A multidisciplinary lifestyle program for metabolic syndrome-associated osteoarthritis: the "Plants for Joints" randomized controlled trial.

OBJECTIVE: To determine the effectiveness of the "Plants for Joints" multidisciplinary lifestyle program in patients with metabolic syndrome-associated osteoarthritis (MSOA). DESIGN: Patients with hip or knee MSOA were randomized to the intervention or control group. The intervention group followed a 16-week program in addition to usual care based on a whole food plant-based diet, physical activity, and stress management. The control group received usual care. The patient-reported Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) total score (range 0-96) was the primary outcome. Secondary outcomes included other patient-reported, anthropometric, and metabolic measures. An intention-to-treat analysis with a linear-mixed model adjusted for baseline values was used to analyze between-group differences. RESULTS: Of the 66 people randomized, 64 completed the study. Participants (84% female) had a mean (SD) age of 63 (6) years and body mass index of 33 (5) kg/m2. After 16 weeks, the intervention group (n = 32) had a mean 11-point larger improvement in WOMAC-score (95% CI 6-16; p = 0.0001) compared to the control group. The intervention group also lost more weight (-5 kg), fat mass (-4 kg), and waist circumference (-6 cm) compared to the control group. Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue, pain interference, C-reactive protein, hemoglobin A1c, fasting glucose, and low-density lipoproteins improved in the intervention versus the control group, while other PROMIS measures, blood pressure, high-density lipoproteins, and triglycerides did not differ significantly between the groups. CONCLUSION: The "Plants for Joints" lifestyle program reduced stiffness, relieved pain, and improved physical function in people with hip or knee MSOA compared to usual care.

A multidisciplinary lifestyle program for rheumatoid arthritis: the 'Plants for Joints' randomized controlled trial.

OBJECTIVE: To determine the effect of a multidisciplinary lifestyle program in patients with RA with low-moderate disease activity. METHODS: In the 'Plants for Joints' (PFJ) parallel-arm, assessor-blind randomized controlled trial, patients with RA and 28-joint DAS (DAS28) ≥2.6 and ≤5.1 were randomized to the PFJ or control group. The PFJ group followed a 16-week lifestyle program based on a whole-food plant-based diet, physical activity and stress management. The control group received usual care. Medication was kept stable 3 months before and during the trial whenever possible. We hypothesized that PFJ would lower disease activity (DAS28). Secondary outcomes included anthropometric, metabolic and patient-reported measures. An intention-to-treat analysis with a linear mixed model adjusted for baseline values was used to analyse between-group differences. RESULTS: Of the 83 people randomized, 77 completed the study. Participants were 92% female with mean (s.d.) age of 55 (12) years, BMI of 26 (4) kg/m2 and mean DAS28 of 3.8 (0.7). After 16 weeks the PFJ group had a mean 0.9-point greater improvement of DAS28 vs the control group (95% CI 0.4, 1.3; P < 0.0001). The PFJ intervention led to greater decreases in body weight (difference -3.9 kg), fat mass (-2.8 kg), waist circumference (-3 cm), HbA1c (-1.3 mmol/mol) and low-density lipoprotein (-0.32 mmol/l), whereas patient-reported outcome measures, blood pressure, glucose and other lipids did not change. CONCLUSION: The 16-week PFJ multidisciplinary lifestyle program substantially decreased disease activity and improved metabolic status in people with RA with low-moderate disease activity. TRIAL REGISTRATION: International Clinical Trials Registry Platform; https://www.who.int/clinical-trials-registry-platform; NL7800.

eHealth to Improve Psychological Functioning and Self-Management of People With Chronic Kidney Disease: A Randomized Controlled Trial.

OBJECTIVE: Psychological distress is common among patients with chronic kidney disease and can interfere with disease self-management. We assessed the effectiveness of the personalized E-GOAL electronic health care pathway with screening and cognitive-behavioral therapy including self-management support, aimed to treat psychological distress and facilitate self-management among people with chronic kidney disease not on dialysis ( N = 121). METHODS: Primary outcome of the open two-arm parallel randomized controlled trial in four Dutch hospitals was psychological distress at posttest directly after the intervention and at 3-month follow-up. Secondary outcomes were physical and mental health-related quality of life, self-efficacy, chronic disease self-management, and personalized outcomes, that is, perceived progress compared with the previous time point on functioning (e.g., mood or social functioning) and self-management (e.g., dietary or medication adherence) outcomes that were prioritized by each individual. RESULTS: Linear mixed-effects analyses showed no significant time-by-group interaction effects for psychological distress, health-related quality of life, self-efficacy, and chronic condition self-management, whereas analyses of covariance showed significantly more perceived progress in the intervention group at posttest on personally prioritized areas of functioning ( b = 0.46, 95% confidence interval = 0.07-0.85) and self-management ( b = 0.55, 95% confidence interval = 0.16-0.95), with Cohen d values of 0.46 and 0.54 (medium effects), respectively. Effects on personalized outcomes were maintained at follow-up. CONCLUSIONS: Compared with regular care only, the electronic health intervention did not reduce psychological distress, whereas personalized outcomes did improve significantly after intervention. Future studies could consider personalized outcomes that reflect individually relevant areas and treatment goals, matching person-tailored treatments. TRIAL REGISTRATION: Registered at the Netherlands Trial Register with study number NTR7555 ( https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7555 ).

"What matters to you?": The relevance of patient priorities in dialysis care for assessment and clinical practice.

BACKGROUND: Dialysis patients are confronted with numerous, complex problems, which make it difficult to identify individual patient's most prominent problems. The objectives of this study were to (1) identify dialysis patients' most prominent problems from a patient perspective and (2) to calculate disease-specific norms for questionnaires measuring these problems. METHODS: One hundred seventy-five patients treated with hemodialysis or peritoneal dialysis completed a priority list on several domains of functioning (e.g., physical health, mental health, social functioning, and daily activities) and a set of matching questionnaires assessing patient functioning on these domains. Patient priorities were assessed by calculating the importance ranking of each domain on the priority list. Subsequently, disease-specific norm scores were calculated for all questionnaires, both for the overall sample and stratified by patient characteristics. RESULTS: Fatigue was listed as patients' most prominent problem. Priorities differed between male and female patients, younger and older patients, and home and center dialysis patients, which was also reflected in their scores on the corresponding domains of functioning. Therefore, next to general norm scores, we calculated corrections to the general norms to take account of patient characteristics (i.e., sex, age, and dialysis type). CONCLUSIONS: Results highlight the importance of having attention for the specific priorities and needs of each individual patient. Adequate disease-specific, norm-based assessment is not only necessary for diagnostic procedures but is an essential element of patient-centered care: It will help to better understand and respect individual patient needs and tailor treatment accordingly.

The Personalized Priority and Progress Questionnaire (PPPQ): A personalized instrument for quality of life and self-management for use in clinical trials and practice.

PURPOSE: The aim of this study was to develop and validate a brief personalized instrument that (1) defines patients' priorities for improvement, (2) measures progress in prioritized quality of life (QoL) and self-management outcomes, and (3) is applicable in both clinical practice and clinical trials. METHODS: The instrument was developed based on the literature on personalized assessment and patient priorities, feedback by clinicians, and six cognitive interviews with patients with chronic kidney disease. The resulting questionnaire, the Personalized Priority and Progress Questionnaire (PPPQ), contains a baseline and follow-op measurement. The baseline measurement assesses functioning on QoL (8 items) and self-management (5 items). The final item evaluates patients' priorities for improvement. The follow-up measurement assesses progress in QoL and self-management. A personalized progress score can be calculated indicating the amount of progress on the QoL or self-management domain that is prioritized by the individual patient. Psychometric properties of the PPPQ were evaluated among patients with chronic kidney disease (n = 121) and patients with kidney failure treated with dialysis (n = 22). RESULTS: The PPPQ showed to be a feasible instrument that is easy and quick to complete. Regarding the construct validity, small to large correlations were found between the items and existing validated questionnaires measuring related constructs. CONCLUSION: The PPPQ proved to be a feasible and valid instrument. The PPPQ can be adapted to match diverse populations and could be a useful tool both in clinical practice (e.g., to identify priorities and tailor treatment) and clinical trials (e.g., to evaluate the effectiveness of personalized interventions).

A better but persistently low health status in women with fibromyalgia during the COVID-19 pandemic: a repeated cross-sectional data analysis.

Multiple overlapping and complementary theoretical arguments suggest that the COVID-19 pandemic could worsen health in fibromyalgia. The aim of this study was to determine mental and physical health in women with fibromyalgia before and during the pandemic. In a 3-sample, repeated cross-sectional design, we analyzed questionnaire data from Dutch women with fibromyalgia, collected in three independent samples: before the COVID-19 pandemic (2018; n = 142) and during the first acute (2020; n = 304) and prolonged (2021; n = 95) phases of the pandemic. Eight dimensions of mental and physical health were assessed using The RAND 36-Item Short Form Health Survey (RAND SF-36). Compared to norm group data, both before and during the pandemic, women with fibromyalgia showed high levels of fatigue and pain and low levels of general health, social functioning, physical functioning, role physical functioning (d > 1.2, very large effect sizes), role emotional functioning, and mental health (0.71 < d < 1.2, medium to large effect sizes). Contrary to theoretical expectation, levels at five health variables before vs. during the pandemic did not differ (p > 0.05), and levels of pain (p < 0.001), role physical functioning (p < 0.001), and physical functioning (p = 0.03) (0.014 ≤ pη2 ≤ 0.042, small effect sizes) reflected a healthier status during than before the pandemic. These findings indicate a somewhat better but persistently low health status in women with fibromyalgia during the pandemic. This suggests that the pandemic may include changed circumstances that are favorable for some women with fibromyalgia.

Psychosocial barriers and facilitators for adherence to a healthy lifestyle among patients with chronic kidney disease: a focus group study.

BACKGROUND: Progression of chronic kidney disease (CKD) may be delayed if patients engage in healthy lifestyle behaviors. However, lifestyle adherence is very difficult and may be influenced by problems in psychosocial functioning. This qualitative study was performed to gain insights into psychosocial barriers and facilitators for lifestyle adherence among patients with CKD not receiving dialysis. METHODS: Eight semi-structured focus groups were conducted with a purposive sample of 24 patients and 23 health care professionals from four Dutch medical centers. Transcripts were analyzed using thematic analysis. Subsequently, the codes from the inductive analysis were deductively mapped onto the Theoretical Domains Framework (TDF). RESULTS: Many psychosocial barriers and facilitators for engagement in a healthy lifestyle were brought forward, such as patients' knowledge and intrinsic motivation, emotional wellbeing and psychological distress, optimism, and disease acceptance. The findings of the inductive analysis matched all fourteen domains of the TDF. The most prominent domains were 'social influences''and 'environmental context and resources', reflecting how patients' environments hinder or support engagement in a healthy lifestyle. CONCLUSIONS: The results indicate a need for tailored behavioral lifestyle interventions to support disease self-management. The TDF domains can guide development of adequate strategies to identify and target individually experienced psychosocial barriers and facilitators.

Increasing the Effectiveness of a Physical Activity Smartphone Intervention With Positive Suggestions: Randomized Controlled Trial.

BACKGROUND: eHealth interventions have the potential to increase the physical activity of users. However, their effectiveness varies, and they often have only short-term effects. A possible way of enhancing their effectiveness is to increase the positive outcome expectations of users by giving them positive suggestions regarding the effectiveness of the intervention. It has been shown that when individuals have positive expectations regarding various types of interventions, they tend to benefit from these interventions more. OBJECTIVE: The main objective of this web-based study is to investigate whether positive suggestions can change the expectations of participants regarding the effectiveness of a smartphone physical activity intervention and subsequently enhance the number of steps the participants take during the intervention. In addition, we study whether suggestions affect perceived app effectiveness, engagement with the app, self-reported vitality, and fatigue of the participants. METHODS: This study involved a 21-day fully automated physical activity intervention aimed at helping participants to walk more steps. The intervention was delivered via a smartphone-based app that delivered specific tasks to participants (eg, setting activity goals or looking for social support) and recorded their daily step count. Participants were randomized to either a positive suggestions group (69/133, 51.9%) or a control group (64/133, 48.1%). Positive suggestions emphasizing the effectiveness of the intervention were implemented in a web-based flyer sent to the participants before the intervention. Suggestions were repeated on days 8 and 15 of the intervention via the app. RESULTS: Participants significantly increased their daily step count from baseline compared with 21 days of the intervention (t107=-8.62; P<.001) regardless of the suggestions. Participants in the positive suggestions group had more positive expectations regarding the app (B=-1.61, SE 0.47; P<.001) and higher expected engagement with the app (B=3.80, SE 0.63; P<.001) than the participants in the control group. No effects of suggestions on the step count (B=-22.05, SE 334.90; P=.95), perceived effectiveness of the app (B=0.78, SE 0.69; P=.26), engagement with the app (B=0.78, SE 0.75; P=.29), and vitality (B=0.01, SE 0.11; P=.95) were found. Positive suggestions decreased the fatigue of the participants during the 3 weeks of the intervention (B=0.11, SE 0.02; P<.001). CONCLUSIONS: Although the suggestions did not affect the number of daily steps, they increased the positive expectations of the participants and decreased their fatigue. These results indicate that adding positive suggestions to eHealth physical activity interventions might be a promising way of influencing subjective but not objective outcomes of interventions. Future research should focus on finding ways of strengthening the suggestions, as they have the potential to boost the effectiveness of eHealth interventions. TRIAL REGISTRATION: Open Science Framework 10.17605/OSF.IO/CWJES; https://osf.io/cwjes.

Open- and Closed-Label Placebo and Nocebo Suggestions About a Sham Transdermal Patch.

OBJECTIVE: Placebo effects may occur when it is known that an inert substance is given (i.e., open-label placebo). It is not yet clear whether these effects are similar to concealed (i.e., closed-label) placebo effects for itch or whether nocebo effects can be induced under open-label conditions. METHODS: Healthy volunteers (n = 112) were randomized to an open-label (I) or closed-label (II) positive suggestions group, or an open-label (III) or closed-label (IV) negative suggestions group. Participants were told, as cover story, that a transdermal caffeine patch would be applied that positively influences cognitive abilities and, as a side effect, positively or negatively (depending on group allocation) influences itch. Participants in the open-label groups were given a rationale explaining placebo and nocebo effect mechanisms. Itch (the primary outcome) was induced at baseline and postsuggestions by histamine iontophoresis. RESULTS: Analyses of variance revealed significantly lower itch in the positive compared with the negative suggestions groups for both open- and closed-label contexts (all, p ≤ .008, Cohen d ≥ 0.47). Self-rated skin response was less severe after positive versus negative suggestions (all, p ≤ .017, Cohen d ≥ 0.33), but no effects on physical skin response were found (all, p ≥ .23, Cohen d ≤ 0.30). CONCLUSIONS: Itch can be reduced by positive compared with negative suggestions under both open- and closed-label conditions. These findings indicate that open-label suggestions may potentially be a tool to use placebo effects for self-reported outcomes in clinical practice, for example, by explaining the role of expectancy in treatment. It needs to be investigated further under which circumstances an open-label rationale may impact placebo and nocebo effects.Trial Registration:www.trialregister.nl; NTR7174.

Conditioned hormonal responses: A systematic review in animals and humans.

In contrast to classical conditioning of physiological responses such as immune responses and drug effects, only a limited number of studies investigated classical conditioning of endocrine responses. The present paper is the first systematic review that integrates evidence from animal and human trials regarding the possibility to condition the endocrine responses. Twenty-six animal and eight human studies were included in the review. We demonstrated that there is accumulating evidence that classical conditioning processes are able to influence specific endocrine responses, such as cortocosterone/cortisol and insulin, while more limited evidence exists for other hormones. Animal and human studies were generally consistent in their findings; however, the limited number of human studies makes it difficult to generalize and translate the results of animal research to humans. Next to methodological recommendations for future studies, we suggest several ways how classically conditioned endocrine responses can be used in clinical practice.

Placebo Effects in the Neuroendocrine System: Conditioning of the Oxytocin Responses.

OBJECTIVE: There is evidence that placebo effects may influence hormone secretion. However, few studies have examined placebo effects in the endocrine system, including oxytocin placebo effects. We studied whether it is possible to trigger oxytocin placebo effects using a classical conditioning paradigm. METHODS: Ninety-nine women were assigned to a conditioned, control, or drug control group. In the two-phase conditioning paradigm, participants in the conditioned and drug control groups received an oxytocin nasal spray combined with a distinctive smell (conditioned stimulus [CS]) for three acquisition days, whereas the control group received placebo spray. Subsequently, the conditioned and control groups received placebo spray with the CS and the drug control group received oxytocin spray for three evocation days. Salivary oxytocin was measured several times during each day. Pain sensitivity and facial evaluation tests previously used in oxytocin research were also administered. RESULTS: On evocation day 1, in the conditioned group, oxytocin significantly increased from baseline to 5 minutes after CS (B[slope] = 19.55, SE = 5.88, p < .001) and remained increased from 5 to 20 (B = -10.42, SE = 5.81, p = .071) and 50 minutes (B = -0.70, SE = 3.37, p = .84). On evocation day 2, a trend for increase in oxytocin was found at 5 minutes (B = 15.22, SE = 8.14, p = .062). No placebo effect was found on evocation day 3 (B = 3.57, SE = 3.26, p = .28). Neither exogenous nor conditioned oxytocin affected pain or facial tasks. CONCLUSIONS: Results indicate that oxytocin release can be conditioned and that this response extinguishes over time. Triggering hormonal release by placebo manipulation offers various clinical possibilities, such as enhancing effects of pharmacological treatments or reducing dosages of medications. TRIAL REGISTRATION: The study was registered as a clinical trial on www.trialregister.nl (number NTR5596).

Exploring the EQ-5D Dimension of Pain/Discomfort in Dermatology Outpatients from a Multicentre Study in 13 European Countries.

Pain and discomfort are important symptoms in dermatology. The aim of this cross-sectional, multicentre study was to describe the prevalence of pain/discomfort and its associations in patients with several dermatological conditions across 13 European countries. The outcome was the prevalence of pain/discomfort according to a question of the EQ-5D questionnaire. Data collected from November 2011 to February 2013 were complete for 3,509 consecutive outpatients. Moderate or extreme pain/discomfort was reported by 55.5% of patients and 31.5% of controls with no skin conditions. The highest proportions were reported by patients with hidradenitis suppurativa (92.9%), leg ulcer (81.4%), prurigo (80%) and lichen planus (75.6%). Pain/discomfort was associated with older age, low educational level, clinical severity, flare on scalp or hands, itch, depression, anxiety, low quality of life, and thoughts of suicide. It is important to enquire specifically about pain/discomfort during clinical consultations and to address it when planning a patient's care.

An Internet-Based Psychological Intervention With a Serious Game to Improve Vitality, Psychological and Physical Condition, and Immune Function in Healthy Male Adults: Randomized Controlled Trial.

BACKGROUND: Recently, internet-based cognitive behavioral therapy (ICBT) and serious gaming interventions have been suggested to enhance accessibility to interventions and engagement in psychological interventions that aim to promote health outcomes. Few studies, however, have investigated their effectiveness in the context of simulated real-life challenges. OBJECTIVE: We aimed to examine the effectivity of a guided ICBT combined with a serious gaming intervention in improving self-reported psychophysiological and immunological health endpoints in response to psychophysiological and immune-related challenges. METHODS: Sixty-nine healthy men were randomly assigned to the intervention condition, receiving ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention. Self-reported vitality was the primary endpoint. Other self-reported psychophysiological and immunological endpoints were assessed following various challenges, including a bacillus Calmette-Guérin vaccination evoking pro-inflammatory responses, 1 and 4 weeks after the intervention period. RESULTS: Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls. Furthermore, wellbeing (P=.024) was higher in the intervention group after the psychophysiological challenges. Although no significant group differences were found for the psychophysiological and immunological endpoints, the data provided preliminary support for increased immunoglobulin antibody responses at the follow-up time points (P<.05). Differential chemokine endpoints between conditions were observed at the end of the test day. CONCLUSIONS: The present study provides some support for improving health endpoints with an innovative ICBT intervention. Future research should replicate and further extend the present findings by consistently including challenges and a wide range of immune parameters into the study design. TRIAL REGISTRATION: Nederlands Trial Register NTR5610; https://www.trialregister.nl/trial/5466.

Chronic pain following laparoscopic living-donor nephrectomy: Prevalence and impact on quality of life.

Chronic postsurgical pain (CPSP) following laparoscopic donor nephrectomy (LDN) is a disregarded topic. In this cross-sectional study, all consecutive patients who underwent an LDN at the Radboud University Medical Center (Radboudumc; 2003-2016) were approached for participation. Five hundred twelve living kidney donors were included and asked to complete two questionnaires, including the McGill Pain Questionnaire and the RAND Short Form-36 Health Status Inventory (RAND SF-36) regarding their health-related quality of life (HRQoL). The mean prevalence of CPSP following LDN was 5.7%, with a mean follow-up time of 6 years. Possible predictors of CPSP following LDN are severe early postoperative pain, previous abdominal surgery, and preexisting backache. The RAND SF-36 revealed an impaired HRQoL in patients with CPSP when compared to patients without CPSP. In conclusion, this study revealed that the prevalence of CPSP following LDN is substantial. Given the possible association between the presence of CPSP and impaired HRQoL scores, living kidney donors should be well informed in the preoperative phase about the risk of CPSP.

Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease.

BACKGROUND: The treatment of persistent symptoms attributed to Lyme disease remains controversial. We assessed whether longer-term antibiotic treatment of persistent symptoms attributed to Lyme disease leads to better outcomes than does shorter-term treatment. METHODS: In a randomized, double-blind, placebo-controlled trial conducted in Europe, we assigned patients with persistent symptoms attributed to Lyme disease--either related temporally to proven Lyme disease or accompanied by a positive IgG or IgM immunoblot assay for Borrelia burgdorferi--to receive a 12-week oral course of doxycycline, clarithromycin plus hydroxychloroquine, or placebo. All study groups received open-label intravenous ceftriaxone for 2 weeks before initiating the randomized regimen. The primary outcome measure was health-related quality of life, as assessed by the physical-component summary score of the RAND-36 Health Status Inventory (RAND SF-36) (range, 15 to 61, with higher scores indicating better quality of life), at the end of the treatment period at week 14, after the 2-week course of ceftriaxone and the 12-week course of the randomized study drug or placebo had been completed. RESULTS: Of the 281 patients who underwent randomization, 280 were included in the modified intention-to-treat analysis (86 patients in the doxycycline group, 96 in the clarithromycin-hydroxychloroquine group, and 98 in the placebo group). The SF-36 physical-component summary score did not differ significantly among the three study groups at the end of the treatment period, with mean scores of 35.0 (95% confidence interval [CI], 33.5 to 36.5) in the doxycycline group, 35.6 (95% CI, 34.2 to 37.1) in the clarithromycin-hydroxychloroquine group, and 34.8 (95% CI, 33.4 to 36.2) in the placebo group (P=0.69; a difference of 0.2 [95% CI, -2.4 to 2.8] in the doxycycline group vs. the placebo group and a difference of 0.9 [95% CI, -1.6 to 3.3] in the clarithromycin-hydroxychloroquine group vs. the placebo group); the score also did not differ significantly among the groups at subsequent study visits (P=0.35). In all study groups, the SF-36 physical-component summary score increased significantly from baseline to the end of the treatment period (P<0.001). The rates of adverse events were similar among the study groups. Four serious adverse events thought to be related to drug use occurred during the 2-week open-label ceftriaxone phase, and no serious drug-related adverse event occurred during the 12-week randomized phase. CONCLUSIONS: In patients with persistent symptoms attributed to Lyme disease, longer-term antibiotic treatment did not have additional beneficial effects on health-related quality of life beyond those with shorter-term treatment. (Funded by the Netherlands Organization for Health Research and Development ZonMw; PLEASE ClinicalTrials.gov number, NCT01207739.).

Antipruritic Placebo Effects by Conditioning H1-antihistamine.

OBJECTIVE: Allergic rhinitis symptoms can be reduced by behaviorally conditioning antihistamine. It is unclear whether these findings extend to histamine-induced itch or work when participants are informed about the conditioning procedure (open-label conditioning). The current study aims to investigate the efficacy of (open-label) antipruritic behavioral conditioning for histamine-induced itch. METHODS: Healthy participants (n = 92; 84% female) were randomized to I) an open-label conditioned, II) closed-label conditioned, III) conditioned-not-evoked control, or IV) nonconditioned control group. A two-phase conditioning paradigm was used. During acquisition, a conditioned stimulus (CS; distinctively tasting beverage) was repeatedly paired with the H1-antihistamine levocetirizine (groups I-III). During evocation, the CS was paired with placebo (I, II), or instead of the CS, water was paired with placebo (III). The nonconditioned control group (IV) received CS with placebo in both phases. Itch after histamine iontophoresis and physiological data (i.e., spirometry, heart rate, skin conductance) were assessed. Combined conditioned and combined control groups were first compared, and analyses were repeated for separate groups. RESULTS: Marginally lower itch was reported in the combined conditioned compared with the control groups (F(1,88) = 2.10, p = .076, ηpartial = 0.02); no differences between separate groups were found. No effects on physiological data were found, except for heart rate, which reduced significantly and consistently for control groups, and less consistently for conditioned groups (group by time interaction: F(7,80) = 2.35, p = .031, ηpartial = 0.17). CONCLUSION: Limited support was found for the efficacy of antipruritic behavioral conditioning, regardless of whether participants were informed about the conditioning procedure. The application of open-label conditioning in patient populations should be further researched. TRIAL REGISTRATION: www.trialregister.nl; ID NTR5544.

Psychosocial consequences of living kidney donation: a prospective multicentre study on health-related quality of life, donor-recipient relationships and regret.

BACKGROUND: Previous studies have indicated decreased health-related quality of life (HRQoL) shortly after kidney donation, returning to baseline in the longer term. However, a subgroup of donors experiences persistent HRQoL problems. To identify which HRQoL aspects are impacted most by the donation and to identify at-risk donors, more specific insight into psychosocial donation consequences is needed. METHODS: The current study examined the HRQoL course, donor-perceived consequences of donation for donors, recipients and donor-recipient relationships, and regret up to 12 months post-donation in donors from seven Dutch transplantation centres. Kidney donor candidates (n = 588) completed self-report questionnaires early in the screening procedure, of which 361 (61%) donated their kidney. RESULTS: Data for 230 donors (64%) with complete assessments before donation and 6 and 12 months post-donation were analysed. Results indicated that donor physical HRQoL was comparable at all time points, except for an increase in fatigue that lasted up to 12 months post-donation. Mental HRQoL decreased at 6 months post-donation, but returned to baseline at 12 months. Donors reported large improvements in recipient's functioning and a smaller influence of the recipient's kidney disease or transplantation on the donor's life over time. A subgroup experienced negative donation consequences with 14% experiencing regret 12 months post-donation. Predictors of regret were more negative health perceptions and worse social functioning 6 months post-donation. The strongest baseline predictors of higher fatigue levels after donation were more pre-donation fatigue, worse general physical functioning and a younger age. CONCLUSIONS: Future research should examine predictors of HRQoL after donation to improve screening and to provide potential interventions in at-risk donors.

Effectiveness of Stress-Reducing Interventions on the Response to Challenges to the Immune System: A Meta-Analytic Review.

BACKGROUND: There is consistent evidence showing an interplay between psychological processes and immune function in health and disease processes. OBJECTIVES: The present systematic review and meta-analysis aims to provide a concise overview of the effectiveness of stress-reducing psychological interventions on the activation of immune responses in both healthy subjects and patients. METHODS: Included are 3 types of challenges: in vivo, in vitro, and psychophysiological. Such challenges are designed to mimic naturally occurring immune-related threats. RESULTS: A systematic literature search was conducted using PubMed, EMBASE, and PsychInfo, resulting in 75 eligible studies. The risk of bias was assessed with the Cochrane risk-of-bias tool. Across all studies, a small-to-medium effect size was found for the effects of psychological interventions on optimization of the immune function (g = 0.33; 95% CI 0.22-0.43). While the largest effects were found for in vivo immune-related challenges (g = 0.61; 95% CI 0.34-0.88; especially on studies that incorporated skin tests and wound healing), studies incorporating psychophysiological challenges and in vitro immune-related stimulations similarly suggest more optimal immune responses among those receiving stress-reducing interventions (g = 0.28; 95% CI 0.15-0.42). CONCLUSION: These findings showed substantial heterogeneity depending on the type of challenge, the study populations, and the intervention types. These data demonstrate support for the effectiveness of stress-reducing psychological interventions in improving immunity in studies that tested immune function by means of incorporating an in vivo,in vitro, or psychophysiological challenge. Future research should more consistently incorporate challenges into the study design to gather more insights in the mechanisms underlying the optimized immune function following a psychological intervention. This is also relevant for clinical practice, as psychological interventions can possibly supplement, or at least partially replace, current drug treatments in various somatic conditions to reduce side effects.

Occurrence, Chronicity and Intensity of Itch in a Clinical Consecutive Sample of Patients with Skin Diseases: A Multi-centre Study in 13 European Countries.

Itch is an unpleasant symptom, affecting many dermatological patients. Studies investigating the occurrence and intensity of itch in dermatological patients often focus on a single skin disease and omit a control group with healthy skin. The aim of this multi-centre study was to assess the occurrence, chronicity and intensity (visual analogue scale 0-10) of itch in patients with different skin diseases and healthy-skin controls. Out of 3,530 dermatological patients, 54.3% reported itch (mean ± standard deviation itch intensity 5.5 ± 2.5), while out of 1,094 healthy-skin controls 8% had itch (3.6 ± 2.3). Chronic itch was reported by 36.9% of the patients and 4.7% of the healthy-skin controls. Itch was most frequent (occurrence rates higher than 80%) in patients with unclassified pruritus, prurigo and related conditions, atopic dermatitis and hand eczema. However, many patients with psychodermatological conditions and naevi also reported itch (occurrence rates higher than 19%).

Illness perceptions and their association with 2 year functional status and change in patients with hand osteoarthritis.

Objective: To investigate the association between illness perceptions and disability both cross-sectionally and over 2 years in patients with hand OA. Methods: Illness perceptions and self-reported disability were assessed at baseline and after 2 years in 384 patients with primary hand OA (mean age 61 years, 84% women, n = 312 with follow-up) with the Illness Perception Questionnaire - Revised (IPQ-R), Functional Index for Hand OA, Australian/Canadian Hand OA Index and HAQ. Risk ratios for high disability (highest quartile) at both time points were estimated for tertiles of IPQ-R dimensions, using Poisson regression. The mean IPQ dimension change difference between patients with and without disability progression (change Functional Index for Hand OA ⩾ 1, Australian/Canadian Hand OA Index > 1.4, HAQ > 0.22) was estimated with linear regression. Analyses were adjusted for age, Doyle index and baseline score. Results: At baseline, stronger negative illness perceptions were associated with high disability. Baseline illness perceptions were also associated with high disability after 2 years, although adjustment made apparent that these associations were confounded by baseline disability status. Most illness perceptions changed over 2 years; understanding increased, OA was regarded as more chronic and fewer emotions and consequences and less personal and treatment control were experienced. The 2 year change in disability was different between patients with and without progression for the illness perceptions of more perceived consequences, symptoms, treatment control and emotions. Conclusion: Illness perceptions seemed to be implicated in disability and its progression. Our results suggest that interventions could focus on improving baseline disability, potentially using illness perceptions to accomplish this goal.