Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain:randomized controlled trial

Objective: To investigate the effectiveness of spinal manipulation combined with myofascial release compared with spinal manipulation alone, in individuals with chronic non-specific low back pain (CNLBP). Design: Randomized controlled trial with three months follow-up. Setting: Rehabilitation clinic. Participants: Seventy-two individuals (between 18 and 50 years of age; CNLBP ≥12 consecutive weeks) were enrolled and randomly allocated to one of two groups: (1) Spinal manipulation and myofascial release – SMMRG; n = 36) or (2) Spinal manipulation alone (SMG; n = 36). Interventions: Combined spinal manipulation (characterized by high velocity/low amplitude thrusts) of the sacroiliac and lumbar spine and myofascial release of lumbar and sacroiliac muscles vs manipulation of the sacroiliac and lumbar spine alone, twice a week, for three weeks. Main outcome measures: Assessments were performed at baseline, three weeks post intervention and three months follow-up. Primary outcomes were pain intensity and disability. Secondary outcomes were quality of life, pressure pain-threshold and dynamic balance. Results: No significant differences were found between SMMRG vs SMG in pain intensity and disability post intervention and at follow-up. We found an overall significant difference between-groups for CNLBP disability (SMG-SMMRG: mean difference of 5.0; 95% confidence interval of difference 9.9; −0.1), though this effect was not clinically important and was not sustained at follow-up. Conclusions: We demonstrated that spinal manipulation combined with myofascial release was not more effective compared to spinal manipulation alone for patients with CNLBP. Clinical trial registration number: NCT03113292

Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial

Objective To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain

Is It Time for a Change? A Cost-Effectiveness Analysis Comparing a Multidisciplinary Integrated Care Model for Residential Homes to Usual Care

OBJECTIVE: The objective of this study was to evaluate the cost-effectiveness of a Multidisciplinary Integrated Care (MIC) model compared to Usual Care (UC) in Dutch residential homes. METHODS: The economic evaluation was conducted from a societal perspective alongside a 6 month, clustered, randomized controlled trial involving 10 Dutch residential homes. Outcome measures included a quality of care weighted sum score, functional health (COOP WONCA) and Quality Adjusted Life-Years (QALY). Missing cost and effect data were imputed using multiple imputation. Bootstrapping was used to analyze differences in costs and cost-effectiveness. RESULTS: The quality of care sum score in MIC was significantly higher than in UC. The other primary outcomes showed no significant differences between the MIC and UC. The costs of providing MIC were approximately €225 per patient. Total costs were €2,061 in the MIC group and €1,656 for the UC group (mean difference €405, 95% -13; 826). The probability that the MIC was cost-effective in comparison with UC was 0.95 or more for ceiling ratios larger than €129 regarding patient related quality of care. Cost-effectiveness planes showed that the MIC model was not cost-effective compared to UC for the other outcomes. INTERPRETATION: Clinical effect differences between the groups were small but quality of care was significantly improved in the MIC group. Short term costs for MIC were higher. Future studies should focus on longer term economic and clinical effects. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN11076857

Two-year effectiveness of a stepped-care depression prevention intervention and predictors of incident depression in primary care patients with diabetes type 2 and/or coronary heart disease and subthreshold depression; data from the Step-Dep cluster randomized controlled trial

Introduction Major depressive disorders (MDD), diabetes mellitus type 2 (DM2) and coronary heart disease (CHD) are leading contributors to the global burden of disease and often co-occur. Objectives To evaluate the two-year effectiveness of a stepped-care intervention to prevent MDD compared to usual care and to develop a prediction model for incident depression in DM2 and/or CHD patients with subthreshold depression. Methods Data of 236 Dutch primary care DM2/CHD patients with subthreshold depression (Patient Health Questionnaire 9 (PHQ-9) score ≥6, no current MDD according to the Mini International Neuropsychiatric Interview (DSM-IV criteria)), who participated in the Step-Dep trial were used. A PHQ-9 score of ≥10 at minimally one measurement during follow-up (at 3, 6, 9, 12 and 24 months) was used to determine the cumulative incidence of MDD. Potential demographic and psychological predictors were measured at baseline via web-based self-reported questionnaires and evaluated using a multivariable logistic regression model. Model performance was assessed with the Hosmer–Lemeshow test, Nagelkerke’s R2 explained variance and Area Under the Receiver Operating Characteristic curve (AUC). Bootstrapping techniques were used to internally validate our model. Results 192 patients (81%) were available at two-year follow-up. The cumulative incidence of MDD was 97/192 (51%). There was no statistically significant overall treatment effect over 24 months of the intervention (OR 1.37; 95% CI 0.52; 3.55). Baseline levels of anxiety, depression, the presence of >3 chronic diseases and stressful life-events predicted the incidence of MDD (AUC 0.80 interquartile range (IQR) 0.79-0.80; Nagelkerke’s R2 0.34 IQR 0.33-0.36). Conclusion A model with four factors predicted depression incidence during two-year follow-up in patients with DM2/CHD accurately, based on the AUC. The Step-Dep intervention did not influence the incidence of MDD. Future depression prevention programs should target patients with these four predictors present, and aim to reduce both anxiety and depressive symptoms

Cost-effectiveness of tailored print communication, telephone motivational interviewing, and a combination of the two: results of an economic evaluation alongside the Vitalum randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>The aim of the present study was to evaluate the cost-effectiveness of tailored print communication (TPC), telephone motivational interviewing (TMI), a combination of the two, and no intervention on two outcomes in adults aged 45 to 70, half of them having hypertension: increasing the number of public health guidelines met for three behaviors (physical activity and fruit and vegetable consumption), and impact on quality adjusted life years (QALYs).</p> <p>Methods</p> <p>Participants (<it>n </it>= 1,629) from 23 Dutch general practices were randomized into one of four groups, which received 4 TPCs, 4 TMIs, 2 of each (combined), or no intervention (control), respectively. The self-reported outcomes, measured at baseline and 73 weeks follow-up (7 months after the last intervention component), were difference in total number of guidelines met at follow-up compared to baseline, and number of QALYs experienced over 73 weeks. The costs of implementing the intervention were estimated using a bottom-up approach.</p> <p>Results</p> <p>At 73 weeks follow-up participants showed increased adherence with 0.62 (TPC), 0.40 (TMI), 0.50 (combined), and 0.26 (control) guidelines compared to baseline, and experienced 1.09, 1.08, 1.08, and 1.07 QALYs, respectively. The costs for the control group were considered to be zero. TMI was more expensive (€107 per person) than both the combined intervention (€80) and TPC (€57). The control condition was most cost-effective for lower ceiling ratios, while TPC had the highest probability of being most cost-effective for higher ceiling ratios (more than €160 per additional guideline met, and €2,851 for each individual QALY).</p> <p>Conclusions</p> <p>For low society's willingness to pay, the control group was most cost-effective for the number of QALYs experienced over 73 weeks. This also applied to the increase in the number of guidelines met at lower ceiling ratios, whereas at higher ceiling ratios, TPC had a higher probability of being more cost-effective than the TMI, combined or control conditions. This also seemed to apply for QALYs experienced over 73 weeks. More research is needed on the long-term efficacy of both TPC and TMI, as well as on how to increase their cost-effectiveness.</p> <p>Trial registration</p> <p>Dutch Trial Register NTR1068</p

Preventive cognitive therapy versus treatment as usual in preventing recurrence of depression:Protocol of a multi-centered randomized controlled trial

Background Major depressive disorder (MDD) is projected to rank second on a list of 15 major diseases in terms of burden in 2030. The contribution of MDD to disability and health care costs is largely due to its highly recurrent nature. Therefore, part of the efforts to reduce the disabling effects of depression should focus on preventing recurrence, especially in patients at high risk of recurrence. The best established effective psychological intervention is cognitive therapy, with indications for prophylactic effects after remission. Methods/Design In this randomized controlled trial (cost-) effectiveness of Preventive Cognitive Therapy (PCT) after response to Acute Cognitive Therapy (A-CT) will be evaluated in comparison with Treatment As Usual (TAU). Remitted patients that responded to A-CT treatment with at least two previous depressive episodes will be recruited. Randomization will be stratified for number of previous episodes. Follow-ups are at 3, 6, 12 and 15 months. The primary outcome measure will be the time to relapse or recurrence of depression meeting DSM-IV criteria for a major depressive episode on the Structured Clinical Interview for DSM-VI Axis I Disorders (SCID-I). Costs will be measured from a societal perspective. Discussion This study is the first to examine the addition of PCT to TAU, compared to TAU alone in patients that recovered from depressive disorder with A-CT. Alongside this effect study a cost effectiveness analysis will be conducted. Furthermore, the study explores potential moderators to examine what works for whom. Trial registration Netherlands Trial Register (NTR): 2599, date of registration: 11-11-2010. Keywords Depression Relapse Recurrence Cognitive Therapy Preventio

(Cost)-effectiveness of case-management by district nurses among primary informal caregivers of older adults with dementia symptoms and the older adults who receive informal care: design of a randomized controlled trial [ISCRTN83135728]

BACKGROUND: Dementia is an incurable disease with devastating consequences for both patients and their relatives. The objective of this study is to describe the study protocol of a randomized controlled trial with assignment to either usual care or case-management by district nurses, among informal caregivers of older adults with dementia symptoms who live at home and the older adults who receive informal care. METHODS/DESIGN: In this randomized controlled trial, effectiveness as well as cost-effectiveness of case-management is evaluated. It concerns case-management in early-detected patients with dementia symptoms and their primary informal caregivers. Participants are followed up to twelve months after baseline assessment. The main outcome measure of the effect evaluation is the caregiver's sense of competence to care for the older person with dementia symptoms. The economic evaluation is performed from a societal perspective. DISCUSSION: This is one of the first trials on case-management that includes an economic evaluation. In addition, it concerns a tailor-made intervention in early-detected patients with dementia symptoms and their caregivers. The results of this randomized controlled trial will provide valuable information for health professionals and policy makers on effectiveness and cost-effectiveness of early tailor-made case-management for patients and their informal caregivers. Moreover, positive effects will challenge current health care systems to move to more pro-active approaches for this group

Diagnostic accuracy of depression questionnaires in adult patients with diabetes: a systematic review and meta-analysis

Importance Comorbid depression is common among patients with diabetes and has severe health consequences, but often remains unrecognized. Several questionnaires are used to screen for depression. A systematic review and meta-analysis regarding the diagnostic accuracy of depression questionnaires in adults with diabetes is unavailable. Objective To conduct a systematic review and meta-analysis to evaluate the diagnostic accuracy of depression questionnaires in adults with type 1 or type 2 diabetes. Data sources PubMed, Embase and PsycINFO were searched from inception to 28 February 2018. Study selection Studies were included when the diagnostic accuracy of depression questionnaires was assessed in a diabetes population and the reference standard was a clinical interview. Data extraction and synthesis Data extraction was performed by one reviewer and checked by another. Two reviewers independently conducted the quality assessment (QUADAS-2). Diagnostic accuracy was pooled in bivariate random effects models. This study is reported according to PRISMA-DTA and is registered with PROSPERO (CRD42018092950). Main Outcome(s) and measure(s) Diagnostic accuracy, expressed as sensitivity and specificity, of depression questionnaires in an adult diabetes population. Results A total 6,097 peer-reviewed articles were screened. Twenty-one studies (N= 5,703 patients) met the inclusion criteria for the systematic review. Twelve different depression questionnaires were identified, of which the CES-D (n=6 studies) and PHQ-9 (n=7 studies) were the most frequently evaluated. Risk of bias was unclear for multiple domains in the majority of studies. In the meta-analyses, five (N= 1,228) studies of the CES-D (≥16), five (N= 1,642) of the PHQ-9 (≥10) and four (N=822) of the algorithm of the PHQ-9 were included in the pooled analysis. The CES-D (≥16) had a pooled sensitivity of 85.0% (95%CI, 71.3-92.8%) and a specificity of 71.6% (95%CI, 62.5-79.2%); the PHQ-9 (≥10) had a sensitivity of 81.5% (95%CI, 57.1-93.5%) and a specificity of 79.7% (95%CI, 62.1-90.4%). The algorithm for the PHQ-9 had a sensitivity of 60.9% (95%CI, 52.3-50 90.8%) and a specificity of 64.0% (95%CI, 53.0-93.9%). Conclusions and relevance This review indicates that the CES-D had the highest sensitivity, whereas the PHQ-9 had the highest specificity, although confidence intervals were wide and overlapping. The algorithm for the PHQ-9 had the lowest sensitivity and specificity. Given the variance in results and suboptimal reporting of studies, further high quality studies are needed to confirm the diagnostic accuracy of these depression questionnaires in patients with diabetes

Grip on challenging behaviour: a multidisciplinary care programme for managing behavioural problems in nursing home residents with dementia. Study protocol

Contains fulltext : 97945.pdf (publisher's version ) (Open Access)BACKGROUND: Behavioural problems are common in nursing home residents with dementia and they often are burdensome for both residents and nursing staff. In this study, the effectiveness and cost-effectiveness of a new care programme for managing behavioural problems will be evaluated. METHODS/DESIGN: The care programme is based on Dutch national guidelines. It will consist of four steps: detection, analysis, treatment and evaluation. A stepped wedge design will be used. A total of 14 dementia special care units will implement the care programme. The primary outcome is behavioural problems. Secondary outcomes will include quality of life, prescription rate of antipsychotics, use of physical restraints and workload and job satisfaction of nursing staff. The effect of the care programme will be estimated using multilevel linear regression analysis. An economic evaluation from a societal perspective will also be carried out. DISCUSSION: The care programme is expected to be cost-effective and effective in decreasing behavioural problems, workload of nursing staff and in increasing quality of life of residents. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR). Trial number: NTR 2141

A supported self-help for recurrent depression in primary care; an economic evaluation alongside a multi-center randomised controlled trial

Background Major depression is a prevalent mental disorder with a high risk of relapse or recurrence. Only few studies have focused on the cost-effectiveness of interventions aimed at the prevention of relapse or recurrence of depression in primary care. Aim To evaluate the cost-effectiveness of a supported Self-help Preventive Cognitive Therapy (S-PCT) added to treatment-as-usual (TAU) compared with TAU alone for patients with a history of depression, currently in remission. Methods An economic evaluation alongside a multi-center randomised controlled trial was performed (n = 248) over a 12-month follow-up. Outcomes included relapse or recurrence of depression and quality-adjusted-life-years (QALYs) based on the EuroQol-5D. Analyses were performed from both a societal and healthcare perspective. Missing data were imputed using multiple imputations. Uncertainty was estimated using bootstrapping and presented using the cost-effectiveness plane and the Cost- Effectiveness Acceptability Curve (CEAC). Cost estimates were adjusted for baseline costs. Results S-PCT statistically significantly decreased relapse or recurrence by15% (95%CI 3;28) compared to TAU. Mean total societal costs were €2,114 higher (95%CI -112;4261). From a societal perspective, the ICER for recurrence of depression was 13,515. At a Willingness To Pay (WTP) of 22,000 €/recurrence prevented, the probability that S-PCT is cost-effective, in comparison with TAU, is 80%. From a healthcare perspective, the WTP at a probability of 80% should be 11,500 €/recurrence prevented. The ICER for QALYs was 63,051. The CEA curve indicated that at a WTP of 30,000 €/QALY gained, the probability that S-PCT is cost-effective compared to TAU is 21%. From a healthcare perspective, at a WTP of 30,000 €/QALY gained, the probability that S-PCT is cost-effective compared to TAU is 46%. Conclusions Though ultimately depending on the WTP of decision makers, we expect that for both relapse or recurrence and QALYs, S-PCT cannot be considered cost-effective compared to TAU