The Effect of Tailored Short Message Service (SMS) on Physical Activity: Results from a Three-Component Randomized Controlled Lifestyle Intervention in Women with PCOS.

This analysis of secondary outcome measures of a randomized controlled trial was conducted to study the effect of a one-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention (LSI), with or without additional Short Message Service (SMS) support, on physical activity and aerobic capacity in overweight or obese women with polycystic ovary syndrome (PCOS). Women diagnosed with PCOS and a BMI > 25 kg/m2 were randomly assigned to LSI with SMS support (SMS+, n = 60), LSI without SMS support (SMS-, n = 63) or care as usual (CAU, n = 60) in order to lose weight. Based on results from the International Physical Activity Questionnaire (IPAQ), we found a significant within-group increase after one year for SMS+ in the high physical activity category (+31%, p < 0.01) and sitting behaviour decreased (Δ -871 min/week, p < 0.01). Moreover, the peak cycle ergometer workload increased within SMS+ (Δ +10 watts, p < 0.01). The SMS+ group also demonstrated a significantly different increase in walking metabolic equivalent of task minutes (METmin)/week compared with CAU after one year (Δ 1106 METmin/week, p < 0.05). Apart from this increase in walking activity, no other between-group differences were found in this trial. Overall, based on within-group results, SMS support seemed to help with improving physical activity and aerobic capacity and decreasing sedentary behaviour.

Evaluation of centers for information and support combining formal and informal care for patients with cancer: a systematic review of the literature.

PURPOSE: Clear information and supportive care are necessary for patients with cancer to effectively manage their condition. Traditionally, healthcare professionals offer information and support via the so-called formal care route. In addition, research has found favorable effects of informal care provided by volunteer programs and informal "walk-in support centers." Less research has been done on initiatives that combine formal and complementary informal supportive care for patients with cancer. This systematic literature study aimed to discover (1) which types of initiatives are described in the literature, (2) what type of care they offer, and (3). how they are evaluated in terms of outcome measures. METHODS: We performed a systematic literature search of MEDLINE, Embase, PsycINFO, and CINAHL. Studies were included if the collaboration between one type of formal care together with one type of informal care was explicitly mentioned in the article. The search was not restricted to a specific cancer type. RESULTS: A total of 4869 records were retrieved and 18 studies were included. In most studies, the care provided consisted of emotional support for, and/or providing information to, patients and their families. Initiatives were evaluated with interviews and questionnaires. Patients with cancer reported that they were satisfied with the care offered, including information, social and emotional support, help with activities of daily living, and family-related issues. Volunteers reported that visits they made were experienced positive and rewarding and the volunteers were confident about their contribution to general healthcare. Some negative experiences were reported by volunteers, e.g., interference of their own cancer diagnosis with volunteer work. The importance of proper training was stressed. CONCLUSIONS: Initiatives combining formal and informal supportive care hold the potential of added value in terms of providing emotional support for, and providing information to, patients with cancer. Support and specific training for volunteers can be viewed as success factors in the involvement of volunteers in formal care practices.

Implementation of the kidney team at home intervention: Evaluating generalizability, implementation process, and effects.

Research has shown that a home-based educational intervention for patients with chronic kidney disease results in better knowledge and communication, and more living donor kidney transplantations (LDKT). Implementation research in the field of renal care is almost nonexistent. The aims of this study were (1) to demonstrate generalizability, (2) evaluate the implementation process, and (3) to assess the relationship of intervention effects on LDKT-activity. Eight hospitals participated in the project. Patients eligible for all kidney replacement therapies (KRT) were invited to participate. Effect outcomes were KRT-knowledge and KRT-communication, and treatment choice. Feasibility, fidelity, and intervention costs were assessed as part of the process evaluation. Three hundred and thirty-two patients completed the intervention. There was a significant increase in KRT-knowledge and KRT-communication among participants. One hundred and twenty-nine out of 332 patients (39%) had LDKT-activity, which was in line with the results of the clinical trials. Protocol adherence, knowledge, and age were correlated with LDKT-activity. This unique implementation study shows that the results in practice are comparable to the previous trials, and show that the intervention can be implemented, while maintaining quality. Results from the project resulted in the uptake of the intervention in standard care. We urge other countries to investigate the uptake of the intervention.

Standard set of patient-reported outcomes for personality disorder.

PURPOSE: The purpose of the article is to present standard set of outcomes for people with personality disorder (PD), in order to facilitate patient outcome measurement worldwide. METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) gathered a multidisciplinary international working group, consisting of 16 experts, including clinicians, nurses, psychologists, methodologists and patient representatives, to develop a standard set of outcome measures for people with PD. The Delphi method was used to reach consensus on the scope of the set, outcome domains, outcome measures, case-mix variables and time points for measuring outcomes in service users. For each phase, a project team prepared materials based on systematic literature reviews and consultations with experts. RESULTS: The working group decided to include PD, as defined by International Classification of Diseases 11th revision (ICD-11). Eleven core outcomes and three optional outcomes across four health domains (mental health, behaviour, functioning and recovery) were defined as those relevant for people with PD. Validated measures for the selected outcomes were selected, some covering more than one outcome. Case-mix variables were aligned to other ICHOM mental health standard sets and consisted of demographic factors and those related to the treatment that people received. The group recommended that most outcomes are measured at baseline and annually. CONCLUSION: The international minimum standard set of outcomes has the potential to improve clinical decision making through systematic measurement and comparability. This will be key in improving the standard of health care for people with PD across the world.

Comparison of a home-based (multi) systemic intervention to promoting Medication AdheRence and Self-management among kidney transplant recipients with care-as-usual: the MARS randomized controlled trial protocol.

BACKGROUND: After kidney transplantation non-adherence and inadequate self-management undermine clinical outcomes and quality of life. Both have been demonstrated to be substantial in all age groups. However, interventions promoting adherence and self-management among kidney transplant recipients that have proven to be effective are scarce. In this study we aim to develop and test an intervention to optimize adherence and self-management. In this article we describe the background and design of the trial entitled 'promoting Medication AdheRence and Self-management among kidney transplant recipients' (MARS-trial)'. METHODS/DESIGN: This is a single-center, parallel arm randomized controlled trial. Nonadherent kidney transplant recipients aged 12 years or older are eligible for inclusion. Patients will be randomly assigned to either the experimental or a control group. The control group will receive care-as-usual. The experimental group will receive care-as-usual plus the MARS-intervention. The MARS-intervention is an outreaching intervention, based on the principles of (multi) systemic therapy which means involving the social network. A standardized intervention protocol is used for consistency but we will tailor the behavior change techniques used to the specific needs and determinants of each patient. The primary outcome of medication adherence will be measured using electronic monitoring. Secondary outcome measures regarding medication adherence and self-management are also assessed. Data is collected at baseline (T0), after a run-in period (T1), at six months post-baseline/end of treatment (T2) and after a six month follow-up period (T3). DISCUSSION: We combined elements of (multi) systemic therapy and evidence-based behavior change techniques to create an outreaching and highly individualized intervention. In this trial we will investigate the impact on medication adherence and self-management after kidney transplantation. TRIAL REGISTRATION: Netherlands Trial Register,trial number NTR7462. Registered 7th September 2018, https://www.trialregister.nl/trial/7264.

Cost-effectiveness of the treatments for critical limb ischemia in the elderly population.

OBJECTIVE: The treatment of critical limb ischemia (CLI), with the intention to prevent limb loss, is often an intensive and expensive therapy. The aim of this study was to examine the cost-effectiveness of endovascular and conservative treatment of elderly CLI patients unsuitable for surgery. METHODS: In this prospective observational cohort study, data were gathered in two Dutch peripheral hospitals. CLI patients aged 70 years or older were included in the outpatient clinic. Exclusion criteria were malignant disease, lack of language skills, and cognitive impairment; 195 patients were included and 192 patients were excluded. After a multidisciplinary vascular conference, patients were divided into three treatment groups (endovascular revascularization, surgical revascularization, or conservative therapy). Subanalyses based on age were made (70-79 years and ≥80 years). The follow-up period was 2 years. Cost-effectiveness of endovascular and conservative treatment was quantified using incremental cost-effectiveness ratios (ICERs) in euros per quality-adjusted life-years (QALYs). RESULTS: At baseline, patients allocated to surgical revascularization had better health states, but the health states of endovascular revascularization and conservative therapy patients were comparable. With an ICER of €38,247.41/QALY (∼$50,869/QALY), endovascular revascularization was cost-effective compared with conservative therapy. This is favorable compared with the Dutch applicable threshold of €80,000/QALY (∼$106,400/QALY). The subanalyses also established that endovascular revascularization is a cost-effective alternative for conservative treatment both in patients aged 70 to 79 years (ICER €29,898.36/QALY; ∼$39,765/QALY) and in octogenarians (ICER €56,810.14/QALY; ∼$75,557/QALY). CONCLUSIONS: Our study has shown that endovascular revascularization is cost-effective compared with conservative treatment of CLI patients older than 70 years and also in octogenarians. Given the small absolute differences in costs and effects, physicians should also consider individual circumstances that can alter the outcome of the intervention. Cost-effectiveness remains one of the aspects to take into consideration in making a clinical decision.

Health-economic outcomes in hospital patients with medical-psychiatric comorbidity: A systematic review and meta-analysis.

BACKGROUND: Hospital inpatients often experience medical and psychiatric problems simultaneously. Although this implies a certain relationship between healthcare utilization and costs, this relationship has never been systematically reviewed. OBJECTIVE: The objective is to examine the extent to which medical-psychiatric comorbidities relate to health-economic outcomes in general and in different subgroups. If the relationship is significant, this would give additional reasons to facilitate the search for targeted and effective treatments for this complex population. METHOD: A systematic review in Embase, Medline, Psycinfo, Cochrane, Web of Science and Google Scholar was performed up to August 2016 and included cross-references from included studies. Only peer-reviewed empirical studies examining the impact of inpatient medical-psychiatric comorbidities on three health-economic outcomes (length of stay (LOS), medical costs and rehospitalizations) were included. Study design was not an exclusion criterion, there were no restrictions on publication dates and patients included had to be over 18 years. The examined populations consisted of inpatients with medical-psychiatric comorbidities and controls. The controls were inpatients without a comorbid medical or psychiatric disorder. Non-English studies were excluded. RESULTS: From electronic literature databases, 3165 extracted articles were scrutinized on the basis of title and abstract. This resulted in a full-text review of 86 articles: 52 unique studies were included. The review showed that the presence of medical-psychiatric comorbidity was related to increased LOS, higher medical costs and more rehospitalizations. The meta-analysis revealed that patients with comorbid depression had an increased mean LOS of 4.38 days compared to patients without comorbidity (95% CI: 3.07 to 5.68, I2 = 31%). CONCLUSIONS: Medical-psychiatric comorbidity is related to increased LOS, medical costs and rehospitalization; this is also shown for specific subgroups. This study had some limitations; namely, that the studies were very heterogenetic and, in some cases, of poor quality in terms of risk of bias. Nevertheless, the findings remain valid and justify the search for targeted and effective interventions for this complex population.

Adverse Effects of Outcome Monitoring Feedback in Patients With Personality Disorders: A Randomized Controlled Trial in Day Treatment and Inpatient Settings.

This study aimed to evaluate the differential effect of outcome monitoring feedback to therapists and to patients on outcomes in cluster B, cluster C, and personality disorder not otherwise specified (PD-NOS) patients. Day treatment patients (n = 112) and inpatients (n = 94) were randomly assigned to a feedback to therapist (FbT), feedback to therapist and patient (FbTP), or no feedback (NFb) condition. Feedback was based on weekly administrations of the Outcome Questionnaire-45 (OQ-45). In cluster B and PD-NOS patients FbTP resulted in increased OQ-45 scores during the first 6 months of therapy for not on track (NOT) patients. In cluster C patients, no adverse effects of feedback were found. These results suggest that for certain personality disorder patient groups, providing feedback during treatment may not always be beneficial, although more research is needed to further assess these effects.

Logical inconsistencies in time trade-off valuation of EQ-5D-5L health states: Whose fault is it?

INTRODUCTION: Inconsistency in the time trade-off (TTO) task in EQ-5D-5L occurs when a respondent gives a higher value to a logically worse health state, the occurrence of inconsistency compromises the quality of the data. It is not yet clear which factors are associated with individual level inconsistency. Relating inconsistency to the characteristics of the respondent, interviewer, and the interview process could be helpful in understanding the causes of inconsistency. The objective of this paper is to discover the factors associated with individual level inconsistencies. METHODS: Twenty interviewers interviewed 1,296 respondents and each respondent valued 10 health states using the EQ-VT platform in 5 cities in China. At the respondent level, inconsistency was identified in terms of severity and quantity and related to the respondent's background characteristics, the time and iterations spent on the wheelchair example task, and the formal TTO tasks, using multilevel multinomial regression analyses. Interviewers' impact on inconsistencies was analyzed using single level multinomial regression analyses. RESULTS: In the full dataset, slight inconsistency was more related to the interview process (Time spent on TTO task: RRR = 1.246 with 95%CI: 1.076,1.441; time spent on Wheelchair example: RRR = 0.815 with 95%CI:0.699,0.952) while severe inconsistency was more related to respondent's gender (Gender: RRR = 2.347 with 95%CI:1.429,3.855). One Interviewer (Interviewer 7: RRR = 7.335 with 95%CI:1.908,28.195) and interviewer's experience (Sequence: RRR = 0.511 with 95%CI:0.385,0.678) in general showed strong influence over inconsistency in the TTO task. CONCLUSION: In conclusion, logical inconsistency in the valuation of EQ-5D-5L health states is associated not only with respondents' characteristics but also with interviewers' performance and the interview process. The role of interviewers and the importance of interviewer training may be more crucial than hitherto believed. This finding could be generalizable to other interviewer-administered health-state valuation study.

Therapeutic assessment promotes treatment readiness but does not affect symptom change in patients with personality disorders: findings from a randomized clinical trial.

The field of clinical personality assessment is lacking in published empirical evidence regarding its treatment and clinical utility. This article reports on a randomized controlled clinical trial (N = 74) allocating patients awaiting treatment in a specialized clinic for personality disorders to either 4 sessions of (a) therapeutic assessment (TA) or (b) a structured goal-focused pretreatment intervention (GFPTI). In terms of short-term outcome, TA demonstrated superior ability to raise outcome expectancies and patient perceptions of progress toward treatment (Cohen's d = 0.65 and 0.56, respectively) and yielded higher satisfaction (d = 0.68). Moreover, patients reported marginally stronger alliance to the TA clinicians than to GFPT clinicians (d = 0.46), even though therapists perceived the alliance as equally positive in both groups. No differences in symptomatic ratings were observed. Results are discussed with reference to treatment utility in this particular patient group.

The effect of outcome monitoring feedback to clinicians and patients in short and long-term psychotherapy: a randomized controlled trial.

OBJECTIVE: Outcome monitoring feedback has become popular, but its effect on treatment outcome has been mixed. Feedback seems most effective for patients who are not progressing well ("not on track" (NOT) cases). There are some indications that patient feedback has an additional effect and that feedback effects differentiate between short- and long-term therapy. This study aimed to evaluate the effect of outcome monitoring feedback to therapists and patients on outcome in short- and long-term psychotherapy. METHODS: Patients (n = 475) were randomly assigned to three conditions: Feedback to therapist (FbT), feedback to therapist and patient (FbTP), and no feedback (NFb). Feedback consisted of progress charts based on the Outcome Questionnaire and a feedback message. RESULTS: In short-term therapies (<35 weeks) FbT and FbTP was preventive of negative change for NOT cases. In long-term therapy only FbTP had a small positive effect on the rate of change. Feedback did not result in better outcomes at treatment ending, although there was a trend for FbTP to have fewer deteriorated cases. CONCLUSIONS: Benefits of feedback were strongest for cases that were not progressing well in short-term therapies when both the patient and therapist received feedback on the patients' progress. Contrary to previous findings, we also found a small effect of feedback to therapists and patients in long-term therapies. Feedback to both patients and therapists may be more effective than feedback to therapists alone due to implementation issues or empowerment of the patient.

Experience of palliative care for patients with head and neck cancer through the eyes of next of kin: impact of an Expert Center.

BACKGROUND: Literature is scarce on the palliative care experiences of patients with head and neck cancer. We report our experience in this patient population after the establishment of our Expert Center. METHODS: We administered a questionnaire to 40 surviving relatives of patients with head and neck cancer after the establishment of our Expert Center and compared the results to a similar group of patients with head and neck cancer before the establishment of our Expert Center. RESULTS: Since the establishment of our Expert Center, we found: an improved evaluation of the psychosocial support offered; better contact between head and neck surgeons, the patients, and families; and improvement in the quantity of information in the palliative phase. Some relatives, however, reported that patients received treatment against their wishes and life was not made as comfortable as possible. CONCLUSION: Important aspects of palliative care, such as psychosocial support and contact between patient and surgeon, have been improved since the establishment of our Expert Center.

Fatigue management in patients with IBD: a randomised controlled trial.

OBJECTIVE: To assess the effectiveness of solution-focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD). DESIGN: Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength--Fatigue (CIS--fatigue) score of ≥ 35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality. RESULTS: Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS-fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed. CONCLUSIONS: SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up.

Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review.

Evaluating a person's suitability for living organ donation is crucial, consisting not only of a medical but also of a thorough psychosocial screening. We performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidates. We searched PubMed, Embase, CINAHL, and PsycINFO until June 22, 2011, following the PRISMA guidelines, complemented by scrutinizing guidelines databases and references of identified publications. Thirty-four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs. Guidelines and consensus statements were inconsistent and lacked concreteness for both their content and process, possibly explaining the observed variability in center-specific evaluation protocols and programs. Overall, recommended screening criteria are not evidence-based and an operational definition of the concept "psychosocial" is missing, causing heterogeneity in terminology. Variation also exists on methods used to psychosocially evaluate potential donors. The scientific basis of predonation psychosocial evaluation needs to be strengthened. There is a need for high-quality prospective psychosocial outcome studies in living donors, a uniform terminology to label psychosocial screening criteria, and validated instruments to identify risk factors.

Psychologic functioning of unspecified anonymous living kidney donors before and after donation.

BACKGROUND: There has been discussion regarding the psychologic functioning of living donors who donate their kidney to an unrelated and unknown patient ("unspecified living donors"). This is the first prospective study to investigate group- and individual-level changes in psychologic functioning among a large group of unspecified donors. METHODS: Forty-nine medically and psychologically screened unspecified living kidney donors completed the Symptom Checklist before and after donation. RESULTS: Group-level analysis showed that overall psychologic symptoms increased after donation (P=0.007); the means remained within the average range of the normal population. Individual-level analysis showed that 33 donors showed no statistically significant change, 3 donors showed a statistically significant decrease, and 13 donors showed a statistically significant increase in psychologic symptoms. Two of the latter donors showed a clinically significant increase. CONCLUSIONS: We found more increases in psychologic symptoms than decreases, particularly if follow-up time was longer. However, for almost all donors, these increases were not clinically significant and the clinically significant changes found are comparable with natural fluctuations in psychologic symptoms in the general population. Possibly, the donors underreported their psychologic symptoms before donation to pass the screening. Due to the low level of predonation symptoms reported, regression to the mean could also explain the results. Although we found that changes were not associated with donation-related factors, it is possible that other donation-related factors or other life events not measured have an influence on psychologic functioning. Therefore, further research is needed to investigate whether the fluctuations are related to the donation process.

Introducing the HOPE (Hypospadias Objective Penile Evaluation)-score: a validation study of an objective scoring system for evaluating cosmetic appearance in hypospadias patients.

OBJECTIVE: To determine the reliability and internal validity of the Hypospadias Objective Penile Evaluation (HOPE)-score, a newly developed scoring system assessing the cosmetic outcome in hypospadias. PATIENTS AND METHODS: The HOPE scoring system incorporates all surgically-correctable items: position of meatus, shape of meatus, shape of glans, shape of penile skin and penile axis. Objectivity was established with standardized photographs, anonymously coded patients, independent assessment by a panel, standards for a "normal" penile appearance, reference pictures and assessment of the degree of abnormality. A panel of 13 pediatric urologists completed 2 questionnaires, each consisting of 45 series of photographs, at an interval of at least 1 week. The inter-observer reliability, intra-observer reliability and internal validity were analyzed. RESULTS: The correlation coefficients for the HOPE-score were as follows: intra-observer reliability 0.817, inter-observer reliability 0.790, "non-parametric" internal validity 0.849 and "parametric" internal validity 0.842. These values reflect good reproducibility, sufficient agreement among observers and a valid measurement of differences and similarities in cosmetic appearance. CONCLUSIONS: The HOPE-score is the first scoring system that fulfills the criteria of a valid measurement tool: objectivity, reliability and validity. These favorable properties support its use as an objective outcome measure of the cosmetic result after hypospadias surgery.

Diagnosis of personality disorders in adolescents: a study among psychologists.

BACKGROUND: Recent guidelines concerning the treatment of personality disorders (PDs) recommend diagnosing PDs in adolescents. However, it remains unclear whether these guidelines influence the current opinions and practices of mental health care professionals. METHODS: Five hundred sixty-six psychologists completed an online survey concerning PDs in adolescents, of whom 367 professionals reported working with adolescents. The survey contained demographical questions (age, gender, profession, work setting) and specific questions related to PD in adolescence. RESULTS: Although a majority of psychologists working with adolescents acknowledged the existence of PDs in adolescents (57.8%), only a small minority diagnoses PDs in adolescence (8.7%) and offers a treatment specifically aimed at targeting PD pathology (6.5%). Reasons for not diagnosing PDs in adolescence mainly concerned the belief that adolescent personality problems are transient (41.2%) and that the DSM-IV-TR does not allow diagnosing PDs in adolescence (25.9%). CONCLUSIONS: Although practice guidelines might have influenced clinicians' opinions about PDs in adolescence, they have had little impact so far on routine clinical practice.

Solution focused therapy: a promising new tool in the management of fatigue in Crohn's disease patients psychological interventions for the management of fatigue in Crohn's disease.

BACKGROUND: Crohn's disease patients have a decreased Quality of Life (QoL) which is in part due to extreme fatigue. In a pilot study we prospectively assessed the feasibility and effect of psychological interventions in the management of fatigue. METHODS: Patients with quiescent Crohn's disease and a high fatigue score according to the Checklist Individual Strength were randomized to Problem Solving Therapy (PST), Solution Focused Therapy (SFT) or to a control group (treatment as usual, TAU). Patients completed the Inflammatory Bowel Disease Questionnaire, the EuroQol-5D, and the Trimbos questionnaire for Costs. RESULTS: Twenty-nine patients were included (12 TAU, 9 PST, 8 SFT), of these 72% were female, mean age was 31 years (range 20-50). The SFT group improved on the fatigue scale in 85.7% of the patients, in the PST group 60% showed improved fatigue scores and in the TAU group 45.5%. Although not significant, in both intervention groups the QoL increased. Medical costs lowered in 57.1% of the patients in the SFT group, in the TAU 45.5% and the in PST group 20%. The drop out rate was highest in the PST group (44%; SFT 12.5%; TAU 8.3%). CONCLUSIONS: PST and SFT both positively affect the fatigue and QoL scores in patients with Crohn's disease. SFT seems most feasible with fewer dropouts and is therefore a promising new tool in the management of fatigue in Crohn's disease patients.

The effectiveness of a training for patients with unexplained physical symptoms: protocol of a cognitive behavioral group training and randomized controlled trial.

BACKGROUND: In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training. METHODS AND DESIGN: A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial. DISCUSSION: If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group in the daily practice of a mental healthcare institution, its transfer to practice should be relatively easy. TRIAL REGISTRATION: Nederlands Trial Register, NTR1609.