Development and Evaluation of a Framework for Identifying and Addressing Spin for Harms in Systematic Reviews of Interventions.

"Spin" refers to misleading reporting, interpretation, and extrapolation of findings in primary and secondary research (such as in systematic reviews). The study of spin primarily focuses on beneficial outcomes. The objectives of this research were threefold: first, to develop a framework for identifying spin associated with harms in systematic reviews of interventions; second, to apply the framework to a set of reviews, thereby pinpointing instances where spin may be present; and finally, to revise the spin examples, offering guidance on how spin can be rectified.The authors developed their framework through an iterative process that engaged an international group of researchers specializing in spin and reporting bias. The framework comprises 12 specific types of spin for harms, grouped by 7 categories across the 3 domains (reporting, interpretation, and extrapolation). The authors subsequently gathered instances of spin from a random sample of 100 systematic reviews of interventions. Of the 58 reviews that assessed harm and the 42 that did not, they found that 28 (48%) and 6 (14%), respectively, had at least 1 of the 12 types of spin for harms. Inappropriate extrapolation of the results and conclusions for harms to populations, interventions, outcomes, or settings not assessed in a review was the most common category of spin in 17 of 100 reviews.The authors revised the examples to remove spin, taking into consideration the context (for example, medical discipline, source population), findings for harms, and methodological limitations of the original reviews. They provide guidance for authors, peer reviewers, and editors in recognizing and rectifying or (preferably) avoiding spin, ultimately enhancing the clarity and accuracy of harms reporting in systematic review publications.

Influence of lack of blinding on the estimation of medication-related harms: a retrospective cohort study of randomized controlled trials.

BACKGROUND: Empirical evidence suggests that lack of blinding may be associated with biased estimates of treatment benefit in randomized controlled trials, but the influence on medication-related harms is not well-recognized. We aimed to investigate the association between blinding and clinical trial estimates of medication-related harms. METHODS: We searched PubMed from January 1, 2015, till January 1, 2020, for systematic reviews with meta-analyses of medication-related harms. Eligible meta-analyses must have contained trials both with and without blinding. Potential covariates that may confound effect estimates were addressed by restricting trials within the comparison or by hierarchical analysis of harmonized groups of meta-analyses (therefore harmonizing drug type, control, dosage, and registration status) across eligible meta-analyses. The weighted hierarchical linear regression was then used to estimate the differences in harm estimates (odds ratio, OR) between trials that lacked blinding and those that were blinded. The results were reported as the ratio of OR (ROR) with its 95% confidence interval (CI). RESULTS: We identified 629 meta-analyses of harms with 10,069 trials. We estimated a weighted average ROR of 0.68 (95% CI: 0.53 to 0.88, P < 0.01) among 82 trials in 20 meta-analyses where blinding of participants was lacking. With regard to lack of blinding of healthcare providers or outcomes assessors, the RORs were 0.68 (95% CI: 0.53 to 0.87, P < 0.01 from 81 trials in 22 meta-analyses) and 1.00 (95% CI: 0.94 to 1.07, P = 0.94 from 858 trials among 155 meta-analyses) respectively. Sensitivity analyses indicate that these findings are applicable to both objective and subjective outcomes. CONCLUSIONS: Lack of blinding of participants and health care providers in randomized controlled trials may underestimate medication-related harms. Adequate blinding in randomized trials, when feasible, may help safeguard against potential bias in estimating the effects of harms.

Methods and Annotated Data Sets Used to Predict the Gender and Age of Twitter Users: Scoping Review.

BACKGROUND: Patient health data collected from a variety of nontraditional resources, commonly referred to as real-world data, can be a key information source for health and social science research. Social media platforms, such as Twitter (Twitter, Inc), offer vast amounts of real-world data. An important aspect of incorporating social media data in scientific research is identifying the demographic characteristics of the users who posted those data. Age and gender are considered key demographics for assessing the representativeness of the sample and enable researchers to study subgroups and disparities effectively. However, deciphering the age and gender of social media users poses challenges. OBJECTIVE: This scoping review aims to summarize the existing literature on the prediction of the age and gender of Twitter users and provide an overview of the methods used. METHODS: We searched 15 electronic databases and carried out reference checking to identify relevant studies that met our inclusion criteria: studies that predicted the age or gender of Twitter users using computational methods. The screening process was performed independently by 2 researchers to ensure the accuracy and reliability of the included studies. RESULTS: Of the initial 684 studies retrieved, 74 (10.8%) studies met our inclusion criteria. Among these 74 studies, 42 (57%) focused on predicting gender, 8 (11%) focused on predicting age, and 24 (32%) predicted a combination of both age and gender. Gender prediction was predominantly approached as a binary classification task, with the reported performance of the methods ranging from 0.58 to 0.96 F1-score or 0.51 to 0.97 accuracy. Age prediction approaches varied in terms of classification groups, with a higher range of reported performance, ranging from 0.31 to 0.94 F1-score or 0.43 to 0.86 accuracy. The heterogeneous nature of the studies and the reporting of dissimilar performance metrics made it challenging to quantitatively synthesize results and draw definitive conclusions. CONCLUSIONS: Our review found that although automated methods for predicting the age and gender of Twitter users have evolved to incorporate techniques such as deep neural networks, a significant proportion of the attempts rely on traditional machine learning methods, suggesting that there is potential to improve the performance of these tasks by using more advanced methods. Gender prediction has generally achieved a higher reported performance than age prediction. However, the lack of standardized reporting of performance metrics or standard annotated corpora to evaluate the methods used hinders any meaningful comparison of the approaches. Potential biases stemming from the collection and labeling of data used in the studies was identified as a problem, emphasizing the need for careful consideration and mitigation of biases in future studies. This scoping review provides valuable insights into the methods used for predicting the age and gender of Twitter users, along with the challenges and considerations associated with these methods.

Alcohol policy framing in South Africa during the early stages of COVID-19: using extraordinary times to make an argument for a new normal.

INTRODUCTION: Public health and alcohol industry actors compete to frame alcohol policy problems and solutions. Little is known about how sudden shifts in the political context provide moments for policy actors to re-frame alcohol-related issues. South Africa's temporary bans on alcohol sales during the COVID-19 pandemic offered an opportunity to study this phenomenon. METHODS: We identified Professor Charles Parry from the South African Medical Research Council as a key policy actor. Parry uses a Twitter account primarily to comment on alcohol-related issues in South Africa. We harvested his tweets posted from March 18 to August 31, 2020, coinciding with the first two alcohol sales bans. We conducted a thematic analysis of the tweets to understand how Parry framed alcohol policy evidence and issues during these 'extraordinary times.' RESULTS: Parry underlined the extent of alcohol-related harm during 'normal times' with scientific evidence and contested industry actors' efforts to re-frame relevant evidence in a coherent and well-constructed argument. Parry used the temporary sales restrictions to highlight the magnitude of the health and social harms resulting from alcohol consumption, particularly trauma, rather than the COVID-19 transmission risks. Parry portrayed the sales ban as a policy learning opportunity (or 'experiment') for South Africa and beyond. CONCLUSIONS: Crisis conditions can provide new openings for public health (and industry) actors to make salient particular features of alcohol and alcohol policy evidence.

Priorities for research to support local authority action on health and climate change: a study in England.

BACKGROUND: Evidence is needed to support local action to reduce the adverse health impacts of climate change and maximise the health co-benefits of climate action. Focused on England, the study identifies priority areas for research to inform local decision making. METHODS: Firstly, potential priority areas for research were identified from a brief review of UK policy documents, and feedback invited from public and policy stakeholders. This included a survey of Directors of Public Health (DsPH) in England, the local government officers responsible for public health. Secondly, rapid reviews of research evidence examined whether there was UK evidence relating to the priorities identified in the survey. RESULTS: The brief policy review pointed to the importance of evidence in two broad areas: (i) community engagement in local level action on the health impacts of climate change and (ii) the economic (cost) implications of such action. The DsPH survey (n = 57) confirmed these priorities. With respect to community engagement, public understanding of climate change's health impacts and the public acceptability of local climate actions were identified as key evidence gaps. With respect to economic implications, the gaps related to evidence on the health and non-health-related costs and benefits of climate action and the short, medium and longer-term budgetary implications of such action, particularly with respect to investments in the built environment. Across both areas, the need for evidence relating to impacts across income groups was highlighted, a point also emphasised by the public involvement panel. The rapid reviews confirmed these evidence gaps (relating to public understanding, public acceptability, economic evaluation and social inequalities). In addition, public and policy stakeholders pointed to other barriers to action, including financial pressures, noting that better evidence is insufficient to enable effective local action. CONCLUSIONS: There is limited evidence to inform health-centred local action on climate change. More evidence is required on public perspectives on, and the economic dimensions of, local climate action. Investment in locally focused research is urgently needed if local governments are to develop and implement evidence-based policies to protect public health from climate change and maximise the health co-benefits of local action.

Characterizing asset-based studies in public health: development of a framework.

Asset-based approaches are becoming more common within public health interventions; however, due to variations in terminology, it can be difficult to identify asset-based approaches. The study aimed to develop and test a framework that could distinguish between asset-based and deficit-based community studies, whilst acknowledging there is a continuum of approaches. Literature about asset-based and deficit-based approaches were reviewed and a framework was developed based on the Theory of Change model. A scoring system was developed for each of the five elements in the framework based on this model. Measurement of community engagement was built in, and a way of capturing how much the study involved an asset approach. The framework was tested on 13 studies examining community-based interventions to investigate whether it could characterize asset-based versus deficit-based studies. The framework demonstrated how much the principles underpinning asset-based approaches were present and distinguished between studies where the approach was deficit-based to those that had some elements of an asset-based approach. This framework is useful for researchers and policymakers when determining how much of an intervention is asset-based and identifying which elements of asset-based approaches lead to an intervention working.

Deficit-based approaches are a common approach to addressing public health issues within a community and involve identifying a health problem or need and finding a way to solve these. However, asset-based approaches, those that involve the community using its assets, or strengths, to enable community members to have more control over their health and wellbeing, are increasingly common. The terminology used to describe these methods varies greatly so it can be difficult to identify whether an approach is more deficit-based or asset-based. To address this a framework was developed to identify and score elements of asset-based studies. We did this by reviewing academic information describing asset-based approaches and built into this a scoring system. This framework was used to assess and measure the degree to which 13 community-based studies took an asset-based approach. The framework was able to identify studies which were more asset-based in their approach compared to those which were more deficit-focused, acknowledging that some studies may have elements of each approach. This framework will be useful for people working in health policy and research who want a resource to help identify asset-based approaches in practice and which aspects of the approach were important for its success in the community.

Updated generic search filters for finding studies of adverse drug effects in Ovid medline and Embase may retrieve up to 90% of relevant studies.

BACKGROUND: The most current objectively derived search filters for adverse drug effects are 15 years old and other strategies have not been developed and tested empirically. OBJECTIVE: To develop and validate search filters to retrieve evidence on adverse drug effects from Ovid medline and Ovid Embase. METHODS: We identified systematic reviews of adverse drug effects in Epistemonikos. From these reviews, we collated their included studies which we then randomly divided into three tests and one validation set of records. We constructed a search strategy to maximise relative recall using word frequency analysis with test set one. This search strategy was then refined using test sets two and three and validated on the final set of records. RESULTS: Of 107 systematic reviews which met our inclusion criteria, 1948 unique included studies were available from medline and 1980 from Embase. Generic adverse drug effects searches in medline and Embase achieved 90% and 89% relative recall, respectively. When specific adverse effects terms were added recall was improved. CONCLUSION: We have derived and validated search filters that retrieve around 90% of records with adverse drug effects data in medline and Embase. The addition of specific adverse effects terms is required to achieve higher recall.

General practitioners' wellbeing during the COVID-19 pandemic: Novel methods with social media data.

BACKGROUND: It is difficult to engage busy healthcare professionals in research. Yet during the COVID-19 pandemic, gaining their perspectives has never been more important. OBJECTIVE: To explore social media data for insights into the wellbeing of UK General Practitioners (GPs) during the Covid-19 pandemic. METHODS: We used a combination of search approaches to identify 381 practising UK NHS GPs on Twitter. Using a two stage social media analysis, we firstly searched for key themes from 91,034 retrieved tweets (before and during the pandemic). Following this we used qualitative content analysis to provide in-depth insights from 7145 tweets related to wellbeing. RESULTS: Social media proved a useful tool to identify a cohort of UK GPs; following their tweets longitudinally to explore key themes and trends in issues related to GP wellbeing during the pandemic. These predominately related to support, resources and public perceptions and fluctuations were identified at key timepoints during the pandemic, all achieved without burdening busy GPs. CONCLUSION: Social media data can be searched to identify a cohort of GPs to explore their wellbeing and changes over time.

The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises.

TRANSLATIONS: For the Chinese, French, German, and Spanish translations of the abstract see Supplementary Materials section.

Methods to Establish Race or Ethnicity of Twitter Users: Scoping Review.

BACKGROUND: A growing amount of health research uses social media data. Those critical of social media research often cite that it may be unrepresentative of the population; however, the suitability of social media data in digital epidemiology is more nuanced. Identifying the demographics of social media users can help establish representativeness. OBJECTIVE: This study aims to identify the different approaches or combination of approaches to extract race or ethnicity from social media and report on the challenges of using these methods. METHODS: We present a scoping review to identify methods used to extract the race or ethnicity of Twitter users from Twitter data sets. We searched 17 electronic databases from the date of inception to May 15, 2021, and carried out reference checking and hand searching to identify relevant studies. Sifting of each record was performed independently by at least two researchers, with any disagreement discussed. Studies were required to extract the race or ethnicity of Twitter users using either manual or computational methods or a combination of both. RESULTS: Of the 1249 records sifted, we identified 67 (5.36%) that met our inclusion criteria. Most studies (51/67, 76%) have focused on US-based users and English language tweets (52/67, 78%). A range of data was used, including Twitter profile metadata, such as names, pictures, information from bios (including self-declarations), or location or content of the tweets. A range of methodologies was used, including manual inference, linkage to census data, commercial software, language or dialect recognition, or machine learning or natural language processing. However, not all studies have evaluated these methods. Those that evaluated these methods found accuracy to vary from 45% to 93% with significantly lower accuracy in identifying categories of people of color. The inference of race or ethnicity raises important ethical questions, which can be exacerbated by the data and methods used. The comparative accuracies of the different methods are also largely unknown. CONCLUSIONS: There is no standard accepted approach or current guidelines for extracting or inferring the race or ethnicity of Twitter users. Social media researchers must carefully interpret race or ethnicity and not overpromise what can be achieved, as even manual screening is a subjective, imperfect method. Future research should establish the accuracy of methods to inform evidence-based best practice guidelines for social media researchers and be guided by concerns of equity and social justice.

Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is characterized by symptoms of inattention or impulsivity or both, and hyperactivity, which affect children, adolescents, and adults. In some countries, methylphenidate is the first option to treat adults with moderate or severe ADHD. However, evidence on the efficacy and adverse events of immediate-release (IR) methylphenidate in the treatment of ADHD in adults is limited and controversial. OBJECTIVES: To evaluate the efficacy and harms (adverse events) of IR methylphenidate for treating ADHD in adults. SEARCH METHODS: In January 2020, we searched CENTRAL, MEDLINE, Embase, eight additional databases and three trial registers. We also searched internal reports on the European Medicines Agency and the US Food and Drug Administration websites. We checked citations of included trials to identify additional trials not captured by the electronic searches. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing IR methylphenidate, at any dose, with placebo or other pharmacological interventions (including extended-release formulations of methylphenidate) for ADHD in adults. Primary outcomes comprised changes in the symptoms of ADHD (efficacy) and harms. Secondary outcomes included changes in the clinical impression of severity and improvement, level of functioning, depression, anxiety and quality of life. Outcomes could have been rated by investigators or participants. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently on the characteristics of the trials, participants, interventions; outcomes and financial conflict of interests. We resolved disagreements by discussion or consulting a third review author. We obtained additional, unpublished information from the authors of one included trial that had reported efficacy data in a graph. We calculated mean differences (MDs) or standardized MDs (SMDs) with 95% confidence intervals (CIs) for continuous data reported on the same or different scales, respectively. We summarized dichotomous variables as risk ratios (RRs) with 95% CI. MAIN RESULTS: We included 10 trials published between 2001 and 2016 involving 497 adults with ADHD. Three trials were conducted in Europe and one in Argentina; the remaining trials did not report their location. The RCTs compared IR methylphenidate with placebo, an osmotic-release oral system (OROS) of methylphenidate (an extended-release formulation), an extended-release formulation of bupropion, lithium, and Pycnogenol® (maritime pine bark extract). Participants comprised outpatients, inpatients in addiction treatment, and adults willing to attend an intensive outpatient program for cocaine dependence. The duration of the follow-up ranged from 6 to 18 weeks. IR methylphenidate versus placebo We found very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce symptoms of ADHD when measured with investigator-rated scales (MD -20.70, 95% CI -23.97 to -17.43; 1 trial, 146 participants; end scores; Adult ADHD Investigator Symptom Report Scale (AISRS), scored from 0 to 54), but the evidence is uncertain. The effect of IR methylphenidate on ADHD symptoms when measured with participant-rated scales was moderate, but the certainty of the evidence is very low (SMD -0.59, 95% CI -1.25 to 0.06; I2 = 69%; 2 trials, 138 participants; end scores). There is very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce the clinical impression of the severity of ADHD symptoms (MD -0.57, 95% CI -0.85 to -0.28; 2 trials, 139 participants; I2 = 0%; change and end scores; Clinical Global Impression (CGI)-Severity scale (scored from 1 (very much improved) to 7 (very much worse))). There is low-certainty evidence that, compared with placebo, IR methylphenidate may slightly impact the clinical impression of an improvement in symptoms of ADHD (MD -0.94, 95% CI -1.37 to -0.51; 1 trial, 49 participants; end scores; CGI-Improvement scale (scored from 1 (very much improved) to 7 (very much worse))). There is no clear evidence of an effect on anxiety (MD -0.20, 95% CI -4.84 to 4.44; 1 trial, 19 participants; change scores; Hamilton Anxiety Scale (HAM-A; scored from 0 to 56); very low-certainty evidence) or depression (MD 2.80, 95% CI -0.09 to 5.69; 1 trial, 19 participants; change scores; Hamilton Depression Scale (HAM-D; scored from 0 to 52); very low-certainty evidence) in analyses comparing IR methylphenidate with placebo. IR methylphenidate versus lithium Compared with lithium, it is uncertain whether IR methylphenidate increases or decreases symptoms of ADHD (MD 0.60, 95% CI -3.11 to 4.31; 1 trial, 46 participants; end scores; Conners' Adult ADHD Rating Scale (scored from 0 to 198); very low-certainty evidence); anxiety (MD -0.80, 95% CI -4.49 to 2.89; 1 trial, 46 participants; end scores; HAM-A; very low-certainty evidence); or depression (MD -1.20, 95% CI -3.81 to 1.41, 1 trial, 46 participants; end scores; HAM-D scale; very low-certainty evidence). None of the included trials assessed participant-rated changes in symptoms of ADHD, or clinical impression of severity or improvement in participants treated with IR methylphenidate compared with lithium. Adverse events were poorly assessed and reported. We rated all trials at high risk of bias due to selective outcome reporting of harms and masking of outcome assessors (failure to blind outcome assessor to measure adverse events). Overall, four trials with 203 participants who received IR methylphenidate and 141 participants who received placebo described the occurrence of harms. The use of IR methylphenidate in these trials increased the risk of gastrointestinal complications (RR 1.96, 95% CI 1.13 to 2.95) and loss of appetite (RR 1.77, 95% CI 1.06 to 2.96). Cardiovascular adverse events were reported inconsistently, preventing a comprehensive analysis. One trial comparing IR methylphenidate to lithium reported five and nine adverse events, respectively. We considered four trials to have notable concerns of vested interests influencing the evidence, and authors from two trials omitted information related to the sources of funding and conflicts of interest. AUTHORS' CONCLUSIONS: We found no certain evidence that IR methylphenidate compared with placebo or lithium can reduce symptoms of ADHD in adults (low- and very low-certainty evidence). Adults treated with IR methylphenidate are at increased risk of gastrointestinal and metabolic-related harms compared with placebo. Clinicians should consider whether it is appropriate to prescribe IR methylphenidate, given its limited efficacy and increased risk of harms. Future RCTs should explore the long-term efficacy and risks of IR methylphenidate, and the influence of conflicts of interest on reported effects.

Declared funding and authorship by alcohol industry actors in the scientific literature: a bibliometric study.

BACKGROUND: Alcohol industry actors are known to be involved in scientific research. Despite concerns regarding bias, the extent of involvement and coverage of this research are unknown. METHODS: We aimed to investigate the extent and type of scientific research 1918-2019 which was supported by the alcohol industry, including alcohol companies themselves and other organizations, such as trade associations. We identified bibliographic records from the Web of Science suite of databases which have named alcohol companies or organizations in the fields relating to author affiliations and support declarations. We then ascertained trends in publications over time, type of support, funding, outlets (such as journal titles), subject areas covered (such as health) and named companies (such as Carlsberg) and organizations (such as Drinkaware). RESULTS: The analysis included 13 481 unique records, 11 014 (82%) were authored or funded by alcohol companies and 2488 (18%) were authored or funded by other organizations. The majority of the records (90%, 12 157/13 481) were journal publications. The most common subject areas covered by the publications were biology (5415/13 481, 40%), chemistry (3937/13 481, 29%) and health (3707/13 481, 27%). In line with general publishing trends, there has been an overall increase in research funded or supported by alcohol companies and organizations since records began. The main exception is the steady decline in company author affiliations, particularly in health-related topics since the mid-1990s. CONCLUSIONS: Alcohol companies and related organizations are extensively involved in or supporting scientific research according to data in Web of Science. This does not, however, necessarily reflect the totality of scientific research produced by alcohol companies and related organizations.

To what extent is multi-morbidity associated with new onset depression in patients attending cardiac rehabilitation?

BACKGROUND: Depression is associated with increased mortality and poor prognosis in patients with cardiovascular disease (CVD). However, little is known about the patient characteristics associated with new onset post heart event depressive symptoms, specifically medical comorbidities, among cardiac rehabilitation (CR) participants. Therefore, this paper examines the comorbidity profile and characteristics associated with new onset depressive symptoms in patients attending CR. METHODS: An observational study using the routine practice data of British Heart Foundation National Audit of Cardiac Rehabilitation (NACR) from the last six years between April 2012 and March 2018. Patients with new onset post heart event depression and no previous documented history of depression were selected as the study population. An independent samples t-test and chi square tests were used to compare the association between new onset depressive symptoms and patient variables including demographics, clinical measures and comorbidities. A binary logistic regression was conducted to investigate the predictors of new onset depressive symptoms employing log-likelihood ratio statistic. RESULTS: The analyses included 109,055 CR patients with new onset depression measured by Hospital Anxiety and Depression Scale (HADS). At baseline assessment, comorbidity measures associated with new onset depressive symptoms were increased total number of comorbidities and a range of comorbidities - including diabetes, angina, arthritis, chronic back problems, asthma, stroke, anxiety, rheumatism, claudication, osteoporosis, chronic bronchitis and emphysema. After multivariate adjustments were done, at the start of CR, the significant predictors of new onset depressive symptoms were physical inactivity, high HADS anxiety score measurement, increased weight, total number of comorbidities, diabetes, stroke, chronic back problems, being from areas with higher levels of social deprivation, being single, and male. CONCLUSION: The research findings establish new insights into the association between patient demographic and clinical variables across a range of comorbidities in patients with new onset post heart event depressive symptoms. At the start of CR, patients with new onset depressive symptoms need to be assessed skilfully as they tend to have a complex multi-morbid presentation linked to psychosocial risk factors known to hinder CR engagement.

Understanding Public Attitudes Toward Researchers Using Social Media for Detecting and Monitoring Adverse Events Data: Multi Methods Study.

BACKGROUND: Adverse events are underreported in research studies, particularly randomized controlled trials and pharmacovigilance studies. A method that researchers could use to identify more complete safety profiles for medications is to use social media analytics. However, patient's perspectives on the ethical issues associated with using patient reports of adverse drug events on social media are unclear. OBJECTIVE: The objective of this study was to explore the ethics of using social media for detecting and monitoring adverse events for research purposes using a multi methods approach. METHODS: A multi methods design comprising qualitative semistructured interviews (n=24), a focus group (n=3), and 3 Web-based discussions (n=20) with members of the public was adopted. Findings from a recent systematic review on the use of social media for monitoring adverse events provided a theoretical framework to interpret the study's findings. RESULTS: Views were ascertained regarding the potential benefits and harms of the research, privacy expectations, informed consent, and social media platform. Although the majority of participants were supportive of social media content being used for research on adverse events, a small number of participants strongly opposed the idea. The potential benefit of the research was cited as the most influential factor to whether participants would give their consent to their data being used for research. There were also some caveats to people's support for the use of their social media data for research purposes: the type of social media platform and consideration of the vulnerability of the social media user. Informed consent was regarded as difficult to obtain and this divided the opinion on whether it should be sought. CONCLUSIONS: Social media users were generally positive about their social media data being used for research purposes; particularly for research on adverse events. However, approval was dependent on the potential benefit of the research and that individuals are protected from harm. Further study is required to establish when consent is required for an individual's social media data to be used.

The development of search filters for adverse effects of medical devices in medline and embase.

BACKGROUND: Objectively derived search filters for adverse drug effects and complications in surgery have been developed but not for medical device adverse effects. OBJECTIVE: To develop and validate search filters to retrieve evidence on medical device adverse effects from ovid medline and embase. METHODS: We identified systematic reviews from Epistemonikos and the Health Technology Assessment (hta) database. Included studies within these reviews that reported on medical device adverse effects were randomly divided into three test sets and one validation set of records. Using word frequency analysis from one test set, we constructed a sensitivity maximising search strategy. This strategy was refined using two other test sets, then validated. RESULTS: From 186 systematic reviews which met our inclusion criteria, 1984 unique included studies were available from medline and 1986 from embase. Generic adverse effects searches in medline and embase achieved 84% and 83% sensitivity. Recall was improved to over 90%, however, when specific adverse effects terms were added. CONCLUSION: We have derived and validated novel search filters that retrieve over 80% of records with medical device adverse effects data in medline and embase. The addition of specific adverse effects terms is required to achieve higher levels of sensitivity.

Development and validation of a search filter to identify equity-focused studies: reducing the number needed to screen.

BACKGROUND: Health inequalities, worse health associated with social and economic disadvantage, are reported by a minority of research articles. Locating these studies when conducting an equity-focused systematic review is challenging due to a deficit in standardised terminology, indexing, and lack of validated search filters. Current reporting guidelines recommend not applying filters, meaning that increased resources are needed at the screening stage. METHODS: We aimed to design and test search filters to locate studies that reported outcomes by a social determinant of health. We developed and expanded a 'specific terms strategy' using keywords and subject headings compiled from recent systematic reviews that applied an equity filter. A 'non-specific strategy' was compiled from phrases used to describe equity analyses that were reported in titles and abstracts, and related subject headings. Gold standard evaluation and validation sets were compiled. The filters were developed in MEDLINE, adapted for Embase and tested in both. We set a target of 0.90 sensitivity (95% CI; 0.84, 0.94) in retrieving 150 gold standard validation papers. We noted the reduction in the number needed to screen in a proposed equity-focused systematic review and the proportion of equity-focused reviews we assessed in the project that applied an equity filter to their search strategy. RESULTS: The specific terms strategy filtered out 93-95% of all records, and retrieved a validation set of articles with a sensitivity of 0.84 in MEDLINE (0.77, 0.89), and 0.87 (0.81, 0.92) in Embase. When combined (Boolean 'OR') with the non-specific strategy sensitivity was 0.92 (0.86, 0.96) in MEDLINE (Embase 0.94; 0.89, 0.97). The number needed to screen was reduced by 77% by applying the specific terms strategy, and by 59.7% (MEDLINE) and 63.5% (Embase) by applying the combined strategy. Eighty-one per cent of systematic reviews filtered studies by equity. CONCLUSIONS: A combined approach of using specific and non-specific terms is recommended if systematic reviewers wish to filter studies for reporting outcomes by social determinants. Future research should concentrate on the indexing standardisation for equity studies and further development and testing of both specific and non-specific terms for accurate study retrieval.

Factors associated with acute depressive symptoms in patients with comorbid depression attending cardiac rehabilitation.

BACKGROUND: The literature suggests that comorbid depression, defined in this paper as a history of depression prior to a cardiovascular event, has an impact on later onset depression as well as constituting increased risk of mortality and adverse cardiac events. However, which factors are associated with depression, specifically in patients with comorbid depression, is unclear. Therefore, this paper investigates the factors associated with depression in patients with comorbid depression attending cardiac rehabilitation (CR). METHODS: This observational study used routinely collected data from the British Heart Foundation National Audit of Cardiac Rehabilitation for the time period between April 2012 and March 2017. CR participants with comorbid depression were selected as the study population. An independent t-test and chi-square test were used to compare the association between acute depression symptoms and baseline characteristics in this population. RESULTS: A total of 2715 CR patients with comorbid depression were analysed. Characteristics associated with acute depressive symptoms in patients with comorbid depression were found to be: young age (MD: 2.71, 95% CI 1.91, 3.50), increased number of comorbidities (MD: -0.50, 95% CI -0.66, - 0.34), increased weight (MD: -1.94, 95% CI -3.35, - 0.52), high BMI (MD: -1.94, 95% CI -3.35, - 0.52), HADS anxiety (MD: -5.17, 95% CI -5.47, - 4.87), comorbid anxiety (52.4%, p <  0.001), physical inactivity (150 min moderate physical activity a week and 75 min vigorous exercise a week; 27.5%, p <  0.001; 5.6%, p <  0.001 respectively), smoking (12.7%, p <  0.001), and being less likely to be partnered (63.6%, p <  0.001). CONCLUSION: The study demonstrated the association between a variety of clinical and socio-demographic factors and depression. The findings of the research indicated that, at CR baseline assessment, caution must be taken with patients with comorbid depression, specifically those with higher level depressive symptoms at the start of rehabilitation. Furthermore, their multi-comorbid condition must also be taken into account. Patients with higher depression symptoms and comorbid depression scored five points higher on the HADS anxiety scale in comparison to patients with lower level depression symptoms at the start of CR, which demonstrated that anxiety and depression are interrelated and present together.

The development of search filters for adverse effects of surgical interventions in medline and Embase.

BACKGROUND: Search filter development for adverse effects has tended to focus on retrieving studies of drug interventions. However, a different approach is required for surgical interventions. OBJECTIVE: To develop and validate search filters for medline and Embase for the adverse effects of surgical interventions. METHODS: Systematic reviews of surgical interventions where the primary focus was to evaluate adverse effect(s) were sought. The included studies within these reviews were divided randomly into a development set, evaluation set and validation set. Using word frequency analysis we constructed a sensitivity maximising search strategy and this was tested in the evaluation and validation set. RESULTS: Three hundred and fifty eight papers were included from 19 surgical intervention reviews. Three hundred and fifty two papers were available on medline and 348 were available on Embase. Generic adverse effects search strategies in medline and Embase could achieve approximately 90% relative recall. Recall could be further improved with the addition of specific adverse effects terms to the search strategies. CONCLUSION: We have derived and validated a novel search filter that has reasonable performance for identifying adverse effects of surgical interventions in medline and Embase. However, we appreciate the limitations of our methods, and recommend further research on larger sample sizes and prospective systematic reviews.

Overview of systematic reviews of therapeutic ranges: methodologies and recommendations for practice.

BACKGROUND: Many medicines are dosed to achieve a particular therapeutic range, and monitored using therapeutic drug monitoring (TDM). The evidence base for a therapeutic range can be evaluated using systematic reviews, to ensure it continues to reflect current indications, doses, routes and formulations, as well as updated adverse effect data. There is no consensus on the optimal methodology for systematic reviews of therapeutic ranges. METHODS: An overview of systematic reviews of therapeutic ranges was undertaken. The following databases were used: Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts and Reviews of Effects (DARE) and MEDLINE. The published methodologies used when systematically reviewing the therapeutic range of a drug were analyzed. Step by step recommendations to optimize such systematic reviews are proposed. RESULTS: Ten systematic reviews that investigated the correlation between serum concentrations and clinical outcomes encompassing a variety of medicines and indications were assessed. There were significant variations in the methodologies used (including the search terms used, data extraction methods, assessment of bias, and statistical analyses undertaken). Therapeutic ranges should be population and indication specific and based on clinically relevant outcomes. Recommendations for future systematic reviews based on these findings have been developed. CONCLUSION: Evidence based therapeutic ranges have the potential to improve TDM practice. Current systematic reviews investigating therapeutic ranges have highly variable methodologies and there is no consensus of best practice when undertaking systematic reviews in this field. These recommendations meet a need not addressed by standard protocols.

Attitudes Toward the Ethics of Research Using Social Media: A Systematic Review.

BACKGROUND: Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. OBJECTIVE: The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. METHODS: A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. RESULTS: In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. CONCLUSIONS: Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an individual assessment of its own ethical issues. Guidelines on ethical conduct should be based on current evidence and standardized to avoid discrepancies between, and duplication across, different institutions, taking into consideration different jurisdictions.