A comprehensive review of economic evaluations of therapeutic drug monitoring interventions for cancer treatments.

Therapeutic drug monitoring (TDM) of cancer drugs has been shown to improve treatment effectiveness and safety. The aim of this paper was to comprehensively review economic evaluations of TDM interventions for cancer drugs. Searches were conducted in 4 electronic databases, Medline, EMBASE, and Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects and the NHS Economic Evaluation Database), from their inception to June 2019. Studies were included if they were economic evaluations of TDM interventions for an active cancer treatment. The quality of reporting of economic evaluations was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS checklist). Of the 11 publications identified, imatinib with TDM and 5-fluorouracil with TDM were the most commonly assessed interventions (4 publications each). Overall study quality was good, with publications meeting 61 to 91% (median 80%) of CHEERS checklist criteria. A variety of studies were used to estimate the clinical effectiveness inputs for the cost effectiveness models. All publications considered TDM to be cost-effective based on an incremental cost-effectiveness ratio below the willingness to pay threshold (64%) or being cost-saving (36%). TDM interventions were considered cost-effective across the economic evaluations. Further clinical research assessing the impact of TDM on overall survival or other long-term health outcomes may enhance the evidence base for TDM in oncology. Future economic evaluations of TDM should explicitly consider uncertainty in the underlying clinical evidence and incorporate changes in the use of newer targeted drugs that form the current standard of care.

A Comparison of Perceptions of Reassurance in Patients with Nontraumatic Neck Pain and Whiplash-Associated Disorders in Consultations with Primary Care Practitioners-An Online Survey.

OBJECTIVES: Neck pain remains highly prevalent and costly worldwide. Although reassurance has been recommended as a first line of treatment, specific advice on the best ways to provide reassurance has not been provided due to lack of evidence. Pain symptoms and experiences differ between patients with whiplash-associated disorder (WAD) and those with nontraumatic neck pain (NTNP). The aims of this study were to 1) identify and compare the concerns, fears, and worries of patients with WAD and NTNP; and 2) determine if patients believe their concerns are addressed by primary care providers. METHODS: These questions were investigated through an online survey, with a convenience sample of 30 participants with NTNP and 20 with WAD. RESULTS: A thematic analysis of survey responses resulted in the following seven themes related to common concerns, and two regarding how well concerns were addressed. Common concerns expressed by both groups shared four themes: 1) further structural damage, 2) psychological distress, 3) concerns about the future, and 4) hardships that eventuate. Theme 5), pain/disability is long term, was specific to WAD. Themes 6), pain is current or reoccurring, and 7), interference with daily life, were specific to NTNP. Regarding how well patient concerns were addressed, two overarching themes were common to both conditions: 1) concerns were addressed, with both groups sharing the subthemes "successful treatment," "reassurance," and "trust"; and 2) concerns were not addressed, where all subthemes were shared with the exception of two unique to NTNP. CONCLUSIONS: This detailed comparison provides information about neck pain patients' concerns and fears, while providing health practitioners support for selecting strategies to promote reassurance appropriately for individual patient needs. Our findings from patients' perspectives enhance the understanding for providing reassurance for neck pain as proposed by our analysis.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

OBJECTIVE: To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. DESIGN: Non-funded, pilot randomized controlled trial of intervention versus usual care. SETTING: International, multicentre, community-based. PARTICIPANTS: Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. INTERVENTIONS: Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. MAIN MEASURES: Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. RESULTS: In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). CONCLUSION: Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

Methodology of the Stroke Self-Management Rehabilitation Trial: an international, multisite pilot trial.

RATIONALE: Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support. However, reports of inadequate understanding of rehabilitation techniques are common. A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers' burden. AIMS: This article describes the methodology of the stroke self-management rehabilitation trial. The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial. DESIGN: Recruitment of a minimum of 20 survivors of stroke and their informal caregivers (where available) in each of the participating centers will occur across multiple international sites. After baseline assessments, participants will be randomly assigned to an intervention or standard care group. The intervention comprises a structured DVD observation and practice schedule over 8 weeks. All participants will complete follow-up assessments. STUDY OUTCOMES: The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores, changes in quality of life, general health, depression, and caregiver burden at 2 months postrandomization. A qualitative analysis of the effects of the intervention will also be undertaken. DISCUSSION: The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden.

Verbal learning and memory following stroke.

OBJECTIVE: The research examined whether verbal learning and memory impairment previously observed 1 year after left hemisphere stroke endures over a longer period and whether stroke sufferers compensate for their impairments using working memory. METHODOLOGY: Twenty-one persons with left hemisphere lesions; 20 with right hemisphere lesions only and 41 matched controls completed the Hopkins Verbal Learning Test-Revised (HVLT-R), a working memory test (Letter-Number Sequencing, LNS) and the Boston Naming Test (BNT). RESULTS: Persons with left hemisphere damage performed more poorly on HVLT-R than controls. They showed poorer immediate recall, delayed recall, recognition and learning, but intact retention, suggesting an encoding impairment. BNT and LNS scores predicted recall in this group. HVLT-R performance of persons with right hemisphere lesions only was comparable to controls. BNT (not LNS) predicted recall in these groups. CONCLUSIONS: Persons with left hemisphere damage relied more on working memory and recruited diverse left hemisphere regions to compensate for their impaired encoding. IMPLICATIONS: Tasks requiring verbal encoding and memory are effortful following left hemisphere stroke. This should be recognized and accommodated.

Relational processing following stroke.

The research examined relational processing following stroke. Stroke patients (14 with frontal, 30 with non-frontal lesions) and 41 matched controls completed four relational processing tasks: sentence comprehension, Latin square matrix completion, modified Dimensional Change Card Sorting, and n-back. Each task included items at two or three levels of relational complexity. Relational processing was impaired in the stroke groups. This was due mainly to items at the intermediate ternary-relational level of complexity. Less complex binary-relational items and more complex quaternary-relational items (the latter are difficult for adults generally) were less sensitive to stroke status. Impairment was greater in frontal than non-frontal stroke patients. Positive inter-correlations among measures supported the domain-general nature of relational processing. Implications for assessment and intervention are discussed.

"I've learned to look at things in a different way": exploring patients' perspectives on participation in physiotherapist delivered integrated stress inoculation training and exercise for acute whiplash.

PURPOSE: To explore patient perspectives of the integrated intervention (intervention arm) of a recent randomised clinical trial that found clinically relevant and sustained benefits of a physiotherapist delivered integrated stress inoculation training (SIT) and exercise for people with acute whiplash-associated disorders (WAD) and at risk of poor recovery. MATERIAL AND METHODS: Twelve patients from the 53 who participated in the SIT and exercise arm of a randomised controlled trial (StressModex RCT) participated in semi-structured interviews. Data were analysed using inductive thematic analysis. RESULTS: Five main themes were identified: "balance between the physical and psychological components," "dealing with stress," "coping with the injury," "pain relief and return to function," and "elements enhancing therapeutic alliance." CONCLUSIONS: The majority of patients found the SIT techniques to be helpful in managing stress and pain, coping with their injury, and returning to function. The patients also found the exercises useful and acknowledged the importance of both the physical and the psychological aspects of whiplash injury.IMPLICATIONS FOR REHABILITATIONPatients with acute WAD at risk of poor recovery welcomed the inclusion of psychological strategies as part of physiotherapy treatment.The patients nominated both the psychological (SIT) component and exercise as assisting them with their stress, pain, and recovery.Physiotherapists could consider including strategies targeting early stress responses in their management of patients with acute WAD.

Impacts of the COVID-19 pandemic, and of government responses to the pandemic, on people who are homeless in Australia: Mapping perceptions of a national sample of homelessness service workers.

People who are homeless are disproportionately impacted by the COVID-19 pandemic, and by government responses to the pandemic. This study maps the perceptions of homelessness service workers in Australia, about the impacts of the COVID-19 pandemic and government responses to it on people who are homeless. An electronic survey was distributed to homelessness service across Australia in June/July 2020, following Australia's 'first wave' of COVID-19. Fifty-nine homelessness services from all eight states/territories responded. Perceptions of impacts on people who are homeless were mapped in six themes: (1) changes in the types of people presenting, (2) overall impacts on peoples' lives, (3) impacts on mental health, (4) impacts of changes in service delivery, (5) impacts of government support and (6) ongoing impacts. The COVID-19 pandemic, and government responses to the pandemic, have affected every aspect of the lives of people who are homeless in Australia. There is a continuing need to support people who are homeless as the world transitions to the 'new normal' of COVID-19, particularly as rates of homelessness increase. Understanding impacts is vital to informing relevant and effective health, social and other supports for this group.

Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder: a randomised controlled trial.

ABSTRACT: Many people with chronic whiplash-associated disorders (WAD) have also symptoms of posttraumatic stress disorder (PTSD), but this is rarely considered in usual predominantly exercise-based interventions. We aimed to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy (TF-CBT) and exercise compared with supportive therapy (ST) and exercise for people with chronic WAD and PTSD. A randomised controlled multicentre trial with concealed allocation, assessor blinding, and blinded analysis was conducted. One hundred three participants with chronic WAD (>3 months and <5 years, grade II) and PTSD were randomised to TF-CBT and exercise (n = 53) or ST and exercise (n = 50). Both interventions comprised 10 weeks of TF-CBT or ST, followed by 6 weeks of exercise. Outcomes were measured at baseline, 10, 16 weeks, 6, and 12 months after randomisation. Analysis was intention to treat using linear mixed models. There was no difference between the interventions on the primary outcome of neck pain-related disability at any time point. At 16 weeks, the treatment effect on the 0 to 100 Neck Disability Index was 0.59 (95% confidence interval [CI] 5.51 to -4.33), at 6 months 1.18 (95% CI 6.15 to -3.78), and at 12 months 1.85 (95% CI 6.81 to -3.11). In addition, there was no difference between the interventions for most secondary outcomes at any time. Exceptions were in favour of TF-CBT and exercise, where improvements in PTSD symptoms were found at 16 weeks. From 16 weeks onwards, both groups achieved a clinically important improvement in neck pain-related disability. However, both groups remained moderately disabled.

The Horse as a Therapist: Effects of an Equine Program Without "Therapy" on the Attention and Behavior of Youth Disengaged from Traditional School.

Background: Equine-assisted therapy may promote positive behavior change in young people "at risk." However, it is not always clear what therapeutic content is involved and if a trained therapist is included. The therapeutic effects of the key part of the "therapy," the horse, are not understood. Objectives: To investigate the impact of an equine program without a therapist on attention and behavioral outcomes of young people "at risk." Design: A within subjects pre-post design. A small sample also completed a control period. Setting/location: A small riding center in a rural area of outer Brisbane, Australia. Subjects: Twelve- to 17-year olds (N = 50; 20 girls; mean age 13.88), attending nontraditional flexischool. Intervention: A 5-week program of 2-h long sessions of equine activities that did not include a trained therapist or specific therapeutic content. Outcome measures: Teacher-report measures of externalizing and internalizing behavior were reported before and after the program through the Behavioral Rating Inventory of Executive Function (BRIEF) and the Strength and Difficulties Questionnaire (SDQ). Results: A paired samples t test resulted in the statistically significant reduction of the BRIEF Global Executive Score between pre and post participation in the equine program (mean difference = -5.89), t(36) = -3.377, p = 0.002 and the SDQ Hyperactivity score (mean difference = -0.727), t(43) = -2.244, p = 0.030. Equine activities may reverse a trajectory of worsening problems. This may especially affect symptoms related to attention deficit hyperactivity disorder. Conclusion: Equine programs may offer an alternative method to reduce poor behavior and improve attention in young people. Benefits in attention may occur even without specific therapeutic content or therapist involvement. It is proposed that some of these benefits come directly from the horse and the interactions with the horse; others are contextual.

Attachment insecurity as a vulnerability factor in the development of chronic whiplash associated disorder - A prospective cohort study.

OBJECTIVES: Attachment theory represents a dynamic model for understanding how pre-existing personality factors may contribute to the development of chronic pain and disability after whiplash injury. The aim of the present study was to investigate the impact of attachment insecurity on disability 6-months post-injury. It was hypothesized that: (1) levels of attachment insecurity assessed at baseline would predict levels of disability six months post-injury, and (2) both attachment dimensions (anxiety and avoidance) would moderate associations between pain and disability, and psychological distress and disability. METHODS: Questionnaire data were collected consecutively from a 1-year cohort of whiplash-injured. Data were collected from the emergency room within 1-month post-injury and at follow up 6-months post-injury (n = 205). RESULTS: Both attachment dimensions were significantly associated with physical and psychosocial disability. Moreover, when attachment avoidance and attachment axiety were at the mean value (0SD) and high (+1SD), there was a significant positive relationship between pain intensity and disability (physical and psychosocial), with the exception of attachment anxiety, that only moderated the association between pain intensity and psychosocial disability when high. Also, when attachment avoidance and attachment axiety were high there was a significant positive relationship between depression and disability. Finally, when attachment avoidance was at the mean level and high there was a significant positive relationship between pain-catastrophizing and psychosocial disability. CONCLUSION: Although the effects sizes for the moderations were small, the results support claims that attachment insecurity, measurable before onset of injury, represents a valuable pre-trauma vulnerability for less optimal recovery after whiplash injury.

Whiplash Patients' Responses on the Impact of Events Scale-R: Congruent With Pain or PTSD Symptoms?

OBJECTIVES: Posttraumatic stress disorder (PTSD) symptoms are common among people with whiplash following a motor vehicle crash. The Impact of Events Scale-Revised (IES-R) screens for PTSD symptoms with psychologist referral recommended for above-threshold scores. Recent data indicate that PTSD symptoms post-whiplash may relate more to pain and disability than the crash itself. This study explored the interpretation of IES-R items by people with whiplash to establish whether responses relate to the crash or to whiplash pain and disability. METHODS: Adults with whiplash scoring >24 on the IES-R were eligible. The 3-step test-interview technique was used and responses analyzed using content analysis. A coding framework was developed, comprising 5 categories: "congruent"-responses related to the crash; "incongruent"-responses did not relate to the crash; "ambiguous"-responses were both congruent and incongruent; "confusion"-participants misunderstood the item content; "not applicable"-irrelevancy of items to participants' circumstances. RESULTS: The 15 participants (mean IES-R=37/88) were inclined to respond congruently to specific PTSD items and incongruently to nonspecific PTSD items. Participants were more inclined to rate nonspecific PTSD items in terms of pain and disability, for example, >60% responded incongruently to item 2: "I had trouble staying asleep"; item 4: "I felt irritable and angry"; item 15: "I had trouble falling asleep"; and item 18: "I had trouble concentrating." DISCUSSION: Incongruent responses on nonspecific PTSD items may inadvertently inflate levels of PTSD symptoms measured with the IES-R for some whiplash patients, raising implications for the assessment and treatment of the psychological sequelae of whiplash.

Assessing emotional and social health using photographs: An innovative research method for rural studies and its applicability in a care-farming program for youth.

A framework for assessing photographs for the emotional and social health of young people (SHAPE) is described and tested, within the context of a rural program. Two independent raters assessed the photographs of participants. To assess inter-rater reliability, Cohen' K and Kendall's W were calculated. The two reviewers' assessments of photographs were in agreement. The assessment of emotional/behavioural display showed 82% agreement. Agreement between reviewers' judgements of proxemics (W = .866), interaction (W = .722), engagement (W = .932) and overall impression (W = .804) were all significant (p < .005). The method yielded results indicating that participants found gardening immediately engaging but their approach to equines exhibited a change from fascination to confidence during the program. The visual-diary method is a useful and sensitive method for research: where resources are limited; to complement traditional measures; for use with people who lack appropriate verbal communication or literacy skills to complete questionnaires; young children; other underrepresented groups.

Recommendations For Core Outcome Domain Set For Whiplash-Associated Disorders (CATWAD).

OBJECTIVE: Inconsistent reporting of outcomes in clinical trials of treatments for Whiplash-associated Disorders (WAD) hinders effective data pooling and conclusions that can be drawn about the effectiveness of tested treatments. The aim of this study was to provide recommendations for core outcome domains that should be included in clinical trials of WAD. MATERIALS AND METHODS: A 3-step process was used: (1) A list of potential core outcome domains were identified from the published literature. (2) Researchers, health care providers, patients, and insurance personnel participated and rated the importance of each domain via a 3-round Delphi survey. A priori criteria for consensus were established. (3) Experts comprising researchers, health care providers, and a consumer representative participated in a multidisciplinary consensus meeting that made final decisions on the recommended core outcome domains. RESULTS: The literature search identified 63 potential core domains. A total of 223 participants were invited to partake in the Delphi surveys, with 41.7% completing round 1, 45.3% round 2, and 51.4% round 3. Eleven core domains met the criteria for inclusion across the entire sample. After the expert consensus meeting, 6 core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life, and Pain. DISCUSSION: A 3-step process was used to recommend core outcome domains for clinical trials in WAD. Six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life, and Pain. The next step is to determine the outcome measurement instruments for each of these domains.

Information needs of patients with whiplash associated disorders: A Delphi study of patient beliefs.

BACKGROUND: Whiplash associated disorders (WAD) result in significant personal and economic costs. Patient education and reassurance are recommended treatments for acute WAD but the information needs of patients have not been investigated. OBJECTIVES: To determine what information whiplash-injured patients believe is important to help recovery in the acute stage of injury. DESIGN: A Delphi design survey series with three rounds. METHOD: Thirty-three participants who had sustained a whiplash injury within the last three years were invited to participate. Participants were asked to provide five statements, in response to an open-ended question, regarding what they believed was the most important information to provide to patients following a whiplash injury. Nineteen patients responded and 85 statements were collected and reviewed independently by two of the authors to remove duplicates. The importance of the remaining items was rated by the participants in the second survey round. Items rated by >50% of participants as important were included in the third survey round. To be deemed key information, >80% of participants had to rate an item as important in this final round. RESULTS: Eighteen items met the criteria for key information. These points addressed four areas: assessment and treatment, recovery and symptoms, patient attitudes during treatment and relationships with health practitioners. CONCLUSIONS: The key information points endorsed by patients in this study may provide useful information to constitute a basis for reassurance and education provided to patients with WAD. The results also suggest that improved relationships between patients with whiplash and health practitioners is required.

What information do patients need following a whiplash injury? The perspectives of patients and physiotherapists.

PURPOSE: The aims of the present study were to identify information that individuals with whiplash associated disorders (WAD) need to know in the early stages of recovery and to establish whether there is a difference between what physiotherapists and whiplash-injured patients perceive as important information. METHOD: Forty-one participants were recruited (20 whiplash-injured patients, 21 physiotherapists). Participants were asked to provide five statements to one open-ended question about what they believe is the most important information individuals with WAD need to know in the early stages of recovery. Participants provided 182 statements which were reviewed independently and organised into themes by two of the authors. RESULTS: Six key themes emerged from the statements. These included general information about whiplash injury, treatment and recovery, reassurance, provision of poor information and patients' interaction with general practitioners, maintaining daily activities, and compensation claims and litigation. Both patients and physiotherapists agreed on the type of general whiplash information that should be provided however, major differences were found with regard to information pertaining to compensation claims and litigation and maintaining daily activities. CONCLUSIONS: The findings of this study provide some insight into the type of information that WAD individuals require in the early stages of recovery. Implications for Rehabilitation The provision of reassurance can be an effective communication tool to decrease patients concerns about their injury and help strengthen the patient-health practitioner relationship. Although clinical guidelines for the management of whiplash injuries recommend that individuals must remain physically active post-injury, statements from the patient group indicate that this information is not always provided and clearly explained to patients. Keeping in line with the patient centred care approach of being responsive to patient needs and values, it is essential for health practitioners to be attentive to patients' preferences regarding the level of participation in treatment decisions. Processes need to be developed to deliver individuals with WAD accurate information regarding compensation claims so that these factors do not distract from focusing on recovery.

Investigating the Fear Avoidance Model in People With Whiplash: The Association Between Fear of Movement and In Vivo Activity.

OBJECTIVES: The aims of this study were to examine the relationship between fear of movement and activity levels in people with whiplash-associated disorders (WAD) over the first 3 months postinjury, to determine the mediating effect of: fear of movement on the relationship between catastrophizing and activity levels, and activity levels on the relationship between fear of movement and disability in patients with WAD. MATERIALS AND METHODS: Ambulatory monitoring of physical activity was conducted for a minimum of 8 waking hours on 2 consecutive days within 4 weeks postinjury and at 12 weeks postinjury for 103 (74 female) people with WAD. Time spent in upright postures (uptime) and time in motion (TIM) were collected along with measures of pain, disability, pain catastrophizing, and fear of movement. The association of self-report outcome measures with uptime and TIM were examined. Mediation analyses were performed to determine the mediating effect of: fear of movement on the relationship between catastrophizing and activity, and activity levels on the relationship between fear of movement and disability. RESULTS: Fear of movement was significantly related to uptime but not TIM. Mediation analyses showed that the relationship between fear of movement and disability was not mediated by activity levels, and that the relationship between catastrophizing and activity levels was not mediated by fear of movement. DISCUSSION: Our data suggests measures of Fear Avoidance Model are not related to general physical activity in people with WAD. Investigation of movements specific to the cervical spine and alternative explanatory models may be required.

A Systematic Review and Meta-Analysis of the Effectiveness of Psychological Interventions Delivered by Physiotherapists on Pain, Disability and Psychological Outcomes in Musculoskeletal Pain Conditions.

OBJECTIVE: This systematic review and meta-analysis examined the effectiveness of physiotherapist delivered psychological interventions combined with physiotherapy on pain, disability, and psychological outcomes for patients with musculoskeletal pain conditions. METHODS: The review was conducted in accordance with the (PRISMA) guidelines. Five databases were systematically searched for randomized controlled trials from inception to May 2016. Studies were required to compare a psychological intervention delivered by physiotherapists combined with physiotherapy to physiotherapy alone or usual care. Physiotherapists delivering the interventions must have undergone training by a psychologist or a health professional trained in the delivery of psychological interventions. RESULTS: A total of 34 articles met the eligibility criteria, of those, 30 were suitable for meta-analysis. There was low to high quality evidence that physiotherapist delivered psychological intervention combined with physiotherapy decreased pain in the short (26 studies, mean difference=-0.37; 95% confidence interval [CI], -0.65 to -0.09) and long term (22 studies, mean difference=-0.38; 95% CI, -0.67 to -0.10) and decreased disability in the short term (29 studies, standardized mean difference =-0.14; 95% CI, -0.26 to -0.01). Effect sizes were small. Low to high quality evidence demonstrated small to medium effects for some psychological outcomes at short-term and long-term follow-ups. DISCUSSION: The results indicate that psychological interventions delivered by physiotherapist show promise to improve health outcomes, particularly psychological outcomes, in musculoskeletal pain conditions.

A core outcome set for clinical trials in whiplash-associated disorders (WAD): a study protocol.

BACKGROUND: Whiplash-associated disorders (WAD) as a consequence of a motor vehicle crash are a costly health burden in Western societies. Up to 50% of injured people do not fully recover. There have been numerous clinical trials and cohort studies conducted for WAD with many varied outcome measures used, making data pooling difficult and hindering meta-analysis. These issues could be addressed through the development of a core outcome set (COS) that should be included in all clinical trials for WAD. The purpose of this project is to develop and disseminate a COS for clinical trials in WAD. METHODS/DESIGN: An international Steering Committee was formed to initiate and support the development of this COS. The project will comprise five phases: (1) a comprehensive review of core outcome domains used in clinical trials in WAD, (2) an international Delphi survey including individuals with WAD, health care providers, clinical researchers and insurance personnel to define the core outcome domains, (3) a meeting of relevant stakeholders to reach consensus regarding the final core outcome domains, (4) identification and evaluation of instruments used to measure the final core outcome domains, and (5) a consensus meeting to agree on the core outcome measurement instruments to be used. DISCUSSION: The aim of this proposal is to complete a five-stage process to develop a COS for all clinical trials in WAD. An implementation strategy will also be proposed.

Post-traumatic stress symptom clusters in acute whiplash associated disorder and their prediction of chronic pain-related disability.

INTRODUCTION: The presence of post-traumatic stress disorder (PTSD) symptoms has been found to be associated with an increased risk of persisting neck pain and disability in motor vehicle crash (MVC) survivors with whiplash injuries. The findings are mixed as to which PTSD symptom(s) best predicts recovery in this population. OBJECTIVES: The aims were (1) to explore the factor structure of the Post-traumatic Stress Diagnostic Scale (PDS) in a sample of acute whiplash-injured individuals following a MVC and (2) to identify the PTSD-symptom clusters that best predict long-term neck pain-related disability in this population as measured by the Neck Pain Disability Index (NDI). METHODS: A sample (N = 146) of whiplash-injured individuals completed the NDI and the PDS at baseline (<1 month) and at 6 months follow-up. RESULTS: Principal component analyses generated 2 symptom clusters: re-experiencing/avoidance and hyperarousal/numbing. Nine trauma-related PTSD symptoms loaded exclusively on the re-experiencing/avoidance cluster and 7 nonspecific PTSD symptoms loaded exclusively on the hyperarousal/numbing cluster. One PTSD symptom (ie, inability to recall an important aspect of the trauma) had no salient loading on either clusters. Structural equation modelling analysis indicated that there was a significant positive relationship between the hyperarousal/numbing symptom cluster and long-term neck pain-related disability, while no significant relationship was found between the re-experiencing/avoidance symptom cluster and long-term neck pain-related disability. CONCLUSION: Given that only the hyperarousal/numbing symptom cluster predicted long-term neck pain-related disability, this finding may have implications in terms of diagnosis, assessment, and management of the psychological impact of whiplash-injured individuals following a MVC.