Validity and reproducibility of the modified STarT Back Tool (Dutch version) for patients with neck pain in primary care

© 2017 Elsevier Ltd Objective To evaluate the reliability and validity of the Dutch version of the STarT Back screening Tool (SBT), for patients with neck pain. Methods We modified the SBT to fit patients with neck pain. General practitioners and physiotherapists included patients who completed both a baseline and a follow-up questionnaire at 3 days and 3 months, respectively. The construct validity was assessed using Pearson's correlation between the SBT and the reference questionnaires. The reproducibility was assessed in the first week using the quadratic weighted kappa and the specific agreement. Predictive validity was assessed using a relative-risk ratio (RR) for, amongst others, persisting disability at 3 months. Content validity was analysed using both floor and ceiling effects. Results In total, 100 patients were included; 58% were categorised as being at “low risk” for persisting disability, 37% at “medium risk” and 5% at “high risk”. As expected for the construct validity, we found a moderate to high correlation for all questions except for activity question 3. The reproducibility had a quadratic-weighted kappa of 0.58, and a specific agreement of 90.9% for “low-risk” and 66.7% for “medium-risk” patients. The RRs for persisting disability for “medium-risk” against “low-risk” patients were 1.5 (95% C.I. 0.9–2.4) and 1.5 (95% C.I. 0.5–4.1) for pain. The sample size for high-risk patients was low. Conclusion The original SBT is modified to fit patients with neck pain in Dutch primary care. The psychometric analysis indicates sufficiently reliable outcomes, although the predictive validity showed statistically insignificant results

Red flags presented in current low back pain guidelines: a review.

OBJECTIVE: The purpose of this study was to identify and descriptively compare the red flags endorsed in guidelines for the detection of serious pathology in patients presenting with low back pain to primary care. METHOD: We searched databases, the World Wide Web and contacted experts aiming to find the multidisciplinary clinical guideline in low back pain in primary care, and selected the most recent one per country. We extracted data on the number and type of red flags for identifying patients with higher likelihood of serious pathology. Furthermore, we extracted data on whether or not accuracy data (sensitivity/specificity, predictive values, etc.) were presented to support the endorsement of specific red flags. RESULTS: We found 21 discrete guidelines all published between 2000 and 2015. One guideline could not be retrieved and after selecting one guideline per country we included 16 guidelines in our analysis from 15 different countries and one for Europe as a whole. All guidelines focused on the management of patients with low back pain in a primary care or multidisciplinary care setting. Five guidelines presented red flags in general, i.e., not related to any specific disease. Overall, we found 46 discrete red flags related to the four main categories of serious pathology: malignancy, fracture, cauda equina syndrome and infection. The majority of guidelines presented two red flags for fracture ('major or significant trauma' and 'use of steroids or immunosuppressors') and two for malignancy ('history of cancer' and 'unintentional weight loss'). Most often pain at night or at rest was also considered as a red flag for various underlying pathologies. Eight guidelines based their choice of red flags on consensus or previous guidelines; five did not provide any reference to support the choice of red flags, three guidelines presented a reference in general, and data on diagnostic accuracy was rarely provided. CONCLUSION: A wide variety of red flags was presented in guidelines for low back pain, with a lack of consensus between guidelines for which red flags to endorse. Evidence for the accuracy of recommended red flags was lacking

Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study.

OBJECTIVE: To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders. METHODS: We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core. RESULTS: In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains. CONCLUSIONS: Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration

The Effectiveness of Treatments for Patients With Medication Overuse Headache: A Systematic Review and Meta-Analysis

© 2016 American Pain Society Worldwide, approximately 1 to 2% of the adult population suffers from chronic headache due to overuse of pain medication. Guidelines recommend acute withdrawal of medication, but the optimal treatment remains unknown. We aimed to evaluate the benefit of treatments for patients with medication overuse headache (MOH). We performed an extensive literature search until November 2015, selecting randomized controlled trials that evaluated interventions for adults with MOH. Two authors assessed the eligible trials and extracted data. We calculated effect estimates and used the random effects model for the pooled analysis. Our primary outcome measures were ‘headache days’ and ‘days with medication.’ Outcome data were categorized as short-term (up to 12 weeks) or long-term (≥12 weeks) outcomes. This review consists of 16 trials including 1,105 patients. Four trials evaluated the use of prednisone with placebo or celecoxib after medication withdrawal; 7 trials evaluated various methods of withdrawal versus other methods of withdrawal, and 5 trials evaluated prophylactic medication compared with placebo or ibuprofen. We found no significant differences in headache days between prednisone versus placebo or between outpatient versus inpatient treatment, but we found a significant difference in days with medication. Overall, we found no benefit of prophylactic medication versus placebo. We found low to very low quality of evidence of no benefit of prednisone, prophylaxis, and various withdrawal interventions. Because the burden of MOH for patients is enormous, larger and high-quality intervention trials are needed. Perspective This article presents a critical look at studies of patients with MOHs. It appears that the withdrawal strategy remains the best treatment option, although there is scant evidence on the efficacy of any treatment options

Few promising multivariable prognostic models exist for recovery of people with non-specific neck pain in musculoskeletal primary care: a systematic review

© 2017 Australian Physiotherapy Association Question Which multivariable prognostic model(s) for recovery in people with neck pain can be used in primary care? Design Systematic review of studies evaluating multivariable prognostic models. Participants People with non-specific neck pain presenting at primary care. Determinants Baseline characteristics of the participants. Outcome measures Recovery measured as pain reduction, reduced disability, or perceived recovery at short-term and long-term follow-up. Results Fifty-three publications were included, of which 46 were derivation studies, four were validation studies, and three concerned combined studies. The derivation studies presented 99 multivariate models, all of which were at high risk of bias. Three externally validated models generated usable models in low risk of bias studies. One predicted recovery in non-specific neck pain, while two concerned participants with whiplash-associated disorders (WAD). Discriminative ability of the non-specific neck pain model was area under the curve (AUC) 0.65 (95% CI 0.59 to 0.71). For the first WAD model, discriminative ability was AUC 0.85 (95% CI 0.79 to 0.91). For the second WAD model, specificity was 99% (95% CI 93 to 100) and sensitivity was 44% (95% CI 23 to 65) for prediction of non-recovery, and 86% (95% CI 73 to 94) and 55% (95% CI 41 to 69) for prediction of recovery, respectively. Initial Neck Disability Index scores and age were identified as consistent prognostic factors in these three models. Conclusion Three externally validated models were found to be usable and to have low risk of bias, of which two showed acceptable discriminative properties for predicting recovery in people with neck pain. These three models need further validation and evaluation of their clinical impact before their broad clinical use can be advocated. Registration PROSPERO CRD42016042204. [Wingbermühle RW, van Trijffel E, Nelissen PM, Koes B, Verhagen AP (2018) Few promising multivariable prognostic models exist for recovery of people with non-specific neck pain in musculoskeletal primary care: a systematic review. Journal of Physiotherapy 64: 16–23

Prospective Cohort Study of Patients With Neck Pain in a Manual Therapy Setting: Design and Baseline Measures.

OBJECTIVES:The purpose of this study was to describe the design and baseline measurements of a prospective multicenter cohort study in patients with neck pain treated by Dutch manual therapists. Objectives of the study were to determine which patients seek help from a manual therapist, to describe usual care manual therapy in patients with neck pain, to examine the occurrence of nonserious adverse events after treatment, to describe predictors of adverse events, and to determine whether the occurrence of nonserious adverse events affect outcome after manual therapy care. METHODS:During a 3-month inclusion period, consecutive patients aged between 18 and 80 years presenting with neck pain in manual therapy practices in The Netherlands were included in the study. Baseline questionnaires included the Numeric Rating Scale, Neck Disability Index (NDI), Neck Bournemouth Questionnaire, Fear Avoidance Beliefs Questionnaire (FABQ), and Patient Expectancy List. Within the treatment episode, manual therapist clinical reasoning and applied interventions were registered and patients reported on adverse events. At the end of the treatment episode and at 12-month follow-up, pain intensity (Numeric Rating Scale), functional outcomes (NDI, Neck Bournemouth Questionnaire), personal factors (FABQ), and global perceived effect were measured. RESULTS:During the 3-month inclusion period, 263 participating manual therapists collected data on 1193 patients with neck pain. Most patients (69.4%) were female. The mean age was 44.7 (±13.7) years. The NDI showed overall mild disability (mean score 26%). Mean scores in pain intensity were moderate (4.8), and there was low risk of prolonged disability owing to personal factors (FABQ). CONCLUSION:This study provides information on baseline characteristics of patients visiting manual therapists for neck pain. In The Netherlands, patients seeking care of manual therapists are comparable to patients in other countries regarding demographics and neck pain characteristics

Think twice before starting a new trial; what is the impact of recommendations to stop doing new trials?

ObjectivesIn evidence-based medicine, we base our conclusions on the effectiveness of interventions on the results of high-quality meta-analysis. If a new randomized controlled trial (RCT) is unlikely to change the pooled effect estimate, conducting the new trial is a waste of resources. We evaluated whether recommendations not to conduct further RCTs reduced the number of trials registered for two scenarios.MethodsAnalysis of registered trials on the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP). We regarded trial protocols relevant if they evaluated the effectiveness of (1) exercise for chronic low back pain (LBP) and (2) cognitive behavioural therapy (CBT) for chronic pain. We calculated absolute and relative numbers and change of registered trials in a pre-set time window before and after publication of the recommendations, both published in 2012.ResultsWe found 1,574 trials registered in the WHO trial registry for exercise in LBP (459 before 2012; 1,115 after) and 5,037 trials on chronic pain (1,564 before 2012; 3,473 after). Before 2012, 13 trials on exercise for LBP (out of 459) fit the selection criteria, compared to 42 trials (out of 1,115) after, which represents a relative increase of 33%. Twelve trials (out of 1,564) regarding CBT for chronic pain, fit the selection criteria before 2012 and 18 trials (out of 3,473) after, representing a relative decrease of 32%. We found that visibility, media exposure and strength of the recommendation were related to a decrease in registered trials.ConclusionsRecommendations not to conduct further RCTs might reduce the number of trials registered if these recommendations are strongly worded and combined with social media attention

Risk models for lower extremity injuries among short- and long distance runners: A prospective cohort study

© 2018 Background: Running injuries are very common. Risk factors for running injuries are not consistently described across studies and do not differentiate between runners of long- and short distances within one cohort. Objectives: The aim of this study is to determine risk factors for running injuries in recreational long- and short distance runners separately. Design: A prospective cohort study. Methods: Recreational runners from four different running events are invited to participate. They filled in a baseline questionnaire assessing possible risk factors about 4 weeks before the run and one a week after the run assessing running injuries. Using logistic regression we developed an overall risk model and separate risk models based on the running distance. Results: In total 3768 runners participated in this study. The overall risk model contained 4 risk factors: previous injuries (OR 3.7) and running distance during the event (OR 1.3) increased the risk of a running injury whereas older age (OR 0.99) and more training kilometers per week (OR 0.99) showed a decrease. Models between short- and long distance runners did not differ significantly. Previous injuries increased the risk of a running injury in all models, while more training kilometers per week decreased this risk. Conclusions: We found that risk factors for running injuries were not related to running distances. Previous injury is a generic risk factor for running injuries, as is weekly training distance. Prevention of running injuries is important and a higher weekly training volume seems to prevent injuries to a certain extent

External validation of prognostic models for recovery in patients with neck pain

BackgroundNeck pain is one of the leading causes of disability in most countries and it is likely to increase further. Numerous prognostic models for people with neck pain have been developed, few have been validated. In a recent systematic review, external validation of three promising models was advised before they can be used in clinical practice.ObjectiveThe purpose of this study was to externally validate three promising models that predict neck pain recovery in primary care.MethodsThis validation cohort consisted of 1311 patients with neck pain of any duration who were prospectively recruited and treated by 345 manual therapists in the Netherlands. Outcome measures were disability (Neck Disability Index) and recovery (Global Perceived Effect Scale) post-treatment and at 1-year follow-up. The assessed models were an Australian Whiplash-Associated Disorders (WAD) model (Amodel), a multicenter WAD model (Mmodel), and a Dutch non-specific neck pain model (Dmodel). Models' discrimination and calibration were evaluated.ResultsThe Dmodel and Amodel discriminative performance (AUC ConclusionsExternal validation of promising prognostic models for neck pain recovery was not successful and their clinical use cannot be recommended. We advise clinicians to underpin their current clinical reasoning process with evidence-based individual prognostic factors for recovery. Further research on finding new prognostic factors and developing and validating models with up-to-date methodology is needed for recovery in patients with neck pain in primary care

Development and internal validation of prognostic models for recovery in patients with non-specific neck pain presenting in primary care

Objectives: Development and internal validation of prognostic models for post-treatment and 1-year recovery in patients with neck pain in primary care. Design: Prospective cohort study. Setting: Primary care manual therapy practices. Participants: Patients with non-specific neck pain of any duration (n = 1193). Intervention: Usual care manual therapy. Outcome measures: Recovery defined in terms of pain intensity, disability, and global perceived improvement directly post-treatment and at 1-year follow-up. Results: All post-treatment models exhibited acceptable discriminative performance after derivation (AUC ≥ 0.7). The developed post-treatment disability model exhibited the best overall performance (R2 = 0.24; IQR, 0.22–0.26), discrimination (AUC = 0.75; 95% CI, 0.63–0.84), and calibration (slope 0.92; IQR, 0.91–0.93). After internal validation and penalization, this model retained acceptable discriminative performance (AUC = 0.74). The five other models, including those predicting 1-year recovery, did not reach acceptable discriminative performance after internal validation. Baseline pain duration, disability, and pain intensity were consistent predictors across models. Conclusion: A post-treatment prognostic model for disability was successfully developed and internally validated. This model has potential to inform primary care clinicians about a patient’s individual prognosis after treatment, but external validation is required before clinical use can be recommended