[Top 5 Research Studies of the month for Italian Primary Care Physicians: March 2024.] / La Top 5 di marzo 2024. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) A simple, well-validated risk score can help clinicians counsel patients with atrial fibrillation regarding the use of DOACs to prevent stroke. The score shares its name with the drug class (the "DOAC" score). 2) Presumably by perturbing the intestinal microbiome, antibiotic treatment is associated with an increase in the likelihood of the development of irritable bowel disease; this is especially true with multiple courses of antibiotics. 3) Patients with uncomplicated gallstones can be managed over time with analgesia and monitoring, though approximately 25% will eventually undergo cholecystectomy over the next 18 months. Still, there appears to be no need to rush to surgery without evidence of common bile duct blockage or acute pancreatitis. 4) Delivering bad news (e.g. a cancer diagnosis) by telephone does not affect levels of anxiety, depression, or satisfaction with care as compared with delivering the news in person. 5) An updated high quality systematic review found that, in conjunction with psychosocial interventions, oral naltrexone (50 mg/day) and oral acamprosate have the strongest evidence for being effective in the treatment of alcohol use disorder.

Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care.

INTRODUCTION: Uncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to identify women with uUTIs in whom antibiotics can be withheld without influencing clinical outcomes. This pilot study aims to provide preliminary evidence on whether a POCT informed management of uUTI in women can safely reduce antibiotic use. METHODS AND ANALYSIS: This is an open-label two-arm parallel cluster-randomised controlled pilot trial. 20 general practices affiliated with the Bavarian Practice-Based Research Network (BayFoNet) in Germany were randomly assigned to deliver patient management based on POCTs or to provide usual care. POCTs consist of phase-contrast microscopy to detect bacteria and urinary dipsticks to detect erythrocytes in urine samples. In both arms, urine samples will be obtained at presentation for POCTs (intervention arm only) and microbiological analysis. Women will be followed-up for 28 days from enrolment using self-reported symptom diaries, telephone follow-up and a review of the electronic medical record. Primary outcomes are feasibility of patient enrolment and retention rates per site, which will be summarised by means and SDs, with corresponding confidence and prediction intervals. Secondary outcomes include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, number of recurrent and upper UTIs and re-consultations and diagnostic accuracy of POCTs versus urine culture as the reference standard. These outcomes will be explored at cluster-levels and individual-levels using descriptive statistics, two-sample hypothesis tests and mixed effects models or generalised estimation equations. ETHICS AND DISSEMINATION: The University of Würzburg institutional review board approved MicUTI on 16 December 2022 (protocol n. 109/22-sc). Study findings will be disseminated through peer-reviewed publications, conferences, reports addressed to clinicians and the local citizen's forums. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05667207.

[Top 4 Research Studies of the month for Italian Primary Care Physicians: February 2024.] / La Top 4 di febbraio 2024. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) For patients with severe fatigue at least 3 months after Covid-19 infection, cognitive behavioral therapy offers significant improvement in symptoms over care as usual. 2) Key changes in the US chronic coronary disease guideline recommendations include the following. Shortening the duration of dual antiplatelet therapy, the use of beta-blockers in patients with chronic coronary disease, not recommending fish oil or omega-3 fatty acids for secondary prevention, not using e-cigarettes as first-line agents (but as secondary agents) for smoking cessation, and incorporating sodium-glucose transport protein 2 inhibitors (Sglt-2i) and glucagon-like peptide-1 (GLP-1) receptor agonists for some patients with chronic coronary disease, including those without comorbid diabetes mellitus. 3) People with irritable bowel syndrome can try various probiotic-containing products to lessen their symptoms, but on the whole, most people will not experience a significant reduction. Products containing Escherichia strains were the most likely to provide a benefit, but these are not widely available. 4) Framing weight loss in terms of its positive effects, rather than by listing the risks of excess weight, increased patients' participation in a weight-loss program and increased their eventual weight loss.

Acute Uncomplicated UTIs in Adults: Rapid Evidence Review.

An acute uncomplicated urinary tract infection (UTI) is a bacterial infection of the lower urinary tract with no sign of systemic illness or pyelonephritis in a noncatheterized, nonpregnant adult with no urologic abnormalities or immunocompromise. In women, a self-diagnosis of a UTI with the presence of typical symptoms (e.g., frequency, urgency, dysuria/burning sensation, nocturia, suprapubic pain), without vaginal discharge, is accurate enough to diagnose an uncomplicated UTI without further testing. Urine culture and susceptibility testing should be reserved for women with recurrent infection, treatment failure, history of resistant isolates, or atypical presentation to make a definitive diagnosis and guide antibiotic selection. First-line antibiotics include nitrofurantoin for five days, fosfomycin in a single dose, trimethoprim for three days, or trimethoprim/sulfamethoxazole for three days. Symptomatic treatment with nonsteroidal anti-inflammatory drugs and delayed antibiotics may be considered because the risk of complications is low. Increased fluids, intake of cranberry products, and methenamine hippurate can prevent recurrent infections. Antibiotic prophylaxis is also effective in preventing recurrence but has a risk of adverse effects and antimicrobial resistance. Men with lower UTI symptoms should always receive antibiotics, with urine culture and susceptibility results guiding the antibiotic choice. Clinicians should also consider the possibility of urethritis and prostatitis in men with UTI symptoms. First-line antibiotics for men with uncomplicated UTI include trimethoprim, trimethoprim/sulfamethoxazole, and nitrofurantoin for seven days. Uncomplicated UTIs in nonfrail women and men 65 years and older with no relevant comorbidities also necessitate a urine culture with susceptibility testing to adjust the antibiotic choice after initial empiric treatment; first-line antibiotics and treatment durations do not differ from those recommended for younger adults.

Exploring general practitioners' decision-making in the management of women with uncomplicated urinary tract infections: a qualitative study.

BACKGROUND: To be effective, interventions aiming at increasing the appropriateness of antibiotic use in primary care should consider the perspectives of prescribing physicians. AIM: To explore the decision-making of general practitioners (GPs) when managing uncomplicated urinary tract infections (uUTIs) in women. DESIGN & SETTING: Semi-structured interviews with 22 GPs in Bavaria and Baden-Wurttemberg (southern Germany). METHOD: Verbatim transcripts analysed through inductive qualitative content analysis. RESULTS: We generated three main themes: factors facilitating the decision-making, factors complicating the decision-making, and consultation modalities. According to participants, following evidence-based recommendations makes the prescription decision smoother. GPs' and patients' prior experiences and beliefs guides decisions towards certain antibiotics, even if those experiences and beliefs contradict evidence-based recommendations. Patient expectations and demands also conditions antibiotic prescribing, favouring it. Organisational constraints like time pressure, the day of the week (eg, before weekends) and a lower cost of antibiotics for patients than alternative treatments favour the decision to prescribe antibiotics. Diagnostic and prognostic uncertainty complicates decision-making, as does scepticism towards evidence-based recommendations. Discordance within the patient-doctor relationship contributed to this complexity. Regarding consultation modalities, a more in-depth consultation, and shared decision-making were seen as helpful in this process. CONCLUSION: We identified different factors as intervening against or for a straightforward management decision when dealing with women with uUTIs. They reveal the complexity behind the GPs' decision-making. Providing GPs with easy-to-apply guidance while removing economic constraints to allocate sufficient consultation time, and supporting shared decision-making may help GPs appropriately manage uUTIs in women.

Identifying the Best Initial Oral Antibiotics for Adults with Community-Acquired Pneumonia: A Network Meta-Analysis.

BACKGROUND: The objective of this network meta-analysis was to compare rates of clinical response and mortality for empiric oral antibiotic regimens in adults with mild-moderate community-acquired pneumonia (CAP). METHODS: We searched PubMed, Cochrane, and the reference lists of systematic reviews and clinical guidelines. We included randomized trials of adults with radiologically confirmed mild to moderate CAP initially treated orally and reporting clinical cure or mortality. Abstracts and studies were reviewed in parallel for inclusion in the analysis and for data abstraction. We performed separate analyses by antibiotic medications and antibiotic classes and present the results through network diagrams and forest plots sorted by p-scores. We assessed the quality of each study using the Cochrane Risk of Bias framework, as well as global and local inconsistency. RESULTS: We identified 24 studies with 9361 patients: six at low risk of bias, six at unclear risk, and 12 at high risk. Nemonoxacin, levofloxacin, and telithromycin were most likely to achieve clinical response (p-score 0.79, 0.71, and 0.69 respectively), while penicillin and amoxicillin were least likely to achieve clinical response. Levofloxacin, nemonoxacin, azithromycin, and amoxicillin-clavulanate were most likely to be associated with lower mortality (p-score 0.85, 0.75, 0.74, and 0.68 respectively). By antibiotic class, quinolones and macrolides were most effective for clinical response (0.71 and 0.70 respectively), with amoxicillin-clavulanate plus macrolides and beta-lactams being less effective (p-score 0.11 and 0.22). Quinolones were most likely to be associated with lower mortality (0.63). All confidence intervals were broad and partially overlapping. CONCLUSION: We observed trends toward a better clinical response and lower mortality for quinolones as empiric antibiotics for CAP, but found no conclusive evidence of any antibiotic being clearly more effective than another. More trials are needed to inform guideline recommendations on the most effective antibiotic regimens for outpatients with mild to moderate CAP.

[Top 4 Research Studies of the month for Italian Primary Care Physicians: December 2023.] / La Top 4 di dicembre 2023. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) According to a high-quality network meta-analysis, oral isotretinoin is the most effective therapy for decreasing the number of inflammatory and non-inflammatory skin lesions in patients with acne vulgaris. 2) Non-steroidal anti-inflammatory drug (Nsaid) use is associated with a small increase (0.004%) in the risk of venous thromboembolism. Combining Nsaid use with a medium-risk hormonal contraceptive increases the risk to 0.011%; the addition of a high-risk hormonal contraceptive increases the risk to 0.023%. 3) For adults who wish to quit smoking, nicotine delivery via e-cigarettes, plus counseling, may be more effective than other means of nicotine replacement, or counseling alone for long-term smoking cessation. 4) We can reassure our patients that nonerosive gastroesophageal reflux disease (Gerd) does not increase the likelihood of esophageal cancer. Erosive Gerd, however, is associated with a doubled - but still low - risk of developing cancer, with the likelihood increasing over time.

[Top 5 Research Studies of the month for Italian Primary Care Physicians: January 2024.] / La Top 5 di gennaio 2024. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) A recent high-quality systematic review (SR) of 76 SRs found that, compared to all other lipid-lowering medications, for overall, primary, and secondary prevention the best balance of benefits, harms, and costs is provided by statins. 2) To our surprise, a network meta-analysis of 12 randomized controlled trials (RCTs) concluded that acetaminophen and ketorolac were more effective than morphine in alleviating pain from renal colic and were less likely than morphine to cause adverse effects and the need for rescue analgesia. 3) Proton pump inbibitors (PPI) use in children is associated with an increased risk of developing serious infections as compared with the use other acid-suppressing therapy. It seems prudent to use antacids and histamine 2 receptor antagonists first and reserve PPIs for nonresponders. 4) Overdiagnosis - the identification of, in this case, breast cancer, that would not have caused symptoms in a person's lifetime - seems to increase with age. In a study including more than 50.000 women aged above 70 who underwent mammography screening, the overdiagnosis rate was 31%, 47% and 51% for women aged 70 to 74 years, 75 to 84 years and over age 85, respectively. 5) An RCT among community-dwelling adults conducted in the US found that using a regular cuff on larger-than-average arms can falsely raise blood pressure readings by almost 5 mmHg, and a regular cuff on an especially thin arm can lower readings by 3.6 mmHg.

[Twelve tips for a good medical consultation in primary care.] / Dodici suggerimenti per una buona consultazione medica nelle cure primarie.

BACKGROUND: The recent pandemic has brought into sharper focus the need, long emphasised in the scientific literature, for a change in primary care that goes beyond the limits of the hyper-specialisation constitutive of Western health systems. While the direction of the cultural and organisational change that needs to be developed is well outlined, little is written about the competencies and values that physicians must acquire in order to shape a new and coherent organisation of services. The patient encounter is the frame in which these competencies take shape, and it is from this perspective that these competencies are examined here. OBJECTIVES: The aim of this narrative review of empirical studies and the multisciplinary literature is to provide primary care physicians with some tips for a good management of the medical consultation. These tips outline the competencies needed in general practice, rethought within the paradigm of complexity of care. RESULTS: The concepts, practices and values on which the 12 tips are based are: a) an attitude of attention to the complexity of care in which the patient's subjectivity can only be understood through an encounter with one's own subjectivity; b) the peculiar method of clinical reasoning in general practice, which includes the early generation of diagnostic hypotheses to be verified using simple and inexpensive tests, such as history taking and physical examination; these tests should have a high negative predictive value to rule out more serious conditions; c) the contextualisation of the working diagnosis (opposed to a definitive diagnosis) as a tool for dealing with complexity; d) the analysis of the evolution of scenarios as a tool for planning and choosing courses of action; e) the assessment of uncertainty in addition to that of measurable risk; f) the involvement of the patient and the use of the test of time as tools for managing uncertainty; g) the centrality of sharing the decision with the patient.

[Top 4 Research Studies of the month for Italian Primary Care Physicians: November 2023.] / La Top 4 di novembre 2023. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) Based on efficacy, safety, and cost, a regimen of terbinafine 250 mg once daily for 12 weeks, followed by a 12-week period of no therapy, and then a 4-week booster of terbinafine 250 mg is preferred for onychomycosis in adults for the outcome of complete cure at 1 year. 2) A high-quality randomized trial found that standard-course antibiotic therapy for children with uncomplicated urinary tract infection was superior to short-course therapy. However, the number needed to treat of 28 suggests that offering short-course therapy is not unreasonable, especially if there is good follow-up in the subsequent weeks. 3) An updated guideline of the American College of Physicians on screening of colorectal cancer adds 2 new recommendations. One is to consider not screening patients aged 45 to 49 years. The other recommendation is against screening using stool Dna, computed tomography colonography, capsule endoscopy, urine, or serum screening tests for colorectal cancer. 4) The US Preventive Services Task Force found additional evidence on the benefit of folic acid supplementation for preventing neural tube defects. Since the critical period starts at least 1 month before conception, the task force recommends a daily supplement of 0.4 mg to 0.8 mg folic acid for all women who plan to or could become pregnant.

[Focusing on patient-oriented evidence that matters: a practical approach to keeping up with new research.] / Evidenze mediche orientate al paziente: un approccio pratico per rimanere aggiornati sugli studi che vale la pena conoscere.

One of the challenges of medical practice, especially primary care because of its breadth, is keeping up with the latest research findings. As physicians, how can we select, among hundreds of thousands of research studies published each year, those worth knowing about? Since 1996, a group of American primary care physicians have been systematically reviewing over 100 journals every month to identify new Patient-Oriented Evidence that Matters (POEMs). To be a POEM, a research study must have the potential to change clinical practice by addressing hard, patient-oriented outcomes, such as mortality, intensity or duration of symptoms, or quality of life, as opposed to disease-oriented (surrogate) outcomes, such as laboratory parameters. In addition, it must be methodologically valid, i.e., reasonably free of bias, with its validity evaluated through objective criteria by experts in evidence-based medicine with no conflicts of interest with the industry. To be useful at the point of care, these studies must be easy to retrieve and require little work to review. Starting from this issue, a selection of POEMs most likely to change and improve Italian primary care practice will be published monthly in Recenti Progressi in Medicina as brief evidence summaries. In addition, yearly, we will present an article summarizing the 20 most important research studies for primary care of the previous year.

[The methodological and relational core competencies of General practice/Family medicine in Primary Care.] / Le competenze distintive metodologiche e relazionali del medico di medicina generale nelle cure primarie.

In this article, we examine three out of the seven distinctive values of General practice/family medicine (Gpfm), as proposed by World Organization of Family Doctors (Wonca) and recently translated into Italian: patient-centered care, continuity of care, and evidence-based care. We believe that these values can contribute to the ongoing debate on the reorganization of the primary care model and the reform of the core curriculum of Italian Gpfm. These three values are the basis of the distinctive methodological and relational competencies of Gpfm. In this contribution, we analyze them through the lens of epistemology of complexity, aiming to highlight the unique aspects of this method and relationship, thus identifying the necessary competencies for Gpfm. The thought and method of care - the first and third values - are analyzed considering that the framework in which Gpfm operates leads to significant modifications of the clinical method. While it certainly encompasses elements of the traditional clinical method, they are executed at different paces and with different objectives, employing distinct strategies. For instance, the epidemiological context with a high prevalence of symptomatic distress but low prevalence of "true" disease needs the early generation of diagnostic hypotheses. These hypotheses are then tested using verbal and physical examinations as exclusion tests with high predictive power. The aim is to arrive at diagnoses that are not exhaustive, yet operational and contextualized. Furthermore, the uncertainty inherent in Gpfm requires the utilization of contextual knowledge related to the patient's environment, negotiation with the patient about the tolerable threshold of decisional uncertainty, their involvement - which increases with greater uncertainty - and the use of the test of time within an organizational and relational protective network. Complex thinking enables reflection on the second value - the relationship - by assigning the physician's subjectivity a place as precious as that of the patient, which is already historically established. Thus, both the physician and patient, as subjects, exist on the same ontological plane but differ methodologically due to their distinct roles. Adopting an epistemology of complexity in Gpfm allows each variable of the system - subjects, context, method, clinical aspects - to regain significance. This approach favours a genuine science in service of humanity.

[Top 5 Research Studies of the month for Italian Primary Care Physicians: October 2023.] / La Top 5 di ottobre 2023. Gli studi clinici che vale la pena conoscere se lavori nelle cure primarie in Italia.

This monthly article provides a selection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. Amoxicillin is no more likely to cause a rash than any other antibiotic in children with infectious mononucleosis. According to a good quality systematic review and network meta-analysis, only a small number of randomized controlled trials, disappointing in overall quality, suggest that for managing neuropsychiatric symptoms in adults with dementia, risperidone has the best balance of effectiveness and adverse effects. In a rigorously conducted double-blind randomized controlled trial, adults with acute low back or neck pain treated with opioids had no benefit in pain relief as those treated with placebo. In a large study of more than 21,000 participants aged 60 to 84 years, taking 60,000 IU vitamin D each month slightly reduced their likelihood of experiencing a major cardiovascular event (number needed to treat = 172 over 5 years). A single screening colonoscopy had higher rates of participation than 5 years of fecal occult blood testing in a high-quality study in which patients were offered free screening with these two methods (84% vs 73%; p<0.001).

[General practitioners knowledge and attitudes on antibiotics and resistance: cross-cultural adaptation and preliminary validation of KAAR-11 questionnaire.] / Conoscenze e attitudini dei medici di medicina generale riguardo all'antibiotico-resistenza e la prescrizione di antibiotici: adattamento cross-culturale e validazione preliminare del questionario KAAR-11.

Inappropriate prescriptions and consumption of antibiotics are the main determinants of the selection of antibiotic resistant bacteria. Italy has a high consumption rate of antibiotics if compared to other European countries and 90% of these drugs are prescribed in an outpatient setting by General Practitioners (GPs). Therefore, as stated by the Italian Medicines Agency (AIFA): «General Practice is [...] a crucial clinical area in which the utilization of these kind of drugs have to be monitored, [...] considering that a relevant quote of prescriptions could be avoided. Achieving a better understanding of the clinical and extra-clinical determinants of GPs prescription habits is, therefore, hugely important to design appropriate interventions to tackle the phenomenon of inappropriate antibiotic use. To the best of our knowledge, there are no published studies measuring GPs knowledge and attitudes on antibiotic resistance and prescriptions in our setting. To fill this lack of knowledge, the aim of our study is the development of a valid and reliable questionnaire in Italian language, able to measure these constructs. In this article, we present the process of cross-cultural adaptation of the KAAR-11 questionnaire from Spanish into Italian language and its preliminary validation.

An evolutionary approach to mania studying Sardinian immigrants to Argentina

Objective: To ascertain lifetime prevalence of positivity to a screening questionnaire for bipolar disorders (BD) in Sardinian immigrants to Argentina and residents of Sardinia and assess whether such positivity affects quality of life (QoL) in either group. Our hypothesis is that screen positivity for BD may be more frequent in immigrants. Methods: Observational study. Subjects were randomly selected from the membership lists of associations of Sardinian immigrants in Argentina. A study carried out in Sardinia using the same methodology was used for comparison. The Mood Disorder Questionnaire was used to screen for mania/hypomania and the Short-Form Health Survey-12 to measure QoL. Results: A higher prevalence of manic/hypomanic episodes was found in Sardinian immigrants to Argentina (p < 0.0001; odds ratio = 3.0, 95% confidence interval 1.87-4.77). Positivity at screening was associated with a lower QoL both in Sardinian immigrants to Argentina and in residents of Sardinia. Conclusions: To the best of our knowledge, this is the first study to show a higher lifetime prevalence of manic/hypomanic episodes in a general-population sample of individuals who migrated to a foreign country. Our results are in agreement with the hypothesis that hyperactive/novelty-seeking features may represent an adaptive substrate in certain conditions of social change.

An evolutionary approach to mania studying Sardinian immigrants to Argentina.

OBJECTIVE:: To ascertain lifetime prevalence of positivity to a screening questionnaire for bipolar disorders (BD) in Sardinian immigrants to Argentina and residents of Sardinia and assess whether such positivity affects quality of life (QoL) in either group. Our hypothesis is that screen positivity for BD may be more frequent in immigrants. METHODS:: Observational study. Subjects were randomly selected from the membership lists of associations of Sardinian immigrants in Argentina. A study carried out in Sardinia using the same methodology was used for comparison. The Mood Disorder Questionnaire was used to screen for mania/hypomania and the Short-Form Health Survey-12 to measure QoL. RESULTS:: A higher prevalence of manic/hypomanic episodes was found in Sardinian immigrants to Argentina (p < 0.0001; odds ratio = 3.0, 95% confidence interval 1.87-4.77). Positivity at screening was associated with a lower QoL both in Sardinian immigrants to Argentina and in residents of Sardinia. CONCLUSIONS:: To the best of our knowledge, this is the first study to show a higher lifetime prevalence of manic/hypomanic episodes in a general-population sample of individuals who migrated to a foreign country. Our results are in agreement with the hypothesis that hyperactive/novelty-seeking features may represent an adaptive substrate in certain conditions of social change.