State-wide implementation of patient-reported outcome measures (PROMs) in specialized outpatient palliative care teams (ELSAH): A mixed-methods evaluation and implications for their sustainable use.

BACKGROUND: Such patient-reported outcome measures (PROMs) and patient-centered outcome measures as the Integrated Palliative Care Outcome Scale (IPOS), Phase of Illness, and IPOS Views on Care (IPOS VoC), facilitate patient-centered care and help improve quality. To ensure sustainability, implementation and usage should be adapted according to setting. When settings involve several distinct teams that differ in terms of views and working practices, it is more difficult to integrate outcome measures into daily care. The ELSAH study aimed to learn how health professionals working in specialized outpatient palliative care (SOPC) viewed the use of these outcome measures in daily care, and what they express is needed for successful sustainable, state-wide application. METHODS: We used a parallel mixed-methods design involving three focus groups (n = 14) and an online-survey based on normalization process theory (n = 76). Most participants were nurses and physicians from 19 SOPC-teams in Hesse, Germany. We used a triangulation protocol including convergence coding matrices to triangulate findings. RESULTS: The majority of health professionals were able to integrate the outcome measures into their working lives and said that it had become a normal part of their day-to-day work. To ensure their sustainable integration into daily care, the motivation and concerns of health professionals should be taken into consideration. Health professionals must clearly recognize how the measures help improve daily care and quality evaluation. CONCLUSIONS: To implement the outcome measures in a number of teams, it will be necessary to take individual team characteristics into account, because they influence motivation and concerncs. Further, it will be necessary to offer opportunities for them to engage in peer support and share information with other teams. The sustainable use of outcome measures in SOPC will require continuous support within each team as well as across teams. When several distinct teams are working in the same setting, a cross-team coordination unit can help to coordinate their work efficiently. TRIAL REGISTRATION: German Clinical Trials Register DRKS-ID: DRKS00012421; www.germanctr.de/DRKS00012421.

Integrating patient- and caregiver-reported outcome measures into the daily care routines of specialised outpatient palliative care: a qualitative study (ELSAH) on feasibility, acceptability and appropriateness.

BACKGROUND: The use of patient-reported outcome measures (PROM) and caregiver-reported outcome measures can raise the patient centeredness of treatment and improve the quality of palliative care. Nevertheless, the everyday implementation of self-report in patients and caregivers is complex, and should be adapted for use in specific settings. We aimed to implement a set of outcome measures that included patient and caregiver self- and proxy-reported outcome measures in specialised outpatient palliative care (SOPC). In this study, we explore how the Integrated Palliative Outcome Scale (IPOS), IPOS Views on Care (IPOS VoC) and the Short-form Zarit Caregiver Burden Interview (ZBI-7) can be feasibly, acceptably and appropriately implemented in the daily care routines of SOPC. METHODS: Five SOPC teams were trained, and used the outcome measures in daily practice. Team members were mainly nurses and physicians. To investigate their feedback, we used a multi-method qualitative design consisting of focus groups with SOPC-team members (n = 14), field notes of meetings and conversations with the SOPC teams. In an iterative process, we analysed the findings using qualitative content analysis and refined use of the outcome measures. RESULTS: We found that integrating patient and caregiver outcome measures into daily care routines in SOPC is feasible. To improve feasibility, acceptability and appropriateness, the resulting burden on patients and relatives should be kept to a minimum, the usefulness of the measures must be understood, they should be used considerately, and administration must be manageable. We removed ZBI-7 from the set of measures as a result of feedback on its content and wording. CONCLUSIONS: SOPC-team members have reservations about the implementation of PROM in SOPC, but with appropriate adjustments, its application in daily care is feasible, accepted and perceived as appropriate. Previous to use, SOPC-team members should be trained in how to apply the measures, in the design of manageable processes that include integration into electronic documentation systems, and in ongoing evaluation and support. They should also be taught how useful the measures can be. TRIAL REGISTRATION: May 19th, 2017, German Clinical Trials Register DRKS-ID: DRKS00012421 .

How can we ensure the success of specialised palliative home-care? A qualitative study (ELSAH) identifying key issues from the perspective of patients, relatives and health professionals.

BACKGROUND: Specialised palliative home-care supports patients with life-limiting diseases in their familiar surroundings. The number of palliative care teams and patients being cared for is increasing worldwide. To assess and improve quality, it is needed to understand, how specialised palliative home-care can be provided successfully. For this purpose we examined the views of all involved stakeholders. AIM: To identify the issues that patients, their relatives and involved health professionals view as important in ensuring the success of specialised palliative home-care. DESIGN: We used a qualitative design based on participant observations, interviews and focus groups following the principles of a Grounded Theory approach. SETTING/PARTICIPANTS: All specialised palliative home-care teams (n = 22) caring for adults in Hesse, Germany, participated. We conducted participant observations (n = 5), and interviewed patients (n = 14), relatives (n = 14) and health professionals working in or collaborating with specialised palliative home-care (n = 30). We also conducted focus groups (n = 4) with health professionals including a member check. RESULTS: Successful specialised palliative home-care needs to treat complex symptoms, and provide comprehensive care including organisation of care, involving relatives and addressing issues of death and dying. Sense of security for patients and relatives is key to enable care at home. Care delivery preferences include a focus on the quality of relationships, respect for individuality and the facilitation of self-determination. CONCLUSIONS: Consideration of the identified key issues can help to ensure successful specialised palliative home-care. Knowledge of these should also be considered when researching and assessing quality of care. TRIAL REGISTRATION: German Clinical Trials Register DRKS-ID: DRKS00012421; http://www.germanctr.de.

Coughing children in family practice and primary care: a systematic review of prevalence, aetiology and prognosis.

BACKGROUND: For evidence-based decision making, primary care physicians need to have specific and reliable information on the pre-test probabilities of underlying diseases and a symptom's course. We performed a systematic review of symptom-evaluating studies in primary care, following three research questions: (1) What is the prevalence of the symptom cough in children consulting primary care physicians? (2) What are the underlying aetiologies of cough and the respective frequencies? (3) What is the prognosis of children with cough? METHODS: Following a pre-defined algorithm and independent double reviewer ratings we searched MEDLINE and EMBASE. All quantitative original research articles in English, French or German were included if they focused on unselected study populations of children consulting a primary care physician for cough. We used the random effects model for meta-analysis in subgroups, if justifiable in terms of heterogeneity. RESULTS: We identified 14 eligible studies on prevalence, five on aetiology and one on prognosis. Prevalence estimates varied between 4.7 and 23.3% of all reasons for an encounter, or up to estimates of 60% when related to patients or consultations. Cough in children is more frequent than in adults, with lowest prevalences in adolescents and in summer. Acute cough is mostly caused by upper respiratory tract infections (62.4%) and bronchitis (33.3%); subacute or chronic cough by recurrent respiratory tract infection (27.7%), asthma (up to 50.4% in cough persisting more than 3 weeks), and pertussis (37.2%). Potentially serious diseases like croup, pneumonia or tuberculosis are scarce. In children with subacute and chronic cough the total duration of cough ranged from 24 to 192 days. About 62.3% of children suffering from prolonged cough are still coughing two months after the beginning of symptoms. CONCLUSION: Cough is one of the most frequent reasons for an encounter in primary care. Our findings fit in with current guideline recommendations supporting a thoughtful wait-and-see approach in acute cough and a special awareness in chronic cough of the possibility of asthma and pertussis. Further evidence of aetiological pre-test probabilities is needed to assess the diagnostic gain based on patient history and clinical signs for differential diagnoses of cough in children.

Prevalence, aetiologies and prognosis of the symptom cough in primary care: a systematic review and meta-analysis.

BACKGROUND: Cough is a relevant reason for encounter in primary care. For evidence-based decision making, general practitioners need setting-specific knowledge about prevalences, pre-test probabilities, and prognosis. Accordingly, we performed a systematic review of symptom-evaluating studies evaluating cough as reason for encounter in primary care. METHODS: We conducted a search in MEDLINE and EMBASE. Eligibility criteria and methodological quality were assessed independently by two reviewers. We extracted data on prevalence, aetiologies and prognosis, and estimated the variation across studies. If justifiable in terms of heterogeneity, we performed a meta-analysis. RESULTS: We identified 21 eligible studies on prevalence, 12 on aetiology, and four on prognosis. Prevalence/incidence estimates were 3.8-4.2%/12.5% (Western primary care) and 10.3-13.8%/6.3-6.5% in Africa, Asia and South America. In Western countries the underlying diagnoses for acute cough or cough of all durations were respiratory tract infections (73-91.9%), influenza (6-15.2%), asthma (3.2-15%), laryngitis/tracheitis (3.6-9%), pneumonia (4.0-4.2%), COPD (0.5-3.3%), heart failure (0.3%), and suspected malignancy (0.2-1.8%). Median time for recovery was 9 to 11 days. Complete recovery was reported by 40.2- 67% of patients after two weeks, and by 79% after four weeks. About 21.1-35% of patients re-consulted; 0-1.3% of acute cough patients were hospitalized, none died. Evidence is missing concerning subacute and chronic cough. CONCLUSION: Prevalences and incidences of cough are high and show regional variation. Acute cough, mainly caused by respiratory tract infections, is usually self-limiting (supporting a "wait-and-see" strategy). We have no setting-specific evidence to support current guideline recommendations concerning subacute or chronic cough in Western primary care. Our study presents epidemiological data under non non-pandemic conditions. It will be interesting to compare these data to future research results of the post-pandemic era.

Regret among primary care physicians: a survey of diagnostic decisions.

BACKGROUND: Experienced and anticipated regret influence physicians' decision-making. In medicine, diagnostic decisions and diagnostic errors can have a severe impact on both patients and physicians. Little empirical research exists on regret experienced by physicians when they make diagnostic decisions in primary care that later prove inappropriate or incorrect. The aim of this study was to explore the experience of regret following diagnostic decisions in primary care. METHODS: In this qualitative study, we used an online questionnaire on a sample of German primary care physicians. We asked participants to report on cases in which the final diagnosis differed from their original opinion, and in which treatment was at the very least delayed, possibly resulting in harm to the patient. We asked about original and final diagnoses, illness trajectories, and the reactions of other physicians, patients and relatives. We used thematic analysis to assess the data, supported by MAXQDA 11 and Microsoft Excel 2016. RESULTS: 29 GPs described one case each (14 female/15 male patients, aged 1.5-80 years, response rate < 1%). In 26 of 29 cases, the final diagnosis was more serious than the original diagnosis. In two cases, the diagnoses were equally serious, and in one case less serious. Clinical trajectories and the reactions of patients and relatives differed widely. Although only one third of cases involved preventable harm to patients, the vast majority (27 of 29) of physicians expressed deep feelings of regret. CONCLUSION: Even if harm to patients is unavoidable, regret following diagnostic decisions can be devastating for clinicians, making them 'second victims'. Procedures and tools are needed to analyse cases involving undesirable diagnostic events, so that 'true' diagnostic errors, in which harm could have been prevented, can be distinguished from others. Further studies should also explore how physicians can be supported in dealing with such events in order to prevent them from practicing defensive medicine.

Prevalence, aetiologies and prognosis of the symptom dizziness in primary care - a systematic review.

BACKGROUND: Dizziness is a common reason for consulting a general practitioner and there is a broad range of possible underlying aetiologies. There are few evidence-based data about prevalence, aetiology and prognosis in primary care. We aimed to conduct a systematic review of symptom-evaluating studies on prevalence, aetiology or prognosis of dizziness in primary care. METHODS: We systematically searched MEDLINE and EMBASE. Two independent researchers screened titles and abstracts according to predefined criteria. We included all studies evaluating the symptoms 'dizziness' or 'vertigo' as a reason for consultation in primary care. We extracted data about study population and methodology and prevalence, aetiology and prognosis. Two raters independently judged study quality and risk of bias. We investigated the variation across studies using forest plots, I2 and prediction intervals. Since we anticipated a great amount of clinical and unexplained statistical heterogeneity, we provided qualitative syntheses instead of pooled estimates. RESULTS: We identified 31 studies (22 on prevalence, 14 on aetiology and 8 on prognosis). Consultation prevalence differs between 1,0 and 15,5%. The most common aetiologies are vestibular/peripheral (5,4-42,1%), benign peripheral positional vertigo (4,3-39,5%), vestibular neuritis (0,6-24,0%), Menière's disease (1,4-2,7%), cardiovascular disease (3,8-56,8%), neurological disease (1,4-11,4%), psychogenic (1,8-21,6%), no clear diagnosis (0,0-80,2%). While studies based on subjective patient assessment reported improvement rates from 37 to 77%, these findings could not be confirmed when applying instruments that measure symptom severity or quality of life. CONCLUSION: There is a broad variety of possible underlying diseases for the symptom dizziness. There exist only few methodologically sound studies concerning aetiology and prognosis of dizziness.

Study protocol: evaluation of specialized outpatient palliative care in the German state of Hesse (ELSAH study) - work package I: assessing the quality of care.

BACKGROUND: In Germany, patients suffering from life-limiting conditions are eligible for specialized outpatient palliative care (SOPC). Evaluation of the quality of this service lacks currently integration of patient-relevant outcomes. There is also no scientific consensus how to prove quality of care in the special context of SOPC adequately. Existing quality reports are primarily based on descriptive structural data which do not allow for estimation of process quality or result quality. The ELSAH study ('Evaluation of Specialized Outpatient Palliative Care in the German state of Hesse') aims to choose - or, if necessary, to adopt - to evaluate and to implement a suit of measures to assess, evaluate and monitor the quality of specialized, home-based palliative care. METHODS: All 22 SOPC teams providing their services in the state of Hesse, Germany, participate in the ELSAH study. The study is divided in two phases: a preparation phase and a main study phase. Based on the findings of the preparation phase we have chosen a preliminary set of instruments including the Integrated Palliative Outcome Scale, Views on Care, Zarit Burden Interview, Phase of Illness, Goal Attainment Scaling, Eastern Cooperative Oncology Group Performance Status, Consumer Quality Indices Palliative Care and Sense of Security in Care. During the main study phase, we will use a mixed-methods approach to evaluate the instruments' psychometric properties (reliability, validity, feasibility and practicability), to identify barriers, facilitators and limitations of their routine use and to explore how their use affects the care within the SOPC setting. DISCUSSION: At the end of this study, an outcome- and patient-centered, validated measurement approach should be provided, adapted for standardized evaluations in SOPC across patient groups, palliative care services and regions nationwide. The standardized application of instruments should allow for making valid statements and comparisons of health care quality in SOPC based on process- and outcome-evaluation rather than relying on structural data only. Moreover, the instruments might directly influence the care of patients in palliative situations. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00012421 ).

The differential diagnosis of tiredness: a systematic review.

BACKGROUND: Tiredness is one of the most frequent complaints in primary care. Although often self-limiting and frequently associated with psychosocial stress, patients but also their physicians are often uncertain regarding a serious cause and appropriate diagnostic work-up. We conducted a systematic review and meta-analysis of studies reporting on differential diagnosis of fatigue in primary care. METHODS: MEDLINE, EMBASE and conference abstracts were searched for primary care based studies of patients presenting with tiredness. Twenty-six studies were included. We report on anaemia, malignancy, serious organic disease, depression and the chronic fatigue syndrome (CFS) as causes of tiredness as presenting complaint. RESULTS: We found considerable heterogeneity of estimates which was reduced by limiting our analysis to high quality studies. Prevalences were as follows-anaemia: 2.8 % (CI (confidence interval) 1.6-4.8 %); malignancy: 0.6 % (CI 0.3-1.3 %); serious somatic disease: 4.3 % (CI 2.7-6.7 %); depression 18.5 % (CI 16.2-21.0 %). Pooling was not appropriate for CFS. In studies with control groups of patients without the symptom of tiredness, prevalence of somatic disease was identical to those complaining of tiredness. Depression, however, was more frequent among those with tiredness. CONCLUSIONS: Serious somatic disease is rare in patients complaining of tiredness. Since prevalence is similar in patients without tiredness, the association may not be causal. Extensive investigations are only warranted in case of specific findings from the history or clinical examination. Instead, attention should focus on depression and psychosocial problems.

Studies of the symptom dyspnoea: a systematic review.

BACKGROUND: To deal with patients suffering from dyspnoea, it is crucial for general practitioners to know the prevalences of different diseases causing dyspnoea in the respective area and season, the likelihood of avoidable life-threatening conditions and of worsening or recovery from disease. AIM: Aim of our project was to conduct a systematic review of symptom-evaluating studies on the prevalence, aetiology, and prognosis of dyspnoea as presented to GPs in a primary care setting. METHODS: We did a systematic review of symptom-evaluating studies on dyspnoea in primary care. For this we included all studies investigating the complaint "dyspnoea" as a primary or secondary consulting reason in general practice. Apart from qualitative studies, all kind of study designs independent from type of data assessment, outcome measurement or study quality were included. Symptom-evaluating studies from other settings than primary care and studies which exclusively included children (age <18 years) were excluded from the review. Studies selecting patients prior to recruitment, e.g. because of an increased probability for a particular diagnosis, were also excluded. RESULTS: This systematic review identified 6 symptom evaluating studies on dyspnoea in the primary care setting. The prevalence of dyspnoea as reason for consultation ranges from 0.87 to 2.59 % in general practice. Among all dyspnoea patients 2.7 % (CI 2.2-3.3) suffer from pneumonia. Further specification of underlying aetiologies seems difficult due to the studies' heterogeneity showing a great variety of probabilities. CONCLUSION: There is a great lack of empirical evidence on the prevalence, aetiology and prognosis of dyspnoea in general practice. This might yield uncertainty in diagnosis and evaluation of dyspnoea in primary care.

Causes of chest pain in primary care--a systematic review and meta-analysis.

AIM: To investigate the frequencies of different and relevant underlying etiologies of chest pain in general practice. METHODS: We systematically searched PubMed and EMBASE. Two reviewers independently rated the eligibility of publications and assessed the risk of bias of included studies. We extracted data to calculate the relative frequencies of different underlying conditions and investigated the variation across studies using forest plots, I(2), tau(2), and prediction intervals. With respect to unexplained heterogeneity, we provided qualitative syntheses instead of pooled estimates. RESULTS: We identified 11 eligible studies comprising about 6500 patients. The overall risk of bias was rated as low in 6 studies comprising about 3900 patients. The relative frequencies of different conditions as the underlying etiologies of chest pain reported by these studies ranged from 24.5 to 49.8% (chest wall syndrome), 13.8 to 16.1% (cardiovascular diseases), 6.6 to 11.2% (stable coronary heart disease), 1.5 to 3.6% (acute coronary syndrome/myocardial infarction), 10.3 to 18.2% (respiratory diseases), 9.5 to 18.2% (psychogenic etiologies), 5.6 to 9.7% (gastrointestinal disorders), and 6.0 to 7.1% (esophageal disorders). CONCLUSION: This information may be of practical value for general practitioners as it provides the pre-test probabilities for a range of underlying diseases and may be suitable to guide the diagnostic process.

Studies of the symptom abdominal pain--a systematic review and meta-analysis.

BACKGROUND: Diagnostic reasoning in primary care patients with abdominal pain is a complex challenge for GPs. To ensure evidence-based decision making for this symptom, GPs need setting-specific knowledge about the prevalence, potential risks for diseases and chance of recovery or risk of undesirable courses of disease. AIM: We conducted a systematic review of symptom-evaluating studies on prevalence, aetiology or prognosis of abdominal pain. METHODS: We included all studies evaluating the symptom 'abdominal pain' as a reason for consultation in primary care. We included all types of study designs except for qualitative studies. Studies focussed solely on children or settings other than primary care were also excluded. RESULTS: We identified 14 studies. Mean consultation prevalence is 2.8% for abdominal pain. In about one-third of patients the underlying cause of abdominal pain cannot be specified. The most common aetiologies are gastroenteritis (7.2-18.7%), irritable bowel disease (2.6-13.2%), urological cause (5.3%) and gastritis (5.2%). About 1 in 10 abdominal pain patients suffers from an acute disease like appendicitis (1.9%), diverticulitis (3.0%), biliary/pancreatic (4.0%) or neoplastic (1.0%) diseases needing immediate therapy. CONCLUSION: There is a high prevalence of patients consulting GPs for abdominal pain. The review identified a comparably high rate of acute underlying diseases in need of further investigation or therapy. At the same time, the underlying cause of the complaints often remains unexplained. Further symptom-evaluating studies are necessary, ideally using standardized methodology in order to gain sufficient evidence for developing much-needed guidelines and decision support tools.

Chest pain in primary care: is the localization of pain diagnostically helpful in the critical evaluation of patients?--A cross sectional study.

BACKGROUND: Chest pain is a common complaint and reason for consultation in primary care. Traditional textbooks still assign pain localization a certain discriminative role in the differential diagnosis of chest pain. The aim of our study was to synthesize pain drawings from a large sample of chest pain patients and to examine whether pain localizations differ for different underlying etiologies. METHODS: We conducted a cross-sectional study including 1212 consecutive patients with chest pain recruited in 74 primary care offices in Germany. Primary care providers (PCPs) marked pain localization and radiation of each patient on a pictogram. After 6 months, an independent interdisciplinary reference panel reviewed clinical data of every patient, deciding on the etiology of chest pain at the time of patient recruitment. PCP drawings were entered in a specially designed computer program to produce merged pain charts for different etiologies. Dissimilarities between individual pain localizations and differences on the level of diagnostic groups were analyzed using the Hausdorff distance and the C-index. RESULTS: Pain location in patients with coronary heart disease (CHD) did not differ from the combined group of all other patients, including patients with chest wall syndrome (CWS), gastro-esophageal reflux disease (GERD) or psychogenic chest pain. There was also no difference in chest pain location between male and female CHD patients. CONCLUSIONS: Pain localization is not helpful in discriminating CHD from other common chest pain etiologies.

In-vivo-validation of a cardiovascular risk prediction tool: the arriba-pro study.

BACKGROUND: Calculation of individual risk is the cornerstone of effective cardiovascular prevention. arriba is a software to estimate the individual risk to suffer a cardiovascular event in 10 years. Prognosis and the absolute effects of pharmacological and lifestyle interventions help the patient make a well-informed decision. The risk calculation algorithm currently used in arriba is based on the Framingham risk algorithm calibrated to the German setting. The objective of this study is to evaluate and adapt the algorithm for the target population in primary care in Germany. METHODS/DESIGN: arriba-pro will be conducted within the primary care scheme provided by a large health care insurer in Baden-Württemberg, Germany. Patients who are counseled with arriba by their general practitioners (GPs) will be included in the arriba-pro cohort. Exposure data from the consultation with arriba such as demographic data and risk factors will be recorded automatically by the practice software and transferred to the study centre. Information on relevant prescription drugs (effect modifiers) and cardiovascular events (outcomes) will be derived from administrative sources. DISCUSSION: The study is unique in simulating a therapy naïve cohort, matching exactly research and application setting, using a robust administrative data base, and, finally, including patients with known cardiovascular disease who have been excluded from previous studies. TRIAL REGISTRATION: The study is registered with Deutsches Register Klinischer Studien (DRKS00004633).

Development and validation of a clinical prediction rule for chest wall syndrome in primary care.

BACKGROUND: Chest wall syndrome (CWS), the main cause of chest pain in primary care practice, is most often an exclusion diagnosis. We developed and evaluated a clinical prediction rule for CWS. METHODS: Data from a multicenter clinical cohort of consecutive primary care patients with chest pain were used (59 general practitioners, 672 patients). A final diagnosis was determined after 12 months of follow-up. We used the literature and bivariate analyses to identify candidate predictors, and multivariate logistic regression was used to develop a clinical prediction rule for CWS. We used data from a German cohort (n = 1212) for external validation. RESULTS: From bivariate analyses, we identified six variables characterizing CWS: thoracic pain (neither retrosternal nor oppressive), stabbing, well localized pain, no history of coronary heart disease, absence of general practitioner's concern, and pain reproducible by palpation. This last variable accounted for 2 points in the clinical prediction rule, the others for 1 point each; the total score ranged from 0 to 7 points. The area under the receiver operating characteristic (ROC) curve was 0.80 (95% confidence interval 0.76-0.83) in the derivation cohort (specificity: 89%; sensitivity: 45%; cut-off set at 6 points). Among all patients presenting CWS (n = 284), 71% (n = 201) had a pain reproducible by palpation and 45% (n = 127) were correctly diagnosed. For a subset (n = 43) of these correctly classified CWS patients, 65 additional investigations (30 electrocardiograms, 16 thoracic radiographies, 10 laboratory tests, eight specialist referrals, one thoracic computed tomography) had been performed to achieve diagnosis. False positives (n = 41) included three patients with stable angina (1.8% of all positives). External validation revealed the ROC curve to be 0.76 (95% confidence interval 0.73-0.79) with a sensitivity of 22% and a specificity of 93%. CONCLUSIONS: This CWS score offers a useful complement to the usual CWS exclusion diagnosing process. Indeed, for the 127 patients presenting CWS and correctly classified by our clinical prediction rule, 65 additional tests and exams could have been avoided. However, the reproduction of chest pain by palpation, the most important characteristic to diagnose CWS, is not pathognomonic.

Coronary heart disease in primary care: accuracy of medical history and physical findings in patients with chest pain--a study protocol for a systematic review with individual patient data.

BACKGROUND: Chest pain is a common complaint in primary care, with coronary heart disease (CHD) being the most concerning of many potential causes. Systematic reviews on the sensitivity and specificity of symptoms and signs summarize the evidence about which of them are most useful in making a diagnosis. Previous meta-analyses are dominated by studies of patients referred to specialists. Moreover, as the analysis is typically based on study-level data, the statistical analyses in these reviews are limited while meta-analyses based on individual patient data can provide additional information. Our patient-level meta-analysis has three unique aims. First, we strive to determine the diagnostic accuracy of symptoms and signs for myocardial ischemia in primary care. Second, we investigate associations between study- or patient-level characteristics and measures of diagnostic accuracy. Third, we aim to validate existing clinical prediction rules for diagnosing myocardial ischemia in primary care. This article describes the methods of our study and six prospective studies of primary care patients with chest pain. Later articles will describe the main results. METHODS/DESIGN: We will conduct a systematic review and IPD meta-analysis of studies evaluating the diagnostic accuracy of symptoms and signs for diagnosing coronary heart disease in primary care. We will perform bivariate analyses to determine the sensitivity, specificity and likelihood ratios of individual symptoms and signs and multivariate analyses to explore the diagnostic value of an optimal combination of all symptoms and signs based on all data of all studies. We will validate existing clinical prediction rules from each of the included studies by calculating measures of diagnostic accuracy separately by study. DISCUSSION: Our study will face several methodological challenges. First, the number of studies will be limited. Second, the investigators of original studies defined some outcomes and predictors differently. Third, the studies did not collect the same standard clinical data set. Fourth, missing data, varying from partly missing to fully missing, will have to be dealt with.Despite these limitations, we aim to summarize the available evidence regarding the diagnostic accuracy of symptoms and signs for diagnosing CHD in patients presenting with chest pain in primary care. REVIEW REGISTRATION: Centre for Reviews and Dissemination (University of York): CRD42011001170.

Does the patient with chest pain have a coronary heart disease? Diagnostic value of single symptoms and signs--a meta-analysis.

AIM: To determine the diagnostic value of single symptoms and signs for coronary heart disease (CHD) in patients with chest pain. METHODS: Searches of two electronic databases (EMBASE 1980 to March 2008, PubMed 1966 to May 2009) and hand searching in seven journals were conducted. Eligible studies recruited patients presenting with acute or chronic chest pain. The target disease was CHD, with no restrictions regarding case definitions, eg, stable CHD, acute coronary syndrome (ACS), acute myocardial infarction (MI), or major cardiac event (MCE). Diagnostic tests of interest were items of medical history and physical examination. Bivariate random effects model was used to derive summary estimates of positive (pLR) and negative likelihood ratios (nLR). RESULTS: We included 172 studies providing data on the diagnostic value of 42 symptoms and signs. With respect to case definition of CHD, diagnostically most useful tests were history of CHD (pLR=3.59), known MI (pLR=3.21), typical angina (pLR=2.35), history of diabetes mellitus (pLR=2.16), exertional pain (pLR=2.13), history of angina pectoris (nLR=0.42), and male sex (nLR=0.49) for diagnosing stable CHD; pain radiation to right arm/shoulder (pLR=4.43) and palpitation (pLR=0.47) for diagnosing MI; visceral pain (pLR=2.05) for diagnosing ACS; and typical angina (pLR=2.60) and pain reproducible by palpation (pLR=0.13) for predicting MCE. CONCLUSIONS: We comprehensively reported the accuracy of a broad spectrum of single symptoms and signs for diagnosing myocardial ischemia. Our results suggested that the accuracy of several symptoms and signs varied in the published studies according to the case definition of CHD.

The Treatment of Coronary Artery Disease.

BACKGROUND: The first coronary artery bypass operation (CABG) was performed on May 2, 1960. The first percutaneous coro - nary intervention (PCI) was performed almost 20 years later. Since then, the invasive treatment of coronary artery disease (CAD) has moved into the spotlight of cardiac medical care. METHODS: We summarize the current status of medical and invasive CAD treatment through a selective review of the literature. RESULTS: More than 800 000 patients currently undergo invasive diagnostic and therapeutic procedures for CAD in Germany each year. The number of coronary artery bypass grafting (CABG) procedures rose to 65 000/year by the turn of the millennium and has been declining since then. In contrast, the number of PCIs in Germany rose to approximately 350 000/year by 2017, and a beginning decline is being observed at present. This development occurred even though, for elective patients, a survival advantage from an invasive procedure compared to medical therapy has been shown in direct comparison only for CABG. CONCLUSION: Conservative treatment is always the baseline treatment and has undergone major advances in the last few decades. Moreover, non-invasive coronary evaluation with computed tomography, as well as non-invasive cardiac stress imaging studies, are increasingly replacing primary invasive coronary evaluations. In this review, we illustrate a mechanistic concept of the appropriate use of CABG and PCI that can improve patient care, while underscoring the importance of interdisciplinary and intersectoral collaboration.

Validation of Cardiovascular Risk Prediction by the Arriba Instrument.

BACKGROUND: It is recommended in cardiovascular prevention guidelines that treatment should be based on overall cardiovascular risk. The arriba instrument has been widely used for this purpose in Germany. The aim of this study is to validate risk prediction by arriba with the aid of morbidity and mortality data from the population- based Study of Health in Pomerania. METHODS: In a longitudinal analysis, the arriba instrument was used to calculate the 10-year overall cardiovascular risk at baseline for subjects who had not sustained any prior cardiovascular event. Cardiovascular event rates were determined from follow-up data, and discrimination and calibration measures for the risk determination algorithm were calculated. RESULTS: Data from 1973 subjects (mean age 51 ± 13 years, 48% men) were included in the analysis. After a median follow-up of 10.9 years, cardiovascular events had occurred in 196 subjects, or 9.8%. The ratio of predicted to observed event rate was 0.8 (95% confidence interval: [0.5; 1.1]), 1.3 [1.0; 1.8], and 1.1 [0.8; 1.4] for subjects at low, intermediate, and high cardiovascular risk, respectively. Arriba underestimated cardiovascular event rates in women and overestimated them in persons aged 30-44 and 45-59. The area under curve was 0.84 [95% CI 0.81; 0.86]. CONCLUSION: The discrimination scores of the arriba instrument resemble those of SCORE-Germany and PROCAM, but a better adjustment to the target population would be desirable. The results support the recommendation of the German Guideline for Cardiovascular Risk Counseling in General Practice for the use of the arriba instrument. An unresolved problem is the failure to consider intervention effects, resulting in an overall mild overestimation of risk.

Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility.

BACKGROUND: Most guidelines concentrate on investigations, treatment, and monitoring instead of patient history and clinical examination. We developed a guideline that dealt with the different aetiologies of chest pain by emphasizing the patient's history and physical signs. The objective of this study was to evaluate the guideline's acceptance and feasibility in the context of a practice test. METHODS: The evaluation study was nested in a diagnostic cross-sectional study with 56 General Practitioners (GPs) and 862 consecutively recruited patients with chest pain. The evaluation of the guideline was conducted in a mixed method design on a sub-sample of 17 GPs and 282 patients. Physicians' evaluation of the guideline was assessed via standardized questionnaires and case record forms. Additionally, practice nursing staff and selected patients were asked for their evaluation of specific guideline modules. Quantitative data was analyzed descriptively for frequencies, means, and standard deviations. In addition, two focus groups with a total of 10 GPs were held to gain further insights in the guideline implementation process. The data analysis and interpretation followed the standards of the qualitative content analysis. RESULTS: The overall evaluation of the GPs participating in the evaluation study regarding the recommendations made in the chest pain guideline was positive. A total of 14 GPs were convinced that there was a need for this kind of guideline and perceived the guideline recommendations as useful. While the long version was partially criticized for a perceived lack of clarity, the short version of the chest pain guideline and the heart score were especially appreciated by the GPs. However, change of clinical behaviour as consequence of the guideline was inconsistent. While on a concrete patient related level, GPs indicated to have behaved as the guideline recommended, the feedback on a more general level was heterogeneous. Several suggestions to improve guideline implementation were made by participating physicians. Due to the small number of practice nursing staff evaluating the flowchart and patients remembering the patient leaflet, no valid results regarding the flowchart and patient leaflet modules could be reported. CONCLUSIONS: Overall, the participating GPs perceived the guideline recommendations as useful to increase awareness and to reflect on diagnostic issues. Although behaviour change in consequence of the guideline was not reported on a general level, guidelines on history taking and the clinical examination may serve an important conservative and practical function in a technology driven environment. Further research to increase the implementation success of the guideline should be undertaken.