Democratising the design and delivery of large-scale randomised, controlled clinical trials in primary care: A personal view.

BACKGROUND: Rapid identification of effective treatments for use in the community during a pandemic is vital for the well-being of individuals and the sustainability of healthcare systems and society. Furthermore, identifying treatments that do not work reduces research wastage, spares people unnecessary side effects, rationalises the cost of purchasing and stockpiling medication, and reduces inappropriate medication use. Nevertheless, only a small minority of therapeutic trials for SARS-CoV-2 infections have been in primary care: most opened too late, struggled to recruit, and few produced actionable results. Participation in research is often limited by where one lives or receives health care, and trial participants may not represent those for whom the treatments are intended. INNOVATIVE TRIALS: The ALIC4E, PRINCIPLE and the ongoing PANORAMIC trial have randomised over 40,500 people with COVID-19. This personal view describes how these trials have innovated in: trial design (by using novel adaptive platform designs); trial delivery (by complementing traditional site-based recruitment ('the patient comes to the research') with mechanisms to enable sick, infectious people to participate without having to leave home ('taking research to the people'), and by addressing the 'inverse research participation law,' which highlights disproportionate barriers faced by those who have the most to contribute, and benefit from, research, and; in transforming the evidence base by evaluating nine medicines to support guidelines and care decisions world-wide for COVID-19 and contribute to antimicrobial stewardship. CONCLUSION: The PRINCIPLE and PANORAMIC trials represent models of innovation and inclusivity, and exemplify the potential of primary care to lead the way in addressing pressing global health challenges.

Adaptive platform trials can efficiently evaluate several treatments in parallel and sequentially'Taking research to people' can democratise participation by enabling sick, contagious people to contribute from home, country-wideThe PRINCIPLE and PANORAMIC Trials innovated in trial design and delivery to produce evidence on nine treatments for COVID-19 in the community.

ANALYSIS OF THE RESULTS OF GP-FM QUESTIONNAIRE REGARDING TRAINING IN THE SPECIALIZATION «OTOLARYNGOLOGY¼ BOTH AT THE UNDERGRADUATE AND POSTGRADUATE LEVELS.

OBJECTIVE: The aim: To research the degree of satisfaction with the training of general practitioners-family medicine (GP-FM) in the specialization "Otorhinolaryngology" in the leading higher educational institutions (HEIs) of Ukraine at undergraduate and postgraduate levels. PATIENTS AND METHODS: Materials and methods: A questionnaire was conducted of 51 GP-FM doctors. RESULTS: Results: The duration of otorhinolaryngology training at a medical HEI was indicated by: 49% of respondents about weeks of training, 19.6% - about months. 31.37% received separate training on ENT examination. 56.9% of people were trained in ENT departments. 76.5% of people were not satisfied with the quality of theoretical knowledge, 52.9% of respondents of practical skills at the undergraduate level. 72.6% of doctors not satisfied with the quality of theoretical knowledge, 56.8% of respondents of practical skills at the post-graduate level. 41.2% of respondents received post-graduate training in otorhinolaryngology at the GP-FM specialization cycle, 72.55% of them in a lecture format. 86.3% of people want to deepen their knowledge of otolaryngology and need to understand the etiopathogenetic mechanisms of ENT pathology. CONCLUSION: Conclusions. The dissonance with the dissatisfaction of the doctors of the GPFM with the quality of the received theoretical knowledge in ENT pathology and the availability of their practical skills was revealed. It is important for GPFM doctors to undergo separate training in ENT examination and pathology with mandatory study and conscious use of etiopathogenetic mechanisms of ENT pathology, especially in inflammatory diseases.

Managing children with daytime urinary incontinence: a survey of Dutch general practitioners.

BACKGROUND: In the Netherlands, parents of children with daytime urinary incontinence (UI) first consult general practitioners (GPs). However, GPs need more specific guidelines for daytime UI management, resulting in care and referral decisions being made without clear guidance. OBJECTIVES: We aimed to identify Dutch GP considerations when treating and referring a child with daytime UI. METHODS: We invited GPs who referred at least one child aged 4-18 years with daytime UI to secondary care. They were asked to complete a questionnaire about the referred child and the management of daytime UI in general. RESULTS: Of 244 distributed questionnaires, 118 (48.4%) were returned by 94 GPs. Most reported taking a history and performing basic diagnostic tests like urine tests (61.0%) and physical examinations (49.2%) before referral. Treatment mostly involved lifestyle advice, with only 17.8% starting medication. Referrals were usually at the explicit wish of the child/parent (44.9%) or because of symptom persistence despite treatment (39.0%). GPs usually referred children to a paediatrician (n = 99, 83.9%), only referring to a urologist in specific situations. Almost half (41.4%) of the GPs did not feel competent to treat children with daytime UI and more than half (55.7%) wanted a clinical practice guideline. In the discussion, we explore the generalisability of our findings to other countries. CONCLUSION: GPs usually refer children with daytime UI to a paediatrician after a basic diagnostic assessment, usually without offering treatment. Parental or child demand is the primary stimulus for referral.

The experiences and thoughts of Turkish family physicians about COVID-19 pandemic: A qualitative study.

BACKGROUND: Efforts to contain the SARS-CoV-2 virus would fall short without strong primary health care. OBJECTIVES: In this study, we aimed to determine the experiences, views and suggestions of family physicians regarding their roles, primary care health systems' preparedness and the challenges/needs for a better organisation during the pandemic via in-depth exploration. METHODS: Twenty-one family physicians working in different cities of Turkey participated in semi-structured interviews between 15/08/2020-21/01/2021. Convenience sampling was used. We did this qualitative study through interviews by telephone. Participants were asked seven open-ended questions. Thematic analysis was used, which included reading the transcript, identifying significant phrases and formulating meanings and validating meanings through research team discussions to reach consensus, identifying themes. RESULTS: Ten of the participants were female and the average age of the participants was 39.5 (SD = 10.5) years. Twelve of the family physicians are specialists in family medicine. Four themes were identified: role of primary care in the pandemic, pandemic preparedness of primary care, challenges of working in primary care centres during the COVID-19 pandemics, and approaches to future pandemics. CONCLUSION: Our study showed that, despite unprepared primary care and undefined roles of family physicians in pandemic planning, family physicians played a significant role in pandemic management.

Sex and income inequalities in preventive services in diabetes.

BACKGROUND: Cancer preventive services (gynaecological cancer screening, colon cancer screening) and cardiometabolic screening are recommended by guidelines to individuals. People with diabetes were less likely to receive them than those without diabetes in some studies. OBJECTIVES: To analyse differences in the coverage of preventive services in people with diabetes compared to non-diabetic individuals and in people with diabetes according to sex and household income. METHODS: We analysed data collected from the European Health Interview Survey 2013-2015, including individuals aged 40-74 (n = 179,318), 15,172 with diabetes from 29 countries. The income of a household (HHI) was described in quintiles. The relationship between the coverage of preventive services (cardiometabolic, vaccination, cancer screening) and sociodemographic characteristics was analysed with multiple logistic regression. RESULTS: Women comprised 53.8% of the total and 40% were 60-74 years. People with diabetes compared to those without diabetes had higher reported coverage of cardiometabolic screening (98.4% vs. 90.0% in cholesterol measurement; 97.0% vs. 93.6% in blood pressure measurement), colorectal cancer screening (27.1% vs. 24.6%) but lower coverage of gynaecological cancer screening (mammography: 29.2% vs. 33.5%, pap smear test: 28.3% vs. 37.9%). Among diabetic patients, women were less likely to receive cholesterol screening (OR = 0.81; 95% CI: 0.72-0.91) and colon cancer screening (OR = 0.79; 95% CI: 0.73-0.86) compared to men. Being affluent was positively associated with receiving cardiometabolic screening and mammography in diabetic patients. CONCLUSION: People with diabetes reported higher coverage of preventive services except gynaecological cancer screening. Disparities were found in diabetes among women and less affluent individuals.

The ill physician who self-discloses: What do patients think?

BACKGROUND: Physicians with a serious illness face difficult decisions about revealing this sensitive information to patients. Self-disclosure of illness is a largely unexplored topic, particularly from the patient's perspective. OBJECTIVES: To learn about patients' emotions and reactions to their family physician's sharing with them about having a major illness. METHODS: The study was carried out in a family practice office in a suburb of Jerusalem, beginning the day that a family physician returned to work after a prolonged illness. A questionnaire study was performed with nine closed and four open questions relating to patients' reactions to learning about the illness. The questionnaire was distributed to 200 consecutive patients ages 18 years or older. Data extraction, compilation, and content analysis were performed to elicit and categorise major themes and issues that arose. RESULTS: A total of 82% of the patients were pleased that the physician shared the information with them and none were displeased. Patients expressed a wide range of reactions to being told of the illness by the physician himself, among them: empathy, surprise, appreciation, pride, criticism, comfort/discomfort, and closeness. The value of sharing personal experience and the unique connection with the family physician were emphasised. CONCLUSION: Physician self-disclosure of major illnesses to patients can reveal the physician's humanity, encourage empathy on the part of patients and strengthen the physician-patient relationship. This report adds to current knowledge about when to share this powerful information with patients and highlights the topic's importance in the education of future doctors.

MediQuit - an electronic deprescribing tool: a pilot study in German primary care; GPs' and patients' perspectives.

BACKGROUND: General practitioners (GPs) are the central coordinators for patients with multimorbidity and polypharmacy in most health care systems. They are entrusted with the challenging task of deprescribing when inappropriate polypharmacy is present. MediQuit (MQu) is a newly developed electronic tool that guides through a deprescribing consultation. It facilitates the identification of a medicine to be discontinued (stage 1), a shared decision-making process weighing the pros and cons (stage 2), and equips patients with take-home instructions on how to discontinue the drug and monitor its impact (stage 3). We here aim to evaluate utility and acceptance of MQu from GPs' and patients' perspectives. METHODS: Uncontrolled feasibility study, in which 16 GPs from two regions in Germany were invited to use MQu in consultations with their multimorbid patients. We collected quantitative data on demography, utility and acceptance of MQu and performed descriptive statistical analyses. RESULTS: Ten GPs performed 41 consultations using MQu. Identification (step 1) and implementation elements (Step 3) were perceived most helpful by GPs. Whereas, shared-decision making elements (step 2) revealed room for improvement. Patients appreciated the use of MQu. They were broadly satisfied with the deprescribing consultation (85%) and with their decision made regarding their medication (90%). CONCLUSIONS: Implementation of MQu in general practice generally seems possible. Patients welcome consultations targeting medication optimization. GPs were satisfied with the support of MQu and likewise gave important hints for future development.

Learning objectives of Belgian general practitioner trainees regarding their hospital training: A qualitative study.

BACKGROUND: In Europe, hospital training is integrated in the postgraduate curriculum of General Practitioners (GPs) according to the European Directives. However, little is known about the specific learning objectives of GP trainees during this training. OBJECTIVES: This exploratory study investigated GP trainees' expected learning objectives for their hospital training and the factors influencing the learning process. METHODS: Semi-structured interviews were conducted in three focus groups consisting of first-year GP trainees before their hospital training. Data were coded thematically and analysed in NVivo. RESULTS: A total of 22 Belgian GP trainees (55% females, average age of 26.2 years) were interviewed. Three major themes emerged: learning objectives, factors influencing learning and organisational aspects. GP trainees mainly wanted to improve their knowledge of common conditions by conducting consultations and follow certain patients' hospitalisation trajectory. Emergency medicine or internal medicine was the preferred specialty. Other GP trainees wanted to learn more about some specific conditions. Conversely, an overloaded work schedule was dreaded to hinder effective learning. Regular meetings and supervision from their hospital trainer were deemed crucial to strengthen GP trainees' learning trajectory. CONCLUSION: GP trainees wanted to learn more about both common conditions and some specific conditions. Their previous year in a GP setting strengthened their confidence and facilitated purposeful learning. Relieving GP trainees from administrative tasks when working as supplementary doctors could strike a better balance between the continuity of the clinical department and their personal learning objectives.

Frequency and management of emergencies in primary care offices: A cross-sectional study in northwestern Germany.

BACKGROUND: Little literature exists on emergencies within primary care offices. OBJECTIVES: We aimed to study the occurrence of emergencies and confidence in dealing with them among primary care physicians (PCPs) in Germany. METHODS: We conducted a cross-sectional study among all PCPs with licences to practice with an own office (n = 915) in a northwestern region in Germany in 2019. Participants were asked to estimate the frequency and type of emergencies that occurred in the last 12 months in their office and about their confidence in managing emergency situations. RESULTS: Answers from 375 PCPs could be analysed (response: 41.0%); 95.7% reported at least one emergency in their office within the last 12 months (mean 12.9). PCPs from rural offices reported more emergencies (on average 13.7 vs. 9.6). Acute coronary syndrome, cardiac arrhythmia and dyspnoea were the most common emergencies. A greater likelihood of feeling more confident in managing medical emergencies was found among male physicians, general internists, PCPs additionally qualified as emergency physicians and those with previous training in the emergency department and intensive care unit. In contrast, more general practitioners felt secure treating paediatric emergencies than general internists (highest level of confidence 22.1% vs. 16.3%). CONCLUSION: In Germany, emergencies in primary care offices occur on average once a month and more often in rural than urban areas. While most PCPs are confident in managing medical emergencies, some differences related to the training path became apparent. Ongoing training programmes may be tailored to improve emergency skills.

Practice and System Factors Impact on Infection Prevention and Control in General Practice during COVID-19 across 33 Countries: Results of the PRICOV Cross-Sectional Survey.

Infection prevention and control (IPC) is an evidence-based approach used to reduce the risk of infection transmission within the healthcare environment. Effective IPC practices ensure safe and quality healthcare. The COVID-19 pandemic highlighted the need for enhanced IPC measures and the World Health Organization (WHO) emphasized the need for strict adherence to the basic principles of IPC. This paper aims to describe the IPC strategies implemented in general practice during the COVID-19 pandemic and to identify the factors that impact their adoption. Data were collected by means of an online self-reported questionnaire among general practices. Data from 4466 practices in 33 countries were included in the analysis. Our results showed a notable improvement in IPC during COVID-19 with more practices reporting that staff members never wore nail polish (increased from 34% to 46.2%); more practices reporting that staff never wear a ring/bracelet (increased from 16.1% to 32.3%); and more practices using a cleaning protocol (increased from 54.9% to 72.7%). Practice population size and the practice payment system were key factors related to adoption of a) range of IPC measures including patient flow arrangements and infrastructural elements. An understanding of the interplay between policy, culture, systemic supports, and behavior are necessary to obtain sustained improvement in IPC measures.

The EGPRN Research Strategy for general practice in Europe.

The European General Practice Research Network (EGPRN) has recently published an updated research strategy with the overall aim being to promote relevant research of the highest quality within general practice/family medicine (GP/FM). The Research Strategy indicates a global direction and serves as a basis for more detailed plans in individual countries that will take into account the characteristics of a country, its specific needs and the level of current research capacity. This paper aims to provide a summary of the EGPRN Research Strategy.The Research Strategy suggests that it is necessary to consider what the knowledge deficits are and to set research priorities. Research capacity building (RCB) is required at all levels. Research in GP/FM will also have to reflect the changes in the profession. An innovative and sustainable-oriented approach to conducting research is needed. Use of existing toolkits and engagement with patient platforms and representative groups are necessary to ensure meaningful user involvement. Knowledge transfer and exchange (KTE) is an important component to ensure a process of exchange between researchers and knowledge users.Working to improve leadership, to support the creation of a research culture in GP/FM and to increase national and international networking are considered as fundamental to ensuring a portfolio of high-quality research and for improving the impact of GP/FM research. The recommendations in the Research Strategy are based on a review of the literature on general practice research from 2010 to 2019 and are set in the context of a theoretical framework.

Integrating general practitioners into crisis management would accelerate the transition from victim to effective professional: Qualitative analyses of a terrorist attack and catastrophic flooding.

BACKGROUND: In 2018, Trèbes, 6,000 inhabitants with nine general practitioners (GPs) in southern France, experienced two tragedies; a terrorist attack in March, in which four people were killed, and a catastrophic flood in October, in which six people died and thousands more were affected. OBJECTIVES: We aimed to obtain a substantive theory for improving crisis management by understanding the personal and professional effects of the two successive disasters on GPs in the same village. METHODS: This qualitative study conducted complete interviews with eight GPs individually, with subsequent analyses involving the conceptualisation of categories based on grounded theory. RESULTS: The analysis revealed that GPs underwent a double status transition. First, doctors who experienced the same emotional shock as the population became victims; their usual professional relationship changed from empathy to sympathy. The helplessness they felt was amplified by the lack of demand from the state to participate in the first emergency measures; consequently, they lost their professional status. In a second phase, GPs regained their values and skills and acquired new ones, thus regaining their status as competent professionals. In this context, the participants proposed integrating a coordinated crisis management system and the systematic development of peer support. CONCLUSION: We obtained valuable information on the stages of trauma experienced by GPs, allowing a better understanding of the effects on personal/professional status. Thus, the inclusion of GPs in adaptive crisis management plans would limit the effects of traumatic dissociation while increasing their professional effectiveness.

Distress and Wellbeing among General Practitioners in 33 Countries during COVID-19: Results from the Cross-Sectional PRICOV-19 Study to Inform Health System Interventions.

Emerging literature is highlighting the huge toll of the COVID-19 pandemic on frontline health workers. However, prior to the crisis, the wellbeing of this group was already of concern. The aim of this paper is to describe the frequency of distress and wellbeing, measured by the expanded 9-item Mayo Clinic Wellbeing Index (eWBI), among general practitioners/family physicians during the COVID-19 pandemic and to identify levers to mitigate the risk of distress. Data were collected by means of an online self-reported questionnaire among GP practices. Statistical analysis was performed using SPSS software using Version 7 of the database, which consisted of the cleaned data of 33 countries available as of 3 November 2021. Data from 3711 respondents were included. eWBI scores ranged from -2 to 9, with a median of 3. Using a cutoff of ≥2, 64.5% of respondents were considered at risk of distress. GPs with less experience, in smaller practices, and with more vulnerable patient populations were at a higher risk of distress. Significant differences in wellbeing scores were noted between countries. Collaboration from other practices and perception of having adequate governmental support were significant protective factors for distress. It is necessary to address practice- and system-level organizational factors in order to enhance wellbeing and support primary care physicians.

Family history tools for primary care: A systematic review.

BACKGROUND: Many medical family history (FH) tools are available for various settings. Although FH tools can be a powerful health screening tool in primary care (PC), they are currently underused. OBJECTIVES: This review explores the FH tools currently available for PC and evaluates their clinical performance. METHODS: Five databases were systematically searched until May 2021. Identified tools were evaluated on the following criteria: time-to-complete, integration with electronic health record (EMR) systems, patient administration, risk-assessment ability, evidence-based management recommendations, analytical and clinical validity and clinical utility. RESULTS: We identified 26 PC FH tools. Analytical and clinical validity was poorly reported and agreement between FH and gold standard was commonly inadequately reported and assessed. Sensitivity was acceptable; specificity was found in half of the reviewed tools to be poor. Most reviewed tools showed a capacity to successfully identify individuals with increased risk of disease (6.2-84.6% of high and/or moderate or increased risk individuals). CONCLUSION: Despite the potential of FH tools to improve risk stratification of patients in PC, clinical performance of current tools remains limited as well as their integration in EMR systems. Twenty-one FH tools are designed to be self-administered by patients.

Help-seeking behaviour in primary care of men and women with a history of abuse: A Dutch cohort study.

BACKGROUND: Previous studies show an association between a history of abuse and higher care demand. However, studies in general practice regarding help-seeking behaviour by patients (mainly male patients) with a history of abuse are scarce. OBJECTIVES: To analyse help-seeking behaviour in general practice of men and women with a history of abuse. METHODS: A cohort study using data from a Dutch primary care registration network from 2015 to 2019. We included all patients aged ≥ 18 years who indicated on a questionnaire that they did or did not have a history of abuse. We analysed differences in contact frequency, types of contact, reason for encounter and diagnoses between men and women with or without a history of abuse. RESULTS: The questionnaire had a response rate of 59% and resulted in 11,140 patients, of which 1271 indicated a history of abuse. Men and women with a history of abuse contact the general practitioner (GP) 1.5 times (95% CI 1.42-1.60) more often than men and women without a history of abuse, especially for psychological (rate ratio 1.97, 95% CI 1.79-2.17) and social (rate ratio 1.93, 95% CI 1.68-2.22) problems. Moreover, when diagnosed with a psychological or social problem, patients with a history of abuse contact the GP twice more often for these problems. CONCLUSION: Compared to men and women without a history of abuse, men and women with a history of abuse visit their GP more often, particularly for psychological and social problems.

Stop smoking advice by practice assistants after routine cervical screening in general practice: A qualitative exploration of potential barriers and enablers.

BACKGROUND: Cervical screening could be an appropriate routine moment to provide female smokers with tailored stop smoking advice. In Dutch general practice, cervical smears are performed by practice assistants. OBJECTIVES: This study was performed in preparation for a randomised trial to identify potential barriers and enablers for a brief stop smoking strategy performed by trained practice assistants after routine cervical screening. METHODS: Between December 2016 and March 2017 three focus group meetings were held with ten practice assistants, three nurses, and six general practitioners to explore their views and expectations towards the proposed approach. We analysed data using thematic analysis. Identified factors are presented within the framework of the Social-Ecological Model. RESULTS: Potential barriers and enablers were identified at individual, interpersonal, and workplace levels. Practice assistants, nurses and GPs did not consider assistants to have a role in stop smoking care. They believed it is feasible to register smoking status but had reservations towards providing advice by assistants, for which knowledge and skills are needed. Practice assistants' own beliefs about smokers and smokers' response to stop smoking advice might influence how assistants and smokers interact. An explanation of why advice is given could help, provided assistants have enough time and experience with the smear. The nurses' availability and general practitioners' view on prevention might affect the delivery of the strategy by the assistant. CONCLUSION: At individual, interpersonal, and workplace levels, several factors could influence the provision of a stop smoking strategy by a practice assistant.

Management and Outcomes of Adults Diagnosed with Acute Pulmonary Embolism in Primary Care: Community-Based Retrospective Cohort Study.

BACKGROUND: The management and outcomes of patients diagnosed with acute pulmonary embolism in primary care have not been characterized. OBJECTIVE: To describe 30-day outcomes stratified by initial site-of-care decisions DESIGN: Multicenter retrospective cohort study PARTICIPANTS: Adults diagnosed with acute pulmonary embolism in primary care in a large, diverse community-based US health system (2013-2019) MAIN MEASURES: The primary outcome was a composite of 30-day serious adverse events (recurrent venous thromboembolism, major bleeding, and all-cause mortality). The secondary outcome was 7-day pulmonary embolism-related hospitalization, either initial or delayed. KEY RESULTS: Among 652 patient encounters (from 646 patients), median age was 64 years; 51.5% were male and 70.7% identified as non-Hispanic white. Overall, 134 cases (20.6%) were sent home from primary care and 518 cases (79.4%) were initially referred to the emergency department (ED) or hospital. Among the referred, 196 (37.8%) were discharged home from the ED without events. Eight patients (1.2%; 95% CI 0.5-2.4%) experienced a 30-day serious adverse event: 4 venous thromboemboli (0.6%), 1 major bleed (0.2%), and 3 deaths (0.5%). Seven of these patients were initially hospitalized, and 1 had been sent home from primary care. All 3 deaths occurred in patients with known metastatic cancer initially referred to the ED, hospitalized, then enrolled in hospice following discharge. Overall, 328 patients (50.3%) were hospitalized within 7 days: 322 at the time of the index diagnosis and 6 following initial outpatient management (4 clinic-only and 2 clinic-plus-ED patients). CONCLUSIONS: Patients diagnosed with acute pulmonary embolism in this primary care setting uncommonly experienced 30-day adverse events, regardless of initial site-of-care decisions. Over 20% were managed comprehensively by primary care. Delayed 7-day pulmonary embolism-related hospitalization was rare among the 51% treated as outpatients. Primary care management of acute pulmonary embolism appears to be safe and could have implications for cost-effectiveness and patient care experience.