Lisa Bero

The influence of pharmaceutical company promotion on prescribing and its impacts have been subject to extensive debate. This review helps to clarify whether and how interactions between clinicians and the pharmaceutical industry influence prescribing. Main objective: to assess the effects, using evidence from randomised trials, and the associations, using evidence from non-randomised studies, of pharmaceutical industry promotional interactions with prescribers (including provision of information, payments, gifts, and samples), compared to no interactions, on the appropriateness, quantity, and cost of prescribed medicines, and on formulary requests. We searched CENTRAL, MEDLINE, Embase, one other database, and two trial registers to January 2025. We included randomised trials, non-randomised trials, controlled before-after studies with at least two intervention sites and at least two control sites, interrupted time series studies with a clearly defined intervention time point and at least three data points both before and after the intervention time, and cross-sectional studies comparing exposure levels and outcomes at a single time point. We also included controlled cohort studies comparing outcomes over time, and case-control studies assessing the effects of past exposures. We included cross-sectional, cohort, and case-control studies if the data covered an entire population or a random sample of a defined population, with a response rate of at least 60%. The critical outcomes were prescribing appropriateness, quantity, and cost, and formulary requests by clinicians exposed to interactions with pharmaceutical companies compared to clinicians not exposed or with less exposure. We used Cochrane's RoB 2 tool to assess bias in randomised controlled trials (RCTs), and the Joanna Briggs Institute tool for cross-sectional studies to assess bias in cross-sectional, cohort, and nested case-control studies. We used study design-specific criteria developed by the Cochrane Effective Practice and Organisation of Care (EPOC) Group to assess bias in controlled before-after studies and interrupted time series studies. We grouped studies into four groups based on exposure type - advertising and education; gifts and payments; free samples; and conflict-of-interest policies - to analyse outcomes. We presented the data in harvest plots and narratively summarised the results. Due to heterogeneity, we were unable to conduct any meta-analyses. We used GRADE to assess the certainty of evidence. We included 93 studies. Most studies (82/93, 88%) were conducted in the USA; 11 were conducted in the European Union or the UK. Sixty of 93 studies (65%) were cross-sectional, along with 23 controlled cohort studies, four controlled before-after studies, four interrupted time series, one nested case-control, and one RCT. Sixty-two studies examined payments, gifts, or other transfers of value; 16 examined advertising or educational activities (primarily delivered through pharmaceutical industry sales representative visits); seven examined free drug samples; and eight examined conflict-of-interest policies, such as restrictions on sales representative visits or the acceptance of gifts and samples. Exposure to pharmaceutical company advertising or education may be associated with decreased prescribing appropriateness (6 studies; 1335 prescribers) and increased prescribing costs (2 studies; 986 prescribers), and is probably associated with an increased quantity of prescriptions (7 studies; 151,399 prescribers), compared to no or less exposure. Prescribers' receipt of gifts and payments from pharmaceutical companies is associated with decreased prescribing appropriateness (10 studies; 2,941,948 prescribers), an increased quantity of prescriptions (39 studies; 3,858,871 prescribers), and is probably associated with increased prescribing costs (25 studies; 2,505,292 prescribers), compared to receiving no or fewer gifts and payments. Evidence on associations between receipt of free samples and prescribing appropriateness (1 study; 10 practices), quantity (4 studies; 150,050 prescribers), and costs (4 studies; 2508 prescribers) is very uncertain. Institutional conflict-of-interest policies are probably associated with improved prescribing appropriateness (2 studies; 3065 prescribers), may be associated with a decreased quantity of prescriptions (6 studies; 110,470 prescribers), and have uncertain effects on costs (2 studies; 33,975 participants), compared to no or more lenient conflict-of-interest policies. There was little evidence examining formulary requests (1 study; 105 prescribers). Prescribers' exposure to pharmaceutical industry advertising and education and their receipt of gifts and payments may be associated with increased formulary requests, but the evidence is very uncertain. We rated two outcomes from the one included RCT as having an overall high risk of bias. The principal risk-of-bias concerns for the cross-sectional and cohort studies related to the identification of confounding factors. For controlled before-after studies, the main concerns were baseline comparability and incomplete outcome data. We judged most domains for interrupted time series studies to be at low risk of bias. Overall, we downgraded the certainty of the evidence for risk of bias and imprecision, and upgraded it for dose-response effects and large effect sizes. Overall, we found that promotional interactions clinicians have with pharmaceutical companies are probably associated with harmful outcomes: less appropriate prescribing, greater quantity of medicines prescribed or provided, higher prescribing costs, and a greater likelihood of recommending hospital formulary additions of the company's drugs. Conversely, in most analyses of organisational conflict-of-interest policies restricting the pharmaceutical industry's promotional interactions with clinicians, restrictions are associated with beneficial outcomes on prescribing...

The integrity of evidence synthesis is threatened by problematic randomised controlled trials, where there are serious concerns about the trustworthiness of the data or findings. Such concerns could be due to research misconduct, including fraud, or due to honest critical errors. If these trials are not detected, they may be inadvertently included in systematic reviews and guidelines, potentially distorting their results. To resolve this problem, the INSPECT-SR (Investigating Problematic Clinical Trials in Systematic Reviews) tool has been developed to assess the trustworthiness of randomised controlled trials. This tool will help researchers to identify and exclude problematic trials from systematic reviews. This article describes the development of INSPECT-SR and presents the tool and an associated guidance document.

Objectives: To describe how medical journals identify and manage conflicts of interest of editors and peer reviewers, how policies are enforced, and whether practices are concordant with policies.Study design and setting: Between April and September 2024, we contacted 250 medical journals, randomly sampled from Clarivate Journal Citation Reports. We sent a questionnaire related to the peer review process, practices for identifying and managing conflicts of interest of editors and peer reviewers, and enforcement of journal policies. We analysed open-ended responses using content analysis. In a subset of journals with conflict of interest policies, we assessed concordance between actual practice and policy content.Results: Of the 250 invited medical journals, 80 (32%) responded to the questionnaire (median completion of questions 94%). Seventy percent of respondents were editors, and 18% publisher representatives. Sixty-six percent of journals identified financial and non-financial interests of editors, 54% did not allow financial interests, and 46% did not allow non-financial interests. Peer reviewers with conflicts of interest were not invited by 66% of journals. Disclosures were required in peer review reports by 41% of journals, 22% verified all or some disclosure information, and 57% informed reviewers on how to handle conflicts of interest. If reviewers had conflicts of interest, 36% of journals would not use the review report. In cases where undisclosed conflicts of interest were identified before or after publication, more than one-third of journals either did not have procedures in place or respondents were unaware of their journal’s practices. For a subset of journals with public policies (N = 55 for editors and N = 54 for peer reviewers), some of the reported practices were discordant with the policy for editors in 45% and for peer reviewers in 50% of journals.Conclusion: The majority of medical journals identify both financial and non-financial interests of editors, but not those of peer reviewers. Conflicts of interest are usually managed by disqualification, but journals often lack procedures, staff are unaware of practices, and practices are not aligned with policies, creating room for inconsistent management of conflicts of interest. These findings highlight the need for comprehensive policies and staff education to promote transparency and integrity in the editorial processes.

Objectives: To describe how medical journals identify and manage conflicts of interest of editors and peer reviewers, how policies are enforced, and whether practices are concordant with policies.Study design and setting: Between April and September 2024, we contacted 250 medical journals, randomly sampled from Clarivate Journal Citation Reports. We sent a questionnaire related to the peer review process, practices for identifying and managing conflicts of interest of editors and peer reviewers, and enforcement of journal policies. We analysed open-ended responses using content analysis. In a subset of journals with conflict of interest policies, we assessed concordance between actual practice and policy content.Results: Of the 250 invited medical journals, 80 (32%) responded to the questionnaire (median completion of questions 94%). Seventy percent of respondents were editors, and 18% publisher representatives. Sixty-six percent of journals identified financial and non-financial interests of editors, 54% did not allow financial interests, and 46% did not allow non-financial interests. Peer reviewers with conflicts of interest were not invited by 66% of journals. Disclosures were required in peer review reports by 41% of journals, 22% verified all or some disclosure information, and 57% informed reviewers on how to handle conflicts of interest. If reviewers had conflicts of interest, 36% of journals would not use the review report. In cases where undisclosed conflicts of interest were identified before or after publication, more than one-third of journals either did not have procedures in place or respondents were unaware of their journal’s practices. For a subset of journals with public policies (N = 55 for editors and N = 54 for peer reviewers), some of the reported practices were discordant with the policy for editors in 45% and for peer reviewers in 50% of journals.Conclusion: The majority of medical journals identify both financial and non-financial interests of editors, but not those of peer reviewers. Conflicts of interest are usually managed by disqualification, but journals often lack procedures, staff are unaware of practices, and practices are not aligned with policies, creating room for inconsistent management of conflicts of interest. These findings highlight the need for comprehensive policies and staff education to promote transparency and integrity in the editorial processes.

Engineering infection controls include a wide range of interventions used indoors to reduce occupants' exposure to respiratory pathogens. To identify and describe primary studies evaluating the effects of engineering infection control interventions designed to reduce the spread of respiratory infections transmitted through indoor air. MEDLINE, Embase, Global Health, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and Environmental Science Collection from database inception to 12 December 2023. English-language primary research articles evaluating engineering infection control interventions. Publication information, population characteristics, intervention details, and all relevant outcomes were abstracted by a reviewer and verified by a second, senior reviewer. A total of 672 studies published between 1929 and 2024 were identified. Most (n = 606) evaluated environmental samples only, 57 included human participants, and 9 included sentinel animal subjects. About half of the studies included at least 1 intervention classified as pathogen inactivation (n = 405), with fewer involving pathogen removal (n = 200) or air exchange or dilution (n = 143). Across all studies, about half (n = 332) measured the quantity of viable nonpathogenic organisms from air samples, followed by the quantity of nonbiological particulates (n = 197) or viable pathogenic organisms (n = 149). Harms, such as toxic byproducts, were rarely measured. Exclusion of non-English-language publications and gray literature. There is substantial heterogeneity in the available evidence. Gaps in evidence include studies measuring efficacy outcomes that are highly relevant for human infection transmission or harms. Refinements in classification of interventions and outcomes could strengthen reporting of these evaluations. National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention. (Registered on Open Science Framework [https://osf.io/5zmhd]).

Rapid changes in the legalized cannabis market have led to the predominance of high-concentration delta-9-tetrahydrocannabinol (THC) cannabis products. To systematically review associations of high-concentration THC cannabis products with mental health outcomes. Ovid MEDLINE through May 2025; EMBASE, Allied and Complementary Medicine Database, Cochrane Library, Database of Abstracts of Reviews of Effects, CINAHL, and Toxicology Literature Online through August 2024. Two reviewers independently selected studies with high-concentration THC defined as greater than 5 mg or greater than 10% THC per serving or labeled as "high-potency concentrate," "shatter," or "dab." Outcomes included anxiety, depression, psychosis or schizophrenia, and cannabis use disorder (CUD). Results were categorized by association direction and by study characteristics. Therapeutic studies were defined by use of cannabis to treat medical conditions or symptoms. Ninety-nine studies (221 097 participants) were included: randomized trials (42%), observational studies (47%), and other interventional study designs (11%); more than 95% had moderate or high risk of bias. In studies not testing for therapeutic effects, high-concentration THC products showed consistent unfavorable associations with psychosis or schizophrenia (70%) and CUD (75%). No therapeutic studies reported favorable results for psychosis or schizophrenia. For anxiety and depression, 53% and 41% of nontherapeutic studies, respectively, reported unfavorable associations, especially among healthy populations. Among therapeutic studies, nearly half found benefits for anxiety (47%) and depression (48%), although some also found unfavorable associations (24% and 30%, respectively). Moderate and high risk of bias of individual studies and limited evaluation of contemporary products. High-concentration THC products are associated with unfavorable mental health outcomes, particularly for psychosis or schizophrenia and CUD. There was some low-quality evidence, inconsistent by population, for therapeutic benefits for anxiety and depression. Colorado General Assembly, House Bill 21-1317.

Objectives: Editors and reviewers of research manuscripts may have conflicts of interest that impact their evaluations. We aimed to characterise medical journals' conflict of interest policies for editors and peer reviewers.Study design and setting: In this cross-sectional study, we randomly sampled 277 medical journals from Clarivate Journal Citation Reports. Two authors independently retrieved public conflict of interest policies and disclosures for editors and peer reviewers from journal websites, and retrieved publishers’ policies when journals also referred to them (January to June 2024). We used content analysis to analyse policies and multivariable mixed-effects logistic regressions to estimate the associations between journal characteristics and having a policy. Results: After excluding 27 journals, we included 250 medical journals in English, of which 177 (71%) had a conflict of interest policy for editors and 174 (70%) for peer reviewers. Of journals with a policy, 137 (77%) and 129 (74%) described disclosure requirements, 160 (90%) and 163 (94%) management strategies, 124 (70%) and 106 (61%) policy enforcement strategies, and 17 (10%) and 15 (9%) processes for appealing decisions. All four concepts were addressed in 16 (9%) policies for editors and 11 (6%) for peer reviewers. Having a policy for editors was associated with higher journal impact factor (adjusted odds ratio (OR): 1.28; 95% confidence interval (CI): 1.05–1.56) and Committee on Publication Ethics (COPE) membership (OR: 3.50; 95% CI: 1.42–8.65). Having a policy for peer reviewers was associated with higher journal impact factor (OR: 1.16; 95% CI: 0.97–1.37) and open access journal (OR: 4.59; 95% CI: 1.11–18.93). For a subgroup of journals referring to their publishers’ policy, the content was concordant for 5 (11%) of 45 journals for editors and 4 (9%) of 47 journals for peer reviewers. Of 250 journals, 14 (6%) had public declarations of interest from editors, and 3 (1%) from peer reviewers.Conclusion: More than two-thirds of medical journals have conflict of interest policies for editors and reviewers; however, policies vary in comprehensiveness, and content is rarely concordant with publishers’ policies. There is potential to improve the content of conflict of interest policies and the transparency of interests in medical journals.