Protocolled practice nurse-led care for children with asthma in primary care: protocol for a cluster randomised trial.

INTRODUCTION: In children with asthma, daily symptoms and exacerbations have a significant impact on the quality of life of both children and parents. More effective use of asthma medication and, consequently, better asthma control is advocated, since both overtreatment and undertreatment are reported in primary care. Trials in adults suggest that asthma control is better when patients receive a regular medical review. Therefore, protocolled care by the general practitioner may also lead to better asthma control in children. However, such protocolled care by the general practitioner may be time consuming and less feasible. Therefore, this study aims to determine whether protocolled practice nurse-led asthma care for children in primary care provides more effective asthma control than usual care. METHODS AND ANALYSIS: The study will be a cluster-randomised open-label trial with an 18-month follow-up. Practice nurses will be the units of randomisation and children with asthma the units of analysis. It is planned to include 180 children aged 6-12 years. Primary outcome will be average asthma control during the 18-month follow-up measured by the Childhood Asthma Control Test (C-ACT). Secondary outcomes include C-ACT scores at t=3, t=6, t=12 and t=18 months; the frequency and severity of exacerbations; cost-effectiveness; quality of life; satisfaction with delivered care; forced expiratory volume in 1 s and forced expiratory flow at 75% and the association of high symptoms scores at baseline and baseline characteristics. Besides, we will conduct identical measurements in a non-randomised sample of children. ETHICS AND DISSEMINATION: This will be the first trial to evaluate the effectiveness of protocolled practice nurse-led care for children with asthma in primary care. The results may lead to improvements in asthma care for children and can be directly implemented in revisions of asthma guidelines.The study protocol was approved by the Medical Research Ethics Committee of the Erasmus Medical Centre in Rotterdam. TRIAL REGISTRATION: NTR6847.

One question might be capable of replacing the Shoulder Pain and Disability Index (SPADI) when measuring disability: a prospective cohort study.

QUESTIONS: Is it possible to replace the Shoulder Pain and Disability Index (SPADI) with a single substitute question for people with shoulder pain, when measuring disability and how well does this substitute question perform as a predictor for recovery. DESIGN: A prospective cohort study. PARTICIPANTS: A total of 356 patients with shoulder pain in primary care. ANALYSES: Convergent, divergent, and "known" groups validity were assessed by using hypotheses testing. Responsiveness was assessed using the Receiver Operating Curve and hypothesis testing. In addition, we performed multivariate regression to assess if the substitute question showed similar properties as the SPADI and if it affected the model itself, using recovery as an outcome. RESULTS: The Spearman correlation coefficient between the total SPADI score and the substitute question was high, and moderate with the Shoulder Disability Questionnaire. The correlation between the substitute question and the EQ-5D-3L was low and the responsiveness was acceptable. The substitute question did not significantly contribute to both prognostic prediction models as opposed to the SPADI. Regardless all models showed poor to fair discrimination. CONCLUSION: The single question is a reasonable substitute for the SPADI and can be used as a screening instrument for shoulder disability in primary clinical practice. It has slightly poorer predictive power and should therefore not be used for prognosis.

A diagnostic study in patients with sciatica establishing the importance of localization of worsening of pain during coughing, sneezing and straining to assess nerve root compression on MRI.

PURPOSE: To test whether the localization of worsening of pain during coughing, sneezing and straining matters in the assessment of lumbosacral nerve root compression or disc herniation on MRI. METHODS: Recently the diagnostic accuracy of history items to assess disc herniation or nerve root compression on magnetic resonance imaging (MRI) was investigated. A total of 395 adult patients with severe sciatica of 6-12 weeks duration were included in this study. The question regarding the influence of coughing, sneezing and straining on the intensity of pain could be answered on a 4 point scale: no worsening of pain, worsening of back pain, worsening of leg pain, worsening of back and leg pain. Diagnostic odds ratio's (DORs) were calculated for the various dichotomization options. RESULTS: The DOR changed into significant values when the answer option was more narrowed to worsening of leg pain. The highest DOR was observed for the answer option 'worsening of leg pain' with a DOR of 2.28 (95 % CI 1.28-4.04) for the presence of nerve root compression and a DOR of 2.50 (95 % CI 1.27-4.90) for the presence of a herniated disc on MRI. CONCLUSIONS: Worsening of leg pain during coughing, sneezing or straining has a significant diagnostic value for the presence of nerve root compression and disc herniation on MRI in patients with sciatica. This study also highlights the importance of the formulation of answer options in history taking.

Prognostic value of magnetic resonance imaging findings in patients with sciatica.

OBJECTIVE This study aimed to determine the prognostic value of MRI variables to predict outcome in patients with herniated disc-related sciatica, and whether MRI could facilitate the decision making between early surgery and prolonged conservative care in these patients. METHODS A prospective observational evaluation of patients enrolled in a randomized trial with 1-year follow-up was completed. A total of 283 patients with sciatica who had a radiologically confirmed disc herniation were randomized either to surgery or to prolonged conservative care with surgery if needed. Outcome measures were recovery and leg pain severity. Recovery was registered on a 7-point Likert scale. Complete/near complete recovery was considered a satisfactory outcome. Leg pain severity was measured on a 0- to 100-mm visual analog scale. Multiple MRI characteristics of the degenerated disc herniation were independently scored by 3 spine experts. Cox models were used to study the influence of MRI variables on rate of recovery, and linear mixed models were used to determine the predictive value of MRI variables for leg pain severity during follow-up. The interaction of each MRI predictor with treatment allocation was tested. There were no study-specific conflicts of interest. RESULTS Baseline MRI variables associated with less leg pain severity were the reader's assessment of presence of nerve root compression (p < 0.001), and assessment of extrusion compared with protrusion of the disc herniation (p = 0.006). Both variables tended to be associated, but not significantly, with satisfactory outcome during follow-up (HR 1.45, 95% CI 0.93-2.24, and HR 1.24, 95% CI 0.96-1.61, respectively). The size of disc herniation at baseline was not associated with outcome. There was no significant change in the effects between treatment groups. CONCLUSIONS MRI assessment of the presence of nerve root compression and extrusion of a herniated disc at baseline was associated with less leg pain during 1-year follow-up, irrespective of a surgical or conservative treatment. MRI findings seem not to be helpful in determining which patients might fare better with early surgery compared with a strategy of prolonged conservative care. Clinical trial registration no.: ISRCTN26872154 ( controlled-trials.com ).

Does Kinesiophobia Modify the Effects of Physical Therapy on Outcomes in Patients With Sciatica in Primary Care? Subgroup Analysis From a Randomized Controlled Trial.

BACKGROUND: A higher level of kinesiophobia appears to be associated with poor recovery in patients with sciatica. OBJECTIVE: The aim of this study was to investigate whether kinesiophobia modifies the effect of physical therapy on outcomes in patients with sciatica. DESIGN: This was a subgroup analysis from a randomized controlled trial. SETTING: The study was conducted in a primary care setting. PATIENTS: A total of 135 patients with acute sciatica participated. INTERVENTION: Patients were randomly assigned to groups that received (1) physical therapy plus general practitioners' care (intervention group) or (2) general practitioners' care alone (control group). MEASUREMENTS: Kinesiophobia at baseline was measured with the Tampa Scale for Kinesiophobia (TSK) and a single substitute question for kinesiophobia (SQK). Pain and recovery were assessed at 3- and 12-month follow-ups. Regression analysis was used to test for interaction between the level of kinesiophobia at baseline and treatment allocation. Subgroup results were calculated for patients classified with high fear of movement and for those classified with low fear of movement. RESULTS: Kinesiophobia at baseline interacted with physical therapy in the analysis with leg pain intensity at 12-month follow-up. Kinesiophobia at baseline did not interact with physical therapy regarding any outcome at 3-month follow-up or recovery at 12-month follow-up. When comparing both treatment groups in the subgroup of patients with high fear of movement (n=73), the only significant result was found for leg pain intensity difference from baseline at 12-month follow-up (intervention group: X̅=-5.0, SD=2.6; control group: X̅=-3.6, SD=2.7). LIMITATIONS: The post hoc study design and relatively small sample size were limitations of the study. CONCLUSIONS: In 135 patients with sciatica, evidence shows that patients with a higher level of kinesiophobia at baseline may particularly benefit from physical therapy with regard to decreasing leg pain intensity at 12-month follow-up.

Diagnostic accuracy of history taking to assess lumbosacral nerve root compression.

BACKGROUND CONTEXT: The diagnosis of sciatica is primarily based on history and physical examination. Most physical tests used in isolation show poor diagnostic accuracy. Little is known about the diagnostic accuracy of history items. PURPOSE: To assess the diagnostic accuracy of history taking for the presence of lumbosacral nerve root compression or disc herniation on magnetic resonance imaging in patients with sciatica. STUDY DESIGN: Cross-sectional diagnostic study. PATIENT SAMPLE: A total of 395 adult patients with severe disabling radicular leg pain of 6 to 12 weeks duration were included. OUTCOME MEASURES: Lumbosacral nerve root compression and disc herniation on magnetic resonance imaging were independently assessed by two neuroradiologists and one neurosurgeon blinded to any clinical information. METHODS: Data were prospectively collected in nine hospitals. History was taken according to a standardized protocol. There were no study-specific conflicts of interest. RESULTS: Exploring the diagnostic odds ratio of 20 history items revealed a significant contribution in diagnosing nerve root compression for "male sex," "pain worse in leg than in back," and "a non-sudden onset." A significant contribution to the diagnosis of a herniated disc was found for "body mass index <30," "a non-sudden onset," and "sensory loss." Multivariate logistic regression analysis of six history items pre-selected from the literature (age, gender, pain worse in leg than in back, sensory loss, muscle weakness, and more pain on coughing/sneezing/straining) revealed an area under the receiver operating characteristic curve of 0.65 (95% confidence interval, 0.58-0.71) for the model diagnosing nerve root compression and an area under the receiver operating characteristic curve of 0.66 (95% confidence interval, 0.58-0.74) for the model diagnosing disc herniation. CONCLUSIONS: A few history items used in isolation had significant diagnostic value and the diagnostic accuracy of a model with six pre-selected items was poor.

Magnetic resonance imaging interpretation in patients with sciatica who are potential candidates for lumbar disc surgery.

BACKGROUND: Magnetic Resonance Imaging (MRI) is considered the mainstay imaging investigation in patients suspected of lumbar disc herniations. Both imaging and clinical findings determine the final decision of surgery. The objective of this study was to assess MRI observer variation in patients with sciatica who are potential candidates for lumbar disc surgery. METHODS: Patients for this study were potential candidates (n = 395) for lumbar disc surgery who underwent MRI to assess eligibility for a randomized trial. Two neuroradiologists and one neurosurgeon independently evaluated all MRIs. A four point scale was used for both probability of disc herniation and root compression, ranging from definitely present to definitely absent. Multiple characteristics of the degenerated disc herniation were scored. For inter-agreement analysis absolute agreements and kappa coefficients were used. Kappa coefficients were categorized as poor (<0.00), slight (0.00-0.20), fair (0.21-0.40), moderate (0.41-0.60), substantial (0.61-0.80) and excellent (0.81-1.00) agreement. RESULTS: Excellent agreement was found on the affected disc level (kappa range 0.81-0.86) and the nerve root that most likely caused the sciatic symptoms (kappa range 0.86-0.89). Interobserver agreement was moderate to substantial for the probability of disc herniation (kappa range 0.57-0.77) and the probability of nerve root compression (kappa range 0.42-0.69). Absolute pairwise agreement among the readers ranged from 90-94% regarding the question whether the probability of disc herniation on MRI was above or below 50%. Generally, moderate agreement was observed regarding the characteristics of the symptomatic disc level and of the herniated disc. CONCLUSION: The observer variation of MRI interpretation in potential candidates for lumbar disc surgery is satisfactory regarding characteristics most important in decision for surgery. However, there is considerable variation between observers in specific characteristics of the symptomatic disc level and herniated disc.

A single question was as predictive of outcome as the Tampa Scale for Kinesiophobia in people with sciatica: an observational study.

QUESTION: In people with sciatica in primary care, can a single question be used to predict outcome at 1 year followup as accurately as validated questionnaires on kinesiophobia, disability, and health-related quality of life? DESIGN: Observational study within a randomised cohort. PARTICIPANTS: 135 people with sciatica in primary care. OUTCOME MEASURES: Kinesiophobia was measured with the Tampa Scale for Kinesiophobia (TSK), disability with the Roland Morris Disability Questionnaire (RDQ), and health-related quality of life with the EQ-5D and the 36-item Short Form (SF-36) Physical Component Summary. Participants also answered a newly devised substitute question for each questionnaire on an 11-point numerical rating scale. Global perceived effect and severity of leg pain were recorded at 1 year follow-up. RESULTS: The correlation coefficient between the TSK and its substitute question was r=0.46 (p<0.001). The substitute question was better at predicting pain severity in the leg at 1 year follow-up than the TSK (addition of explained variation of 11% versus 4% in a logistic regression analysis). The TSK and its substitute question did not significantly differ in their prediction of global perceived effect at 1 year follow-up. The other substitute questions and both the RDQ and EQ-5D did not contribute significantly to one or both of their prediction models. CONCLUSION: It may be feasible to replace the TSK by a single substitute question for predicting outcome in people with sciatica in primary care. The other substitute questions did not consistently predict outcome at 1 year follow-up.