Patient-Reported Outcome Measures Used for Neck Disorders: An Overview of Systematic Reviews.

BACKGROUND: The evaluation of patient-reported outcome measures for the neck from multiple systematic reviews will provide a broader view of, and may identify potential conflicting or consistent results for, their psychometric properties. OBJECTIVES: The purpose of this study was to conduct an overview of systematic reviews and synthesize evidence to establish the current state of knowledge on psychometric properties of patient-reported outcome measures for patients with neck disorders. METHODS: In this overview of systematic reviews, an electronic search of 6 databases (MEDLINE, Embase, CINAHL, ILC, the Cochrane Central Register of Controlled Trials, and LILACS) was conducted to identify reviews that addressed at least one measurement property of outcome measures for people with neck pain. Only systematic reviews with patient-reported outcome measures were included in the analysis. Risk of bias was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR). Data on measurement properties were extracted from each systematic review. RESULTS: From 13 systematic reviews, 8 patient-reported outcome measures were evaluated in 2 or more reviews. Risk-of-bias scores ranged from moderate (5-7) to high (4 and lower). Findings on internal consistency, test-retest reliability, construct validity, responsiveness to change, and content and structural validity were synthesized for the Neck Disability Index (NDI) in 11 systematic reviews; the Northwick Park Neck Pain Questionnaire and Neck Pain and Disability scale (NPDS) in 6 systematic reviews; the Copenhagen Neck Functional Disability Scale in 5 systematic reviews; the Neck Bournemouth Questionnaire in 4 systematic reviews; the Core Neck Pain Questionnaire and Patient-Specific Functional Scale in 3 systematic reviews, and the Whiplash Disability Questionnaire in 2 systematic reviews. CONCLUSION: High-quality evidence was found of good to excellent internal consistency and moderate to excellent test-retest reliability for the NDI. Moderate-quality evidence was found of good to excellent internal consistency and good test-retest reliability for the Northwick Park Neck Pain Questionnaire. High-quality evidence was found of excellent test-retest reliability and good to strong construct validity with pain scales for the Copenhagen Neck Functional Disability Scale. Moderate-quality evidence was found of unclear to excellent internal consistency and moderate to strong concurrent associations with the NDI and global assessment of change for the Neck Pain and Disability scale. Moderate-quality evidence was found of excellent internal consistency for the Whiplash Disability Questionnaire and of high test-retest reliability for the Patient-Specific Functional Scale. J Orthop Sports Phys Ther 2018;48(10):775-788. Epub 22 Jun 2018. doi:10.2519/jospt.2018.8131.

A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults.

BACKGROUND: Healthcare systems are not well designed to help people maintain or improve their health. They are generally not person-focused or well-coordinated. The objective of this study is to evaluate the effectiveness of the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) approach in older adults. The overarching hypothesis is that using the Health TAPESTRY approach to achieve better integration of the health and social care systems into a person's life that centers on meeting a person's health goals and needs will result in optimal aging. METHODS/DESIGN: This is a 12-month delayed intervention pragmatic randomized controlled trial. The study will be performed in Hamilton, Ontario, Canada in the two-site McMaster Family Health Team. Participants will include 316 patients who are 70 years of age or older. Participants will be randomized to the Health TAPESTRY approach or control group. The Health TAPESTRY approach includes intentional, proactive conversations about a person's life and health goals and health risks and then initiation of congruent tailored interventions that support achievement of those goals and addressing of risks through (1) trained volunteers visiting clients in their homes to serve as a link between the primary care team and the client; (2) the use of novel technology including a personal health record from the home to link directly with the primary healthcare team; and (3) improved processes for connections, system navigation, and care delivery among interprofessional primary care teams, community service providers, and informal caregivers. The primary outcome will be the goal attainment scaling score. Secondary outcomes include self-efficacy for managing chronic disease, quality of life, the participant perspective on their own aging, social support, access to health services, comprehensiveness of care, patient empowerment, patient-centeredness, caregiver strain, satisfaction with care, healthcare resource utilization, and cost-effectiveness. Implementation processes will also be evaluated. The main comparative analysis will take place at 6 months. DISCUSSION: Evidence of the individual elements of the Health TAPESTRY platform has been shown in isolation in the previous research. However, this study will better understand how to best integrate them to maximize the system's transformation of person-focused, primary care for older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT02283723.

Pharmacological, psychological, and patient education interventions for patients with neck pain: results of an international survey.

BACKGROUND: Examination of practice patterns compared to existing evidence identifies knowledge to practice gaps. OBJECTIVES: To describe the utilization of pharmacological, patient education, primary psychological interventions and relaxation therapies in patients with neck pain by clinicians. METHODS: An international cross-sectional survey was conducted to determine the use of these interventions amongst 326 clinicians treating patients with neck pain. RESULTS: Nineteen countries participated. Results were analyzed by usage amongst physical therapists (39%) and chiropractors (35%), as they were the predominant respondents. Patient education (95%) and relaxation therapies (59%) were the most utilized interventions. Tests of subgroup differences determined that physical therapists used patient education significantly more than chiropractors. Use of medications and primary psychological interventions were reported by most to be outside of scope of practice. The high rate of patient education is consistent with supporting evidence. However, usage of relaxation therapies is contrary to evidence suggesting no benefit for improved pain or function for chronic neck pain. CONCLUSION: This survey indicates that patient education and relaxation therapies are common treatments provided by chiropractors and physical therapists for patients with neck pain. Future research should address gaps associated with variable practice patterns and knowledge translation to reduce usage of interventions shown to be ineffective.

Use of BNP and NT-proBNP for the diagnosis of heart failure in the emergency department: a systematic review of the evidence.

Our purpose was to determine the test performance characteristics of BNP and NT-proBNP in the diagnosis of heart failure for patients presenting to an emergency department or urgent care center. We searched Medline, Embase, AMED, Cochrane, Cochrane Database of Systematic Reviews, and CINAHL for English-language articles published between 1989 and June 2012. Studies were limited to those using FDA-approved assays. We examined test performance at three pre-specified cutpoints (manufacturers' suggested, researchers' optimal, and lowest) and considered the effect of age, gender, ethnicity and renal function. We used the QUADAS-2 tool to examine risk of bias and applicability, and the AHRQ Methods Guide to assess the strength of evidence. Seventy-six articles met our inclusion criteria, 37 examined BNP, 25 examined NT-proBNP, and 14 examined both. Pooled sensitivity and specificity for BNP at the three pre-specified cutpoints were 95, 91, and 95 % (sensitivity) and 55, 80, and 67 % (specificity), respectively. For NT-proBNP, sensitivity and specificity at the same cutpoints were 91, 90, and 96 % (sensitivity) and 67, 74, and 55 % (specificity). Both BNP and NT-proBNP perform well to rule out, but less well to rule in, the diagnosis of heart failure among persons presenting to emergency departments or urgent care centers. Both BNP and NT-proBNP levels are positively associated with age and negatively associated with renal function. However, the effect of these factors with respect to selecting optimal cutpoints is unclear. For BNP, 100 pg/mL appears to be a consensus cutpoint. No clear consensus has emerged for NT-proBNP, but the age-adjusted cutpoints of 450 pg/mL for <50 years, 900 pg/mL for 50-75 years and 1,800 pg/mL for >75 years appear promising and merit greater scrutiny and validation.

Performance of BNP and NT-proBNP for diagnosis of heart failure in primary care patients: a systematic review.

National and international guidelines have been published recommending the use of natriuretic peptides as an aid to the diagnosis of heart failure (HF) in acute settings; however, few specific recommendations exist for governing the use of these peptides in primary care populations. To summarize the available data relevant to the diagnosis of HF in primary care patient population, we systematically reviewed the literature to identify original articles that investigated the diagnostic accuracy of B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) in primary care settings. The search yielded 25,864 articles in total: 12 investigating BNP and 20 investigating NT-proBNP were relevant to our objective and included in the review. QUADAS-2 and GRADE were used to assess the quality of the included articles. Diagnostic data were pooled based on three cutpoints: lowest and optimal, as chosen by study authors, and manufacturers' suggested. The effect of various determinants (e.g., age, gender, BMI, and renal function) on diagnostic performance was also investigated. Pooled sensitivity and specificity of BNP and NT-proBNP using the lowest [0.85 (sensitivity) and 0.54 (specificity)], optimal (0.80 and 0.61), and manufacturers' (0.74 and 0.67) cutpoints showed good performance for diagnosing HF. Similar performance was seen for NT-proBNP: lowest (0.90 and 0.50), optimal (0.86 and 0.58), and manufacturers' (0.82 and 0.58) cutpoints. Overall, we rated the strength of evidence as high because further studies will be unlikely to change the estimates diagnostic performance.

Treatment preferences amongst physical therapists and chiropractors for the management of neck pain: results of an international survey.

BACKGROUND: Clinical practice guidelines on the management of neck pain make recommendations to help practitioners optimize patient care. By examining the practice patterns of practitioners, adherence to CPGs or lack thereof, is demonstrated. Understanding utilization of various treatments by practitioners and comparing these patterns to that of recommended guidelines is important to identify gaps for knowledge translation and improve treatment regimens. AIM: To describe the utilization of interventions in patients with neck pain by clinicians. METHODS: A cross-sectional international survey was conducted from February 2012 to March 2013 to determine physical medicine, complementary and alternative medicine utilization amongst 360 clinicians treating patients with neck pain. RESULTS: The survey was international (19 countries) with Canada having the largest response (38%). Results were analyzed by usage amongst physical therapists (38%) and chiropractors (31%) as they were the predominant respondents. Within these professions, respondents were male (41-66%) working in private practice (69-95%). Exercise and manual therapies were consistently (98-99%) used by both professions but tests of subgroup differences determined that physical therapists used exercise, orthoses and 'other' interventions more, while chiropractors used phototherapeutics more. However, phototherapeutics (65%), Orthoses/supportive devices (57%), mechanical traction (55%) and sonic therapies (54%) were not used by the majority of respondents. Thermal applications (73%) and acupuncture (46%) were the modalities used most commonly. Analysis of differences across the subtypes of neck pain indicated that respondents utilize treatments more often for chronic neck pain and whiplash conditions, followed by radiculopathy, acute neck pain and whiplash conditions, and facet joint dysfunction by diagnostic block. The higher rates of usage of some interventions were consistent with supporting evidence (e.g. manual therapy). However, there was moderate usage of a number of interventions that have limited support or conflicting evidence (e.g. ergonomics). CONCLUSIONS: This survey indicates that exercise and manual therapy are core treatments provided by chiropractors and physical therapists. Future research should address gaps in evidence associated with variable practice patterns and knowledge translation to reduce usage of some interventions that have been shown to be ineffective.

Psychological Care, Patient Education, Orthotics, Ergonomics and Prevention Strategies for Neck Pain: An Systematic Overview Update as Part of the ICON Project.

OBJECTIVES: To conduct an overview on psychological interventions, orthoses, patient education, ergonomics, and 1°/2° neck pain prevention for adults with acute-chronic neck pain. SEARCH STRATEGY: Computerized databases and grey literature were searched (2006-2012). SELECTION CRITERIA: Systematic reviews of randomized controlled trials (RCTs) on pain, function/disability, global perceived effect, quality-of-life and patient satisfaction were retrieved. DATA COLLECTION & ANALYSIS: Two independent authors selected articles, assessed risk of bias using AMSTAR tool and extracted data. The GRADE tool was used to evaluate the body of evidence and an external panel to provide critical review. MAIN RESULTS: We retrieved 30 reviews (5-9 AMSTAR score) reporting on 75 RCTs with the following moderate GRADE evidence. For acute whiplash associated disorder (WAD), an education video in emergency rooms (1RCT, 405participants] favoured pain reduction at long-term follow-up thus helping 1 in 23 people [Standard Mean Difference: -0.44(95%CI: -0.66 to -0.23)). Use of a soft collar (2RCTs, 1278participants) was not beneficial in the long-term. For chronic neck pain, a mind-body intervention (2RCTs, 1 meta-analysis, 191participants) improved short-term pain/function in 1 of 4 or 6 participants. In workers, 2-minutes of daily scapula-thoracic endurance training (1RCT, 127participants) over 10 weeks was beneficial in 1 of 4 participants. A number of psychosocial interventions, workplace interventions, collar use and self-management educational strategies were not beneficial. REVIEWERS' CONCLUSIONS: Moderate evidence exists for quantifying beneficial and non-beneficial effects of a limited number of interventions for acute WAD and chronic neck pain. Larger trials with more rigorous controls need to target promising interventions.

Results of an International Survey of Practice Patterns for Establishing Prognosis in Neck Pain: The ICON Project.

Results of an international survey of health care providers for neck pain are reported. The survey specifically collected self-reported practice patterns for establishing a prognosis in neck pain. Over 440 responses from 27 countries were collected. Descriptive results indicate that respondents assigned large prognostic impact to factors including mechanism of injury and psychological or behavioral constructs. Range of motion, age and sex were routinely collected despite relatively moderate impact on prognosis. A comparison between chiropractic and manual/physical therapy groups showed differences in practice patterns that were unlikely to affect prognostic accuracy. The results suggest a gap exists between current best-evidence and actual practice when the goal is to establish a prognosis in neck pain.

A description of the methodology used in an overview of reviews to evaluate evidence on the treatment, harms, diagnosis/classification, prognosis and outcomes used in the management of neck pain.

BACKGROUND: Neck Pain (NP) is a common musculoskeletal disorder and the literature provides conflicting evidence about its management. OBJECTIVE: To describe the methodology used to conduct an overview of reviews (OvR) and to characterize the distribution and risk of bias profiles across the evidence for all areas of NP management. METHODS: Standard systematic review (SR) methodology was employed. MEDLINE, CINAHL, EMBASE, ILC, Cochrane CENTRAL, and LILACS were searched from 2000 to March 2012; Narrative and SR and clinical practice guidelines (CPG) evaluating the efficacy of treatment (benefits and harms), diagnosis/classification, prognosis, and outcomes were eligible. For treatment, articles were limited to SRs from 2005 forward. Risk of bias of SR was assessed with the AMSTAR; the AGREE II was used to critically appraise the CPGs. RESULTS: From 2476 articles, 508 were eligible for full text screening. A total of 341 articles were included. Treatment (n=117) had the greatest yield. Other clinical areas had less literature (diagnosis=54, prognosis=16, outcomes=27, harms=16). There were no SR for classification and narrative reviews were problematic for this topic. There was great overlap across different databases within each clinical area except for those for outcome measures. Risk of bias assessment using the AMSTAR of eligible SRs showed a similar trend across different clinical areas. CONCLUSION: A summary of methods used to review the literature in five clinical areas of NP management have been described. The challenges of selecting and synthesizing eligible articles in an OvR required customized solutions across different areas of clinical focus.

An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project.

Given the challenges of chronic musculoskeletal pain and disability, establishing a clear prognosis in the acute stage has become increasingly recognized as a valuable approach to mitigate chronic problems. Neck pain represents a condition that is common, potentially disabling, and has a high rate of transition to chronic or persistent problems. As a field of research, prognosis in neck pain has stimulated several empirical primary research papers, and a number of systematic reviews. As part of the International Consensus on Neck (ICON) project, we sought to establish the general state of knowledge in the area through a structured, systematic review of systematic reviews (overview). An exhaustive search strategy was created and employed to identify the 13 systematic reviews (SRs) that served as the primary data sources for this overview. A decision algorithm for data synthesis, which incorporated currency of the SR, risk of bias assessment of the SRs using AMSTAR scoring and consistency of findings across SRs, determined the level of confidence in the risk profile of 133 different variables. The results provide high confidence that baseline neck pain intensity and baseline disability have a strong association with outcome, while angular deformities of the neck and parameters of the initiating trauma have no effect on outcome. A vast number of predictors provide low or very low confidence or inconclusive results, suggesting there is still much work to be done in this field. Despite the presence of multiple SR and this overview, there is insufficient evidence to make firm conclusions on many potential prognostic variables. This study demonstrates the challenges in conducting overviews on prognosis where clear synthesis critieria and a lack of specifics of primary data in SR are barriers.

Use of outcome measures in managing neck pain: an international multidisciplinary survey.

PURPOSE: To determine the outcome measures practice patterns in the neck pain management of various health disciplines. METHODS: A survey of 381 clinicians treating patients with neck pain was conducted. RESULTS: Respondents were more commonly male (54%) and either chiropractors (44%) or physiotherapists (32%). The survey was international (24 countries with Canada having the largest response (44%)). The most common assessment was a single-item pain assessment (numeric or visual analog) used by 75% of respondents. Respondents sometimes or routinely used the Neck Disability Index (49%), the Patient Specific Functional Scale (28%), and the Disabilities of the Arm, Shoulder and Hand (32%). Work status was recorded in terms of time lost by more than 50% of respondents, but standardized measures of work limitations or functional capacity testing were rarely used. The majority of respondents never used fear of movement, psychological distress, quality of life, participation measures, or global ratings of change (< 10% routinely use). Use of impairment measurers was prevalent, but the type selected was variable. Quantitative sensory testing was used sometimes or routinely by 53% of respondents, whereas 26% never used it. Ratings of segmental joint mobility were commonly used to assess motion (44% routinely use), whereas 66% of respondents never used inclinometry. Neck muscle strength, postural alignment and upper extremity coordination were assessed sometimes or routinely by a majority of respondents (>56%). With the exception of numeric pain ratings and verbal reporting of work status, all outcomes measures were less frequently used by physicians. Years of practice did not affect practice patterns, but reimbursement did affect selection of some outcome measures. CONCLUSIONS: Few outcome measures are routinely used to assess patients with neck pain other than a numeric pain rating scale. A comparison of practice patterns to current evidence suggessts overutilization of some measures that have questionable reliability and underutilization of some with better supporting evidence. This practice analysis suggests that there is substantial need to implement more consistent outcome measurement in practice. International consensus and better clinical measurement evidence are needed to support this.

An ICON Overview on Physical Modalities for Neck Pain and Associated Disorders.

INTRODUCTION: Neck pain is common, can be disabling and is costly to society. Physical modalities are often included in neck rehabilitation programs. Interventions may include thermal, electrotherapy, ultrasound, mechanical traction, laser and acupuncture. Definitive knowledge regarding optimal modalities and dosage for neck pain management is limited. PURPOSE: To systematically review existing literature to establish the evidence-base for recommendations on physical modalities for acute to chronic neck pain. METHODS: A comprehensive computerized and manual search strategy from January 2000 to July 2012, systematic review methodological quality assessment using AMSTAR, qualitative assessment using a GRADE approach and recommendation presentation was included. Systematic or meta-analyses of studies evaluating physical modalities were eligible. Independent assessment by at least two review team members was conducted. Data extraction was performed by one reviewer and checked by a second. Disagreements were resolved by consensus. RESULTS: Of 103 reviews eligible, 20 were included and 83 were excluded. Short term pain relief - Moderate evidence of benefit: acupuncture, intermittent traction and laser were shown to be better than placebo for chronic neck pain. Moderate evidence of no benefit: pulsed ultrasound, infrared light or continuous traction was no better than placebo for acute whiplash associated disorder, chronic myofascial neck pain or subacute to chronic neck pain. There was no added benefit when hot packs were combined with mobilization, manipulation or electrical muscle stimulation for chronic neck pain, function or patient satisfaction at six month follow-up. CONCLUSIONS: The current state of the evidence favours acupuncture, laser and intermittent traction for chronic neck pain. Some electrotherapies show little benefit for chronic neck pain. Consistent dosage, improved design and long term follow-up continue to be the recommendations for future research.

A survey of patient's perceptions of what is "adverse" in manual physiotherapy and predicting who is likely to say so.

OBJECTIVES: The primary objective was to describe the patient perspective regarding the identification and occurrence of adverse responses related to manual therapy. A secondary objective evaluated predictors of the incidence rate of adverse responses identified by patients receiving manual physiotherapy. STUDY DESIGN AND SETTING: A cross-sectional survey of patients receiving manual physiotherapy recruited by physiotherapists in Canada was conducted. The survey included questions about the symptoms patients identified as adverse, causal associations with treatment, and the impact of contextual factors. Descriptive statistics are reported, and Poisson modeling predicted factors associated with identification of adverse responses. RESULTS: A response rate of 76.2% (324 of 425) was obtained. Having lumbar spine dysfunction was a significant predictor of all adverse responses (incidence rate ratio [IRR] 95% confidence interval [CI] = 1.513 [1.025, 2.235], P = 0.037) and was associated with 51% greater identification of adverse responses compared with those with an extremity disorder. Expectation of soreness was "protective" against identifying major adverse responses (IRR [95% CI] = 0.915 [0.838, 0.999], P = 0.047); they had an 8.5% lower rate of identifying major adverse responses relative to those without this expectation. CONCLUSIONS: The patient perspective is important to consider if a comprehensive framework for defining adverse responses in manual therapies is to be developed.

Testing the risk of bias tool showed low reliability between individual reviewers and across consensus assessments of reviewer pairs.

OBJECTIVES: To assess the reliability of the Cochrane Risk of Bias (ROB) tool between individual raters and across consensus agreements of pairs of reviewers and examine the impact of study-level factors on reliability. STUDY DESIGN AND SETTING: Two reviewers assessed risk of bias for 154 randomized controlled trials (RCTs). For 30 RCTs, two reviewers from each of four centers assessed risk of bias and reached consensus. We assessed interrater agreement using kappas and the impact of study-level factors through subgroup analyses. RESULTS: Reliability between two reviewers was fair for most domains (κ=0.24-0.37), except sequence generation (κ=0.79, substantial). Reliability results across reviewer pairs: sequence generation, moderate (κ=0.60); allocation concealment and "other sources of bias," fair (κ=0.37-0.27); and other domains, slight (κ=0.05-0.09). Reliability was influenced by the nature of the outcome, nature of the intervention, study design, trial hypothesis, and funding source. Variability resulted from different interpretation of the tool rather than different information identified in the study reports. CONCLUSION: Low agreement has implications for interpreting systematic reviews. These findings suggest the need for detailed guidance in assessing the risk of bias.

Beliefs and practice patterns in spinal manipulation and spinal motion palpation reported by canadian manipulative physiotherapists.

PURPOSE: This practice survey describes how Fellows of the Canadian Academy of Manipulative Physiotherapy (FCAMPT) use spinal manipulation and mobilization and how they perceive their competence in performing spinal assessment; it also quantifies relationships between clinical experience and use of spinal manipulation. METHODS: A cross-sectional survey was designed based on input from experts and the literature was administered to a random sample of the FCAMPT mailing list. Descriptive (including frequencies) and inferential statistical analyses (including linear regression) were performed. RESULTS: The response rate was 82% (278/338 eligible FCAMPTs). Most (99%) used spinal manipulation. Two-thirds (62%) used clinical presentation as a factor when deciding to mobilize or manipulate. The least frequently manipulated spinal region was the cervical spine (2% of patients); 60% felt that cervical manipulation generated more adverse events. Increased experience was associated with increased use of upper cervical manipulation among male respondents (14% more often for every 10 years after certification; ß, 95% CI=1.37, 0.89-1.85, p<0.001) but not among female respondents. Confidence in palpation accuracy decreased in lower regions of the spine. CONCLUSION: The use of spinal manipulation/mobilization is prevalent among FCAMPTs, but is less commonly used in the neck because of a perceived association with adverse events.

Objectif: Cette enquête sur la pratique explique comment les membres de la Canadian Academy of Manipulative Physiotherapy (CAMPT) utilisent la manipulation ou la mobilisation vertébrale et comment ils perçoivent leur compétence en évaluation vertébrale. Elle visait également à quantifier la relation entre l'expérience clinique et l'utilisation de la manipulation vertébrale. Méthode: Une enquête transversale a été conçue à partir des observations d'experts et de la littérature. Son questionnaire a ensuite été envoyé à un échantillon aléatoire de membres de la CAMPT apparaissant sur la liste d'envoi de cet organisme. Des analyses descriptives (y compris les fréquences) et des analyses statistiques par inférence (y compris une régression linéaire) ont été réalisées. Résultats: Le taux de réponse était de 82% (278 de 338 membres admissibles de la CAMPT). La plupart des répondants (99%) ont recours à la manipulation vertébrale. Les deux tiers (62%) ont utilisé la présentation clinique comme facteur au moment de décider de mobiliser ou de manipuler. La région vertébrale le moins fréquemment manipulée était la colonne cervicale (2% des patients); 60% des répondants estiment que la manipulation cervicale engendre plus d'effets indésirables. Une plus grande expérience était associée à une plus grande utilisation de la manipulation cervicale supérieure chez les répondants de sexe masculin (14% plus souvent pour chaque tranche de 10 ans suivant l'agrément); ß1,37, IC de 95%=0,89­1,85, p<0,001, mais ce n'était pas le cas chez les répondants de sexe féminin. La confiance dans la précision de la palpation diminuait pour les zones inférieures de la colonne vertébrale. Conclusion: La manipulation ou la mobilisation vertébrale est plus fréquemment utilisée par les membres de la CAMPT, mais est moins couramment utilisée pour le cou en raison de son association à des effets indésirables.

Determining adverse events in patients with neck pain receiving orthopaedic manual physiotherapy: a pilot and feasibility study.

PURPOSE: To pilot and determine the feasibility of estimating adverse events in patients with neck pain treated with cervical manipulation/mobilization by Canadian orthopaedic manual physiotherapists (OMPTs) using an online data-collection system to provide estimates for a future larger multi-centre international study. METHODS: In a prospective multi-site two-group cohort study, participants received usual care and either (a) combined manipulation and mobilization or (b) mobilization only. Study feasibility objectives and criteria for success were set a priori. Data were analyzed using descriptive statistics. RESULTS: A total of 20 patients were recruited from 6 of 16 participating centres, 17 to the mobilization group and 3 to the combined group. Barriers to data collection included low recruitment, difficulties in using the online data-collection system, and clinicians' and patients' being too busy to participate. Missing data for the primary outcome averaged 28.5%. A total of 69 symptom occurrences were reported during the treatment phase, all benign and transient. Most began within 0-12 hours after treatment (66/69, 95.6%) and lasted for 0-2 days (56/69, 81.2%). Kappa estimates of agreement between therapists and patients on reporting of adverse symptoms across visits 1-5 was substantial (κ=0.68; 95% CI, 0.52-0.84; p<0.01). CONCLUSIONS: This pilot study demonstrates substantial challenges in conducting a large multi-centre trial. Brief, benign, and transient adverse events were common; no substantial adverse events were observed.

Objectif : Déterminer, dans le cadre d'un projet pilote, s'il est possible d'estimer les événements indésirables chez les patients dont la douleur au cou est traitée par manipulation/mobilisation cervicale effectuée par des physiothérapeutes manuels orthopédiques (PTMO) du Canada en utilisant un système de collecte des données en ligne pour produire des estimations en vue d'une future étude internationale multicentrique de plus grande envergure. Méthodes : On a procédé à une étude de cohorte prospective à deux groupes multisites; les participants ont reçu les soins habituels et a) une manipulation et une mobilisation combinées ou b) une mobilisation seulement. Les objectifs relatifs à la faisabilité de l'étude et les critères de réussite ont été établis d'avance. On a utilisé des statistiques descriptives. Résultats : Vingt patients ont été recrutés de six centres participants sur 16, soit 17 dans le groupe qui a subi une mobilisation et trois dans celui qui a subi le traitement combiné. Les obstacles à la collecte des données ont inclus l'effectif peu nombreux recruté, la difficulté à utiliser le système de collecte de données en ligne et le fait que les cliniciens et les patients étaient trop occupés pour participer. Les données manquantes pour le résultat primaire se sont établies en moyenne à 28,5%. Au total, on a signalé 69 occurrences de symptômes au cours de la phase de traitement, tous bénins et provisoires. La plupart ont commencé dans les 0 à 12 heures suivant le traitement (66/69, 95,6%) et ont duré de 0 à 2 jours (56/69, 81,2%). Les estimations kappa de la convergence entre les thérapeutes et les patients en ce qui concerne la déclaration de symptômes indésirables entre les visites 1 et 5 étaient importantes (κ=0,68; IC à 95%, 0,52 à 0,84; p<0,01). Conclusions : Cette étude pilote démontre qu'un essai multicentrique d'envergure pose des défis importants. Les effets indésirables brefs, bénins et provisoires étaient courants et l'on n'a observé aucun événement indésirable important.

Chapter 5: assessing risk of bias as a domain of quality in medical test studies.

Assessing methodological quality is a necessary activity for any systematic review, including those evaluating the evidence for studies of medical test performance. Judging the overall quality of an individual study involves examining the size of the study, the direction and degree of findings, the relevance of the study, and the risk of bias in the form of systematic error, internal validity, and other study limitations. In this chapter of the Methods Guide for Medical Test Reviews, we focus on the evaluation of risk of bias in the form of systematic error in an individual study as a distinctly important component of quality in studies of medical test performance, specifically in the context of estimating test performance (sensitivity and specificity). We make the following recommendations to systematic reviewers: 1) When assessing study limitations that are relevant to the test under evaluation, reviewers should select validated criteria that examine the risk of systematic error, 2) categorizing the risk of bias for individual studies as "low," "medium," or "high" is a useful way to proceed, and 3) methods for determining an overall categorization for the study limitations should be established a priori and documented clearly.

Predictors of surgical outcomes following anterior transposition of ulnar nerve for cubital tunnel syndrome: a systematic review.

PURPOSE: Although cubital tunnel syndrome is the second most common nerve entrapment neuropathy, few studies explore potential predictor(s) of surgical outcomes. The purpose of this systematic review was to determine which factors affect the postoperative outcome for patients who undertake anterior transposition of the ulnar nerve. METHODS: We included all studies reporting predictor(s) of clinical, electrophysiological study, or functional outcome after any anterior transposition of the ulnar nerve. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and CINAHL from 1980 to April 2011 and reference lists of articles. Two reviewers performed study selection, assessment of methodological quality, and data extraction independently of each other. RESULTS: We assessed 26 studies including 2 randomized controlled trials, 10 cohort studies, and 14 case series. Overall, the methodological quality of the studies ranged from low to moderate. Six aspects of prognosis were sufficiently studied for a narrative evidence synthesis on age, duration of symptom, severity of operative status, preoperative electrodiagnostic testing results, type of surgery, and work compensation status. Evidence was conflicting across studies in terms of both the direction and intensity of the impact of these 6 potential predictors on surgical outcomes. CONCLUSIONS: Because of conflicting results, we were unable to conclude which predictor(s) affect surgical outcomes after anterior transposition of the ulnar nerve. Surgeons who are aware of only a limited number of prognostic studies and their limited scope of evidence may not appreciate the extent of the inconsistency about whether factors commonly viewed as prognostic actually have a noteworthy impact on outcomes achieved. Such factors may be identified in the future with higher-quality studies, because limitations in the current research undoubtedly contribute to the controversies observed.

What does the evidence tell us about design of future treatment trials for whiplash-associated disorders?

STUDY DESIGN: Reflective critique and recommendation development. OBJECTIVE: To reflect on limitations in past trials and propose recommendations on innovative trial designs and methodologies for whiplash-associated disorders (WAD). SUMMARY OF BACKGROUND DATA: The cost of doing clinical research and risk of retaining an evidence void is an overarching threat to lessening the transition of WAD to chronicity. METHODS: Review trial limitations on neck pain and propose recommendations to amend these. RESULTS: Three innovative trial designs, 20 methodological recommendations, and two knowledge translation (KT) research strategies are proposed. Many of the gaps in our current understanding of neck disorders can be linked to an inadequate research design and implementation. Increased utilization of three design options for evaluating therapies could lead to a more accurate and efficient understanding of the merits of various therapies singly and multimodal. Increased utilization of mixed methods or biological subcomponents may advance our understanding of neck disorders and the resulting disability. There is a need for harmonization and standardization across participant disorder classification; identification and tracking of prognostic factors and adverse events; adequate intervention description and dosing; and outcome selection comparable across studies and across International Classification Framework domains. Reasons for discordant conclusions including subjective elements need to be explored in future trials using qualitative methods. KT research that defines the barriers to implementation of existing knowledge and strategies to reduce the evidence to practice gap is urgently needed. CONCLUSION: Our recommendations suggest an overarching need for adherence to CONSORT guidelines, a consensus taxonomy illuminating neck pain characterization, prognostic indicators, and diagnostic criteria as well as a core set of trial outcomes. Innovative trial design could lead to a more accurate and efficient understanding of the merits of various therapies. As the evidence emerges, studies of KT can inform us how it will impact clinical actions.

Testing a tool for the classification of study designs in systematic reviews of interventions and exposures showed moderate reliability and low accuracy.

OBJECTIVES: To develop and test a study design classification tool. STUDY DESIGN: We contacted relevant organizations and individuals to identify tools used to classify study designs and ranked these using predefined criteria. The highest ranked tool was a design algorithm developed, but no longer advocated, by the Cochrane Non-Randomized Studies Methods Group; this was modified to include additional study designs and decision points. We developed a reference classification for 30 studies; 6 testers applied the tool to these studies. Interrater reliability (Fleiss' κ) and accuracy against the reference classification were assessed. The tool was further revised and retested. RESULTS: Initial reliability was fair among the testers (κ=0.26) and the reference standard raters κ=0.33). Testing after revisions showed improved reliability (κ=0.45, moderate agreement) with improved, but still low, accuracy. The most common disagreements were whether the study design was experimental (5 of 15 studies), and whether there was a comparison of any kind (4 of 15 studies). Agreement was higher among testers who had completed graduate level training versus those who had not. CONCLUSION: The moderate reliability and low accuracy may be because of lack of clarity and comprehensiveness of the tool, inadequate reporting of the studies, and variability in tester characteristics. The results may not be generalizable to all published studies, as the test studies were selected because they had posed challenges for previous reviewers with respect to their design classification. Application of such a tool should be accompanied by training, pilot testing, and context-specific decision rules.