The patient enablement instrument for back pain: reliability, content validity, construct validity and responsiveness.

BACKGROUND: Currently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the 'Patient Enablement Instrument', we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test-retest reliability, measurement error, responsiveness and floor and ceiling effects. METHODS: The PEI-BP consists of 6 items that are rated on a 0-10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test-retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire-physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain. RESULTS: The PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test-retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population. CONCLUSIONS: The PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended. TRIAL REGISTRATION: Not applicable.

Tibial translation and muscle activation during rehabilitation exercises 5 weeks after anterior cruciate ligament reconstruction.

The aim of this study was to compare different rehabilitation exercises with respect to dynamic anterior tibial translation and muscle activation 5 weeks after an anterior cruciate ligament (ACL) reconstruction. Another aim was to compare the ACL-reconstructed knee with the ACL-injured and the uninjured knees for differences in anterior tibial translation and muscle activation during the exercises. Sagittal tibial translation and muscle activation were measured during the Lachman test (static translation) and during seven rehabilitation exercises (dynamic translation) in 19 patients. Results obtained 5 weeks after ACL reconstruction were compared with those obtained before the ACL reconstruction (ACL-deficient and uninjured knee). After ACL reconstruction the seated knee extension produced more anterior tibial translation than the straight leg raise and standing on one leg. The ACL reconstruction reduced the static and the dynamic tibial translation and the tibial translations measured in ACL-reconstructed knees were similar to those measured in uninjured knees. After ACL reconstruction, the patients used a joint stiffening strategy that used more hamstring activation and reduced the dynamic tibial translation. Although all exercises tested are suitable for rehabilitation after ACL reconstruction, to protect the graft from excessive strain, the straight leg raise and squat on one leg are preferable for quadriceps training in the early phase of rehabilitation.

Parent's conceptions of intensive group training. The case of cerebral palsy.

PURPOSE: The aim was to explore what wants and needs intensive group training (IGT) fulfil for parents of children with cerebral palsy (CP) and what problems that may arise due to participation. METHODS: A phenomenograpical approach was used. Semi-structured interviews were conducted to elicit information about what participation means to parents. RESULTS: Five overarching categories expressing positive functions of IGT were identified: IGT as knowledge promotion, as a complementary training resource, as a bracket to ordinary life, as a means to promote relations with therapists, and as a leisure-activity. One category: IGT as risk for ill-being expresses perceived problems. Each category is in turn divided into a number of subconceptions - 13 conceptions of this kind were identified. CONCLUSIONS: The conceptions express positive and negative functions of IGT as perceived by parents. These functions in turn can be considered as reflections of basic wants and needs. The results demonstrate that IGT have a potential to contribute to feelings of enhanced care competence among parents, of being supported and of increased strength and vitality. All parents did not have needs of participation in IGT for themselves. There is also a risk that IGT is experienced as an additional burden and may have negative effects on family-functioning.

Effectiveness and expectations of intensive training: a comparison between child and youth rehabilitation and conductive education.

OBJECTIVE: To compare the effectiveness of two intensive training-programmes from a professional and parent perspective. To describe and compare the type of expectations of the two intensive training programmes with the self-reported individualized goals. DESIGN: Quasi-experimental with two groups. SETTING AND INTERVENTION: Traditional health care and conductive education. PATIENTS AND THEIR PARENTS: Fifty-four children with cerebral palsy, 3-16 years old. METHODS: Data included a self-reported individualized goal measure (SRIGM), before and after the ITP. Individualized goals were classified according to the International Classification of Functioning (ICF). Clinical measures (CM) included repeated measures with Gross Motor Function Measure (GMFM) and Pediatric Evaluation of Disability Inventory-Functional Skills (PEDI-FS). RESULTS: Twenty-eight parents out of 54 perceived a clinically significant improvement on the SRIGM with no significant difference between the training programmes. Most individualized goals were formulated in the domain of Mobility (115 out of 248) and Neuromusculoskeletal and movement-related functions (64 out of 248 goals) of ICF in both training programmes. There was no difference in the proportion of improvement measured with SRIGM compared to the CM, if an improvement in any dimension in GMFM or domain in PEDI FS was counted. CONCLUSION: There were no major differences in outcome and expectations between the training programmes. Parents' expectations were mainly directed towards improvement in prerequisites of motor function and mobility skills. The SRIGM confirmed the outcome on the CM.

Predictive factors for arm pain, neck pain, neck specific disability and health after anterior cervical decompression and fusion.

BACKGROUND: Predictive factors for a low arm and neck pain, and good health after anterior cervical decompression and fusion (ACDF) with a cervical carbon fibre intervertebral fusion cage (CIFC) are still lacking. METHOD: A prospective consecutive study to investigate which preoperative factors that could predict a good outcome with regard to arm pain, neck pain, Neck Disability Index (NDI) and general health three years after ACDF with CIFC was conducted. Thirty-four patients were included before surgery. Measurements took place the day before, six months, one year and three years after ACDF. FINDINGS: In multivariate analysis, to be a non-smoker before surgery was the most important factor for a low postoperative arm pain, a low pain frequency was the most important factor for low postoperative neck pain, normal rating on Distress and Risk Assessment Method (DRAM) was the most important factor for high function on NDI and a low initial pain intensity was the most important factor for good postoperative health. For all outcome variables a normal rating on DRAM was an important factor for a good outcome. CONCLUSIONS: Non-smoking, a low pain level and normal rating on DRAM were the best preoperative predictors of a good outcome in ACDF. Inclusion criteria for surgery should be based on a bio psychosocial model and DRAM seems to be useful for including the traditional inclusion criteria.

Descriptions of functioning and health and relations to a gross motor classification in adults with cerebral palsy.

PURPOSE: The aim of this study was to describe functioning and health, and explore the use of the Gross Motor Function Classification System (GMFCS) in an adult population with cerebral palsy (CP). METHODS: From a cohort of 199 persons, 48 persons were selected for structured interviews and functional assessments regarding activities of daily living, motor function, range of motion, pain and general health. RESULTS: A third of the population had deteriorated in function from adolescence to adulthood according to the GMFCS. The majority were independent in personal ADL, but many of those were dependent in instrumental ADL. Motor function scores reflected problems in walking ability, and limited ROM and pain were common in all functional levels. General health was lower than in a general population. GMFCS seems valid for classifying adults with CP since it is correlated with instruments measuring motor function and ADL in terms of dependence. CONCLUSION: Decreased functional ability and secondary musculoskeletal problems are common in adults with CP and general health can be associated with those problems. It is important to further explore health aspects and relations between health status and self-perceived health. The GMFCS is a useful tool, especially for comparisons throughout the life span, but in order to use in an adult population further development is needed.

Increased prevalence of oxidant stress and inflammation in patients with moderate to severe chronic kidney disease.

BACKGROUND: The prevalence of increased oxidative stress and acute-phase inflammation in patients with chronic kidney disease (CKD) has not been thoroughly investigated. METHODS: Biomarkers of oxidative stress and acute-phase inflammation were measured in a cohort of 60 patients with stage 3-5 CKD compared to a healthy subject cohort. Levels of oxidative stress and inflammation were also compared to estimated glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease (MDRD) formula. RESULTS: All biomarkers of oxidative stress (plasma protein carbonyl group content, plasma free F2-isoprostane content, plasma protein reduced thiol content) and all markers of inflammation [C-reactive protein (CRP), interleukin-6 (IL-6)] differed significantly between CKD patients and healthy subjects. There was no significant relationship between estimated GFR and any oxidative stress or inflammation biomarker. CRP levels were higher in patients with known coronary vascular disease (CVD) and in patients not taking angiotensin II inhibitors. Plasma IL-6 levels were significantly higher in patients with known coronary vascular disease and lower in patients taking statins. Biomarkers of oxidative stress were significantly higher in patients with diabetes and hypercholesterolemia. CONCLUSION: There is evidence of increased oxidative stress and acute-phase inflammation in patients with stage 3-5 chronic kidney disease compared to healthy subjects that does not closely correlate with estimates of GFR. Among CKD patients, inflammatory biomarkers correlate with known CVD and inversely correlate with the use of angiotensin II inhibitors and statins. A further increase in oxidative stress was noted in diabetic and hypercholesterolemic patients. Inflammation and oxidative stress may contribute to cardiovascular risk in CKD patients.

The COPE index--a first stage assessment of negative impact, positive value and quality of support of caregiving in informal carers of older people.

Data was collected in five countries from informal carers of older people (n = 577) via a common protocol. Carers completed: (1) a 17-item version of the Carers of Older People in Europe (COPE) Index, an assessment of carers' perceptions of their role : (2) a questionnaire on demographic and caregiving circumstances : and (3) three instruments included for the criterion validation of the COPE Index (the General Health Questionnaire, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF). Principal Component Analysis of the COPE Index was followed by internal consistency analysis of emergent components. Scales derived by summing items loading on the components were analyzed for their association with the criterion measures. Two components, negative impact and positive value, emerged consistently across countries. A third component, quality of support was less consistent across countries. Scales derived from the negative impact and positive value components were internally consistent and significantly associated with the criterion validity measures. These two scales and four items drawn from the quality of support component were retained in the final COPE Index. While further testing is required, the COPE Index has current utility in increasing understanding of the role perceptions of carers of older people.

Patient evaluation of the care and rehabilitation process in geriatric hospital care.

PURPOSE: To gain a deeper understanding of how elderly persons experience and evaluate the care and rehabilitation process. METHOD: Qualitative interview data from elderly patients were analysed using a grounded theory approach. The patients were interviewed twice, at the beginning of geriatric hospital care and some weeks after discharge. RESULTS: The patient-perceived outcome of the care and rehabilitation process reflected two dimensions; the effect on their health and the quality of the process, i.e. how their needs were met. The analysis revealed that the patients' needs differed during the care and rehabilitation process. It also indicated that patients perceived their needs and the care differently based on their previous experience of the care unit, their perceived trajectory of illness and their "patient character" which represented the patient's definition of himself/herself and the situation. A hypothetical model of the patients' evaluation process has been derived. CONCLUSION: The results indicate the importance of using a process perspective in the assessment and the interpretation of patient-perceived outcome of care and rehabilitation, and that patient expectations, trajectories of illness and the patient character must be taken into consideration.

Prognostic factors for perceived pain and function at one-year follow-up in primary care patients with neck pain.

PURPOSE: To identify prognostic factors for perceived pain and function with focus at one-year follow-up in primary care patients treated for non-specific neck pain. METHODS: A prospective study was performed including 193 neck pain patients. Before and after treatment period, and 12 months after the start date for treatment, patients completed a questionnaire including background data and aspects of pain, function and general health. Linear multiple regression analysis was used to identify prognostic factors with the dependent variables Oswestry score and pain intensity at 12-month follow-up. Response rate 81%. RESULTS: At 12-month follow-up, Oswestry score identified four prognostic factors: pain intensity; well-being; expectations of treatment; and duration of current episode. Adjusted R2 for the model was 0.32, and 20% of the patients had three of the four prognostic factors at entry, indicating risk of poor outcome. The dependent variable pain intensity revealed three prognostic factors: Oswestry score; duration of current episode; and similar problem during the previous five years. Adjusted R2 was 0.24, and 60% of the patients had two of the three prognostic factors at entry, indicating risk of poor outcome. CONCLUSIONS: Different prognostic factors (with the exception of duration of current episode) were identified by the two outcome variables. Thus the results suggest that it should be taken into account whether an impairment or disability outcome is used.

Weight distribution in the sitting position in patients with paralytic scoliosis: pre- and postoperative evaluation.

Patients with paralytic scoliosis spend most of their time in the sitting position. The spinal deformity, pelvic obliquity and uneven weight distribution on the seating surface necessitates frequent seating adaptations in the wheelchair. In this prospective study, 45 wheelchair-bound patients were evaluated preoperatively and 43 postoperatively. The pre- and postoperative evaluation was done by an independent observer. Surgical correction was performed between 1993 and 1996. Assessments included sitting balance on a box; number of seating supports in the wheelchair; weight distribution on the seating surface, measured with a computerized EMED system; Cobb angle; hip dislocation; mediolateral translation of T1 and of the apex vertebra with reference to a perpendicular line drawn upwards from the spinal process of S1; and pelvic obliquity from a line drawn between the most proximal points in the iliac crests. X-rays for the measurement of Cobb angle and pelvic obliquity were performed in sitting position. Reference values for normal weight distribution on the seating surface were obtained for 27 normal subjects and revealed a mean value of 59% of weight supported on one side. A stepwise regression analysis on the preoperative results showed that pelvic obliquity and thoracolumbar/lumbar spinal imbalance explained weight distribution on the seating surface (R(2)=0.45). There were significant improvements in all variables except in sitting balance and imbalance of T1, 1 year postoperatively. When dividing the material into two subgroups, the results showed no significant difference in any of the assessed parameters of the scoliosis, pelvic obliquity, or sitting position between individuals with even (50-59% on one side) and those with uneven (60-100% on one side) weight distribution postoperatively. The results of the assessment showed a significant improvement after surgical correction, but the majority still had pelvic obliquity and uneven weight distribution in a sitting position. The weight distribution on the seating surface preoperatively was explained by thoracolumbar/lumbar spinal imbalance and pelvic obliquity, with R(2)= 0.45. There were no significant differences in any variables in comparisons between individuals with even weight distribution and those with uneven weight distribution. For the group with even weight distribution, however, the mean pelvic obliquity was 6 degrees and in the group with uneven weight distribution the mean pelvic obliquity was 12 degrees. Attention to seating surface and adjustment of seating position is needed for patients with paralytic scoliosis.

Intra- and inter-tester reliability and reference values for hand strength.

The intra- and inter-tester reliability for measurement of handgrip strength and indexgrip strength using the Jamar dynamometer was investigated in 32 healthy volunteers, and the intra-tester reliability in 13 patients with cervical radiculopathy. The results from the reliability studies showed that handgrip and indexgrip strength measured with the Jamar dynamometer is a reliable method (ICC values 0.85-0.98) and can be recommended for use in clinical practice. Age- and sex-specific reference values for handgrip strength and indexgrip strength were measured with the Jamar dynamometer in 101 randomly selected healthy volunteers, aged 25-64 years. The results from the reference value study showed that sex is a more important determinant of hand strength than age, height and body weight. The reference values for hand strength improve the potential for objective evaluation of patients with arm/hand disorders caused by cervical radiculopathy.

Intra- and inter-tester reliability and reference values for isometric neck strength.

BACKGROUND AND PURPOSE: Age- and sex-specific reference values for neck strength based on reliable measurements in the upright position are lacking. The aim of the present study was to determine intra- and inter-tester reliability and age- and sex-specific reference values for isometric neck strength in extension, flexion and lateral flexion in sitting position measured with the David Back Clinic 140 (DBC 140) equipment. METHOD: The reliability of the DBC 140 equipment was investigated in 30 healthy volunteers and reference values were obtained from 101 healthy men and women. RESULTS: The reliability study showed that neck strength measured with the DBC 140 equipment has almost perfect intra- and inter-tester reliability (ICC values between 0.85 and 0.97). The mean value of the first in a series of three measurements was the highest for all three test leaders and for almost all directions. Results from the reference value study showed that gender is a much more important determinant of neck strength than age, body weight or body mass index (BMI). Neck strength in women was, on average, 55% of that in men, and when adjusted for body weight or BMI, the percentages were 70% and 59%, respectively. In all directions observed, neck strength decreased by approximately 20% from age 25 to 64 years. CONCLUSIONS: Measurements of neck strength taken in upright position with the DBC 140 equipment have almost perfect intra- and inter-tester reliability and justify the use of this test procedure. The use of the first measurement in a test series can be recommended for use in clinical practice since it was shown to be the maximal test value and thus, had a very low intra-tester difference. The use of reference values for neck strength when evaluating patients with neck disorders needs to take gender into account.

A 12-year follow-up of subjects initially sicklisted with neck/shoulder or low back diagnoses.

BACKGROUND AND PURPOSE: Neck/shoulder and low back pain are common in the Western world and can cause great personal and economic consequences, but so far there are few long term follow-up studies of the consequences of back pain, especially studies that separate the location of back pain. More knowledge is needed about different patterns of risk factors and prognoses for neck/shoulder and low back pain, respectively, and they should not be treated as similar conditions. The aim of the present study was to investigate possible long-term differences in neck/shoulder and low back symptoms, experienced over a 12-year period, with regard to work status, present health, discomfort and influence on daily activities. METHOD: A retrospective cohort study of individuals sicklisted with neck/shoulder or low back diagnoses 12 years ago was undertaken. Included were all 213 people who, in 1985, lived in the municipality of Linköping, Sweden, were aged 25-34 years and who had taken at least one new period of sickleave lasting > 28 days with a neck/shoulder or low back diagnosis. In 1996, a questionnaire was mailed to the 204 people who were still resident in Sweden (response rate 73%). RESULTS: Those initially absent with neck/shoulder diagnoses rated their present state of discomfort as worse than those sicklisted with low back diagnoses. Only 4% of the neck/shoulder group reported no present discomfort compared with 25% of the low back group. Notably, both groups reported the same duration of low back discomfort during the last year, which may indicate a higher risk for symptoms in more than one location for subjects with neck/shoulder problems. CONCLUSIONS: Individuals with sickness absence of more than 28 days with neck/shoulder or low back diagnoses appear to be at high risk of developing long-standing symptoms significantly more so for those initially having neck/shoulder diagnoses.

Development of reverse transcriptase PCR assays for detection of active human herpesvirus 6 infection.

We developed reverse transcriptase (RT) PCR assays for the detection of mRNA from three spliced genes of human herpesvirus 6 (HHV-6), the immediate-early genes U16/U17 and U89/U90 and the late gene U60/U66. Sequence analysis determined the splicing sites of these genes. The new assays may be instrumental in investigating the association between HHV-6 and disease.

An in vivo model for HIV resistance development.

Treatment of human immunodeficiency virus (HIV-1) with drugs targeted to the reverse transcriptase (RT) rapidly selects for drug-resistant virus. It is essential to develop a suitable animal model that allows the study of the emergence and reversal of drug resistance. A monkey model was previously developed on the basis of a hybrid virus (RT-SHIV) of simian immunodeficiency virus (SIV) with its RT exchanged for HIV-1 RT. In the present study cynomolgus monkeys infected with RT-SHIV were treated with varying doses of the non-nucleoside RT inhibitor nevirapine. The drug was administered for 2-3 weeks, in agreement with clinical experience of resistance development during nevirapine monotherapy. This resulted in the selection of mutants with Y181C and K103N changes in RT, which correspond to the HIV-1 mutations in nevirapine-resistant HIV-1 patients. The mutants coexisted at varying levels with wild-type virus and fluctuations in the proportion of mutants could be closely monitored. Low-dose treatment was not more efficient in induction of mutations than a virus-inhibiting dose. Structured therapy interruptions could be performed. The monkey RT-SHIV infection offers an in vivo model to determine effects of therapies on resistance development.

Anti-HIV type 1 activity of 3'-fluoro-3'-deoxythymidine for several different multidrug-resistant mutants.

The objective of this work was to test the antiviral activity of a potent nucleoside reverse transcriptase inhibitor, 3'-fluoro-3'-deoxythymidine (FLT), on both a wild-type human immunodeficiency virus (HIV-1) isolate and multidrug-resistant HIV-1 patient isolates. Drug-resistant viral isolates were selected on the basis of four different categories of well-characterized and representative multidrug-resistant mutants. The isolates included three variants containing 151M alone or in combination; three variants containing 215Y and 41L, 67N, 184V, 210W, and 219N in combination; two insertion mutant viruses (69 + EA and 69 + SA); and two deletion mutant viruses (del67NG and del67GS), the latter two groups both also containing other significant mutations. The activity of FLT and AZT against these isolates was determined by drug susceptibility assays and by measuring viral antigen p24 by ELISA. The cytotoxicity of FLT and AZT was assessed in PHA-stimulated PBMCs. Development of resistant mutants under FLT pressure was attempted by passaging HIV-1 isolates in SupT1 cells and stepwise increasing the concentration of FLT. The multidrug-resistant mutant HIV-1 isolates exhibited 7-fold to >100-fold increased resistance to AZT, but showed IC(50) values for FLT of 0.0014-0.0168 microM, which were lower than or similar to that of wild type (0.0075 microM). The cellular cytotoxicities of FLT and AZT fell into a similar range in PBMCs. The development of HIV mutants resistant to FLT appeared to be slower than for other RT inhibitors. HIV isolates with mutations resulting in multidrug resistance had no evidence of resistance to FLT. FLT may be useful in salvage therapies for patients harboring resistant strains and a reassessment of its therapeutic potential seems required.

Urea-PETT compounds as a new class of HIV-1 reverse transcriptase inhibitors. 3. Synthesis and further structure-activity relationship studies of PETT analogues.

The further development of allosteric HIV-1 RT inhibitors in the urea analogue series of PETT (phenylethylthiazolylthiourea) derivatives is described here. The series includes derivatives with an ethyl linker (1-5) and racemic (6-16) and enantiomeric (17-20) cis-cyclopropane compounds. The antiviral activity was determined both at the RT level and in cell culture on both wild-type and mutant forms of HIV-1. Most compounds have anti-HIV-1 activity on the wt in the nanomolar range. Resistant HIV-1 was selected in vitro for some of the compounds, and the time for resistant HIV-1 to develop was longer for urea-PETT compounds than it was for reference compounds. Preliminary pharmacokinetics in rats showed that compound 18 is orally bioavailable and penetrates well into the brain. The three-dimensional structure of complexes between HIV-1 RT and two enantiomeric compounds (17 and 18) have been determined. The structures show similar binding in the NNI binding pocket. The propionylphenyl moieties of both inhibitors show perfect stacking to tyrosine residues 181 and 188. The cyclopropyl moiety of the (+)-enantiomer 18 exhibits optimal packing distances for the interactions with leucine residue 100 and valine residue 179.

A critical analysis of randomised clinical trials on neck pain and treatment efficacy. A review of the literature.

The efficacy of physiotherapy or chiropractic treatment for patients with neck pain was analysed by reviewing 27 randomised clinical trials published 196-1995. Three different methods were employed: systematic analyses of; methodological quality; comparison of effect size; analysis of inclusion criteria, intervention and outcome according to The Disablement Process model. The quality of most of the studies was low; only one-third scored 50 or more of a possible 100 points. Positive outcomes were noted for 18 of the investigations, and the methodological quality was high in studies using electromagnetic therapy, manipulation, or active physiotherapy. High methodological quality was also noted in studies with traction and acupuncture, however, the interventions had either no effect or a negative effect on outcome. Pooling data and calculation of effect size showed that treatments used in the studies were effective for pain, range of motion, and activities of daily living. Inclusion criteria, intervention, and outcome were based on impairment in most of the analysed investigations. Broader outcome assessments probably would have revealed relationships between treatment effect and impairment, functional limitation and disability.