Demographic and clinical characteristics of patients with hereditary angioedema in Canada.

BACKGROUND: Data on the clinical and demographic features of Canadian patients with hereditary angioedema (HAE) are lacking. OBJECTIVE: To describe the clinical and demographic features in a large Canadian HAE cohort and compare them with patients with HAE in other countries. METHODS: An online questionnaire was distributed to the members of 2 Canadian HAE patient groups to collect information on demographics and HAE clinical characteristics. All participants 18 years of age or older with HAE type I or II were eligible. Frequency, location, prodromes, and triggers of HAE attacks, including types of HAE treatment, were characterized. RESULTS: Among the 90 participants who completed the online survey, 57% self-identified as having HAE type 1 and 26% HAE type II. The average diagnostic delay was 11 years. In the preceding 6 months, 24% of the participants had no attacks and 35% experienced greater than 5 attacks. The most frequently affected regions of the body were the abdomen (83%), arms orlegs (63%), face (41%), and larynx or throat (41%). Approximately 87% of the participants reported having access to C1 inhibitor at home, and 69% reported using it for long-term prophylaxis. CONCLUSION: Canadian patients with HAE share common clinical characteristics with patients with HAE in other countries. They had a delay in HAE diagnosis and a high burden of disease, as indicated by the high frequency of attacks in the preceding 6 months. This study provides a better understanding of the demographic and clinical characteristics of Canadian patients with HAE.

Clinical trials and tribulations: lessons from spinal cord injury studies registered on ClinicalTrials.gov.

STUDY DESIGN: Article. OBJECTIVE: ClinicalTrials.gov is an online trial registry that provides public access to information on past, present, and future clinical trials. While increasing transparency in research, the quality of the information provided in trial registrations is highly variable. The objective of this study is to assess key areas of information on ClinicalTrials.gov in interventional trials involving people with spinal cord injuries. SETTING: Interventional trials on ClinicalTrials.gov involving people with spinal cord injuries. METHODS: A subset of data on interventional spinal cord injury trials was downloaded from ClinicalTrials.gov. Reviewers extracted information pertaining to study type, injury etiology, spinal cord injury characteristics, timing, study status, and results. RESULTS: Of the interventional trial registrations reviewed, 62.5%, 58.6%, and 24.3% reported injury level, severity, and etiology, respectively. The timing of intervention relative to injury was reported in 72.8% of registrations. Most trials identified a valid study status (89.2%), but only 23.5% of those completed studies had posted results. CONCLUSIONS: Our review provides a snapshot of interventional clinical trials conducted in the field of spinal cord injury and registered in ClinicalTrials.gov. Areas for improvement were identified with regards to reporting injury characteristics, as well as posting results.

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations.

Accurate safety information in published clinical trials guides the assessment of risk-benefit, as well as the design of future clinical trials. Comprehensive reporting of adverse events, toxicity, and discontinuations from acute spinal cord injury clinical trials is an essential step in this process. Here, we sought to assess the degree of "satisfactoriness" of reporting in past clinical trials in spinal cord injury. A review of citations from MEDLINE and EMBASE identified eligible clinical trials in acute (within 30 days) spinal cord injury. English language studies, published between 1980 and 2020, with sensory, motor, or autonomic neurological assessments as the primary outcome measure were eligible for inclusion. Criteria were then established to qualify the safety reporting as satisfactory (i.e., distinguished severe/life-threatening events), partially satisfactory, or unsatisfactory (i.e., only mentioned in general statements, or reported but without distinguishing severe events). A total of 40 trials were included. Satisfactory reporting for clinical adverse events was observed in 30% of trials; partially satisfactory was achieved by 10% of the trials, and the remaining 60% were unsatisfactory. The majority of trials were determined to be unsatisfactory for the reporting of laboratory-defined toxicity (82.5%); only 17.5% were satisfactory. Discontinuations were satisfactorily reported for the majority of trials (80%), with the remaining partially satisfactory (5%) or unsatisfactory (15%). Reporting of safety in clinical trials for acute spinal cord injury is suboptimal. Due to the complexities of acute spinal cord injury (e.g., polytrauma, multiple systems affected), tailored and specific standards for tracking adverse events and safety reporting should be established.

Quality of life in patients with hereditary angioedema in Canada.

BACKGROUND: Hereditary angioedema (HAE) is associated with decreased quality of life (QoL), which has typically been measured using a generic non-disease-specific questionnaire. OBJECTIVE: We aimed to assess the QoL in patients with HAE type I and II in Canada using a previously validated HAE-specific questionnaire. METHODS: An online questionnaire was sent to the members of two Canadian HAE patient groups to collect data on demographics, HAE clinical course, and QoL scores. All patients 18 years of age or older with HAE type I or II were eligible. The impact of the available clinical factors on the QoL scores was evaluated. Multiple linear regression was performed using clinically relevant factors to predict HAE QoL outcome. RESULTS: Among the 72 patients in the study, the mean total HAE QoL score was 102 (±23) (SD) on a scale of 25 to 135, with higher scores indicating better QoL. Although the total QoL scores correlated positively with patients' level of satisfaction and perceived control (P < .001 for both), it correlated negatively with the number of acute attacks (P = .03). Yet, the types of treatment did not have an impact on the QoL. Predictors, including sex, comorbidities, and the number of attacks, only explained 12% of the variance in the total QoL scores. CONCLUSION: HAE continues to impair QoL in Canadian patients despite receiving recommended treatment. Although the frequency of attacks affects QoL, patients' experience with their HAE care also affects QoL substantially. The study highlights the importance of considering patients' experience with their HAE care as physicians develop an appropriate management plan.

The Damaged Spinal Cord Is a Suitable Target for Stem Cell Transplantation.

Background. Given individuals with spinal cord injury (SCI) approaching 2 million, viable options for regenerative repair are desperately needed. Human central nervous system stem cells (HuCNS-SC) are self-renewing, multipotent adult stem cells that engraft, migrate, and differentiate in appropriate regions in multiple animal models of injured brain and spinal cord. Preclinical improved SCI locomotor function provided rationale for the first-in-human SCI clinical trial of HuCNS-SC cells. Evidence of feasibility and long-term safety of cell transplantation into damaged human cord is needed to foster translational progression of cellular therapies. Methods. A first-ever, multisite phase I/IIa trial involving surgical transplantation of 20 million HuCNS-SC cells into the thoracic cord in 12 AIS A or B subjects (traumatic, T2-T11 motor-complete, sensory-incomplete), aged 19 to 53 years, demonstrated safety and preliminary efficacy. Six-year follow-up data were collected (sensory thresholds and neuroimaging augmenting clinical assessments). Findings. The study revealed short- and long-term surgical and medical safety (well-tolerated immunosuppression in population susceptible to infections). Preliminary efficacy measures identified 5/12 with reliable sensory improvements. Unfortunately, without thoracic muscles available for manual muscle examination, thoracic motor changes could not be measured. Lower limb motor scores did not change during the study. Cervical cord imaging revealed, no tumor formation or malformation of the lesion area, and secondary supralesional structural changes similar to SCI control subjects. Interpretation. Short- and long-term safety and feasibility support the consideration of cell transplantation for patients with complete and incomplete SCI. This report is an important step to prepare, foster, and maintain the therapeutic development of cell transplantation for human SCI.

Lessons learned from the pilot study of an orthostatic hypotension intervention in the subacute phase following spinal cord injury.

Context: Following spinal cord injury (SCI) at the cervical or upper-thoracic level, orthostatic hypotension (OH) is observed in 13-100% of patients. This study aimed to test the feasibility of conducting a randomized controlled trial combining a dynamic tilt-table (Erigo®) and functional electrical stimulation (FES) to mitigate OH symptoms in the subacute phase after SCI. Design: Pilot study. Setting: A tertiary rehabilitation hospital. Participants: Inpatients who had a C4-T6 SCI (AIS A-D) less than 12 weeks before recruitment, and reported symptoms of OH in their medical chart. Interventions: Screening sit-up test to determine eligibility, then 1 assessment session and 3 intervention sessions with Erigo® and FES for eligible participants. Outcome measures: Recruitment rate, duration of assessment and interventions, resources used, blood pressure, and Calgary Presyncope Form (OH symptoms). Results: Amongst the 232 admissions, 148 inpatient charts were reviewed, 11 inpatients met all inclusion criteria, 7 participated in a screening sit-up test, and 2 exhibited OH. Neither of the two participants recruited in the pilot study was able to fully complete the assessment and intervention sessions due to scheduling issues (i.e. limited available time). Conclusion: This pilot study evidenced the non-feasibility of the clinical trial as originally designed, due to the low recruitment rate and the lack of available time for research in participant's weekday schedule. OH in the subacute phase after SCI was less prevalent and less incapacitating than expected. Conventional management and spontaneous resolution of symptoms appeared sufficient to mitigate OH in most patients with subacute SCI.

Development of Tissue Integrity indicators to advance the quality of spinal cord injury rehabilitation: SCI-High Project.

Objective: To establish structure, process and outcome indicators to evaluate tissue integrity in Canadians with spinal cord injury or disease (SCI/D) in the first 18 months following inpatient rehabilitation admission. Method: A Working Group comprised of Canadian subject matter experts in the Domain of Tissue Integrity was formed to define the construct of tissue integrity. A literature review was conducted and a Driver diagram produced to identify factors that influence tissue integrity in individuals with SCI/D. Facilitated meetings were conducted to identify and achieve consensus on structure, process and outcome indicators. Rapid cycle testing was used to pilot test proposed indicators for face validity and feasibility within a quality improvement context. Results: The structure indicators are the proportion of patients with SCI/D who have access to a mirror for skin checks and the proportion of patients who have access to patient education on tissue integrity; the process indicator is the proportion of patients who completed daily head-to-toe skin checks; the intermediary outcome indicator is pressure injury (PI) incidence during inpatient rehabilitation; and the final outcome indicator is the proportion of individuals with intact skin at 18 months following rehabilitation admission. Conclusion: The set of indicators established for the Domain of Tissue Integrity are specifically focused on aspects of care that can impact the maintenance of tissue integrity and the prevention of PI and align with current practice guidelines. The implementation and evaluation of these indicators nationally have the potential to improve care for Canadians with SCI/D.

The challenge of recruitment for neurotherapeutic clinical trials in spinal cord injury.

STUDY DESIGN: Narrative review by individuals experienced in the recruitment of participants to neurotherapeutic clinical trials in spinal cord injury (SCI). OBJECTIVES: To identify key problems of recruitment and explore potential approaches to overcoming them. METHODS: Published quantitative experience with recruitment of large-scale, experimental neurotherapeutic clinical studies targeting central nervous system and using primary outcome assessments validated for SCI over the last 3 decades was summarized. Based on this experience, potential approaches to improving recruitment were elicited from the authors. RESULTS: The rate of recruitment has varied between studies, depending on protocol design and other factors, but particularly inclusion/exclusion criteria. The recruitment rate also ranged over an order of magnitude between individual centers in a given study. In older multicenter studies, average recruitment rate was approximately one person per study center per month. More recent trials experienced lower rates of recruitment and potential reasons for this trend were examined. The current roles and potential of various stakeholder organizations in addressing problems of recruitment were explored. In addition, recent developments in methodology may help reduce the number of subjects required for well-powered studies. CONCLUSIONS: Several approaches are emerging to improve clinical trial design, efficacy outcome measures, and quantifiable surrogate markers, all of which should reduce the number of participants required for adequate statistical power. There is a growing sense of cooperation between various stakeholders but more should be done to bring together consumer and provider groups to improve recruitment and the effectiveness and relevance of neurotherapeutic clinical trials.

An inclusive, online Delphi process for setting targets for best practice implementation for spinal cord injury.

RATIONALE, AIMS, AND OBJECTIVES: The Spinal Cord Injury Knowledge Mobilization Network is a pan-Canadian community of practice composed of seven rehabilitation hospitals. The goal of this network is to utilize implementation science processes to facilitate the adoption of best practice in spinal cord injury (SCI) rehabilitation. In addition to selecting specific practices for implementation, a key aspect of effective implementation is the engagement of stakeholders in decision-making processes. To achieve this, the network utilized a Delphi process to reach consensus on two pressure ulcer prevention and management practices to be implemented in SCI inpatient rehabilitation. A diverse, multidisciplinary panel of clinicians, researchers, sponsoring agency representatives, and persons with SCI participated in this process. METHOD: An online Delphi process was conducted in order to prioritize pressure ulcer prevention and management best practice recommendations and performance indicators for implementation. The process was conducted in six stages: (1) steering committee selection; (2) identification and selection of evidence; (3) participant selection and recruitment; (4) survey development; (5) identification of voting criteria; and (6) five rounds of voting. RESULTS: The Delphi process resulted in the selection of two best practices: (1) comprehensive risk assessment and (2) education for pressure ulcer prevention and management in persons with SCI. CONCLUSIONS: In this Delphi process, a large expert panel achieved consensus on best practice recommendations and associated performance indicators for implementation. This process was undertaken as a first step towards optimization of service delivery and outcomes for persons with SCI across Canada.

Clinical Outcomes from a Multi-Center Study of Human Neural Stem Cell Transplantation in Chronic Cervical Spinal Cord Injury.

Human neural stem cell transplantation (HuCNS-SC®) is a promising central nervous system (CNS) tissue repair strategy in patients with stable neurological deficits from chronic spinal cord injury (SCI). These immature human neural cells have been demonstrated to survive when transplanted in vivo, extend neural processes, form synaptic contacts, and improve functional outcomes after experimental SCI. A phase II single blind, randomized proof-of-concept study of the safety and efficacy of HuCNS-SC transplantation into the cervical spinal cord was undertaken in patients with chronic C5-7 tetraplegia, 4-24 months post-injury. In Cohort I (n = 6) dose escalation from 15,000,000 to 40,000,000 cells was performed to determine the optimum dose. In Cohort II an additional six participants were transplanted at target dose (40,000,000) and compared with four untreated controls. Within the transplant group, there were nine American Spinal Injury Association Impairment Scale (AIS) B and three AIS A participants with a median age at transplant of 28 years with an average time to transplant post-injury of 1 year. Immunosuppression was continued for 6 months post-transplant, and immunosuppressive blood levels of tacrolimus were achieved and well tolerated. At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging. In summary, the incremental dose escalation design established surgical safety, tolerability, and feasibility in Cohort I. Interim analysis of Cohorts I and II demonstrated a trend toward Upper Extremity Motor Score (UEMS) and Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) motor gains in the treated participants, but at a magnitude below the required clinical efficacy threshold set by the sponsor to support further development resulting in early study termination.

Effectiveness of 4-Aminopyridine for the Management of Spasticity in Spinal Cord Injury: A Systematic Review.

Background: Spasticity is a common secondary complication of spinal cord injury (SCI), which can severely impact functional independence and quality of life. 4-Aminopyridine (4-AP) is a potassium channel blocker that has been studied as an intervention for spasticity in individuals with SCI. Objective: To conduct a systematic review of the available evidence regarding the effectiveness of 4-AP for the management of spasticity in individuals with SCI. Methods: A comprehensive literature search was conducted on five electronic databases for articles published in English up to January 2017. Studies were included if (1) the sample size was three or more subjects, (2) the population was ≥50% SCI, (3) the subjects were ≥18 years old, (4) the treatment was 4-AP via any route, and (5) spasticity was assessed before and after the intervention. Subject characteristics, study design, intervention protocol, assessment methods, side effects, adverse events, and outcomes were extracted from selected studies. Randomized controlled trials (RCTs) were evaluated for methodological quality using the Physiotherapy Evidence Database (PEDro) tool. Levels of evidence were assigned using a modified Sackett scale. Results: Nine studies met inclusion criteria with a pooled sample size of 591 subjects. Six studies were RCTs (PEDro = 6-10, Level 1 evidence) and three studies were pre-post tests (Level 4 evidence). There was a wide range in duration, severity, and level of SCI across subjects. Oral 4-AP was investigated in five studies; one study reported significant improvements on the Ashworth Scale (AS), while the remaining four studies found no improvement. Three studies found no significant improvements on the Spasm Frequency Scale. Intravenous 4-AP was investigated in three studies; no significant improvements were found on the AS or in the Reflex Score. Intrathecal 4-AP was investigated in one study, which did not find significant improvements on the AS. Conclusion: There is weak evidence supporting the effectiveness of 4-AP in reducing spasticity post SCI. Future research should utilize contemporary measures of spasticity and address methodological limitations such as small sample sizes.

Establishing the competences of clinical reasoning for nursing students in Taiwan: From the nurse educators' perspectives.

BACKGROUND: Clinical reasoning is an essential core competence for nurses. Maintaining quality of care and safety of patients results from cultivation of student's clinical reasoning competency. However, the concept of clinical reasoning in nursing students is complex and its meaning and process needs further clarification. OBJECTIVES: The objectives were to explore the meaning of clinical reasoning competency in Taiwanese nursing students and to operationalize the concept in order to structure a framework illustrating the process of clinical reasoning. SETTING AND PARTICIPANTS: Thirteen seasoned nursing experts who had more than ten years of experience in nursing education or clinical practice participated in the interviews. The interviews were conducted in settings that the participants perceived as convenient, quiet and free of disturbance. METHODS: Semi-structured interviews were conducted. The interviews were audio-recorded and field notes were taken. The data were analyzed using Waltz et al.'s (2010) method of content analysis. RESULTS: The data revealed four domains and 11 competency indicators. The four domains include: awareness of clinical cues, confirmation of clinical problems, determination and implementation of actions, and evaluation and self-reflection. Each domain comprises of 2-4 indicators of clinical reasoning competency. In addition, this study established a framework for cultivation of clinical reasoning competency in nursing students. CONCLUSION: The indicators of clinical reasoning competency in nursing students are interwoven, interactive and interdependent to form a dynamic process. The findings of this study may facilitate evaluation of nursing students' clinical reasoning competency and development of instruments to assess clinical reasoning in nursing students.

Emerging Safety of Intramedullary Transplantation of Human Neural Stem Cells in Chronic Cervical and Thoracic Spinal Cord Injury.

BACKGROUND: Human central nervous system stem cells (HuCNS-SC) are multipotent adult stem cells with successful engraftment, migration, and region-appropriate differentiation after spinal cord injury (SCI). OBJECTIVE: To present data on the surgical safety profile and feasibility of multiple intramedullary perilesional injections of HuCNS-SC after SCI. METHODS: Intramedullary free-hand (manual) transplantation of HuCNS-SC cells was performed in subjects with thoracic (n = 12) and cervical (n = 17) complete and sensory incomplete chronic traumatic SCI. RESULTS: Intramedullary stem cell transplantation needle times in the thoracic cohort (20 M HuCNS-SC) were 19:30 min and total injection time was 42:15 min. The cervical cohort I (n = 6), demonstrated that escalating doses of HuCNS-SC up to 40 M range were well tolerated. In cohort II (40 M, n = 11), the intramedullary stem cell transplantation needle times and total injection time was 26:05 ± 1:08 and 58:14 ± 4:06 min, respectively. In the first year after injection, there were 4 serious adverse events in 4 of the 12 thoracic subjects and 15 serious adverse events in 9 of the 17 cervical patients. No safety concerns were considered related to the cells or the manual intramedullary injection. Cervical magnetic resonance images demonstrated mild increased T2 signal change in 8 of 17 transplanted subjects without motor decrements or emerging neuropathic pain. All T2 signal change resolved by 6 to 12 mo post-transplant. CONCLUSION: A total cell dose of 20 M cells via 4 and up to 40 M cells via 8 perilesional intramedullary injections after thoracic and cervical SCI respectively proved safe and feasible using a manual injection technique.

Using Training Needs Assessment to Develop a Nurse Preceptor-Centered Training Program.

BACKGROUND: Studies reveal that most nurse preceptor preparation programs do not meet nurse preceptors' training needs. This study thus developed a nurse preceptor-centered training program (NPCTP) in Taiwan. METHOD: The ADDIE model was used for the instructional design. On the basis of the nurse preceptors' training needs assessment, the research team developed the NPCTP. Content was adopted from the authentic experiences of preceptors and new graduate nurses (NGNs) using interview data to make 81 videos with computer avatars and 10 live actor films. Each course was taught as nine instructional events. The NPCTP was evaluated using reflection quizzes, preceptors' self-evaluations, NGNs' evaluations, and focus group interviews. RESULTS: The NPCTP enhanced preceptors' clinical teaching behaviors and had a positive influence on NGNs. The NGN evaluation was even better than the preceptors' self-evaluation. CONCLUSION: This article provides the what and how for an NPCTP in Taiwan. J Contin Nurs Educ. 2017;48(5):220-229.

The lived experiences of aboriginal adolescent survivors of childhood cancer during the recovering process in Taiwan: A descriptive qualitative research.

PURPOSE: The purpose of this study was to understand the experiences of Taiwanese aboriginal adolescent survivors of childhood cancer during the process of recovery. METHOD: A snowball sampling strategy was used to recruit participants from the pediatrics unit of a medical center in the eastern region of Taiwan. In-depth interviews were conducted with 11 aboriginal adolescent childhood cancer survivors. The data were analyzed using content analysis. RESULTS: The results revealed three major themes with subthemes within each theme. The three major themes are: roots of resilience, transformation and growth, and meaning of traditional rituals for resilience. The three subthemes within "roots of resilience" include: "feeling secure through company of family, care and financial support", "receiving support from the important others and religion" and "learning to self-adjust". The three subthemes revealed within "transformation and growth" are: restructuring the relationship with peers, "appreciating parents' hard work", and "learning to seize the moment". The two subthemes within "meaning of traditional rituals to resilience" include: "feeling blessed with the power of ancestral spirits" and "strengthening ethnic identity". CONCLUSION: This study provided insight into the experiences of aboriginal adolescents as they recovered from childhood cancer. The experiences made positive impacts by inspiring growth in maturity and consolidating aboriginal ethnic identity. The adolescents were empowered by support from family, friends and clansmen, and by their participation in aboriginal rituals. As healthcare professionals care for the aboriginal adolescents, it is critical to consider this culturally and ethnically specific knowledge/experience of surviving cancer to improve quality of care.

Effects of Home-Based Tai Chi and Lower Extremity Training and Self-Practice on Falls and Functional Outcomes in Older Fallers from the Emergency Department-A Randomized Controlled Trial.

OBJECTIVES: To compare the effects of guided home-based tai chi chuan (TCC) and lower extremity training (LET) and of levels of self-practice on falls and functional outcomes in older fallers. DESIGN: Randomized controlled trial. SETTING: Taipei, Taiwan. PARTICIPANTS: Individuals aged 60 and older who had fall-related emergency department visits at least 6 months before participating in the study and ambulated independently at baseline (N = 456). INTERVENTION: Six months of TCC or LET. MEASUREMENTS: Four types of fall measures (falls, time to first fall, fallers, recurrent fallers) and six functional measures (handgrip strength, balance, mobility, fear of falling, depression, cognitive function). RESULTS: The TCC group was significantly less likely than the LET group to experience any falls during the 6-month intervention (incidence rate ratio (IRR) = 0.30, 95% confidence interval (CI) = 0.15-0.60), and the effects remained significant after 12 months of follow-up (IRR = 0.32, 95% CI = 0.14-0.71). These effects remained significant for injurious falls during the 6-month intervention (IRR = 0.33, 95% CI = 0.16-0.68) and the entire 18-month study (IRR = 0.39, 95% CI = 0.18-0.83). Similar results were obtained when another two fall measures (time to first fall, number of fallers) were used. Moreover, participants who independently practiced TCC or LET seven times per week or more were significantly less likely to experience injurious falls during the 6-month intervention (IRR = 0.41, 95% CI = 0.20-0.83) and the 18-month study (IRR = 0.43, 95% CI = 0.21-0.87) than their counterparts, had a significantly longer time to first injurious fall, and were significantly less likely to have an injurious fall during the 6-month intervention. Cognitive function improved to a greater extent in the TCC group than in the LET group over the 18-month study. CONCLUSION: Home-based TCC may reduce the incidence of falls and injurious falls more than conventional LET in older fallers, and the effects may last for at least 1 year.

The development and validation of the Clinical Teaching Behavior Inventory (CTBI-23): Nurse preceptors' and new graduate nurses' perceptions of precepting.

BACKGROUND: Few studies have examined the perceptions of clinical teaching behaviors among both nurse preceptors and preceptees. PURPOSES: To develop a Clinical Teaching Behavior Inventory (CTBI) for nurse preceptors' self-evaluation, and for new graduate nurse preceptee evaluation of preceptor clinical teaching behaviors and to test the validity and reliability of the CTBI. METHODS: This study used mixed research techniques in five phases. Phase I: based on a literature review, the researchers developed an instrument to measure clinical teaching behaviors. Phase II: 17 focus group interviews were conducted with 63 preceptors and 24 new graduate nurses from five hospitals across Taiwan. Clinical teaching behavior themes were extracted from the focus group data and integrated into the domains and items of the CTBI. Phase III: two rounds of an expert Delphi study were conducted to determine the content validity of the instrument. Phase IV: a total of 290 nurse preceptors and 260 new graduate nurses were recruited voluntarily in the same five hospitals in Taiwan. Of these, 521 completed questionnaires to test the construct validity of CTBI by using confirmatory factory analysis. Phase V: the internal consistency and reliability of the instrument were tested. RESULTS: CTBI consists of 23 items in six domains: (1) 'Committing to Teaching'; (2) 'Building a Learning Atmosphere'; (3) 'Using Appropriate Teaching Strategies'; (4) 'Guiding Inter-professional Communication'; (5) 'Providing Feedback and Evaluation'; and (6) 'Showing Concern and Support'. The confirmatory factor analysis yielded a good fit and reliable scores for the CTBI-23 model. CONCLUSIONS: The CTBI-23 is a valid and reliable instrument for identifying the clinical teaching behaviors of a preceptor as perceived by preceptors and new graduate preceptees. The CTBI-23 depicts clinical teaching behaviors of nurse preceptors in Taiwan.