Perspectives on the diagnosis and management of functional cognitive disorder: An international Delphi study.

BACKGROUND: Current proposed criteria for functional cognitive disorder (FCD) have not been externally validated. We sought to analyse the current perspectives of cognitive specialists in the diagnosis and management of FCD in comparison with neurodegenerative conditions. METHODS: International experts in cognitive disorders were invited to assess seven illustrative clinical vignettes containing history and bedside characteristics alone. Participants assigned a probable diagnosis and selected the appropriate investigation and treatment. Qualitative, quantitative and inter-rater agreement analyses were undertaken. RESULTS: Eighteen diagnostic terminologies were assigned by 45 cognitive experts from 12 countries with a median of 13 years of experience, across the seven scenarios. Accurate discrimination between FCD and neurodegeneration was observed, independently of background and years of experience: 100% of the neurodegenerative vignettes were correctly classified and 75%-88% of the FCD diagnoses were attributed to non-neurodegenerative causes. There was <50% agreement in the terminology used for FCD, in comparison with 87%-92% agreement for neurodegenerative syndromes. Blood tests and neuropsychological evaluation were the leading diagnostic modalities for FCD. Diagnostic communication, psychotherapy and psychiatry referral were the main suggested management strategies in FCD. CONCLUSIONS: Our study demonstrates the feasibility of distinguishing between FCD and neurodegeneration based on relevant patient characteristics and history details. These characteristics need further validation and operationalisation. Heterogeneous labelling and framing pose clinical and research challenges reflecting a lack of agreement in the field. Careful consideration of FCD diagnosis is advised, particularly in the presence of comorbidities. This study informs future research on diagnostic tools and evidence-based interventions.

Missingness mechanisms and generalizability of patient reported outcome measures in colorectal cancer survivors - assessing the reasonableness of the "missing completely at random" assumption.

BACKGROUND: Patient-Reported Outcome Measures (PROM) provide important information, however, missing PROM data threaten the interpretability and generalizability of findings by introducing potential bias. This study aims to provide insight into missingness mechanisms and inform future researchers on generalizability and possible methodological solutions to overcome missing PROM data problems during data collection and statistical analyses. METHODS: We identified 10,236 colorectal cancer survivors (CRCs) above 18y, diagnosed between 2014 and 2018 through the Danish Clinical Registries. We invited a random 20% (2,097) to participate in a national survey in May 2023. We distributed reminder e-mails at day 10 and day 20, and compared Initial Responders (response day 0-9), Subsequent Responders (response day 10-28) and Non-responders (no response after 28 days) in demographic and cancer-related characteristics and PROM-scores using linear regression. RESULTS: Of the 2,097 CRCs, 1,188 responded (57%). Of these, 142 (7%) were excluded leaving 1,955 eligible CRCs. 628 (32%) were categorized as initial responders, 418 (21%) as subsequent responders, and 909 (47%) as non-responders. Differences in demographic and cancer-related characteristics between the three groups were minor and PROM-scores only marginally differed between initial and subsequent responders. CONCLUSION: In this study of long-term colorectal cancer survivors, we showed that initial responders, subsequent responders, and non-responders exhibit comparable demographic and cancer-related characteristics. Among respondents, Patient-Reported Outcome Measures were also similar, indicating generalizability. Assuming Patient-Reported Outcome Measures of subsequent responders represent answers by the non-responders (would they be available), it may be reasonable to judge the missingness mechanism as Missing Completely At Random.

Validity and screening capacity of the FCR-1r for fear of cancer recurrence in long-term colorectal cancer survivors.

PURPOSE: Existing fear of cancer recurrence (FCR) screening measures is being shortened to facilitate clinical use. This study aimed to evaluate the validity and screening capacity of a single-item FCR screening measure (FCR-1r) in long-term colorectal cancer (CRC) survivors with no recurrence and assess whether it performs as well in older as in younger survivors. METHODS: All Danish CRC survivors above 18, diagnosed and treated with curative intent between 2014 and 2018, were located through a national patient registry. A questionnaire including the FCR-1r, which measures FCR on a 0-10 visual analog scale, alongside the validated Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) as a reference standard was distributed between November 2021 and May 2023. Screening capacity and cut-offs were evaluated with a receiver-operating characteristic analysis (ROC) in older (≥ 65 years) compared to younger (< 65 years) CRC survivors. Hypotheses regarding associations with other psychological variables were tested as indicators of convergent and divergent validity. RESULTS: Of the CRC survivors, 2,128/4,483 (47.5%) responded; 1,654 (36.9%) questionnaires were eligible for analyses (median age 76 (range 38-98), 47% female). Of the responders, 85.2% were aged ≥ 65. Ninety-two participants (5.6%) reported FCRI-SF scores ≥ 22 indicating clinically significant FCR. A FCR-1r cut-off ≥ 5/10 had 93.5% sensitivity and 80.4% specificity for detecting clinically significant FCR (AUC = 0.93, 95% CI 0.91-0.94) in the overall sample. The discrimination ability was significantly better in older (AUC = 0.93, 95% CI 0.91-0.95) compared to younger (0.87, 95% (0.82-0.92), p = 0.04) CRC survivors. The FCR-1r demonstrated concurrent validity against the FCRI-SF (r = 0.71, p < 0.0001) and convergent validity against the short-versions of the Symptom Checklist-90-R subscales for anxiety (r = 0.38, p < 0.0001), depression (r = 0.27, p < 0.0001), and emotional distress (r = 0.37, p < 0.0001). The FCR-1r correlated weakly with employment status (r = - 0.09, p < 0.0001) and not with marital status (r = 0.01, p = 0.66) indicating divergent validity. CONCLUSIONS: The FCR-1r is a valid tool for FCR screening in CRC survivors with excellent ability to discriminate between clinical and non-clinical FCR, particularly in older CRC survivors.

Managing persistent physical symptoms when being social and active is the norm: a qualitative study among young people in Denmark.

BACKGROUND: An increasing number of young people in Western countries report persistent physical symptoms (PPS). PPS may disturb everyday activities and they may have negative consequences for later adult mental and physical health. Still little is known about how young people handle PPS in their everyday lives. This study examines how young people with PPS attempt to manage their symptoms while staying engaged in their daily activities and what is at stake in these attempts. METHODS: This qualitative study involved semi-structured interviews with 11 young people with PPS. Photo-elicitation was used to capture the participants' experiences as they occurred in their everyday lives. The data material was analysed using a thematic analysis approach, as well as theory on subjectivity and social acceleration. RESULTS: The participants employed alleviating measures and tried to find patterns between their activities and the severity of their symptoms in order to adjust their activity level. Decisions not to participate in social activities were accompanied by feelings of missing out. The participants' attempts at adjusting their activity level was challenged by norms of being social and active, and they experienced difficulty prioritizing their activities and explaining their symptoms to others. CONCLUSION: PPS shaped the participants' sense of how to act towards their bodies and social relationships in interaction with societal norms. The participants' subject formation and symptom experiences should thus be seen as a biosocial process.

"I was Treated by the Program, the Therapist, and Myself": Feasibility of an Internet-Based Treatment Program for Gambling Disorder.

The majority of people with problematic gambling behavior never seek or receive professional help. Internet-based treatment approaches have been shown to help patients overcome practical and psychological barriers associated with face-to-face therapy. In this uncontrolled pilot study, we explored the feasibility of the eight-module therapist-guided internet-based treatment program SpilleFri ("Free from Gambling") for patients with gambling disorder (GD). We included 24 patients seeking treatment at a Danish hospital-based treatment clinic. The focus of the feasibility study was evaluation of recruitment and retention rates, data completion rates, treatment response, satisfaction, and program utility. In addition, a series of semi-structured interviews were conducted to explore patient-perceived acceptability and potential barriers to treatment completion and positive outcome. Treatment acceptability among therapists was examined in a focus group interview. Sixteen of the included patients completed the program, yielding an acceptable treatment dropout rate (29.17%), and 82.35% of treatment completers provided full data at all assessment points. Overall, patients were satisfied with the treatment received, and patient interviews highlighted multiple psychological as well as practical benefits associated with the treatment form and content. Patients with more severe gambling symptoms at baseline might be more likely to drop out before treatment completion than patients with less severe symptoms. The results suggest that SpilleFri may be a feasible alternative to face-to-face treatment for GD. However, the uncontrolled design and small sample size of the study limit the robustness of the findings. In the future, the effect of SpilleFri treatment should be examined in a randomized controlled trial.Clinical trial registrations: The study protocol was prospectively registered at clinicaltrials.gov (TRN: NCT05051085; registration date: September 21, 2021).

Examine the public health impacts of functional somatic disorders using the DanFunD study.

Background: Persistent physical symptoms (e.g. pain, fatigue) are prevalent in the population and some persons may develop a functional somatic disorder (FSD). We still need to explore the limits between general bodily sensations and FSD, and great controversies exist as regard delimitation, occurrence, risk factors, prognosis, and costs of FSD in the general population. This is mainly due to the lack of focused, sufficient powered, population-based epidemiological studies. Material and Methods: The DanFunD study is the largest focused population-based study on FSD and has the potential to answer these crucial questions regarding the FSD disorders. DanFunD has its origin in the Copenhagen area of Denmark and was initiated in 2009 by an interdisciplinary team of researchers including basic scientists, clinical researchers, epidemiologists, and public health researchers. A population-based cohort of nearly 10,000 people have filled in detailed questionnaires, gone through a thorough health examination, and a biobank is established. The cohort was re-examined after five years. Results:The prevalence of FSD in the Danish population is about 10-15% and is twice as common in women as in men. Persons with FSD report impaired daily activities and low self-perceived health, which qualifies FSD as a major public health problem. The research plan to unravel the risk factors for FSD employs a bio-psycho-social approach according to a detailed plan. Preliminary results are presented, and work is in progress. Likewise, plans for assessing prognosis and health care costs are provided. Conclusion: We invite researchers in the field to collaborate on this unique data material.

Adverse childhood experiences in patients with severe health anxiety: No evidence for an increased frequency compared to patients with obsessive-compulsive disorder.

Theoretical models of health anxiety emphasize adverse childhood experiences in the development of the disorder, but few studies examine such events in patients with severe health anxiety and the results are difficult to compare across studies. The present study examined adult retrospective reports of illness-related and traumatic childhood experiences in 31 patients with severe health anxiety, 32 non-clinical control participants, and a clinical control group of 33 patients with obsessive-compulsive disorder. No evidence of an increased frequency of adverse childhood experiences in patients with severe health anxiety was found. However, patients with severe health anxiety who had experienced the death of a friend or family member or a major upheaval during childhood, perceived these events as having been more traumatic than the control participants. These findings suggest that biases in how adverse childhood experiences are interpreted or remembered might play a role in severe health anxiety. The findings are discussed in relation to the cognitive behavioral model of health anxiety, and some of the processes in interpretation and memory that could explain how adverse childhood experiences might play a role in the development and maintenance of severe health anxiety are outlined.

Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.

BACKGROUND: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). METHODS: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. RESULTS: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant. CONCLUSIONS: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

The impact of the Covid-19 pandemic on mental and physical health in Denmark - a longitudinal population-based study before and during the first wave.

BACKGROUND: In the continuation of the first wave of the Covid-19 outbreak in Denmark, unprecedented restrictions with great impact on the citizen's everyday life were implemented. The objectives of this study were to investigate the influence of the Covid-19 pandemic on mental and physical health in the Danish population during the spring 2020 first wave outbreak and lockdown. METHODS: A sample from the adult Danish population (n = 2190) were included. Self-reported measures of illness worry (Whiteley-6-R), emotional distress (SCL-90), and physical symptom load (SLC-90) were obtained before and during the first wave of the pandemic and compared with Wilcoxon signed-rank tests. Impact of covariates on physical and mental health was evaluated with ordinal regression analyses. Results from a tailored questionnaire regarding the Covid-19 pandemic were presented to explore the direct impact of the pandemic. RESULTS: We only found minor increases in illness worry, emotional distress and physical symptom load (0-1 points difference, p ≤ 0.007) during the Covid-19 pandemic compared to before the pandemic. Sex, age, education, and physical disease were not associated with illness worry, emotional distress, or physical symptom load. Overall, the participants were trustful in the authorities' recommendations and felt that they managed the pandemic and the restrictions to a great extent despite that some expected great/major future consequences of the pandemic. CONCLUSIONS: This study suggested that the first wave of the Covid-19 pandemic only had minor impact on mental and physical health in the Danish general population. Future studies should address the impact of the second wave of the pandemic and the renewed implementation of the concomitant restrictions.

Development of an eHealth programme for self-management of persistent physical symptoms: a qualitative study on user needs in general practice.

BACKGROUND: Persistent physical symptoms (PPS) are estimated to be present in 17% of patients in general practice. Hence, general practitioners (GPs) play a key role in both the diagnostic assessment and the management of PPS. However, research indicates a need to improve their strategies to support self-help in patients, and eHealth tools may serve as an opportunity. This study aimed to explore patients' and GPs' needs related to self-management of PPS. The study was designed to inform the future development of eHealth interventions in this field. METHODS: This qualitative study was based on 20 semi-structured interviews (6 GPs and 14 patients with PPS). Interviews were audiotaped, transcribed verbatim and analysed through a five-step thematic analysis approach. First, we conducted an inductive analysis to identify and explore emerging subthemes. Second, using a deductive mapping strategy, we categorised the derived subthemes according to the COM-B behaviour change model and its three domains: capability, opportunity and motivation. RESULTS: We identified eleven subthemes in the patient interviews and seven subthemes in the GP interviews. Several unmet needs emerged. First, we identified a need to consider PPS early in the illness trajectory by taking a bio-psycho-social approach. Second, both patients and GPs need better skills to manage uncertainty. Third, hope is important for the patients. Fourth, patients need guidance from their GP in how to self-manage their PPS. CONCLUSIONS: This study provides important insight into key issues and needs related to capability, opportunity and motivation that should be addressed in the design of future eHealth self-management interventions targeting patients with PPS in general practice in order to support and improve care.

A new measure of excessive parental worries about children's health: Development of the Health Anxiety by Proxy Scale (HAPYS).

OBJECTIVE: Health anxiety by proxy is a newly introduced term to describe parents' experience of excessive and unpleasant worries about their child's health. This article describes the development of a new measure, the Health Anxiety by Proxy Scale (HAPYS), for systematic assessment of health anxiety by proxy. METHOD: The development of the HAPYS was performed over three phases. (1) Patients clinically assessed to have health anxiety by proxy participated in semi-structured interviews to elaborate their experience of worries regarding their child's health and their related behaviours, and to examine the face validity of items in an existing questionnaire: 'Illness Worry Scale - parent version'. (2) Based on the findings from Phase 1 the project group and a panel of experts selected and formulated questionnaire items and scoring formats. (3) The HAPYS was pilot-tested twice using cognitive interviewing with healthy parents and parents with health anxiety by proxy followed by further adjustments. RESULTS: The final version of HAPYS consists of 26 items characteristic of health anxiety by proxy and of an impact section with five items. CONCLUSION: Based on the pilot testing the HAPYS showed good face and content validity. It holds the potential to be a valid questionnaire to help clinicians across health care settings assess parents suffering from health anxiety by proxy.

Study protocol: a randomized controlled trial comparing the efficacy of therapist guided internet-delivered cognitive therapy (TG-iConquerFear) with augmented treatment as usual in reducing fear of cancer recurrence in Danish colorectal cancer survivors.

BACKGROUND: Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors. METHODS/DESIGN: A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100). DISCUSSION: This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.

Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care.

BACKGROUND: Psychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type. METHODS: In a randomised controlled three-armed trial, consecutively referred patients aged 20-50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses. RESULTS: A total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4-6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC. CONCLUSIONS: Patients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.

Encoding and retrieval biases for health-related scenes in patients with severe health anxiety.

Severe health anxiety is a disorder characterised by excessive worries about harbouring or having a serious illness. The present study examines cognitive biases in evaluation and memory for health-related scenes in severe health anxiety in order to provide insights into the effect of these biases and the formation of illness intrusions in severe health anxiety. Twenty patients with severe health anxiety and 20 healthy participants completed a computerised task consisting of encoding, involuntary retrieval, voluntary retrieval and recognition of health-related, negative and neutral scenes. The results demonstrated that patients with severe health anxiety reported more negative emotional valence and greater physiological arousal to health-related scenes, both during encoding (ps < .031, ηp2 > .09) and retrieval (ps < .044, ds > 0.18). Furthermore, in contrast to the comparison group, patients with severe health anxiety did not show shorter retrieval time for health-related scenes during involuntary compared with voluntary retrieval (p = .789, d = 0.08), possibly due to greater demands on emotion regulation during involuntary retrieval. The results suggest an important role for negative emotional valence and physiological arousal to health-related stimuli in severe health anxiety, and highlight how cognitive biases in evaluation and memory might be at play in this disorder.

Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations.

OBJECTIVE: The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. METHODS: The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. RESULTS: The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. CONCLUSIONS: The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.

Effects of maternal health anxiety on children's health complaints, emotional symptoms, and quality of life.

Little is known about family risk factors and intergenerational transmission of psychological disturbance in the development of health anxiety (HA). This study investigated HA and related concepts in 8- to 17-year-old children who had been exposed to different maternal health status. Using a family case-control design, three family groups were included: (1) 50 case children of mothers with severe (HA); (2) 49 control children of mothers with rheumatoid arthritis (RA); and (3) 51 control children of healthy mothers. Children and mothers completed a battery of standardised questionnaires. Case children reported significantly higher level of HA symptoms than children of mothers with RA but not compared to children of healthy mothers. There was no significant difference between the children's self-reports in the three groups with regard to anxiety symptoms in general, physical complaints, or quality of life. In contrast, mothers with HA reported their children as having more emotional and physical symptoms than mothers in one or both control groups. Compared to mothers with RA but not healthy mothers, mothers with HA also reported more visits to the general practitioner with their children during the past year. The findings suggest that maternal HA only weakly affects children's own report of HA and thereby may not be a strong risk factor for the development of HA symptoms in childhood. However, mothers with severe HA seem to conceive their children as more ill and present them more often in the health care system which could, therefore, be an important target for intervention in adult patients.

Self-help interventions for persistent physical symptoms: a systematic review of behaviour change components and their potential effects.

Persistent physical symptoms (PPS) remain a challenge in the healthcare system due to time-constrained consultations, uncertainty and limited specialised care capacity. Self-help interventions may be a cost-effective way to widen the access to treatment. As a foundation for future interventions, we aimed to describe intervention components and their potential effects in self-help interventions for PPS. A systematic literature search was made in PubMed, EMBASE, PsycINFO and CENTRAL. Fifty-one randomised controlled trials were included. Interventions were coded for effect on outcomes (standardised mean difference ≥0.2) related to symptom burden, anxiety, depression, quality of life, healthcare utilisation and sickness absence. The Behaviour Change Technique (BCT) Taxonomy v1 was used to code intervention components. An index of potential was calculated for each BCT within an outcome category. Each BCT was assessed as 'potentially effective' or 'not effective' based on a two-sided test for binomial random variables. Sixteen BCTs showed potential effect as treatment components. These BCTs represented the themes: goals and planning, feedback and monitoring, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents and identity. The results suggest that specific BCTs should be included in new PPS self-help interventions aiming to improve the patients' physical and mental health.

Measurement properties of the Health Anxiety by Proxy Scale (HAPYS): A new questionnaire to assess parents' worries about their child's health.

OBJECTIVE: Health anxiety by proxy refers to parents' excessive worries about their child's health. The Health Anxiety by Proxy scale (HAPYS) is a new self-report questionnaire to assess parents' worries and behaviors regarding their child's health. This study aimed to investigate the measurement properties of the HAPYS. METHODS: Questionnaires were completed by 204 parents, and a HAPYS score was obtained for 200 parents: 39 parents diagnosed with health anxiety, 33 parents with different anxiety disorders, 33 parents with a Functional Somatic Disorder, and 95 healthy parents. We evaluated the following measurement properties: structural validity, reliability, convergent validity ((pain catastrophizing, parents' reports of child's emotional and physical symptoms), discriminant validity (parental reports of child's well-being), and known-groups validity (see compared groups above). RESULTS: HAPYS demonstrated a one factor dimensionality, and excellent internal reliability (α = 0.95; CI: 0.93-0.97) and test-retest reliability after two weeks (ICC = 0.91; CI: 0.87-0.94). Convergent validity with the construct of parental catastrophizing about child pain was good (r = 0.72; CI: 0.64-0.78)). Good known-groups validity was demonstrated by the largest total HAPYS score observed in parents with health anxiety (median = 35; IQR: 9-53) and the lowest score in healthy parents (median = 9; IQR: 5-15) (p < 0.001). CONCLUSION: The findings support that HAPYS is a useful measure of health anxiety by proxy. Future research should examine the measurement properties in larger samples and different languages with further statistical analyses of structural validity.

Participatory design of bodysymptoms.org: An interactive web resource to explain multisystem functional somatic symptoms.

OBJECTIVE: There is a lack of trustworthy information about Functional Somatic Symptoms (FSS) on the internet. This means integrative bio-psycho-social explanations of FSS and related health advice are not readily available to the public. To explore and address this problem, we carried out the bodysymptoms project, with the aim to build a website which presents current widely accepted explanations for FSS and shows how different explanations are inter-connected. METHODS: Bodysymptoms was set up as a research-in-action project with a diverse range of international stakeholder-participants, combining approaches from patient and public involvement in healthcare with participatory design. 7 participants with lived experience of multi-system functional symptoms took part in the project and measures of meaningful engagement throughout the project were rated highly. This manuscript describes the methodology by which the website was developed. RESULTS: Through iterative cycles we determined the requirements for an interactive explanatory model and co-created a novel online health interactive resource with integrated actionable health advice. The target end user are young adults with persistent physical symptoms, maintained by functional mechanisms. The overall aim is to empower people at risk of developing functional disorders to seek better health outcomes. The website is intended to be used prior to or alongside engagement with healthcare. CONCLUSION: Bringing lived experience and multi-disciplinary perspectives into dialogue through participatory design can harness the power of research to create immediate shared value. This project has resulted in a usable open access website, bodysymptoms.org, which provides education about FSS for patients, healthcare professionals and members of the public looking to understand FSS.