Magnetic resonance imaging for diagnosing lumbar spinal pathology in adult patients with low back pain or sciatica: a diagnostic systematic review.

PURPOSE: In about 5% of all cases LBP is associated with serious underlying pathology requiring diagnostic confirmation and directed treatment. Magnetic resonance imaging (MRI) is often used for this diagnostic purpose yet its role remains controversial. Consequently, this review aimed to summarize the available evidence on the diagnostic accuracy of MRI for identifying lumbar spinal pathology in adult low back pain (LPB) or sciatica patients. METHODS: MEDLINE, EMBASE and CINAHL were searched (until December 2009) for observational studies assessing the diagnostic accuracy of MRI compared to a reference test for the identification of lumbar spinal pathology. Two reviewers independently selected studies for inclusion, extracted data and assessed methodological quality. Pooled summary estimates of sensitivity and specificity with 95% confidence intervals were calculated for homogenous subsets of studies. RESULTS: Eight studies were included in this review. Strata were defined for separate pathologies i.e. lumbar disc herniation (HNP) and spinal stenosis. Five studies comparing MRI to findings at the surgery for identifying HNP were included in a meta-analysis. Pooled analysis resulted in a summary estimate of sensitivity of 75% (95% CI 65-83%) and specificity of 77% (95% CI 61-88%). For spinal stenosis pooling was not possible. CONCLUSIONS: The results suggest that a considerable proportion of patients may be classified incorrectly by MRI for HNP and spinal stenosis. However, the evidence for the diagnostic accuracy of MRI found by this review is not conclusive, since the results could be distorted due to the limited number of studies and large heterogeneity.

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol.

BACKGROUND: Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. METHODS: Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. DISCUSSION: This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.

Missing data and imputation: a practical illustration in a prognostic study on low back pain.

OBJECTIVE: When designing prediction models by complete case analysis (CCA), missing information in either baseline (predictors) or outcomes may lead to biased results. Multiple imputation (MI) has been shown to be suitable for obtaining unbiased results. This study provides researchers with an empirical illustration of the use of MI in a data set on low back pain, by comparing MI with the more commonly used CCA. Effects will be shown of imputing missing information on the composition and performance of prognostic models, distinguishing imputation of missing values in baseline characteristics and outcome data. METHODS: Data came from the Beliefs about Backpain cohort, a study of psychologic obstacles to recovery in primary care back pain patients in the United Kingdom. Candidate predictors included demographics, back pain characteristics, and psychologic variables. Complete case analysis was compared with MI within patients with complete outcome but missing baseline data (n=809) and patients with missing baseline or outcome data (n=1591). Multiple imputation was performed by a Multiple Imputation by Chained Equations procedure. RESULTS: Cases with missing outcome data (n=782, 49.1%) or with missing baseline data (n=116, 8%) both differed from complete cases regarding the distribution of some predictors and more often had a poor outcome. When comparing CCA with MI, model composition showed to be affected. CONCLUSIONS: Complete case analysis can give biased results, even when only small amounts of data are missing. Now that MI is available in standard statistical software, we recommend that it be used to handle missing data.

Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial.

OBJECTIVE: To evaluate the effectiveness of manual therapy (MT) in participants with chronic tension-type headache (CTTH). SUBJECTS AND METHODS: We conducted a multicentre, pragmatic, randomised, clinical trial with partly blinded outcome assessment. Eighty-two participants with CTTH were randomly assigned to MT or to usual care by the general practitioner (GP). Primary outcome measures were frequency of headache and use of medication. Secondary outcome measures were severity of headache, disability and cervical function. RESULTS: After 8 weeks (n = 80) and 26 weeks (n = 75), a significantly larger reduction of headache frequency was found for the MT group (mean difference at 8 weeks, -6.4 days; 95% CI -8.3 to -4.5; effect size, 1.6). Disability and cervical function showed significant differences in favour of the MT group at 8 weeks but were not significantly different at 26 weeks. CONCLUSIONS: Manual therapy is more effective than usual GP care in the short- and longer term in reducing symptoms of CTTH. Dutch Trial Registration no. TR 1074.

Prediction of persistent shoulder pain in general practice: comparing clinical consensus from a Delphi procedure with a statistical scoring system.

BACKGROUND: In prognostic research, prediction rules are generally statistically derived. However the composition and performance of these statistical models may strongly depend on the characteristics of the derivation sample. The purpose of this study was to establish consensus among clinicians and experts on key predictors for persistent shoulder pain three months after initial consultation in primary care and assess the predictive performance of a model based on clinical expertise compared to a statistically derived model. METHODS: A Delphi poll involving 3 rounds of data collection was used to reach consensus among health care professionals involved in the assessment and management of shoulder pain. RESULTS: Predictors selected by the expert panel were: symptom duration, pain catastrophizing, symptom history, fear-avoidance beliefs, coexisting neck pain, severity of shoulder disability, multisite pain, age, shoulder pain intensity and illness perceptions. When tested in a sample of 587 primary care patients consulting with shoulder pain the predictive performance of the two prognostic models based on clinical expertise were lower compared to that of a statistically derived model (Area Under the Curve, AUC, expert-based dichotomous predictors 0.656, expert-based continuous predictors 0.679 vs. 0.702 statistical model). CONCLUSIONS: The three models were different in terms of composition, but all confirmed the prognostic importance of symptom duration, baseline level of shoulder disability and multisite pain. External validation in other populations of shoulder pain patients should confirm whether statistically derived models indeed perform better compared to models based on clinical expertise.

Functional outcome in older adults with joint pain and comorbidity: design of a prospective cohort study.

BACKGROUND: Joint pain is a highly prevalent condition in the older population. Only a minority of the older adults consult the general practitioner for joint pain, and during consultation joint pain is often poorly recognized and treated, especially when other co-existing chronic conditions are involved. Therefore, older adults with joint pain and comorbidity may have a higher risk of poor functional outcome and decreased quality of life (QoL), and possibly need more attention in primary care. The main purpose of the study is to explore functioning in older adults with joint pain and comorbidity, in terms of mobility, functional independence and participation and to identify possible predictors of poor functional outcome. The study will also identify predictors of decreased QoL. The results will be used to develop prediction models for the early identification of subgroups at high risk of poor functional outcome and decreased QoL. This may contribute to better targeting of treatment and to more effective health care in this population. METHODS/DESIGN: The study has been designed as a prospective cohort study, with measurements at baseline and after 6, 12 and 18 months. For the recruitment of 450 patients, 25 general practices will be approached. Patients are eligible for participation if they are 65 years or older, have at least two chronic conditions and report joint pain on most days. Data will be collected using various methods (i.e. questionnaires, physical tests, patient interviews and focus groups). We will measure different aspects of functioning (e.g. mobility, functional independence and participation) and QoL. Other measurements concern possible predictors of functioning and QoL (e.g. pain, co-existing chronic conditions, markers for frailty, physical performance, psychological factors, environmental factors and individual factors). Furthermore, health care utilization, health care needs and the meaning and impact of joint pain will be investigated from an older person's perspective. DISCUSSION: In this paper, we describe the protocol of a prospective cohort study in Dutch older adults with joint pain and comorbidity and discuss the potential strengths and limitations of the study.

The search for stable prognostic models in multiple imputed data sets.

BACKGROUND: In prognostic studies model instability and missing data can be troubling factors. Proposed methods for handling these situations are bootstrapping (B) and Multiple imputation (MI). The authors examined the influence of these methods on model composition. METHODS: Models were constructed using a cohort of 587 patients consulting between January 2001 and January 2003 with a shoulder problem in general practice in the Netherlands (the Dutch Shoulder Study). Outcome measures were persistent shoulder disability and persistent shoulder pain. Potential predictors included socio-demographic variables, characteristics of the pain problem, physical activity and psychosocial factors. Model composition and performance (calibration and discrimination) were assessed for models using a complete case analysis, MI, bootstrapping or both MI and bootstrapping. RESULTS: Results showed that model composition varied between models as a result of how missing data was handled and that bootstrapping provided additional information on the stability of the selected prognostic model. CONCLUSION: In prognostic modeling missing data needs to be handled by MI and bootstrap model selection is advised in order to provide information on model stability.

Diagnostic testing for celiac disease among patients with abdominal symptoms: a systematic review.

CONTEXT: The symptoms and consequences of celiac disease usually resolve with a lifelong gluten-free diet. However, clinical presentation is variable and most patients presenting with abdominal symptoms in primary care will not have celiac disease and unnecessary diagnostic testing should be avoided. OBJECTIVE: To summarize evidence on the performance of diagnostic tests for identifying celiac disease in adults presenting with abdominal symptoms in primary care or similar settings. DATA SOURCES: A literature search via MEDLINE (beginning in January 1966) and EMBASE (beginning in January 1947) through December 2009 and a manual search of references for additional relevant studies. STUDY SELECTION: Diagnostic studies were selected if they had a cohort or nested case-control design, enrolled adults presenting with nonacute abdominal symptoms, the prevalence of celiac disease was 15% or less, and the tests used included gastrointestinal symptoms or serum antibody tests. DATA EXTRACTION: Quality assessment using the Quality Assessment of Diagnostic Accuracy Studies tool and data extraction were performed by 2 reviewers independently. Sensitivities and specificities were calculated for each study and pooled estimates were computed using bivariate analysis if there was clinical and statistical homogeneity. DATA SYNTHESIS: Sixteen studies were included in the review (N = 6085 patients). The performance of abdominal symptoms varied widely. The sensitivity of diarrhea, for example, ranged from 0.27 to 0.86 and specificity from 0.21 to 0.86. Pooled estimates for IgA antiendomysial antibodies (8 studies) were 0.90 (95% confidence interval [CI], 0.80-0.95) for sensitivity and 0.99 (95% CI, 0.98-1.00) for specificity (positive likelihood ratio [LR] of 171 and negative LR of 0.11). Pooled estimates for IgA antitissue transglutaminase antibodies (7 studies) were 0.89 (95% CI, 0.82-0.94) and 0.98 (95% CI, 0.95-0.99), respectively (positive LR of 37.7 and negative LR of 0.11). The IgA and IgG antigliadin antibodies showed variable results, especially for sensitivity (range, 0.46-0.87 and range, 0.25-0.93, respectively). One recent study using diamidated gliadin peptides showed good specificity (> or = 0.94), but evidence is limited in this target population. CONCLUSION: Among adult patients presenting with abdominal symptoms in primary care or other unselected populations, IgA antitissue transglutaminase antibodies and IgA antiendomysial antibodies have high sensitivity and specificity for diagnosing celiac disease.

Corticosteroid injection for trigger finger in adults.

BACKGROUND: Trigger finger is a disease of the tendons of the hand leading to triggering (locking) of affected fingers, dysfunction and pain. Available treatments include local injection with corticosteroids, surgery, or splinting. OBJECTIVES: To summarize the evidence on the efficacy and safety of corticosteroid injections for trigger finger in adults using the following endpoints: treatment success, frequency of triggering or locking, functional status of the affected fingers, and severity of pain of the fingers. SEARCH STRATEGY: The databases CENTRAL, DARE, MEDLINE (1966 to November 2007), EMBASE (1956 to November 2007), CINAHL (1982 to November 2007), AMED (1985 to November 2007) and PEDro (a physiotherapy evidence database) were searched. SELECTION CRITERIA: We selected randomized and controlled clinical trials evaluating efficacy and safety of corticosteroid injections for trigger finger in adults. DATA COLLECTION AND ANALYSIS: The databases were searched for titles of eligible studies. After screening abstracts of these studies, full text articles of studies which fulfilled the selection criteria were obtained. Data were extracted using a predefined electronic form. The methodological quality of included trials was assessed by using items from the checklist developed by Jadad and the Delphi list. We planned to extract data regarding information on the primary outcome measures: treatment success, frequency of triggering or locking, and functional impairment of fingers, severity of the trigger finger; and the secondary outcome measures: proportion of patients with side effects, types of side effects, and patient satisfaction with injection. MAIN RESULTS: Two randomized controlled studies were found that involved 63 participants: 34 were allocated to corticosteroids and lidocaine, and 29 were allocated to lidocaine alone. Corticosteroid injection with lidocaine was more effective than lidocaine alone on treatment success at four weeks (relative risk 3.15, 95% CI 1.34 to 7.40). The number needed to treat to benefit was 3. No adverse events or side effects were reported. AUTHORS' CONCLUSIONS: The effectiveness of local corticosteroid injections was studied in only two small randomized controlled trials of poor methodological quality. Both studies showed better short-term effects of corticosteroid injection combined with lidocaine compared to lidocaine alone on the treatment success outcome. In one study the effects of corticosteroid injections lasted up to four months. No adverse effects were observed. The available evidence for the effectiveness of intra-tendon sheath corticosteroid injection for trigger finger can be graded as a silver level evidence for superiority of corticosteroid injections combined with lidocaine over injections with lidocaine alone.

Corticosteroid injection for de Quervain's tenosynovitis.

BACKGROUND: De Quervain's tenosynovitis is a disorder characterised by pain on the radial (thumb) side of the wrist and functional disability of the hand. It can be treated by corticosteroid injection, splinting and surgery. OBJECTIVES: To summarise evidence on the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis. SEARCH STRATEGY: We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 2), MEDLINE (1966 to April 2009), EMBASE (1956 to April 2009), CINAHL (1982 to April 2009), AMED (1985 to April 2009), DARE, Dissertation Abstracts and PEDro (physiotherapy evidence database). SELECTION CRITERIA: Randomised and controlled clinical trials evaluating the efficacy and safety of corticosteroid injections for de Quervain's tenosynovitis. DATA COLLECTION AND ANALYSIS: After screening abstracts of studies identified by the search we obtained full text articles of studies which fulfilled the selection criteria. We extracted data using a predefined electronic form. We assessed the methodological quality of included trials by using the checklist developed by Jadad and the Delphi list. We extracted data on the primary outcome measures: treatment success; severity of pain or tenderness at the radial styloid; functional impairment of the wrist or hand; and outcome of Finkelstein's test, and the secondary outcome measures: proportion of patients with side effects; type of side effects and patient satisfaction with injection treatment. MAIN RESULTS: We found one controlled clinical trial of 18 participants (all pregnant or lactating women) that compared one steroid injection with methylprednisolone and bupivacaine to splinting with a thumb spica. All patients in the steroid injection group (9/9) achieved complete relief of pain whereas none of the patients in the thumb spica group (0/9) had complete relief of pain, one to six days after intervention (number needed to treat to benefit (NNTB) = 1, 95% confidence interval (CI) 0.8 to 1.2). No side effects or local complications of steroid injection were noted. AUTHORS' CONCLUSIONS: The efficacy of corticosteroid injections for de Quervain's tenosynovitis has been studied in only one small controlled clinical trial, which found steroid injections to be superior to thumb spica splinting. However, the applicability of our findings to daily clinical practice is limited, as they are based on only one trial with a small number of included participants, the methodological quality was poor and only pregnant and lactating women participated in the study. No adverse effects were observed.

Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial.

BACKGROUND: Patients with Chronic Tension Type Headache (CTTH) report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being) and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles.We present the design of a randomised clinical trial (RCT) evaluating the effectiveness of manual therapy (MT) compared to usual care by the general practitioner (GP) in patients with CTTH. METHODS AND DESIGN: Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS).Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques), exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. DISCUSSION: This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible.The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

Research priorities for non-pharmacological therapies for common musculoskeletal problems: nationally and internationally agreed recommendations.

BACKGROUND: Musculoskeletal problems such as low back pain, neck, knee and shoulder pain are leading causes of disability and activity limitation in adults and are most frequently managed within primary care. There is a clear trend towards large, high quality trials testing the effectiveness of common non-pharmacological interventions for these conditions showing, at best, small to moderate benefits. This paper summarises the main lessons learnt from recent trials of the effectiveness of non-pharmacological therapies for common musculoskeletal conditions in primary care and provides agreed research priorities for future clinical trials. METHODS: Consensus development using nominal group techniques through national (UK) and international workshops. During a national Clinical Trials Thinktank workshop in April 2007 in the UK, a group of 30 senior researchers experienced in clinical trials for musculoskeletal conditions and 2 patient representatives debated the possible explanations for the findings of recent high quality trials of non-pharmacological interventions. Using the qualitative method of nominal group technique, these experts developed and ranked a set of priorities for future research, guided by the evidence from recent trials of treatments for common musculoskeletal problems. The recommendations from the national workshop were presented and further ranked at an international symposium (hosted in Canada) in June 2007. RESULTS: 22 recommended research priorities were developed, of which 12 reached consensus as priorities for future research from the UK workshop. The 12 recommendations were reduced to 7 agreed priorities at the international symposium. These were: to increase the focus on implementation (research into practice); to develop national musculoskeletal research networks in which large trials can be sited and smaller trials supported; to use more innovative trial designs such as those based on stepped care and subgrouping for targeted treatment models; to routinely incorporate health economic analysis into future trials; to include more patient-centred outcome measures; to develop a core set of outcomes for new trials of interventions for musculoskeletal problems; and to focus on studies that advance methodological approaches for clinical trials in this field. CONCLUSION: A set of research priorities for future trials of non-pharmacological therapies for common musculoskeletal conditions has been developed and agreed through national (UK) and international consensus processes. These priorities provide useful direction for researchers and research funders alike and impetus for improvement in the quality and methodology of clinical trials in this field.

Prognosis of fatigue and functioning in primary care: a 1-year follow-up study.

PURPOSE: Although fatigue is a common presenting symptom in primary care and its course and outcomes often remain unclear, cohort studies among patients seeking care for fatigue are scarce. We therefore aimed to investigate patterns in the course of fatigue and relevant secondary outcomes in a large cohort of patients who sought care for a main symptom of fatigue. METHODS: We performed an observational cohort study in 147 primary care practices. Patients consulting their general practitioner for a new episode of fatigue were sent questionnaires at 1, 4, 8, and 12 months after baseline. We collected measures of fatigue, perceived health and functioning, absenteeism, psychological symptoms, and sleep using the Checklist Individual Strength, the 36-Item Short Form Health Survey, the Four-Dimensional Symptoms Questionnaire, and the Pittsburgh Sleep Questionnaire Inventory. Patients were classified into 4 subgroups based on fatigue severity scores over time. We assessed patterns in the course of all outcomes in these subgroups and in the total population, and tested changes over time and differences between subgroups. RESULTS: A total of 642 patients were enrolled in the study. Response rates during follow-up ranged between 82% and 88%. For 75% of the patients, 4 distinct groups could be discerned: 26% of patients had continuously high scores for fatigue, 17% had a fast recovery, 25% had a slow recovery, and 32% initially improved but then had a recurrence of fatigue. Patterns for the secondary outcomes of symptoms and functioning were all similar to the pattern for fatigue within each of the subgroups. CONCLUSIONS: The findings of this study suggest a longitudinal relationship between the severity of fatigue, impaired functioning, psychological symptoms, and poor sleep. Physicians should be aware that a substantial proportion of patients seeking care for fatigue have these additional health and psychosocial problems.

Impact of physical symptoms on perceived health in the community.

OBJECTIVE: Physical symptoms, such as musculoskeletal pain, dizziness, or headache, are common. People with more symptoms are reported to use more healthcare and have higher sickness absenteeism. We studied the impact of the number of symptoms on perceived health in a community sample. METHODS: Between June 2005 and March 2006, a random sample of 4741 adults was selected from the records of five general practices in The Netherlands. They were sent a questionnaire regarding the frequency and impact of physical symptoms, and other factors that may influence health (potential confounders or modifiers), including lifestyle factors, childhood illness experiences, and psychological factors. We studied the association between increasing number of physical symptoms and perceived health using the SF-36 as the outcome measure. RESULTS: Response rate was 53.5% (n=2447). Fatigue was the most commonly reported symptom with a prevalence of 57%, followed by headache (40%) and back pain (39%). More than half of responders reported three symptoms or more. Responders with multiple symptoms were more often female, had lower educational level, less often paid work, higher body mass index, more negative childhood health experiences, and higher scores for anxiety and depression. Multiple symptoms were strongly associated with perceived health, especially among responders with negative illness perceptions, more anxiety, or those reporting family members with a chronic illness during childhood. CONCLUSION: Physical symptoms are common and often seem to be mild. However, increasing number of symptoms is strongly associated with poorer physical, emotional, and social functioning. Different somatization processes may explain our findings.

Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research.

OBJECTIVE: Research in general practice has grown considerably over the past decades, but many projects face problems when recruiting patients. Lasagna's Law states that medical investigators overestimate the number of patients available for a research study. We aimed to assess factors related to success or failure of recruitment in general practice research. STUDY DESIGN AND SETTING: Survey among investigators involved in primary care research in The Netherlands. Face-to-face interviews were held with investigators of 78 projects, assessing study design and fieldwork characteristics as well as success of patient recruitment. RESULTS: Studies that focused on prevalent cases were more successful than studies that required incident cases. Studies in which the general practitioner (GP) had to be alert during consultations were less successful. When the GP or practice assistant was the first to inform the patient about the study, patient recruitment was less successful than when the patient received a letter by mail. There was a strong association among these three factors. CONCLUSION: Lasagna's Law also holds in Dutch primary care research: many studies face recruitment problems. Awareness of study characteristics affecting participation of GPs and patients may help investigators to improve their study design.

Good generalizability of a prediction rule for prediction of persistent shoulder pain in the short term.

OBJECTIVE: To evaluate the generalizability of recently developed clinical prediction rules for the prognosis of shoulder pain in general practice. STUDY DESIGN AND SETTING: A large research program, consisting of a prognostic cohort study and three randomized controlled trials with 6 months follow-up, was carried out in The Netherlands. The clinical prediction rules were derived from the results of the prognostic cohort study (n=587). The main outcome measure was persistent symptoms at 6 weeks or 6 months. The control groups of the trials who received usual care were merged (n=212), and used to validate the prediction rules by studying calibration and discrimination. RESULTS: The prediction rule for short-term outcome showed reasonable calibration and discriminative ability in this validation cohort. The area under the receiver operating characteristic curve (AUC) was 0.72 compared to 0.74 in the derivation cohort. The prediction rule for long-term outcome performed less well. Discriminative ability (AUC) decreased to 0.56 in the validation cohort compared to 0.67 in the derivation cohort. CONCLUSION: The prediction rule for the short-term (6 weeks) prognosis showed good generalizability. The prediction rule for the long-term prognosis showed poor generalizability.

The Shoulder Disability Questionnaire differentiated well between high and low disability levels in patients in primary care, in a cross-sectional study.

OBJECTIVES: To investigate the usefulness of the Shoulder Disability Questionnaire (SDQ) for cross-sectional discriminative purposes, we assessed the discriminative ability of items, internal consistency, content validity, and construct validity. STUDY DESIGN AND SETTING: Two hundred patients recruited in primary and secondary care identified their chief functional limitations, scored their shoulder pain, and completed the SDQ. Two physical therapists assessed the range of motion, muscle force, and scored the severity of disability. RESULTS: Comparison of the chief functional limitations of the patients with the SDQ items confirmed the content validity of the SDQ. Cronbach's alpha describing the internal consistency was 0.79. Construct validity was confirmed for patients with different levels of pain, range of active abduction, muscle force, ability to perform activities in daily life, and the severity of disability scored by the physical therapists. However, the differences in the SDQ-score between extreme groups were less evident in the secondary care population. In patients in the secondary care rheumatology clinic, the discriminative ability of most SDQ items was very limited. CONCLUSION: The presented results suggest that the SDQ appears to be a useful discriminative instrument, especially in the primary care setting.

Quality criteria were proposed for measurement properties of health status questionnaires.

OBJECTIVES: Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. STUDY DESIGN AND SETTING: Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. RESULTS: For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. CONCLUSION: Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.

Nurse-led case management for ambulatory complex patients in general health care: a systematic review.

OBJECTIVE: The aim of this study was to summarize the available literature on the effectiveness of ambulatory nurse-led case management for complex patients in general health care. METHOD: We searched MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and Cinahl. We included randomized controlled trials, controlled clinical trials, controlled before/after study, and time series studies; identified references were screened by two reviewers. Two reviewers rated the quality of each article. Data extracted from the selected publications included design, characteristics of the participants, the intervention, type of outcome measures, and results. RESULTS: We identified 10 relevant publications. Nine studies used readmission rate as primary outcome. Fewer studies investigated duration of hospital readmissions, emergency department (ED) visits, functional status, quality of life, or patient satisfaction. In general, results with regard to the effectiveness of case management were conflicting. CONCLUSION: There is moderate evidence that case management has a positive effect on patient satisfaction and no effect on ED visits. It was not possible to draw firm conclusions on the other outcomes.

Prediction of an unfavourable course of low back pain in general practice: comparison of four instruments.

BACKGROUND: Several instruments can be used to identify patients with an unfavourable course of low back pain in general practice. However, it is unclear which instrument is the predictor of outcome. AIM: To compare the predictive performance (that is, calibration and discrimination) of risk estimation by GPs with assessments using the Orebro Musculoskeletal Pain Screening Questionnaire, the Low Back Pain Perception Scale (LBPPS), and a prediction rule developed for this purpose. DESIGN OF STUDY: A prospective cohort study with 1-year follow-up. SETTING: General practice in The Netherlands. METHOD: The outcome 'unfavourable course of low back pain' was defined as having no clinically important improvement at minimally 50% of the measurements at 6, 13, 26, and 52 weeks. Logistic regression analyses were used to study associations between potential predictors and outcome. RESULTS: In total, 60 GPs recruited 314 patients to the study (16 patients were excluded from analysis due to missing data on the course of low back pain). Over a third of patients (112/298) showed an unfavourable course of low back pain on follow-up. Risk estimation by GPs, the Orebro questionnaire, the LBPPS, and the prediction rule had discriminative ability (area under the curve) of 0.59 (95% CI [confidence intervals] = 0.52 to 0.66); 0.61 (95% CI = 0.54 to 0.67); 0.59 (95% CI = 0.52 to 0.66); and 0.75 (95% CI = 0.69 to 0.81) respectively. The prediction rule included history of low back pain, self-perceived risk to develop chronic low back pain, no solicitous responses of the patient's partner (as reported by the patient), frequent walking at work, and 'pain catastrophising'. CONCLUSION: Although the prediction rule performed best with regard to calibration and discrimination, it needs to be externally validated. Risk estimation by GPs performs as well as other instruments and, at present, seems to be the best available option.