Comparative analysis of head-tilt and forward head position during laptop use between females with postural induced headache and healthy controls.

OBJECTIVES: To compare 1) maximum manually induced head-protraction, head-tilt and forward head position and 2) the evolution of head-tilt and forward head position during a laptop-task between a headache- and control-group. METHODS: Angles for maximum head-protraction, head-tilt and forward head position of 12 female students with postural induced headache and 12 female healthy controls were calculated at baseline and while performing a laptop-task. RESULTS: The headache-group demonstrated an increased passive head-protraction of 22.30% compared to the control-group. The ratio of forward head position during habitual sitting to the maximum head-protraction differed significantly (p = 0.046) between headache-group (1.4 ± 0.4) and the control-group (1.1 ± 0.2). The headache-group showed a biphasic forward head position and head-tilt profile. These profiles differed significantly (p < 0.05) between groups and were negatively correlated (rE = -0.927). CONCLUSION: The headache-group showed a larger passive head-protraction with a habitual forward head-position further located from the end-range. During the laptop-task forward head position and head-tilt behaved biphasically with a more static forward head position and a more dynamic head-tilt.

Adaptation and standardization of a Western tool for assessing child development in non-Western low-income context.

BACKGROUND: Due to lack of culturally relevant assessment tools, little is known about children's developmental profiles in low income settings such as Ethiopia. The objective of this study was to adapt and standardize the Denver II for assessing child development in Jimma Zone, South West Ethiopia. METHODS: Culture-specific test items in Denver II were modified. After translation into two local languages, all test items were piloted and fine-tuned. Using 1597 healthy children 4 days to 70.6 months of age, the 25, 50, 75 and 90 % passing ages were determined for each test item as milestones. Milestones attainment on the adapted version and the Denver II were compared on the 90 % passing age. Reliability of the adapted tool was examined. RESULTS: A total of 36 (28.8 %) test items, mostly from personal social domain, were adapted. Milestones attainment ages on the two versions differed significantly on 42 (34 %) test items. The adapted tool has an excellent inter-rater on 123 (98 %) items and substantial to excellent test-retest reliability on 119 (91 %) items. CONCLUSIONS: A Western developmental assessment tool can be adapted reliably for use in low-income settings. Age differences in attaining milestones indicate a correct estimation of child development requires a population-specific standard.

Pilot Study: Combining Formal and Peer Education with FibroScan to Increase HCV Screening and Treatment in Persons who use Drugs.

BACKGROUND: Treatment uptake for hepatitis C virus (HCV) infection remains low in persons who inject drugs (PWID), due to lack of knowledge and low perceived need for treatment. Therefore, we conducted a pilot study to assess the influence on knowledge and willingness for HCV screening and treatment among persons who use drugs (PWUD) by combining formal and peer education with FibroScan measurement. METHODS: Clients of the Center for Alcohol and other Drug problems (CAD) in Limburg (Belgium) were randomized into a control group, which received the standard of care, and an intervention group, which received an innovative combination of formal and peer education followed by FibroScan. Knowledge of HCV infection and willingness for screening and treatment were evaluated at baseline, after intervention and 1 and 3months after intervention by means of questionnaires. RESULTS: Baseline knowledge was similar for the control (n=27) and the intervention group (n=25) (58 vs. 59%; p=0.67). Immediately after the information session, knowledge increased to 86% (p<0.001) in the intervention group. After 3months, knowledge decreased significantly (69%; p=0.01). No significant changes in knowledge were found in the control group. Baseline willingness for treatment was 81% in both the control and intervention groups, but after 1 month decreased in the control group (44%) and remained stable in the intervention group (75%). Differences in actual screening uptake between the control and intervention group were not significant (7% vs. 20%). Four percent of the intervention group and no one in the control group started treatment. CONCLUSION: The small number of subjects should be considered when interpreting the results of this study. In brief, the single information session significantly improved HCV knowledge among PWUD, but did not result in a higher uptake for screening and treatment. This could signify that there are other important reasons, besides lack of knowledge, not to undergo screening or start treatment. The fact that knowledge decreased after 3months indicates that it would be beneficial to repeat the information session regularly.

Validation of a single-stage fixed-rate step test for the prediction of maximal oxygen uptake in healthy adults.

Healthcare professionals with limited access to ergospirometry remain in need of valid and simple submaximal exercise tests to predict maximal oxygen uptake (VO2max ). Despite previous validation studies concerning fixed-rate step tests, accurate equations for the estimation of VO2max remain to be formulated from a large sample of healthy adults between age 18-75 years (n > 100). The aim of this study was to develop a valid equation to estimate VO2max from a fixed-rate step test in a larger sample of healthy adults. A maximal ergospirometry test, with assessment of cardiopulmonary parameters and VO2max , and a 5-min fixed-rate single-stage step test were executed in 112 healthy adults (age 18-75 years). During the step test and subsequent recovery, heart rate was monitored continuously. By linear regression analysis, an equation to predict VO2max from the step test was formulated. This equation was assessed for level of agreement by displaying Bland-Altman plots and calculation of intraclass correlations with measured VO2max . Validity further was assessed by employing a Jackknife procedure. The linear regression analysis generated the following equation to predict VO2max (l min(-1) ) from the step test: 0·054(BMI)+0·612(gender)+3·359(body height in m)+0·019(fitness index)-0·012(HRmax)-0·011(age)-3·475. This equation explained 78% of the variance in measured VO2max (F = 66·15, P<0·001). The level of agreement and intraclass correlation was high (ICC = 0·94, P<0·001) between measured and predicted VO2max . From this study, a valid fixed-rate single-stage step test equation has been developed to estimate VO2max in healthy adults. This tool could be employed by healthcare professionals with limited access to ergospirometry.

Longitudinal Analyses of Presenteeism and Its Role as a Predictor of Sick Leave in Patients With Ankylosing Spondylitis.

OBJECTIVE: To investigate, in a cohort of patients with ankylosing spondylitis (AS) adequately treated with infliximab, changes over time in presenteeism and the role of presenteeism relative to that of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in predicting sick leave. METHODS: Data were analyzed from 71 patients with paid work and taking a stable dose of infliximab participating in a 96-week study with 5 assessment points. Covariates included presenteeism, sick leave, time, sex, age, BASDAI, BASFI, Bath Ankylosing Spondylitis Metrology Index, and part- or full-time work. Presenteeism represented the AS impact on productivity (by visual analog scale, range 0-10, where 10 = completely unproductive). Sick leave represented the number of days absent from work due to AS in the last 6 months. A linear mixed-effects model for presenteeism, and hurdle and zero-inflated count models for sick leave were explored. RESULTS: Mean ± SD presenteeism ranged from 2.2 ± 2.2 to 3.8 ± 7.8, and sick leave occurred in 8-17% of the patients during the 6-month period. Presenteeism positively correlated with BASDAI and BASFI, but was not significantly influenced by time. The chance of incurring sick leave was affected by presenteeism but not by BASDAI and BASFI. Conditional on being absent from work, the effect of presenteeism on the length of sick leave (in days) was much stronger than BASDAI and BASFI. For presenteeism ≥5, an increase of 1 unit in presenteeism yielded an increase by 36-40% (or 2-12 days) in the length of sick leave during the following 6 months. CONCLUSION: Presenteeism, even measured by a simple visual analog scale, was an important factor to explain future sick leave.

Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol.

PURPOSE: Dermatitis is a very frequent and distressing side effect of radiation therapy that may necessitate a treatment interruption when evolving towards more severe forms such as moist desquamation (MD). The aim of this study was to compare the efficacy of two topical agents, a dexpanthenol cream vs a hydroactive colloid gel combining absorbing and moisturising properties, in preventing MD in breast cancer patients. METHODS: This retrospective study compared two successive groups of breast cancer patients undergoing radiotherapy after breast-sparing surgery between 2008 and 2012. A group of 267 patients applied a 5% dexpanthenol cream on the irradiated zone throughout the course of their radiotherapy. Another group of 216 patients applied first the dexpanthenol cream then replaced it by the hydroactive colloid gel after 11-14 days of radiotherapy. Radiation treatment (total dose, technique, and equipment) was the same for the two groups. The clinical outcomes were the occurrence and time to onset of moist desquamation. KEY RESULTS: The overall incidence of MD was significantly lower in patients who applied the hydroactive colloid gel (16%) than in those who applied the dexpanthenol cream (32%, odds-ratio = 0.35). Also, MD occurred significantly later with the hydroactive colloid gel than with the dexpanthenol cream (hazard ratio = 0.39). CONCLUSIONS: Compared with the dexpanthenol cream, the hydroactive colloid gel significantly reduced the risk of developing MD in patients undergoing radiotherapy for breast cancer. These promising results warrant further research on the efficacy of hydroactive colloid gels in managing radiation dermatitis.

Optimization of the transcranial magnetic stimulation protocol by defining a reliable estimate for corticospinal excitability.

The goal of this study was to optimize the transcranial magnetic stimulation (TMS) protocol for acquiring a reliable estimate of corticospinal excitability (CSE) using single-pulse TMS. Moreover, the minimal number of stimuli required to obtain a reliable estimate of CSE was investigated. In addition, the effect of two frequently used stimulation intensities [110% relative to the resting motor threshold (rMT) and 120% rMT] and gender was evaluated. Thirty-six healthy young subjects (18 males and 18 females) participated in a double-blind crossover procedure. They received 2 blocks of 40 consecutive TMS stimuli at either 110% rMT or 120% rMT in a randomized order. Based upon our data, we advise that at least 30 consecutive stimuli are required to obtain the most reliable estimate for CSE. Stimulation intensity and gender had no significant influence on CSE estimation. In addition, our results revealed that for subjects with a higher rMT, fewer consecutive stimuli were required to reach a stable estimate of CSE. The current findings can be used to optimize the design of similar TMS experiments.

A single session of 1 mA anodal tDCS-supported motor training does not improve motor performance in patients with multiple sclerosis.

PURPOSE: To assess the effects of atDCS on motor performance in patients with multiple sclerosis (MS). Previously, anodal transcranial direct current stimulation (atDCS) has been shown to improve motor performance in healthy subjects and neurodegenerative populations. However, the effect of atDCS on motor performance is not examined in MS. METHODS: In the current study, a sham controlled double-blind crossover design was used to evaluate the effect of 20 minutes of 1 mA atDCS or sham tDCS (stDCS) on a unimanual motor sequence-training task, consisting of sequential finger presses on a computer keyboard with the most impaired hand. Patients received stimulation (atDCS or stDCS) during motor training. tDCS was applied over the primary motor cortex contralateral to the most impaired hand. Motor performance was assessed immediately before, during and 30 minutes after stimulation. RESULTS: Although we need to be careful with the interpretation of the data due to lack of power, our results showed no significant effect of atDCS on motor performance. CONCLUSIONS: Our findings indicate that atDCS-supported motor training was not able to improve motor performance more than sham-supported motor training. Possibly, the effects of atDCS are mediated by specific MS-related characteristics. Furthermore, increasing atDCS intensity and offering multiple stimulation sessions might be necessary to optimize motor performance resulting from atDCS-supported motor training.

Anodal tDCS increases corticospinal output and projection strength in multiple sclerosis.

The application of anodal transcranial direct current stimulation (atDCS) to the human brain has been shown to elicit corticospinal (CS) excitability changes. This study evaluated the effect of a single session of atDCS on CS excitability in patients with multiple sclerosis (MS). atDCS and sham tDCS (stDCS) were applied to the primary motor cortex (M1) contralateral to the more severely impaired hand for 20min in a double-blinded crossover design. Changes in CS excitability were assessed using transcranial magnetic stimulation (TMS). The area under the recruitment curves increased significantly after application of atDCS (+56.58%, p=0.023) but not after stDCS. A sigmoidal curve-analysis revealed a higher plateau of the curve after atDCS (+22.2%, p<0.001). Our results showed that atDCS over M1 has the ability to increase CS output and projection strength in MS-patients, suggesting that atDCS can be considered during neural rehabilitation to facilitate motor recovery in MS.

Is motor learning mediated by tDCS intensity?

Although tDCS has been shown to improve motor learning, previous studies reported rather small effects. Since physiological effects of tDCS depend on intensity, the present study evaluated this parameter in order to enhance the effect of tDCS on skill acquisition. The effect of different stimulation intensities of anodal tDCS (atDCS) was investigated in a double blind, sham controlled crossover design. In each condition, thirteen healthy subjects were instructed to perform a unimanual motor (sequence) learning task. Our results showed (1) a significant increase in the slope of the learning curve and (2) a significant improvement in motor performance at retention for 1.5 mA atDCS as compared to sham tDCS. No significant differences were reported between 1 mA atDCS and sham tDCS; and between 1.5 mA atDCS and 1 mA atDCS.

Age-related differences in corticospinal excitability during a choice reaction time task.

Age-related declines in central processing may affect corticospinal (CS) excitability that underlies the emergence of voluntary responses to external stimuli. We used single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex to explore the evolution of CS excitability in 14 young and ten elderly healthy right-handed participants. Motor-evoked potentials (MEPs) were elicited in the right or left first dorsal interosseus (FDI) during the preparatory and premotor periods of a choice reaction time (CRT) task, which required selection of left or right index finger responses. Both age groups showed significant suppression of CS excitability in the preparatory period. However, suppression was generally less pronounced in older than in young adults. Moreover, our data indicated that a reduced suppression in the right FDI during the preparatory period was associated with longer reaction times (RTs) in older adults only. In the premotor period, both age groups demonstrated comparable facilitation levels towards movement onset. Our findings indicate that increased RTs among older individuals could be directly associated with declines in preparatory processes.

Effect of a cardiovascular prevention program on health behavior and BMI in highly educated adults: a randomized controlled trial.

OBJECTIVE: To examine the effects and dose-response effects of an intervention on health behavior (fat intake, physical activity, and smoking) and Body Mass Index (BMI) in a sample of highly educated adults. METHODS: Participants were randomized to a 'usual care' condition (=medical assessment) (n=106) and an intervention condition (=cardiovascular prevention program) that additionally included a website and one-on-one coaching (by e-mail, telephone, and/or face-to-face) (n=208). The participants could select their own intervention dose and delivery mode. RESULTS: Participants completed questionnaires at baseline (n=93; n=194) and 6 months post-baseline (n=84; n=168). The intervention was not more effective than 'usual care' but a higher intervention dose led to better outcomes for fat intake and physical activity, independent of baseline motivation. Furthermore, the effect of combining different delivery modes was dependent on the behavioral context. CONCLUSION: A higher intervention dose led to better results but allowing people to select their own intervention dose probably undermined the potential intervention effect. PRACTICE IMPLICATIONS: The present study highlights the importance of intervention dose and delivery mode for the development, evaluation, and optimization of health promotion programs.

Age-related differences in human corticospinal excitability during simple reaction time.

Age-related declines in central processing may delay the facilitation of corticospinal (CS) tracts that underlie emergence of voluntary responses to external stimuli. To explore this effect, single pulse transcranial magnetic stimulation (TMS) was applied to the left motor cortex at different latencies from the go-signal (auditory tone) during a simple reaction time (SRT) task with the right or left thumb [i.e. right (RHM) or left hand move (LHM)]. Motor evoked potentials (MEPs) in the right abductor pollicis brevis (APB) were recorded from eleven healthy right-handed participants (aged 22-65; six young adults and five old adults). Both age groups showed significant facilitation of CS excitability approximately 100-120 ms from the onset of the go-signal in the RHM SRT that occurred before the onset of EMG voluntary burst, with no evidence for motor slowing in old adults. Old adults demonstrated a significant facilitation of MEPs in the time that preceded the go-signal for RHM SRT and a marked depression of CS excitability in preparation for the LHM SRT that was sustained up to 80 ms after the onset of the go-signal. Both effects were not seen in young adults. While the small number of participants may hinder the generality of the present observations, this pilot study suggests for the first time that old adults implemented selective tuning of CS excitability prior to the onset of the go command to speed up their response generation.

Exploring the effects of a 20-week whole-body vibration training programme on leg muscle performance and function in persons with multiple sclerosis.

OBJECTIVE: To investigate the acute effects of long-term whole-body vibration on leg muscle performance and functional capacity in persons with multiple sclerosis. DESIGN: A randomized controlled trial. SUBJECTS: Twenty-five patients with multiple sclerosis (mean age 47.9 ± 1.9 years; Expanded Disability Status Scale 4.3 ± 0.2) were assigned randomly to whole-body vibration training (n = 11) or to a control group (n = 14). METHODS: The whole-body vibration group performed static and dynamic leg squats and lunges on a vibration platform (25-45 Hz, 2.5 mm amplitude) during a 20-week training period (5 training sessions per 2-week cycle), and the control group maintained their usual lifestyle. PRE-, MID- (10 weeks) and POST- (20 weeks) knee-muscle maximal isometric and dynamic strength, strength endurance and speed of movement were measured using isokinetic dynamometry. Function was determined through the Berg Balance Scale, Timed Up and Go, Two-minute Walk Test and the Timed 25-Foot Walk Test. RESULTS: Leg muscle performance and functional capacity were not altered following 10 or 20 weeks of whole-body vibration. CONCLUSION: Under the conditions of the present study, the applied 20-week whole-body vibration exercise protocol did not improve leg muscle performance or functional capacity in mild- to moderately impaired persons with multiple sclerosis during and immediately after the training programme.

Occurrence of bad splits during sagittal split osteotomy.

OBJECTIVES: The objectives of this study were to determine the incidence of bad splits in sagittal split osteotomies (SSOs), performed at the same hospital, and if the occurrence was reduced over time because of technical progress and/or surgical experience. Bad splits were defined as buccal or lingual plate fractures. STUDY DESIGN: The files of all patients (n = 1008) who underwent bilateral or unilateral SSO between October 1989 and October 2009 were reviewed retrospectively. RESULTS: A bad split occurred in 14 SSO sites (14 of 2005 sites). No bilateral bad splits occurred. There was no notable decrease of bad splits over the 20 years. All bad splits were resolved perioperatively by plate-osteosynthesis without the additional need of intermaxillary fixation. All patients with a bad split had a good and functional occlusion 6 months postoperatively. No infections occurred at the site of the bad splits. No bad splits occurred in patients younger than 20 years. No particular type of dental-facial deformity, or skeletal class according to the Angle's classification could be correlated with cases of bad splits as a predisposing risk factor. CONCLUSION: Even if precautions are taken, a bad split can occur during SSO of the mandible. This complication is manageable because of its low incidence (0.7 % of all SSOs) and uneventful healing. A significant decrease in incidence did not occur during the 20-year period, and neither technical progress nor the surgeon's experience further reduced the incidence of bad splits.

Long-term TENS treatment improves tactile sensitivity in MS patients.

BACKGROUND: Transcutaneous electrical nerve stimulation (TENS) is commonly used in neurorehabilitation for the treatment of pain and spasticity. OBJECTIVE: The long-term effects of sensory stimulation by means of TENS on hand sensitivity were investigated in patients with multiple sclerosis (MS). METHODS: TENS was applied for 3 weeks (1 hour per day) on the median nerve region of the dominant hand. Sensitivity was assessed by the Semmes-Weinstein monofilaments before and 12 hours following the last intervention as well as 3 weeks later. RESULTS: Long-lasting increases in tactile sensitivity were achieved by repetitive stimulation of sensory afferents with TENS in MS patients but not in healthy subjects. This increased sensitivity was not only restricted to the median nerve area but also expanded to the ulnar nerve area. Remarkably, MS patients reached the same level of sensitivity as healthy subjects immediately after the intervention, and long-term effects were reported 3 weeks later. CONCLUSIONS: The findings of this study demonstrated lasting improvements in tactile sensitivity of the fingers as a result of a long-term TENS intervention in MS patients, who ultimately reached a level comparable with that of healthy subjects.

Neuromuscular electrical stimulation as a possible means to prevent muscle tissue wasting in artificially ventilated and sedated patients in the intensive care unit: A pilot study.

OBJECTIVE: The aim of this study was to explore if electrical stimulation could prevent muscle atrophy. MATERIAL AND METHODS: Patients were hospitalized for postoperative coronary artery bypass graftin, chronic obstructive pulmonary disease, ventilatory failure, or acute cerebro-vascular accident, and were divided into an intervention group or a control group. The intervention group underwent daily 30 minute training with an intermittent neuromuscular electrical stimulation applied to the right quadriceps muscle. Heart rate, respiration rate, systolic and diastolic blood pressure, and oxygen saturation were monitored before, during, and after electrical stimulation. Circumference of both thighs was measured. RESULTS: The intervention resulted in a significant reduction of muscle atrophy in the stimulated as compared with the non-stimulated limb (p < 0.05), without making any impact on cardiovascular, respiratory and, hemodynamic characteristics. CONCLUSIONS: Muscle atrophy is prevented by intermittent neuromuscular electrical stimulation while this intervention showed no obvious impact on the cardio-respiratory conditions of the patients.

Influence of freeze-thawing on hyaluronic acid binding of human spermatozoa.

Mature human spermatozoa have at least three specific hyaluronic acid (HA) binding proteins present on their sperm membrane. These receptors play a role in the acrosome reaction, hyaluronidase activity, hyaluronan-mediated motility and sperm-zona and sperm-oolemmal binding. Cryopreservation of spermatozoa can cause ultrastructural and even molecular damage. The aim of this study was to investigate if HA binding receptors of human spermatozoa remain functional after freeze-thawing. Forty patients were enrolled in the study. Semen samples were analysed before and after cryopreservation. Parameters analysed included concentration, motility, morphology and hyaluronan binding. Samples were frozen in CBS straws using a glycerol-glucose-based cryoprotectant. HA binding was studied using the sperm-hyaluronan binding assay. Freeze-thawing resulted in a significant decline in motility: the percentage of motile spermatozoa reduced from 50.6 to 30.3% (P < 0.001). HA binding properties of frozen-thawed spermatozoa remained unchanged after the freeze-thawing process: 68.5 +/- 17.1% spermatozoa of the neat sample were bound to HA, as were 71.3 +/- 20.4 of the frozen-thawed sample. This study indicates that freeze-thawing did not alter the functional hyaluronan binding sites of mature motile spermatozoa, and therefore will not alter their fertilizing potential.

Health-related quality of life and tolerability in treatment-experienced HIV-1-infected patients on tipranavir versus comparator regimens.

BACKGROUND: Antiretroviral therapy including tipranavir boosted with ritonavir (TPV/r) has shown superior viral suppression and immunological response compared with comparator ritonavir-boosted protease inhibitor (CPI/r) regimens in treatment-experienced HIV-1-infected patients. This study assesses the influence of adverse events (AEs) on health-related quality of life (HRQOL) and change in HRQOL in patients treated with TPV/r versus CPI/r regimens. METHODS: Changes in HRQOL over 48 weeks were assessed using Medical Outcomes Study HIV Health Survey (MOS-HIV) data combined from two randomized, open-label, Phase III studies (RESIST-1 and RESIST-2). Generalized estimating equations (GEE) were used to compare physical health and mental health summary scores and 10 subscale scores, and to compare scores of patients with and without AEs. To compare AE incidences in the two treatment groups, AEs were exposure-adjusted. RESULTS: There were 984 patients in the HRQOL analysis. AE occurrence and severity resulted in significantly lower MOS-HIV scores across both treatment arms (P<0.05). Overall incidence of AEs was higher in the CPI/r versus TPV/r group (562.8 versus 514.4 per 100 patient-exposure years); treatment-related AEs were more frequent in the TPV/r group (75.0 versus 56.6 per 100 patient-exposure years). HRQOL was maintained in patients on TPV/r over 48 weeks of treatment across all summary and subscale scores. Compared with CPI/r, TPV/r was associated with a significant but small (SD<0.2) improvement in pain scores (+4.8 points; P<0.05). CONCLUSIONS: HRQOL was maintained across both summary and all subscale scores from baseline to 48 weeks in the TPV/r and CPI/r treatment arms, despite the incidence of treatment-related AEs.

Handling missing quality of life data in HIV clinical trials: what is practical?

AIMS: Missing health-related quality of life (HRQOL) data in clinical trials can impact conclusions but the effect has not been thoroughly studied in HIV clinical trials. Despite repeated recommendations to avoid complete case (CC) analysis and last observation carried forward (LOCF), these approaches are commonly used to handle missing data. The goal of this investigation is to describe the use of different analytic methods under assumptions of missing completely at random (MCAR), missing at random (MAR), and missing not at random (MNAR) using HIV as an empirical example. METHODS: Medical Outcomes Study HIV (MOS-HIV) Health Survey data were combined from two large open-label multinational HIV clinical trials comparing treatments A and B over 48 weeks. Inclusion in the HRQOL analysis required completion of the MOS-HIV at baseline and at least one follow-up visit (weeks 8, 16, 24, 40, 48). Primary outcomes for the analysis were change from week 0 to 48 in mental health summary (MHS), physical health summary (PHS), pain and health distress scores analyzed using CC, LOCF, generalized estimating equations (GEE), direct likelihood and sensitivity analyses using joint mixed-effects model, and Markov chain Monte Carlo (MCMC) multiple imputation. Time and treatment were included in all models. Baseline and longitudinal variables (adverse event and reason for discontinuation) were only used in the imputation model. RESULTS: A total of 511 patients randomized to treatment A and 473 to treatment B completed the MOS-HIV at baseline and at least one follow-up visit. At week 48, 71% of patients on treatment A and 31% on treatment B completed the MOS-HIV survey. Examining changes within each treatment group, CC and MCMC generally produced the largest or most positive changes. The joint model was most conservative; direct likelihood and GEE produced intermediate results; LOCF showed no consistent trend. There was greater spread for within-group changes than between-group differences (within MHS scores for treatment A: -0.1 to 1.6, treatment B: 0.4 to 2.0; between groups: -0.7 to 0.4; within PHS scores for treatment A: -1.5 to 0.4, treatment B: -1.7 to -0.2; between groups: 0.1 to 1.1). The size of within-group changes and between-group differences was of similar magnitude for the pain and health distress scores. In all cases, the range of estimates was small <0.2 SD (less than 2 points for the summary scores and 5 points for the subscale scores). CONCLUSIONS: Use of the recommended likelihood-based models that do not require assumptions of MCAR was very feasible. Sensitivity analyses using auxiliary information can help to investigate the potential effect that missing data have on results but require planning to ensure that relevant data are prospectively collected.