Initial Invitations Research Articles

Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial

IntroductionASCEND PLUS is a randomised controlled trial assessing the effects of oral semaglutide on the primary prevention of cardiovascular events in around 20,000 individuals with type 2 diabetes in the UK. The trial’s innovative design includes a decentralised direct-to-participant invitation, recruitment, and follow-up model, relying on self-completion of online forms or telephone or video calls with research nurses, with no physical sites. Extensive patient and public involvement and engagement (PPIE) was essential to the design and conduct of ASCEND PLUS.AimTo report the process and conduct of PPIE activity in ASCEND PLUS, evaluate effects on trial design, reflect critically on successes and aspects that could have been improved, and identify themes and learning relevant to implementation of PPIE in future trials.MethodsPPIE activity was coordinated centrally and included six PPIE focus groups and creation of an ASCEND PLUS public advisory group (PAG) during the design phase. Recruitment to these groups was carefully considered to ensure diversity and inclusion, largely consisting of adults living with type 2 diabetes from across the UK. Two members of the PAG also joined the trial Steering Committee. Steering Committee meetings, focus groups, and PAG meetings were conducted online, with two hybrid workshops to discuss PPIE activity and aspects of the trial.ResultsPPIE activity was critical to shaping the design and conduct of ASCEND PLUS. Key examples included supporting choice for participants to either complete the screening/consent process independently online, or during a telephone or video call interview with a research nurse. A concise ‘initial information leaflet’ was developed to be sent with the initial invitations, with the ‘full’ information leaflet sent later to those interested in joining the trial. The PAG reviewed the content and format of participant- and public-facing materials, including written documents, online screening forms, animated videos, and the trial website, to aid clarity and accessibility, and provided input into the choice of instruments to assess quality of life.ConclusionsPPIE is integral in ASCEND PLUS and will continue throughout the trial. This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial.

Open-ended initial invitations are particularly helpful in eliciting forensically relevant information from child witnesses

BackgroundOpen-ended prompting is an essential tool for interviewers to elicit evidentiary information from children reporting abuse. To date, no research has examined whether different types of open-ended prompts elicit details with differing levels of forensic relevance. ObjectiveTo examine interviewers' use of three open-ended prompt subtypes (initial invitations, breadth prompts, and depth prompts) and compare the forensic relevance of the information elicited by each. Participants and settingTranscripts of field interviews conducted by 53 police interviewers with children aged 6- to 16-years alleging abuse were examined. MethodsIn each transcript, initial invitations, breadth prompts, and depth prompts were identified, and the child's response was parsed into clauses. Clauses were classified according to their forensic relevance: essential to the charge (i.e., a key point of proof or element of the offence), relevant to the offending (i.e., what occurred before, during, or after an incident but not an essential detail), context (i.e., background information), irrelevant to the charge, no information provided, or repeated information already provided earlier. ResultsInterviewers posed fewer initial invitations than breadth and depth prompts, p < .001, ηp2 = 0.58. Initial invitations elicited higher proportions of essential and relevant clauses than breadth and depth prompts; depth prompts further elicited higher proportions of essential clauses than breadth prompts, ps ≤ 0.001. We found few effects of children's age. ConclusionsInitial invitations are a particularly useful subtype of open-ended prompt for interviewers to elicit details that are legislatively essential for prosecution of crimes from children of all ages.

Lessons Learned From the Public Health Workforce's Experiences With the COVID-19 Response

Limited research is available on the COVID-19 response experiences of local, state, and federal public health workers in the United States. Although the response to COVID-19 is still presenting challenges to the public health workforce, public health systems must also begin to consider lessons learned that can be applied to future disasters. During July and August 2021, a random sample of participants from a cross-sectional study of the public health workforce was invited to participate in interviews to obtain information on the current state of public health operations, the ongoing response to the COVID-19 crisis, and takeaways for improving future preparedness and response planning. Interviews were transcribed and inductively coded to identify themes. Twenty-four initial interview invitations were sent, and random substitutions were made until thematic saturation was reached when 17 interviews were completed. Four thematic categories were identified, including challenges related to (1) ongoing lack of political support or policy guidance; (2) fluctuations in, and uncertainty about, future funding and associated requirements; (3) job expectations, including remote work and data-sharing capabilities; and (4) the mental health toll of sustained response and related burnout. As the public health response to the COVID-19 pandemic continues in its third year, it is crucial to identify lessons learned that can inform future investment in order to sustain a public health workforce and a public health preparedness and response system that is resilient to future disasters.

Impact of the COVID-19 Pandemic on Prostate Cancer Radiotherapy Practice Patterns: A Northeast Regional Longitudinal Survey Study

Purpose/Objective(s)During the COVID-19 pandemic, the National Comprehensive Cancer Network (NCCN) provided management guidelines for prostate cancer (PCa) patients undergoing radiation therapy (RT). It is unknown whether or not radiation oncologists adopted these treatment recommendations. We assessed whether Northeast (NE) radiation oncologists managed PCa differently or according to guidelines during the 2020 Spring and the 2020-2021 Winter surges, as this region was affected profoundly by both waves.Materials/Methods847 NE radiation oncologists were identified from the ASTRO membership directory. The NE region was defined as states of: CT, MA, ME, NH, NJ, NY, PA, RI, VT. A link to an anonymous electronic survey was disseminated with hypothetical PCa patient scenarios for RT during the COVID-19 pandemic to elucidate practice patterns. Eligible participants had to indicate they regularly treat PCa patients. The initial survey was distributed in early Summer 2020 to understand practice patterns during the Spring surge. During the COVID-19 Winter peak, participants who voluntarily provided their email addresses not linked to survey responses were recontacted to complete a follow-up (FU) survey.ResultsOf 847 initial survey invitations, 333 participants indicated that they did not treat PCa. Of the remaining 514 participants, 151 indicated that they treated PCa and fully completed the survey (30% response rate). The response rate among 100 participants for the FU survey was 68%. Among initial respondents, 59% practice in non-academic settings. For favorable intermediate-risk PCa scenarios, 55% of respondents elected to delay moderately/conventionally fractionated RT in the initial survey. In the FU survey, 75% of respondents were in favor of treating without delay. For unfavorable intermediate- and high-risk PCa scenarios after three months of androgen deprivation therapy (ADT), 53.4% elected to delay scheduled RT in the initial survey, while 85% would treat as planned in the FU survey. In the above scenarios, there was little consideration of a 5 fraction RT schedule. For the post-prostatectomy salvage scenario where no ADT was considered, 35% favored treating with 1.8-2 Gy per fraction without delay during the initial survey (3% favored 20 fractions); 60% elected to move forward with RT in the FU survey.ConclusionThis survey evaluated NE radiation oncology PCa practice patterns during the COVID-19 pandemic, finding that most physicians were in favor of delaying RT during the Spring surge, in concordance with the NCCN recommendation. Subsequently, the winter surge FU survey demonstrated that physicians were more comfortable treating without delay. This is likely attributed to increased health and safety guidelines, as well as policies in place to minimize exposure in radiation oncology departments.

Prevalence of Sexual Victimization Among Female and Male College Students: A Methodological Note With Data.

This study provides insight on how sample recruitment methods may affect reported rates of sexual victimization on college campuses. The study compares sexual victimization rates among students who complete surveys after initial requests with those who complete them only after multiple reminders. Using probability sampling methods, undergraduate students from 12 universities were invited to complete a survey on campus violence; initial invitations were followed with up to five reminders. Women (n = 1,008) and men (n = 344) who completed surveys were categorized as early, middle, or late responders based on the number of reminders required to convert them from non-responders to responders. About 24.2% of women and 15.6% of men reported sexual victimization in the previous two months. In initial analyses, female early and late responders did not differ on sexual victimization, but males did. Male late responders reported higher rates of sexual victimization than early responders. In sensitivity analyses that re-defined early and late responders, women who were early responders reported more sexual victimization than women who were late responders, while men who were early responders reported less sexual victimization than men who were late responders. These findings suggest that researchers may underestimate sexual victimization rates for male college students unless multiple attempts are made to solicit their participation. Researchers are encouraged to utilize multiple reminders to increase research participation.

Systematic Development of Materials for Inviting Low Health-Literate Individuals to Participate in Preconception Counseling.

In this study we aimed to systematically analyze problems in the recruitment of women with low health literacy for preconception counseling and to adapt and evaluate written invitations for this group. In a problem analysis (stage 1) we used structured interviews (n = 72) to assess comprehension of the initial invitations, perception of perinatal risks, attitude and intention to participate in preconception counseling. These outcomes were used to adapt the invitation. The adapted flyer was pretested in interviews (n = 16) (stage 2) and evaluated in structured interviews among a new group of women (n = 67) (stage 3). Differences between women in stages 1 and 3 regarding comprehension, risk perception, attitude and intention to participate in counseling were analyzed by linear regression analysis and chi-square tests. Women in stage 3 (who read the adapted flyer) had a more positive attitude towards participation in preconception counselling and a better understanding of how to apply for a consultation than women in stage 1 (who read the initial invitations). No differences were found in intention to participate in preconception counseling and risk perception. Systematic adaptation of written invitations can improve the recruitment of low health-literate women for preconception counselling. Further research should gain insight into additional strategies to reach and inform this group.

A Challenge to Disrupt the Disruptive Process of Residency Interview Invitations.

A Challenge to Disrupt the Disruptive Process of Residency Interview Invitations.

Finding a Common Ground: Therapist Responsiveness to Male Clients Who Have Acted Violently Against Their Female Partner

Men in treatment for intimate partner violence (IPV) do often present with problem formulations that do not fit the therapeutic endeavor of personal change and may, therefore, challenge therapists in their effort to build an alliance. However, the therapist's initial contributions are also likely to influence whether the client finds it worthwhile to become involved in a working alliance. In a qualitative study of the in-session interactions between experienced therapists and men in IPV individual therapy, we looked for variations in therapist responsiveness to the client's initial invitations to identify whether and, eventually, how the two parties were able to reach common ground for working together. We studied therapist-client interactions in 20 therapy cases, including 10 completed cases with good outcomes and 10 dropout cases. Two sessions during the early phase of the therapy and the final session were audiotaped and transcribed verbatim. The transcriptions were analyzed following the guidelines of constructivist grounded theory. The analysis revealed three interactional patterns: co-creative exploration, pull-avoid repetitions, and tiptoeing softly around, each of which was associated with a distinctive set of therapist strategies. Clients participating in the co-creative pattern appeared to experience the most successful treatment. Our findings suggest that a model of therapist responses to client invitations is valuable for the conceptualization of the therapeutic alliance during the early sessions of psychotherapy. The findings also highlight the importance of clarifying and expanding upon the client's personal experience with his abuse to form a viable working alliance.

Population-based organized cervical cancer screening pilot program in France.

In France, cervical cancer screening is recommended every 3 years for women aged 25-65 years. With the exception of a few local organized programs, screening is mainly opportunistic. In view of setting up a nationwide population-based organized screening program, a pilot intervention was implemented in nine geographic areas using a common protocol. Women aged 25-65 years who had not undergone a cytological screening in the past 3 years were invited for screening during 2010-2012 and reminded up to 1 year after the initial invitation. Cytological results and follow-up data were collected up to the end of 2014 for all women screened irrespective of whether spontaneously or following invitation. Aggregate data were centralized nationally. Among the 2.4 million women from the total target population aged 25-65 years, 1.3 million were invited for screening. The overall screening coverage during 2010-2012 was 62.3%, with wide variations across geographic areas, ranging from 41.6 to 72.5%. Initial invitations and reminders enabled nearly 280 000 women to be screened, corresponding to an estimated increase in coverage of 12% points. Overall, 4.2% of the women screened had an abnormal smear. A total of 5180 high-grade cervical precancers and 323 invasive cervical cancers were reported, corresponding to detection rates of, respectively, 623 and 39 per 100 000 women screened 3-yearly. This study indicates that such organized screening may markedly improve the uptake of cervical cancer screening. On the basis of this pilot program, nationwide organized cervical cancer screening is currently being rolled out in France.

A cross-sectional survey assessing factors associated with reading cancer screening information: previous screening behaviour, demographics and decision-making style

BackgroundThere is broad agreement that cancer screening invitees should know the risks and benefits of testing before deciding whether to participate. In organised screening programmes, a primary method of relaying this information is via leaflets provided at the time of invitation. Little is known about why individuals do not engage with this information. This study assessed factors associated with reading information leaflets provided by the three cancer screening programmes in England.MethodsA cross-sectional survey asked screening-eligible members of the general population in England about the following predictor variables: uptake of previous screening invitations, demographic characteristics, and ‘decision-making styles’ (i.e. the extent to which participants tended to make decisions in a way that was avoidant, rational, intuitive, spontaneous, or dependent). The primary outcome measures were the amount of the leaflet that participants reported having read at their most recent invitation, for any of the three programmes for which they were eligible. Associations between these outcomes and predictor variables were assessed using binary or ordinal logistic regression.ResultsAfter exclusions, data from 275, 309, and 556 participants were analysed in relation to the breast, cervical, and bowel screening programmes, respectively. Notable relationships included associations between regularity of screening uptake and reading (more of) the information leaflets for all programmes (e.g. odds ratio: 0.16 for participants who never/very rarely attended breast screening vs. those who always attended previously; p = .009). Higher rational decision-making scores were associated with reading more of the cervical and bowel screening leaflets (OR: 1.13, p < .0005 and OR: 1.11, p = .045, respectively). Information engagement was also higher for White British participants compared with other ethnic groups for breast (OR: 3.28, p = .008) and bowel (OR: 2.58, p = .015) information; an opposite relationship was observed for older participants (OR: 0.96, p = .048; OR: 0.92, p = .029).ConclusionsInterventions that increase screening uptake may also increase subsequent engagement with information. Future research could investigate how to improve engagement at initial invitations. There may also be scope to reduce barriers to accessing non-English information and alternative communication strategies may benefit participants who are less inclined to weigh up advantages and disadvantages as part of their decision-making.

1685 - Population-based organized cervical cancer screening pilot program in France

In France, cervical cancer screening is recommended every 3 years for women aged 25-65 years. With the exception of a few local organized programs, screening is mainly opportunistic. In view of setting up a nationwide population-based organized screening program, a pilot intervention was implemented in nine geographic areas using a common protocol. Women aged 25-65 years who had not undergone a cytological screening in the past 3 years were invited for screening during 2010-2012 and reminded up to 1 year after the initial invitation. Cytological results and follow-up data were collected up to the end of 2014 for all women screened irrespective of whether spontaneously or following invitation. Aggregate data were centralized nationally. Among the 2.4 million women from the total target population aged 25-65 years, 1.3 million were invited for screening. The overall screening coverage during 2010-2012 was 62.3%, with wide variations across geographic areas, ranging from 41.6 to 72.5%. Initial invitations and reminders enabled nearly 280 000 women to be screened, corresponding to an estimated increase in coverage of 12% points. Overall, 4.2% of the women screened had an abnormal smear. A total of 5180 high-grade cervical precancers and 323 invasive cervical cancers were reported, corresponding to detection rates of, respectively, 623 and 39 per 100 000 women screened 3-yearly. This study indicates that such organized screening may markedly improve the uptake of cervical cancer screening. On the basis of this pilot program, nationwide organized cervical cancer screening is currently being rolled out in France.

Perspective of Saudi women in the Makkah region on breast cancer awareness.

OBJECTIVE:To assess the perspective of Saudi women in the Makkah region on breast cancer awareness and early detection.MATERIALS AND METHODS:A mixed method study was conducted among 25-65 years old healthy Saudi females from Makkah region during the awareness campaign in October 2014. The participants were recruited by personal invitations at the women's places of work and social gatherings. The initial invitations were issued by either the research coordinator or the investigator. All women were asked to complete a short questionnaire on basic knowledge on breast cancer. This was followed by focus group discussions. All interviews were carried out by female breast cancer consultant oncologists. All discussion transcripts were summarized and categorized into main themes; data presented as frequencies and percentages.RESULTS:Forty Saudi females, aged 25-65 years, were included in the study. Nearly 38% of them had never attended any awareness campaign on breast cancer. Only 10% of the participants correctly answered all five basic questions on the risk and early detection of breast cancer; 63% of the women had never been taught breast self-examination. Participants' perception was discussed in five focus groups. Four themes were identified during the discussions: knowledge about breast cancer and screening; resources of breast cancer awareness; social support for access to awareness program; and beliefs on breast cancer and early detection.CONCLUSION:We recommend that strategies on breast cancer awareness in our population should focus on early detection by improving the knowledge and skills of women. These strategies should include programs widely accessible through primary health-care centers and other health-care institutions. In addition, we recommend that physicians and family members should be involved in these programs.

Emerging concept: bringing our trainees into focus

EditorialEmerging concept: bringing our trainees into focusJennifer C. SullivanJennifer C. SullivanDepartment of Physiology, Georgia Regents University, Augusta, GeorgiaPublished Online:15 Jul 2015https://doi.org/10.1152/ajprenal.00179.2015This is the final version - click for previous versionMoreSectionsPDF (28 KB)Download PDF ToolsExport citationAdd to favoritesGet permissionsTrack citations the american journal of physiology-Renal Physiology is pleased to announce a new series of articles named Mini-Review: Emerging Concepts. The goal of this series of articles is to focus on current topics and emerging areas of research that trainees in renal physiology are addressing. These reviews will be no longer than 1,500 words, are limited to one figure, and consistent with the goals of the journal, will address a broad range of physiological and pathophysiological subjects relating to the kidney and urinary tract including both basic science and clinical studies. Since these mini-reviews will often cover emerging or developing areas of research, they will have a much narrower scope than traditional, full-length review articles and will typically focus on a single question. Therefore, while the primary purpose of full-length review articles remains to educate readers by providing a comprehensive view of completed works in a concise, unified format, the mini-reviews will provide our readers with an introduction to an area that is still evolving with the potential to shape the direction of the field in the future. As with all manuscripts considered for publication in the American Journal of Physiology-Renal Physiology, all mini-reviews will undergo peer review, however, the review criteria will reflect the focused nature and space constraints of this article series.This is an invitation-based series of articles. Initial invitations were extended to all of the trainee and early career finalists and awardees selected by the American Physiological Society Renal Section Awards committee for acknowledgment at Experimental Biology 2014. This included all finalists for the 2014 Renal Section Pre-Doctoral and Post-Doctoral Excellence in Renal Research Awards and the Renal Section Research Recognition Awardees. As such, a secondary goal of this series of mini-reviews is to more fully engage our trainees in helping to lead the field of renal physiology. The first of these mini-reviews has been published in a recent issue of the journal (2).There is an ever-expanding literature base implicating immune cells in the development of hypertension and the related renal injury (for recent reviews, see Refs. 3–5) and the authors of our first published mini-review are pioneers in this field. Guzik et al. (1) were the first to demonstrate that Rag-1−/− mice, which lack B and T lymphocytes, have a blunted hypertensive response to ANG II infusion. Adoptive transfer of T lymphocytes into male Rag−/− mice restored the hypertensive response to ANG II; adoptive transfer of B lymphocytes did not alter the blood pressure response.An emerging area of research related to immune cells in hypertension is immunological memory. Immunological memory allows for protection against an antigen that has previously been encountered. While the formation of memory T cells is critical for the ability of the immune system to respond to pathogens, Itani and Harrison (2) suggest that memory T cells may also be important in maintaining T cell activation in sustained hypertension. Better understanding of the activation of specific T cell subtypes in hypertension holds the potential to provide novel methods to treat and hypertension and the related end-organ damage.DISCLOSURESNo conflicts of interest, financial or otherwise, are declared by the author.AUTHOR CONTRIBUTIONSAuthor contributions: J.C.S. drafted manuscript; J.C.S. edited and revised manuscript; J.C.S. approved final version of manuscript.REFERENCES1. Guzik TJ, Hoch NE, Brown KA, McCann LA, Rahman A, Dikalov S, Goronzy J, Weyand C, Harrison DG. Role of the T cell in the genesis of angiotensin II induced hypertension and vascular dysfunction. J Exp Med 204: 2449–2460, 2007.Crossref | PubMed | ISI | Google Scholar2. Itani HA, Harrison DG. Memories that last in hypertension. Am J Physiol Renal Physiol 308: F1197–F1199, 2015.Link | ISI | Google Scholar3. Mattson DL. Infiltrating immune cells in the kidney in salt-sensitive hypertension and renal injury. Am J Physiol Renal Physiol 307: F499–F508, 2014.Link | ISI | Google Scholar4. Trott DW, Harrison DG. The immune system in hypertension. Adv Physiol Educ 38: 20–24, 2014.Link | ISI | Google Scholar5. Zhang J, Crowley SD. Role of T lymphocytes in hypertension. Curr Opin Pharmacol 21: 14–19, 2015.Crossref | PubMed | ISI | Google ScholarAUTHOR NOTESAddress for reprint requests and other correspondence: J. C. Sullivan, 1459 Laney Walker Blvd., Georgia Regents Univ., Augusta, GA 30912 (e-mail: [email protected]edu). Download PDF Back to Top Next FiguresReferencesRelatedInformation More from this issue > Volume 309Issue 2July 2015Pages F89-F89 Copyright & PermissionsCopyright © 2015 the American Physiological Societyhttps://doi.org/10.1152/ajprenal.00179.2015History Published online 15 July 2015 Published in print 15 July 2015 Metrics

A comparison of different strategies used to invite subjects with a positive faecal occult blood test to a colonoscopy assessment. A randomised controlled trial in population-based screening programmes

ObjectiveThe purpose of this parallel randomised controlled trial was to compare compliance with different modalities used to invite patients with a positive immunochemical faecal occult blood test (FIT+) for a total colonoscopy (TC). MethodFIT+ patients from nine Italian colorectal cancer screening programmes were randomised to be invited for a TC initially by mail or by phone and, for non-compliers, to be recalled by mail, for counselling with a general practitioner, or to meet with a specialist screening practitioner (nurse or healthcare assistant). ResultsIn all, 3777 patients were randomised to different invitation strategies. Compliance with an initial invitation by mail and by phone was similar (86.0% vs. 84.0%, relative risk — RR: 1.02; 95%CI 0.97–1.08). Among non-responders to the initial invitation, compliance with a recall by appointment with a specialist practitioner was 50.4%, significantly higher than with a mail recall (38.1%; RR:1.33; 95%CI 1.01–1.76) or with a face-to-face counselling with the GP (30.8%; RR:1.45;95%CI 1.14–1.87). ConclusionCompliance with an initial invitation for a TC by mail and by phone was similar. A personal meeting with a specialist screening practitioner was associated with the highest compliance among non-compliers with initial invitations, while the involvement of GPs in this particular activity seemed less effective.

Semantic physical science.

The articles in this special issue arise from a workshop and symposium held in January 2012 (Semantic Physical Science’). We invited people who shared our vision for the potential of the web to support chemical and related subjects. Other than the initial invitations, we have not exercised any control over the content of the contributed articles.

"Booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods: internal pilot and feasibility study

BackgroundSystematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.MethodsParticipants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mailout. Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mailout of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.ResultsForty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.ConclusionsThe main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.Trial RegistrationISRCTN: ISRCTN56495859, ClinicalTrials (NCT): NCT00836459

Clinical pharmacology: A definition

This may seem like a late date for such a statement, but clinical pharmacology, the latest portfolio in medicine, suffers from the lack of an established and recognized definition; and what is even more distressing to clinical pharmacologists is that, even to those who use the term with some assurance, it often seems to mean different things. The reason for the confusion is not newness alone; the term itself is basically unclear and to a degree even inaccurate. It seems at once to imply such diverse aspects of drugs and their nature and application as applied pharmacology, clinical trials, therapeutics, drug screening, and pharmacology in the clinic (as against the animal laboratory) as well as human pharmacology and, of course, all the methodology involved. As a result in different hands it is used differently. Yet, despite the need to consolidate the subject, there are reasons for perpetuating a title which so early in its history already seems to be a misnomer. It has gained wide acceptance; to shift to a different and more precise but unrecognized term might result in a large step backward at a critical juncture when the need for progress in the discipline is urgent and at a time when the discipline has received its initial invitations to participate on an equal basis in modern medical society.