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Enhancing the trustworthiness of pain research: A call to action.
The personal, social and economic burden of chronic pain is enormous. Tremendous research efforts are being directed toward understanding, preventing, and managing chronic pain. Yet patients with chronic pain, clinicians and the public are sometimes poorly served by an evidence architecture that contains multiple structural weaknesses. These include incomplete research governance, a lack of diversity and inclusivity, inadequate stakeholder engagement, poor methodological rigour and incomplete reporting, a lack of data accessibility and transparency, and a failure to communicate findings with appropriate balance. These issues span pre-clinical research, clinical trials and systematic reviews and impact the development of clinical guidance and practice. Research misconduct and inauthentic data present a further critical risk. Combined, they increase uncertainty in this highly challenging area of study and practice, drive the provision of low value care, increase costs and impede the discovery of more effective solutions. In this focus article, we explore how we can increase trust in pain science, by examining critical challenges using contemporary examples, and describe a novel integrated conceptual framework for enhancing the trustworthiness of pain science. We end with a call for collective action to address this critical issue. Perspective: Multiple challenges can adversely impact the trustworthiness of pain research and health research more broadly. We present ENTRUST-PE, a novel, integrated framework for more trustworthy pain research with recommendations for all stakeholders in the research ecosystem, and make a call to action to the pain research community.
The Association between COVID-19 Status and Economic Costs in the Early Stages of the COVID-19 Pandemic: Evidence from a UK Symptom Surveillance Digital Survey.
INTRODUCTION: In the absence of a vaccination programme, the coronavirus disease 2019 (COVID-19) pandemic had substantial impacts on population health and wellbeing and health care services. We explored the association between COVID-19 status, sociodemographic, socioeconomic and clinical factors and economic costs during the second wave of the COVID-19 pandemic. DATA: The study used patient-reported digital survey and symptom surveillance data collected between July and December 2020, in collaboration with a primary care computerised medical record system supplier, EMIS Health, in the UK. The study included 11,534 participants. METHODS: Generalised linear models (GLM) and two-part regression models were used to estimate factors associated with economic costs (£sterling, 2022 prices) estimated from two perspectives: (i) a UK National Health Service (NHS) and personal social services (PSS) perspective and (ii) a societal perspective. RESULTS: Experience of the onset of COVID-19 symptoms started more than 3 months ago was associated with significantly higher NHS and PSS costs (GLM: £319.8, two-part: £171.7) (p < 0.001) and societal costs (GLM: £776.9, two-part: £675.6) (p < 0.001) in both models. A positive test result within the previous 14 days was associated with significantly higher NHS and PSS costs (two-part: £389.1) (p < 0.05) and societal costs (GLM: £470.7, two-part: £439.2) (p < 0.01). Age between 31 and 55 years was associated with significantly higher societal costs than age between 16 and 30 years. CONCLUSION: This study identifies and quantifies factors associated with the economic costs incurred during the second wave of the COVID-19 pandemic in the UK. The results of our study can inform cross-country comparisons and other cost comparisons.
Respiratory Syncytial Virus-related Community Chronic Obstructive Pulmonary Disease Exacerbations and Novel Diagnostics: A Binational Prospective Cohort Study
Rationale: Respiratory syncytial virus (RSV) is a common global respiratory virus that is increasingly recognized as a major pathogen in frail older adults and as a cause of chronic obstructive pulmonary disease (COPD) exacerbations. There is no single test for RSV in adults that has acceptable diagnostic accuracy. Trials of RSV vaccines have recently shown excellent safety and efficacy against RSV in older adults; defining the frequency of RSV-related community infections and COPD exacerbations is important for vaccine deployment decisions. Objectives: This prospective study aimed to establish the frequency of outpatient-managed RSV-related exacerbations of COPD in two well-characterized patient cohorts using a combination of diagnostic methods. Methods: Participants were recruited at specialist clinics in London, United Kingdom, and Groningen, the Netherlands, beginning in 2017 and observed for three consecutive RSV seasons, during exacerbations, and at least twice yearly. RSV infections were detected by RT-PCR and serologic testing. Measurements and Main Results: A total of 377 patients with COPD attended 1,999 clinic visits and reported 310 exacerbations. There were 27 RSV-related exacerbations (8.7% of the total); of these, seven were detected only by PCR, 16 only by serology, and four by both methods. Increases in RSV-specific Nucleoprotein antibody were as sensitive as those in the antibody to Pre-Fusion or Post-Fusion for serodiagnosis of RSV-related exacerbations. Conclusions: RSV is associated with 8.7% of outpatientmanaged COPD exacerbations in this study. Antibodies to RSV Nucleoprotein may have diagnostic value and are potentially important in a vaccinated population. The introduction of vaccines that prevent RSV is expected to benefit patients with COPD.
Digging for Literature on Tailoring Cultural Offers With and for Older People From Ethnic Minority Groups: A Scoping Review
ABSTRACTIntroductionSocial prescribing addresses non‐medical issues (e.g., loneliness, financial worries, housing problems) affecting physical and/or mental health. It involves connecting people to external support or services, including ‘cultural offers’–events, groups and activities run within or by cultural organisations. Such offers need to be acceptable and accessible to diverse populations if forming part of a social prescription.MethodsA scoping review was conducted to identify what existing literature, conducted in the United Kingdom, tells us about tailoring cultural offers for older people (aged 60+ years) from ethnic minority groups. Relevant literature was searched for on electronic databases, through Google, via a questionnaire to cultural organisations and by contacting the study's advisory group.ResultsScreening of 906 references–59 of which were read as full documents–resulted in six sources being included in the review. Some cultural activities described within them were run in traditional cultural spaces (e.g., museums, art galleries). Others were held in community centres. Data suggested that attending with others could reduce concerns about belonging. Barriers to engagement included low energy, language, poor confidence, accessing transport and unfamiliarity with a setting and/or activities. Provision of familiar food could help make people feel welcomed.ConclusionsReviewed papers showed that consulting with target groups is important to ensure that activities are inclusive and sympathetically delivered. The review also highlighted a paucity of published research on the topic; this means that cultural providers have little evidence to draw on when developing cultural offers for older people from ethnic minority groups.
Medical school ranking and provider outpatient Medicare Part D claims for antibiotics among older patients in the USA.
BACKGROUND: Our study aimed to assess whether there was a relationship between graduating from higher-ranked medical schools and the rate of prescribing antibiotics among Medicare Part D providers in the USA. METHODS: The study obtained data from the Medicare Part D Prescribers (FY2013-2021) and the Doctor and Clinicians National repositories. A regression model was fitted to assess the relationship between provider medical school ranking and the rate of antibiotic days supplied per 100 beneficiaries at the provider level. RESULTS: A total of 197 540 providers were included. No association was found between the medical school ranking and the rate of antibiotics days supplied per 100 beneficiaries. Instead, the type of provider is associated with the prescription rates. Hospitalists and Emergency Medicine providers had fewer days supplied per 100 beneficiaries than Family Medicine providers. In contrast, students, more experienced providers (>20 years since medical school graduation) and females had more days supplied per 100 beneficiaries. CONCLUSION: Our study highlights the need for robust outpatient stewardship interventions and incorporating an outcome-based approach to antibiotic stewardship curricula in medical and mid-level provider schools.
Methodological literature on the reporting of systematic reviews of health economic evaluations: a scoping review protocol
Systematic reviews of health economic evaluations play a crucial role in informing evidence-based healthcare decisions, yet they lack standardized reporting guidelines. A project has been initiated that aims to extend the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline for systematic reviews of health economic evaluations (PRISMA-EconEval). This scoping review forms a foundation for the PRISMA-EconEval project, aiming to identify, map, and extract candidate reporting items from the methodological literature. The scoping review will follow the PRISMA Extension for Scoping Reviews (PRISMA-ScR) Checklist and involve comprehensive searches in databases such as PubMed MEDLINE, Embase, and Web of Science, covering the period from 2015 to 2024. Supplementary searching, reference checking and citation searching will target grey literature, overlooked studies and evidence prior to 2015. Inclusion criteria will focus on methodological papers that provide frameworks or recommendations for reporting systematic reviews of health economic evaluations and enhanced case studies that critically discuss methods and reporting structures. The extracted data will be coded and analyzed to produce an initial list of candidate reporting items, structured according to conventional sections of a systematic review (e.g., title, abstract, methods, results). This initial list will be used in the subsequent stages of the project and disseminated through a peer-reviewed publication and presentations at international conferences. The outcome of this scoping review will significantly contribute to the development of a comprehensive PRISMA-EconEval reporting guideline, aimed at enhancing the transparency, consistency, and quality of systematic reviews of health economic evaluations, and provide an essential tool for authors, editors, peer-reviewers, and stakeholders.
Evaluating the efficacy and mechanisms of a ketogenic diet as adjunctive treatment for people with treatment-resistant depression: A protocol for a randomised controlled trial
Background: One-third of people with depression do not respond to antidepressants, and, after two adequate courses of antidepressants, are classified as having treatment-resistant depression (TRD). Some case reports suggest that ketogenic diets (KDs) may improve some mental illnesses, and preclinical data indicate that KDs can influence brain reward signalling, anhedonia, cortisol, and gut microbiome which are associated with depression. To date, no trials have examined the clinical effect of a KD on TRD. Methods: This is a proof-of-concept randomised controlled trial to investigate the efficacy of a six-week programme of weekly dietitian counselling plus provision of KD meals, compared with an intervention involving similar dietetic contact time and promoting a healthy diet with increased vegetable consumption and reduction in saturated fat, plus food vouchers to purchase healthier items. At 12 weeks we will assess whether participants have continued to follow the assigned diet. The primary outcome is the difference between groups in the change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 weeks. PHQ-9 will be measured at weeks 2, 4, 6 and 12. The secondary outcomes are the differences between groups in the change in remission of depression, change in anxiety score, functioning ability, quality of life, cognitive performance, reward sensitivity, and anhedonia from baseline to 6 and 12 weeks. We will also assess whether changes in reward sensitivity, anhedonia, cortisol awakening response and gut microbiome may explain any changes in depression severity. Discussion: This study will test whether a ketogenic diet is an effective intervention to reduce the severity of depression, anxiety and improve quality of life and functioning ability for people with treatment-resistant depression.
The Heterogeneous Effect of COVID-19 on the Gender Gap in Iran
Abstract COVID-19 has impacted all human beings, but more severely people with baseline vulnerabilities, and especially women. The impact is even more pronounced in developing countries where gender gap bias is more acute. We use the national data set of the Labor Force Survey, from 2015 to summer 2020, to assess the heterogeneous impacts of the downturn on the employment of women in Iran. Findings show that women have disproportionately exited the labor market, which widens the gender gap in the participation rate. They also show a slower recovery for women compared to men. In contrast, when remaining in the labor market women’s working hours are less affected than men’s. Overall, our findings show a heterogeneous effect from the pandemic among women regarding their education level, age, and occupational choices.
Gatekeeping in primary care: Analysing GP referral patterns and specialist consultations in the NHS
This study investigates the impact of increasing the number of gatekeeper General Practitioners (GPs) on referral rates and specialist treatments. Gatekeeping is a supply-side strategy implemented to control health expenditure and improve efficiency by limiting patient access to services below marginal cost. It aims to address specialist moral hazard by reducing the overuse of expensive diagnostics and replacing them with more cost-effective GP diagnostic information. Using administrative data from 2004 to 2011, we examine whether the availability of gatekeeper GPs in local areas is associated with changes in outpatient referrals and elective admissions. Our findings reveal that increasing GP supply in socioeconomically disadvantaged areas leads to a decrease in both outpatient referrals and elective admissions. However, these effects are less pronounced in prosperous areas or regions with high GP referral rates. Interestingly, we observe that having more GP practices in a specific area implies higher referral rates and elective admissions. These findings offer valuable insights that can assist policymakers in crafting targeted policies to effectively reduce healthcare costs and enhance the overall efficiency of the health system.
Retraction Note: Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments(Trials, (2022), 23, 62, 10.1186/s13063-021-05965-4)
This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1186/s13063-021-05965-4.
Serum and mucosal antibody-mediated protection and identification of asymptomatic respiratory syncytial virus infection in community-dwelling older adults in Europe
Introduction: Respiratory syncytial virus (RSV) causes acute respiratory tract infection (ARTI) and reinfects adults throughout life, posing a risk for hospitalization in older adults (>60 years) with frailty and comorbidities. Methods: To investigate serum and mucosal antibodies for protection against RSV infections, baseline serum samples were compared for RSV-pre- and -post-fusion (F) binding, and RSV-A2 neutralizing IgG antibodies between symptomatic RSV-ARTI (N = 30), non-RSV (RSV negative) ARTI (N = 386), and no ARTI (N = 338). Mucosal RSV-pre-F IgA and IgG levels, as well as serum RSV-G IgG antibodies, were analyzed to determine their association with protection from symptomatic RSV-ARTI in a subset study. Results: Using a receiver operating characteristic (ROC) analysis, we established thresholds of 1.4- to 1.6-fold change (FC) for RSV-pre-F and -post-F, and RSV-A2 neutralizing IgG antibodies, respectively, enabling the identification of asymptomatic RSV cases with high sensitivity and specificity (>80% and >90%, respectively). As a result, serum RSV-pre-F, RSV-G IgG, and mucosal pre-F binding IgA antibodies showed correlations with protection against symptomatic RSV infection. RSV-pre-F IgG antibodies were correlated with protection from RSV infections irrespective of the symptoms. Discussion: This study provides insights into antibody-mediated protection for symptomatic RSV infection in a community-dwelling older-adult population and establishes a threshold to identify asymptomatic RSV infection using a data-driven approach.
Immigrant status and likelihood of opioid treatment. Lessons from Spain's National Health Service
This study investigates opioid prescription patterns among immigrants and native populations in Spain, using novel patient health records from the Base de Datos Clínicos de Atención Primaria (BDCAP). We examined two subsets of data from 2017 and 2018, specifically targeting individuals diagnosed with musculoskeletal (MSK) issues and new cancer diagnoses, as these conditions frequently involve pain management. Our empirical analysis involved estimating a series of linear and count data models to explore the relationship between regions of origin, socioeconomic factors, and the probability of opioid use, controlling for a rich set of health conditions, and primary care centers fixed effects. Despite previously documented healthcare inequities, Spain demonstrates no major differences in opioid prescriptions between immigrants and natives, highlighting the effectiveness of its National Health Service (NHS). This contrasts sharply with the opioid crises in the United States and Canada. The absence of significant disparities underscores the importance of comprehensive healthcare systems and stringent regulations on opioid prescribing practices, as observed in European guidelines. Policy implications include the need to maintain and strengthen public healthcare systems to ensure equitable access to essential medications like opioids and to continue monitoring and regulating opioid prescribing practices to safeguard public health.
Observing many researchers using the same data and hypothesis reveals a hidden universe of uncertainty
This study explores how researchers’ analytical choices affect the reliability of scientific findings. Most discussions of reliability problems in science focus on systematic biases. We broaden the lens to emphasize the idiosyncrasy of conscious and unconscious decisions that researchers make during data analysis. We coordinated 161 researchers in 73 research teams and observed their research decisions as they used the same data to independently test the same prominent social science hypothesis: that greater immigration reduces support for social policies among the public. In this typical case of social science research, research teams reported both widely diverging numerical findings and substantive conclusions despite identical start conditions. Researchers’ expertise, prior beliefs, and expectations barely predict the wide variation in research outcomes. More than 95% of the total variance in numerical results remains unexplained even after qualitative coding of all identifiable decisions in each team’s workflow. This reveals a universe of uncertainty that remains hidden when considering a single study in isolation. The idiosyncratic nature of how researchers’ results and conclusions varied is a previously underappreciated explanation for why many scientific hypotheses remain contested. These results call for greater epistemic humility and clarity in reporting scientific findings.