Reliability, construct and concurrent validity of a smartphone-based cognition test in multiple sclerosis.

BACKGROUND: Early detection and monitoring of cognitive dysfunction in multiple sclerosis (MS) may be enabled with smartphone-adapted tests that allow frequent measurements in the everyday environment. OBJECTIVES: The aim of this study was to determine the reliability, construct and concurrent validity of a smartphone-adapted Symbol Digit Modalities Test (sSDMT). METHODS: During a 28-day follow-up, 102 patients with MS and 24 healthy controls (HC) used the MS sherpa® app to perform the sSDMT every 3 days on their own smartphone. Patients performed the Brief International Cognitive Assessment for MS at baseline. Test-retest reliability (intraclass correlation coefficients, ICC), construct validity (group analyses between cognitively impaired (CI), cognitively preserved (CP) and HC for differences) and concurrent validity (correlation coefficients) were assessed. RESULTS: Patients with MS and HC completed an average of 23.2 (SD = 10.0) and 18.3 (SD = 10.2) sSDMT, respectively. sSDMT demonstrated high test-retest reliability (ICCs > 0.8) with a smallest detectable change of 7 points. sSDMT scores were different between CI patients, CP patients and HC (all ps < 0.05). sSDMT correlated modestly with the clinical SDMT (highest r = 0.690), verbal (highest r = 0.516) and visuospatial memory (highest r = 0.599). CONCLUSION: Self-administered smartphone-adapted SDMT scores were reliable and different between patients who were CI, CP and HC and demonstrated concurrent validity in assessing information processing speed.

Performance validity in outpatients with multiple sclerosis and cognitive complaints.

BACKGROUND: Suboptimal performance during neuropsychological assessment renders cognitive test results invalid. However, suboptimal performance has rarely been investigated in multiple sclerosis (MS). OBJECTIVES: To investigate potential underlying mechanisms of suboptimal performance in MS. METHODS: Performance validity testing, neuropsychological assessments, neuroimaging, and questionnaires were analyzed in 99 MS outpatients with cognitive complaints. Based on performance validity testing patients were classified as valid or invalid performers, and based on neuropsychological test results as cognitively impaired or preserved. Group comparisons and correlational analyses were performed on demographics, patient-reported, and disease-related outcomes. RESULTS: Twenty percent displayed invalid performance. Invalid and valid performers did not differ regarding demographic, patient-reported, and disease-related outcomes. Disease severity of invalid and valid performers with cognitive impairment was comparable, but worse than cognitively preserved valid performers. Lower performance validity scores related to lower cognitive functioning, lower education, being male, and higher disability levels (p < 0.05). CONCLUSION: Suboptimal performance frequently occurs in patients with MS and cognitive complaints. In both clinical practice and in cognitive research, suboptimal performance should be considered in the interpretation of cognitive outcomes. Identification of factors that differentiate between suboptimal and optimal performers with cognitive impairment needs further exploration.

Neuroprotective effects of exercise in people with progressive multiple sclerosis (Exercise PRO-MS): study protocol of a phase II trial.

BACKGROUND: Neurodegeneration, rather than inflammation, plays a key role in the progressive phase of multiple sclerosis (MS). Current disease modifying treatment options for people with progressive MS (PMS) do not specifically target neurodegeneration. Preliminary evidence suggests that exercise therapy might have neuroprotective effects. However, neuroprotective effect studies of exercise interventions in PMS are scarce and the possible mode of action underlying neuroprotective effects of exercise are unknown and need to be elucidated. The main aim of this phase II trial is to assess whether progressive resistance training (PRT) and high intensity interval training (HIIT), can slow down neurodegeneration in people with PMS. METHODS: In a single-blinded phase II clinical trial with an extended baseline period, 60 people with PMS will be randomly assigned to PRT or HIIT. The participants should have had a relapse onset of MS with confirmed disease progression, however still ambulatory. The duration of the study is 48 weeks, consisting of 16 weeks baseline period (no intervention), 16 weeks intervention and 16 weeks follow-up. Patient-tailored training will be performed 3 times per week for one hour in groups, led by an experienced physiotherapist. The primary outcome measure is neurodegeneration, measured as whole brain atrophy on magnetic resonance imaging (MRI). Secondary outcome parameters will include other biomarkers associated with neurodegeneration (i.e. regional brain atrophy, lesion load, white matter integrity, resting state functional connectivity, blood biomarkers (brain derived neurotrophic factor (BDNF) and serum neurofilament light (sNFL)), patient functioning (physical and cognitive) and cardiovascular risk factors. DISCUSSION: Besides the primary outcome measures, this study will examine a large variety of biomarkers associated with neurodegeneration after an exercise intervention. Combining outcome parameters may help to elucidate the mode of action underlying neuroprotective effects of exercise. TRIAL REGISTRATION: This trial is prospectively registered at the Dutch Trial Registry (number NL8265, date 06-01-2020).

Influence of personalized extended interval dosing on the natalizumab wearing-off effect - a sub-study of the NEXT-MS trial.

BACKGROUND AND OBJECTIVES: Wearing-off symptoms during natalizumab treatment in multiple sclerosis are characterized by an increase of MS-related symptoms prior to natalizumab administration. The influence of extended interval dosing (EID) on wearing-off symptoms are important to consider, as this might cause hesitancy in initiating or continuing EID. METHODS: Participants of the NEXT-MS trial, in which treatment intervals are adjusted based on drug concentrations, were divided into two groups: an extended group containing participants with at least one week of additional interval extension, and a group with a fixed interval during the trial (range 4-7 weeks). Changes in the occurrence, frequency, onset, and severity of wearing-off symptoms were evaluated. RESULTS: 255 participants were included (extended group n = 171, fixed group n = 84). The odds on occurrence of wearing-off symptoms in the extended group did not increase after extending the treatment interval. Additional analyses for frequency, onset, and severity of wearing-off symptoms showed no changes over time. Mean decrease in natalizumab drug concentration did not influence the frequency of wearing-off symptoms. DISCUSSION: Wearing-off symptoms were not reinforced by further extending the natalizumab interval. Wearing-off symptoms might increase in a minority of patients after EID, although our data support the view that wearing-off symptoms appear to be unrelated to the decrease in natalizumab trough drug concentrations.

Removal of valproic acid by plasmapheresis in a patient treated for multiple sclerosis.

We present a case of a patient with multiple sclerosis who was treated with plasmapheresis and valproic acid. We used therapeutic drug monitoring to determine whether plasma concentrations of valproic acid were kept within the therapeutic window and to determine the amount of valproic acid that was removed by plasmapheresis.

Introducing Multiple Screener: An unsupervised digital screening tool for cognitive deficits in MS.

BACKGROUND: Cognitive deficits affect up to 70% of all patients with Multiple Sclerosis (MS) and have a significant impact on quality of life. Cognitive assessments need to be performed by a neuropsychologist and are often time-consuming, hampering timely identification and adequate monitoring of cognitive decline in MS. OBJECTIVE: To develop a time-efficient, unsupervised, digital tool to screen for cognitive deficits in MS. METHODS: A digital (adjusted) version of the Brief International Cognitive Assessment for MS, including the Symbol Digit Modalities Test (SDMT, information processing speed), the California Verbal Learning Test (CVLT-II, verbal memory) and the Spatial Recall Test (SPART, visuospatial memory) was developed: Multiple Screener (intellectual property of Sanofi Genzyme). Firstly, the clarity and feasibility of the tool was confirmed by 16 patients with MS (mean age 50.9 years (SD 9.4, range 37-68). Next, in 60 healthy controls (HCs, mean age 44.5 years (SD 14.0, range 18-67), intraclass correlation coefficients (ICC) were calculated to describe how strongly the digital version resembled the paper and pencil-based assessment. Finally, 236 HCs (mean age 42.8 years (SD 12.8, range 18-69) were included to obtain norm scores for each test. RESULTS: ICCs between digital and paper and pencil-based assessment were excellent to good (SDMT (ICC 0.79, confidence interval (CI) 0.67-0.87); CVLT-II (ICC 0.77, CI 0.64-0.85); SPART (ICC 0.61, CI 0.42-0.75)). For each test, a regression-based correction for the effect of age was applied on the raw scores before converting them to norm Z-scores. Additionally, the SDMT scores needed correction for education and the CVLT-II for education and sex (subgroups were created). CONCLUSIONS: Performance on an adjusted, digital version of the BICAMS correlates highly with the standard paper-and-pencil based test scores in HCs. Multiple Screener is an unsupervised, digital tool, with available norm scores, ultimately allowing for easy monitoring of cognitive decline in patients with MS.

Acute-phase responsiveness of mannose-binding lectin in community-acquired pneumonia is highly dependent upon MBL2 genotypes.

Mannose-binding lectin (MBL) is a pattern recognition receptor of the complement system and plays an important role in innate immunity. Whether or not MBL acts as an acute-phase response protein in infection has been an issue of extensive debate, because MBL responses have shown a high degree of heterogeneity. Single nucleotide polymorphisms (SNPs) in the promoter (wild-type Y versus X) and exon 1 (A versus 0) of the MBL2 gene can lead to MBL deficiency. This study investigated the influence of SNPs in the promoter and exon 1 of the MBL2 gene on the acute-phase responsiveness of MBL in 143 patients with community-acquired pneumonia. Acute-phase reactivity was observed only in MBL-sufficient genotypes (YA/YA, XA/YA, XA/XA and YA/0). In patients with wild-type exon 1 genotype A/A, positive acute-phase responses were associated with the presence of the YA haplotype and negative responses with its absence. Genotypes YA/0 and XA/XA produced equal levels of MBL in convalescence. In the acute phase, however, patients with genotype XA/XA displayed negative acute-phase responses more often than those with genotype YA/0. Correlation of MBL and C-reactive protein levels in the acute phase of pneumonia also depended upon the MBL2 genotype. In conclusion, acute-phase responsiveness of MBL was highly dependent upon the MBL2 genotype. These data suggest that heterogeneity in protein responses in the acute phase of disease should always be viewed in the light of possible influences of genetic differences in both structural and regulatory parts of the gene.

Recommendations for the successful control of a large outbreak of vancomycin-resistant Enterococcus faecium in a non-endemic hospital setting.

BACKGROUND: A large outbreak of three epidemic vancomycin-resistant Enterococcus faecium (VRE) clones affected the study hospital for almost two years. AIM: To describe the strategy to successfully control this outbreak and eradicate VRE from the study hospital. METHODS: Infection control interventions started after detection of VRE in three patients. Hospital-wide surveillance was started after ongoing transmission despite isolation precautions, cleaning and contact tracing. Hygiene education and discipline were enhanced. Despite these interventions, additional measures were required to control the outbreak, such as ward disinfection with hydrogen peroxide vapour and the introduction of a VRE quarantine ward. Ultimately, ciprofloxacin prophylaxis for haematological patients on chemotherapy was abandoned. FINDINGS: Over a 22-month period, 242 VRE carriers were identified. Of these, 128 (53%) patients were detected by hospital-wide surveillance alone. Three epidemic clones were detected: ST494-vanA (N = 160), ST78-vanA (N = 23) and ST117-vanB (N = 32). In total, 5614 possible contacts were identified. VRE transmission occurred on 13 out of 23 wards. VRE was cultured from clinical specimens in 22 patients (seven with bacteraemia). Since January 2014, no further transmission of these VRE clones has been observed. CONCLUSION: Infection control measures according to international guidelines were insufficient to expose the outbreak to its full extent and control it. Its full extent only became apparent after sustained hospital-wide screening. Successful control of this hospital-wide VRE outbreak was feasible, but required great effort. Final containment and eradication of the epidemic clones was achieved by environmental decontamination with hydrogen peroxide vapour, strict isolation precautions, a VRE quarantine ward and antimicrobial stewardship.

Citrulline is an essential constituent of antigenic determinants recognized by rheumatoid arthritis-specific autoantibodies.

Only a few autoantibodies that are more or less specific for RA have been described so far. The rheumatoid factor most often tested for is not very specific for RA, while the more specific antiperinuclear factor for several reasons is not routinely used as a serological parameter. Here we show that autoantibodies reactive with synthetic peptides containing the unusual amino acid citrulline, a posttranslationally modified arginine residue, are specifically present in the sera of RA patients. Using several citrulline-containing peptide variants in ELISA, antibodies could be detected in 76% of RA sera with a specificity of 96%. Sera showed a remarkable variety in the reactivity pattern towards different citrulline-containing peptides. Affinity-purified antibodies were shown to be positive in the immunofluorescence-based antiperinuclear factor test, and in the so-called antikeratin antibody test, and were reactive towards filaggrin extracted from human epidermis. The specific nature of these antibodies and the presence of these antibodies early in disease, even before other disease manifestations occur, are indicative for a possible role of citrulline-containing epitopes in the pathogenesis of RA.

Pneumococcal conjugate vaccination response in patients after community-acquired pneumonia, differences in patients with S. pneumoniae versus other pathogens.

OBJECTIVES: The goal of this study is to investigate the immune response to the 13-valent pneumococcal conjugate vaccine (PCV13) in former pneumococcal CAP patients. We hypothesize that an impaired or suboptimal humoral immune response against (specific) pneumococcal serotypes might explain the vulnerability for pneumococcal disease. METHODS: Hospitalised adult CAP patients who participated in two trials (2004-2006 (n=201) and, 2007-2009 (n=304)) were screened. Patients eligible for inclusion had CAP caused by either S. pneumoniae (pneuCAP) or due to another well-defined pathogen (otherCAP). Serotype-specific pneumococcal antibody concentrations (total IgG and IgG2/IgG1) before and 3-4weeks after PCV13 administration were measured (Luminex) and compared between pneuCAP and otherCAP patients. RESULTS: We vaccinated 60 patients:i.e. 34 pneuCAP and 26 otherCAP patients. In the pneuCAP group, 74% of patients were categorized as good responders (≥9/13 serotypes with concentration≥1300ng/ml), versus 77% in the otherCAP group. Significantly fewer full responders (i.e. 13/13 serotypes with a concentration≥1300ng/mL) were identified in the pneuCAP group (15% vs 42% respectively, p=0.02). For serotype 1, total IgG and IgG2/IgG1 subset post-vaccination concentrations were significantly lower among pneuCAP patients. Our additional case-series showed that of 16 pneuCAP patients who were infected by a serotype included in PCV13 three patients did not respond against the serotype originally responsible for their CAP episode, including one former bacteraemic pneumococcal CAP patient who also failed to show a response against the serotype responsible for CAP during infection. Thirteen patients did respond to the previously infecting serotype following PCV13 including three patients who had bacteraemic pneumococcal pneumonia and did not show a response during infection against the serotype responsible for CAP. CONCLUSIONS: Our results confirm the immunogenic properties of PCV13 in former pneumococcal CAP patients including patients previously regarded as potential hyporesponders. A slightly diminished overall humoral response to polysaccharides characterizes the former pneumococcal CAP patients. ClinicalTrials.gov Identifier: NCT02141009.

Evidence for additional genetic risk indicators of relapse-onset MS within the HLA region.

BACKGROUND: Human leukocyte antigen (HLA)-DR2 carriership is associated with an increased risk for MS. Genome searches using microsatellite markers have consistently shown that additional genetic factors contribute to susceptibility for MS. OBJECTIVE: To identify loci within the HLA region that predispose to relapse-onset MS independently of HLA-DR2. METHOD: A case-control study involving 159 patients with definite relapse-onset MS and 273 control subjects was conducted. Six highly polymorphic microsatellite markers encoded within the HLA-C to DR region, that is, D6S1014, D6S273, TNFa, MIB, C1_2_5, and C1_3_2, three single-nucleotide tumor necrosis factor (TNF) promoter gene polymorphisms at positions -238, -308, and -376, and HLA-DR2 carriership were typed. RESULTS: These data confirmed the well-known association between the HLA-DR2 haplotype and relapse-onset MS, yielding an odds ratio (OR) of 3.6 (95% CI: 2.4 to 5.4; p < 0.0001). Multivariate analyses revealed that C1_3_2*354 was also associated with an increased risk for developing relapse-onset MS independently of HLA-DR2 (OR: 2.0; 95% CI: 1.2 to 3.1; p = 0.004). This allele is encoded within an ancestral haplotype that is highly linked to HLA-DR3. The joint effect of this ancestral haplotype and HLA-DR2 resulted in an OR of 8.7 (95% CI: 2.7 to 29; p < 0.0001) to develop relapse-onset MS. In addition, a protective risk factor was found: carriers of TNFa*107 had a 0.5-fold lower risk to develop relapse-onset MS (95% CI: 0.3 to 0.9; p = 0.026). CONCLUSION: Within the HLA region, other loci besides HLA-DR2 haplotype modulate susceptibility for relapse-onset MS.

Screening for autoantibodies to the nucleolar U3- and Th(7-2) ribonucleoproteins in patients' sera using antisense riboprobes.

In this study we report the detection of autoantibodies to the nucleolar U3- and Th(7-2) ribonucleoprotein (RNP) particles in sera from patients with connective tissue diseases. The method described employs radioactively labelled antisense U3- and Th RNA which are hybridized to immunoprecipitated U3- or Th RNA from a HeLa cell extract. Of the 66 sera that were screened with this method seven sera (11%) precipitated only Th RNP, 16 sera (24%) precipitated only U3 RNP and 4 sera (6%) precipitated both U3- and Th RNP. Both anti-U3 RNP and anti-Th RNP activity appeared to be mostly associated with scleroderma or scleroderma-associated diseases. Using this method we also showed that some of the Th RNP particles in a cell extract are associated with the La autoantigen. We conclude that for the identification of immunoprecipitated RNAs this method is very sensitive and provides unambiguous data.

The prognostic value of the antiperinuclear factor, anti-citrullinated peptide antibodies and rheumatoid factor in early rheumatoid arthritis.

OBJECTIVE: To study the prognostic value of the antiperinuclear factor (APF), determined by an indirect immunofluorescence test (IIF) and a recently developed anti-citrullinated cyclic peptide (CCP) ELISA, in combination with rheumatoid factor (RF) status, in early RA (< 1 year). METHODS: A total of 249 participants in a randomized trial of treatment strategies were divided into 4 groups according to their APF (or CCP) and RF status at baseline. Differences in disability, joint involvement and radiological damage over a 3-year period were analysed. RESULTS: APF-IIF results differed from CCP-ELISA in 42 cases (17%); 38 of the 42 had a positive IIF and negative ELISA value. Disability after 3 years did not differ significantly between the RF and APF groups. APF- patients had significantly lower Thompson joint scores compared to APF+ patients (6 vs 24 for CCP-ELISA; 2 vs 24 for IIF). RF+APF+ patients exhibited more radiological damage compared to RF-APF- patients. RF+APF- and RF-APF+ patients had intermediate scores. Within the RF+ and RF- groups, APF+ was associated with more radiological damage and thus yielded prognostic information in addition to RF. In this respect, the results of ELISA and IIF were comparable. Thirty percent of the RF+APF+ patients had a radiological score higher than 45, compared to 13% of the RF+APF-, none of the RF-APF+, and 2% of RF-APF- patients (p < 0.001). In addition, more large joints were affected in APF+ than in APF- patients, while no difference was observed between RF+ and RF- patients. CONCLUSION: APF has prognostic value in addition to RF for joint involvement and radiological damage in early RA. The CCP-ELISA technique for APF assessment may facilitate its use in clinical practice. However, the prognostic value of the two tests lies in their ability to predict mild disease. Reliable identification at baseline of individual patients with progressive disease is still not possible.

Shoulder disorders in general practice: prognostic indicators of outcome.

BACKGROUND: Shoulder pain is common in primary health care. Nevertheless, information on the outcome of shoulder disorders is scarce, especially for patients encountered in general practice. AIM: To study the course of shoulder disorders in general practice and to determine prognostic indicators of outcome. METHOD: For this prospective follow-up study, 11 Dutch general practitioners recruited 349 patients with new episodes of shoulder pain. The participants filled out a questionnaire at presentation and further ones after 1, 3, 6 and 12 months; these contained questions on the nature, severity and course of the shoulder complaints. The association between potential prognostic indicators and the status of shoulder complaints (absence or presence of symptoms) was evaluated after one and 12 months of follow-up. RESULTS: After one month, 23% of all patients showed complete recovery; this figure increased to 59% after one year. A speedy recovery seemed to be related to preceding overuse or slight trauma and early presentation. A high risk of persistent or recurrent complaints was found for patients with concomitant neck pain and severe pain during the day at presentation. CONCLUSION: A considerable number of patients (41%) showed persistent symptoms after 12 months. It may be possible to distinguish patients who will show a speedy recovery from those with a high risk of long-standing complaints by determining whether there is a history of slight trauma or overuse, an early presentation or an absence of concomitant neck pain.

On autonomy and participation in rehabilitation.

PURPOSE: To explore the concept of autonomy as a basis for social participation, with particular reference to rehabilitation. METHOD: A study of relevant literature from the field of rehabilitation, building on theory developed in other fields (ethics, social sciences), and deriving important concepts and strategies for rehabilitation practice. RESULTS: The focus of rehabilitation for people with a chronic disabling condition is shifting from a biomedical to a client-centred perspective. Conceptions of autonomy vary among individuals and cultures, but a crucial distinction can be made between decisional autonomy (the ability to make decisions without external restraint) and executional autonomy (the ability to act as one wishes). The liberal-individualist account of autonomy over-emphasizes physical independence and does not sufficiently recognize the inter-dependency of all people, including those with disabilities. An ethic of care, complementary to the principle of respect for autonomy, should guide the development of rehabilitation strategies to enhance individual autonomy and participation in daily living. For rehabilitation, this entails an attentive attitude, maximizing opportunities for informed choices, taking full account of each person's preferences, needs and social contexts. CONCLUSIONS: Autonomy is central to client-centred rehabilitation since it is a pre-requisite for effective participation. It is suggested that autonomy, conceived as a basis for participation, is the ultimate aim of rehabilitation.

Prescription pattern for orthoses in The Netherlands: use and experience in the ambulatory phase of Duchenne muscular dystrophy.

In the Netherlands ankle-foot orthoses (AFO), standing frames (SF), knee-ankle-foot orthoses (KAFO) and orthopaedic footwear are frequently prescribed for patients with Duchenne muscular dystrophy. Little is known, however, about the prescription pattern and the experience of patients. A questionnaire was sent to 25 rehabilitation physicians treating 53 patients with Duchenne muscular dystrophy. The use of orthoses and the patients' experience was measured during 1 year of follow-up. Our results show prescription of AFO 91%, of SF 61% and of KAFO 22%. Indications were limited passive dorsiflexion and Vignos classification 6. Patient-related factors were reasons to discontinue or to refrain from using orthoses. The prescribed duration for KAFO varied greatly. Patients' experience scores for SF and KAFO were high. The time that the orthoses were worn differed greatly from the recommended time. Ready-made shoes were prescribed for equinovarus during ambulation. Similarly, ready-made shoes or custom-made shoes were advised for wheelchair-dependent patients. This study shows no uniform prescription pattern for AFO, SF. KAFO and orthopaedic footwear. The prescription pattern was influenced by patient-related factors and actual use greatly differed from the recommended time.

Orthopaedic sequelae in neurologically recovered obstetrical brachial plexus injury. Case study and literature review.

PURPOSE: Description of shoulder sequelae in obstetrical brachial plexus injury (OBPI) patients who had spontaneous functional recovery, in the context of historical and current conservative methods of treatment. METHOD: Case study of a baby with serious complications, followed by a review of the literature from 1900 until 2001 about conservative treatment of OBPI with respect to the prevention of shoulder complications. RESULTS: Description of contractures and bony deformities did not show important discrepancies over time, other than more detailed images because of new technical possibilities. There is no agreement on the explanation of the development of these deformities. Secondary changes caused by muscular imbalance and longstanding contracture are recognized by all authors. A primary osteoarticular lesion was recognized as a possible cause in the beginning of the twentieth century, then forgotten for a long time and only in the 1980s had gained interest again. The main change in treatment concerns the use of arm braces. This was strongly recommended in the first half of the twentieth century, then advised against and is at this moment not anymore mentioned. CONCLUSIONS: There is no consensus on the cause of contractures and bony deformities in children with OBPI. Conservative methods of treatment have changed over the years, without research on the outcome of these treatment changes.

Handicap questionnaires: what do they assess?

BACKGROUND AND PURPOSE: There is an increasing need to get insight into the social and societal impact of chronic conditions on a person's life, i.e. person-perceived handicap. The purpose of this study is to report how current handicap questionnaires assess handicap. METHOD: A literature search using both Medline and the database of the Dutch Institute of Allied Health Professions (NPi) was conducted for handicap questionnaires. Questionnaires were included if addressing handicaps or life roles, environmental influences and social consequences of a disease. Excluded were questionnaires focusing on only impairments, disabilities or quality of life. RESULTS AND CONCLUSION: 20 questionnaires were identified. Handicap is not uniformly defined in these questionnaires. Based on different concepts, the various questionnaires encompass different domains and different aspects are emphasized in similar domains. Fourteen questionnaires assess society-perceived handicaps, and do not address the life roles, care needs or individual problem-experience. Six questionnaires are to some extent person-perceived, but a generic person-perceived handicap questionnaire could not be identified. It is concluded that development of a generic person-perceived handicap questionnaire is essential for adequate assessment of needs, outcome, and relevance of rehabilitation interventions from the individual's point of view.

Effectiveness of corticosteroid injections versus physiotherapy for treatment of painful stiff shoulder in primary care: randomised trial.

OBJECTIVE: To compare the effectiveness of corticosteroid injections with physiotherapy for the treatment of painful stiff shoulder. DESIGN: Randomised trial. SETTING: 40 general practices. SUBJECTS: 109 patients consulting general practitioners for shoulder pain were enrolled in the trial. INTERVENTIONS: Patients were randomly allocated to 6 weeks of treatment either with corticosteroid injections (53) or physiotherapy (56). MAIN OUTCOME MEASURES: Outcome assessments were carried out 3, 7, 13, 26, and 52 weeks after randomisation; some of the assessments were done by an observer blind to treatment allocation. Primary outcome measures were the success of treatment as measured by scores on scales measuring improvement in the main complaint and pain, and improvement in scores on a scale measuring shoulder disability. RESULTS: At 7 weeks 40 (77%) out of 52 patients treated with injections were considered to be treatment successes compared with 26 (46%) out of 56 treated with physiotherapy (difference between groups 31%, 95% confidence interval 14% to 48%). The difference in improvement favoured those treated with corticosteroids in nearly all outcome measures; these differences were statistically significant. At 26 and 52 weeks differences between the groups were comparatively small. Adverse reactions were generally mild. However, among women receiving treatment with corticosteroids adverse reactions were more troublesome: facial flushing was reported by 9 women and irregular menstrual bleeding by 6, 2 of whom were postmenopausal. CONCLUSIONS: The beneficial effects of corticosteroid injections administered by general practitioners for treatment of painful stiff shoulder are superior to those of physiotherapy. The differences between the intervention groups were mainly the result of the comparatively faster relief of symptoms that occurred in patients treated with injections. Adverse reactions were generally mild but doctors should be aware of the potential side effects of injections of triamcinolone, particularly in women.