Assessment of the impact of a patient clinical trials handbook among pharmacy students

BACKGROUND: Patient education in the basic concepts of clinical trials is necessary to promote understanding of the informed consent process and enhance patients' decision-making. It has been suggested that patients' knowledge and attitudes are improved by being given general written information about clinical trials. OBJECTIVE: This pilot study was conducted to determine the effect of a patient education handbook on the knowledge, attitudes, and motivations of pharmacy students regarding clinical trials. METHODS: A patient clinical trials handbook was developed at a 7th-grade reading level for the Department of Veterans Affairs Cooperative Studies Program and tested in PharmD students. Students were randomized to the experimental group (received handbook) or the control group (no handbook). They were given 15 to 20 minutes to read the handbook, after which they were asked to respond to a questionnaire adapted from previous studies. The questionnaire included 25 true/false questions testing participants' knowledge of clinical trials, 5 questions on attitudes toward clinical trials scored on a 5-point Likert scale, and 6 questions concerning their motivation toward participation in hypothetical clinical trial scenarios scored on a 5-point Likert scale. The experimental group was also asked to rate the informativeness, helpfulness, and clarity of the handbook on a 5-point Likert scale. RESULTS: There were 40 students in the experimental group and 50 in the control group. Knowledge scores were significantly higher in the experimental group compared with the control group (mean [SD] percentage of correct answers, 88.7% [8.0%] vs 82.6% [9.0%], respectively; P < 0.001). Positive attitudes toward clinical trials were also increased in the experimental group compared with the control group; specifically, participants expressed significantly greater clarity of understanding of clinical trials (mean score, 1.4 [0.5] vs 0.8 [0.6]; P < 0.001) and relief associated with knowing about clinical trials (mean score, 0.8 [0.8] vs 0.4 [0.7]; P = 0.017). There were no between-group differences in students' motivation to participate in the hypothetical clinical trial scenarios. A high proportion of students (95%) found the handbook informative, helpful, and understandable. CONCLUSIONS: The patient clinical trials handbook increased knowledge and positive attitudes regarding clinical trials among pharmacy students participating in this study.     

Effect size estimation for combined single-case experimental designs

Abstract

The methodology of single-case experimental designs (SCED) has been expanding its efforts toward rigorous design tactics to address a variety of research questions related to intervention effectiveness. Effect size indicators appropriate to quantify the magnitude and the direction of interventions have been recommended and intensively studied for the major SCED design tactics, such as reversal designs, multiple-baseline designs across participants, and alternating treatment designs. In order to address complex and more sophisticated research questions, two or more different single-case design tactics can be merged (i.e., “combined SCEDs”). The two most common combined SCEDs are (a) a combination of a multiple-baseline design across participants with an embedded ABAB reversal design, and (b) a combination of a multiple-baseline design across participants with an embedded alternating treatment design. While these combined designs have the potential to address complex research questions and demonstrate functional relations, the development and use of proper effect size indicators lag behind and remain unexplored. Therefore, this study probes into the quantitative analysis of combined SCEDs using regression-based effect size estimates and two-level hierarchical linear modeling. This study is the first demonstration of effect size estimation for combined designs.     

Assessment of clinical competencies by the foreign medical graduate examination in the medical sciences

A test to assess clinical competence requires the inclusion of a domain consisting of multiple clinical competencies. Although some can be tested in simulated clinical settings with standardized patients, others should not be tested in such integrated clinical encounters because of the limited amount of time that can be allotted in a case‐specific context. This is particularly true of diagnosis/management competencies, which include problem identification and differential diagnosis, interpretation of diagnostic and laboratory procedures, and patient management.

In this study, responses to all 139 multiple‐choice questions (MCQs) addressing diagnosis/management competencies in the July 1989 Day 2 component of the Foreign Medical Graduate Examination in the Medical Sciences (FMGEMS) were compared with the entire Day 2 scores and with the other categories of MCQs in that component. The results show that FMGEMS Day 2 scores are reliable in measuring the ability of examinees to address diagnosis/management competencies.     

Why, when, and how should pharmacogenetics be applied in clinical studies?: current and future approaches to study designs

The growing interest in incorporating pharmacogenetics (PGx) into drug development and clinical practice raises several questions: which study designs best reveal relevant pharmacogenetic biomarkers, best clarify specific hypotheses in PGx, and result in the largest gain of clinical evidence in this field? In this review, we present and compare a variety of PGx-related study designs. The type and quality of evidence gained by each category of study design is evaluated, and an appropriate timeline for the integration of pharmacogenetic studies into drug development is proposed. A summary of the pros and cons of the different study designs might help investigators decide how best to incorporate PGx into drug research. Using different scenarios to explain how genetic polymorphisms influence drug action, we illustrate how this knowledge can be translated into individualized drug choices, individualized dosage determination based on pharmacogenetic diagnostics, and other types of monitoring in order to make drug therapies safer and more effective.     

Optimal adaptive group sequential design with flexible timing of sample size determination

Flexible sample size designs, including group sequential and sample size re-estimation designs, have been used as alternatives to fixed sample size designs to achieve more robust statistical power and better trial efficiency. In this work, a new representation of sample size re-estimation design suggested by Cui et al. [5,6] is introduced as an adaptive group sequential design with flexible timing of sample size determination. This generalized adaptive group sequential design allows one time sample size determination either before the start of or in the mid-course of a clinical study. The new approach leads to possible design optimization on an expanded space of design parameters. Its equivalence to sample size re-estimation design proposed by Cui et al. provides further insight on re-estimation design and helps to address common confusions and misunderstanding. Issues in designing flexible sample size trial, including design objective, performance evaluation and implementation are touched upon with an example to illustrate.     

Issues in cross-cultural comparative research

It is the purpose of this article to describe the methodological issues when designing qualitative cultural comparative studies, which may be used to address health disparities. Overall, two broad types of comparative studies were found: primary and secondary comparative studies. Methodological issues to consider when designing primary studies were reviewed. The main areas discussed in this article relate to sampling and study purpose, sample boundaries, theoretical context, concept development, analogous comparisons, and systematic comparisons. Nurses are in a prime position to pose the qualitative research questions needed to address health disparities within their clinical settings. It is suggested that awareness of the method types and issues might inspire further qualitative comparative work.     

Sex Hormones and Pain: The Evidence From Functional Imaging

There is a substantial body of epidemiological and clinical evidence suggesting that the sex hormones, particularly estradiol and progesterone, play a role in pain. Behavioral studies have not been useful in understanding the relationship between sex hormones and pain perception, and certainly have not helped to elucidate the mechanisms by which such effects may be mediated. This review aims to address the additional insights functional imaging has given us into the role of sex hormones in pain. Functional imaging techniques and experimental designs are discussed before the literature investigating specific questions relating to hormones and pain is reviewed. Finally, we conclude by considering how results of studies imaging the influence of sex hormones in related areas such as emotion and cognition also may inform our understanding of this complex area.     

Evaluation of drug cost reduction resulting from the free supply of investigational drugs

Excluding all other costs or benefits of participation in clinical trials, the objective of this study was to evaluate and analyse the cost avoidance represented by the free supply of the investigational drug in place of paying for a marketed drug. The cost avoided was defined as money that would most likely have been spent, but not because of inclusion of the patient in the clinical study. Only studies for which a marketed alternative drug was available with a standard dosage have been analysed. The numbers of delivered doses or the treatment durations were tabulated from pharmacy dispensing records for each study, and were used to calculate the medication cost avoided. No marketed alternative drug was available for 10 of 56 clinical studies. In total, in 2000, the cost avoidance was estimated between [symbol: see text] 585,492 and [symbol: see text] 603,674, with a wide variability between studies or between patients (CV: 120-520%). The two disease categories associated with the largest cost avoidance were multiple sclerosis and growth hormone deficiency. The cost avoidance was essentially of benefit to the medical insurance or the patient (98%) and was lower than [symbol: see text] 10,000 for the hospital, because 91% of patients are not hospitalised. So, why are clinical studies involving ambulatory patients performed in hospital? Of the 56 studies analysed, 46 could be shown to be non-innovative, because a marketed alternative drug was available. Few studies appeared to permit free access to treatment with non-reimbursable marketed drugs.     

Severity Grading of Childhood Poisoning: The Multicentre Study of Poisoning in Children (MSPC) Score

The evidence base of clinical toxicology suffers in comparison to other clinical disciplines. There is an excess of case reports and case series with little in the way of case control or cohort studies, and very few randomized controlled trials. While randomized controlled trials are rightly regarded as the gold standard for interventional studies, they have limitations that are particularly evident in the practice of clinical toxicology. Properly conducted observational studies using quantitative, epidemiological methods [nonrandomized trials, cohort studies (prospective and retrospective), case control methods] can provide answers that may be impossible to obtain from randomized controlled trials. Development of a strong evidence base is essential for progress in clinical toxicology. Whether that evidence base is derived from randomized controlled trials or observational studies, it is essential to collect data. Important observations can be made from basic clinical data and systematic collection of those data into some form of electronic database has significant advantages. A clinical database provides accurate information in the areas of clinical practice, quality assurance (audit), and research. In the area of research, an appropriately designed database can be both a source of hypotheses as well as a vehicle to test them. It can also serve as a repository of research data in subsequent randomized controlled trials.     

Effectiveness of Cognitive Behavioral Therapy for Individuals with Autism Spectrum Disorders and Comorbid Obsessive-Compulsive Disorder: A Review of the Research

Autism spectrum disorders (ASD) and obsessive-compulsive disorder (OCD) are highly comorbid, precipitating an urgent need to identify evidence-based practices that might be used to address this comorbidity exclusively. The aim of this study was to conduct a review of intervention research and clinical reports to examine the use of cognitive behavioral therapy (CBT) with individuals who have comorbid ASD and OCD. Based on the pre-determined review inclusion criteria, 11 studies were included in the review: three randomized control trials (RCT), one case controlled study, two single subject experimental designs, and five case studies. These studies offer promising data on the use of CBT interventions for individuals with ASD and comorbid OCD as well as for individuals with OCD and comorbid ASD when standard CBT protocol is enhanced with modifications such as parental involvement, increased use of visuals, personalized treatment metaphors, self-monitoring, positive reinforcement, and use of clear language and instructions. Limitations and implications for future research and practice are discussed.     

Factors in the clinical learning environment that influence caring behaviors of undergraduate nursing students: An integrative review

AimThe aim is to explore literature on the influence of the clinical learning environment on caring behaviors of undergraduate nursing students.BackgroundCaring is a fundamental aspect of nursing practice. However, factors of and in clinical learning environment that help shape the caring behaviors of nursing students as part of their education journey remain understudied.DesignA modified version of Cooper’s five-stage integrative review method was used.MethodsFour databases (Cumulative Index of Nursing and Allied Health, PubMed, Scopus and Embase) were searched for research studies published from 2011 to 2021 in peer reviewed journals, written in English and addressing caring behaviors among nursing students in the clinical learning environment. A combination of keywords with Boolean operators was used including: “nursing students OR nursing undergraduates OR student nurses” and “clinical learning environment” AND “caring behaviors”. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines.ResultsEmpirical evidence was drawn from 11 studies including seven qualitative designs, three quantitative designs and one mixed method design. The results of this review suggest that factors in the clinical learning environment influence nursing students’ ability to develop caring behaviors. Specifically, the five themes of: [1] role modeling of clinical faculty and professional nurses, [2] creating a conducive clinical learning environment, [3] effective communication skills, [4] positive effect of simulation and [5] alternative clinical placements may facilitate the development of caring behaviors among nursing students.ConclusionThe findings highlight the factors in the clinical learning environment that influence nursing students’ caring behaviors. Improving students’ clinical learning experiences and implementing more effective role modeling and teaching strategies may advance their caring abilities. The information generated from this review provides evidence on how to enhance the clinical learning environment to develop students’ caring behaviors, subsequently leading to more optimal patient outcomes.     

Thrombolysis during cardiopulmonary resuscitation in fulminant pulmonary embolism: a review.

OBJECTIVE: To review current knowledge on thrombolysis in patients with fulminant pulmonary embolism (FPE) who need cardiopulmonary resuscitation (CPR). DATA SOURCES: The bibliography for the study was compiled through a search of different databases between 1966 and 2000. References cited in the articles selected were also reviewed. STUDY SELECTION: The selection criteria included all reports published on thrombolysis, pulmonary embolism, and CPR, from case reports and case series to controlled studies. DATA SYNTHESIS: Very few studies evaluated thrombolysis in cases of FPE that required CPR and most of these were clinical case reports and case series with a low level of scientific evidence. There has been no clinical trial to address this issue. CONCLUSIONS: FPE can frequently produce cardiac arrest, which has an extremely high mortality despite application of the usual CPR measures. The administration of thrombolytic therapy during CPR could help to reduce the mortality, although it has classically been contraindicated. There are no published clinical trials or other high-grade studies that evaluated the efficacy and safety of this approach. From the few existing studies, it can be inferred that thrombolysis may be efficacious and safe for patients with FPE who need CPR. However, a clinical trial is required to provide evidence of value for sound clinical decision-making.     

Clinical effects of date palm (Phoenix dactylifera L.): A systematic review on clinical trials

PurposeThe aim of present study was to review and categorize the clinical trials investigating the clinical effects of different botanical parts of dates compared with any controls.MethodsAll clinical trials (randomized, pilot, quasi-experimental, cross-over. and non-randomized clinical trials) evaluating the clinical effects of date palm from 2000 until August 2019 in English and Persian languages were included in this systematic review. The methodological quality of the included studies was evaluated according to the risk of bias assessment of Cochrane handbook of systematic reviews, and then reported using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.ResultsTwenty-six studies met the inclusion criteria. Studies were performed in 8 categories based on different botanical parts of date palm. These categories were obstetrics, gynecology, oncology, dermatology, hematology, gastroenterology, endocrinology, metabolism, and infertility. A total of 38 % of included studies were randomized controlled trials. Further, 80 % of the included studies had performance and detection bias. Finally, about 50 % of them had selection bias and about 20 % had attrition and reporting bias.ConclusionThe widespread consumption of date palm as medicinal and botanical plant suggests the importance of this plant in human healthcare. The clinical trials conducted so far have explained a number of clinical effects of date palm. However, there is not enough clinical evidence to support the clinical effects in other review articles and traditional medical systems, and further randomized controlled trials with robust designs and methods are required.     

Observational studies: a review of study designs,challenges and strategies to reduce confounding

There are several methods in which one can assess the relationship between an intervention and an outcome. Randomized controlled trials (RCTs) are considered as the gold standard for evaluating interventions. However, for many questions of clinical importance, RCTs would be impractical or unethical. Clinicians must rely on observational studies for the best available evidence when RCTs are unavailable. This article provides an overview of observational research designs to facilitate the understanding and appraising of their validity and applicability in clinical practice. Major methodological issues of observational studies including selection bias and confounding are also discussed. In addition, strategies to minimize these problems in the design and analytical phases of a study are highlighted. Knowledge of the strengths, weaknesses and recent methodological advances in observational studies can assist clinicians to make informed decisions about whether a particular observational study would provide useful information to enhance patient care.     

Analyzing the teaching effectiveness of clinical nursing faculty of full- and part-time generic BSN, LPN-BSN, and RN-BSN nursing students.

Effective clinical teaching has been a focus for scrutiny across the health-care disciplines. Nursing researchers have investigated students' and faculty members' views of effective clinical teaching. Various students (diploma, ADN, BSN) and their respective faculty have been studied, and some investigators have researched opinions of part-time students. No study was available that analyzed effective clinical teaching from the perspectives of students representing various formats of nursing education (basic BSN, RN-BSN, LPN-BSN students) and whether they were full or part time. The purpose of the study was to examine full- and part-time basic BSN, LPN-BSN, and RN-BSN students' ratings of effective clinical teaching behaviors. A stratified sample (n = 198) of baccalaureate nursing students (basic, LPN-BSN, RN-BSN) who represented both full- and part-time attendees was obtained. Students were informed about the study's purpose and asked to complete a demographic questionnaire and two instruments, by Knox and Mogan [Knox, J. E., & Mogan, J. (1985). Important clinical teaching behaviors as perceived by university nursing faculty, students, and graduates. The Journal of Nursing Education , 10, 295-301] and Zimmerman and Westfall [Zimmerman, L., & Westfall, J. (1988). The development and validation of a scale measuring effective clinical teaching behaviors. The Journal of Nursing Education , 27, 274-277], measuring perceptions of effective clinical teaching. Responses to open-ended questions were recorded on one instrument. Data were analyzed using summary and inferential statistics utilizing SPSS version 12.0. Responses to open-ended questions were thematically analyzed. Findings from the study demonstrated that part-time students rated their clinical instructors statistically significantly higher in effective clinical teaching and associated subscales. Type of student (basic BSN, LPN-BSN, RN-BSN) did not affect students' ratings. Type of program format and type of student did not interact to affect ratings at a statistically significant level. Implications for nursing education, administration, and future research are delineated.     

腹腔镜和开腹术后宫颈癌患者的心理状况及影响因素的研究

目的调查宫颈癌患者腹腔镜术后和开腹术后的心理状况及其影响因素。方法运用症状自评量表(SCL-90)评定两种不同手术方法组患者的心理状况并通过自行设计的多项目调查表综合分析其影响因素。结果宫颈癌患者SCL-90躯体化,强迫,抑郁,焦虑,恐惧,偏执,精神病性因子7个明显高于全国女性常模(P<0.01),腔镜组患者与开腹组患者相比较躯体化,焦虑,人际关系和抑郁因子差异有显著性(P<0.05)。结论宫颈癌术后群体有比较明显的心理问题,其中腹腔镜组患者较开腹组患者的心理健康状态好。术后患者的心理状况低下与家庭关系,手术方式,临床分期有关。     

Patient and carer perspectives: a man with inoperable lung cancer

Background: Palliative care professionals have recognized the importance of hope for their patients. However, they sometimes experience hope as a barrier for end-of-life communication, for instance when patients have unrealistic hope. A hope communication tool (HCT) may help them to address hope during clinical encounters but has not been developed yet. The objective of this study was to examine the feasibility of a HCT for palliative care professionals.

Method: Based on synthesis studies of hope, a hope communication tool (HCT) was developed. Palliative care professionals were asked to use and evaluate the tool by making use of a written evaluation scheme, mainly consisting of open-ended questions. Similarities and differences between participants and suggestions for revisions were thematically analyzed and discussed within the research team.

Results: Fourteen healthcare professionals (nine females; mean age 50.9 years) participated in the study: nine nurses, three physicians and two chaplains. The HCT helped participants to reach depth and address end-of-life issues. Most participants used it for other reasons than described in the tool. They used it when they faced difficulties that related to patients’ hope or hope-related themes, such as unrealistic hope or fear. Participants also gave feedback on the open or abstract character of questions, the assumptions of questions, and the distinctions between categories.

Discussion: The HCT is feasible and helps to reach depth and address end-of-life issues. The findings lead to a revised HCT. Future research should examine the impact of the use of this revised tool on patients.