Spontaneous Complaints Research Articles

Absence of Relationship Between Self-Reported Sleep Measures and Amyloid Load in Elderly Subjects.

Objective: To determine the relationships between self-reported sleep profile and cortical amyloid load in elderly subjects without dementia.Methods: This cross-sectional study included 143 community-dwelling participants aged ≥70 years (median: 73 years [70–85]; 87 females) with spontaneous memory complaints but dementia-free. Sociodemographic characteristics, health status, neuropsychological tests, sleep, and 18F-florbetapir (amyloid) PET data were collected. The clinical sleep interview evaluated nighttime sleep duration, but also daytime sleep duration, presence of naps, and restless leg syndrome (RLS) at time of study. Validated questionnaires assessed daytime sleepiness, insomnia, and risk of sleep apnea. The cortical standardized uptake value ratio (SUVr) was computed across six cortical regions. The relationship between sleep parameters and SUVr (cut-off ratio>1.17 and tertiles) was analyzed using logistic regression models.Results: Amyloid-PET was positive in 40.6% of participants. Almost 40% were at risk for apnea, 13.5% had RLS, 35.5% insomnia symptoms, 22.1% daytime sleepiness, and 18.8% took sleep drugs. No significant relationship was found between positive amyloid PET and nighttime sleep duration (as a continuous variable, or categorized into <6; 6–7; ≥7 h per night). Logistic regression models did not show any association between SUVr and daytime sleep duration, 24-h sleep duration, naps, RLS, daytime sleepiness, insomnia symptoms, and sleep apnea risk (before and after adjustment for APOEε4 and depressive symptoms).Conclusion: Our study did not confirm the association between amyloid-PET burden, poor sleep quantity/quality in elderly population, suggesting that the interplay between sleep, and amyloid is more complex than described.

Prevalência, intensidade e desconforto da sede no paciente cirúrgico no pós-operatório imediato

Objetivo: Avaliar a prevalência, a intensidade e o desconforto da sede no período pós-operatório imediato. Método: Estudo epidemiológico, transversal, descritivo, quantitativo, realizado em um hospital universitário do Sul do Brasil, de agosto a setembro de 2012. A amostra foi composta de 386 pacientes em recuperação anestésica de cirurgias eletivas e de urgência. Foi utilizado um questionário semiestruturado composto de dados demográficos, clínicos e variáveis relacionadas à sede. Resultados: A prevalência de sede foi de 78% (303 pacientes), com intensidade média de 6,94 (desvio padrão — DP=2,2) e queixa espontânea de sede em 38,3% dos casos (116 pacientes). Os desconfortos relatados foram: boca seca, procura por água, hipossalivação, garganta seca, lábios ressecados, língua seca e vontade de deglutir. Todos os desconfortos apresentaram correlação de Pearson positiva em relação à presença de sede. Conclusão: A sede no pós-operatório imediato é intensa, prevalente e com sinais periféricos desconfortáveis. Essas evidências fundamentam a necessidade da identificação, da mensuração, da avaliação e do tratamento do sintoma sede de forma intencional neste período

PO-01-066 Sexual problems and dysfunctions: Do patients accurately report their complaints?

The most common reasons for medical assistance in men are erectile and ejaculation disorders, whereas in women are interest and arousal disorders. There may be, however, a disparity between the sexual complaints that first motivated the patient to look for help and those found on the clinical interview and screening questionnaires. Our aim is to investigate the difference between the spontaneous sexual complaints and those found on validated questionnaires. A clinical sample of 47 subjects (51% male) referred to our Sexology Outpatient Clinic was enrolled in the study. Participants completed a sociodemographic questionnaire and a set of validated clinical instruments (Female Sexual Function Index (FSFI) and International Index of Erectile Function (IIEF)). Statistical analysis was performed on STATA13.1. Subjects’ mean age was 40.6±10.1 (males) and 36.4±7.8 (females). Men were referred for erectile dysfunction (ED) (58.3%,n=14), premature ejaculation (33.3%,n=8) and low sexual desire (8.3%,n=2). When IIEF was applied, 75% met criteria for ED. The median value for erectile function dimension is 10 (interquartile range (IQR) 7-20.5), for the orgasm dimension was 8.5 (IQR 6-10), and for desire 7 (IQR 3.5-9). Median values for sexual satisfaction and overall satisfaction were very low: 5.5 (IQR 4.5-7.5) and 3.5 (IQR 2-5.5) respectively. Women were referred for low sexual desire (43.8%,n=10), anorgasmia (34.8%,n=8), genital pain (17.4%,n=4) and arousal disorder (4.3%,n=1). When FSFI was applied, the median value for all dimensions was below the cut-off: desire 1.5 (IQR 1.2-2.7), arousal 1.35 (IQR 0.6-2.1), lubrication 1.35 (IQR 0.6-2.7), orgasm 1.2 (IQR 0.6-1.6), satisfaction 1.7 (IQR 1.0-2.8) and genital pain 1.8 (IQR 0.6-4.2).

A clinical screening tool for objective and subjective cognitive disorders in multiple sclerosis.

Cognitive dysfunction is common in multiple sclerosis (MS). Deficits can affect attention, concentration, planning, and memory. They can have severe functional consequences in many domains. Cognitive complaints are frequently associated with other confounding factors (fatigue, anxiety, depression, or treatment side effects). In most cases, cognitive assessment is proposed after a spontaneous complaint, but determining the extent of discomfort perceived by the patient, the influence of coexisting factors, or the optimal timing for a more complete neuropsychological assessment is difficult. The objective of this work was to evaluate the feasibility and relevance of a fast global assessment of both objective and subjective cognitive dysfunction in MS. MS patients underwent a brief cognitive assessment including 7 visual analogue scales (VASs) asking about the patient's subjective level of discomfort in various domains, a memory test (Barbizet's lion story), a commonly used test of information processing speed (Symbol Digit Modalities Test [SDMT]) and self-reporting questionnaires for fatigue and mood (Fatigue Severity Scale [FSS] and Hospital Anxiety and Depression Scale [HADS]). Spearman correlation coefficients among scores were estimated. The mean age of the 73 patients included was 48.3 (SD 11.1) years; 78% were females and 52.8% had the remittent-recurrent MS form, 8.3% the primary progressive form, and 38.9% the secondary progressive form. In less than 20min, this brief cognitive assessment was able to identify symptoms and quantify discomfort level. Symptoms of fatigue and anxiety frequently coexisted with cognitive complaints. We found modest correlations between scores on the VAS fatigue and the FSS and between scores on the VAS mood and the HADS. Analytical evaluation revealed that most patients had similar SDMT and recall profiles; however, a small proportion showed a dissociation between these 2 tests, which validated the inclusion of both tests in the assessment. Accounting for coexisting factors (e.g., anxiety and fatigue) and their functional repercussions is essential for prioritizing these problems within the context of multidisciplinary patient treatment. Considering the possible multifactorial character of cognitive dysfunction in MS, it is essential to ask patients about their experiences and to take into account cognitive complaints in the follow-up of patients. The assessment tool we propose is simple and easy to use in a clinical setting and provides the information necessary for requesting (or not) a more complete neuropsychological assessment.

To assess and compare dexamethasone, lignocaine, and tramadol in reduction of propofol-induced vascular pain

Introduction: Propofol (2,6 di-isopropyl phenol) is a widely used agent for induction of anesthesia, although pain during its injection remains a concern for all anesthesiologists. Pain on intravascular injection of propofol is very incapacitating, and the trouble still remains and has never been eradicated. Materials and Methods: After taking approval from the Institutional Review Board, this randomized controlled study was conducted on patients undergoing elective surgeries under general anesthesia. Two hundred and ten adult patients of either sex aged 28–60 years weighing between 40 and 80 kg were included into three groups: Group L – received 60 mg of preservative-free lignocaine hydrochloride, Group D – received 12 mg of dexamethasone sodium phosphate, and Group T – received 100 mg of tramadol hydrochloride. Venous occlusion was done at the level of mid-fore-arm by inflating a noninvasive blood pressure cuff to a pressure of 60 mmHg. Study drug was then injected over 10 s by consultant who was blinded to the procedure. After 2 min of study drug, venous occlusion was released following which propofol 0.5 mg/kg was injected over 5 s. Spontaneous complaints of pain and behavioral signs which included facial grimace, arm withdrawal, vocal and verbal rating score were recorded by the second anesthesiologist who was unaware of the group allocation. Results: All three drugs reduced the intensity and severity of propofol-induced vascular pain. Incidence of pain in lignocaine, dexamethasone, and tramadol Groups were 15%, 32.8%, and 31.4%, respectively. There was significant pain relief (P = 0.045 and 0.042, respectively) when comparing Group L and D, Group L and T. Pain relief between Group D and T was statistically similar (P = 0.8). The incidence of hand withdrawal was significantly higher in the tramadol group (P Conclusion: Use of pretreatment with drugs is required to prevent propofol-induced vascular pain. Both tramadol and dexamethasone are equally efficacious in reducing propofol-induced vascular pain, though both are less effective when compared with lignocaine. Dexamethasone has an added advantage of preventing postoperative nausea and vomiting when compared with both lignocaine and tramadol.

A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial.

Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people. This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults. One hundred and twenty older adults (≥ 65years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness. We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency. The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.

Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial

BackgroundChinese external therapy (CET) is a topical application with mainly Chinese herb medicine therapy with thousands of years of historical implications and is a clinical routine that is commonly used for relieving joint-related symptoms in patients with arthritis in Chinese hospitals. However, there is a paucity of modern medical evidence to support its effectiveness and safety. Thus, we propose to implement a randomized, double-blinded, placebo-controlled clinical trial in patients with rheumatoid arthritis (RA) using, as the experimental intervention, topical application of a hospital-compounded gel preparation of Tripterygium wilfordii Hook F (TwHF).MethodsThis study will be an 8-week double-blinded, randomized, placebo-controlled clinical trial conducted at Guang’anmen Hospital in Beijing, China, and 168 patients with moderately active RA will be randomly assigned with a 1:1 ratio to apply a topical gel preparation containing TwHF or placebo. The primary outcome variable will be the proportion of subjects, by study group, to achieve a 20% improvement in the American College of Rheumatology criteria (ACR20) by week 8. Secondary outcome measures to be assessed at weeks 4 or 8 will include: measurement of ACR20 response rate at week 4, ACR50 response rate, the changes in DAS28 score, and joint synovitis classification assessment monitored by musculoskeletal ultrasound. Safety evaluations conducted at weeks 4, 8 and 12 will be based on spontaneous complaints by the study subjects, but special emphasis will be focused on cutaneous allergy and alterations of menstruation in premenopausal female participants. Statistical analyses will be performed using the intention to treat analysis data set.DiscussionThis proposed clinical trail is designed to evaluate the efficacy and safety of CET based on a single topically-applied agent in a relatively large patient population with RA. This study protocol gives a detailed description of the usage and dosage of the topical compound TwHF gel and the methodology of this study. In addition, it is hoped that the outcomes of this study will be viewed as supporting the generalizability of CET in the setting of inflammatory rheumatic diseases. The results of this study are expected to have important public health implications for Asian RA patients that currently utilize CET as a complimentary treatment.Trial registrationClinical trial gov Identifier: NCT02818361. Registrated on Jun. 15, 2016.

Spontaneously Reported Symptoms by Informants Are Associated with Clinical Severity in Dementia Help-Seekers.

To investigate the predictive value of symptoms of dementia that the person or an informant noticed spontaneously in determining the clinical severity of dementia. Cross-sectional. Community-based open-referral dementia assessment service in Hong Kong between 2005 and 2013. Help-seekers for dementia assessment service and their informants (N = 965 dyads). Participants underwent a clinical dementia interview based on the Clinical Dementia Rating. Spontaneous complaints that the person and the informant made that had prompted their help-seeking of groups with interview results suggestive of no impairment, mild cognitive impairment, and dementia were compared. Logistic regression was used to evaluate the predictive value of spontaneous complaints for clinical severity. Independent raters blinded to clinical results coded spontaneously reported symptoms into theoretical themes: memory, executive function, language, time and place orientation, neuropsychiatric, mood, and avolition. Memory problems were the most frequently reported complaints for participants (87.7%) and their informants (95.5%), followed by self-reported language (33.0%) and informant-reported orientation (33.0%) difficulties. Informant-reported but not self-reported symptoms predicted clinical severity. Compared with the persons themselves, informants reported more pervasive symptoms corresponding to clinical severity. Persons with dementia self-reported fewer types of symptoms than their healthy or mildly impaired counterparts. Spontaneously reported language and orientation symptoms by the informant distinguished persons with mild or worse dementia (P < .001, Nagelkerke coefficient of determination = 29.7%, percentage correct 85.6%). The type and pervasiveness of symptoms spontaneously that informants reported predicted clinical severity. This may provide a quick reference for triage.

Impact of pain on cognitive functions in primary Sjögren syndrome with small fiber neuropathy: 10 cases and a literature review.

Primary Sjögren syndrome (pSS) is a chronic systemic autoimmune disease characterized by xerophthalmia, xerostomia, and potential peripheral or central neurological involvement. In pSS, the prevalence of cognitive disorders is generally sparse across literature and the impact of pain on cognitive profile is unclear. The aim of this study was to determine the relation between pain, cognitive complaint, and impairment in a very homogenous population of 10 pSS patients with painful small fiber neuropathy (PSFN) and spontaneous cognitive complaint. Neurological exam, neuropsychological assessment, clinical evaluation measuring pain level, fatigue, anxiety, depression, and cognitive complaint were performed. Our results showed that 100% of patients had cognitive dysfunction especially in executive domain (80%). The most sensitive test was the Wisconsin Card Sorting Test (WCST), abnormal in 70% of our population. Moreover, we found clear cut significant correlations between pain levels and 3 measures of WCST: the number of errors (R = –0.768, P = .0062), perseverations (R = 0.831, P = .0042), and categories (R = 0.705, P = .02). In the literature review, the impact of pain is underexplored and results could be discordant. In a homogeneous cohort of pSS patients with PSFN, a cognitive complaint seems to be a valid reflection of cognitive dysfunction marked by a specific executive profile found with the WCST. In this preliminary study, this profile is linked to the level of pain and highlights that an appropriate management of pain control and a cognitive readaptation in patients could improve the quality of life.

Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial

No large trials have been done to investigate the efficacy of an intervention combining a specific compound and several lifestyle interventions compared with placebo for the prevention of cognitive decline. We tested the effect of omega 3 polyunsaturated fatty acid supplementation and a multidomain intervention (physical activity, cognitive training, and nutritional advice), alone or in combination, compared with placebo, on cognitive decline. The Multidomain Alzheimer Preventive Trial was a 3-year, multicentre, randomised, placebo-controlled superiority trial with four parallel groups at 13 memory centres in France and Monaco. Participants were non-demented, aged 70 years or older, and community-dwelling, and had either relayed a spontaneous memory complaint to their physician, limitations in one instrumental activity of daily living, or slow gait speed. They were randomly assigned (1:1:1:1) to either the multidomain intervention (43 group sessions integrating cognitive training, physical activity, and nutrition, and three preventive consultations) plus omega 3 polyunsaturated fatty acids (ie, two capsules a day providing a total daily dose of 800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid), the multidomain intervention plus placebo, omega 3 polyunsaturated fatty acids alone, or placebo alone. A computer-generated randomisation procedure was used to stratify patients by centre. All participants and study staff were blinded to polyunsaturated fatty acid or placebo assignment, but were unblinded to the multidomain intervention component. Assessment of cognitive outcomes was done by independent neuropsychologists blinded to group assignment. The primary outcome was change from baseline to 36 months on a composite Z score combining four cognitive tests (free and total recall of the Free and Cued Selective Reminding test, ten Mini-Mental State Examination orientation items, Digit Symbol Substitution Test, and Category Naming Test) in the modified intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT00672685). 1680 participants were enrolled and randomly allocated between May 30, 2008, and Feb 24, 2011. In the modified intention-to-treat population (n=1525), there were no significant differences in 3-year cognitive decline between any of the three intervention groups and the placebo group. Between-group differences compared with placebo were 0·093 (95% CI 0·001 to 0·184; adjusted p=0·142) for the combined intervention group, 0·079 (-0·012 to 0·170; 0·179) for the multidomain intervention plus placebo group, and 0·011 (-0·081 to 0·103; 0·812) for the omega 3 polyunsaturated fatty acids group. 146 (36%) participants in the multidomain plus polyunsaturated fatty acids group, 142 (34%) in the multidomain plus placebo group, 134 (33%) in the polyunsaturated fatty acids group, and 133 (32%) in the placebo group had at least one serious emerging adverse event. Four treatment-related deaths were recorded (two in the multidomain plus placebo group and two in the placebo group). The interventions did not raise any safety concerns and there were no differences between groups in serious or other adverse events. The multidomain intervention and polyunsaturated fatty acids, either alone or in combination, had no significant effects on cognitive decline over 3 years in elderly people with memory complaints. An effective multidomain intervention strategy to prevent or delay cognitive impairment and the target population remain to be determined, particularly in real-world settings. French Ministry of Health, Pierre Fabre Research Institute, Gerontopole, Exhonit Therapeutics, Avid Radiopharmaceuticals.

Patients with burning mouth sensations. A clinical investigation of causative factors in a group of "compete denture wearers" Jordanian population.

AimTo find out the prevalence of “true” burning mouth syndrome and study the association between patients’ spontaneous complaints of burning mouth and systemic conditions in a group of middle age and elderly “denture wearers” patients in Jordan.MethodsA group of 129 patients (112 female and 17 male) of “complete denture wearers” subjects aged 40 years and over attended prosthetic clinic at King Hussein Medical Hospital complaining from oral burning, with no oral lesion possibly responsible for the burning sensations were selected. Assessment of oral and general status was done based on questioners, detailed history taking, medical records and extra and intraoral examination. The existed complete dentures retention, stability, jaw relationship and the free way space were evaluated. The current blood test and instrumental protocol for examination of patients with burning mouth complains were performed for each patient. Then those studied patients with burning mouth sensations including “true” burning mouth syndrome have been compared to the controls with regard to the presence of local problem, undermined local, systemic or psychological disease.ResultsThe diagnosis of “true” burning mouth syndrome was established in (2.3%) of the studied population two females and one male. In most patients (58%) more than one site was affected. Significant positive associations were found between local factors (i.e., wearing complete dentures with unsatisfactory retention or jaw relationship, dry mouth or candidasis) and patients suffering from burning mouth sensation. The results also show that some systemic or psychological disorders were significantly more present among patients with burning mouth symptoms when compared to the control group (p < 0.05).ConclusionSpontaneous symptoms of burning mouth without mucosal signs should be considered as a manifestation of undermind pathology and/or distress, and the multi-factorial causes of burning mouth syndrome and sensation need to be referred to the suitable specialist for better treatment results.

Cross-Sectional and Prospective Associations Between β-Amyloid in the Brain and Chair Rise Performance in Nondementia Older Adults With Spontaneous Memory Complaints.

The objectives of this study were to examine the cross-sectional and prospective associations of muscle functional performance as assessed by a chair rise test and brain amyloid load among nondemented older adults with spontaneous memory complaints. This is a secondary analysis, with an observational design, using data from the MAPT randomized controlled trial. Individuals assessed for brain amyloid load (florbetapir F18 positron emission tomography) and without clinical dementia (N = 269 aged 75.2±4.2 years; 60.2% women) participated in the study. Cortical and regional standard uptake value ratios (SUVRs) were obtained. The main outcome measure was the 5-repetition chair rise performance (maximum speed-higher is better), which was assessed at baseline and at 6, 12, 24, and 36 months. Adjusted multiple linear (cross-sectional) and mixed-effect (overtime) regressions were performed. Any of mean cortical (regions of interest) and each regional SUVRs (anterior cingulate, anterior putamen, caudate, hippocampus, medial orbitofrontal cortex, occipital cortex, parietal cortex, pons, posterior cingulate, posterior putamen, precuneus, semioval center, and temporal cortex) were not associated to chair rise after adjustment for multiplicity. These findings were obtained for both cross-sectional and prospective associations. Brain amyloid was not found to be associated to chair rise performance in nondemented older adults with memory complaints. Potential mechanisms on the links, if any, of amyloid load with physical performance are probably not dependent on muscle function.

Patient Complaints and Adverse Surgical Outcomes.

One factor that affects surgical team performance is unprofessional behavior exhibited by the surgeon, which may be observed by patients and families and reported to health care organizations in the form of spontaneous complaints. The objective of this study was to assess the relationship between patient complaints and adverse surgical outcomes. A retrospective cohort study used American College of Surgeons National Surgical Quality Improvement Program data from an academic medical center and included 10 536 patients with surgical procedures performed by 66 general and vascular surgeons. The number of complaints for a surgeon was correlated with surgical occurrences (P < .01). Surgeons with more patient complaints had a greater rate of surgical occurrences if the surgeon's aggregate preoperative risk was higher (β = .25, P < .05), whereas there was no statistically significant relationship between patient complaints and surgical occurrences for surgeons with lower aggregate perioperative risk (β = -.20, P = .77).

Prevention of impaired mobility in the elderly in primary care: a brief report

The loss autonomy in the aging population is a major public health issue. Mobility impairment, which precedes loss of autonomy, could yet be accessible to multi-modal and personalised programs to enhance balance and physical performances, and avoid loss of autonomy. Moreover, such preventive programs are likely to be more effective when the patients are taken in charge before presenting with difficulties in daily living. The aging demographics and the consequences of the loss of autonomy clearly indicate a need for better addressing these patients with lowering mobility, even though they will mostly have subtle symptoms and no spontaneous complaints. This could be achieved by improving the screening of mobility impairment and the development of specific personalised preventive programs in primary care. In this brief narrative review, we aimed to summarise the current body of knowledge on mobility impairment prevention in the elderly, and open the field for future research in primary care.

Analysing Time to Event Data in Dementia Prevention Trials: The Example of the GuidAge Study of EGb761.

Time-to-event analysis is frequently used in medical research to investigate potential disease-modifying treatments in neurodegenerative diseases. Potential treatment effects are generally evaluated using the logrank test, which has optimal power and sensitivity when the treatment effect (hazard ratio) is constant over time. However, there is generally no prior information as to how the hazard ratio for the event of interest actually evolves. In these cases, the logrank test is not necessarily the most appropriate to use. When the hazard ratio is expected to decrease or increase over time, alternative statistical tests such as the Fleming-Harrington test, provide a better sensitivity. An example of this comes from a large, five-year randomised, placebo-controlled prevention trial (GuidAge) in 2854 community-based subjects making spontaneous memory complaints to their family physicians, which evaluated whether treatment with EGb761 can modify the risk of developing AD. The primary outcome measure was the time to conversion from memory complaint to Alzheimer's type dementia. Although there was no significant difference in the hazard function of conversion between the two treatment groups according to the preplanned logrank test, a significant treatment-by-time interaction for the incidence of AD was observed in a protocol-specified subgroup analysis, suggesting that the hazard ratio is not constant over time. For this reason, additional post hoc analyses were performed using the Fleming-Harrington test to evaluate whether there was a signal of a late effect of EGb761. Applying the Fleming-Harrington test, the hazard function for conversion to dementia in the placebo group was significantly different from that in the EGb761 treatment group (p = 0.0054), suggesting a late effect of EGb761. Since this was a post hoc analysis, no definitive conclusions can be drawn as to the effectiveness of the treatment. This post hoc analysis illustrates the interest of performing another randomised clinical trial of EGb761 explicitly testing the hypothesis of a late treatment effect, as well as of using of better adapted statistical approaches for long term preventive trials when it is expected that prevention cannot have an immediate effect but rather a delayed effect that increases over time.

Unsolicited Patient Complaints in Ophthalmology: An Empirical Analysis from a Large National Database

The number of unsolicited patient complaints about a physician has been shown to correlate with increased malpractice risk. Using a large national patient complaint database, we evaluated the number and content of unsolicited patient complaints about ophthalmologists to identify significant risk factors for receiving a complaint. Retrospective cohort study. Ophthalmologists, nonophthalmic surgeons, nonophthalmic nonsurgeons. We analyzed 2087 unsolicited or spontaneous complaints reported about 815 ophthalmologists practicing in 24 academic and nonacademic organizations using the Patient Advocacy Reporting System (PARS). Complaints against 5273 nonophthalmic surgeons and 19487 nonophthalmic nonsurgeons during the same period were used for comparison. Complaint type profiles were assigned using a previously validated standardized coding system. We (1) described the distribution of complaints against ophthalmologists; (2) compared the distribution and rates of patient complaints about ophthalmologists with those of nonophthalmic surgeons and nonophthalmic nonsurgeons in the database; (3) analyzed differences in complaint type profiles and quantity of complaints by ophthalmic subspecialty, practice setting, physician gender, medical school type, and graduation date; and (4) identified significant risk factors for high numbers of unsolicited patient complaints after adjusting for other covariates. Unsolicited patient complaints. Ophthalmologists had significantly fewer complaints per physician than other nonophthalmic surgeons and nonsurgeons. Sixty-three percent of ophthalmologists had 0 complaints, whereas 10% of ophthalmologists accounted for 61% of all complaints. Ophthalmologists from academic centers, female ophthalmologists, and younger ophthalmologists had significantly more complaints (P< 0.01), and general ophthalmologists had significantly fewer complaints than subspecialists (P < 0.05). After adjusting for covariates using multivariable analysis, working at an academic center was a statistically significant risk factor (adjusted relative risk, 1.82; 95% confidence interval, 1.36-2.43; P < 0.001). Ophthalmologists had significantly fewer complaints than nonophthalmic surgeons and nonophthalmic nonsurgeons, and by implication may have a lower malpractice risk as a group. Nevertheless, a small number of ophthalmologists generated a disproportionate number of complaints. Working at an academic center was a significant independent risk factor for having more patient complaints. Further research is needed to clarify the underlying reasons for this association and to identify interventions that may decrease this risk.

Swallowing and pharyngo-esophageal manometry in obstructive sleep apnea

IntroductionUpper airway nerve and muscle damage associated with obstructive sleep apnea may impair the strength and dynamics of pharyngeal and esophageal contractions during swallowing. ObjectiveTo evaluate the presence of alterations in pharyngoesophageal manometry in patients with obstructive sleep apnea with and without oropharyngeal dysphagia. MethodsThis study prospectively evaluated 22 patients with obstructive sleep apnea without spontaneous complaints of dysphagia, using a questionnaire, fiberoptic endoscopic evaluation of swallowing, and pharyngoesophageal manometry, including measurement of the upper and lower esophageal sphincter pressures and mean pharyngeal pressures at three levels during swallowing. ResultsThe dysphagia group consisted of 17 patients (77.3%) in whom swallowing abnormalities were detected on fiberoptic endoscopic evaluation of swallowing (n=15; 68.2%) and/or in the questionnaire (n=7; 31.8%). The five remaining cases comprised a control group without oropharyngeal dysphagia. In all cases of abnormalities on fiberoptic endoscopic evaluation of swallowing, there was premature bolus leakage into the pharynx. There was no statistically significant difference between the groups regarding any of the pharyngoesophageal manometry measurements, age, or severity of obstructive sleep apnea. ConclusionPharyngoesophageal manometry detected no statistically significant difference between the groups with and without oropharyngeal dysphagia.

Male sexual function can be maintained without aromatization: randomized placebo-controlled trial of dihydrotestosterone (DHT) in healthy, older men for 24 months.

Male sexual function is highly androgen dependent but whether aromatization of testosterone (T) to estradiol is required remains contentious. This study aims to investigate the effects of selective estrogen deficiency induced by a nonaromatizable androgen, dihydrotestosterone (DHT), on sexual function of healthy middle-aged and older men. Randomized clinical trial of daily transdermal DHT (70 mg) or placebo gel treatment in 114 healthy middle-aged and older (>50 years, mean 60.5 years) men without known prostate disease maintaining selective estrogen deficiency for 24 months. The end points were responses to a psychosexual and mood questionnaire completed before, at 3 months, then at 6 monthly intervals during and 3 months after study. Data were analyzed by mixed model analysis of variance for repeated measures using age and body mass index (BMI) as covariates and including interactions of treatment with age and time-on-study. DHT treatment increased serum DHT with complete suppression of serum T, luteinizing hormone, follicle stimulating hormone, and estradiol throughout the 24-month study resulting in reduced spinal bone density. There were no spontaneous complaints, or discontinuations for, adverse effects on sexual function during the study. DHT administration had no effects on any of 33 measures of sexual function and mood, apart from a mild, but significant decrease in overall sexual desire, which was reversible after cessation of treatment. Increasing age and less often increasing BMI were associated with significant decreases in most aspects of sexual function. We conclude that aromatization plays only a minimal role in maintenance of sexual function in healthy eugonadal middle-aged or older men, but age and obesity are significantly associated with decreases in most aspects of self-reported sexual function and satisfaction. The dependence of male sexual function on aromatization may be conditional on age and obesity and can be overcome by a nonaromatizable androgen.

Patient-, health worker-, and health facility-level determinants of correct malaria case management at publicly funded health facilities in Malawi: results from a nationally representative health facility survey

BackgroundPrompt and effective case management is needed to reduce malaria morbidity and mortality. However, malaria diagnosis and treatment is a multistep process that remains problematic in many settings, resulting in missed opportunities for effective treatment as well as overtreatment of patients without malaria.MethodsPrior to the widespread roll-out of malaria rapid diagnostic tests (RDTs) in late 2011, a national, cross-sectional, complex-sample, health facility survey was conducted in Malawi to assess patient-, health worker-, and health facility-level factors associated with malaria case management quality using multivariate Poisson regression models.ResultsAmong the 2,019 patients surveyed, 34% had confirmed malaria defined as presence of fever and parasitaemia on a reference blood smear. Sixty-seven per cent of patients with confirmed malaria were correctly prescribed the first-line anti-malarial, with most cases of incorrect treatment due to missed diagnosis; 31% of patients without confirmed malaria were overtreated with an anti-malarial. More than one-quarter of patients were not assessed for fever or history of fever by health workers. The most important determinants of correct malaria case management were patient-level clinical symptoms, such as spontaneous complaint of fever to health workers, which increased both correct treatment and overtreatment by 72 and 210%, respectively (p < 0.0001). Complaint of cough was associated with a 27% decreased likelihood of correct malaria treatment (p = 0.001). Lower-level cadres of health workers were more likely to prescribe anti-malarials for patients, increasing the likelihood of both correct treatment and overtreatment, but no other health worker or health facility-level factors were significantly associated with case management quality.ConclusionsIntroduction of RDTs holds potential to improve malaria case management in Malawi, but health workers must systematically assess all patients for fever, and then test and treat accordingly, otherwise, malaria control programmes might miss an opportunity to dramatically improve malaria case management, despite better diagnostic tools.

Sleep in children with high functioning autism: polysomnography, questionnaires and diaries in a non-complaining sample

Sleep disorders in children with autism are frequently reported on questionnaires filled by parents. The aim of this study was to characterize sleep using objective and subjective measures in the same sample of autistic children without comorbidities and no primary complaints of sleep disorders. Eleven autistic children (10.3 ± 2.2 years) diagnosed with ADI-R and ADOS criteria and 13 typically-developing children (10.2 ± 2.0 years) were recruited. Exclusion criteria comprised the use of psychotropic medication, a full IQ lower than 75, a history of epilepsy and spontaneous complaints of sleep disorders from the parents. After their children were recruited, parents filled a sleep diary for 2 weeks and the Child Sleep Habit Questionnaire (CSHQ); children were then recorded for 2 consecutive nights in a sleep laboratory. Sleep stages of night 2 were scored according to Rechtschaffen and Kales (1968) using 20 s. epochs. Stage 2 sleep spindles and K-complexes were visually scored on bilateral prefrontal and central electrodes; REM sleep rapid eye movements were also scored. Variables were log transformed when abnormally distributed. Groups were compared using t -tests for independent samples. Sleep diaries showed a longer sleep latency in autistic children (43.6 ± 39.0 mn vs. 17.2 ± 17.5 mn, p = .037). The CSHQ showed no significant group differences. Polysomnographically recorded sleep latency was longer in autistic children (33.0 ± 8.3 min vs. 14.4 ± 4.6 min, p = .023), the duration of stages 3 and 4 (slow-wave sleep: SWS) was shorter (18.2 ± 3.2% vs 23.6 ± 5.7%; p = .009) but total sleep time was similar (539.7 ± 54.3 vs. 560.8 ± 60.2; p = .94). Sleep spindle density (per hour of Stage 2) was similar in both groups at central electrodes and Fp1 but it was lower at Fp2 (119.2 ± 97.7 vs. 225.5 ± 122.2, p = .03). The density of K-complexes was lower at the four electrodes (.0001 < p < .01). REM sleep parameters (latency, duration, distribution, eye movement density) were not different between groups. These results show that autistic children without subjectively reported sleep difficulties according to the CSHQ show signs of poor sleep on sleep diaries and polysomnography. Sleep diaries disclosed longer sleep latencies. Most polysomnographic differences were in nonREM sleep, raising the hypothesis of a difficulty for autistics to synchronize their cortical activity, possibly leading to impaired cortical sleep protective mechanisms such as sleep spindles and K-complexes. Canadian Institute for Health Research; ”Fonds de recherche du Québec – Santé”.