How effective is topical miconazole or amorolfine for mild to moderately severe onychomycosis in primary care: the Onycho Trial - a randomised double-blind placebo-controlled trial.

OBJECTIVES: To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis. DESIGN: Randomised, double-blind, placebo-controlled trial, with computer-generated treatment allocation at a 1:1:1 ratio. SETTING: Primary care, recruitment from February 2020 to August 2022. PARTICIPANTS: 193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)). INTERVENTIONS: Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution). MAIN OUTCOME MEASURES: Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability. RESULTS: Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability. CONCLUSIONS: Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis. TRIAL REGISTRATION NUMBER: WHO ICTRP NL8193.

Self-initiated lifestyle changes during a fasting-mimicking diet programme in patients with type 2 diabetes: a mixed-methods study.

BACKGROUND: Lifestyle changes, especially regarding diet quality and physical activity, are important in the management of type 2 diabetes (T2D). This mixed-methods study explores self-initiated lifestyle changes in patients with T2D who followed a periodic fasting-mimicking diet (FMD). METHODS: Quantitative data were obtained from the Fasting In diabetes Treatment trial (November 2018 to August 2021) in which 100 participants with T2D, using metformin only or no medication, were randomised to receive a monthly 5-day FMD for twelve months next to usual care, or usual care only. Diet quality and physical activity questionnaires were completed at baseline, six and twelve months. Changes over time were analysed using linear mixed models. Focus groups were organized with FMD participants to explore experiences regarding self-initiated lifestyle changes. The qualitative data was analysed using the Theoretical Domains Framework. RESULTS: Questionnaires were available from 49 FMD participants and 43 controls. No differences in diet quality were found. Total physical activity in the FMD participants changed from 34.6 to 38.5 h per week (h/wk) from baseline to twelve months, while in controls it changed from 34.9 to 29.0 h/wk (between group difference, p = 0.03). In six focus groups with FMD participants (n = 20), individual participants perceived the FMD as an encouragement for (minor) lifestyle changes. There were no barriers to behaviour change related to the FMD. Important facilitators of healthy behaviour were an increase in awareness of the impact of lifestyle on health (knowledge), better physical fitness (physical) and health improvement (reinforcement). Facilitators unrelated to the FMD included family support (social influences) and opportunities in the neighbourhood (environmental context and resources), while barriers unrelated to the FMD were experiencing health problems (physical) and social events (social influences). CONCLUSIONS: Using an FMD for five consecutive days per month did not affect diet quality in between FMD periods in quantitative analysis, but increased the number of hours per week spent on physical activity. Qualitative analysis revealed self-initiated improvements in both diet quality and physical activity in individual participants using an FMD. Healthcare professionals could use an FMD programme as a 'teachable moment' to stimulate additional lifestyle changes. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03811587. Registered 22 January 2019.

Impact of dietary carbohydrate, fat or protein restriction on the human gut microbiome: a systematic review.

Restriction of dietary carbohydrates, fat and/or protein is often used to reduce body weight and/or treat (metabolic) diseases. Since diet is a key modulator of the human gut microbiome, which plays an important role in health and disease, this review aims to provide an overview of current knowledge of the effects of macronutrient-restricted diets on gut microbial composition and metabolites. A structured search strategy was performed in several databases. After screening for inclusion and exclusion criteria, thirty-six articles could be included. Data are included in the results only when supported by at least three independent studies to enhance the reliability of our conclusions. Low-carbohydrate (<30 energy%) diets tended to induce a decrease in the relative abundance of several health-promoting bacteria, including Bifidobacterium, as well as a reduction in short-chain fatty acid (SCFA) levels in faeces. In contrast, low-fat diets (<30 energy%) increased alpha diversity, faecal SCFA levels and abundance of some beneficial bacteria, including Faecalibacterium prausnitzii. There were insufficient data to draw conclusions concerning the effects of low-protein (<10 energy%) diets on gut microbiota. Although the data of included studies unveil possible benefits of low-fat and potential drawbacks of low-carbohydrate diets for human gut microbiota, the diversity in study designs made it difficult to draw firm conclusions. Using a more uniform methodology in design, sample processing and sharing raw sequence data could foster our understanding of the effects of macronutrient restriction on gut microbiota composition and metabolic dynamics relevant to health. This systematic review was registered at https://www.crd.york.ac.uk/prospero as CRD42020156929.

Oral versus intravenous antibiotic treatment of moderate-to-severe community-acquired pneumonia: a propensity score matched study.

Community-acquired Pneumonia (CAP) guidelines generally recommend to admit patients with moderate-to-severe CAP and start treatment with intravenous antibiotics. This study aims to explore the clinical outcomes of oral antibiotics in patients with moderate-to-severe CAP. We performed a nested cohort study of an observational study including all adult patients presenting to the emergency department of the Haga Teaching Hospital, the Netherlands, between April 2019 and May 2020, who had a blood culture drawn. We conducted propensity score matching with logistic and linear regression analysis to compare patients with moderate-to-severe CAP (Pneumonia Severity Index class III-V) treated with oral antibiotics to patients treated with intravenous antibiotics. Outcomes were 30-day mortality, intensive care unit admission, readmission, length of stay (LOS) and length of antibiotic treatment. Of the original 314 patients, 71 orally treated patients were matched with 102 intravenously treated patients. The mean age was 73 years and 58% were male. We found no significant differences in outcomes between the oral and intravenous group, except for an increased LOS of + 2.6 days (95% confidence interval 1.2-4.0, p value < 0.001) in those treated intravenously. We conclude that oral antibiotics might be a safe and effective treatment for moderate-to-severe CAP for selected patients based on the clinical judgement of the attending physician.

Association between onychomycosis and ulcerative complications in patients with diabetes: a longitudinal cohort study in Dutch general practice.

INTRODUCTION: Diabetic foot ulcers are feared complications of diabetes mellitus (DM), requiring extensive treatment and hospital admissions, ultimately leading to amputation and increased mortality. Different factors contribute to the development of foot ulcers and related complications. Onychomycosis, being more prevalent in patients with diabetes, could be an important risk factor for developing ulcers and related infections. However, the association between onychomycosis and diabetic complications has not been well studied in primary care. RESEARCH DESIGN AND METHODS: To determine the impact of onychomycosis on ulcer development and related complications in patients with diabetes in primary care, a longitudinal cohort study was carried out using routine care data from the Extramural Leiden University Medical Center Academic Network. Survival analyses were performed through Cox proportional hazards models with time-dependent covariates. RESULTS: Data from 48 212 patients with a mean age of 58 at diagnosis of DM, predominantly type 2 (87.8%), were analysed over a median follow-up of 10.3 years. 5.7% of patients developed an ulcer. Onychomycosis significantly increased the risk of ulcer development (HR 1.37, 95% CI 1.13 to 1.66), not affected by antimycotic treatment, nor after adjusting for confounders (HR 1.23, 95% CI 1.01 to 1.49). The same was found for surgical interventions (HR 1.54, 95% CI 1.35 to 1.75) and skin infections (HR 1.48, CI 95% 1.28 to 1.72), again not affected by treatment and significant after adjusting for confounders (HR 1.32, 95% CI 1.16 to 1.51 and HR 1.27, 95% CI 1.10 to 1.48, respectively). CONCLUSIONS: Onychomycosis significantly increased the risk of ulcer development in patients with DM in primary care, independently of other risk factors. In addition, onychomycosis increased the risk of surgeries and infectious complications. These results underscore the importance of giving sufficient attention to onychomycosis in primary care and corresponding guidelines. Early identification of onychomycosis during screening and routine care provides a good opportunity for timely recognition of increased ulcer risk.

Perceptions and beliefs of general practitioners on their role in the cancer screening programmes in the Netherlands: a mixed-methods study.

BACKGROUND: In the Netherlands, population-based cancer screening programmes (CSPs) are organized aiming at cervical, breast and colorectal cancer. For a CSP to be effective, high participation rates are essential; however, there is an alarming downward trend, including wide regional variation in screening uptake. General practitioner (GP) involvement can have a stimulating effect on screening participation. Current GP involvement is however, limited, varies between the programmes and has changed over time. Unexplored is what GPs think of their role(s) in the CSPs. The aim of this study was therefore to map the perceptions and beliefs of GPs regarding their current and future role in the Dutch CSPs. METHODS: A mixed-methods sequential explanatory study was conducted in the Leiden/The Hague area of the Netherlands, between the end of 2021 and 2022. A questionnaire was developed and distributed among 110 GPs. The aggregated results obtained from the questionnaires served as starting points for conducting semi-structured interviews, with purposefully selected GPs. With this sequential approach we aimed to further enhance the understanding of the questionnaire data, and delved into the topics that emerged from the questionnaire responses. RESULTS: In total, 46 GPs completed the online questionnaire (response rate 42%). Subsequent five semi-structured comprehensive interviews were conducted. GPs indicated that they frequently encounter the CSP in their daily practice and consider it important. They also emphasised it is important that GPs remain closely involved with the CSPs in the future. Nevertheless, GPs also repeatedly mentioned that they are not eager to take on more logistical/organizational tasks. They are however willing to empower CSPs in a positive manner. CONCLUSION: GPs were generally positive about the CSPs and their current role within these programmes. Nevertheless, several options have been proposed to improve the CSPs, especially to increase screening uptake for populations in a socioeconomically disadvantaged position. Since it is of utmost importance to screen those who are most at risk of developing the screening-specific tumours, efforts should be made to achieve this goal.

Exploring timing and delivery of lifestyle advice following an acute cardiac event hospitalization: The cardiac patient's perspective.

OBJECTIVE: To explore the perspective of cardiac patients regarding the timing and manner of delivering lifestyle advice following an acute cardiac event hospitalization. METHODS: Dutch cardiac patients who experienced a cardiac event hospitalization participated in a semi-structured interview (n = 14) or a cross-sectional survey study (n = 119). RESULTS: Our findings indicate that cardiac patients are receptive to lifestyle advice throughout the care trajectory. Advice delivered by a cardiologist had the highest self-reported impact. Furthermore, receiving advice at multiple phases during the care trajectory was associated with a greater intention to change lifestyle (B = 0.37, CI = 0.17 - 0.57). Patients favored clear-cut, feasible, and friendly but confronting advice. Moreover, they stressed the importance of advice being aligned with their identity and beliefs about the causes of their disease. CONCLUSION: The period following an acute cardiac event provides a unique opportunity to offer tailored and patient-centered lifestyle advice. This "teachable window" for lifestyle change, when used wisely, may improve health outcomes for cardiac patients. PRACTICE IMPLICATIONS: Healthcare professionals should initiate lifestyle advice already during hospitalization and continue during follow-up appointments and cardiac rehabilitation. Advice should be feasible and empathy-based, as well as tailored to the patient's needs, values, and perceptions of the causes of their cardiovascular disease.

Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial.

AIMS/HYPOTHESIS: The aim of this study was to evaluate the impact on metabolic control of periodic use of a 5-day fasting-mimicking diet (FMD) programme as an adjunct to usual care in people with type 2 diabetes under regular primary care surveillance. METHODS: In this randomised, controlled, assessor-blinded trial, people with type 2 diabetes using metformin as the only glucose-lowering drug and/or diet for glycaemic control were randomised to receive 5-day cycles of an FMD monthly as an adjunct to regular care by their general practitioner or to receive regular care only. The primary outcomes were changes in glucose-lowering medication (as reflected by the medication effect score) and HbA1c levels after 12 months. Moreover, changes in use of glucose-lowering medication and/or HbA1c levels in individual participants were combined to yield a clinically relevant outcome measure ('glycaemic management'), which was categorised as improved, stable or deteriorated after 1 year of follow-up. Several secondary outcome measures were also examined, including changes in body weight. RESULTS: One hundred individuals with type 2 diabetes, age 18-75 years, BMI ≥27 kg/m2, were randomised to the FMD group (n=51) or the control group (n=49). Eight FMD participants and ten control participants were lost to follow-up. Intention-to-treat analyses, using linear mixed models, revealed adjusted estimated treatment effects for the medication effect score (-0.3; 95% CI -0.4, -0.2; p<0.001), HbA1c (-3.2 mmol/mol; 95% CI -6.2, -0.2 and -0.3%; 95% CI -0.6, -0.0; p=0.04) and body weight (-3.6 kg; 95% CI -5.2, -2.1; p<0.001) at 12 months. Glycaemic management improved in 53% of participants using FMD vs 8% of control participants, remained stable in 23% vs 33%, and deteriorated in 23% vs 59% (p<0.001). CONCLUSIONS/INTERPRETATION: Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA1c despite the reduction in medication use, and appears to be safe in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03811587 FUNDING: The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra.

Treatment failure of Helicobacter Pylori in primary care.

BACKGROUND: Due to increasing antibiotic resistance, the worldwide efficacy of Helicobacter pylori (Hp) eradication treatment has decreased. AIM: To determine antimicrobial resistance of Hp in primary care. DESIGN & SETTING: Retrospective cohort study using real-world routine health care data from 80 general practices in the Netherlands. METHOD: Patients with ICPC-codes for gastric symptoms or ATC-code for acid inhibition in the period 2010-2020 were selected. Main outcomes were antimicrobial resistance of Hp, defined as the prescription of a second eradication treatment within 12 months, and clinical remission of gastric symptoms, defined as no usage of acid inhibition one year following eradication therapy. RESULTS: We identified 138,455 patients with gastric symptoms and/or acid inhibition use (mean age 57 years [SD 18.2], 43% male). A total of 5,224 (4%) patients received a Hp eradication treatment. A second treatment was prescribed to 416 (8%) of those patients. From these, 380 patients received amoxicillin-clarithromycin, 16 amoxicillin-metronidazole and 11 clarithromycin-metronidazole as first regimen and were considered antimicrobial resistant. We observed a 0.8% increment per year of patients requiring a second eradication treatment (P=0.003, 95% CI 0.33-1.22). After successful eradication, 2,329/4,808 (48%) patients used acid inhibition compared to 355/416 (85%) patients following treatment failure (P<0.001). CONCLUSION: Antimicrobial treatment is not successful in almost one-tenth of Hp infections in primary care after a first treatment containing clarithromycin and/or metronidazole. Although the treatment failure rate is not as high as reported in secondary care, the increasing trend is concerning and may require revision of the current guidelines.

Severe drug eruption from oral terbinafine for mild onychomycosis-A case report from family practice and literature review: "Just an innocent little pill?"

Onychomycosis is the most prevalent nail disease and is frequently encountered in clinical practice. Despite having multiple therapeutic options, of which systemic antifungals are the most effective, treatment is not always mandatory in all patients. Especially when considering systemic treatment, the risk of adverse reactions may outweigh the potential benefits of treatment. In this case report, we present a clinical case of a 49-year-old male patient with a blank past medical history who experienced a severe drug eruption from terbinafine prescribed for mild onychomycosis that required discontinuation of terbinafine, additional evaluation, and treatment of this adverse reaction.

Diagnostic accuracy of urine biomarkers for urinary tract infection in older women: a case-control study.

OBJECTIVES: Urinary tract infection (UTI) is common among older women. However, diagnosis is challenging because of frequent chronic lower urinary tract symptoms, cognitive impairment, and a high prevalence of asymptomatic bacteriuria (ASB). Current urine diagnostics lack specificity, leading to unnecessary treatment and antimicrobial resistance. This study aimed to evaluate the diagnostic accuracy of 12 urine biomarkers for diagnosing UTI in older women. METHODS: In this case-control study, cases were women ≥65 years with ≥2 new-onset lower urinary tract symptoms, pyuria, and one uropathogen ≥104 CFU/mL. Controls were asymptomatic and classified as ASB (one uropathogen ≥105 CFU/mL), negative culture, or mixed flora. Urine biomarker concentrations were measured through liquid chromatography-mass spectrometry and ELISA. Diagnostic accuracy parameters of individual biomarkers and a biomarker model were derived from receiver operating characteristic curves. RESULTS: We included 162 community-dwelling and institutionalized older women. Five urine inflammatory biomarkers demonstrated high discriminative ability (area under the curve ≥0.80): interleukin 6, azurocidin, neutrophil gelatinase-associated lipocalin, tissue inhibitor of metalloproteinases 2, and C-X-C motif chemokine 9. Azurocidin exhibited the highest diagnostic accuracy (sensitivity 86% [95% CI 75%-93%] and specificity 89% [95% CI 82%-94%] at 16.7 ng/mmol creatinine). A combined biomarker and pyuria model showed improved diagnostic accuracy in patients with UTI and ASB, compared with pyuria alone. DISCUSSION: We identified several urine biomarkers that accurately differentiated older women with UTI from asymptomatic women, including ASB. These findings represent a potential advancement towards improved diagnostics for UTI in older women and warrant validation in a diverse population.

Dutch GPs' perspectives on addressing obesity: a qualitative study.

BACKGROUND: Early diagnosis and treatment of obesity in primary care may help to tackle the obesity pandemic. Nonetheless, GPs frequently fail to address obesity and demonstrate limited adherence to guidelines. AIM: To explore Dutch GPs' perspectives on addressing obesity regarding the following three target behaviours: discussing weight; diagnosing; and referring patients with obesity. DESIGN & SETTING: A qualitative focus group study with Dutch GPs. METHOD: Six focus groups were conducted with a purposive sample of 21 GPs. Thematic analysis was performed using deductive coding, according to the Theoretical Domains Framework (TDF). RESULTS: For discussing weight, the main barriers identified were a presented complaint unrelated to obesity (environmental context and resources), concerns about a negative response from the patient (beliefs about consequences), and worries about obesity being a sensitive subject to discuss (emotions). A long-term trustworthy relationship (social influences) facilitated discussing weight. For diagnosing patients with obesity, the main barriers were related to resources; for example, lack of (appropriate) measuring equipment and time (environmental context and resources). For referring patients with obesity, the main barriers were no referral options nearby (environmental context and resources), and doubts about the positive effects of the referral on weight change (beliefs about consequences). CONCLUSION: Different barriers for discussing weight, diagnosing, and referring patients with obesity were identified, underscoring the importance for tailored interventions to these specific behaviours. Improving knowledge and skills of GPs seems insufficient as this study showed that particular attention should be paid to establishing long-term relationships, addressing GPs' beliefs about consequences, and creating a supportive environment with sufficient time and resources.

Stakeholder perspectives on payment reform in maternity care in the Netherlands: A Q-methodology study.

Based on theoretical notions, there is consensus that alternative payment models to the common fee-for-service model have the potential to improve healthcare quality through increased collaboration and reduced under- and overuse. This is particularly relevant for maternity care in the Netherlands because perinatal mortality rates are relatively high in comparison to other Western countries. Therefore, an experiment with bundled payments for maternity care was initiated in 2017. However, the uptake of this alternative payment model remains low, as also seen in other countries, and fee-for-service models prevail. A deeper understanding of stakeholders' perspectives on payment reform in maternity care is necessary to inform policy makers about the obstacles to implementing alternative payment models and potential ways forward. We conducted a Q-methodology study to explore perspectives of stakeholders (postpartum care managers, midwives, gynecologists, managers, health insurers) in maternity care in the Netherlands on payment reform. Participants were asked to rank a set of statements relevant to payment reform in maternity care and explain their ranking during an interview. Factor analysis was used to identify patterns in the rankings of statements. We identified three distinct perspectives on payment reform in maternity care. One general perspective, broadly supported within the sector, focusing mainly on outcomes, and two complementary perspectives, one focusing more on equality and one focusing more on collaboration. This study shows there is consensus among stakeholders in maternity care in the Netherlands that payment reform is required. However, stakeholders have different views on the purpose and desired design of the payment reform and set different conditions. Working towards payment reform in co-creation with all involved parties may improve the general attitude towards payment reform, may enhance the level of trust among stakeholders, and may contribute to a higher uptake in practice.

Molluscum contagiosum survey - common approach and attitude towards treatment and research in Dutch general practice.

BACKGROUND: Molluscum contagiosum (MC) can cause significant burden in children. So far, pharmacological treatment has not been proven beneficial. More rigorous interventions have not been well studied. Current guidelines advise a "wait and see" policy. However, children and their parents frequently visit their GP requesting intervention. Therefore, the aim of this study was to gain insight into the approach to MC by GPs and parents' expectations and to investigate willingness to participate in an interventional study. METHODS: A survey study was carried out among GPs and parents using a questionnaire for each group inquiring about MC and potential study participation. Descriptive statistics were used to analyze results and logistical regression to investigate factors influencing participation. RESULTS: The majority of GPs (88%) preferred an expectative approach; only 21% were willing to participate in a trial as proposed. GPs estimating ≥ 50% of parents would request treatment, were more likely to participate. Most responding parents did or would visit their GP requesting treatment. In contrast to GPs, 58% were willing to participate. Parents preferring cryotherapy or curettage were more likely to participate. CONCLUSION: Our study demonstrated that the majority of GPs preferred a conservative approach, adhering to current guidelines. However, most parents preferred treatment to resolve MC and symptoms. Parents' willingness to participate was much higher than GP's, reflecting parents' desire for treatment. These findings underscore the need for continued therapeutic research. Careful preparation and selection of GPs and patients will be essential to ensure the feasibility of such an endeavor. TRIAL REGISTRATION: This survey study was not part of a clinical trial.

Observational Data for Integrated Maternity Care: Experiences with a Data-Infrastructure for Parents and Children in the Netherlands.

Introduction: Observational data are increasingly seen as a valuable source for integrated care research. Especially since the growing availability of routinely collected data and quasi-experimental methods. The aim of this paper is to describe the potentials and challenges when using observational data for integrated maternity care research, based on our experience from developing and working with the Data-InfrAstructure for ParEnts and childRen (DIAPER). Methods and Results: We provide a description of DIAPER, which is a linked data-infrastructure on the individual level based on maternity care claims data, quality and utilization of maternity care and data from municipal registries, covering the life course from preconception to adulthood. We then discuss potentials and practical applications of DIAPER such as to evaluate alternative payment models for integrated maternity care, to set the policy agenda regarding postpartum care, to provide insights into value of care and into provider variation, and to evaluate (policy) interventions designed to promote and support integrated maternity care. This is relevant for several stakeholders: policy makers, payers, providers and clients/patients. Based on experiences with DIAPER, we identify remaining challenges: missing data sources (especially self-reported outcomes), suboptimal quality of data, privacy concerns and potential biases introduced during data linkage, and describe how these challenges were tackled within the applications of DIAPER. Conclusions: With DIAPER we demonstrated that using observational data can be of added value for integrated care research, but also that challenges remain. It is essential to keep exploring and developing the possibilities of observational data and continue the discussions in the scientific community. Learning from each other's successes and failures will be critical.

Validating and Improving Adjusted Clinical Group's Future Hospitalization and High-Cost Prediction Models for Dutch Primary Care.

The rise in health care costs, caused by older and more complex patient populations, requires Population Health Management approaches including risk stratification. With risk stratification, patients are assigned individual risk scores based on medical records. These patient stratifications focus on future high costs and expensive care utilization such as hospitalization, for which different models exist. With this study, the research team validated the accuracy of risk prediction scores for future hospitalization and high health care costs, calculated by the Adjusted Clinical Group (ACG)'s risk stratification models, using Dutch primary health care data registries. In addition, they aimed to adjust the US-based predictive models for Dutch primary care. The statistical validity of the existing models was assessed. In addition, the underlying prediction models were trained on 95,262 patients' data from de Zoetermeer region and externally validated on data of 48,780 patients from Zeist, Nijkerk, and Urk. Information on age, sex, number of general practitioner visits, International Classification of Primary Care coded information on the diagnosis and Anatomical Therapeutic Chemical Classification coded information on the prescribed medications, were incorporated in the model. C-statistics were used to validate the discriminatory ability of the models. Calibrating ability was assessed by visual inspection of calibration plots. Adjustment of the hospitalization model based on Dutch data improved C-statistics from 0.69 to 0.75, whereas adjustment of the high-cost model improved C-statistics from 0.78 to 0.85, indicating good discrimination of the models. The models also showed good calibration. In conclusion, the local adjustments of the ACG prediction models show great potential for use in Dutch primary care.

Making sense of a myocardial infarction in relation to changing lifestyle in the five months following the event: An interpretative phenomenological analysis.

OBJECTIVE: Previous research has shown that experiencing an acute cardiac event, such as a myocardial infarction (MI), can lead to lifestyle changes. This study aimed to explore the potential of a MI as a 'teachable moment' (TM) for positive lifestyle changes and to identify psychosocial sensemaking processes that facilitate or hinder the presence of a TM. METHOD: We conducted semi-structured interviews with 14 patients who suffered their first MI and were hospitalized in a larger Dutch city. Participants were interviewed twice, respectively one and five months after their hospitalization. They were encouraged to explain how they experienced their MI and how this had affected their lifestyle. We used an Interpretative Phenomenological Analysis approach to the data collection and analysis. FINDINGS: The participants varied in their willingness to adopt a healthy lifestyle due to their MI. Most participants experienced their event as a TM for changing specific health behaviors, for example facilitated by reflecting on self-concept or social roles and by constructing and comprehending a personal narrative of their MI. Some participants struggled to follow through on their intentions to change their behavior, for example because of a negative attitude towards a healthy behavior or because they perceived it as incongruent to their identity. Only three participants maintained most former health behaviors, for example because they failed to acknowledge their MI as severe or because of earlier life events that elicited more blunted cognitive responses. CONCLUSION: Cardiac patients may experience a TM, which is the consequence of interrelated processes of psychosocial sensemaking. As this does not occur at a singular time point, we suggest using the term 'teachable window' rather than 'moment'. Given these findings, there is a window of opportunity to provide continuous psychosocial and lifestyle support during and after hospitalization for acute cardiac events.

Evaluation of an integrated care pathway for out-of-hospital treatment of older adults with an acute moderate-to-severe lower respiratory tract infection or pneumonia: protocol of a mixed methods study.

INTRODUCTION: Older adults with an acute moderate-to-severe lower respiratory tract infection (LRTI) or pneumonia are generally treated in hospitals causing risk of iatrogenic harm such as functional decline and delirium. These hospitalisations are often a consequence of poor collaboration between regional care partners, the lack of (acute) diagnostic and treatment possibilities in primary care, and the presence of financial barriers. We will evaluate the implementation of an integrated regional care pathway ('The Hague RTI Care Bridge') developed with the aim to treat and coordinate care for these patients outside the hospital. METHODS AND ANALYSIS: This is a prospective mixed methods study. Participants will be older adults (age≥65 years) with an acute moderate-to-severe LRTI or pneumonia treated outside the hospital (care pathway group) versus those treated in the hospital (control group). In addition, patients, their informal caregivers and treating physicians will be asked about their experiences with the care pathway. The primary outcome of this study will be the feasibility of the care pathway, which is defined as the percentage of patients treated outside the hospital, according to the care pathway, whom fully complete their treatment without the need for hospitalisation within 30 days of follow-up. Secondary outcomes include the safety of the care pathway (30-day mortality and occurrence of complications (readmissions, delirium, falls) within 30 days); the satisfaction, usability and acceptance of the care pathway; the total number of days of bedridden status or hospitalisation; sleep quantity and quality; functional outcomes and quality of life. ETHICS AND DISSEMINATION: The Medical Research Ethics Committee Leiden The Hague Delft (reference number N22.078) has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. The results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN68786381.

Implementation of a group-based lifestyle intervention programme (Healthy Heart) in general practices in The Netherlands: a mixed-methods study.

BACKGROUND: Lifestyle intervention programmes target behavioural risk factors that contribute to cardiovascular diseases (CVDs). Unfortunately, sustainable implementation of these programmes can be challenging. Gaining insights into the barriers and facilitators for successful implementation is important for maximising public health impact of these interventions. The Healthy Heart (HH) programme is an example of a combined lifestyle intervention programme. AIM: To analyse the reach, adoption, and implementation of the HH programme. DESIGN & SETTING: A mixed-methods study conducted in a general practice setting in The Netherlands. METHOD: Quantitative data were collected from the Healthy Heart study (HH study), a non-randomised cluster stepped-wedge trial to assess the effect of the HH programme on patients at high risk of developing CVDs at practice level. Qualitative data were obtained through focus groups. RESULTS: Out of 73 approached general practices, 55 implemented the HH programme. A total of 1082 patients agreed to participate in the HH study, of whom 64 patients were referred to the HH programme and 41 patients participated. Several barriers for participation were identified such as time investment, lack of risk perception, and being confident in changing lifestyle on their own. Important barriers for healthcare providers (HCPs) to refer a patient were time investment, lack of information to sufficiently inform patients, and preconceived notions regarding which patients the programme was suitable for. CONCLUSION: This study has offered insights from a patient and HCP perspective regarding barriers and facilitators for implementation of the group-based lifestyle intervention programme. The identified barriers and facilitators, and the suggested improvements, can be used by others who wish to implement a similar programme.

Ruling out acute coronary syndrome in primary care with a clinical decision rule and a capillary, high-sensitive troponin I point of care test: study protocol of a diagnostic RCT in the Netherlands (POB HELP).

INTRODUCTION: Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the emergency department (ED). Only 10%-20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress. METHODS AND ANALYSIS: The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6 ng/L, 99th percentile 23 ng/L, cut-off value between negative and positive used in this study 3.8 ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion. ETHICS AND DISSEMINATION: The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses. TRIAL REGISTRATION NUMBERS: NL9525 and NCT05827237.