Reframing conceptualizations of primary care involvement in opioid use disorder treatment.

BACKGROUND: Opioid-related harms and opioid use disorder (OUD) are health priorities requiring urgent policy responses. There have been many calls for improved OUD care in primary care, as well as increasing involvement of primary care providers in countries like Canada and Australia, which have been experiencing high rates of opioid-related harms. METHODS: Using Starfield's 4Cs conceptualization of primary care functions, we examined how and why primary care systems may be suited towards, or pose challenges to providing OUD care, and identified health system opportunities to address these challenges. We conducted 14 semi-structured interviews with 16 key informants with experience in opioid use policy in Canada and Australia. RESULTS: Primary care was identified to be an ideal setting for OUD care delivery due to its potential as the first point of contact in the health system; the opportunity to offer other health services to people with OUD; and the ability to coordinate care with other health providers (e.g. specialists, social workers) and thus also provide care continuity. However, challenges include a lack of resources and support for chronic disease management more broadly in primary care, and the prevailing model of OUD treatment, where addictions care is not seen as part of comprehensive primary care. Additionally, the highly regulated OUD policy landscape is also a barrier, manifesting as a 'regulatory cascade' in which restrictive oversight of OUD treatment passes from regulators to health providers to patients, normalizing the overly restrictive nature and inaccessibility of OUD care. CONCLUSIONS: While primary care is an essential arena for providing OUD care, existing sociocultural, political, health professional, and health system factors have led to the current model of care that limits primary care involvement. Addressing this may involve structurally embedding OUD care into primary care and strengthening primary care in general.

Federal opioid agonist therapy policy: interrupted time series analysis of the impact of the methadone exemption removal across eight provinces in Canada.

BACKGROUND: Federal deregulation of opioid agonist therapies are an attractive policy option to improve access to opioid use disorder care and achieve widespread beneficial impacts on growing opioid-related harms. There have been few evaluations of such policy interventions and understanding effects can help policy planning across jurisdictions. METHODS: Using health administrative data from eight of ten Canadian provinces, this study evaluated the impacts of Health Canada's decision in May 2018 to rescind the requirement for Canadian health professionals to obtain an exemption from the Canadian Drugs and Substance Act to prescribe methadone for opioid use disorder. Over the study period of June 2017 to May 2019, we used descriptive statistics to capture overall trends in the number of agonist therapy prescribers across provinces and we used interrupted time series analysis to determine the effect of this decision on the trajectories of the agonist therapy prescribing workforces. RESULTS: There were important baseline differences in the numbers of agonist therapy prescribers. The province with the highest concentration of prescribers had 7.5 more prescribers per 100,000 residents compared to the province with the lowest. All provinces showed encouraging growth in the number of prescribers through the study period, though the fastest growing province grew 4.5 times more than the slowest. Interrupted time series analyses demonstrated a range of effects of the federal policy intervention on the provinces, from clearly positive changes to possibly negative effects. CONCLUSIONS: Federal drug regulation policy change interacted in complex ways with provincial health professional regulation and healthcare delivery, kaleidoscoping the effects of federal policy intervention. For Canada and other health systems such as the US, federal policy must account for significant subnational variation in OUD epidemiology and drug regulation to maximize intended beneficial effects and mitigate the risks of negative effects.

Methadone Prescribing Regulation for Opioid Use Disorder in Canada: Evidence for an East-West Policy Divide.

Opioid agonist therapy (OAT) is a key element in the response to opioid-related harms in Canada. In May 2018, Health Canada rescinded the requirement for obtaining a federal exemption for methadone prescribing. This comparative analysis examined provincial OAT policies and policy changes in response to this federal policy change. Policies and changes were regionalized; despite having lower rates of opioid-related harms, eastern provinces had looser regulatory regimes compared with western provinces, which became even looser after the federal policy change. Diverse knowledge and policy networks need to be fostered to bridge this east-west divide in substance use care policy.

An international comparative policy analysis of opioid use disorder treatment in primary care across nine high-income jurisdictions.

BACKGROUND: Opioid use disorder (OUD) and opioid-related harms are current health priorities in many high-income countries such as Canada. Opioid agonist therapy (OAT) is an effective evidence-based treatment for OUD, but access is often limited. AIMS: To describe and compare OUD treatment policies across nine international jurisdictions, and to understand how they are situated within their primary care and health systems. METHODS: Using policy documents, we collected data on health systems, drug use epidemiology, drug policies, and OUD treatment from Australia, Canada, France, Germany, Ireland, Portugal, Sweden, Switzerland, and Taiwan. We used the health system dynamics framework and adapted definitions of low- and high-threshold treatment to describe and compare OUD treatment policies, and to understand how they may be shaped by their health systems context. RESULTS: Broad similarities across jurisdictions included the OAT pharmacological agents used and the need for supervised dosing; however, preferred OAT, treatment settings, primary care and specialist physicians' roles, and funding varied. Most jurisdictions had elements of lower-threshold treatment access, such as the availability of treatment through primary care and multiple OAT options, but the higher-threshold criteria of supervised dosing. CONCLUSIONS: From the Canadian perspective, there are opportunities to improve accessibility of OUD care by drawing on how different jurisdictions incorporate multidisciplinary care, regulate OAT medications, remunerate healthcare professionals, and provide funding for services.

Understanding the Dynamics of More Restrictive Medicines Policy: A Case Study of Codeine Up-Scheduling in Australia.

BACKGROUND: There has been increasing concern over opioid-related harms across the world. In Australia in 2018, codeine-containing products were up-scheduled from over-the-counter access at pharmacies, to requiring a prescription. The drug regulator's decision to up-schedule was contentious and widely debated, due to the potentially large impact on consumers and healthcare professionals. This study aimed to analyse influences on the codeine up-scheduling policy. METHODS: This retrospective policy analysis used the Advocacy Coalition Framework (ACF) to understand how policy actors with shared beliefs formed adversarial coalitions to shape policy. Data were drawn from documents (regulator policy documents, public submissions, news reports, organisational media releases and position statements) and semi-structured interviews with 15 key policy actors. Codes were generated relating to policy processes and actor beliefs; broad themes included the role of health professionals, perceptions of opioids, impact on consumers, and the role of government in healthcare. RESULTS: Two coalitions in this policy subsystem were identified: (1) supportive [with respect to the up-scheduling], and (2) opposing. The key evident beliefs of the supportive coalition were that the harms of codeine outweighed the benefits, and that government regulation was the best pathway for protecting consumers. The opposing coalition believed that the benefits of codeine accessible through pharmacists outweighed any harms, and consumers should manage their health without any more intervention than necessary. The policy decision reflected the influence of the supportive coalition, and this analysis highlighted the importance of their public health framing of the issue, the acceptability of their experts and supporting evidence, and the perceived legitimacy of the up-scheduling process. CONCLUSION: Understanding these coalitions, their beliefs, and how they are translated through existing policy processes and institutions provides insight for those interested in influencing future health policy. Specific lessons include the importance of strategic frames and advocacy, and engagement with formal policy processes.

Buprenorphine deregulation as an opioid crisis policy response - A comparative analysis between France and the United States.

BACKGROUND: In passing the Maintstreaming Addiction Treatment Act, the United States has abolished its federal X waiver, considered a major barrier to the wider buprenorphine prescribing needed to respond to opioid-related harms. Advocates for this policy have drawn on the French response of deregulating buprenorphine prescribing to address increasing overdose mortality around the turn of the millennium. So far, such policy advocacy has incompletely accounted for contextual and health system differences between the two countries. METHODS: Using the health system dynamics framework, this analysis compares France from 1995 to 2003 (the relevant period of buprenorphine reform) to the US from 2018 until today (the comparison period to explore potential impacts of reform). We used it to guide examination of a) contextual issues relating to opioid use epidemiology and b) health system factors including prescriber supply, sector organization, and insurance coverage for primary care to draw relevant policy learning for the contemporary US. RESULTS: We identified that the US had a 22.5-fold higher mortality rate and a 2.3-fold higher opioid use disorder (OUD) rate compared to France, despite having rates of prescribed buprenorphine per-capita higher than, and per-person with OUD comparable to, than that of France. These wide gulfs between the scales and nature of the problems between France and the US suggest that relaxing restrictions on buprenorphine prescribing through abolishing the X waiver will be insufficient for achieving hoped-for reductions in overdose mortality. CONCLUSION: Health system strengthening with a focus on improvements in primary care prescriber supply, coverage, and coordination are likely higher yield policy complements to relaxing buprenorphine regulation. Such an approach would better prepare the US to adapt to ongoing dynamics and uncertainties in the opioid crisis and to optimize the already relatively high levels of buprenorphine prescribing.

How policy problems and solutions travel in the scientific literature: An international scientometric analysis of the French Model of opioid use disorder care.

RATIONALE: The 2007 article 'Why buprenorphine is so successful in treating opiate addiction in France' has been widely cited to promote various solutions to growing opioid-related harms across multiple jurisdictions globally. However, selective promotion of aspects of the French experience or promotion of the French experience without considering relevant contextual factors may inform policies that will not bring the same outcomes as in France, including the introduction of possible unintended negative consequences. The scientific literature is one important arena in which policy solutions are identified, evaluated, promoted and disseminated. Scientific communication of the French opioid use disorder care model offers a timely and relevant example through which to examine how problem representations travel and to consider the effects of these representations. AIMS AND OBJECTIVES: We aimed to explore where, when, and how the content of this 2007 index article has travelled through the scientific literature. METHOD: Informed by Bacchi's understanding of problem representation, we conducted a scientometric analysis of the index article. This included categorical analyses using a combination of citation metadata and content data to identify patterns across locations and time. RESULTS: Researchers in the United States and Anglophone countries affirmatively cited specific index study content, namely less stringent regulations and positive outcomes, such as reductions in overdose deaths and increases in buprenorphine utilization. These citations were more common after 2015 and were more likely to be in discussion sections of nonempirical publications. Researchers from France cited similar content but did so nonaffirmatively, and throughout the study period. Likewise, the French citations were mostly agenda-setting citations in the introductory sections of empirical studies. US studies received the highest attention based on number of citations and Altmetric scores. CONCLUSION: US studies, by focusing on less stringent buprenorphine regulation as the primary solution of concern, have constructed opioid-related harms as a problem of restrictive regulations for buprenorphine. This selective focus on regulation, as opposed to other aspects of the French Model elucidated in the index article such as changes pertaining to the values and financing that structure health service delivery, represents an important missed opportunity for evidence-informed policy learning across jurisdictions.

The Impact of Suboxone's Market Exclusivity on Cost of Opioid Use Disorder Treatment.

BACKGROUND: Buprenorphine-naloxone is an essential part of the response to opioid poisoning rates in North America. Manipulating market exclusivity is a strategy manufacturers use to increase profitability, as evidenced by Suboxone in the USA. OBJECTIVE: To investigate excess costs of buprenorphine-naloxone due to unmerited market exclusivity (no legal patent or data protection) in Canada. METHODS: Using controlled interrupted time-series, this study examined changes in the cost of buprenorphine-naloxone before and after the first generics were listed on public formularies. Methadone cost was the control. Public data from the Canadian Institute of Health Information in British Columbia, Manitoba, and Saskatchewan were used. All buprenorphine-naloxone and methadone claims (2010-2019) accepted for payment by the provincial drug plan/programme were collected. Primary outcome was mean cost per mg of buprenorphine-naloxone after the first listing of generics. RESULTS: Mean cost per mg of buprenorphine-naloxone before the first listing of generics was $1.21 CAD in British Columbia, $1.27 CAD in Manitoba, and $0.85 CAD in Saskatchewan. Following the introduction of generics, the cost per mg decreased by $0.22 CAD (95% CI - 0.33 to - 0.10; p = 0.0014) in British Columbia, $0.36 CAD (95% CI - 0.58 to - 0.13; p = 0.004) in Manitoba, and $0.27 CAD (95% CI - 0.50 to - 0.05; p = 0.03) in Saskatchewan. Mean cost per mg decreased by $0.26 CAD (95% CI - 0.38 to - 0.13; p = 0.0004) after a third generic was introduced in British Columbia. Excess costs to public formularies during the 4- to 5-year period prior to the listing of generics were $1,992,558 CAD in British Columbia, $80,876 CAD in Manitoba, and $4130 CAD in Saskatchewan. If buprenorphine-naloxone cost $0.61 CAD (mean cost after the third generic entered) instead of $1.21 CAD per mg during the pre-generics period, public payers in British Columbia could have saved $5,016,220 CAD between 2011 and 2015. CONCLUSIONS: Unmerited 6 years of market exclusivity for brand-name buprenorphine-naloxone in Canada resulted in substantial excess costs. There is an urgent need to implement policies that can help reduce costs for high-priority drugs in Canada.

The tension between national consistency and jurisdictional professional expansion: The case of pharmacist-administered vaccinations.

BACKGROUND: The COVID-19 pandemic has highlighted the importance of coordinating policies on vaccinations at the national level. In Australia, the regulation and management of pharmacist-administered vaccination programs are the responsibility of each of the eight jurisdictions (six states and two territories), and have been developed independently of each other, leading to substantial variation. Consequently, there are variations regarding which vaccines pharmacists can administer, the minimum age, and whether these vaccines are publicly funded. OBJECTIVE(S): To identify opportunities for a nationally consistent approach to pharmacist-administered vaccinations in Australia. METHODS: This policy analysis used the Multiple Streams Framework to identify barriers and enablers within the three "streams" of problem, policy, and politics, and how they affected the development of a national approach. Data were drawn from semi-structured interviews with 13 key policy actors and documents (pre-budget submissions and parliamentary inquiry reports). Themes were generated around actor interests, current and proposed pharmacist vaccination programs, and policymaking processes. RESULTS: From the pharmacy sector, there was little clarity around the need for a nationally consistent approach. This issue was linked to their ultimate goal of expanding pharmacist vaccination programs; it was seen as a means for states/territories with smaller programs to 'catch up' to other jurisdictions. There was also no unified policy approach from this sector; additionally, decision-makers within jurisdictional health departments faced different service delivery models, policy priorities, agendas, and policy actor relationships. Lastly, there was no federal body that had the capacity to coordinate a national approach. Possible enablers include refining the problem definition and re-framing it to a patient-centric model. CONCLUSIONS: Coordination of vaccination policies is an ongoing policy issue with implications for pharmacist vaccination programs and other health policy areas in which a national approach is being considered. This analysis provides insight into how this may be developed in the future.

"Never waste a good crisis": Opportunities and constraints from the COVID-19 pandemic on pharmacists' scope of practice.

BACKGROUND: In response to the COVID-19 pandemic, many pharmacy-based or pharmacist-delivered services were introduced or amended to mitigate the pandemic's health and social impact. This happened within the context of pharmacists seeking more opportunities to increase their clinical responsibilities and play a larger role in primary care. OBJECTIVE(S): To analyse the policymaking context and pharmacy responses to COVID-19 that enable or constrain the expansion of pharmacists' scope of practice. METHODS: This study is a policy analysis of documentary data detailing changes in pharmacy policy in Australia, drawing on a "policy space analysis" framework to identify opportunities and constraints to policy reform. Data were collected from news for health professionals; federal/jurisdictional legislation and media releases; and guidelines and directives from government health departments and agencies. Changes to pharmacy practice were identified and classified according to type. For each change, potential opportunities and constraints for expanding pharmacists' scope of practice were identified. RESULTS: Four categories of changes were identified: medicines limits/restrictions; alternatives to paper prescriptions; public health measures; and community pharmacist-delivered services. Opportunities from the pandemic response that could expand scope of practice include the potential permanence of temporary measures that increase pharmacists' responsibilities; remuneration to legitimise services; political acknowledgement of medicines safety and access as a priority; and government need to quickly address crises. Constraints include the potential permanence of temporary measures that restrict pharmacists' practice; negative perceptions of pharmacists from other clinicians; intra-professional disagreements regarding pharmacy-based services; and lack of pharmacist representation in institutional structures. CONCLUSIONS: This analysis demonstrates that the pandemic responses and policy context may facilitate expansion of pharmacists' scope of practice, and identifies possible avenues to do so; it also highlights constraints that need to be further addressed to achieve this goal.

Cross-sectional study of preprints and final journal publications from COVID-19 studies: discrepancies in results reporting and spin in interpretation.

OBJECTIVE: To compare results reporting and the presence of spin in COVID-19 study preprints with their finalised journal publications. DESIGN: Cross-sectional study. SETTING: International medical literature. PARTICIPANTS: Preprints and final journal publications of 67 interventional and observational studies of COVID-19 treatment or prevention from the Cochrane COVID-19 Study Register published between 1 March 2020 and 30 October 2020. MAIN OUTCOME MEASURES: Study characteristics and discrepancies in (1) results reporting (number of outcomes, outcome descriptor, measure, metric, assessment time point, data reported, reported statistical significance of result, type of statistical analysis, subgroup analyses (if any), whether outcome was identified as primary or secondary) and (2) spin (reporting practices that distort the interpretation of results so they are viewed more favourably). RESULTS: Of 67 included studies, 23 (34%) had no discrepancies in results reporting between preprints and journal publications. Fifteen (22%) studies had at least one outcome that was included in the journal publication, but not the preprint; eight (12%) had at least one outcome that was reported in the preprint only. For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications.At least one instance of spin occurred in both preprints and journals in 23/67 (34%) studies, the preprint only in 5 (7%), and the journal publications only in 2 (3%). Spin was removed between the preprint and journal publication in 5/67 (7%) studies; but added in 1/67 (1%) study. CONCLUSIONS: The COVID-19 preprints and their subsequent journal publications were largely similar in reporting of study characteristics, outcomes and spin. All COVID-19 studies published as preprints and journal publications should be critically evaluated for discrepancies and spin.

Policies affecting the supply and access of opioid analgesics: a scoping review protocol.

OBJECTIVE: This scoping review aims to describe and map the range of evaluated policies that affect the supply and access of opioids for analgesic therapy. INTRODUCTION: There has been increasing concern regarding the rise in opioid analgesic misuse and related harms, including overdose deaths. In response, policies have been developed and implemented to reduce the burden of opioid-related problems, including strategies that aim to affect the supply and/or access of opioid analgesics. However, little is known about the range and nature of these policies, including whether they have been evaluated for effectiveness and how. INCLUSION CRITERIA: Studies to be included must evaluate the effectiveness of policies directly designed to affect the supply and/or access of opioids for analgesic therapy, and measure clinical and health services outcomes quantitatively. Studies that assessed interventions or factors impacting the use of these policies, measured only utilization of the policy itself, and/or measured outcomes regarding attitudes and behaviors towards these policies will be excluded. Literature on policies for the treatment and management of opioid abuse, overdose, or addiction will be excluded. METHODS: Multiple databases will be searched including MEDLINE, Embase, PsycINFO, Scopus, and Web of Science using keywords, indexed terms, and phrases for the following concepts: opioid, policy, evaluation, and clinical context. Each included study will be rated using a modified version of the JBI Levels of Evidence framework. Details on included policies and their assessment will be extracted, and results presented in diagrams and tables.

Digital contact tracing technologies in epidemics: a rapid review.

BACKGROUND: Reducing the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a global priority. Contact tracing identifies people who were recently in contact with an infected individual, in order to isolate them and reduce further transmission. Digital technology could be implemented to augment and accelerate manual contact tracing. Digital tools for contact tracing may be grouped into three areas: 1) outbreak response; 2) proximity tracing; and 3) symptom tracking. We conducted a rapid review on the effectiveness of digital solutions to contact tracing during infectious disease outbreaks. OBJECTIVES: To assess the benefits, harms, and acceptability of personal digital contact tracing solutions for identifying contacts of an identified positive case of an infectious disease. SEARCH METHODS: An information specialist searched the literature from 1 January 2000 to 5 May 2020 in CENTRAL, MEDLINE, and Embase. Additionally, we screened the Cochrane COVID-19 Study Register. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster-RCTs, quasi-RCTs, cohort studies, cross-sectional studies and modelling studies, in general populations. We preferentially included studies of contact tracing during infectious disease outbreaks (including COVID-19, Ebola, tuberculosis, severe acute respiratory syndrome virus, and Middle East respiratory syndrome) as direct evidence, but considered comparative studies of contact tracing outside an outbreak as indirect evidence. The digital solutions varied but typically included software (or firmware) for users to install on their devices or to be uploaded to devices provided by governments or third parties. Control measures included traditional or manual contact tracing, self-reported diaries and surveys, interviews, other standard methods for determining close contacts, and other technologies compared to digital solutions (e.g. electronic medical records). DATA COLLECTION AND ANALYSIS: Two review authors independently screened records and all potentially relevant full-text publications. One review author extracted data for 50% of the included studies, another extracted data for the remaining 50%; the second review author checked all the extracted data. One review author assessed quality of included studies and a second checked the assessments. Our outcomes were identification of secondary cases and close contacts, time to complete contact tracing, acceptability and accessibility issues, privacy and safety concerns, and any other ethical issue identified. Though modelling studies will predict estimates of the effects of different contact tracing solutions on outcomes of interest, cohort studies provide empirically measured estimates of the effects of different contact tracing solutions on outcomes of interest. We used GRADE-CERQual to describe certainty of evidence from qualitative data and GRADE for modelling and cohort studies. MAIN RESULTS: We identified six cohort studies reporting quantitative data and six modelling studies reporting simulations of digital solutions for contact tracing. Two cohort studies also provided qualitative data. Three cohort studies looked at contact tracing during an outbreak, whilst three emulated an outbreak in non-outbreak settings (schools). Of the six modelling studies, four evaluated digital solutions for contact tracing in simulated COVID-19 scenarios, while two simulated close contacts in non-specific outbreak settings. Modelling studies Two modelling studies provided low-certainty evidence of a reduction in secondary cases using digital contact tracing (measured as average number of secondary cases per index case - effective reproductive number (R eff)). One study estimated an 18% reduction in R eff with digital contact tracing compared to self-isolation alone, and a 35% reduction with manual contact-tracing. Another found a reduction in R eff for digital contact tracing compared to self-isolation alone (26% reduction) and a reduction in R eff for manual contact tracing compared to self-isolation alone (53% reduction). However, the certainty of evidence was reduced by unclear specifications of their models, and assumptions about the effectiveness of manual contact tracing (assumed 95% to 100% of contacts traced), and the proportion of the population who would have the app (53%). Cohort studies Two cohort studies provided very low-certainty evidence of a benefit of digital over manual contact tracing. During an Ebola outbreak, contact tracers using an app found twice as many close contacts per case on average than those using paper forms. Similarly, after a pertussis outbreak in a US hospital, researchers found that radio-frequency identification identified 45 close contacts but searches of electronic medical records found 13. The certainty of evidence was reduced by concerns about imprecision, and serious risk of bias due to the inability of contact tracing study designs to identify the true number of close contacts. One cohort study provided very low-certainty evidence that an app could reduce the time to complete a set of close contacts. The certainty of evidence for this outcome was affected by imprecision and serious risk of bias. Contact tracing teams reported that digital data entry and management systems were faster to use than paper systems and possibly less prone to data loss. Two studies from lower- or middle-income countries, reported that contact tracing teams found digital systems simpler to use and generally preferred them over paper systems; they saved personnel time, reportedly improved accuracy with large data sets, and were easier to transport compared with paper forms. However, personnel faced increased costs and internet access problems with digital compared to paper systems. Devices in the cohort studies appeared to have privacy from contacts regarding the exposed or diagnosed users. However, there were risks of privacy breaches from snoopers if linkage attacks occurred, particularly for wearable devices. AUTHORS' CONCLUSIONS: The effectiveness of digital solutions is largely unproven as there are very few published data in real-world outbreak settings. Modelling studies provide low-certainty evidence of a reduction in secondary cases if digital contact tracing is used together with other public health measures such as self-isolation. Cohort studies provide very low-certainty evidence that digital contact tracing may produce more reliable counts of contacts and reduce time to complete contact tracing. Digital solutions may have equity implications for at-risk populations with poor internet access and poor access to digital technology. Stronger primary research on the effectiveness of contact tracing technologies is needed, including research into use of digital solutions in conjunction with manual systems, as digital solutions are unlikely to be used alone in real-world settings. Future studies should consider access to and acceptability of digital solutions, and the resultant impact on equity. Studies should also make acceptability and uptake a primary research question, as privacy concerns can prevent uptake and effectiveness of these technologies.

The SSSPIN study-spin in studies of spin: meta-research analysis.

OBJECTIVES: To identify and calculate the prevalence of spin in studies of spin. DESIGN: Meta-research analysis (research on research). SETTING: 35 studies of spin in the scientific literature. MAIN OUTCOME MEASURES: Spin, categorised as: reporting practices that distort the presentation and interpretation of results, creating misleading conclusions; discordance between results and their interpretation, with presentation of favourable conclusions that are not supported by the data or results; attribution of causality when study design does not support it; and over-interpretation or inappropriate extrapolation of results. RESULTS: Five (14%) of 35 spin studies contained spin categorised as reporting practices that distort the presentation and interpretation of results (n=2) or categorised as over-interpretation or inappropriate extrapolation of results (n=3). CONCLUSION: Spin occurs in research on spin. Although researchers on this topic should be sensitive to spinning their findings, our study does not undermine the need for rigorous interventions to reduce spin across various research fields. CONCLUSION WITH SPIN: Our hypothesis that spin will be less prevalent in spin studies than in studies on other topics has been proven. Spin scholars are less likely to spin their conclusions than other researchers, and they should receive substantial resources to launch and test interventions to reduce spin and research waste in reporting.

Commercialization of User Data by Developers of Medicines-Related Apps: a Content Analysis.

BACKGROUND: Developers of medicines-related apps collect a variety of technical, health-related, and identifying user information to improve and tailor services. User data may also be used for promotional purposes. Apps, for example, may be used to skirt regulation of direct-to-consumer advertising of medicines. Researchers have documented routine and extensive sharing of user data with third parties for commercial purposes, but little is known about the ways that app developers or "first" parties employ user data. OBJECTIVE: We aimed to investigate the nature of user data collection and commercialization by developers of medicines-related apps. APPROACH: We conducted a content analysis of apps' store descriptions, linked websites, policies, and sponsorship prospectuses for prominent medicines-related apps found in the USA, Canada, Australia, and UK Google Play stores in late 2017. Apps were included if they pertained to the prescribing, administration, or use of medicines, and were interactive. Two independent coders extracted data from documents using a structured, open-ended instrument. We performed open, inductive coding to identify the range of promotional strategies involving user data for commercial purposes and wrote descriptive memos to refine and detail these codes. KEY RESULTS: Ten of 24 apps primarily provided medication adherence services; 14 primarily provided medicines information. The majority (71%, 17/24) outlined at least one promotional strategy involving users' data for commercial purposes which included personalized marketing of the developer's related products and services, highly tailored advertising, third-party sponsorship of targeted content or messaging, and sale of aggregated customer insights to stakeholders. CONCLUSIONS: App developers may employ users' data in a feedback loop to deliver highly targeted promotional messages from developers, and commercial sponsors, including the pharmaceutical industry. These practices call into question developers' claims about the trustworthiness and independence of purportedly evidenced-based medicines information and may create a risk for mis- or overtreatment.

Data sharing practices of medicines related apps and the mobile ecosystem: traffic, content, and network analysis.

OBJECTIVES: To investigate whether and how user data are shared by top rated medicines related mobile applications (apps) and to characterise privacy risks to app users, both clinicians and consumers. DESIGN: Traffic, content, and network analysis. SETTING: Top rated medicines related apps for the Android mobile platform available in the Medical store category of Google Play in the United Kingdom, United States, Canada, and Australia. PARTICIPANTS: 24 of 821 apps identified by an app store crawling program. Included apps pertained to medicines information, dispensing, administration, prescribing, or use, and were interactive. INTERVENTIONS: Laboratory based traffic analysis of each app downloaded onto a smartphone, simulating real world use with four dummy scripts. The app's baseline traffic related to 28 different types of user data was observed. To identify privacy leaks, one source of user data was modified and deviations in the resulting traffic observed. MAIN OUTCOME MEASURES: Identities and characterisation of entities directly receiving user data from sampled apps. Secondary content analysis of company websites and privacy policies identified data recipients' main activities; network analysis characterised their data sharing relations. RESULTS: 19/24 (79%) of sampled apps shared user data. 55 unique entities, owned by 46 parent companies, received or processed app user data, including developers and parent companies (first parties) and service providers (third parties). 18 (33%) provided infrastructure related services such as cloud services. 37 (67%) provided services related to the collection and analysis of user data, including analytics or advertising, suggesting heightened privacy risks. Network analysis revealed that first and third parties received a median of 3 (interquartile range 1-6, range 1-24) unique transmissions of user data. Third parties advertised the ability to share user data with 216 "fourth parties"; within this network (n=237), entities had access to a median of 3 (interquartile range 1-11, range 1-140) unique transmissions of user data. Several companies occupied central positions within the network with the ability to aggregate and re-identify user data. CONCLUSIONS: Sharing of user data is routine, yet far from transparent. Clinicians should be conscious of privacy risks in their own use of apps and, when recommending apps, explain the potential for loss of privacy as part of informed consent. Privacy regulation should emphasise the accountabilities of those who control and process user data. Developers should disclose all data sharing practices and allow users to choose precisely what data are shared and with whom.

'Spin' in published biomedical literature: A methodological systematic review.

In the scientific literature, spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favourable light. The presence of spin in biomedical research can negatively impact the development of further studies, clinical practice, and health policies. This systematic review aims to explore the nature and prevalence of spin in the biomedical literature. We searched MEDLINE, PreMEDLINE, Embase, Scopus, and hand searched reference lists for all reports that included the measurement of spin in the biomedical literature for at least 1 outcome. Two independent coders extracted data on the characteristics of reports and their included studies and all spin-related outcomes. Results were grouped inductively into themes by spin-related outcome and are presented as a narrative synthesis. We used meta-analyses to analyse the association of spin with industry sponsorship of research. We included 35 reports, which investigated spin in clinical trials, observational studies, diagnostic accuracy studies, systematic reviews, and meta-analyses. The nature of spin varied according to study design. The highest (but also greatest) variability in the prevalence of spin was present in trials. Some of the common practices used to spin results included detracting from statistically nonsignificant results and inappropriately using causal language. Source of funding was hypothesised by a few authors to be a factor associated with spin; however, results were inconclusive, possibly due to the heterogeneity of the included papers. Further research is needed to assess the impact of spin on readers' decision-making. Editors and peer reviewers should be familiar with the prevalence and manifestations of spin in their area of research in order to ensure accurate interpretation and dissemination of research.