Cognitive behavioural therapy versus multidisciplinary rehabilitation treatment for patients with chronic fatigue syndrome: study protocol for a randomised controlled trial (FatiGo).

BACKGROUND: Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome. METHODS: One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments. DISCUSSION: The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77567702.

Chronic low back pain: physical training, graded activity with problem solving training, or both? The one-year post-treatment results of a randomized controlled trial.

Several treatment principles for the reduction of chronic low back pain associated disability have been postulated. To examine whether a combination of a physical training and an operant-behavioral graded activity with problem solving training is more effective than either alone in the long-term, a cluster randomized controlled trial was conducted. In total 172 patients, 18-65 years of age, with chronic disabling non-specific low back pain referred for rehabilitation treatment, were randomized in clusters of four consecutive patients to 10 weeks of aerobic training and muscle strengthening of back extensors (active physical treatment; APT), 10 weeks of gradual assumption of patient relevant activities based on operant-behavioral principles and problem solving training (graded activity plus problem solving training; GAP), or APT combined with GAP (combination treatment; CT). The primary outcome was the Roland Disability Questionnaire adjusted for centre of treatment, cluster, and baseline scores. Secondary outcomes were patients' main complaints, pain intensity, self-perceived improvement, depression and six physical performance tasks. During the one-year follow-up, there were no significant differences between each single treatment and the combination treatment on the primary outcome, the Roland Disability Questionnaire. Among multiple other comparisons, only one significant difference emerged, with GAP and APT showing higher self-perceived improvement than CT. We conclude that the combination treatment integrating physical, graded activity with problem solving training is not a better treatment option for patients with chronic low back pain.

Disuse and physical deconditioning in the first year after the onset of back pain.

For years, physical deconditioning has been thought to be both a cause and a result of back pain. As a consequence physical reconditioning has been proposed as treatment-goal in patients with chronic low back pain (LBP). However, it is still unclear whether a patient's physical fitness level really decreases after pain-onset. The objectives of the present study were, firstly, to test the assumption that long-term non-specific LBP leads to a decrease of the level of physical activity (disuse), secondly, to evaluate any development of physical deconditioning as a result of disuse in CLBP, and thirdly, to evaluate predictors for disuse in CLBP. A longitudinal cohort study over one year including 124 patients with sub-acute LBP (i.e., 4-7 weeks after pain onset) was performed. Main outcome measures were change in physical activity level (PAL) and physical fitness (measured by changes in body weight, body fat and muscle strength) over one year. Hypothesized predictors for disuse were: pain catastrophizing; fear of movement; depression; physical activity decline; the perceived level of disability and PAL prior to pain. Results showed that only in a subgroup of patients a PAL-decrease had occurred after the onset of pain, whereas no signs of physical deconditioning were found. Negative affect and the patients' perceived physical activity decline in the subacute phase predicted a decreased level of PAL over one year. Based on these results, we conclude that as to the assumption that patients with CLBP suffer from disuse and physical deconditioning empirical evidence is still lacking.

Is there any role for allergen avoidance in the primary prevention of childhood asthma?

In this article we discuss 3 hypotheses to attempt to understand why preventive measures thus far studied with the aim of preventing (or delaying) the development of asthma have shown such disappointing results. The most likely explanation is that the development of a multifactorial disease, such as asthma, is extremely difficult, if not impossible, to prevent by eliminating only one risk factor. In a meta-analysis we investigated the effect of a multifaceted and monofaceted intervention in 10 prospective birth cohorts of a total of 3473 children on a diagnosis of asthma. Multifaceted intervention studies had an odds ratio (OR) of 0.73 (95% CI, 0.55-0.97), whereas the monointervention studies had an OR of 1.22 (95% CI, 0.83-1.78) in patients younger than 5 years and an OR of 0.52 (95% CI, 0.32-0.84) versus 0.93 (95% CI, 0.66-1.31) in patients older than 5 years. We therefore hypothesize that studies with a multifaceted approach will have a much greater chance of being successful than studies using a monofaceted approach, with the latter being unlikely to yield a clinically relevant reduction of asthma.

Impact of accessible sexual and reproductive health care on poor and underserved adolescents in Managua, Nicaragua: a quasi-experimental intervention study.

BACKGROUND: The objective of this study was to evaluate a competitive voucher program intended to make sexual and reproductive health care (SRHC) accessible to adolescents from disadvantaged areas of Managua. METHODS: A quasi-experimental intervention study was performed in which 28,711 vouchers that gave free access to SRHC in 20 health centers, were distributed to adolescents. To evaluate the impact, community sampling took place in markets, neighborhoods, and outside schools where self-administered questionnaires were distributed. The study comprised a random sample of 3,009 female adolescents, ages 12 to 20 years old, 904 voucher receivers and 2,105 nonreceivers. Their use of SRHC, and knowledge and use of contraceptives and condoms were measured. RESULTS: Voucher receivers had a significantly higher use of SRHC compared with nonreceivers, 34% versus 19% (adjusted odds ratio, 3.1; 95% confidence interval, 2.5-3.8). The highest influence was seen among respondents at schools, where use was 24% relative to 6% in nonreceivers (adjusted odds ratio, 5.9; 95% confidence interval, 3.7-9.5). Voucher receivers answered significantly more questions correctly that were related to knowledge of contraceptives and sexually transmitted infections than nonreceivers. At schools, sexually active voucher receivers had a significantly higher use of modern contraceptives than nonreceivers, 48% versus 33% (adjusted odds ratio, 2.3; 95% confidence interval, 1.2-4.4); and in neighborhoods, condom use during last sexual contact was significantly greater among voucher receivers than nonreceivers (adjusted odds ratio, 2.5; 95% confidence interval, 1.4-4.5). CONCLUSION: The voucher program succeeded in increasing access to SRHC for poor and underserved girls. The needs of adolescents were met with a relatively simple intervention through existing health facilities. Many adolescents appeared willing to protect themselves against the risks of sexual intercourse. This suggest that access to SRHC can play an important role in changing youth behavior and increase the use of contraceptives and condoms.

The costs of epilepsy in three different populations of patients with epilepsy.

The purpose of this study was to estimate the costs of care in three different populations of patients with epilepsy (general practices (GP), University Hospital (UH), and Epilepsy Center (EC)), and to analyse the distribution of costs by type of services for each patient group. A cost diary was developed to obtain prospective information on epilepsy-attributable service use over a period of 3 months. Similar information over the previous 3 months was obtained from a cost questionnaire. In addition, a quality of life inventory (QOLIE-31) was used. Standard cost lists were applied for the valuation of the direct cost items. A sensitivity analysis was performed for certain cost items for which no reliable data were available. One hundred and sixteen patients with established epilepsy were included, and the mean costs per patient per month (in Euros) ranged from 52.08 to 357.63. Patients from GP appeared to have lower direct costs, spent less time in seeking or undergoing a treatment, and reported lower seizure frequencies and less severe seizure types than the patients from the other patient groups. Patients from the EC reported the highest productivity changes and unemployment rates and also had the lowest scores on the QOLIE-31. The cost items anti-epileptic drugs, hospital services, unpaid care, and transportation accounted for the majority of the total direct costs.

Environmental exposure reduction in high-risk newborns: where do we start?

BACKGROUND: When analyzing the effect of environmental exposure reduction measures on asthma in high-risk children, one must know how far asthmatic families already have applied such measures, because this would affect the effectiveness and efficiency of interventions aimed at reducing environmental exposure. OBJECTIVE: To describe the room for improvement by asthmatic families in mite, pet, and food allergen reducing measures and in parental passive smoking and to determine the resulting levels of mite and pet allergens by the applied sanitation measures. METHODS: Data were sampled by observation, weekly diary entries, and questionnaire when the infant was 6 months old and 1 year old. Dust samples were collected by vacuuming the living room floor and the parental and infant mattresses. Multiple logistic regression analyses were applied with the use of mattress encasing, having a smooth floor covering, having pets, exclusive breast-feeding and/or hypoallergenic formula during the infant's first 6 months, and passive smoking as the dependent variables. RESULTS: Frequencies of applied measures were as follows: having a smooth floor covering, 36%; daily house cleaning, 27%; use of parental and infant antimite mattress encasings, 13% and 9%, respectively; keeping no pets, 66%; no cow's milk-based regular formula, 13%; no solid foods in the first 6 months of life, 28%; and abstinence of smoking by the mother prenatally, 89%; by the mother postnatally, 85%; and by her partner, 76%. Having a smooth floor covering and daily cleaning but not use of antimite mattress encasings resulted in significantly lower mite and pet allergen levels. CONCLUSIONS: There is (still) enough room for improvement to reduce exposure to inhalant and food allergens, especially by application of mattress encasings, exclusive breast-feeding and/or hypoallergenic formula feeding, and postponing the time until first solids are given.

The diagnosis of epileptic and non-epileptic seizures.

The aim of this prospective population-based study was to systematically define a cluster of diagnostic items which can assist in the early identification and classification of epileptic and non-epileptic seizures. A cohort of patients aged > or =14 years, suspected with a first epileptic seizure, were included in this study. A team of neurologists evaluated and classified all cases. Diagnostic items for epileptic and non-epileptic seizures were identified using logistic regression analysis. Three hundred and fifty cases entered this study. Distinctive features for epileptic seizures were postictal confusion (OR 0.09), an epileptiform EEG pattern (OR 0.02), and abnormal neuroimaging findings (OR 0.07), whereas for non-epileptic seizures of organic origin there was a history of hypertension (OR 7.5), and provoking factors (OR 13.4) such as exercise and warmth. Diagnostic items for seizures of non-organic origin were a history of febrile seizures (OR 5.8), treatment by a psychologist or psychiatrist (OR 9.1), and presentiment of the seizure (OR 3.7) such as a feeling of choking and palpitations. A separate analysis for the patients who were systematically investigated provided some additional diagnostic items for the different subgroups of patients. For instance, back arching during the seizure for the patients with seizures of non-organic origin and female sex for the patients with non-epileptic seizures of organic origin.