Roadside screening tests for cannabis use: A systematic review.

As more countries legalize recreational cannabis, roadside screening programs are imperative to detect and deter driving under the influence of cannabis. This systematic review evaluated roadside screening tests for cannabis use. We searched six databases (inception-March 2020) and grey literature sources for primary studies evaluating test characteristics of roadside screening tests for cannabis use compared to laboratory tests for cannabinoids in blood or oral fluid. The synthesis was focused on sensitivity and specificity of delta-9-tetrahydrocannabinol (THC) detection. 101 studies were included. Oral fluid tests were higher in specificity and lower in sensitivity compared to urine tests when evaluated against blood laboratory tests. Oral fluid tests were higher in sensitivity and similar in specificity compared to observational tests when evaluated against blood and oral fluid laboratory tests. Sensitivity was variable among oral fluid tests; two instrumented immunoassays (Draeger DrugTest 5000 [5 ng/mL THC cut-off] and Alere DDS 2 Mobile Test System) appeared to perform best, but definitive conclusions could not be drawn due to imprecise estimates. Specificities were similar. Overall, oral fluid tests showed the most promise for use in roadside screening for blood THC levels over legal limits; their continued development and testing are warranted. Urine tests are generally inadvisable, and observational tests require sensitivity improvements.

Cannabis-Impaired driving: ethical considerations for the primary care practitioner.

Background: Widespread cannabis consumption and recreational cannabis legalization is thought to have led to an increase in motor vehicle accidents, although there currently lacks ethical guidance for primary care practitioners on cannabis-impaired driving.Objective: The aim was to develop an ethical framework for primary care providers on cannabis-impaired driving.Methods: An ethical analysis in the form of a critical interpretive review was undertaken, using a systematic approach to determine the appropriate action to a given situation with evidence to substantiate its claims. The search strategy was designed to answer the research question: What are some ethical concerns for primary care providers to consider when cannabis-impaired driving is suspected? Four databases were searched in December 2021 using keywords related to cannabis, impaired driving, ethics, and primary care. The resulting evidence was synthesized as recommendations for primary care practice.Results: The ethical approach for primary care practitioners in addressing cannabis-impaired driving can be summarized as the duty to always inform, provide care through prevention and harm reduction strategies, and report when necessary. The prevention of cannabis-impaired driving should not fall on the sole responsibility of primary care practitioners. As this review offers a high-level discussion of the ethical considerations in cannabis-impaired driving, specific recommendations will depend upon the legal and policy designations of individual jurisdictions.Conclusion: Ultimately, the practitioner should manage cannabis-impaired driving in a way that fosters the therapeutic relationship in patient-centered care, through motivational discussions, collaboration with specialists, skills for self-management, patient empowerment, and support. KEY MESSAGES Take-Home Points for Primary Care Practitioners in Cannabis-Impaired Driving • For patients who report driving frequently and using cannabis, the frequency of use, dosage, form of cannabis, tolerance levels, and withdrawal symptoms should be discussed, while informing the patient of the risks, harms, and legal consequences associated with cannabis-impaired driving. • The practitioner's primary responsibility in the cannabis-impaired driving context is to provide care to patients who drive and consume cannabis, which may include referring patients to mental health care to manage addictive or problematic behaviors associated with cannabis use. • Practitioners may have a duty to report cannabis-impaired driving to legal authorities (such as law enforcement) when the user engages in harmful behavior to themselves or others.

A systematic review of the effects of e-cigarette use on lung function.

Given the increasing use of e-cigarettes and uncertainty surrounding their safety, we conducted a systematic review to determine the effects of e-cigarettes on measures of lung function. We systematically searched EMBASE, MEDLINE, and PsycINFO databases via Ovid, the Cochrane CENTRAL database, and the Web of Science Core from 2004 until July 2021, identifying 8856 potentially eligible studies. A total of eight studies (seven studying immediate effects and one long-term effects, 273 total participants) were included. The risk of bias was assessed using the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) and Cochrane risk of bias tools. These studies suggest that vaping increases airway resistance but does not appear to impact forced expiratory volume in one second (FEV1), forced vital capacity (FVC), or FEV1/FVC ratio. However, given the limited size and follow-up duration of these studies, larger, long-term studies are required to further determine the effects of e-cigarettes on lung function.

"Who needs an app? Fertility patients' use of a novel mobile health app".

Objective: The number of couples experiencing infertility treatment has increased, as has the number of women and men experiencing infertility treatment-related stress and anxiety. Therefore, there is a need to provide information and support to both men and women facing fertility concerns. To achieve this goal, we designed a mhealth app, Infotility, that provided men and women with tailored medical, psychosocial, lifestyle, and legal information. Methods: This study specifically examined how fertility factors (e.g. time in infertility treatment, parity), socio-demographic characteristics (e.g. gender, education, immigrant status), and mental health characteristics (e.g. stress, depression, anxiety, fertility-related quality of life) were related to male and female fertility patients' patterns of use of the Infotility app. Results: Overall, the lifestyle section of the app was the most highly used section by both men and women. In addition, women without children and highly educated women were more likely to use Infotility. No demographic, mental health or fertility characteristics were significantly associated with app use for men. Conclusion: This study shows the feasibility of a mhealth app to address the psychosocial and informational needs of fertility patients.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance. Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Interventions to Prevent Drugged Driving: A Systematic Review.

CONTEXT: Literature suggests that cannabis legalization may increase fatal motor vehicle collisions. However, evidence on the effectiveness of interventions to prevent drugged driving is limited. EVIDENCE ACQUISITION: MEDLINE, PsycINFO, Web of Science, Embase, SafetyLit, Criminal Justice Database, Transport Research International Documentation, bibliographies, and relevant gray literature were searched systematically through May 2020. Randomized and nonrandomized studies of preventive interventions measuring drugged driving outcomes were included. Evidence certainty was judged per Grading of Recommendations Assessment, Development, and Evaluation guidelines to designate quality ratings from very low to high. EVIDENCE SYNTHESIS: The search identified 11 RCTs and 17 nonrandomized studies conducted predominantly among youth (aged 15-25 years; n=33,711 of 37,117 active research participants). In the public, cannabis packaging with health warnings increases the knowledge about drugged driving effects (high certainty); roadside drug testing can reduce drugged driving among cannabis users (moderate certainty); media campaigns may increase deterrent attitudes and knowledge (low certainty); and state sanctions, including traffic offense criminalization, license withdrawal, and per se drugged driving laws, may have little or no effect on drug-related fatalities or injuries (very low-low certainty). For youth or previous offenders, motivational interviewing can prevent drugged driving and driver education programs can increase knowledge (moderate certainty), whereas drug abuse prevention, substance abuse treatment, and driver rehabilitation may prevent drugged driving (very low certainty). CONCLUSIONS: Overall, there is evidence to support the interventions that may improve drugged driving knowledge, attitudes, and behaviors. However, the impact of such interventions on measures of drugged driving-related morbidity and mortality is uncertain. Further research is urgently required to address these gaps in knowledge.

Information needs of people seeking fertility services in Canada: a mixed methods analysis.

BACKGROUND: Infertility is a challenging experience associated with high levels of psychological distress. Many people seeking fertility services use the internet to obtain information about their conditions and treatments. OBJECTIVES: This mixed-methods study aimed to describe the information-seeking experience of people seeking fertility services with respect to the fulfillment of their individually defined information needs and explore relationships between the fulfillment of information needs and psychological outcomes. METHODS: One hundred and four participants completed a survey with close-ended and open-ended questions about their experience using an informational web-based application (app) called 'Infotility' and about their mental well-being before and after using the app. The questionnaires administered were the The Mobile Application Rating Scale (uMARS), the Fertility Quality of Life questionnaire (FertiQol), the Patient Empowerment Questionnaire (PEQ) and the General Anxiety Disorder 7-item Scale (GAD-7). Eleven participants completed in-depth qualitative interviews about their experience using the app. A thematic analysis was used to interpret qualitative results and quantitization was used to dichotomize participants into those with met information needs versus those with unmet information needs. Google Analytics was used to compare participants' reported experience with their actual use of the app. RESULTS: The results of this study show that there is variability in the amount of information that people seeking fertility services wish to receive. Participants whose information needs were met reported improved psychological outcomes after using the app, while those with unmet needs showed no change in their psychological outcomes. CONCLUSIONS: Our results suggest that fulfilling information needs was associated with improved psychological outcomes in people seeking fertility services. Our results also suggest that individual differences in information needs should be considered when developing health educational materials.

Association between legalization of recreational cannabis and fatal motor vehicle collisions in the United States: an ecologic study.

BACKGROUND: With the recent legalization of recreational cannabis in Canada, cannabis-impaired driving is an important public safety concern. Our aim was to examine the association between recreational cannabis legalization and fatal motor vehicle collisions using data from the United States, which present a timely natural experiment of cannabis legalization. METHODS: We conducted an ecologic study using the number of fatal motor vehicle collisions and the associated number of deaths for US jurisdictions with legalized recreational cannabis (2007-2018) retrieved from the US Fatality Analysis Reporting System. We examined jurisdiction-specific rates of fatal motor vehicle collisions and associated deaths before and after recreational cannabis legalization using Poisson regression and meta-analyzed estimates across jurisdictions using DerSimonian and Laird random-effects models. RESULTS: After adjustment for calendar year, legalization was associated with increases in rates of fatal motor vehicle collisions (incidence rate ratio [IRR] 1.15, 95% confidence interval [CI] 1.06-1.26) and associated deaths (IRR 1.16, 95% CI 1.06-1.27). Differences between the first 12 months after legalization relative to subsequent months were inconclusive for rates of fatal motor vehicle collisions (IRR 0.92, 95% CI 0.84-1.02) and associated deaths (IRR 0.92, 95% CI 0.84-1.01). INTERPRETATION: Recreational cannabis legalization in the US was associated with a relative increased risk of fatal motor vehicle collisions of 15% and a relative increase in associated deaths of 16%, with no conclusive difference between the first and subsequent years after legalization. These findings raise concern that there could be a similar increase in fatal motor vehicle collisions and associated deaths in Canada following recreational cannabis legalization.

Recency of immigration and utilization of dental care services in Canada.

OBJECTIVES: To investigate the association between recency of immigration to Canada and the utilization of dental health services. METHODS: The cross-sectional study sample (n = 2137) was drawn from the 2015-2016 Canadian Community Health Survey (CCHS). It consisted of Canadian residents aged 12 years and older who resided in the two provinces and one territory who opted into the optional dental module and gave valid responses to the questions 'How often do you usually see a dental professional, such as a dentist, a dental hygienist or a denturologist?' and 'Length of time since immigration to Canada?' for the outcome and independent variable, respectively. Multinomial logistic regression was used to analyse the data, and all statistics were weighted using sampling weights provided by Statistics Canada. RESULTS: The adjusted odds ratios were lower for recent immigrants than for established immigrants and for visits more than once per year (OR = 0.35; 95% CI 0.14, 0.92), about once per year (OR = 0.34; 95% CI 0.13, 0.90) and for less than once per year (OR = 0.22; 95% CI 0.07, 0.64) than for those who never visited a dental professional. Recent immigrants, males, individuals aged 70 years or more and those with a low household income were less likely to visit a dental professional than established immigrants, females, younger age groups or those with higher incomes. CONCLUSION: Better policies are needed to address the dental health concerns of recent immigrants who may suffer from poorer dental health, to ensure that they receive the care they require.

Identifying and Classifying Tools for Health Policy Ethics Review: A Systematic Search and Review.

Ethical review and analysis of health policy may help to ensure policies address the needs of society and align with relevant values and principles. Indeed, researchers and bioethicists have recognized the need for ethical frameworks specifically for public health applications. The objective of this research was to compile structured tools for ethical review of (drafted or existing) health policy and to analyze these tools for their scope and philosophical underpinnings. A systematic search and review of academic and grey literature was conducted to compile existing tools designed for health policy ethics review. The search yielded 13 health policy ethical review tools. Qualitative content analysis revealed that all of the tools were influenced by multiple ethical values and that a majority were influenced by more than one ethical theory. The most common values were non-maleficence and beneficence (92.3%). The most common influencing ethical theory was the Principles Approach (92.3%). The structure of the tools demonstrates a heterogeneity of methodology designs to approach policy ethics review. This research offers a unique contribution to the bioethics field that provides a useful resource and understanding of the current ethical review tools for health policy.

Physician Perspectives on Mammography Screening for Average-Risk Women: "Like a Double-Edged Sword".

BACKGROUND: On balance, the benefits and harms of mammography screening put systematic screening for average-risk women into question. Since screening decisions frequently occur in primary care, it is important to understand what family physicians think of the evidence on mammography screening, and how they intend to use this information in practice. METHODS: Using a cross-sectional design, we obtained data from a group of physician participants who rated the daily Patient-Oriented Evidence that Matters (POEM), which is a short, research-based synopsis. Physicians responded to closed and open-ended questions, based on the validated Information Assessment Method. Quantitative data were assessed with descriptive statistics. The qualitative data were subjected to inductive and deductive iterative thematic analysis. These data were organized into subthemes, and then grouped into major themes. RESULTS: Four relevant POEMs were identified. Each of these POEMs was rated by 1243 to 1351 physicians, and these ratings provided 310 comments. Three major themes emerged across all 4 POEMs: 1) perspectives on information presented in POEMs, 2) applying this information in practice, and 3) confronting clinical and cultural realities. Our findings highlight important differences in the ways physicians value research-based information on mammography screening and use this information in their practice. CONCLUSIONS: Although POEMs about mammography screening raise awareness of harms and benefits, deeply rooted ideas illustrate how any change process is complex. In sum, rethinking breast cancer screening for average-risk women is challenging.

Predictors of infertility-related concerns in a Canadian survey of men and women seeking fertility treatment.

OBJECTIVE: To examine if and how factors associated with infertility-related concerns and opportunity to discuss concerns differ between male and female fertility patients. METHODS: A cross-sectional survey of 313 female and 254 male patients recruited from Canadian fertility clinics. An online survey asked about sociodemographic characteristics, psychological distress, the severity of psychosocial concerns on a scale of 0 (not concerned) to 5 (very concerned) related to fertility treatment, and their opportunity and desire to discuss concerns with healthcare providers (HCPs). RESULTS: For women, higher stress, educational attainment and being childless were associated with higher concern (F(6, 287) = 14.73, p < .001). For men, higher stress, being religious and longer treatment duration were associated with higher concern (F(8, 222) = 9.87, p < .001). No significant difference existed between men's and women's average concern scores (t(558) = -1.62, p = .11) or opportunity to discuss concerns (t(149) = 0.28, p = .78). CONCLUSION: Our results indicate an unmet need and desire for support among subgroups of patients who were concerned about psychosocial issues related to infertility, but did not have the opportunity to discuss these issues with HCPs. PRACTICE IMPLICATIONS: There is a need to tailor resources to address the concerns of male and female fertility patients from diverse sociodemographic backgrounds and with different fertility histories.

Towards a Patient-Centred Regulation of Gamete Donation in Canada.

Commercial gamete donation in Canada is prohibited by the Assisted Human Reproduction Act. However, the Act permits gamete recipients to reimburse donors for donation-related expenses. Until recently, the types of expenses that were eligible and the process for reimbursing donors were not specified. In 2016, Health Canada announced its intent to develop regulations that would regulate gamete donor reimbursement; it released the proposed policy in 2017. As a result of consultations with Canadian lawmakers, physicians, and patients, debates surrounding commercial gamete donation are being revisited. Considering the ethical implications of gamete donation payment arrangements, a patient-centred care framework is useful going forward in the regulation of this practice. Patient-centred values of communication, respecting relational autonomy, and respecting patient interests should guide decisions regarding regulation of gamete donation arrangements in Canada.

Engaging older adults in discharge planning: case studies illuminating approaches adopted by family members that promote relational autonomy.

Background: Discharge decisions have significant implications for older adults and their involved family members. Evidence of older adult and family members' engagement in discharge decision-making, however, varies widely. Some recent work shows assumed associations between ageing, diminished participation in healthcare decision-making and increased reliance on family members. Other research suggests that family members adopt strategies to promote older adults' participation in decision-making. Relational autonomy theory suggests that individuals have differing levels of autonomy and that individuals' agency can be supported (or marginalized) by others.Purpose: Using three case studies, we examine traditional and relational conceptions of autonomy and explore how relational approaches could inform healthcare practice.Methods: Taking a critical feminist bioethics perspective, we present a secondary analysis of three microethnographic case studies focused on discharge planning with older adults in one Canadian inpatient rehabilitation setting. The data consist of observations of discharge planning family conferences and semi-structured interviews with older adults and family members.Results: Tensions between older adults' wishes to return home and their diminished participation in discharge decisions, and family members' assumption of a primary role in discharge decision-making and their wish for the older adult to move to a supported setting were apparent. To reconcile these tensions, the older adults' family members in these cases employed strategies to promote older adults' participation in decision-making that were consistent with relational autonomy theory.Conclusion and implications for practice: The analysis suggests that older adults' participation in discharge decision-making processes could be better promoted through relational approaches.Implications for rehabilitation • Adopting an approach guided by relational autonomy might better enable patients to participate in decision-making than would an approach guided by traditional conceptions of autonomy. • Rehabilitation professionals could seek assistance from family members and guide them toward collaborative partnerships. • A range of strategies may be employed to customize relational approaches to enhance autonomy: • having several different conversations with patients to enable multiple chances to contribute knowledge and views; • involving family members or taking the time to explain information several different times and in diverse manners; • showing patients videos or photos of discharge locations; • exploring a breadth of potential discharge options; • accompanying patients to visit different options in person; and • getting patients in touch with individuals who have made similar choices. • It is recognized that taking a relational approach might be time-consuming and that practice contexts may not be conducive to such practice.

Scrutinizing screening: a critical interpretive review of primary care provider perspectives on mammography decision-making with average-risk women.

CONTEXT: A decision to undertake screening for breast cancer often takes place within the primary care setting, but current controversies such as overdiagnosis and inconsistent screening recommendations based on evolving evidence render this a challenging process, particularly for average-risk women. Given the responsibility of primary care providers in counseling women in this decision-making process, it is important to understand their thoughts on these controversies and how they manage uncertainty in their practice. OBJECTIVE: To review the perspectives and approaches of primary care providers regarding mammography decision-making with average-risk women. DESIGN AND METHODS: This study is a critical interpretive review of peer-review literature that reports primary care provider perspectives on mammography screening decision-making. Ovid MEDLINE®, Ovid PsycInfo, and Scopus databases were searched with dates from 2002 to 2017 using search terms related to mammography screening, uncertainty, counseling, decision-making, and primary health care providers. RESULTS: Nine articles were included following a review process involving the three authors. Using an inductive and iterative approach, data were grouped into four thematic categories: (1) perceptions on the effectiveness of screening, screening initiation age, and screening frequency; (2) factors guiding primary care providers in the screening decision-making process, including both provider and patient-related factors, (3) uncertainty faced by primary care providers regarding guidelines and screening discussions with their patients; and (4) informed decision-making with average-risk women, including factors that facilitate and hinder this process. DISCUSSION: The discussion of results addresses several factors about the diversity of perspectives and practices of physicians counseling average-risk women regarding breast cancer screening. This has implications for the challenge of understanding and explaining evidence, what should be shared with average-risk women considering screening, the forms of knowledge that physicians value to guide screening decision-making, and the consent process for population-based screening initiatives. Within the data, there was little attention placed on how physicians coped with uncertainty in practice. Given the dual responsibility of physicians in caring for both individuals and the larger population, further research should probe more deeply into how they balance their duties to individual patients with those to the larger population they serve.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective: To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants: The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results: The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance: The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.