The Multiple Sclerosis impact Profile (MSIP). Development and testing psychometric properties of an ICF-based health measure

PURPOSE: The aim of this study was to develop and test the structure of the Multiple Sclerosis Impact Profile (MSIP), and to evaluate its reliability and validity within a large group of MS patients. METHOD: Data were obtained from a postal survey of 377 patients attending the Groningen MS centre of the university hospital and 153 patients from the MS patients' association. RESULTS: Factor analysis showed that the MSIP comprised domains representing the four components of the International Classification (ICF). The body functions component comprised two factors, which we divided into three scales: 'muscles and muscle movement functions' (MMF), 'excretion and reproductive functions' (ERF) and 'mental functions' (MF). The activities component comprised one factor, which we divided into two scales: 'basic movement functions' (BMF) and 'activities of daily living' (ADL). The participation component comprised one factor: 'participation in life situations' (PLS). The environmental factors component comprised one factor: 'environmental factors' (EF). Four clinically relevant 'symptom' items were added to the questionnaire as single items. The MISP scales yielded sufficient to good internal consistency coefficients. Analysis of the convergent, divergent and known-groups validity indicated that the MSIP measures the physical, psychological and social impact of MS and discriminates between categories of course of disease and disease severity. CONCLUSION: The MSIP seems to be a reliable and valid ICF-based outcome measure that covers a broad range of clinically relevant aspects of health. ICF can play an important role in measurement development and improvement of a unified and standard language in clinical practice and research.     

ChAd63-MVA–vectored Blood-stage Malaria Vaccines Targeting MSP1 and AMA1: Assessment of Efficacy Against Mosquito Bite Challenge in Humans

The induction of cellular immunity, in conjunction with antibodies, may be essential for vaccines to protect against blood-stage infection with the human malaria parasite Plasmodium falciparum. We have shown that prime-boost delivery of P. falciparum blood-stage antigens by chimpanzee adenovirus 63 (ChAd63) followed by the attenuated orthopoxvirus MVA is safe and immunogenic in healthy adults. Here, we report on vaccine efficacy against controlled human malaria infection delivered by mosquito bites. The blood-stage malaria vaccines were administered alone, or together (MSP1+AMA1), or with a pre-erythrocytic malaria vaccine candidate (MSP1+ME-TRAP). In this first human use of coadministered ChAd63-MVA regimes, we demonstrate immune interference whereby responses against merozoite surface protein 1 (MSP1) are dominant over apical membrane antigen 1 (AMA1) and ME-TRAP. We also show that induction of strong cellular immunity against MSP1 and AMA1 is safe, but does not impact on parasite growth rates in the blood. In a subset of vaccinated volunteers, a delay in time to diagnosis was observed and sterilizing protection was observed in one volunteer coimmunized with MSP1+AMA1—results consistent with vaccine-induced pre-erythrocytic, rather than blood-stage, immunity. These data call into question the utility of T cell-inducing blood-stage malaria vaccines and suggest that the focus should remain on high-titer antibody induction against susceptible antigen targets.     

Neurofeedback treatment in autism. Preliminary findings in behavioral,cognitive, and neurophysiological functioning

Effects of neurofeedback treatment were investigated in children with autism spectrum disorders (ASD). Sixty percent of the participants in the treatment group successfully reduced excessive theta power during neurofeedback treatment. Reduction of theta power was confirmed by pre- and post-QEEG measures. Parents of participants in the neurofeedback treatment group reported significant improvements in reciprocal social interactions and communication skills, relative to the parents of the control group. Set-shifting skills improved following neurofeedback treatment relative to the control group. The reduction of theta power is assumed to reflect modulation of activity in the anterior cingulate cortex (ACC), which is known to be involved in social and executive dysfunctions in autism.     

Diagnostic Accuracy of Xpert MTB/RIF for Extrapulmonary Tuberculosis Specimens: Establishing a Laboratory Testing Algorithm for South Africa

South Africa implemented Xpert MTB/RIF as the initial diagnostic test for pulmonary tuberculosis (TB). Xpert MTB/RIF''s accuracy for diagnosing extrapulmonary tuberculosis (EPTB) was investigated. EPTB specimens (n = 7,916) from hospitalized patients received over a 6-month period at a high-throughput TB referral laboratory in Johannesburg were investigated. Large-volume specimens were centrifuged, tissue biopsy specimens homogenized, and all specimens checked for growth of contaminating bacteria on blood agar. Contaminated samples received NALC-NaOH (N-acetyl-l-cysteine–sodium hydroxide) decontamination prior to liquid culture. Residual specimens (volumes > 1 ml) after inoculation of culture (n = 1,175) were tested using the Xpert MTB/RIF sputum protocol. Using culture as the reference, Xpert MTB/RIF''s overall sensitivity was 59% (95% confidence interval [95% CI], 53% to 65%) and specificity was 92% (CI, 90% to 94%), with the highest sensitivities of 91% (95% CI, 78% to 97%) for pus, 80% (95% CI, 56% to 94%) for lymph node aspirates, and 51% (95% CI, 44% to 58%) for fluids (ascitic, 59%; pleural, 47%). A difference in sensitivities was noticed between specimens classified as having a thick (87% [95% CI, 76% to 94%]) versus clear (watery) (48% [95% CI, 36% to 61%]) appearance. This was unchanged with traces of blood (52% [95% CI, 44% to 60%]) or precentrifugation (57% [95% CI, 28% to 82%]) among clear specimens. Xpert MTB/RIF generated an additional 124 specimen results that were contaminated by Mycobacterial Growth Indicator Tubes (MGIT; 10.5%) and diagnosed rifampin (RIF) resistance earlier (9.6% [25/260]). Xpert MTB/RIF''s performance on EPTB specimens provides very promising results and should be considered for incorporation into national TB guidelines. Xpert MTB/RIF is less affected by contaminating bacteria and reduces laboratory labor and diagnostic delay compared to traditional methods.     

Are the outcomes of clinical pathways evidence‐based? A critical appraisal of clinical pathway evaluation research

Aim and objective To evaluate the validity of study outcomes of published papers that report the effects of clinical pathways (CP). Method Systematic review based on two search strategies, including searching Medline, CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of Knowledge^SM. We included randomized controlled or quasi‐experimental studies evaluating the efficacy of clinical pathway application. Assessment of the methodological quality of the studies included randomization, power analysis, selection bias, validity of outcome indicators, appropriateness of statistical tests, direct (matching) and indirect (statistical) control for confounders. Outcomes included length of stay, costs, readmission rate and complications. Two reviewers independently assessed the methodological quality of the selected papers and recorded the findings with an evaluation tool developed from a set of items for quality assessment derived from the Cochrane Library and other publications. Results The study sample comprised of 115 publications. A total of 91.3% of the studies comprised of retrospective studies and 8.7% were randomized controlled studies. Using a quality‐scoring assessment tool, 33% of the papers were classified as of good quality, whereas 67% were classified as of low quality. Of the studies, 10.4% controlled for confounding by matching and 59.1% adopted parametric statistical tests without testing variables on normal distribution. Differences in outcomes were not always statistically tested. Conclusion Readers should be cautious when interpreting the results of clinical pathway evaluation studies because of the confounding factors and sources of contamination affecting the evidence‐based validity of the outcomes.