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.

ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi.

BACKGROUND: In biomedical research, it is often desirable to seek consensus among individuals who have differing perspectives and experience. This is important when evidence is emerging, inconsistent, limited, or absent. Even when research evidence is abundant, clinical recommendations, policy decisions, and priority-setting may still require agreement from multiple, sometimes ideologically opposed parties. Despite their prominence and influence on key decisions, consensus methods are often poorly reported. Our aim was to develop the first reporting guideline dedicated to and applicable to all consensus methods used in biomedical research regardless of the objective of the consensus process, called ACCORD (ACcurate COnsensus Reporting Document). METHODS AND FINDINGS: We followed methodology recommended by the EQUATOR Network for the development of reporting guidelines: a systematic review was followed by a Delphi process and meetings to finalize the ACCORD checklist. The preliminary checklist was drawn from the systematic review of existing literature on the quality of reporting of consensus methods and suggestions from the Steering Committee. A Delphi panel (n = 72) was recruited with representation from 6 continents and a broad range of experience, including clinical, research, policy, and patient perspectives. The 3 rounds of the Delphi process were completed by 58, 54, and 51 panelists. The preliminary checklist of 56 items was refined to a final checklist of 35 items relating to the article title (n = 1), introduction (n = 3), methods (n = 21), results (n = 5), discussion (n = 2), and other information (n = 3). CONCLUSIONS: The ACCORD checklist is the first reporting guideline applicable to all consensus-based studies. It will support authors in writing accurate, detailed manuscripts, thereby improving the completeness and transparency of reporting and providing readers with clarity regarding the methods used to reach agreement. Furthermore, the checklist will make the rigor of the consensus methods used to guide the recommendations clear for readers. Reporting consensus studies with greater clarity and transparency may enhance trust in the recommendations made by consensus panels.

Pharmaceutical Company Targets and Strategies to Address Climate Change: Content Analysis of Public Reports from 20 Pharmaceutical Companies.

The pharmaceutical industry produces a large proportion of health system greenhouse gas (GHG) emissions, contributing to climate change. This urgently needs to be addressed. We aimed to examine pharmaceutical company climate change targets, GHG emissions, and strategies to reduce them. We performed content analysis of the 20 largest pharmaceutical companies' publicly available 2020/2021 reports, focusing on extracting information on their reported climate change targets, GHG emissions (and whether companies had demonstrated any reduction in emissions over their reporting period), and strategies being implemented to reduce company emissions and meet their targets. Nineteen companies have committed to reducing GHG emissions, ten to carbon neutrality and eight to net zero emissions between 2025 and 2050. Companies showed largely favorable reductions in scope 1 (in-house) and scope 2 (purchased energy), with variable results in scope 3 (supply chain) emissions. Strategies to reduce emissions included optimizing manufacturing and distribution, and responsible sourcing of energy, water, and raw materials. Pharmaceutical companies are setting climate change targets and reporting reduced emissions via a range of strategies. This varies, with scope to track actions and accountability to targets, improve consistency of reporting, especially of scope 3 emissions, and collaborate on novel solutions. There is need for further mixed methods research on progress with achieving reported climate change targets, as well as implementation of strategies to reduce emissions within the pharmaceutical industry.

ACCORD guideline for reporting consensus-based methods in biomedical research and clinical practice: a study protocol.

BACKGROUND: Structured, systematic methods to formulate consensus recommendations, such as the Delphi process or nominal group technique, among others, provide the opportunity to harness the knowledge of experts to support clinical decision making in areas of uncertainty. They are widely used in biomedical research, in particular where disease characteristics or resource limitations mean that high-quality evidence generation is difficult. However, poor reporting of methods used to reach a consensus - for example, not clearly explaining the definition of consensus, or not stating how consensus group panellists were selected - can potentially undermine confidence in this type of research and hinder reproducibility. Our objective is therefore to systematically develop a reporting guideline to help the biomedical research and clinical practice community describe the methods or techniques used to reach consensus in a complete, transparent, and consistent manner. METHODS: The ACCORD (ACcurate COnsensus Reporting Document) project will take place in five stages and follow the EQUATOR Network guidance for the development of reporting guidelines. In Stage 1, a multidisciplinary Steering Committee has been established to lead and coordinate the guideline development process. In Stage 2, a systematic literature review will identify evidence on the quality of the reporting of consensus methodology, to obtain potential items for a reporting checklist. In Stage 3, Delphi methodology will be used to reach consensus regarding the checklist items, first among the Steering Committee, and then among a broader Delphi panel comprising participants with a range of expertise, including patient representatives. In Stage 4, the reporting guideline will be finalised in a consensus meeting, along with the production of an Explanation and Elaboration (E&E) document. In Stage 5, we plan to publish the reporting guideline and E&E document in open-access journals, supported by presentations at appropriate events. Dissemination of the reporting guideline, including a website linked to social media channels, is crucial for the document to be implemented in practice. DISCUSSION: The ACCORD reporting guideline will provide a set of minimum items that should be reported about methods used to achieve consensus, including approaches ranging from simple unstructured opinion gatherings to highly structured processes.

Management Of Community-Acquired Pneumonia: An Observational Study In UK Primary Care.

PURPOSE: In primary care, initial diagnosis of community-acquired pneumonia (CAP) is made on clinical judgment without radiological confirmation or knowledge of the causative organism. Use of CRB65 score has been recommended for assessing the severity of CAP and thereby determining clinical management, but it is not known how frequently these scores are used in primary care. PATIENTS AND METHODS: Primary care consultations in adults with a diagnostic code for CAP between 1 January 2009 and 31 December 2016 were extracted from the Optimum Patient Care Research Database, which at the time of data extraction had over 3.4 million patients in the UK. Episodes without antibiotic prescription on day of diagnosis were excluded, as were records describing past events. Patients admitted to hospital on day of diagnosis were excluded, but were included in exploratory analysis of CRB65 recording. RESULTS: In total, 4734 episodes of CAP in adults managed in primary care between 1 January 2009 and 31 December 2016 were included. A range of investigations/observations were recorded, including pulse rate (10.7%), chest examinations (9.1%) and blood tests (5.4%). CRB65 scores were recorded in 19 (0.4%) episodes of CAP, 17 of which were after the publication of the NICE guidelines in December 2014. CRB65 recording was no more frequent in 3819 episodes referred to hospital (12, 0.3%; p=0.63), but where recorded, CRB65 scores were higher (Median: 1.0 [interquartile range: 0.5-1.0] vs 2.0 [interquartile range: 1.0-2.0], p=0.04). The most commonly prescribed antibiotic was amoxicillin (40.3%), and 85.9% of episodes had a prescription length of seven days. CONCLUSION: CRB65 scores are seldom recorded in UK primary care. Given that these scores are embedded in UK guidelines, further work is required to assess feasibility and barriers to use of CRB65 scores in primary care.

Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review.

BACKGROUND: Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. METHODS: Using terms related to 'medical writer' and 'observational study', we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2018). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2018) and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. RESULTS: Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed), publication in journals with an impact factor (one study), a higher quality of written English (one study), and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). CONCLUSIONS: This systematic review of eight observational studies suggests that PMWS is positively associated with measures of overall quality of reporting of clinical trials and may improve the timeliness of publication.

Open access policies of leading medical journals: a cross-sectional study.

OBJECTIVES: Academical and not-for-profit research funders are increasingly requiring that the research they fund must be published open access, with some insisting on publishing with a Creative Commons Attribution (CC BY) licence to allow the broadest possible use. We aimed to clarify the open access variants provided by leading medical journals and record the availability of the CC BY licence for commercially funded research. METHODS: We identified medical journals with a 2015 impact factor of ≥15.0 on 24 May 2017, then excluded from the analysis journals that only publish review articles. Between 29 June 2017 and 26 July 2017, we collected information about each journal's open access policies from their websites and/or by email contact. We contacted the journals by email again between 6 December 2017 and 2 January 2018 to confirm our findings. RESULTS: Thirty-five medical journals publishing original research from 13 publishers were included in the analysis. All 35 journals offered some form of open access allowing articles to be free-to-read, either immediately on publication or after a delay of up to 12 months. Of these journals, 21 (60%) provided immediate open access with a CC BY licence under certain circumstances (eg, to specific research funders). Of these 21, 20 only offered a CC BY licence to authors funded by non-commercial organisations and one offered this option to any funder who required it. CONCLUSIONS: Most leading medical journals do not offer to authors reporting commercially funded research an open access licence that allows unrestricted sharing and adaptation of the published material. The journals' policies are therefore not aligned with open access declarations and guidelines. Commercial research funders lag behind academical funders in the development of mandatory open access policies, and it is time for them to work with publishers to advance the dissemination of the research they fund.

Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23-0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37-3.03) and funding source (RR 1.75; 95% CI, 1.18-2.60). Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

OBJECTIVES: Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). DESIGN: Cross-sectional study. STUDY SAMPLE: Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). MAIN OUTCOME MEASURES: Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. RESULTS: The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). CONCLUSIONS: In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting.

Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review.

OBJECTIVE: To update the findings of the 2005 systematic review of population-based studies assessing the epidemiology of gastro-oesophageal reflux disease (GERD). DESIGN: PubMed and Embase were screened for new references using the original search strings. Studies were required to be population-based, to include ≥ 200 individuals, to have response rates ≥ 50% and recall periods <12 months. GERD was defined as heartburn and/or regurgitation on at least 1 day a week, or according to the Montreal definition, or diagnosed by a clinician. Temporal and geographic trends in disease prevalence were examined using a Poisson regression model. RESULTS: 16 studies of GERD epidemiology published since the original review were found to be suitable for inclusion (15 reporting prevalence and one reporting incidence), and were added to the 13 prevalence and two incidence studies found previously. The range of GERD prevalence estimates was 18.1%-27.8% in North America, 8.8%-25.9% in Europe, 2.5%-7.8% in East Asia, 8.7%-33.1% in the Middle East, 11.6% in Australia and 23.0% in South America. Incidence per 1000 person-years was approximately 5 in the overall UK and US populations, and 0.84 in paediatric patients aged 1-17 years in the UK. Evidence suggests an increase in GERD prevalence since 1995 (p<0.0001), particularly in North America and East Asia. CONCLUSIONS: GERD is prevalent worldwide, and disease burden may be increasing. Prevalence estimates show considerable geographic variation, but only East Asia shows estimates consistently lower than 10%.

Antibiotic prescribing and outcomes of lower respiratory tract infection in UK primary care.

BACKGROUND: Lower respiratory tract infection (LRTI) is common in the community and may result in hospitalization or death. This observational study aimed to investigate the role of antibiotics in the management of LRTI in the primary care setting in the United Kingdom. METHODS: Patients receiving a first diagnosis of LRTI during 2004 and satisfying inclusion and data quality criteria were identified in the General Practice Research Database. Factors associated with respiratory infection-related hospital admissions and death in the 3 months following the initial diagnosis were identified using Cox proportional hazards regression. RESULTS: Antibiotic prescribing on the day of diagnosis was associated with a decreased rate of respiratory infection-related hospital admission (hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.58 to 0.92), while antibiotic prescribing in the previous 7 days (HR, 1.92; 95% CI, 1.24 to 2.96) and prior referral or hospitalization (HR, 1.48; 95% CI, 1.20 to 1.83) were associated with an increased risk of hospital admission. Female sex (HR, 0.73; 95% CI, 0.64 to 0.84), allergic rhinitis (HR, 0.48; 95% CI, 0.27 to 0.83), influenza vaccination (HR, 0.75; 95% CI, 0.65 to 0.87), prior inhaled corticosteroid use (HR, 0.63; 95% CI, 0.52 to 0.76), and antibiotic prescription on the day of diagnosis (HR, 0.31; 95% CI, 0.26 to 0.37) were associated with decreased respiratory infection-related mortality, while a Charlson comorbidity index of >or= 2 (HR, 2.24; 95% CI, 1.72 to 2.92), antibiotic prescription in the previous 7 days (HR, 1.56; 95% CI, 1.20 to 2.03), and frequent consultation (HR, 1.62; 95% CI, 1.09 to 2.40) were associated with increased mortality. CONCLUSIONS: Antibiotic prescribing on the day of LRTI diagnosis was associated with reductions in hospital admissions and mortality related to respiratory infection. Antibiotics may help to prevent adverse outcomes for some patients with LRTI.

Community-acquired pneumonia mortality: a potential link to antibiotic prescribing trends in general practice.

BACKGROUND: Community prescribing of antibiotics has decreased substantially in the UK in recent years. We examine the association between pneumonia mortality and recent changes in community-based antibiotic prescribing for lower respiratory tract infections (LRTI). METHODS: Retrospective analysis of aggregated data for pneumonia mortality, influenza incidence, and antibiotic prescribing for LRTI in England and Wales during 12-week winter periods between 1993/94 and 1999/2000. RESULTS: Winter antibiotic prescribing for LRTI showed a 30.0% decline since 1995/96. Over the same period, there was a 50.6% increase in winter excess pneumonia mortality adjusted for influenza incidence. Negative binomial regression analysis showed that the incidence of influenza alone had a significant association with winter pneumonia mortality (P<0.001). The analysis also showed the reduction in antibiotic prescribing had a small but significant association with mortality (P<0.001), when simultaneously modelling for influenza incidence. CONCLUSIONS: Our findings suggest an association between recent reductions in antibiotic prescribing for LRTI in general practice and an increase in pneumonia mortality in England and Wales. This retrospective study of aggregate data represents the first attempt to assess the effect of limiting antibiotic prescribing on patient outcomes, and highlights the need to identify which patients benefit from antibiotic treatment for LRTI.