which aspects of context impact at key points in the improvement trajectory. The review will also consider the influence of context on improvement outcomes (provider- and patient-level), spread and sustainability. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will consult with experts and stakeholders in the early stages to focus the review and develop a programme theory consisting of explanatory ‘context–mechanism–outcome’ configurations. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review advisory group will oversee the review process. Review findings will follow RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications.  Discussion  The review will update and consolidate evidence on the contextual conditions for effective improvement and distil new knowledge to inform the design and development of context-sensitive QI initiatives. This review ties in with the study of improvement programmes as vehicles of change and the development of an evidence base around healthcare improvement by addressing whether QI initiatives can work in all contexts.  Systematic review registration  PROSPERO CRD4201706213