Telephone consultation for cancer survivors with unclarified need for rehabilitation in a primary healthcare setting: a mixed methods process evaluation.

PURPOSE: To evaluate the implementation of telephone consultations to assess cancer patients' needs for rehabilitation, with focus on patients' acceptance, health professionals' experience and contextual factors. METHODS: A mixed methods process evaluation was conducted at a primary healthcare rehabilitation clinic. Cancer survivors above 18 years of age with an unclarified rehabilitation need at discharge from hospital, was offered a telephone consultation provided by health professionals. Data on implementation and acceptability were collected using medical records systems, data collection forms and semi-structured interviews with six patients and two health professionals. RESULTS: Eighty-one cancer survivors were referred to the intervention, and 54% continued to further rehabilitation. The telephone consultations were executed approximately eight days after referral and took on average 44 min to deliver. Overall, the patients found that the telephone consultation addressed what they considered the most important topics, and the health professionals found the intervention to be acceptable. Both patients and health professionals reported challenges regarding the referral process. CONCLUSION: Patient acceptance of the intervention was high, and the telephone consultation was implemented to a high degree, resulting in more than half of the patients continuing to further rehabilitation. Patients' and health professionals' perspectives provided valuable insights about contextual factors.

Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial).

INTRODUCTION: Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation. METHODS AND ANALYSIS: In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors. ETHICS AND DISSEMINATION: The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences. TRIAL REGISTRATION NUMBER: NCT04795843.

Assistive devices among people living at home with advanced cancer: Use, non-use and who have unmet needs for assistive devices?

OBJECTIVE: To investigate which assistive devices people with advanced cancer have and whether they are in use. In addition, to explore the characteristics of people with advanced cancer who have unmet needs for assistive devices. METHODS: This descriptive cross-sectional study used data from a randomised controlled trial evaluating efficacy of an occupational therapy-based intervention. Participants were 237 people with advanced cancer. Data were collected by means of instruments about demography, functioning and assistive devices. RESULTS: The most frequent assistive devices possessed by the participants were as follows: (1) small aids for dressing (47%), (2) Pillow for positioning (40%) and (3) electrically operated adjustable bed (39%). The prevalence of assistive devices was 92% (95% confidence interval [CI]: 88%-95%) with 14.2% non-use, largest for trolley tables (50%). In all, 27.4% of the participants were found to have unmet needs for assistive devices. These participants had similar characteristics to the other participants except from lower activity of daily living (ADL) ability (p values = <0.001). CONCLUSION: The assistive devices possessed by the participants were primarily for positioning and resting, and most were in use. More than a fourth of the participants had unmet needs for assistive devices and were characterised by lower ADL ability.

Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data. DESIGN: Economic evaluation alongside a randomized controlled trial with two-year follow-up. SETTING: Patients from the outpatient clinics of a university hospital and a general hospital. SUBJECTS: A total of 82 lumbar spinal fusion patients. INTERVENTIONS: Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation. MAIN MEASURES: Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects. RESULTS: No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion. CONCLUSION: This case manager-assisted rehabilitation programme was unlikely to be cost-effective.

Subgroup effects of occupational therapy-based intervention for people with advanced cancer.

Background: Many people with advanced cancer have decreased ability to perform activities of daily living (ADL). We recently performed a randomized, controlled trial (RCT) assessing the efficacy of an occupational therapy-based program, the 'Cancer Home-Life Intervention' in people with advanced cancer (N = 242) and found no overall effects on ADL ability. However, heterogeneity of treatment effect may disguise subgroup differences.Objective: To investigate whether subgroups of people with advanced cancer gain positive effects from the 'Cancer Home-Life Intervention' on ADL ability.Material and method: An exploratory subgroup analysis including 191 participants from a RCT. The outcome was ADL motor ability measured by the Assessment of Motor and Process Skills (AMPS). Subgroups were defined by age, gender, years of education, type of primary tumor, functional level, and activity problems.Results: The 'Cancer Home-Life Intervention' had no statistically significant effect in the six subgroups. Modifying effects of age (0.30 [95% CI: -0.05 to 0.64]) and gender (0.23 [95% CI: -0.11 to 0.57]) were not found.Conclusion: There were no subgroup effects of the 'Cancer Home-Life Intervention'on ADL motor ability. Some indications suggest greater effects for those aged below 69 years; however, this result should be interpreted with caution.

The effects of respiratory physiotherapy after lung resection: Protocol for a systematic review.

BACKGROUND: The main treatment of lung cancer (stage 1 and 2) is lung resection surgery. The risk of postoperative pulmonary complications is high and therefore standard postoperative care involves respiratory physiotherapy. The purpose of this systematic review is to create an overview of the evidence on respiratory physiotherapy after lung resection surgery on mortality rate (within 30 days) and postoperative pulmonary complications. METHODS AND ANALYSIS: The review will include randomized or quasi-randomized controlled studies investigating the effect of all types of respiratory physiotherapy on mortality and postoperative pulmonary complications after lung resection surgery. Furthermore, the effect of respiratory physiotherapy is evaluated on secondary outcomes such as length of hospital stay, lung volumes and function, and adverse events. The method of the planned review is described in this paper. The literature search will include the databases PubMed, Cochrane (Central), Embase, Cinahl and PEDro. The literature search is being performed in 2017. If meta-analyses are not undertaken, a narrative synthesis of the available data will be provided. The protocol was registered in PROSPERO on the 10th of October 2016 (registration number CRD42016048956). ETHICS AND DISSEMINATION: Conclusion of this systematic review is expected available in the second half of 2017.

Preoperative cognitive-behavioural intervention improves in-hospital mobilisation and analgesic use for lumbar spinal fusion patients.

BACKGROUND: Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge. We aimed to examine if a preoperative intervention of cognitive-behavioural therapy (CBT) could influence the early postsurgical outcome following lumbar spinal fusion surgery (LSF). METHODS: Ninety patients undergoing LSF due to degenerative spinal disorders were randomly allocated to either the CBT group or the control group. Both groups received surgery and postoperative rehabilitation. In addition, the CBT group received a preoperative intervention focussed on pain coping using a CBT approach. Primary outcome was back pain during the first week (0-10 scale). Secondary outcomes were mobility, analgesic consumption, and length of hospitalisation. Data were retrieved using self-report questionnaires, assessments made by physical therapists and from medical records. RESULTS: No difference between the groups' self-reported back pain (p = 0.76) was detected. Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days. Analgesic consumption tended to be lower in the CBT group, whereas length of hospitalisation was unaffected by the CBT intervention. CONCLUSION: Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase, despite equally high levels of self-reported acute postsurgical pain in the two groups, and a slightly lower intake of rescue analgesics in the CBT group. This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention. TRIAL REGISTRATION: The study was approved by the Danish Protection Agency (2011-41-5899) and the Ethics Committee of the Central Denmark Region (M-20110047). The trial was registered in Current Controlled Trials ( ISRCTN42281022 ).

Preoperative Cognitive-Behavioral Patient Education Versus Standard Care for Lumbar Spinal Fusion Patients: Economic Evaluation Alongside a Randomized Controlled Trial.

STUDY DESIGN: A cost-effectiveness analysis conducted alongside a randomized clinical trial. OBJECTIVE: To assess the cost-effectiveness of a preoperative cognitive-behavioral therapy (CBT) intervention compared to usual care for patients undergoing lumbar spinal fusion surgery (LSF). SUMMARY OF BACKGROUND DATA: The clinical effectiveness of a preoperative CBT intervention for patients undergoing LSF has been investigated in a randomized clinical trial. Economic evaluation is however essential for decision makers to make informed choices regarding allocation of scarce resources. METHODS: 90 patients undergoing LSF were randomly allocated to usual care (control group) or usual care plus a preoperative CBT intervention (CBT group). Outcome parameters included quality-adjusted life years (QALY), based on the EQ-5D, and pain-related disability, based on the Oswestry disability index (ODI). Health care use and productivity loss were estimated from national registers. RESULTS: One year after LSF the estimated QALY was significantly better for the CBT group with 0.710 (95% CI 0.670; 0.749) versus 0.636 (95% CI 0.5573; 0.687). For the ODI, the CBT group reported significantly larger disability reductions at 3 months (P = 0.003) and 6 months (P = 0.047), but not at 1 year (P = 0.082). There was no difference in the overall costs of the two groups (-€89 (95% CI -12,080; 11,902)), leading to a 70% probability of the CBT intervention being cost-effective at a willingness-to-pay of €40,000 for one additional QALY. For an additional gain of 15 ODI points the probability was 90% at a threshold of €10,000. These results remained largely unaffected by relevant sensitivity analyses, confirming the robustness of findings. CONCLUSION: Preoperative CBT appears to be more effective and cost neutral when considering the overall health care sector and labor market perspective, supporting the implementation of preoperative CBT in the course of treatment for LSF surgery in a Danish context.

Does a preoperative cognitive-behavioral intervention affect disability, pain behavior, pain, and return to work the first year after lumbar spinal fusion surgery?

STUDY DESIGN: A randomized clinical trial including 90 patients. OBJECTIVE: To examine the effect of a preoperative cognitive-behavioral intervention (CBT) for patients undergoing lumbar spinal fusion (LSF) surgery. SUMMARY OF BACKGROUND DATA: Few published studies have looked at the potential of rehabilitation to improve outcomes after LSF. Rehabilitation programs using CBT are recommended. Furthermore, initiating interventions preoperatively seems beneficial, but only limited data exist in the field of spine surgery. METHODS: Patients with degenerative disc disease or spondylolisthesis undergoing LSF were randomized to usual care (control group) or preoperative CBT and usual care (CBT group). Primary outcome was change in Oswestry Disability Index from baseline to 1-year follow-up. Secondary outcomes were catastrophizing, fear avoidance belief, work status, and back and leg pain. RESULTS: At 1-year follow-up, there was no statistically significant difference between the CBT group and the control group in Oswestry Disability Index score (P = 0.082). However, the CBT group had achieved a significant reduction of -15 points (-26; -4) already at 3 months (between group difference P = 0.003), and this reduction was maintained throughout the year. There were no differences between groups at 1-year follow-up with regard to any of the secondary outcomes. CONCLUSION: Participating in a preoperative CBT intervention in addition to usual care did not produce better outcomes at 1-year follow-up for patients undergoing LSF. Although the reduction in disability was achieved much faster in the CBT group, resulting in a significant difference between groups already 3 months after surgery, it did not translate into a faster return to work. Our findings support the need for further research into the use of targeted rehabilitation interventions among patients with elevated levels of catastrophizing and fear avoidance beliefs. LEVEL OF EVIDENCE: 2.

Description and design considerations of a randomized clinical trial investigating the effect of a multidisciplinary cognitive-behavioural intervention for patients undergoing lumbar spinal fusion surgery.

BACKGROUND: The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. METHODS/DESIGN: The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control: intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. DISCUSSION: It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42281022.

The Canadian Occupational Performance Measure's semi-structured interview: its applicability to lumbar spinal fusion patients. A prospective randomized clinical study.

BACKGROUND: Although lumbar spinal fusion has been performed for more than 70 years, few studies have examined rehabilitation strategies for spinal fusion patients, and there is only sparse information about the patient's activity level after surgery. The Canadian Occupational Performance Measure (COPM) is a standardized semi-structured interview, developed to identify patients' problems in relation to activities of daily living (ADL). The COPM has neither been examined in a randomised clinical study nor employed in relation to lumbar spinal fusion patients. We aimed to examine whether or not the use of the semi-structured interview COPM during in-hospital rehabilitation could: (1) identify more ADL-related problems of importance to the patients after discharge from the hospital, (2) enhance the patients' ADL performance after discharge from hospital METHOD: Eighty-seven patients undergoing a lumbar spinal fusion caused by degenerative diseases were randomly assigned to either use of the COPM or to standard treatment. RESULTS AND CONCLUSION: Use of the COPM during hospitalization helped in identifying more ADL problems encountered by patients during the first 3 months post-discharge period as COPM served to identify more treatment goals and plans of action. Use of the COPM had no impact on the patients' ADL performance, and the difference is so small that COPM may be of little clinical consequence.