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Background In August 2021, we published in Environmental Health a Toolkit for detecting misused epidemiological methods with the goal of providing an organizational framework for transparently evaluating epidemiological studies, a body of evidence, and resultant conclusions. Tsuda et al., the first group to utilize the Toolkit in a systematic fashion, have offered suggestions for its modification. Main body Among the suggested modifications made by Tsuda et al., we agree that rearrangement of Part A of the Toolkit to reflect the sequence of the epidemiological study process would facilitate its usefulness. Expansion or adaptation of the Toolkit to other disciplines would be valuable but would require the input of discipline-specific expertise. We caution against using the sections of the Toolkit to produce a tally or cumulative score, because none of the items are weighted as to importance or impact. Rather, we suggest a visual representation of how a study meets the Toolkit items, such as the heat maps used to present risk of bias criteria for studies included in Cochrane reviews. We suggest that the Toolkit be incorporated in the sub-specialty known as “forensic epidemiology,” as well as in graduate training curricula, continuing education programs, and conferences, with the recognition that it is an extension of widely accepted ethics guidelines for epidemiological research. Conclusion We welcome feedback from the research community about ways to strengthen the Toolkit as it is applied to a broader assemblage of research studies and disciplines, contributing to its value as a living tool/instrument. The application of the Toolkit by Tsuda et al. exemplifies the usefulness of this framework for transparently evaluating, in a systematic way, epidemiological research, conclusions relating to causation, and policy decisions. Postscript We note that our Toolkit has, most recently, inspired authors with discipline-specific expertise in the field of Conservation Biology to adapt it for use in the Biological Sciences.

ObjectivesTo understand how and why Australian cancer physicians interact with the pharmaceutical industry.DesignQualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes.SettingGiven the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians’ experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom.Participants16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%).Outcome measuresThe analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped.ResultsSix themes were identified that fell within two broad categories: cancer physicians’views and experiences of interactionsandmanagement of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a ‘middle road’. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome.ConclusionsCancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.

PURPOSE: Interactions between cancer physicians and the pharmaceutical industry may create conflicts of interest that can adversely affect patient care. We aimed to survey cancer physicians regarding their attitudes toward and interactions with industry. METHODS: We surveyed Australian cancer physicians between December 2020 and February 2021, questioning how often they interacted with industry and their attitudes toward this. We also assessed factors associated with accepting payments from industry and the amount received, and opinions on policies and industry influence. We used logistic and linear regression to examine links between attitudes and behaviors. RESULTS: There were 116 responses (94 complete). Almost half (n = 53 of 115, 46.1%) felt that there was a positive relationship between cancer physicians and industry. Most (n = 79 of 104, 76.0%) interacted with industry at least once a month, and 67.7% (n = 63 of 93) had received nonresearch payments from industry previously, with a median value of 2,000 Australian dollars over 1 year. Most respondents believed that interactions could influence prescribing while simultaneously denying influence on their own prescribing (n = 66 of 94, 70.2%). Those who judged general sales representative interactions (odds ratio [OR] 9.37 [95% CI, 1.05 to 83.41], P = .045) or clinician sponsorship (OR 3.22 [95% CI, 1.01 to 10.30], P = .049) to be more acceptable also met with sales representatives more frequently. Physicians were more likely to accept industry payments when they deemed sponsorship of clinicians for conferences (OR 10.55 [95% CI, 2.33 to 47.89], P = .002) or honoraria for advisory board membership more acceptable (OR 3.91 [95% CI, 1.04 to 14.74], P = .04) or when they had higher belief in industry influence over own prescribing (OR 25.51 [95% CI, 2.70 to 241.45], P = .005). CONCLUSION: Australian cancer physicians interact with industry frequently, and those who feel positive about these interactions are likely to do so more often. More research is needed to understand the motivations behind these interactions.

Objective:The present study aims to examine the relationship between study funding sources, author conflicts of interest (COI) and conclusions in studies supporting vitamin D and Ca intake cited in bone health guideline recommendations.Design:Cross-sectionalSetting:Forty-seven global bone health guidelines with vitamin D and/or Ca recommendations for adults aged 40 years and above.Participants:The evidence cited to support the recommendations was extracted by two independent reviewers and classified by type of recommendation, article characteristics, study design, types of funding sources and conflict of interest (COI) disclosure and direction of study conclusions.Results:Of 156 articles cited to support the bone health recommendations, 120 (77 %) disclosed a funding source, and 43 (28 %) declared that at least one author had a COI. Compared with articles with non-commercial or no funding source, those funded by commercial sponsors tended to have a study conclusion favourable towards vitamin D/Ca (relative risk (95 % CI): 1·32 (0·94, 1·87), P = 0·16), but the association was not statistically significant (Fisher’s exact test). Compared to those with a COI disclosure statement, articles with missing or unclear COI disclosure were more likely to have favourable conclusions (1·56 (1·05, 2·31), P = 0·017) (Fisher’s exact test).Conclusion:In the evidence underpinning a sample of global bone health guidelines, COI disclosure was low and studies with missing or unclear COI disclosures were more likely to have favourable study conclusions than those with disclosures, suggesting a need for greater transparency of COI in bone health guidelines.

Mobile apps are poised to become a major source of health guidance; however, concerns about their quality and safety remain. Governments, clinicians, and health researchers are struggling to determine how to adequately evaluate the content and function of mobile health apps to guide consumers toward apps that will effectively and safely support their health. Researchers are both adapting existing research methods, such as those for systematic reviews, and exploring novel methods toward this aim. The purpose of this systematic review was to describe prevalent and emerging methods for searching, data extraction, and analysis in the context of mobile health apps and commercial app stores.A systematic search was conducted on April 6, 2016, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, for published studies that evaluated health-related apps targeted at consumers in a commercial app store, and a descriptive content analysis of their methods was performed.Although the majority of studies self-identified as "reviews" or "systematic reviews," their claims to have performed an exhaustive, replicable, and systematic search and data extraction are unsupported, given the nature of commercial app stores' search engines and personalized app content. Currently, studies of health-related app content are largely descriptive, and most use surrogate and one-dimensional outcome measures for app content quality.This field is rapidly developing, and innovative methods for systematic searches, multidimensional quality assessment, and contextualizing content assessment are emerging. Areas for future methodologic development are highlighted, including expanding definitions of app "content" and assessing risk of bias.

Objective In a randomized, controlled trial evaluating the impact of clinical pharmacists’ consultations on physicians’ prescribing decisions, a seven-member physician/pharmacist panel developed an instrument to characterize and quantify the full range of drug-prescribing problems. The instrument was tested for validity and reliability. Sample The instrument was applied in reviewing prescribing for 236 geriatric outpatients. Methods To ensure internal validity of the instrument, five panel meetings were devoted to reaching a consensus on procedures, categories, criteria, and scoring. Each case was evaluated independently by two reviewers and each drug in the regimen was evaluated for drug-drug interactions, dosage, schedule, allergic reactions, therapeutic duplication, use of drugs without established diagnoses, and inappropriate drugs for the patient's clinical conditions; discrepancies were adjudicated by the panel chairperson. Self-reported adverse effects of 60 study patients who were interviewed, and hospital readmissions of all study patients were used to test the external validity of the instrument. Results Inter-rater reliability improved over time, reaching a high of 97.1 percent after six months. A positive association was determined between the prescribing scores and the number of reported adverse effects (rho=0.28, p=0.02). Although the number of patients with drug-related hospital readmissions was too few to establish a significant association between the prescribing scores and readmissions, the findings were expected. Conclusions Given current requirements for drug utilization reviews in hospitals, health maintenance organizations, and Medicaid programs, this instrument may prove to be very useful.

The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

Evidence points to commercial sponsorship and personal financial gains for researchers leading to reporting more favorable results, tainting the climate of academic integrity, and negative public perceptions. Research institutions attempt to protect their own reputations and those of their faculty through establishing thresholds for reporting financial involvement and through committee review that may suggest that the sponsoring organization impose management practices designed to reduce conflicts or declining the funding. In one prominent university research system, a quarter of research projects reviewed required management because of conflicts of interest, the most common of these stemming from high "consulting fees" paid to researchers. The degree of understanding of policies regarding conflicts among researchers is uneven, and some regard these as private matters. Differences of opinion exist in the research community over whether disclosure of financial interests, although necessary, is sufficient to ensure a reasonable level of freedom from bias and to maintain public trust.