Primary Care Clinical Practice Research Articles

The Impact of the COVID-19 Pandemic on Incidence and Short-Term Survival for Common Solid Tumours in the United Kingdom: A Cohort Analysis.

The COVID-19 pandemic profoundly affected healthcare systems and patients. There is a need to comprehend the collateral effects of the pandemic on non-communicable diseases. We examined the impact of the pandemic on short-term survival for common solid tumours, including breast, colorectal, head and neck, liver, lung, oesophageal, pancreatic, prostate, and stomach cancer in the UK. This was a population-based cohort study of electronic health records from the UK primary care Clinical Practice Research Datalink GOLD database. In sum, 12,259,744 eligible patients aged ≥18 years with ≥1 year's history identified from January 2000 to December 2022 were included. We estimated age-standardised incidence and short-term (one- and two-year) survival for several common cancers from 2000 to 2019 (in five-year strata) and compared these to 2020-2022 using the Kaplan-Meier method. Incidence decreased for most cancers in 2020 and recovered to different extents in 2021-2022. Short-term survival improved for most cancers between 2000 and 2019, but then declined, albeit minimally, for those diagnosed in 2020-2022. This was most pronounced for colorectal cancer, with one-year survival falling from 78.8% (95% CI 78%-79.6%) in 2015-2019 to 77% (95% CI 75.6-78.3%) for those diagnosed in 2020-2022. Short-term survival for many cancers was impacted, albeit minimally, by the pandemic in the UK, with reductions in survivorship from colorectal cancer equivalent to returning to the mortality seen in the first decade of the 2000s. While data on longer-term survival are needed to fully comprehend the impact of COVID-19 on cancer care, our findings illustrate the need for an urgent and substantial commitment from the UK National Health Service to address the existing backlog in cancer screening and diagnostic procedures to improve cancer care and mortality.

Risk factors for asthma-related hospital and intensive care admissions in children, adolescents and adults: a cohort study using primary and secondary care data

BackgroundAsthma remains a common cause of hospital admissions across the life course. We estimated the contribution of key risk factors to asthma-related hospital and intensive care unit (ICU) admissions in...

The impact of the UK COVID-19 lockdown on the screening, diagnostics and incidence of breast, colorectal, lung and prostate cancer in the UK: a population-based cohort study.

The COVID-19 pandemic had collateral effects on many health systems. Cancer screening and diagnostic tests were postponed, resulting in delays in diagnosis and treatment. This study assessed the impact of the pandemic on screening, diagnostics and incidence of breast, colorectal, lung, and prostate cancer; and whether rates returned to pre-pandemic levels by December, 2021. This is a cohort study of electronic health records from the United Kingdom (UK) primary care Clinical Practice Research Datalink (CPRD) GOLD database. The study included individuals registered with CPRD GOLD between January, 2017 and December, 2021, with at least 365 days of clinical history. The study focused on screening, diagnostic tests, referrals and diagnoses of first-ever breast, colorectal, lung, and prostate cancer. Incidence rates (IR) were stratified by age, sex, and region, and incidence rate ratios (IRR) were calculated to compare rates during and after lockdown with rates before lockdown. Forecasted rates were estimated using negative binomial regression models. Among 5,191,650 eligible participants, the first lockdown resulted in reduced screening and diagnostic tests for all cancers, which remained dramatically reduced across the whole observation period for almost all tests investigated. There were significant IRR reductions in breast (0.69 [95% CI: 0.63-0.74]), colorectal (0.74 [95% CI: 0.67-0.81]), and prostate (0.71 [95% CI: 0.66-0.78]) cancer diagnoses. IRR reductions for lung cancer were non-significant (0.92 [95% CI: 0.84-1.01]). Extrapolating to the entire UK population, an estimated 18,000 breast, 13,000 colorectal, 10,000 lung, and 21,000 prostate cancer diagnoses were missed from March, 2020 to December, 2021. The UK COVID-19 lockdown had a substantial impact on cancer screening, diagnostic tests, referrals, and diagnoses. Incidence rates remained significantly lower than pre-pandemic levels for breast and prostate cancers and associated tests by December, 2021. Delays in diagnosis are likely to have adverse consequences on cancer stage, treatment initiation, mortality rates, and years of life lost. Urgent strategies are needed to identify undiagnosed cases and address the long-term implications of delayed diagnoses.

Compassion and equity-focused clinical genomics training for health professional learners.

There remains an urgent need for expanded genomics training in undergraduate medical education, especially as genetic and genomic assessments become increasingly important in primary care and routine clinical practice across specialties. Physician trainees continue to report feeling poorly prepared to provide effective consultation or interpretation of genomic test results. Here we report on the development, pilot implementation, and evaluation of an elective offering for pre-clinical medical students called the Sanford Precision Health Scholars Immersive Learning Experience (PHS), which was designed leveraging genetic counseling expertise as one means to address this need. This 9-week course, piloted in Fall 2021 at UC San Diego, afforded students the opportunity to build technical skills and competencies in clinical genomics while identifying, addressing, and engaging with pervasive health disparities in genomics. Interactive exercises focused students' learning on strategies for empathic and compassionate patient interactions while supporting the application of concepts and knowledge to future practice. Upon completion of the course, participants reported increases in confidence related to skills required for clinical genomics practice. Drawing on learnings from this pilot implementation, recommendations for refining the program include deepening pedagogical engagement with ethical issues, expanding the offering to trainees across health professions, including pharmacy students, and incorporating an optional experiential learning component. Educational offerings, like PHS, that are designed with the input of genetic counseling expertise may ease pressures on the genetic counseling profession by building a more genomic-literate healthcare workforce that can better support efforts to expand access for patients.

Clinical assessment and management of vaginismus.

Vaginismus is one of the leading causes ofpainful sex (dyspareunia) for women. General practitioners (GPs) play a vital role in diagnosing and treating vaginismus, as well as coordinating a multidisciplinary team to support people with vaginismus. The aim of this article is to summarise what is currently known about vaginismus, including its aetiology and contributing factors, how a diagnosis can be made, the implications of vaginismus on primary care clinical practice and the available treatment options for people with vaginismus. The article focuses on treating vaginismus exclusively, where other possible medical causes or comorbidities have been examined andexcluded (eg vulvodynia). GPs play a vital role in helping people recover from vaginismus through validating people's experiences, making an accurate diagnosis and making referrals to other relevant health professionals. GPs can also offer a range of treatment options for people with vaginismus. While the management of vaginismus can be time-consuming and take some trial and error, multidisciplinary care with multimodal therapy often results in positive patient outcomes.

Protocolo diagnóstico de la pirosis retroesternal

Pyrosis is one of the typical symptoms of gastroesophageal reflux disease. It is one of the most common causes for consultation in primary care and gastrointestinal department clinical practice. In Spain, it has been reported that approximately one out of every three people has pyrosis on a regular basis. Therefore, its diagnosis is of utmost importance. Pyrosis’ favorable response to empirical treatment with proton pump inhibitors allows for diagnosing it in the absence of alarm symptoms. If alarm signs are present, an upper gastrointestinal endoscopy (UGIE) should be performed as soon as possible. Patients who do not respond to medical treatment and whose UGIE does not show abnormalities compatible with gastroesophageal reflux disease should undergo a pH meter test±esophageal impedance testing without treatment.

Collateral effects of the COVID-19 pandemic on endocrine treatments for breast and prostate cancer in the UK: a cohort study.

The COVID-19 pandemic affected cancer screening, diagnosis and treatments. Many surgeries were substituted with bridging therapies during the initial lockdown, yet consideration of treatment side effects and their management was not a priority. To examine how the changing social restrictions imposed by the pandemic affected incidence and trends of endocrine treatment prescriptions in newly diagnosed (incident) breast and prostate cancer patients and, secondarily, endocrine treatment-related outcomes (including bisphosphonate prescriptions, osteopenia and osteoporosis), in UK clinical practice from March 2020 to June 2022. Population-based cohort study using UK primary care Clinical Practice Research Datalink GOLD database. There were 13,701 newly diagnosed breast cancer patients and 12,221 prostate cancer patients with ⩾1-year data availability since diagnosis between January 2017 and June 2022. Incidence rates (IR) and incidence rate ratios (IRR) were calculated across multiple time periods before and after lockdown to examine the impact of changing social restrictions on endocrine treatments and treatment-related outcomes, including osteopenia, osteoporosis and bisphosphonate prescriptions. In breast cancer patients, aromatase inhibitor (AI) prescriptions increased during lockdown versus pre-pandemic [IRR: 1.22 (95% confidence interval (CI): 1.11-1.34)], followed by a decrease post-first lockdown [IRR: 0.79 (95% CI: 0.69-0.89)]. In prostate cancer patients, first-generation antiandrogen prescriptions increased versus pre-pandemic [IRR: 1.23 (95% CI: 1.08-1.4)]. For breast cancer patients on AIs, diagnoses of osteopenia, osteoporosis and bisphosphonate prescriptions were reduced across all lockdown periods versus pre-pandemic (IRR range: 0.31-0.62). During the first 2 years of the pandemic, newly diagnosed breast and prostate cancer patients were prescribed more endocrine treatments compared to pre-pandemic due to restrictions on hospital procedures replacing surgeries with bridging therapies. But breast cancer patients had fewer diagnoses of osteopenia and osteoporosis and bisphosphonate prescriptions. These patients should be followed up in the coming years for signs of bone thinning. Evidence of poorer management of treatment-related side effects will help assess resource allocation for patients at high risk for bone-related complications.

Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial.

To perform an economic evaluation on a multicomponent intervention programme for patients with fibromyalgia syndrome compared with usual clinical practice in primary care. A cost-utility analysis was conducted alongside a pragmatic randomised controlled trial (ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT04049006) from a societal perspective, a human capital approach, and a 1-year time horizon. Patients diagnosed with fibromyalgia syndrome from the public health system in south Catalonia, Spain. Crude and adjusted incremental cost- utility ratios were estimated to compare the treatment strategies based on cost estimations (direct medical costs and productivity losses) and quality-adjusted life years. One-way and 2-way deterministic sensitivity analyses were performed. The final analysed sample comprised 297 individuals, 161 in the intervention group and 136 in the control group. A crude incremental cost-utility ratio of € 1,780.75 and an adjusted ratio of € 851.67 were obtained, indicating that the programme significantly improved patients' quality of life with a cost-increasing outcome that fell below the cost-effectiveness threshold. The sensitivity analysis confirmed these findings when varying large cost components, and showed dominance when increasing session attendance. The proposed multicomponent intervention programme was cost-effective compared with usual care for fibromyalgia, which supports its addition to standard practice in the regional primary care service.

Pre-diagnostic prescribing patterns in dyspnoea patients with as-yet-undiagnosed lung cancer: A longitudinal study of linked primary care and cancer registry data

IntroductionPatients with as-yet undiagnosed lung cancer (LC) can present to primary care with non-specific symptoms such as dyspnoea, often in the context of pre-existing chronic obstructive pulmonary disease (COPD). Related medication prescriptions pre-diagnosis might represent opportunities for earlier diagnosis, but UK evidence is limited. Consequently, we explored prescribing patterns of relevant medications in patients who presented with dyspnoea in primary care and were subsequently diagnosed with LC. MethodLinked primary care (Clinical Practice Research Datalink) and National Cancer Registry data were used to identify 5434 patients with incident LC within a year of a dyspnoea presentation in primary care between 2006 and 2016. Primary care prescriptions relevant to dyspnoea management were examined: antibiotics, inhaled medications, oral steroids, and opioid analgesics. Poisson regression models estimated monthly prescribing rates during the year pre-diagnosis. Variation by COPD status (52 % pre-existing, 36 % COPD-free, 12 % new-onset) was examined. Inflection points were identified indicating when prescribing rates changed from the background rate. Results63 % of patients received 1 or more relevant prescriptions 1–12 months pre-diagnosis. Pre-existing COPD patients were most prescribed inhaled medications. COPD-free and new-onset COPD patients were most prescribed antibiotics. Most patients received 2 or more relevant prescriptions. Monthly prescribing rates of all medications increased towards time of diagnosis in all patient groups and were highest in pre-existing COPD patients. Increases in prescribing activity were observed earliest in pre-existing COPD patients 5 months pre-diagnosis for inhaled medications, antibiotics, and steroids, ConclusionResults indicate that a diagnostic window of appreciable length exists for potential earlier LC diagnosis in some patients. Lung cancer diagnosis may be delayed if early symptoms are misattributed to COPD or other benign conditions.

Estimating disease burden using national linked electronic health records: a study using an English population-based cohort.

Background: Electronic health records (EHRs) have the potential to be used to produce detailed disease burden estimates. In this study we created disease estimates using national EHR for three high burden conditions, compared estimates between linked and unlinked datasets and produced stratified estimates by age, sex, ethnicity, socio-economic deprivation and geographical region. Methods: EHRs containing primary care (Clinical Practice Research Datalink), secondary care (Hospital Episode Statistics) and mortality records (Office for National Statistics) were used. We used existing disease phenotyping algorithms to identify cases of cancer (breast, lung, colorectal and prostate), type 1 and 2 diabetes, and lower back pain. We calculated age-standardised incidence of first cancer, point prevalence for diabetes, and primary care consultation prevalence for low back pain. Results: 7.2 million people contributing 45.3 million person-years of active follow-up between 2000-2014 were included. CPRD-HES combined and CPRD-HES-ONS combined lung and bowel cancer incidence estimates by sex were similar to cancer registry estimates. Linked CPRD-HES estimates for combined Type 1 and Type 2 diabetes were consistently higher than those of CPRD alone, with the difference steadily increasing over time from 0.26% (2.99% for CPRD-HES vs. 2.73 for CPRD) in 2002 to 0.58% (6.17% vs. 5.59) in 2013. Low back pain prevalence was highest in the most deprived quintile and when compared to the least deprived quintile the difference in prevalence increased over time between 2000 and 2013, with the largest difference of 27% (558.70 per 10,000 people vs 438.20) in 2013. Conclusions: We use national EHRs to produce estimates of burden of disease to produce detailed estimates by deprivation, ethnicity and geographical region. National EHRs have the potential to improve disease burden estimates at a local and global level and may serve as more automated, timely and precise inputs for policy making and global burden of disease estimation.

Comparison of causal forest and regression-based approaches to evaluate treatment effect heterogeneity: an application for type 2 diabetes precision medicine

ObjectivePrecision medicine requires reliable identification of variation in patient-level outcomes with different available treatments, often termed treatment effect heterogeneity. We aimed to evaluate the comparative utility of individualized treatment selection strategies based on predicted individual-level treatment effects from a causal forest machine learning algorithm and a penalized regression model.MethodsCohort study characterizing individual-level glucose-lowering response (6 month reduction in HbA1c) in people with type 2 diabetes initiating SGLT2-inhibitor or DPP4-inhibitor therapy. Model development set comprised 1,428 participants in the CANTATA-D and CANTATA-D2 randomised clinical trials of SGLT2-inhibitors versus DPP4-inhibitors. For external validation, calibration of observed versus predicted differences in HbA1c in patient strata defined by size of predicted HbA1c benefit was evaluated in 18,741 patients in UK primary care (Clinical Practice Research Datalink).ResultsHeterogeneity in treatment effects was detected in clinical trial participants with both approaches (proportion predicted to have a benefit on SGLT2-inhibitor therapy over DPP4-inhibitor therapy: causal forest: 98.6%; penalized regression: 81.7%). In validation, calibration was good with penalized regression but sub-optimal with causal forest. A strata with an HbA1c benefit > 10 mmol/mol with SGLT2-inhibitors (3.7% of patients, observed benefit 11.0 mmol/mol [95%CI 8.0–14.0]) was identified using penalized regression but not causal forest, and a much larger strata with an HbA1c benefit 5–10 mmol with SGLT2-inhibitors was identified with penalized regression (regression: 20.9% of patients, observed benefit 7.8 mmol/mol (95%CI 6.7–8.9); causal forest 11.6%, observed benefit 8.7 mmol/mol (95%CI 7.4–10.1).ConclusionsConsistent with recent results for outcome prediction with clinical data, when evaluating treatment effect heterogeneity researchers should not rely on causal forest or other similar machine learning algorithms alone, and must compare outputs with standard regression, which in this evaluation was superior.

Successful Integration of HIV PrEP in Primary Care and Women's Health Clinical Practice: A Model for Implementation.

Ending the HIV Epidemic is contingent upon the increased utilization of pre-exposure prophylaxis (PrEP). The majority of PrEP in the United States is prescribed in specialty care settings; however, to achieve national implementation goals, it is necessary to expand PrEP services in primary care and women's health clinics. To this end, a prospective cohort study was conducted of health care providers participating in one of three rounds of a virtual program aimed at increasing the number of PrEP prescribers in primary care and women's health clinics within the NYC Health and Hospitals network, the public healthcare system of New York City. Provider prescribing behavior was compared at pre-intervention (August 2018-September 2019) and post-intervention (October 2019-February 2021). Among 104 providers, the number prescribing PrEP increased from 12 (11.5%) to 51 (49%) and the number of individual patients on PrEP increased from 19 to 128. The program utilized clinical integration models centering on existing STI management workflows and was associated with increased numbers of PrEP prescribers and volume of prescriptions in primary care and women's health clinics. The dissemination of similar programs could support national scale-up of PrEP.

Step-Wise Management of Anemia in Patients With Chronic Kidney Disease in Primary Care: Qualitative Study.

Anemia is common in chronic kidney disease (CKD) and is associated with increased cardiovascular risk and reduced quality of life, but is often sub-optimally managed. Most patients are managed in primary care alongside other comorbidities. Interventions to improve the management of anemia in CKD in this setting are needed. We conducted a qualitative study to evaluate how an audit-based education (ABE) intervention might improve the management of anemia in CKD. We explored outcomes that would be relevant to practitioners and patients, that exposed variation of practice from National Institute for Health and Care Excellence (NICE) guidelines, and whether the intervention was feasible and acceptable. Practitioners (n = 5 groups) and patients (n = 7) from 4 London general practices participated in discussions. Practitioners welcomed the evidence-based step-wise intervention. However, prescribing erythropoiesis-stimulating agents (ESAs) was felt to be outside of their scope of practice. There was a gap between NICE guidance and clinical practice in primary care. Iron studies were not well understood and anemia management was often conservative or delayed. Patients were often unaware of having CKD, and were more concerned about their other comorbidities, but largely trusted their GPs to manage them appropriately. The first steps of the intervention were welcomed by practitioners, but they expressed concerns about independently prescribing ESAs. Renal physicians and GPs could develop shared care protocols for ESA use in primary care. There is scope to improve awareness of renal anemia, and enhance knowledge of guideline recommendations; and our intervention should be modified accordingly.

Do preventative care guidelines emphasize behaviour change? A content analysis of three commonly used Australian general practice guidelines.

Preventive health is a core part of primary care clinical practice and it is critical for both disease prevention and reducing the consequences of chronic disease. In primary care, the 5As framework is often used to guide behaviour change consultations for smoking, nutrition, alcohol use and physical activity. Our objective was to analyze the emphasis placed on each 5As term in commonly used guidelines in Australian general practice and compare this to behaviour change terms/concepts essential to effective consultations. A content analysis was undertaken to explore frequency of 5A terms and key behaviour change concepts/terms chapter-by-chapter across the three most commonly used guidelines in Australian general practice. The prevalence of each 5As term differed in all three guidelines, with 'Arrange'being mentioned the least often. Behaviour change concepts and terms, such as patient-centredness, listening, trust and tailoring, were infrequently used and were often confined to a separate chapter of the guidelines. The language and content of the guidelines contrast with known effective components of behaviour change consultations. Future revisions could reconsider emphasis of 5As terms to avoid paternalistic approaches, improve shared language across guidelines and incorporate behavioural science principles to enhance preventative care delivery.

Psychometric qualities of the patient rated Wrist/Hand evaluation (PRWHE) in dutch primary care patients with wrist complaints

BackgroundKnowledge on the course, disability and functionality of wrist complaints is still compendious in primary care guidelines, despite the high prevalence in primary care. Valid questionnaires can facilitate the monitoring of patients in primary care and research initiatives. In this study, we aimed to study the psychometric qualities of the Dutch version of the Patient Rated Wrist/Hand Evaluation (PRWHE-DLV) among adults with (sub)acute wrist complaints in primary care.MethodsAn observational cohort of 35 adults with (sub)acute wrist complaints in Dutch primary care was established. The content validity of the PRWHE-DLV was validated by assessing the floor and ceiling effects at baseline (T0). Reproducibility was assessed by the test-retest reliability between T0 and T1 (2–5 days after T0), using the Intra-class Correlation Coefficient. The construct validity was assessed based on the correlation between the PRWHE-DLV and the Quick-DASH, Physical Component Score (SF-12), VAS-function, Physical Functioning (SF-12), VAS-pain and Bodily Pain (SF-12) at T0. Responsiveness was defined as the ability of the PRWHE-DLV to measure change 3 weeks after T0 (internal) and the relation of these changes to clinically important outcomes (external).ResultsPsychometric qualities of the PRWHE-DLV demonstrated high content validity with no floor or ceiling effects, excellent reliability (Intra-class correlation coefficient = 0.90; 95% CI 0.80–0.95), high construct validity with the validated Quick-DASH and VAS score (r = 0.85 with Quick-DASH, r = 0.75 with VAS-function and r = 0.78 with VAS-pain) and high responsiveness.ConclusionThe PRWHE-DLV provided reliable and adequate information for primary care clinical practice.

Contributions of nursing students during their clinical practice in primary care: Adaptation and validation of a scale

AimTo adapt the ‘Nursing Student Contributions to Clinical Settings’ scale (CEEEC, Spanish acronym), designed for specialized care and to evaluate the validity and reliability of a measure in the primary health care setting. Additionally, a description of the contributions of nursing students to primary health care in Spain is presented, based on the perception of preceptor nurses. MethodsA multicenter cross-sectional study was conducted in Spain, involving a committee of nursing experts who participated in a Delphi panel (n = 5) and cognitive interviews (n = 5) and a sample of nursing preceptors (n = 300) from 57 primary health care centers (2019–2020). The CEEEC was reviewed by experts for the conceptual semantic adequacy of the 24 items for its application in primary health care. Nurse preceptors’ responses to the CEEEC scale were used to study the validity and reliability of the measure, including factor analysis, convergent validity with the Health Sciences-Evidence Based Practice scale and a matched test-retest over a three-week interval. ResultsAccording to the consensus of experts, the CEEEC scale is valid for primary health care with minimal modifications (change "patient" to "user"). Based on the analysis of responses to the scale, the corrected item-total correlations of the 24 items were ≥ 0.40 and were grouped into a single factor, explaining 46.3% of the variance. The Cronbach's alpha value was 0.95. Regarding convergent validity, there was a positive correlation between the CEEEC scale and the score of the Health Sciences-Evidence Based Practice scale (Pearson’s coefficient= 0.33; p < 0.001). The overall intraclass correlation coefficient was 0.91. Finally, the mean CEEEC score was 61.9 points (range 0–96). The two most positive contributions were ‘Nursing students enable nursing professionals to perform their teaching role’ and ‘Nursing students become future professionals who know the healthcare facility’. ConclusionsThe CEEEC scale provides a valid and reliable measure of nursing students' contributions to primary health care. Nursing students’ contributions to Spanish primary health care were positive, especially towards the nursing profession and healthcare organizations.

Effectiveness and quality of life in asthmatic patients treated with budesonide/formoterol via Elpenhaler® device in primary care. The “SKIRON” real world study

Aim: Inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combination therapy is used for the effective control of asthma. Aim of this study was to collect data on the effectiveness, safety, quality of life, and patient satisfaction from a fixed dose combination of budesonide/formoterol administered with the Elpenhaler® device following 3-months’ treatment.Methods: A 3-month real-life, multicentre, one-arm, prospective observational study (SKIRON study-NCT03055793) was conducted, using the following questionnaires: Asthma Control Questionnaire (ACQ-6) for asthma control assessment, MiniAQLQ questionnaire for QoL assessment, and Feeling of Satisfaction with Inhaler questionnaire (FSI-10) for patients’ satisfaction with the inhaler device. Comorbidities and safety data were also recorded during the study.Results: We enrolled 1,174 asthmatic patients following standard clinical practice in primary care from 126 sites in urban and rural areas of Greece. The majority of patients (71.5%) had at least one comorbidity. A statistically significant improvement in the ACQ-6 score was noted at 3 months compared to the baseline evaluation (mean ± SD 2.19 ± 0.97 at baseline vs. 0.55 ± 0.56 at 3 months; mean change −1.64 (95%CI −1.69, −1.57), p < 0.0001). MiniAQLQ score was statistically and clinically significantly improved, compared to baseline, (4.55 ± 1.04 at baseline vs. 6.37 ± 0.64 at 3 months; mean change 1.82 (95%CI 1.75, 1.87), p < 0.0001). The mean FSI-10 score of 44.2 ± 5.4 indicated patient satisfaction and ease-of-use of the Elpenhaler® device.Conclusions: In this large real-world study of inadequately-controlled asthma patients in primary care settings, the treatment with budesonide/formoterol FDC with the Elpenhaler® device was associated with significant improvement in patients’ asthma control and quality of life.

Comparative Adherence and Persistence of Single- and Multiple-Inhaler Triple Therapies Among Patients with Chronic Obstructive Pulmonary Disease in an English Real-World Primary Care Setting.

PurposeTriple therapy comprising a long-acting muscarinic antagonist, long-acting β2-agonist and inhaled corticosteroid is recommended for patients with chronic obstructive pulmonary disease (COPD) who continue to experience frequent exacerbations or symptoms whilst receiving dual therapy. Adherence and persistence to multiple-inhaler triple therapy (MITT) is known to be poor. This study assessed comparative adherence to single-inhaler triple therapy (SITT) versus MITT in a real-world setting in England.Patients and MethodsThis was a retrospective cohort study using linked primary care (Clinical Practice Research Datalink Aurum) and secondary care (Hospital Episode Statistics [HES] Admitted Patient Care) data to identify patients with COPD who were newly initiated on SITT or MITT between November 2017 and June 2019. Eligible patients were aged ≥35 years and had a forced expiratory volume in 1 second/forced vital capacity <0.7, linkage to HES and continuous registration with a general practitioner for 12 months pre- and 6 months post-initiation. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Adherence was measured using the proportion of days covered by days’ supply of SITT or MITT prescriptions. Persistence was measured with a gap of >30 days between the end of a prescription and the following refill used to determine non-persistence.ResultsOverall, 4080 SITT and 6579 MITT users comprised the study cohort. After weighting, the baseline characteristics between the cohorts were comparable (absolute standardized mean difference <10%). SITT users had significantly higher adherence than MITT users at 6, 12, and 18 months post-initiation (p<0.001 for all comparisons). Median persistence was higher among SITT users than MITT users (5.09 months vs 0.99 months).ConclusionPatients with COPD in England initiating SITT had significantly better adherence and persistence compared with MITT initiators. These improvements continued at least 18 months following treatment initiation.

Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care.

BackgroundTobacco addiction is the leading cause of preventable morbidity and mortality worldwide, but only 1 in 20 cessation attempts is supervised by a health professional. The potential advantages of mobile health (mHealth) can circumvent this problem and facilitate tobacco cessation interventions for public health systems. Given its easy scalability to large populations and great potential, chatbots are a potentially useful complement to usual treatment.ObjectiveThis study aims to assess the effectiveness of an evidence-based intervention to quit smoking via a chatbot in smartphones compared with usual clinical practice in primary care.MethodsThis is a pragmatic, multicenter, controlled, and randomized clinical trial involving 34 primary health care centers within the Madrid Health Service (Spain). Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). The interventions in both arms were based on the 5A’s (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of patients, although participants were unblinded to group assignment. An intention-to-treat analysis, using the baseline-observation-carried-forward approach for missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes.ResultsThe trial was conducted between October 1, 2018, and March 31, 2019. The sample included 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 (SD 10.82) years and gender ratio of 59.3% (304/513) women and 40.7% (209/513) men. Of them, 232 patients (45.2%) completed the follow-up, 104/242 (42.9%) in the IG and 128/271 (47.2%) in the CG. In the intention-to-treat analysis, the biochemically validated abstinence rate at 6 months was higher in the IG (63/242, 26%) compared with that in the CG (51/271, 18.8%; odds ratio 1.52, 95% CI 1.00-2.31; P=.05). After adjusting for basal CO-oximetry and bupropion intake, no substantial changes were observed (odds ratio 1.52, 95% CI 0.99-2.33; P=.05; pseudo-R2=0.045). In the IG, 61.2% (148/242) of users accessed the chatbot, average chatbot-patient interaction time was 121 (95% CI 121.1-140.0) minutes, and average number of contacts was 45.56 (SD 36.32).ConclusionsA treatment including a chatbot for helping with tobacco cessation was more effective than usual clinical practice in primary care. However, this outcome was at the limit of statistical significance, and therefore these promising results must be interpreted with caution.Trial RegistrationClinicaltrials.gov NCT 03445507; https://tinyurl.com/mrnfcmtdInternational Registered Report Identifier (IRRID)RR2-10.1186/s12911-019-0972-z

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol

IntroductionLack of standardised clinical data collection may lead to reduced quality in musculoskeletal (MSK)-related clinical care and research. Little is known about the availability and characteristics of minimal clinical data...