A cluster randomized controlled trial aimed at implementation of local quality improvement collaboratives to improve prescribing and test ordering performance of general practitioners: Study Protocol

<p>Abstract</p> <p>Background</p> <p>The use of guidelines in general practice is not optimal. Although evidence-based methods to improve guideline adherence are available, variation in physician adherence to general practice guidelines remains relatively high. The objective for this study is to transfer a quality improvement strategy based on audit, feedback, educational materials, and peer group discussion moderated by local opinion leaders to the field. The research questions are: is the multifaceted strategy implemented on a large scale as planned?; what is the effect on general practitioners' (GPs) test ordering and prescribing behaviour?; and what are the costs of implementing the strategy?</p> <p>Methods</p> <p>In order to evaluate the effects, costs and feasibility of this new strategy we plan a multi-centre cluster randomized controlled trial (RCT) with a balanced incomplete block design. Local GP groups in the south of the Netherlands already taking part in pharmacotherapeutic audit meeting groups, will be recruited by regional health officers. Approximately 50 groups of GPs will be randomly allocated to two arms. These GPs will be offered two different balanced sets of clinical topics. Each GP within a group will receive comparative feedback on test ordering and prescribing performance. The feedback will be discussed in the group and working agreements will be created after discussion of the guidelines and barriers to change. The data for the feedback will be collected from existing and newly formed databases, both at baseline and after one year.</p> <p>Discussion</p> <p>We are not aware of published studies on successes and failures of attempts to transfer to the stakeholders in the field a multifaceted strategy aimed at GPs' test ordering and prescribing behaviour. This pragmatic study will focus on compatibility with existing infrastructure, while permitting a certain degree of adaptation to local needs and routines.</p> <p>Trial registration</p> <p>Nederlands Trial Register ISRCTN40008171</p

The SMILE study: a study of medical information and lifestyles in Eindhoven, the rationale and contents of a large prospective dynamic cohort study

<p>Abstract</p> <p>Background</p> <p>Health problems, health behavior, and the consequences of bad health are often intertwined. There is a growing need among physicians, researchers and policy makers to obtain a comprehensive insight into the mutual influences of different health related, institutional and environmental concepts and their collective developmental processes over time.</p> <p>Methods/Design</p> <p>SMILE is a large prospective cohort study, focusing on a broad range of aspects of disease, health and lifestyles of people living in Eindhoven, the Netherlands. This study is unique in its kind, because two data collection strategies are combined: first data on morbidity, mortality, medication prescriptions, and use of care facilities are continuously registered using electronic medical records in nine primary health care centers. Data are extracted regularly on an anonymous basis. Secondly, information about lifestyles and the determinants of (ill) health, sociodemographic, psychological and sociological characteristics and consequences of chronic disease are gathered on a regular basis by means of extensive patient questionnaires. The target population consisted of over 30,000 patients aged 12 years and older enrolled in the participating primary health care centers.</p> <p>Discussion</p> <p>Despite our relatively low response rates, we trust that, because of the longitudinal character of the study and the high absolute number of participants, our database contains a valuable set of information.</p> <p>SMILE is a longitudinal cohort with a long follow-up period (15 years). The long follow-up and the unique combination of the two data collection strategies will enable us to disentangle causal relationships. Furthermore, patient-reported characteristics can be related to self-reported health, as well as to more validated physician registered morbidity. Finally, this population can be used as a sampling frame for intervention studies. Sampling can either be based on the presence of certain diseases, or on specific lifestyles or other patient characteristics.</p

Utilization of mechanical power and associations with clinical outcomes in brain injured patients: a secondary analysis of the extubation strategies in neuro-intensive care unit patients and associations with outcome (ENIO) trial

Background: There is insufficient evidence to guide ventilatory targets in acute brain injury (ABI). Recent studies have shown associations between mechanical power (MP) and mortality in critical care populations. We aimed to describe MP in ventilated patients with ABI, and evaluate associations between MP and clinical outcomes. Methods: In this preplanned, secondary analysis of a prospective, multi-center, observational cohort study (ENIO, NCT03400904), we included adult patients with ABI (Glasgow Coma Scale ≤ 12 before intubation) who required mechanical ventilation (MV) ≥ 24&nbsp;h. Using multivariable log binomial regressions, we separately assessed associations between MP on hospital day (HD)1, HD3, HD7 and clinical outcomes: hospital mortality, need for reintubation, tracheostomy placement, and development of acute respiratory distress syndrome (ARDS). Results: We included 1217 patients (mean age 51.2&nbsp;years [SD 18.1], 66% male, mean body mass index [BMI] 26.3 [SD 5.18]) hospitalized at 62 intensive care units in 18 countries. Hospital mortality was 11% (n = 139), 44% (n = 536) were extubated by HD7 of which 20% (107/536) required reintubation, 28% (n = 340) underwent tracheostomy placement, and 9% (n = 114) developed ARDS. The median MP on HD1, HD3, and HD7 was 11.9&nbsp;J/min [IQR 9.2-15.1], 13&nbsp;J/min [IQR 10-17], and 14&nbsp;J/min [IQR 11-20], respectively. MP was overall higher in patients with ARDS, especially those with higher ARDS severity. After controlling for same-day pressure of arterial oxygen/fraction of inspired oxygen (P/F ratio), BMI, and neurological severity, MP at HD1, HD3, and HD7 was independently associated with hospital mortality, reintubation and tracheostomy placement. The adjusted relative risk (aRR) was greater at higher MP, and strongest for: mortality on HD1 (compared to the HD1 median MP 11.9&nbsp;J/min, aRR at 17&nbsp;J/min was 1.22, 95% CI 1.14-1.30) and HD3 (1.38, 95% CI 1.23-1.53), reintubation on HD1 (1.64; 95% CI 1.57-1.72), and tracheostomy on HD7 (1.53; 95%CI 1.18-1.99). MP was associated with the development of moderate-severe ARDS on HD1 (2.07; 95% CI 1.56-2.78) and HD3 (1.76; 95% CI 1.41-2.22). Conclusions: Exposure to high MP during the first week of MV is associated with poor clinical outcomes in ABI, independent of P/F ratio and neurological severity. Potential benefits of optimizing ventilator settings to limit MP warrant further investigation

Disease or no disease? Disagreement on diagnoses between self-reports and medical records of adult patients

BACKGROUND: Previous studies reported moderate to good agreement between patients' self-reported diseases and physicians' registered diseases. Disagreement might hamper a good doctor-patient relationship and hamper good quality of care. Disagreement can be associated with demographic and psychosocial patient characteristics. OBJECTIVES: To evaluate the level of agreement on reported chronic diseases between patients and their general practitioners (GPs); to assess whether disagreement relates to patient characteristics. METHODS: This study is embedded in a large GP based prospective cohort. Questionnaires of 2893 patients reporting on 14 chronic diseases are used. The agreement (percentage) between self-reported chronic diseases and the medical records was assessed first by descriptive statistics. To control for agreement by chance alone Cohen's kappa value was calculated. Type of (dis) agreement was further evaluated and associated with patient characteristics. RESULTS: Despite high agreement on diseases between patients and GPs, kappa's varied from 0.17 (inflammatory joint diseases and rheumatoid arthritis) to 0.86 (diabetes mellitus). Most often under-reporting and over-reporting was related to a decreased physical and mental quality of life and higher age. CONCLUSION: kappa values between patients and GPs appeared to be low in this study.peerreview_statement: The publishing and review policy for this title is described in its Aims & Scope. aims_and_scope_url: http://www.tandfonline.com/action/journalInformation?show=aimsScope&journalCode=igen20status: publishe

High-flow Nasal Cannula therapy: A feasible treatment for vulnerable elderly COVID-19 patients in the wards

Background: Invasive mechanical ventilation is the treatment of choice in COVID-19 patients when hypoxemia persists, despite maximum conventional oxygen administration. Some frail patients with severe hypoxemic respiratory failure are deemed not eligible for invasive mechanical ventilation. Objectives: To investigate whether High-flow nasal cannula (HFNC) in the wards could serve as a rescue therapy in these frail patients. Methods: This retrospective cohort study included frail COVID-19 patients admitted to the hospital between March 9th and May 1st 2020. HFNC therapy was started in the wards. The primary endpoint was the survival rate at hospital discharge. Results: Thirty-two patients with a median age of 79.0 years (74.5–83.0) and a Clinical Frailty Score of 4 out of 9 (3–6) were included. Only 6% reported HFNC tolerability issues. The overall survival rate was 25% at hospital discharge. Conclusions: This study suggests that, when preferred, HFNC in the wards could be a potential rescue therapy for respiratory failure in vulnerable COVID-19 patients

High-flow Nasal Cannula therapy

Background: Invasive mechanical ventilation is the treatment of choice in COVID-19 patients when hypoxemia persists, despite maximum conventional oxygen administration. Some frail patients with severe hypoxemic respiratory failure are deemed not eligible for invasive mechanical ventilation. Objectives: To investigate whether High-flow nasal cannula (HFNC) in the wards could serve as a rescue therapy in these frail patients. Methods: This retrospective cohort study included frail COVID-19 patients admitted to the hospital between March 9th and May 1st 2020. HFNC therapy was started in the wards. The primary endpoint was the survival rate at hospital discharge. Results: Thirty-two patients with a median age of 79.0 years (74.5–83.0) and a Clinical Frailty Score of 4 out of 9 (3–6) were included. Only 6% reported HFNC tolerability issues. The overall survival rate was 25% at hospital discharge. Conclusions: This study suggests that, when preferred, HFNC in the wards could be a potential rescue therapy for respiratory failure in vulnerable COVID-19 patients.</p

Utilization of mechanical power and associations with clinical outcomes in brain injured patients: a secondary analysis of the extubation strategies in neuro-intensive care unit patients and associations with outcome (ENIO) trial

Background: There is insufficient evidence to guide ventilatory targets in acute brain injury (ABI). Recent studies have shown associations between mechanical power (MP) and mortality in critical care populations. We aimed to describe MP in ventilated patients with ABI, and evaluate associations between MP and clinical outcomes. Methods: In this preplanned, secondary analysis of a prospective, multi-center, observational cohort study (ENIO, NCT03400904), we included adult patients with ABI (Glasgow Coma Scale ≤ 12 before intubation) who required mechanical ventilation (MV) ≥ 24 h. Using multivariable log binomial regressions, we separately assessed associations between MP on hospital day (HD)1, HD3, HD7 and clinical outcomes: hospital mortality, need for reintubation, tracheostomy placement, and development of acute respiratory distress syndrome (ARDS). Results: We included 1217 patients (mean age 51.2 years [SD 18.1], 66% male, mean body mass index [BMI] 26.3 [SD 5.18]) hospitalized at 62 intensive care units in 18 countries. Hospital mortality was 11% (n = 139), 44% (n = 536) were extubated by HD7 of which 20% (107/536) required reintubation, 28% (n = 340) underwent tracheostomy placement, and 9% (n = 114) developed ARDS. The median MP on HD1, HD3, and HD7 was 11.9 J/min [IQR 9.2–15.1], 13 J/min [IQR 10–17], and 14 J/min [IQR 11–20], respectively. MP was overall higher in patients with ARDS, especially those with higher ARDS severity. After controlling for same-day pressure of arterial oxygen/fraction of inspired oxygen (P/F ratio), BMI, and neurological severity, MP at HD1, HD3, and HD7 was independently associated with hospital mortality, reintubation and tracheostomy placement. The adjusted relative risk (aRR) was greater at higher MP, and strongest for: mortality on HD1 (compared to the HD1 median MP 11.9 J/min, aRR at 17 J/min was 1.22, 95% CI 1.14–1.30) and HD3 (1.38, 95% CI 1.23–1.53), reintubation on HD1 (1.64; 95% CI 1.57–1.72), and tracheostomy on HD7 (1.53; 95%CI 1.18–1.99). MP was associated with the development of moderate-severe ARDS on HD1 (2.07; 95% CI 1.56–2.78) and HD3 (1.76; 95% CI 1.41–2.22). Conclusions: Exposure to high MP during the first week of MV is associated with poor clinical outcomes in ABI, independent of P/F ratio and neurological severity. Potential benefits of optimizing ventilator settings to limit MP warrant further investigation