Development, validation and feasibility of a Patient Satisfaction Questionnaire for evaluating the quality performance of a diagnostic small fibre neuropathy service: A qualitative study.

INTRODUCTION AND AIM: Small fibre neuropathy (SFN) is a peripheral neuropathy, leading to neuropathic pain and autonomic dysfunction. An evidence-based standardized patient diagnostic SFN service has been implemented in the Netherlands for improving patient-centred SFN care. However, the quality of care of this diagnostic SFN service has never been assessed from a patient perspective. The aim of this study was to develop and validate an SFN-Patient Satisfaction Questionnaire (SFN-PSQ) to measure the quality performance of a standardized diagnostic SFN service. METHODS: A descriptive qualitative study to create the SFN-PSQ was performed using the (COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. For item generation and content development, domains and/or items from validated PSQs were selected. The content development and content validity were performed using a Delphi method with SFN expert caregivers with different backgrounds. By using the three-step-test method in individual cognitive interviews, the content validity by patients was finalized. RESULTS: In one online Delphi panel round, the content of the first concept of the SFN-PSQ was validated, which resulted in the second concept of the SFN-PSQ. From July 2019 till March 2020, nine patients consented to participate in the individual cognitive interviews. The most significant changes of the new questionnaire were adding domains and items concerning the waiting list, the diagnostic services and consultation by the hospital psychiatrist. Also, a differentiation was made for both an inpatient and outpatient diagnostic SFN service. Furthermore, the clarity and intelligibility of the domains/items were improved, resulting in an increased comprehension of the SFN-PSQ. Ultimately, the new developed SFN-PSQ consisted of 10 domains and 51 items, suitable for measuring patient satisfaction of the neurological analysis in patients with SFN. CONCLUSION: Through item generation, expert opinions and interviews with patients, the SFN-PSQ was developed and validated, and feasibility was confirmed. The structure of the questionnaire, based on the logistic and diagnostic SFN pathway, could be used as a model in other hospitals to improve the quality, continuity and access of SFN care and other chronic diseases taking into account potential cross-cultural differences. PATIENT OR PUBLIC CONTRIBUTION: Caregivers were involved in the item generation and content development of the questionnaire. Patients were directly involved in testing the content validity and feasibility of the SFN-PSQ. CLINICAL TRIAL REGISTRATION: Not applicable.

The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg.

BACKGROUND: Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied. METHODS: In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. INCLUSION CRITERIA: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. EXCLUSION CRITERIA: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods. DISCUSSION: NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study. Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643 .

EXPOSURE IN VIVO VERSUS PAIN-CONTINGENT PHYSICAL THERAPY IN COMPLEX REGIONAL PAIN SYNDROME TYPE I: A COST-EFFECTIVENESS ANALYSIS.

OBJECTIVES: The aim of this study was to evaluate the cost-effectiveness of exposure in vivo (EXP, a cognitive-behavioral treatment targeting pain-related fear) in Complex Regional Pain Syndrome Type I (CRPS-I), as compared to pain-contingent physical therapy (PPT). METHODS: Data from a randomized controlled trial were used to compare the cost-effectiveness of EXP versus PPT from a societal perspective. Intervention costs, other healthcare costs, costs to patient and family, and productivity losses were included. The main outcomes were changes in the SF-36 physical component scale and quality-adjusted life-years. Changes were followed until 6 months after treatment. Uncertainty was estimated using nonparametric bootstrap analysis, cost-effectiveness acceptability curves and cost-effectiveness planes. Sensitivity analyses were performed to check robustness of findings. RESULTS: Forty-six patients were randomized and thirty-eight completed the study. Over 6 months, EXP resulted in greater improvement in physical health-related quality of life and quality-adjusted life-years than PPT. Despite higher initial treatment costs, EXP showed a tendency to reduce all costs compared with PPT; healthcare costs were significantly reduced. Furthermore, the cost-effectiveness planes were in favor of EXP. Sensitivity analyses, for different program costs and complete cases only, confirmed robustness of these findings. CONCLUSIONS: EXP, a cognitive-behavioral treatment, seems more cost-effective than PPT in CRPS patients with pain-related fear. The initial higher costs for EXP are offset by a long-term reduction of costs for healthcare use, and a tendency to lower work absenteeism and reduced societal costs. Due to low sample sizes, replication of findings is required to confirm results.

Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

BACKGROUND: Chronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual. METHODS/DESIGN: Pragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, ß = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations. DISCUSSION: A pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.

Is exposure in vivo cost-effective for chronic low back pain? A trial-based economic evaluation.

BACKGROUND: Back pain is one of the most expensive health complaints. Comparing the economic aspects of back pain interventions may therefore contribute to a more efficient use of available resources. This study reports on a long-term cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) of two treatments as viewed from a societal perspective: 1) exposure in vivo treatment (EXP), a recently developed cognitive behavioral treatment for patients with chronic low back pain who have elevated pain-related fear and 2) the more commonly used graded activity (GA) treatment. METHODS: Sixty-two patients with non-specific chronic low back pain received either EXP or GA. Primary data were collected at four participating treatment centers in the Netherlands. Primary outcomes were self-reported disability (for the CEA) and quality-adjusted life years (for the CUA). Program costs, health care utilization, patient and family costs, and production losses were measured by analyzing therapy records and cost diaries. Data was gathered before, during, and after treatment, and at 6 and 12 months after treatment. Non-parametric bootstrap analyses were used to quantify the uncertainty concerning the cost-effectiveness ratio. In addition, cost-effectiveness planes and cost-effectiveness acceptability curves were performed. RESULTS: EXP showed a tendency to reduce disability, increase quality adjusted life years and decrease costs compared to GA. The incremental cost-effectiveness ratios of both the CEA and CUA are in favor of EXP. CONCLUSIONS: Based on these results, implementing EXP for this group of patients seems to be the best decision. TRIAL REGISTRATION: ISRCTN88087718.

Patient satisfaction and patient accessibility in a small fiber neuropathy diagnostic service in the Netherlands: A single-center, prospective, survey-based cohort study.

INTRODUCTION: Small fiber neuropathy (SFN) is a common cause of neuropathic pain in peripheral neuropathies. Good accessibility of diagnostics and treatment is necessary for an accurate diagnosis and treatment of SFN. Evidence is lacking on the quality performance of the diagnostic SFN service in the Netherlands. Our aim was to determine the patient satisfaction and -accessibility of the diagnostic SFN service, and to identify areas for improvement. METHODS: In a single-center, prospective, survey-based cohort study, 100 visiting patients were asked to fill in the SFN patient satisfaction questionnaire (SFN-PSQ), with 10 domains and 51 items. Cut-off point for improvement was defined as ≥ 25% dissatisfaction on an item. A chi-square test and linear regression analyses was used for significant differences and associations of patient satisfaction. RESULTS: From November 2020 to May 2021, 98 patients with SFN-related complaints filled in the online SFN-PSQ within 20 minutes. In 84% of the patients SFN was confirmed, average age was 55.1 (52.5-57.8) years and 67% was female. High satisfaction was seen in the domains 'Waiting List Period', Chest X-ray', 'Consultation with the Doctor or Nurse Practitioner (NP)', 'Separate Consultation with the Doctor or NP about Psychological Symptoms', and 'General' of the SFN service. Overall average patient satisfaction score was 8.7 (IQR 8-10) on a 1-to-10 rating scale. Main area for improvement was shortening the 8-week period for receiving the results of the diagnostic testing (p < 0.05). General health status was statistically significant associated with patient satisfaction (p < 0.05). CONCLUSION: A good reflection of the high patient satisfaction and -accessibility of the SFN-service is shown, with important points for improvement. These results could help hospitals widely to optimize the logistic and diagnostic pathway of SFN analysis, benchmarking patient satisfaction results among the hospitals, and to improve the quality of care of comparable SFN services.

Cost-effectiveness of an intervention to reduce fear of falling.

OBJECTIVES: The aim of this study was to assess whether a multicomponent cognitive behavioral group intervention is preferable to usual care in terms of (healthcare) costs and effects on fear of falling and activity avoidance. METHODS: This economic evaluation was embedded in a randomized controlled trial among 540 community-living adults in the Netherlands, aged 70 years and older who reported fear of falling and fear-induced activity avoidance. The participants allocated to the intervention group received a multicomponent cognitive behavioral group intervention consisting of eight weekly sessions and a booster session. The sessions were aimed at instilling realistic views of falls, reducing fall risk, and increasing activity and safe behavior. Participants in the control group received usual care. Cost outcome measures were healthcare costs, and patient and family costs. Clinical outcomes were fear of falling and activity avoidance. All outcomes were assessed at baseline and at 2, 8, and 14 months by means of registration forms, self-administered questionnaires, and interviews by telephone. RESULTS: Participants were randomly allocated to intervention (n = 280) and control groups (n = 260). Costs for the intervention program were on average €276 per person. Total costs per person were comparable (€4,925 in intervention group and €4,828 in control group). Furthermore, favorable effects of the program were observed for fear of falling and activity avoidance. CONCLUSIONS: This study showed that the intervention program is preferable to usual care in terms of costs and effects. The program had comparable costs and significantly reduced fear of falling and associated activity avoidance among older community-living persons.

Living with small fiber neuropathy: insights from qualitative focus group interviews.

OBJECTIVE: Small fiber neuropathy (SFN) is characterized by chronic neuropathic pain and autonomic dysfunction. Currently, symptomatic pharmacological treatment is often insufficient and frequently causes side effects. SFN patients have a reduced quality of life. However, little is known regarding whether psycho-social variables influence the development and maintenance of SFN-related disability and complaints. Additional knowledge may have consequences for the treatment of SFN. For example, factors such as thinking, feeling, and behavior are known to play roles in other chronic pain conditions. The aim of this study was to obtain further in-depth information about the experience of living with SFN and related chronic pain. METHODS: Fifteen participants with idiopathic SFN participated in a prospective, semi-structured, qualitative, focus group interview study. The focus groups were audio-recorded, transcribed, and analyzed cyclically after each interview. RESULTS: The following main themes were identified: "pain appraisal", "coping", "social, work, and health environment", and "change in identity". Catastrophic thoughts and negative emotions were observed. Living with SFN resulted in daily limitations and reduced quality of life. CONCLUSIONS: Given the results, it can be concluded that an optimal treatment should include biological, psychological, and social components.

Effectiveness of Exposure in Vivo for Patients with Painful Diabetic Neuropathy: a Pilot Study of Effects on Physical Activity and Quality of Life.

OBJECTIVE: To evaluate the effects of personalized exposure in vivo on level of physical activity and quality of life in patients with painful diabetic neuropathy. DESIGN: Randomized, single-case, ABC design. SUBJECTS: Twelve patients with painful diabetic neuropathy, age > 18 years, diabetes mellitus type II, Clinical Neurological Examination score > 5, Diabetic Neuropathy Symptom Score ≥ 1 and Douleur Neuropathique 4 Questions score ≥ 3. METHODS: The treatment consists of an Intensive screening, followed by an 8-week exposure in vivo intervention specifically adapted to the needs/risks of patients with painful diabetic neuropathy, and 6-months follow-up. Outcome measures included daily and non-daily measures of physical activity, quality of life, metabolic parameters, disability, depression, general and painful diabetic neuropathy-related anxiety, pain intensity and pain catastrophizing. RESULTS: Due to high drop-out rates (n = 6 during screening, n = 2 during treatment, n = 1 after treatment), only 3 participants completed the study. Slight, but non-significant, changes in physical activity and disability were observed. In quality of life, no changes were observed. CONCLUSION: Analysis of the reasons for the high drop-out rate indicate that exposure in vivo may have added value in patients with painful diabetic neuropathy only for those patients: (i) whose daily life functioning is impaired mainly by the painful diabetic neuropathy; (ii) in whom painful diabetic neuropathy-related fears are exaggerated and irrational; (iii) in whom specific activities evoke the painful diabetic neuropathy-related fears; (iv) whose spouse and healthcare providers are involved in the treatment; and (v) who are willing to change their daily behaviour. Further research is needed into this subject.

The relation between parental chronic pain, pain-related attention and interpretation biases in pain-free adolescents.

BACKGROUND: Children of chronic pain patients run greater risk for developing chronic pain themselves. Exposure to chronic pain of the parent might install cognitive (e.g., pain catastrophizing, interpretation and attentional bias) and affective (e.g., pain anxiety) vulnerability which increase the risk for the development of chronic pain complaints in offspring. This study examines whether pain-free offspring of parents with chronic pain complaints make more health-threatening interpretations and display a stronger pain-related attentional bias compared to the offspring of pain-free parents. We furthermore examined differences between both groups on pain catastrophizing, pain anxiety and somatic symptoms and explored the relations between parental pain catastrophizing and aforementioned pain vulnerability measures in offspring. METHODS: Offspring of parents with chronic pain complaints (n = 24) and pain-free parents (n = 27) completed measures of attentional bias (i.e., pictorial dot probe), interpretation bias (i.e., ambiguous word association task), pain catastrophizing, pain anxiety and somatic symptoms. Parents completed measures of pain catastrophizing and psychological distress. RESULTS: No differences between offspring of parents with and without pain complaints were observed on pain catastrophizing, pain anxiety and somatic symptoms. Both groups of healthy adolescents predominantly showed benign, non-health-threatening interpretations. Children of pain-free parents showed an attention bias for pain stimuli, while offspring of parents with pain complaints showed no such bias. CONCLUSIONS: Future research is needed to further elucidate the precise role of parental pain in the development of pain-related biases and the significance of these biases in the onset and/or maintenance of a chronic pain condition in children and adolescents. SIGNIFICANCE: Parental chronic pain may install psychological vulnerability for developing chronic pain and associated complaints in offspring. This study did not show differences in pain-directed attentional and interpretation bias between offspring of parents with chronic pain complaints and offspring of pain-free parents. Further (longitudinal) research is needed to elucidate the precise role of parental pain factors in the development of pain-related vulnerability in offspring of chronic pain parents, thereby identifying important targets for the prevention and early intervention of chronic pain.

Biopsychosocial Rehabilitation Treatment "Exposure In Vivo" for Patients with Painful Diabetic Neuropathy: Development of a Treatment Protocol.

OBJECTIVE: Painful diabetic neuropathy is associated with low quality of life, depression and anxiety. Patients are limited in their performance of activities of daily living due to fears related to their condition. Treatment modalities are needed to help patients cope with their pain and pain-related disability. Exposure in vivo is an effective treatment in other chronic pain syndromes, increasing patients' functional ability and quality of life. This paper presents an Exposure in vivo treatment protocol for patients with painful diabetic neuropathy. PROTOCOL: An 8-week Exposure in vivo treatment protocol was specifically adapted to the needs and risks of patients with painful diabetic neuropathy. New screening tools were developed for patients with PDN; the Painful Diabetic Neuropathy Anxiety Rasch-Transformed Questionnaire (PART-Q30) identifies specific fears related to painful diabetic neuropathy (e.g. fear of hypoglycaemia); and a customized version of the Photograph-series Of Daily Activities (PHODA-PDN) detects fear-eliciting activities related to the condition in individual patients. During Exposure in vivo, catastrophic interpretations regarding painful stimuli are challenged and corrected, thereby diminishing pain-related fear and enabling the patient to re-engage in activities of daily living. An interdisciplinary team provides Exposure in vivo in 1-h sessions twice a week. DISCUSSION: To the best of our knowledge, this treatment protocol is the first intervention using Exposure in vivo specifically adapted to the needs and risks of patients with painful diabetic neuropathy.

The Dutch version of the self-report Child Activity and Limitations Interview in adolescents with chronic pain.

PURPOSE: To assess the factor structure, related constructs and internal consistency of the Child Activity Limitation Interview 21-Child version for use in Dutch-language countries. METHODS: Cross-sectional validation study: After forward and back translation of the Dutch version of the Child Activity Limitation Interview 21-Child adolescents (11-21 years old) with chronic musculoskeletal pain completed an assessment. The assessment contained the Dutch Child Activity Limitation Interview, and questionnaires about demographics, pain intensity, functional disability, anxiety and depression. Internal consistency and construct validity were evaluated through exploratory factor analysis (principal axis factoring with oblique rotation) and hypotheses testing using pain intensity, activity limitations, anxiety and depression as comparative constructs. RESULTS: Seventy-four adolescents completed the assessment. Exploratory factor analysis resulted in a two-factor structure, explaining 50% of the variance. Internal consistency was good (Cronbach's α = 0.91 total scale, α = 0.90 Factor 1, α = 0.80 Factor 2). All nine hypotheses were confirmed. CONCLUSION: The Dutch version can be used to assess pain-related disability in Dutch-speaking adolescents comparable to the study sample. Scores on both subscales provide insight into the severity of the pain-related disability in both daily routine and more physically vigorous activities. Implications for Rehabilitation Chronic pain is a disabling disorder which not only impacts physically but restricts quality of life. This study provides clinicians a questionnaire to measure pain-related disability and quantify the impact of pain on the daily living of adolescents. The advantage of the Dutch version of the Child Activity and Limitations Interview over other measurements is that it can distinguish limitations in daily activities from more physically vigorous activities.

Living with painful diabetic neuropathy: insights from focus groups into fears and coping strategies.

OBJECTIVE: Painful diabetic neuropathy (PDN) is known to negatively affect quality of life. Being physically active is a crucial part of successful diabetes self-management, but regimen adherence is often low. Coping strategies and fears have shown to be related to less physical activity (PA). The aim of the present study was to obtain more in-depth information on psychological risk factors leading to less PA in persons with PDN. DESIGN: Three semi-structured focus group interviews were conducted with a representative sample of persons with PDN (N = 12). Data were transcribed verbatim and analysed using a hybrid method of thematic analyses and a grounded theory approach. MAIN OUTCOME MEASURES: Fears and coping strategies related to PA in persons with PDN. RESULTS: Several specific fears were identified; fear of hypoglycaemia, fear of pain increase, fear of total exhaustion, fear of physical injury, fear of falling, fear of loss of identity, and fear of negative evaluation by others. To cope with these fears, avoidance, remaining active, cognitive distraction, and acceptance strategies were described. CONCLUSION: In persons with PDN, diabetes-related fears and pain-related fears play a role in less engagement in PA, indicating the need for new methods for improving self-management in persons with PDN.

Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain.

INTRODUCTION: Patients' initial beliefs about the success of a given pain treatment are shown to affect final treatment outcome. The Credibility/Expectancy Questionnaire (CEQ) has recently been developed as measure of treatment credibility and expectancy. OBJECTIVE: The objectives of this study were (1) to investigate the factor structure of the CEQ in a sample of chronic low back pain (CLBP) patients by means of a confirmatory factor analysis, (2) to examine the association between treatment credibility and expectancy and patient characteristics, and (3) to assess whether treatment expectancy and credibility are associated with the outcome of rehabilitation treatment. METHODS: CLBP patients (n=167) were randomized to either active physical therapy (n=51), cognitive-behavioral therapy (n=57), or a combination therapy (n=59), and completed the CEQ after a careful explanation of the treatment rationale. RESULTS: Confirmatory factor analysis supported the 2-factor structure (credibility/expectancy) of the CEQ. Lower credibility was associated with higher pain-related fear and lower internal control of pain, and lower expectancy with higher levels of pain-related fear and no radiating pain. Multiple linear regression analyses revealed that after controlling for age, sex, treatment center, pain-intensity at baseline, duration of disability, and irrespective of the treatment offered, expectancy was significantly associated with disability and satisfaction. Credibility was significantly associated with patient-specific symptoms and satisfaction. For global perceived effect, treatment expectancy was predictive in active physical therapy only, and treatment credibility was a significant predictor in combination therapy only. DISCUSSION: Although the associations found were low to modest, these results underscore the importance of expectancy and credibility for the outcome of different active interventions for CLBP and might contribute to the development of more effective treatments.

Long-term effectiveness and costs of a brief self-management intervention in women with pregnancy-related low back pain after delivery.

BACKGROUND: Pregnancy-related low back pain is considered an important health problem and potentially leads to long-lasting pain and disability. Investigators draw particular attention to biomedical factors but there is growing evidence that psychosocial and social factors might be important. It prompted us to start a large cohort study (n = 7526) during pregnancy until one year after delivery and a nested randomized controlled intervention study in the Netherlands. METHODS: A randomized controlled trial (n = 126) nested within a cohort study, of brief self-management techniques versus usual care for treatment of women with persisting non-specific pregnancy-related low back pain three weeks after delivery. Women in the intervention group were referred to a participating physiotherapist. Women in the usual care group were free to choose physiotherapy, guidance by a general practitioner or no treatment. Follow up took place at 3 months, 6 months and one year after delivery.Outcomes included change in limitations in activities (RDQ), pain (VAS), severity of main complaints (MC), global feeling of recovery (GPE), impact on participation and autonomy (IPA), pain-related fear (TSK), SF-36, EuroQol and a cost diary. For the outcome measures, series of mixed models were considered. For the outcome variable global perceived effect (GPE) a logistic regression analysis is performed. RESULTS: Intention-to-treat outcomes showed a statistical significant better estimated regression coefficient RDQ -1.6 {-2.9;-0.5} associated with treatment, as well as better IPA subscale autonomy in self-care -1.0 {-1.9;-0.03} and TSK -2.4 {-3.8;-1.1} but were not clinical relevant over time. Average total costs in the intervention group were much lower than in usual care, primarily due to differences in utilization of sick leave but not statistically significant. CONCLUSION: Brief self-management techniques applied in the first 3 months after delivery may be a more viable first-line approach but further research is needed to draw inference on costs and to determine whether no care is a better option in the long term. TRIAL REGISTRATION: [ISRCTN08477490].

Dutch version of the Fear of Pain Questionnaire for adolescents with chronic pain.

BACKGROUND: Fear of pain is important in the development and maintenance of chronic pain. The Fear of Pain Questionnaire-Child version has been developed to assess pain related fear in children and adolescents. OBJECTIVE: Translating the original questionnaire into Dutch, and investigating internal consistency and construct validity to enable use in the Dutch pain rehabilitation setting for treatment and research. METHODS: Cross-sectional validation study: After forward and back translation of the FOPQ-C, adolescents (11-22 years old) with chronic musculoskeletal pain completed an assessment containing the Dutch Fear of Pain Questionnaire, and questionnaires about demographics, pain catastrophizing, functional disability, and pain intensity. Internal consistency and construct validity were evaluated through exploratory factor analysis (principal axis factoring with oblique rotation) and hypotheses testing using pain catastrophizing, functional disability, and pain intensity as comparative constructs. RESULTS: Eighty-six adolescents completed the assessment. Exploratory factor analysis resulted in a two-factor structure, explaining 43% of the variance. Internal consistency was strong (Cronbach's α = 0.92 total scale, α = 0.88 factor 1, and α = .86 factor 2). Five out of 6 hypotheses were confirmed. CONCLUSIONS: The Dutch version demonstrated good internal consistency and good construct validity in a population of adolescents with chronic musculoskeletal pain. Implications for rehabilitation The Fear of Pain Questionnaire-Child version was developed to measure fear of pain and avoidance in children and adolescents with chronic pain. Identification of fear of pain and activities that are being avoided are important during screening and assessment of the adolescent for chronic pain rehabilitation treatment. The presence of fear of pain and/or avoidance behavior is important information to shape and target multidisciplinary rehabilitation treatment.

Measuring perceived harmfulness of physical activities in patients with chronic low back pain: the Photograph Series of Daily Activities--short electronic version.

UNLABELLED: Cognitive-behavioral models of chronic low back pain (CLBP) predict that dysfunctional assumptions about the harmfulness of activities may maintain pain-related fear and disability levels. The Photograph Series of Daily Activities (PHODA) is an instrument to determine the perceived harmfulness of daily activities in patients with CLBP. This study examined the psychometric properties of a short electronic version of the PHODA (PHODA-SeV). The results show that the PHODA-SeV measures a single factor and has a high internal consistency. The test-retest reliability and stability of the PHODA-SeV over a 2-week time interval are good, with discrepancies between 2 measurements over 20 points suggesting true change. The construct validity is supported by the finding that both self-reported pain severity and fear of movement/(re)injury were uniquely related to the PHODA-SeV. Validity is further corroborated by the finding that patients who have received exposure in vivo, that aimed to systematically reduce the perceived harmfulness of activities, had significantly lower PHODA-SeV scores after treatment than patients receiving graded activity that did not address these assumptions. The findings support the PHODA-SeV as a valid and reliable measure of the perceived harmfulness of activities in patients with CLBP. Preliminary normative data of the PHODA-SeV are presented. PERSPECTIVE: This article describes a pictorial measurement tool (PHODA-SeV) for the assessment of the perceived harmfulness of activities in patients with chronic low back pain. The PHODA-SeV has good psychometric properties and can be used to elaborate on the contribution of beliefs about harmful consequences of activities to pain and disability.

Comparison of two recruitment strategies for patients with chronic shoulder complaints.

BACKGROUND: Recruiting adequate numbers of participants represents a major problem to the completion of randomised clinical trials in primary care. Information on different recruitment strategies applied in one trial is scarce. AIM: To evaluate the application of two recruitment strategies in one trial. DESIGN OF STUDY: The study was performed within the framework of a randomised clinical trial on the effectiveness of a behavioural treatment for patients with chronic shoulder complaints. SETTING: Thirty-two general practices in the Netherlands. METHOD: Patients recruited during a consultation with their GP for chronic shoulder complaints were compared with patients recruited by advertisement in a local newspaper as regards baseline characteristics, withdrawals (drop-outs and losses to follow-up) and post-treatment clinical outcomes. RESULTS: Patients recruited by the GPs (n = 83) were similar to those recruited by advertisement (n = 83) in terms of demographic characteristics and clinical outcome measures at baseline, but differed slightly in disease characteristics and treatment preferences. Recruitment strategy was not related to reasons for or numbers of withdrawals. Improvements on outcome measures were greater in patients recruited by the GPs, irrespective of allocated treatment. Results on the clinical effectiveness of treatments at the end of the treatment period or during follow-up were neither modified by recruitment strategy, nor by differences between the two strategy groups in patient characteristics found at baseline. CONCLUSION: Using two recruitment strategies did not influence the outcomes on clinical effectiveness in this trial.However, recruitment strategy should be considered as a putative modifying factor in the design of a study.

Implications of process evaluation for clinical effectiveness and clinical practice in a trial on chronic shoulder complaints.

OBJECTIVE: The intervention process was evaluated in a randomised clinical trial on the effectiveness of a behavioural Graded Exercise Therapy (GET) programme for patients with chronic shoulder complaints in primary care settings. This process evaluation was done for three reasons: first, to know whether the programme was performed as planned; second, to know whether or not this treatment is feasible in normal practice; third, to identify needs for improvement of the protocol to facilitate implication. METHODS: We evaluated the extent to which the programme is being applied according to protocol, patient adherence to the programme and the suitability of the programme according to patients and physiotherapists. Twenty participating physiotherapists and 87 patients allocated to GET were asked to evaluate the intervention process. Furthermore, a sample of 10 patients, taken from the total number of 87 patients allocated to GET, was invited to take part in a focus group interview at the end of the study. We evaluated the intervention process using a treatment registration form filled in by the physiotherapists during treatment, evaluation forms filled in independently by physiotherapists and patients 26 weeks after the start of the treatment period, and information gathered during the focus group interview at the end of the study. RESULTS: GET was applied according to protocol to an acceptable extent, and participating patients showed satisfactory adherence to the programme. CONCLUSIONS: Clinical effectiveness of GET in this trial is not influenced by flaws in the application of the programme or by lack of patient adherence. PRACTICE IMPLICATIONS: The programme could be improved in terms of the process of goal-setting, and the implementation of GET could be facilitated if the programme is embedded in a multidisciplinary approach in primary care.

Treatment Fidelity of a Nurse-Led Motivational Interviewing-Based Pre-Treatment in Pain Rehabilitation.

Treatment fidelity and proficiency of a nurse-led motivational interviewing (MI)-based pre-treatment and control condition was evaluated. A random sample was scored by means of the Motivational Interviewing Treatment Integrity (MITI) scale, and a second rater was in charge. MI fidelity was satisfactory for three out of five ratings. Most mean ratings were higher in the MI-based intervention, but differences were not statistically significant. The threshold for beginning MI proficiency was only exceeded for one score and one additional measure. In general, higher levels of fidelity in the intervention condition confirmed that MI was partially applied there. Although the quality of MI delivery as well as mixed inter-rater reliabilities of the fidelity scores leaves room for improvement, robust findings between the two raters were found. These results suggest the need for rigor selection of MI counselors on beforehand, and continuous supervision. Furthermore, fidelity check in studies using MI is needed.