The impact of informal leader nurses on patient satisfaction.

BACKGROUND: The relationship between informal leaders, i.e., highly competent individuals who have influence over peers without holding formal leadership positions, and organisational outcomes has not been adequately assessed in health care. AIMS: We evaluated the relationships between informal leaders and experience, job satisfaction and patient satisfaction, among hospital nurses. METHODS: Floor nurses in non-leadership positions participated in an online survey and rated colleagues' leadership behaviours. Nurses identified as informal leaders took an additional survey to determine their leadership styles via the Multifactor Leadership QuestionnaireTM . Six months of patient satisfaction data were linked to the nursing units. RESULTS: A total of 3,456 (91%) nurses received peer ratings and 628 (18%) were identified as informal leaders. Informal leaders had more experience (13.2 ± 10.9 vs. 8.4 ± 9.7 years, p < 0.001) and higher job satisfaction than their counterparts (4.8 ± 1.2 vs. 4.5 ± 1.1, p = 0.007). Neither the proportion of informal leaders on a unit nor leadership style was associated with patient satisfaction (p = 0.53, 0.46, respectively). CONCLUSION: While significant relationships were not detected between patient satisfaction and styles/proportion of informal leaders, we found that informal leaders had more years of experience and higher job satisfaction. More work is needed to understand the informal leaders' roles in achieving organisational outcomes. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse informal leaders are unique resources and health care organisations should utilise them for optimal outcomes.

Factors Associated With Rehabilitation Outcomes After Traumatic Brain Injury: Comparing Functional Outcomes Between TBIMS Centers Using Hierarchical Linear Modeling.

OBJECTIVE: To examine differences in patient outcomes across Traumatic Brain Injury Model Systems (TBIMS) rehabilitation centers and factors that influence these differences using hierarchical linear modeling (HLM). SETTING: Sixteen TBIMS centers. PARTICIPANTS: A total of 2056 individuals 16 years or older with moderate to severe traumatic brain injury (TBI) who received inpatient rehabilitation. DESIGN: Multicenter observational cohort study using HLM to analyze prospectively collected data. MAIN OUTCOME MEASURES: Functional Independence Measure and Disability Rating Scale total scores at discharge and 1 year post-TBI. RESULTS: Duration of posttraumatic amnesia (PTA) demonstrated a significant inverse relationship with functional outcomes. However, the magnitude of this relationship (change in functional status for each additional day in PTA) varied among centers. Functional status at discharge from rehabilitation and at 1 year post-TBI could be predicted using the slope and intercept of each TBIMS center for the duration of PTA, by comparing it against the average slope and intercept. CONCLUSIONS: HLM demonstrated center effect due to variability in the relationship between PTA and functional outcomes of patients. This variability is not accounted for in traditional linear regression modeling. Future studies examining variations in patient outcomes between centers should utilize HLM to measure the impact of additional factors that influence patient rehabilitation functional outcomes.

Improving diabetes care and outcomes with community health workers.

BACKGROUND: Type II diabetes continues to be a major health problem in USA, particularly in minority populations. The Diabetes Equity Project (DEP), a clinic-based diabetes self-management and education program led by community health workers (CHWs), was designed to reduce observed disparities in diabetes care and outcomes in medically underserved, predominantly Hispanic communities. OBJECTIVE: The purpose of this study was to evaluate the impact of the DEP on patients' clinical outcomes, diabetes knowledge, self-management skills, and quality of life. METHODS: The DEP was implemented in five community clinics from 2009 to 2013 and 885 patients completed at least two visits with the CHW. Student's paired t-tests were used to compare baseline clinical indicators with indicators obtained from patients' last recorded visit with the CHW and to assess differences in diabetes knowledge, perceived competence in managing diabetes, and quality of life. A mixed-effects model for repeated measures was used to examine the effect of DEP visits on blood glucose (HbA1c), controlling for patient demographics, clinic and enrolment date. RESULTS: DEP patients experienced significant (P < 0.0001) improvements in HbA1c control, blood pressure, diabetes knowledge, perceived competence in managing diabetes, and quality of life. Mean HbA1c for all DEP patients decreased from 8.3% to 7.4%. CONCLUSION: Given the increasing prevalence of diabetes in USA and documented disparities in diabetes care and outcomes for minorities, particularly Hispanic patients, new models of care such as the DEP are needed to expand access to and improve the delivery of diabetes care and help patients achieve improved outcomes.

Variations in Inpatient Rehabilitation Functional Outcomes Across Centers in the Traumatic Brain Injury Model Systems Study and the Influence of Demographics and Injury Severity on Patient Outcomes.

OBJECTIVE: To compare patient functional outcomes across Traumatic Brain Injury Model Systems (TBIMS) rehabilitation centers using an enhanced statistical model and to determine factors that influence those outcomes. DESIGN: Multicenter observational cohort study. SETTING: TBIMS centers. PARTICIPANTS: Patients with traumatic brain injury (TBI) admitted to 19 TBIMS rehabilitation centers from 2003-2012 (N=5505). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Functional outcomes of patients with TBI. RESULTS: Individuals with lower functional status at the time of admission, longer duration of posttraumatic amnesia, and higher burden of medical comorbidities continued to have worse functional outcomes at discharge from inpatient rehabilitation and at the 1-year follow-up, whereas those who were employed at the time of injury had better outcomes at both time periods. Risk-adjusted patient functional outcomes for patients in most TBIMS centers were consistent with previous research. However, there were wide performance differences for a few centers even after using more recently collected data, improving on the regression models by adding predictors known to influence functional outcomes, and using bootstrapping to eliminate confounds. CONCLUSIONS: Specific patient, injury, and clinical factors are associated with differences in functional outcomes within and across TBIMS rehabilitation centers. However, these factors did not explain all the variance in patient outcomes, suggesting a role of some other predictors that remain unknown.

Comparative effectiveness of traumatic brain injury rehabilitation: differential outcomes across TBI model systems centers.

OBJECTIVE: To measure patient functional outcomes across rehabilitation centers. SETTING: Traumatic Brain Injury Model System (TBIMS) centers. PARTICIPANTS: Patients with traumatic brain injury (TBI) admitted to 21 TBIMS rehabilitation centers (N = 6975, during 1999-2008). DESIGN: Retrospective analysis of prospectively collected data. MAIN MEASURES: Center-specific functional outcomes of TBI patients using Functional Independence Measure, Disability Rating Scale, and Glasgow Outcome Scale-Extended. RESULTS: There were large differences in patient characteristics across centers (demographics, TBI severity, and functional deficits at admission to rehabilitation). However, even after taking those factors into account, there were significant differences in functional outcomes of patients treated at different TBIMS centers. CONCLUSION: There are significant differences in functional outcomes of TBI patients across rehabilitation centers.

Development of a tool to measure user experience following electronic health record implementation.

OBJECTIVE: The aim of this study was to develop a survey tool to assess electronic health record (EHR) implementation to guide improvement initiatives. BACKGROUND: Survey tools are needed for ongoing improvement and have not been developed for aspects of EHR implementation. METHODS: The Baylor EHR User Experience (UX) survey was developed to capture 5 concept domains: training and competency, usability, infrastructure, usefulness, and end-user support. Validation efforts included content validity assessment, a pilot study, and analysis of 606 nurse respondents. The revised tool was sent to randomly sampled EHR nurse-users in 11 acute care facilities. RESULTS: A total of 1,301 nurses responded (37%). Internal consistency of the survey tool was excellent (Cronbach's α = .892). Survey responses including 1,819 open comments were used to identify and prioritize improvement efforts in areas such as education, support, optimization of EHR functions, and vendor change requests. CONCLUSION: The Baylor EHR UX survey was a valid tool that can be useful for prioritizing improvement efforts in relation to EHR implementation.

Impact of a transitional care program for heart failure patients at Baylor Scott & White Health: a pilot study.

Heart failure is a chronic health condition characterized by complex symptom management and costly hospitalizations. Hospitalization for the treatment of heart failure symptoms is common; however, many hospitalizations are thought to be preventable with effective self-management. This study describes the small, pilot implementation of a new, interventional, self-management heart failure program, "Engagement in Heart Failure Care" (EHFC), developed to assist heart failure patients with the management of disease symptoms following discharge from an inpatient hospital stay. EHFC was designed to engage patients in managing their symptoms and coaching them in skills that enable them to access medical and supportive care services across community, clinic, and hospital settings to help address both their current and future needs. The results of this pilot study suggest that EHFC's coaching model may have positive benefits on key health and well-being indicators of the patients enrolled.

The intensity and frequency of moral distress among different healthcare disciplines.

INTRODUCTION: The objectives of this study are to assess and compare differences in the intensity, frequency, and overall severity of moral distress among a diverse group of healthcare professionals. METHODS: Participants from within Baylor Health Care System completed an online seven-point Likert scale (range, 0 to 6) moral distress survey containing nine core clinical scenarios and additional scenarios specific to each participant's discipline. Higher scores reflected greater intensity and/or frequency of moral distress. RESULTS: More than 2,700 healthcare professionals responded to the survey (response rate 18.14 percent); survey respondents represented multiple healthcare disciplines across a variety of settings in a single healthcare system. Intensity of moral distress was high in all disciplines, although the causes of highest intensity varied by discipline. Mean moral distress intensity for the nine core scenarios was higher among physicians than nurses, but the mean moral distress frequency was higher among nurses. Taking into account both intensity and frequency, the difference in mean moral distress score was statistically significant among the various disciplines. Using post hoc analysis, differences were greatest between nurses and therapists. CONCLUSIONS: Moral distress has previously been described as a phenomenon predominantly among nursing professionals.This first-of-its-kind multidisciplinary study of moral distress suggests the phenomenon is significant across multiple professional healthcare disciplines. Healthcare professionals should be sensitive to situations that create moral distress for colleagues from other disciplines. Policy makers and administrators should explore options to lessen moral distress and professional burnout that frequently accompanies it.

From bedside to graveside: increased stress among healthcare chaplains.

The authors conducted a survey of Baylor Health Care System chaplains in an attempt to understand the stress they experience when leading funeral services of staff, staff family members, and patients. The intensity of stress experienced by these chaplains appears to be related to the cause of death, the deceased's age, and the relationship the deceased had with the chaplain. Further research is needed to corroborate these findings as well as to investigate how chaplains manage their own grief when they are involved in the grief experiences of patients and families.

The risk of subsequent joint arthroplasty after primary unilateral total knee arthroplasty, a 10-year study.

The purposes of this study were to determine the probabilities of subsequent lower extremity arthroplasty after index knee arthroplasty for osteoarthritis and to evaluate the demographic as well as radiographic factors that may predict progression to arthroplasty in the contralateral knee. Between 1984 and 1994, 646 patients, aged 40 to 75 years, with a primary cruciate-retaining knee were identified. The 10-year probability of having a contralateral knee after index knee was 36%. When grade 4 radiographic changes were present, the probability increased to 70%. Demographic factors played no role in the risk of future contralateral knee. The radiographic grade of the contralateral knee at the time of index surgery was found to correlate strongly with the future risk of contralateral total knee.

Health-related quality of life and patient satisfaction after global endometrial ablation for menorrhagia in women with bleeding disorders: a follow-up survey and systematic review.

OBJECTIVE: The purpose of this study was to describe health-related quality of life and satisfaction after global endometrial ablation in women with bleeding disorders and a systematic review of the literature. STUDY DESIGN: A follow-up survey was mailed to 36 patients with bleeding disorders and 110 reference patients (no coagulopathies) who underwent global endometrial ablation for menorrhagia. The survey included a generic (SF-12) and menorrhagia multi-attribute utility scale questionnaires. RESULTS: Ninety-six women (66%) responded. The total menorrhagia multiattribute utility scale score increased from 35-100 in bleeding disorder cohort (P = .03) and from 48-100 in the reference cohort (P < .001). Although postablation SF-12 mental domain scores were comparable in both cohorts (55 vs 55; P = .67), physical domain scores were lower in the bleeding disorder cohort (50 vs 56; P < .001). High satisfaction was reported by both cohorts (95% vs 84%; P = .60). CONCLUSION: Global endometrial ablation improved health-related quality of life for women with bleeding disorders and had high satisfaction rates.

Health care reform at trauma centers--mortality, complications, and length of stay.

OBJECTIVE: The Trauma Quality Improvement Program has demonstrated existence of significant variations in risk-adjusted mortality across trauma centers. However, it is unknown whether centers with lower mortality rates also have reduced length of stay (LOS), with associated cost savings. We hypothesized that LOS is not primarily determined by unmodifiable factors, such as age and injury severity, but is primarily dependent on the development of potentially preventable complications. METHODS: The National Trauma Data Bank (2002-2006) was used to include patients (older than 16 years) with at least one severe injury (Abbreviated Injury Scale score ≥ 3) from Level I and II trauma centers (217,610 patients, 151 centers). A previously validated risk-adjustment algorithm was used to calculate observed-to-expected mortality ratios for each center. Poisson regression was used to determine the relationship between LOS, observed-to-expected mortality ratios, and complications while controlling for confounding factors, such as age, gender, mechanism, insurance status, comorbidities, and injuries and their severity. RESULTS: Large variations in LOS (median, 4-8 days) were observed across trauma centers. There was no relationship between mortality and LOS. The most important predictor of LOS was complications, which were associated with a 62% increase. Injury severity score, shock, gunshot wounds, brain injuries, intensive care unit admission, and comorbidities were less important predictors of LOS. CONCLUSION: Quality improvement programs focusing on mortality alone may not be associated with reduced LOS. Hence, the Trauma Quality Improvement Program should also focus on processes of care that reduce complications, thereby shortening LOS, which may lead to significant cost savings at trauma centers.

Surgical correction of "cam-type" femoroacetabular impingement: a cadaveric comparison of open versus arthroscopic debridement.

PURPOSE: The goal of this study was to compare open and arthroscopic surgical techniques for "cam-type" femoroacetabular impingement in terms of feasibility and reliability. METHODS: We used 5 fresh-frozen cadaver specimens (10 hips). Anteroposterior and cross-table radiographs were taken for each. The head-neck union diameter was measured for each. The amount of bone resection at the anterolateral quadrant of the head-neck union was planned for each, with specific references to width, length, depth, and position. One side was randomly assigned to the open group and the other to the arthroscopic group. Surgical time, position of the osteotomy, and variation of the length, width, and depth of the final osteotomy with respect to the proposed dimensions were compared. RESULTS: In all specimens partial resection of the anterior-lateral femoral head-neck junction with improvement of the femoral head-neck offset was accomplished. A statistically significant difference (P < .05) was observed for surgical time between the open and arthroscopic groups (shorter in open group). CONCLUSIONS: When comparing surgical precision, no statistically significant differences were found between the open and arthroscopic procedures in any of the measurements. The depth and width of the osteoplasty were reliably obtained by the arthroscopic technique. However, there was a tendency to underestimate the osteoplasty length with the arthroscopic procedure. Positioning the osteoplasty was also less reliable with the arthroscopic procedure than with the open procedure because of the tendency to place the osteoplasty more posterior and distally than intended. CLINICAL RELEVANCE: Surgical resection of the femoral neck prominence and/or part of the anterolateral neck has been reported to improve femoral head offset and alleviate impingement. This study attempts to document the accuracy of this resection when done arthroscopically compared with an open procedure.

Cost-effectiveness of negative pressure wound therapy for postsurgical patients in long-term acute care.

OBJECTIVES: To evaluate the cost-effectiveness of negative pressure wound therapy (NPWT) using reticulated open-cell foam (NPWT/ROCF) as delivered by a Vacuum-Assisted Closure* (KCI Licensing, Inc, San Antonio, Texas) in patients with complex wounds in a long-term acute care (LTAC) setting. These patients are routinely discharged to LTAC hospitals with the goal of accelerating wound healing and timely transfer to a lower acuity care setting and are usually affected with serious comorbidities and deep, complex wounds with exposed anatomical structures, which require extended care (stay > 25 days). DESIGN: A retrospective chart review was conducted to determine the average daily wound volume reduction, average daily wound area reduction, and average cost per cubic centimeter of wound volume reduction for patients treated with NPWT/ROCF as compared with topical advanced moist healing strategies (non-NPWT). SETTING: All patients received treatment in an LTAC hospital. PARTICIPANTS: Patients admitted from November 2001 to August 2004 were identified using a computerized hospital database. The inclusion criteria were postsurgical patients of at least 18 years of age, with a single acute wound. INTERVENTION: Patients were treated with either NPWT/ROCF or advanced moist wound-healing therapies (non-NPWTs). MEASUREMENTS: Data collected included age, sex, wound measurements, Bates-Jensen Wound Assessment Tool severity score, procedures performed, wound care products and devices used, wound-healing outcomes, and costs associated with treatment. RESULTS: Fifty-one patients met the inclusion criteria: 36 were identified as NPWT/ROCF and 15 as non-NPWT. The NPWT/ROCF patients showed a statistically significantly higher average daily rate of volume reduction as compared with the advanced moist wound-healing group (5.02 +/- 13.36 vs 0.40 +/- 0.88 cm(3)/day; P = .046). The cost per cubic centimeter reduction was $11.90/cm(3) in the NPWT/ROCF group versus $30.92/cm in the moist wound-healing group. CONCLUSION: Postsurgical LTAC patients who were treated by NPWT/ROCF had a more accelerated rate of wound closure, compared with patients treated with advanced moist wound-healing therapy. These results suggest that, for this patient group, NPWT/ROCF may be more clinically effective in reducing wound volume, compared with advanced moist wound healing. Furthermore, the lower cost per cubic centimeter volume reduction suggests that NPWT/ROCF produces a more favorable cost-effective solution. Therefore, it is important when developing a wound-healing strategy that cost decisions be based on overall cost and not individual product cost when using advanced technology as part of the overall treatment plan. This study serves as a basis for further work in cost-benefit analysis when considering evidence-based outcomes in wound care.

Predictors of complications and outcomes of external hemipelvectomy wounds: account of 160 consecutive cases.

BACKGROUND: Hemipelvectomy has high wound complication rates. This study aimed to determine variables that may influence hemipelvectomy wound morbidity. METHODS: The records of 160 consecutive hemipelvectomy patients were reviewed with a focus on demographics, treatment, and surgical techniques. Multivariate analysis was used to determine risk factors for postoperative hemipelvectomy wound infection and flap necrosis. RESULTS: There were 31 standard, 62 modified, and 67 extended hemipelvectomy patients in whom 19 contiguous visceral, 62 spinal, 4 contralateral pelvic resections, and 1 contralateral hemipelvectomy were performed. Hospital mortality rate was 5%, and overall morbidity was 54%. Wound complications such as infection (39%) and flap necrosis (26%) were the most common. For modified, standard, and extended hemipelvectomies, rates of wound infection were 29%, 34%, and 51% (P = .036) and rates of flap necrosis were 16%, 25%, and 35% (P = .046), respectively. Longer operative time and increased complexity were associated with higher wound infection and flap necrosis rates. The hemipelvectomy flap design did not influence the frequency of wound infection (P = .173) or flap necrosis (P = .098). Common iliac vessel ligation was the most statistically significant predictor of flap necrosis and was associated with the 2.7-fold increase in flap necrosis rate (P = .001) in patients undergoing posterior flap hemipelvectomy. CONCLUSIONS: External hemipelvectomy has low mortality but high morbidity. Postoperative wound infection and flap necrosis are multifactorial events related to length and extent of operation. Level of vascular ligation strongly influenced flap necrosis rate for posterior flap hemipelvectomy.

Segmental vs. extended colectomy: measurable differences in morbidity, function, and quality of life.

PURPOSE: The colon coordinates fecal elimination while reabsorbing excess fluid. Extended colonic resection removes synchronous and prevents metachronous disease but may adversely alter bowel function and health-related quality of life to a greater degree than segmental resection. This study examined the short-term morbidity and long-term function and quality of life after colon resections of different extents. METHODS: Patients undergoing extended resections (n = 201, subtotal colectomy with ileosigmoid or total abdominal colectomy with ileorectal anastomosis) and segmental colonic resections (n = 321) during 1991 to 2003 were reviewed for perioperative outcomes and surveyed for bowel function and quality of life using an institutional questionnaire and a validated quality of life instrument (response rate: 70 percent). RESULTS: The most common indication for extended resections was multiple polyps, and for segmental resections, single malignancy. The complication-free rate was 75.4 percent after segmental resections, 42.8 percent after ileosigmoid anastomosis, and 60 percent after ileorectal anastomosis. Median daily stool frequency was two after segmental resections, four after ileosigmoid anastomosis, and five after ileorectal anastomosis, despite considerable dietary restrictions (55.6 percent) and medication use (19.6 percent daily) after ileorectal anastomosis. Significant proportions of patients felt restricted from preoperative social activity (31.5 percent), housework (20.4 percent), recreation (31.5 percent), and travel (42.6 percent) after ileorectal anastomosis. The overall quality of life after segmental resection, ileosigmoid anastomosis, and ileorectal anastomosis was 98.5, 94.9, and 91.2, respectively. CONCLUSIONS: Measurable compromises in long-term bowel function and quality of life were observed after extended vs. segmental resections. The relative differences in patient-related outcomes should be deliberated against the clinical benefits of extended resection for the individual patient.

The impact of missing data and how it is handled on the rate of false-positive results in drug development.

In drug development, a common choice for the primary analysis is to assess mean changes via analysis of (co)variance with missing data imputed by carrying the last or baseline observations forward (LOCF, BOCF). These approaches assume that data are missing completely at random (MCAR). Multiple imputation (MI) and likelihood-based repeated measures (MMRM) are less restrictive as they assume data are missing at random (MAR). Nevertheless, LOCF and BOCF remain popular, perhaps because it is thought that the bias in these methods lead to protection against falsely concluding that a drug is more effective than the control. We conducted a simulation study that compared the rate of false positive results or regulatory risk error (RRE) from BOCF, LOCF, MI, and MMRM in 32 scenarios that were generated from a 2(5) full factorial arrangement with data missing due to a missing not at random (MNAR) mechanism. Both BOCF and LOCF inflated RRE were compared to MI and MMRM. In 12 of the 32 scenarios, BOCF yielded inflated RRE compared with eight scenarios for LOCF, three scenarios for MI and four scenarios for MMRM. In no situation did BOCF or LOCF provide adequate control of RRE when MI and MMRM did not. Both MI and MMRM are better choices than either BOCF or LOCF for the primary analysis.

Early versus late initiation of negative pressure wound therapy: examining the impact on home care length of stay.

Because of the high cost of some wound management regimens, payors may require that moist wound therapies be used before other treatment approaches, such as negative pressure wound therapy (NPWT), are implemented but few studies have investigated the effect of delayed initiation of NPWT on patient outcomes. To examine the impact of early versus late initiation of NPWT on patient length of stay in home health care, a nonrandomized, retrospective analysis was performed on the Outcome and Assessment Information Set (OASIS) information for home care patients with NPWT-treated Stage III or Stage IV pressure ulcers (N = 98) or surgical wounds (N = 464) gathered between July 2002 and September 2004. Early initiation of NPWT following the start of home care was defined as <30 days for pressure ulcers and <7 days for surgical wound patients. Median duration of NPWT was 31 days (range 3 to 169) for pressure ulcers and 27 days (range 5 to 119) for the surgical wound group. Median lengths of stay in the early treatment groups were 85 days (range 11 to 239) for pressure ulcers and 57 days (range 7 to 119) for the surgical group versus 166 days (range 60 to 657) and 87 days (range 31 to 328), respectively, for the late treatment pressure ulcer and surgical groups (P < 0.0001). After controlling demographic patient variables, regression analysis indicated that for each day NPWT initiation was delayed, almost 1 day was added to the total length of stay (beta = 0.96, P <0.0001 [pressure ulcers]; beta = 0.97, P <0.0001 [surgical wounds]). Early initiation of NPWT may be associated with shorter length of stay for patients receiving home care for Stage III or Stage IV pressure ulcers or surgical wounds. Additional studies to ascertain the cost-effectiveness of treatments and treatment approaches in home care patients are needed.

Barriers and Benefits to the Use of Patient-Reported Outcome Measures in Routine Clinical Care: A Qualitative Study.

Patient-reported outcomes (PROs) provide information on how health care affects patient health and well-being and represent a patient-centered approach. Despite this potential, PROs are not widely used in clinical settings. Semi-structured focus groups were conducted with 3 stakeholder groups (patients, providers, and health care administrators) to determine the top 5 perceived barriers and benefits of PRO implementation. The Delphi technique was employed to obtain consensus and rank order responses. Patients perceived survey length to be important, whereas providers and administrators perceived time to collect data and patient health literacy, respectively, as the greatest barriers to PRO implementation. The greatest perceived benefits were the ability to track changes in clinical symptoms over time, improved quality of care, and better disease control among patients, providers, and administrators, respectively. These results may guide the development of novel frameworks for PRO implementation by addressing perceived barriers and building on the perceived benefits to encourage adoption of PROs.

Publication bias for CAM trials in the highest impact factor medicine journals is partly due to geographical bias.

OBJECTIVE: To assess the presence of publication bias and its relation to geographical bias in clinical trials involving complementary and alternative medicine (CAM) published in the highest impact factor general medicine journals. STUDY DESIGN AND SETTING: All CAM clinical trials published in the four highest impact factor general medicine journals, Lancet and British Medical Journal (European), and New England Journal of Medicine and Journal of American Medical Association (U.S.), between 1965 and 2004 were abstracted using Medline. Three reviewers abstracted data from the individual studies. In a multivariate analysis, factors predictive of a positive study were assessed. RESULTS: A total of 259 studies met the inclusion criteria. CAM trials published in the European journals were significantly more likely to be positive compared to those published in the U.S. journals (76% vs. 50%, odds ratio [OR]=3.15, P<0.0001). Studies originating outside of the United States were significantly more likely to be positive compared to the U.S. studies (75% vs. 49%, P<0.0001). Adjusting for location and other variables in a multivariate model, the OR for European vs. U.S. journals to publish a positive CAM trial was 1.95 (P=0.11). CONCLUSION: Publication bias related to CAM trials among the highest impact factor general medicine journals is partly due to geographical bias.