ACcurate COnsensus Reporting Document (ACCORD) explanation and elaboration: Guidance and examples to support reporting consensus methods.

BACKGROUND: When research evidence is limited, inconsistent, or absent, healthcare decisions and policies need to be based on consensus amongst interested stakeholders. In these processes, the knowledge, experience, and expertise of health professionals, researchers, policymakers, and the public are systematically collected and synthesised to reach agreed clinical recommendations and/or priorities. However, despite the influence of consensus exercises, the methods used to achieve agreement are often poorly reported. The ACCORD (ACcurate COnsensus Reporting Document) guideline was developed to help report any consensus methods used in biomedical research, regardless of the health field, techniques used, or application. This explanatory document facilitates the use of the ACCORD checklist. METHODS AND FINDINGS: This paper was built collaboratively based on classic and contemporary literature on consensus methods and publications reporting their use. For each ACCORD checklist item, this explanation and elaboration document unpacks the pieces of information that should be reported and provides a rationale on why it is essential to describe them in detail. Furthermore, this document offers a glossary of terms used in consensus exercises to clarify the meaning of common terms used across consensus methods, to promote uniformity, and to support understanding for consumers who read consensus statements, position statements, or clinical practice guidelines. The items are followed by examples of reporting items from the ACCORD guideline, in text, tables and figures. CONCLUSIONS: The ACCORD materials - including the reporting guideline and this explanation and elaboration document - can be used by anyone reporting a consensus exercise used in the context of health research. As a reporting guideline, ACCORD helps researchers to be transparent about the materials, resources (both human and financial), and procedures used in their investigations so readers can judge the trustworthiness and applicability of their results/recommendations.

Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

"You Probably Won't Notice Any Symptoms": Blood Pressure in Pregnancy-Discourses of Contested Expertise in an Era of Self-Care and Responsibilization.

Pregnancy is not a disease or illness, but requires clinical surveillance as life-threatening complications can develop. Preeclampsia, one such potentially serious complication, puts both mother and baby at risk. Self-monitoring blood pressure in the general population is well established, and its potential in pregnancy is currently being explored. In the context of self-monitoring, the information and guidance given to women regarding hypertension, and the literature they themselves seek out during pregnancy, are vital to perceptions of disease risk and subsequent responses to, and management of, any symptoms. Drawing on online, offline, official, and unofficial sources of information, discourses are examined to provide analysis of how self-responsibilization is reflected in contemporary information, advice, and guidance drawn from multiple sources. A paradox emerges between the paternalistic and lay discourses that seek to challenge and regain control. Findings are discussed in the context of Foucault's governmentality and medical power.

Opportunities to diagnose fibrotic lung diseases in routine care: A primary care cohort study.

BACKGROUND AND OBJECTIVE: Temporal trends of healthcare use in the period before a diagnosis of pulmonary fibrosis are poorly understood. We investigated trends in respiratory symptoms and LR HRU in the 10 years prior to diagnosis. METHODS: We analysed a primary care clinical cohort database (UK OPCRD) and assessed patients aged ≥40 years who had an electronically coded diagnosis of pulmonary fibrosis between 2005 and 2015 and a minimum 2 years of continuous medical records prior to diagnosis. Exclusion criteria consisted of electronic codes for recognized causes of pulmonary fibrosis such as CTD, sarcoidosis or EAA. RESULTS: Data for 2223 patients were assessed. Over the 10 years prior to diagnosis of pulmonary fibrosis, there was a progressive increase in HRU across multiple LR-related domains. Five years before diagnosis, 18% of patients had multiple healthcare contacts for LR complaints; this increased to 79% in the year before diagnosis, with 38% of patients having five or more healthcare contacts. CONCLUSION: There are opportunities to diagnose pulmonary fibrosis at an earlier stage; research into case-finding algorithms and strategies to educate primary care physicians is required.

Wild data: how front-line hospital staff make sense of patients' experiences.

Patient-centred care has become the touchstone of healthcare policy in developed healthcare systems. The ensuing commodification of patients' experiences has resulted in a mass of data but little sense of whether and how such data are used. We sought to understand how front-line staff use patient experience data for quality improvement in the National Health Service (NHS). We conducted a 12-month ethnographic case study evaluation of improvement projects in six NHS hospitals in England in 2016-2017. Drawing on the sociology of everyday life, we show how front-line staff worked with a notion of data as interpersonal and embodied. In addition to consulting organisationally sanctioned forms of data, staff used their own embodied interactions with patients, carers, other staff and the ward environment to shape improvements. The data staff found useful involved face-to-face interaction and dialogue; were visual, emotive, and allowed for immediate action. We draw on de Certeau to re-conceptualise this as 'wild data'. We conclude that patient experience data are relational, and have material, social and affective dimensions, which have been elided in the literature to date. Practice-based theories of the everyday help to envision 'patient experience' not as a disembodied tool of managerialism but as an embedded part of healthcare staff professionalism.

What influences birth place preferences, choices and decision-making amongst healthy women with straightforward pregnancies in the UK? A qualitative evidence synthesis using a 'best fit' framework approach.

BACKGROUND: English maternity care policy has supported offering women choice of birth setting for over twenty years, but only 13% of women in England currently give birth in settings other than obstetric units (OUs). It is unclear why uptake of non-OU settings for birth remains relatively low. This paper presents a synthesis of qualitative evidence which explores influences on women's experiences of birth place choice, preference and decision-making from the perspectives of women using maternity services. METHODS: Qualitative evidence synthesis of UK research published January 1992-March 2015, using a 'best-fit' framework approach. Searches were run in seven electronic data bases applying a comprehensive search strategy. Thematic framework analysis was used to synthesise extracted data from included studies. RESULTS: Twenty-four papers drawing on twenty studies met the inclusion criteria. The synthesis identified support for the key framework themes. Women's experiences of choosing or deciding where to give birth were influenced by whether they received information about available options and about the right to choose, women's preferences for different services and their attributes, previous birth experiences, views of family, friends and health care professionals and women's beliefs about risk and safety. The synthesis additionally identified that women's access to choice of place of birth during the antenatal period varied. Planning to give birth in OU was straightforward, but although women considering birth in a setting other than hospital OU were sometimes well-supported, they also encountered obstacles and described needing to 'counter the negativity' surrounding home birth or birth in midwife-led settings. CONCLUSIONS: Over the period covered by the review, it was straightforward for low risk women to opt for hospital birth in the UK. Accessing home birth was more complex and contested. The evidence on freestanding midwifery units (FMUs) is more limited, but suggests that women wanting to opt for an FMU birth experienced similar barriers. The extent to which women experienced similar problems accessing alongside midwifery units (AMUs) is unclear. Women's preferences for different birth options, particularly for 'hospital' vs non-hospital settings, are shaped by their pre-existing values, beliefs and experience, and not all women are open to all birth settings.

Validating the Concept of COPD Control: A Real-world Cohort Study from the United Kingdom.

The concept of Chronic Obstructive Pulmonary Disease (COPD) control has been developed to inform therapeutic decision-making. We explored the validity of a definition of COPD control in a representative population of patients with COPD in the United Kingdom. Electronic medical records and linked COPD questionnaire data from the Optimum Patient Care Research Database were used to characterize control status. Patients were aged ≥40 years, with spirometry-confirmed COPD, current or ex-smokers, and continuous records throughout the study period. Control was evaluated based on COPD stability and patients' (i) clinical features or (ii) COPD Assessment Test (CAT) score over a three-month baseline period and linked to time to first exacerbation. Of 2788 eligible patients, 2511 (90%) had mild/moderate COPD and 277 (10%) had severe/very severe COPD based on Body Mass Index, Obstruction, Dyspnoea, Exacerbations (BODEx) cut-off of 4. Within the mild/moderate cohort, 4.5% of patients were controlled at baseline according to clinical features and 21.5% according to CAT threshold of 10. Within the severe/very severe cohort, no patients were controlled at baseline according to the proposed clinical features and 8.3% were controlled according to CAT threshold of 20. Compared with uncontrolled patients, time to first exacerbation was longer for controlled patients with mild/moderate COPD but not for those with severe/very severe COPD. Lowering the BODEx threshold for severity classification to 2 increased the number of patients achieving control. CAT scores were not good predictors of the risk of future exacerbation. With the proposed definition, very few patients were defined as controlled.

Asthma outcomes and costs of therapy with extrafine beclomethasone and fluticasone.

BACKGROUND: Characteristics of inhaled corticosteroids (ICSs) differ, but data comparing the real-life effectiveness of various ICSs for asthma are lacking. OBJECTIVE: We sought to compare real-life asthma outcomes and costs of extrafine hydrofluoroalkane (HFA)-beclomethasone and fluticasone administered through a pressurized metered-dose inhaler. METHODS: This retrospective matched cohort study examined database markers of asthma control from a large US longitudinal health care claims database over 1 baseline and 1 outcome year for 10,312 patients with asthma aged 12 to 80 years receiving their first ICS as HFA-beclomethasone or fluticasone and matched on baseline demographic characteristics and asthma severity. RESULTS: Patients started on HFA-beclomethasone had significantly higher odds (adjusted odds ratio, 1.19; 95% CI; 1.08-1.31) of achieving overall control (risk and impairment), which was defined as no hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection and less than 2 puffs per day of short-acting ß-agonist; they also experienced a lower rate of respiratory-related hospitalizations or referrals (adjusted rate ratio, 0.82; 95% CI, 0.73-0.93) than patients started on fluticasone. Other database outcome measures were similar in the 2 cohorts. Prescribed HFA-beclomethasone doses were lower (P < .001) than fluticasone doses (median, 320 µg/d [interquartile range, 160-320 µg/d] vs 440 µg/d [interquartile range, 176-440 µg/d]). Adjusted respiratory-related health care costs were significantly lower for HFA-beclomethasone than fluticasone (mean, $1869 [95% CI, $1727-$2032] vs $2259 [95% CI, $2111-$2404]), representing a mean annual savings of $390 (95% CI, $165-$620) per patient prescribed HFA-beclomethasone rather than fluticasone. CONCLUSIONS: Asthma treatment outcomes were similar or better with HFA-beclomethasone prescribed at significantly lower doses and with lower costs than fluticasone.

Implications of bone metastasis on response to systemic therapy in patients with advanced renal cell carcinoma: A systematic literature review.

INTRODUCTION: Bone metastases negatively affect prognosis in patients with advanced renal cell carcinoma (aRCC). We conducted a systematic literature review to identify clinical trial publications including patients with aRCC with and without bone metastases. METHODS: The review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta­Analyses (PRISMA) guidelines and registered with PROSPERO (CRD42022355436). MEDLINE and Embase databases were searched (September 2, 2022) to identify publications reporting efficacy and safety outcomes for patients with/without bone metastasis from clinical trials of systemic RCC therapies. Risk of bias was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Of 526 publications screened, 19 were eligible: seven (from five studies) reported phase 3 trials, six reported phase 2 trials, one reported phase 1b/2 trials, and five were pooled analyses. Five publications reported moderate-quality evidence, while 14 were graded as low- or very low-quality evidence, suggesting a high potential for uncertainty. Five studies reported benefits of investigational therapies versus comparators in patients with and without bone metastases; these studies included cabozantinib, nivolumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab treatment arms. Data were also available for nivolumab plus ipilimumab. Bone metastases were consistently associated with poor prognosis in patients with aRCC. Preliminary data support the hypothesis that therapies targeting pathways implicated in the development of bone metastases may be beneficial, and warrant further investigation. However, data to support treatment decision-making are lacking. CONCLUSION: Our findings highlight the need for clinical data to assist in defining the optimal treatment for patients with aRCC and bone metastasis.

Self-monitoring blood pressure in Pregnancy: Evaluation of health professional experiences of the BUMP trials.

BACKGROUND: The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether they improved detection or control of hypertension for women at risk of hypertension or with hypertension during pregnancy. This process evaluation aimed to understand healthcare professionals' perspectives and experiences of the BUMP trials of self-monitoring of blood pressure during pregnancy. METHODS: Twenty-two in-depth qualitative interviews and an online survey with 328 healthcare professionals providing care for pregnant people in the BUMP trials were carried out across five maternity units in England. RESULTS: Analysis used Normalisation Process Theory to identify factors required for successful implementation and integration into routine practice. Healthcare professionals felt self-monitoring of blood pressure did not over-medicalise pregnancy for women with, or at risk of, hypertension. Most said self-monitored readings positively affected their clinical encounters and professional roles, provided additive information on which to base decisions and enriched their relationships with pregnant people. Self-monitoring of blood pressure shifts responsibilities. Some healthcare professionals felt women having responsibility to decide on timing of monitoring and whether to act on self-monitored readings was unduly burdensome, and resulted in healthcare professionals taking additional responsibility for supporting them. CONCLUSIONS: Despite healthcare professionals' early concerns that self-monitoring of blood pressure might over-medicalise pregnancy, our analysis shows the opposite was the case when used in the care of pregnant people with, or at higher risk of, hypertension. While professionals retained ultimate clinical responsibility, they viewed self-monitoring of blood pressure as a means of sharing responsibility and empowering women to understand their bodies, to make judgements and decisions, and to contribute to their care.

Characteristics of patients preferring once-daily controller therapy for asthma and COPD: a retrospective cohort study.

BACKGROUND: Patient preference is an important factor when choosing an inhaler device for asthma or chronic obstructive pulmonary disease (COPD). AIMS: To identify characteristics of patients with asthma or COPD who prefer a once-daily controller medication regimen. METHODS: This retrospective observational study used electronic patient records and linked outcomes from patient-completed questionnaires in a primary care database. We compared the characteristics of patients indicating a preference for once-daily therapy with those who were unsure or indicating no preference. RESULTS: Of 3,731 patients with asthma, 2,174 (58%) were women; the mean age was 46 years (range 2-94). Of 2,138 patients with COPD, 980 (46%) were women; the mean age was 70 years (range 35-98). Approximately half of the patients in each cohort indicated once-daily preference, one-quarter were unsure, and one-quarter did not prefer once-daily therapy. In patients with asthma or COPD, the preference for once-daily controller medication was significantly associated with poor adherence and higher concerns about medication. In asthma, good control and low self-perceived controller medication need were associated with once-daily preference. By contrast, in COPD, a high self-perceived need for controller medication was associated with once-daily preference. There was no significant relationship between once-daily preference and age, sex, disease severity, or exacerbation history. CONCLUSIONS: Understanding patient preferences may help prescribers to individualise therapy better for asthma and COPD.

Costs of management of acute respiratory infections in older adults: A systematic review and meta-analysis.

Background: Acute respiratory infections (ARIs) accounted for an estimated 3.9 million deaths worldwide in 2015, of which 56% occurred in adults aged 60 years or older. We aimed to identify the cost of ARI management in older adults (≥50 years) in order to develop an evidence base to assist decision-making for resource allocation and inform clinical practice. Methods: We searched 8 electronic databases including Global Health, Medline and EMBASE for studies published between January 1, 2000 and December 31, 2021. Total management costs per patient per ARI episode were extracted and meta-analysis was conducted by World Health Organization (WHO) region and World Bank income level. All costs were converted and inflated to Euros (€) (2021 average exchange rate). The quality of included studies and the potential risk of bias were evaluated. Results: A total of 42 publications were identified for inclusion, reporting cost data for 8 082 752 ARI episodes in older adults across 20 countries from 2001 to 2021. The majority (86%) of studies involved high-income countries based in Europe, North America and Western Pacific. The mean cost per episode was €17 803.9 for inpatient management and €128.9 for outpatient management. Compared with costs reported for patients aged &lt;65 years, inpatient costs were €154.1, €7 018.8 and €8 295.6 higher for patients aged 65-74 years, 75-84 years and over 85 years. ARI management of at-risk patients with comorbid conditions and patients requiring higher level of care, incurred substantially higher costs for hospitalization: €735.9 and €1317.3 respectively. Conclusions: ARIs impose a substantial economic burden on health systems, governments, patients and societies. This study identified high ARI management costs in older adults, reinforcing calls for investment by global health players to quantify and address the scale of the challenge. There are large gaps in data availability from low-income countries, especially from South East Asia and Africa regions.

Self-monitoring of blood pressure in pregnancy: A mixed methods evaluation of a national roll-out in the context of a pandemic.

OBJECTIVE: To evaluate how English maternity units implemented self-monitoring of blood pressure (SMBP) in pregnancy in response to the COVID-19 pandemic. DESIGN: Mixed methods including surveys, anonymised patient data and in-depth interviews with women. SETTING: Maternity units across England. PARTICIPANTS: 45 maternity units completed a survey about the implementation of SMBP (supported by the provision of guidance and blood pressure monitors) during the pandemic, 166 women completed a survey about their experiences of SMBP, and 23 women took part in in-depth interviews. Clinical data from 627 women undertaking SMBP were available from 13 maternity units. RESULTS: SMBP was predominantly used to provide additional BP monitoring for hypertensive or high-risk pregnant women. Overall maternity units and women were positive about its use in terms of reducing the need for additional face-to-face contacts and giving women more control and insight into their own BP. However, there were challenges in setting up SMBP services rapidly and embedding them within existing care pathways, particularly around interpreting readings and managing the provision of monitors. CONCLUSIONS: A considerable proportion of maternity units in England commenced a SMBP service for hypertensive or high-risk women from March 2020. There is a need for further research into appropriate care pathways, including guidance around white coat or masked hypertension and the use of SMBP postnatally.

Reassessing the evidence hierarchy in asthma: evaluating comparative effectiveness.

Classical randomized controlled trials are the gold standard in medical evidence because of their high internal validity. However, their necessarily strict design can limit their external validity and the ability to extrapolate these data to real world patients. Therefore, alternatively designed studies may play a complementary role in evaluating the comparative effectiveness of therapies in nonidealized patients in more naturalistic, real world settings. Observational studies have high external validity and can evaluate real world outcomes. Their strength lies in hypothesis generation and testing and in identifying areas in which further clinical trials may be required. Pragmatic trials are designed to maximize applicability of trial results to usual care settings by relying on clinically important outcomes and enrolling a wide range of participants. A combination of these approaches is preferable and necessary.

Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study.

BACKGROUND: Long-term randomized trials comparing asthma outcomes between inhaled corticosteroids in real-world populations are lacking. As such, rigorously conducted observational studies to complement the findings of randomized trials are needed. OBJECTIVE: We sought to compare asthma-related outcomes over 1 year as recorded in a large primary care database for patients aged 5 to 60 years receiving a first prescription (initiation population) or dose increase (step-up population) of hydrofluoroalkane (HFA)-beclomethasone or fluticasone. METHODS: We used a retrospective matched cohort study in which patients were matched on baseline demographic and disease severity measures. Coprimary outcomes were asthma control (a composite measure comprising no unplanned visit or hospitalization for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection) and exacerbation rate. RESULTS: More than 80% of patients in each population achieved asthma control; 10% and 16% of patients in the initiation and step-up populations, respectively, received add-on or combination therapy during the year. Fluticasone was prescribed at significantly higher doses than HFA-beclomethasone for both populations (P

'Team ethnography visual maps': Methods for identifying the ethnographic object in multiple sites of fieldwork.

Team ethnography is becoming more popular in research. However, there is currently limited understanding of how multiple ethnographers working together actually share their experiences of conducting team ethnography. There is also an associated lack of explanation regarding how evidence and conclusions are drawn from such collective endeavour. This article attempts to address this absence of detail regarding the practice and conduct of team ethnography. In the following account, the authors present details of the design, development and application of 'team ethnography visual maps' and the collaborative reflexivity that took place within 'team ethnography data sessions' that were each embedded within a mixed methods study of frontline services located in six different National Health Service Trusts throughout England (UK). After a presentation of the ethnographic methods and analyses that occurred as part of team ethnography, they are then discussed in terms of their applied and academic value from a methodological perspective.

The use of roflumilast in COPD: a primary care perspective.

Therapeutic interventions in chronic obstructive pulmonary disease (COPD) shown to reduce exacerbations include smoking cessation, vaccination and appropriate pharmacological therapy. Long-acting bronchodilators are the cornerstone of COPD pharmacotherapy, whereas inhaled corticosteroids and mucolytics have shown benefit in subgroups of patients. Despite management with existing therapies, clinical trials confirm the persistent nature of exacerbations throughout the course of the disease. Roflumilast - a phosphodiesterase-4 (PDE4) inhibitor - received European Marketing Approval in 2010 and represents a new class of drug in the management of COPD. Through selective inhibition of the PDE4 enzyme, roflumilast prevents the breakdown of cyclic AMP, which plays an important role in regulating inflammatory cell activity. Early trials in patients with a forced expiratory volume in one second (FEV1) less than 50% predicted suggest that roflumilast offers sustained and significant improvement in lung function and a reduction in exacerbations compared with placebo, irrespective of concomitant bronchodilator therapy. Common adverse events include headache, diarrhoea and weight loss, with the majority occurring at the beginning of treatment, being transient and not leading to sequelae. Serious adverse events tended to be low across all studies. Roflumilast is currently licensed in Europe, and is indicated as maintenance treatment in severe COPD (i.e. in patients with post-bronchodilator FEV1 <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. Clear identification of patients eligible for roflumilast will require improved characterisation and phenotyping of patients in primary care, including lung function measurement, accurate health status classification, and recording of chronic cough and regular sputum production.