The Lymphedema Evaluation in Gynecological cancer Study (LEGS): Design of a prospective, longitudinal, cohort study

Background The Lymphoedema Evaluation in Gynecological cancer Study (LEGS) was a longitudinal, observational, cohort study prospectively evaluating the incidence and risk factors of lower-limb lymphedema after treatment for gynecological cancer. Here we describe the study protocol and characteristics of the sample. Methods Women with a newly diagnosed gynecological cancer between June 1, 2008 and February 28, 2011, aged 18 years or older, and treated at one of six hospitals in Queensland, Australia, were eligible. Lymphedema was assessed by circumference measurements, bioimpedance spectroscopy, and self-reported swelling. LEGS incorporated a cohort of patients requiring surgery for benign gynecological conditions for comparison purposes. Data were collected prior to surgery and at regular intervals thereafter up to 2-years post-diagnosis. Results 546 women participated (408 cancer, 138 benign), with a 24-month retention rate of 78%. Clinical and treatment characteristics of participants were similar to the Queensland gynecological cancer population, except for a higher proportion of early-stage cervical cancers recruited to LEGS compared with Queensland proportions (89% versus 55%, respectively). Discussion Few imbalances were observed between participants with complete and incomplete follow-up data. The prospective design and collection of objective and patient-reported outcome data will allow comprehensive assessment of incidence and risk factors of lower-limb lymphedema.

Cross-cultural adaptation, reliability and validity of the Turkish version of the spine functional index

Background The Spine Functional Index (SFI) is a patient reported outcome measure with sound clinimetric properties and clinical viability for the determination of whole-spine impairment. To date, no validated Turkish version is available. The purpose of this study is to cross-culturally adapted the SFI for Turkish-speaking patients (SFI-Tk) and determine the psychometric properties of reliability, validity and factor structure in a Turkish population with spine musculoskeletal disorders. Methods The SFI English version was culturally adapted and translated into Turkish using a double forward and backward method according to established guidelines. Patients (n = 285, cervical = l29, lumbar = 151, cervical and lumbar region = 5, 73% female, age 45 ± 1) with spine musculoskeletal disorders completed the SFI-Tk at baseline and after a seven day period for test-retest reliability. For criterion validity the Turkish version of the Functional Rating Index (FRI) was used plus the Neck Disability Index (NDI) for cervical patients and the Oswestry Disability Index (ODI) for back patients. Additional psychometric properties were determined for internal consistency (Chronbach’s α), criterion validity and factor structure. Results There was a high degree of internal consistency (α = 0.85, item range 0.80-0.88) and test-retest reliability (r = 0.93, item range = 0.75-0.95). The factor analysis demonstrated a one-factor solution explaining 24.2% of total variance. Criterion validity with the ODI was high (r = 0.71, p < 0.001) while the FRI and NDI were fair (r = 0.52 and r = 0.58, respectively). The SFI-Tk showed no missing responses with the ‘half-mark’ option used in 11.75% of total responses by 77.9% of participants. Measurement error from SEM and MDC90 were respectively 2.96% and 7.12%. Conclusions The SFI-Tk demonstrated a one-factor solution and is a reliable and valid instrument. The SFI-Tk consists of simple and easily understood wording and may be used to assess spine region musculoskeletal disorders in Turkish speaking patients.

Validation of a Spanish version of the Spine Functional Index

Background The Spine Functional Index (SFI) is a recently published, robust and clinimetrically valid patient reported outcome measure. Objectives The purpose of this study was the adaptation and validation of a Spanish-version (SFI-Sp) with cultural and linguistic equivalence. Methods A two stage observational study was conducted. The SFI was cross-culturally adapted to Spanish through double forward and backward translation then validated for its psychometric characteristics. Participants (n = 226) with various spine conditions of >12 weeks duration completed the SFI-Sp and a region specific measure: for the back, the Roland Morris Questionnaire (RMQ) and Backache Index (BADIX); for the neck, the Neck Disability Index (NDI); for general health the EQ-5D and SF-12. The full sample was employed to determine internal consistency, concurrent criterion validity by region and health, construct validity and factor structure. A subgroup (n = 51) was used to determine reliability at seven days. Results The SFI-Sp demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96). The factor structure was one-dimensional and supported construct validity. Criterion specific validity for function was high with the RMQ (r = 0.79), moderate with the BADIX (r = 0.59) and low with the NDI (r = 0.46). For general health it was low with the EQ-5D and inversely correlated (r = −0.42) and fair with the Physical and Mental Components of the SF-12 and inversely correlated (r = −0.56 and r = −0.48), respectively. The study limitations included the lack of longitudinal data regarding other psychometric properties, specifically responsiveness. Conclusions The SFI-Sp was demonstrated as a valid and reliable spine-regional outcome measure. The psychometric properties were comparable to and supported those of the English-version, however further longitudinal investigations are required.

Fall rates in hospital rehabilitation units after individualised patient and staff education programmes: A pragmatic, stepped-wedge, cluster-randomised controlled trial

- Background Falls are the most frequent adverse events that are reported in hospitals. We examined the effectiveness of individualised falls-prevention education for patients, supported by training and feedback for staff, delivered as a ward-level programme. - Methods Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge, cluster-randomised study, undertaken during a 50 week period. Units were randomly assigned to intervention or control groups by use of computer-generated, random allocation sequences. We included patients admitted to the unit during the study with a Mini-Mental State Examination (MMSE) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional, in addition to usual care. We provided information about patients' goals, feedback about the ward environment, and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients. The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers. All analyses were by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials registry, number ACTRN12612000877886). - Findings Between Jan 13, and Dec 27, 2013, 3606 patients were admitted to the eight units (n=1983 control period; n=1623 intervention period). There were fewer falls (n=196, 7·80/1000 patient-days vs n=380, 13·78/1000 patient-days, adjusted rate ratio 0·60 [robust 95% CI 0·42–0·94], p=0·003), injurious falls (n=66, 2·63/1000 patient-days vs 131, 4·75/1000 patient-days, 0·65 [robust 95% CI 0·42–0·88], p=0·006), and fallers (n=136 [8·38%] vs n=248 [12·51%] adjusted odds ratio 0·55 [robust 95% CI 0·38 to 0·81], p=0·003) in the intervention compared with the control group. There was no significant difference in length of stay (intervention median 11 days [IQR 7–19], control 10 days [6–18]). - Interpretation Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units.

Disturbed appetite and nutrient intake in peritoneal dialysis patients

OBJECTIVE Malnutrition is common among peritoneal dialysis (PD) patients. Reduced nutrient intake contributes to this. It has long been assumed that this reflects disturbed appetite. We set out to define the appetite profiles of a group of PD patients using a novel technique. DESIGN Prospective, cross-sectional comparison of PD patients versus controls. SETTING Teaching hospital dialysis unit. PATIENTS 39 PD patients and 42 healthy controls. INTERVENTION Visual analog ratings were recorded at hourly intervals to generate daily profiles for hunger and fullness. Summary statistics were generated to compare the groups. Food intake was measured using 3-day dietary records. MAIN OUTCOME MEASURES Hunger and fullness profiles. Derived hunger and fullness scores. RESULTS Controls demonstrated peaks of hunger before mealtimes, with fullness scores peaking after meals. The PD profiles had much reduced premeal hunger peaks. A postmeal reduction in hunger was evident, but the rest of the trace was flat. The PD fullness profile was also flatter than in the controls. Mean scores were similar despite the marked discrepancy in the profiles. The PD group had lower peak hunger and less diurnal variability in their hunger scores. They also demonstrated much less change in fullness rating around mealtimes, while the mean and peak fullness scores were little different. The reported nutrient intake was significantly lower for PD. CONCLUSION The data suggest that PD patients normalize their mean appetite perception at a lower level of nutrient intake than controls, suggesting that patient-reported appetite may be misleading in clinical practice. There is a loss of the usual daily variation for the PD group, which may contribute to their reduced food intake. The technique described here could be used to assess the impact of interventions upon the abnormal PD appetite profile.

The Early Prevention of Obesity in CHildren (EPOCH) collaboration : an individual patient data prospective meta-analysis

Background: Efforts to prevent the development of overweight and obesity have increasingly focused early in the life course as we recognise that both metabolic and behavioural patterns are often established within the first few years of life. Randomised controlled trials (RCTs) of interventions are even more powerful when, with forethought, they are synthesised into an individual patient data (IPD) prospective meta-analysis (PMA). An IPD PMA is a unique research design where several trials are identified for inclusion in an analysis before any of the individual trial results become known and the data are provided for each randomised patient. This methodology minimises the publication and selection bias often associated with a retrospective meta-analysis by allowing hypotheses, analysis methods and selection criteria to be specified a priori. Methods/Design: The Early Prevention of Obesity in CHildren (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine if early intervention for childhood obesity impacts on body mass index (BMI) z scores at age 18-24 months. Additional research questions will focus on whether early intervention has an impact on children’s dietary quality, TV viewing time, duration of breastfeeding and parenting styles. This protocol includes the hypotheses, inclusion criteria and outcome measures to be used in the IPD PMA. The sample size of the combined dataset at final outcome assessment (approximately 1800 infants) will allow greater precision when exploring differences in the effect of early intervention with respect to pre-specified participant- and intervention-level characteristics. Discussion: Finalisation of the data collection procedures and analysis plans will be complete by the end of 2010. Data collection and analysis will occur during 2011-2012 and results should be available by 2013. Trial registration number: ACTRN12610000789066

Investigating the cost-effectiveness of video telephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial

Background Providing ongoing family centred support is an integral part of childhood cancer care. For families living in regional and remote areas, opportunities to receive specialist support are limited by the availability of health care professionals and accessibility, which is often reduced due to distance, time, cost and transport. The primary aim of this work is to investigate the cost-effectiveness of videotelephony to support regional and remote families returning home for the first time with a child newly diagnosed with cancer Methods/design We will recruit 162 paediatric oncology patients and their families to a single centre randomised controlled trial. Patients from regional and remote areas, classified by Accessibility/Remoteness Index of Australia (ARIA+) greater than 0.2, will be randomised to a videotelephone support intervention or a usual support control group. Metropolitan families (ARIA+ ≤ 0.2) will be recruited as an additional usual support control group. Families allocated to the videotelephone support intervention will have access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. Families in the usual support control group will receive standard care i.e., specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone for families who live far away from the hospital. The primary outcome measure is parental health related quality of life as measured using the Medical Outcome Survey (MOS) Short Form SF-12 measured at baseline, 4 weeks, 8 weeks and 12 weeks. The secondary outcome measures are: parental informational and emotional support; parental perceived stress, parent reported patient quality of life and parent reported sibling quality of life, parental satisfaction with care, cost of providing improved support, health care utilisation and financial burden for families. Discussion This investigation will establish the feasibility, acceptability and cost-effectiveness of using videotelephony to improve the clinical and psychosocial support provided to regional and remote paediatric oncology patients and their families.

Planning volunteer responses to low-volume mass gatherings: do event characteristics predict patient workload?

INTRODUCTION: Workforce planning for first aid and medical coverage of mass gatherings is hampered by limited research. In particular, the characteristics and likely presentation patterns of low-volume mass gatherings of between several hundred to several thousand people are poorly described in the existing literature. OBJECTIVES: This study was conducted to: 1. Describe key patient and event characteristics of medical presentations at a series of mass gatherings, including events smaller than those previously described in the literature; 2. Determine whether event type and event size affect the mean number of patients presenting for treatment per event, and specifically, whether the 1:2,000 deployment rule used by St John Ambulance Australia is appropriate; and 3. Identify factors that are predictive of injury at mass gatherings. METHODS: A retrospective, observational, case-series design was used to examine all cases treated by two Divisions of St John Ambulance (Queensland) in the greater metropolitan Brisbane region over a three-year period (01 January 2002-31 December 2004). Data were obtained from routinely collected patient treatment forms completed by St John officers at the time of treatment. Event-related data (e.g., weather, event size) were obtained from event forms designed for this study. Outcome measures include: total and average number of patient presentations for each event; event type; and event size category. Descriptive analyses were conducted using chi-square tests, and mean presentations per event and event type were investigated using Kruskal-Wallis tests. Logistic regression analyses were used to identify variables independently associated with injury presentation (compared with non-injury presentations). RESULTS: Over the three-year study period, St John Ambulance officers treated 705 patients over 156 separate events. The mean number of patients who presented with any medical condition at small events (less than or equal to 2,000 attendees) did not differ significantly from that of large (>2,000 attendees) events (4.44 vs. 4.67, F = 0.72, df = 1, 154, p = 0.79). Logistic regression analyses indicated that presentation with an injury compared with non-injury was independently associated with male gender, winter season, and sporting events, even after adjusting for relevant variables. CONCLUSIONS: In this study of low-volume mass gatherings, a similar number of patients sought medical treatment at small (<2,000 patrons) and large (>2,000 patrons) events. This demonstrates that for low-volume mass gatherings, planning based solely on anticipated event size may be flawed, and could lead to inappropriate levels of first-aid coverage. This study also highlights the importance of considering other factors, such as event type and patient characteristics, when determining appropriate first-aid resourcing for low-volume events. Additionally, identification of factors predictive of injury presentations at mass gatherings has the potential to significantly enhance the ability of event coordinators to plan effective prevention strategies and response capability for these events.

Impact of a government triple zero awareness campaign on emergency department patient characteristics

Objective: To evaluate the impact of a government triple zero community awareness campaign on the characteristics of patients attending an ED. Methods: A study using Emergency Department Information System data was conducted in an adult metropolitan tertiary-referral teaching hospital in Brisbane. The three outcomes measured in the 3 month post-campaign period were arrival mode, Australasian Triage Scale and departure status. These measures reflect ambulance usage, clinical urgency and illness severity, respectively. They were compared with those in the 3 month pre-campaign period. Multivariate logistic regression models were used to investigate the impacts of the campaign on each of the three outcome measures after controlling for age, sex, day and time of arrival, and daily minimum temperature. Results: There were 17 920 visits in the pre- and 17 793 visits in the post-campaign period. After the campaign, fewer patients arrived at the ED by road ambulance (odds ratio [OR] 0.90, 95% confidence interval [CI] 0.80–1.00), although the impact of the campaign on the arrival mode was only close to statistical significance (Wald χ2-test, P= 0.055); and patients were significantly less likely to have higher clinical urgency (OR 0.86, 95% CI 0.79–0.94), while more likely to be admitted (OR 1.68, 95% CI 1.38–2.05) or complete treatment in the ED (OR 1.46, 95% CI 1.23–1.73) instead of leaving without waiting to be seen. Conclusions: The campaign had no significant impact on the arrival mode of the patients. After the campaign, the illness acuity of the patients decreased, whereas the illness severity of the patients increased.

The impact of a model of nurse education to improve knowledge and recognition of delirium in older persons by registered nurses

Introduction: Delirium is a serious issue associated with high morbidity and mortality in older hospitalised people. Early recognition enables diagnosis and treatment of underlying cause/s, which can lead to improved patient outcomes. However, research shows knowledge and accurate nurse recognition of delirium and is poor and lack of education appears to be a key issue related to this problem. Thus, the purpose of this randomised controlled trial (RCT) was to evaluate, in a sample of registered nurses, the usability and effectiveness of a web-based learning site, designed using constructivist learning principles, to improve acute care nurse knowledge and recognition of delirium. Prior to undertaking the RCT preliminary phases involving; validation of vignettes, video-taping five of the validated vignettes, website development and pilot testing were completed. Methods: The cluster RCT involved consenting registered nurse participants (N = 175) from twelve clinical areas within three acute health care facilities in Queensland, Australia. Data were collected through a variety of measures and instruments. Primary outcomes were improved ability of nurses to recognise delirium using written validated vignettes and improved knowledge of delirium using a delirium knowledge questionnaire. The secondary outcomes were aimed at determining nurse satisfaction and usability of the website. Primary outcome measures were taken at baseline (T1), directly after the intervention (T2) and two months later (T3). The secondary outcomes were measured at T2 by participants in the intervention group. Following baseline data collection remaining participants were assigned to either the intervention (n=75) or control (n=72) group. Participants in the intervention group were given access to the learning intervention while the control group continued to work in their clinical area and at that time, did not receive access to the learning intervention. Data from the primary outcome measures were examined in mixed model analyses. Results: Overall, the effect of the online learning intervention over time comparing the intervention group and the control group were positive. The intervention groups‘ scores were higher and the change over time results were statistically significant [T3 and T1 (t=3.78 p=<0.001) and T2 and T1 baseline (t=5.83 p=<0.001)]. Statistically significant improvements were also seen for delirium recognition when comparing T2 and T1 results (t=2.58 p=0.012) between the control and intervention group but not for changes in delirium recognition scores between the two groups from T3 and T1 (t=1.80 p=0.074). The majority of the participants rated the website highly on the visual, functional and content elements. Additionally, nearly 80% of the participants liked the overall website features and there were self-reported improvements in delirium knowledge and recognition by the registered nurses in the intervention group. Discussion: Findings from this study support the concept that online learning is an effective and satisfying method of information delivery. Embedded within a constructivist learning environment the site produced a high level of satisfaction and usability for the registered nurse end-users. Additionally, the results showed that the website significantly improved delirium knowledge & recognition scores and the improvement in delirium knowledge was retained at a two month follow-up. Given the strong effect of the intervention the online delirium intervention should be utilised as a way of providing information to registered nurses. It is envisaged that this knowledge would lead to improved recognition of delirium as well as improvement in patient outcomes however; translation of this knowledge attainment into clinical practice was outside the scope of this study. A critical next step is demonstrating the effect of the intervention in changing clinical behaviour, and improving patient health outcomes.

How do allied health professionals evaluate new models of care? What are we measuring and why?

The aim of this study was to identify what outcome measures or quality indicators are being used to evaluate advanced and new roles in nine allied health professions and whether the measures are evaluating outcomes of interest to the patient, the clinician, or the healthcare provider. A systematic search strategy was used. Medical and allied health databases were searched and relevant articles extracted. Relevant studies with at least 1 outcome measure were evaluated. A total of 106 articles were identified that described advanced roles, however, only 23 of these described an outcome measure in sufficient detail to be included for review. The majority of the reported measures fit into the economic and process categories. The most reported outcome related to patients was satisfaction surveys. Measures of patient health outcomes were infrequently reported. It is unclear from the studies evaluated whether new models of allied healthcare can be shown to be as safe and effective as traditional care for a given procedure. Outcome measures chosen to evaluate these services often reflect organizational need and not patient outcomes. Organizations need to ensure that high-quality performance measures are chosen to evaluate the success of new health service innovations. There needs to be a move away from in-house type surveys that add little or no valid evidence as to the effect of a new innovation. More importance needs to be placed on patient outcomes as a measure of the quality of allied health interventions.

Minimum important difference between patients with rheumatoid arthritis : the patient's perspective

OBJECTIVE: To determine the point at which differences in clinical assessment scores on physical ability, pain and overall condition are sufficiently large to correspond to a subjective perception of a meaningful difference from the perspective of the patient. METHODS: Forty patients with a diagnosis of rheumatoid arthritis participated in an evening of clinical assessment and one-on-one conversations with each other regarding their arthritic condition. The assessments included tender and swollen joint counts, clinician and patient global assessments, participant assessment of pain and the Health Assessment Questionnaire (HAQ) on physical ability. After each conversation, participants rated themselves relative to their conversational partner on physical ability, pain and overall condition. These subjective comparative ratings were compared to the differences of the individual clinical assessments. RESULTS: In total there were 120 conversations. Generally participants judged themselves as less disabled than others. They rated themselves as "somewhat better" than their conversation partner when they had a (mean) 7% better score on the HAQ, 6% less pain, and 9% better global assessment. In contrast, they rated themselves as "somewhat worse" when they had a (mean) 16% worse score on the HAQ, 16% more pain, and 29% worse global assessment. CONCLUSIONS: Patients view clinically important differences in an asymmetric manner. These results can provide guidance in interpreting results and planning clinical trials.

Design of a professional development programme for palliative care nurses (Part Two)

Yates et al (1996) provided a review of the literature on educational approaches to improving psychosocial care of terminally ill patients and their families and suggested that there was an urgent need for innovation in this area. A programme of professional development currently being offered to 181 palliative care nurses in Queensland, Australia, was also described. This paper presents research in progress evaluating this programme which involves use of a quasi-experimental pre-post test design. It also includes process and outcome measures to assess effectiveness in improving the participant's ability to provide psychosocial care to patients and families. Research examining the effectiveness of various educational programmes on care of the dying has offered equivocal results (Yates et al 1996). Degner and Gow (1988a) noted that the inconsistencies found in research into death education result from inadequate study designs, variations in the conceptualisation and measurement of the outcomes of the programmes and flaws in data analysis. Such studies have often lacked a theoretical basis, few have employed well-controlled experimental designs, and the programme outcomes have generally been limited to the participant's 'death anxiety', or other death attitudes which have been variously defined and measured. Whilst Degner and Gow (1988b) have reported that undergraduate nursing students who participated in a care of the dying educational programme demonstrated more 'approach caring' behaviours than a control group, the impact of education programmes on patient care has rarely been examined. Failure to link education to nursing practice and subsequent clinical outcomes has, however, been seen as a major limitation of nursing knowledge in this area (Degner et al 1991). This paper describes an approach to researching the effectiveness of professional development programmes for palliative care nurses.

A pilot trial of mobile, patient-performed teledermoscopy

BACKGROUND Early detection by skin self-examination (SSE) could improve outcomes from melanoma. Mobile teledermoscopy may aid this process. OBJECTIVES To establish clinical accuracy of SSE plus mobile teledermoscopy compared to clinical skin examination (CSE) and test whether providing people with detailed SSE instructions improves accuracy. METHODS Men and women 50-64 years (n=58) performed SSE plus mobile teledermoscopy in their homes between May and November 2013 and were given technical instructions plus detailed SSE instructions (intervention) or technical instructions only (control). Within three months, they underwent a CSE. Outcome measures included: a) body sites examined, lesions photographed, and missed; b) sensitivityof SSE plus mobile teledermoscopy compared to in-person CSE using either patients or lesions as denominator, and; c) concordance of telediagnosis with CSE. RESULTS: 49 of 58 randomised participants completed the study, and submitted 309 lesions to the teledermatologist (156 intervention; 153 control group). Intervention group participants were more likely to submit lesions from their legs compared to control (p=0.03), no other differences between groups in number or site of missed lesions.11 participants (22%) did not photograph 14 pigmented lesions the dermatologist considered worthwhile photographing or requiring clinical monitoring. Sensitivity of SSE plus mobile teledermoscopy was 81.8% (95% confidence interval 64.5-93.0) using the patient as the denominator and 41.9 (27.6-56.2) using the lesion as denominator.-There was substantial agreement between telediagnosis and CSE (Kappa =0.90) accounting for differential diagnoses. CONCLUSIONS SSE plus mobile teledermoscopy is promising for surveillance of particular lesions even without provision of detailed SSE instructions, but in the format tested in this study, consumers may overlook lesions and send many non-pigmented lesions. This investigation demonstrates that high quality dermoscopic images can be taken by patients at home and for those sent, telediagnosis is highly accurate.

Confirmatory factory analysis of the Neck Disability Index in a general problematic neck population indicates a one-factor model

BACKGROUND CONTEXT: The Neck Disability Index frequently is used to measure outcomes of the neck. The statistical rigor of the Neck Disability Index has been assessed with conflicting outcomes. To date, Confirmatory Factor Analysis of the Neck Disability Index has not been reported for a suitably large population study. Because the Neck Disability Index is not a condition-specific measure of neck function, initial Confirmatory Factor Analysis should consider problematic neck patients as a homogenous group. PURPOSE: We sought to analyze the factor structure of the Neck Disability Index through Confirmatory Factor Analysis in a symptomatic, homogeneous, neck population, with respect to pooled populations and gender subgroups. STUDY DESIGN: This was a secondary analysis of pooled data. PATIENT SAMPLE: A total of 1,278 symptomatic neck patients (67.5% female, median age 41 years), 803 nonspecific and 475 with whiplash-associated disorder. OUTCOME MEASURES: The Neck Disability Index was used to measure outcomes. METHODS: We analyzed pooled baseline data from six independent studies of patients with neck problems who completed Neck Disability Index questionnaires at baseline. The Confirmatory Factor Analysis was considered in three scenarios: the full sample and separate sexes. Models were compared empirically for best fit. RESULTS: Two-factor models have good psychometric properties across both the pooled and sex subgroups. However, according to these analyses, the one-factor solution is preferable from both a statistical perspective and parsimony. The two-factor model was close to significant for the male subgroup (p<.07) where questions separated into constructs of mental function (pain, reading headaches and concentration) and physical function (personal care, lifting, work, driving, sleep, and recreation). CONCLUSIONS: The Neck Disability Index demonstrated a one-factor structure when analyzed by Confirmatory Factor Analysis in a pooled, homogenous sample of neck problem patients. However, a two-factor model did approach significance for male subjects where questions separated into constructs of mental and physical function. Further investigations in different conditions, subgroup and sex-specific populations are warranted.