Digital interventions to improve adherence to maintenance medication in asthma.

BACKGROUND: Asthma is the most common chronic lung condition worldwide, affecting 334 million adults and children globally. Despite the availability of effective treatment, such as inhaled corticosteroids (ICS), adherence to maintenance medication remains suboptimal. Poor ICS adherence leads to increased asthma symptoms, exacerbations, hospitalisations, and healthcare utilisation. Importantly, suboptimal use of asthma medication is a key contributor to asthma deaths. The impact of digital interventions on adherence and asthma outcomes is unknown. OBJECTIVES: To determine the effectiveness of digital interventions for improving adherence to maintenance treatments in asthma. SEARCH METHODS: We identified trials from the Cochrane Airways Trials Register, which contains studies identified through multiple electronic searches and handsearches of other sources. We also searched trial registries and reference lists of primary studies. We conducted the most recent searches on 1 June 2020, with no restrictions on language of publication. A further search was run in October 2021, but studies were not fully incorporated. SELECTION CRITERIA: We included randomised controlled trials (RCTs) including cluster- and quasi-randomised trials of any duration in any setting, comparing a digital adherence intervention with a non-digital adherence intervention or usual care. We included adults and children with a clinical diagnosis of asthma, receiving maintenance treatment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures for data collection. We used GRADE to assess quantitative outcomes where data were available. MAIN RESULTS: We included 40 parallel randomised controlled trials (RCTs) involving adults and children with asthma (n = 15,207), of which eight are ongoing studies. Of the included studies, 30 contributed data to at least one meta-analysis. The total number of participants ranged from 18 to 8517 (median 339). Intervention length ranged from two to 104 weeks. Most studies (n = 29) reported adherence to maintenance medication as their primary outcome; other outcomes such as asthma control and quality of life were also commonly reported. Studies had low or unclear risk of selection bias but high risk of performance and detection biases due to inability to blind the participants, personnel, or outcome assessors. A quarter of the studies had high risk of attrition bias and selective outcome reporting. We examined the effect of digital interventions using meta-analysis for the following outcomes: adherence (16 studies); asthma control (16 studies); asthma exacerbations (six studies); unscheduled healthcare utilisation (four studies); lung function (seven studies); and quality of life (10 studies). Pooled results showed that patients receiving digital interventions may have increased adherence (mean difference of 14.66 percentage points, 95% confidence interval (CI) 7.74 to 21.57; low-certainty evidence); this is likely to be clinically significant in those with poor baseline medication adherence. Subgroup analysis by type of intervention was significant (P = 0.001), with better adherence shown with electronic monitoring devices (EMDs) (23 percentage points over control, 95% CI 10.84 to 34.16; seven studies), and with short message services (SMS) (12 percentage points over control, 95% CI 6.22 to 18.03; four studies). No significant subgroup differences were seen for interventions having an in-person component versus fully digital interventions, adherence feedback, one or multiple digital components to the intervention, or participant age. Digital interventions were likely to improve asthma control (standardised mean difference (SMD) 0.31 higher, 95% CI 0.17 to 0.44; moderate-certainty evidence) - a small but likely clinically significant effect. They may reduce asthma exacerbations (risk ratio 0.53, 95% CI 0.32 to 0.91; low-certainty evidence). Digital interventions may result in a slight change in unscheduled healthcare utilisation, although some studies reported no or a worsened effect. School or work absence data could not be included for meta-analysis due to the heterogeneity in reporting and the low number of studies. They may result in little or no difference in lung function (forced expiratory volume in one second (FEV1)): there was an improvement of 3.58% predicted FEV1, 95% CI 1.00% to 6.17%; moderate-certainty evidence); however, this is unlikely to be clinically significant as the FEV1 change is below 12%. Digital interventions likely increase quality of life (SMD 0.26 higher, 95% CI 0.07 to 0.45; moderate-certainty evidence); however, this is a small effect that may not be clinically significant. Acceptability data showed positive attitudes towards digital interventions. There were no data on cost-effectiveness or adverse events. Our confidence in the evidence was reduced by risk of bias and inconsistency. AUTHORS' CONCLUSIONS: Overall, digital interventions may result in a large increase in adherence (low-certainty evidence). There is moderate-certainty evidence that digital adherence interventions likely improve asthma control to a degree that is clinically significant, and likely increase quality of life, but there is little or no improvement in lung function. The review found low-certainty evidence that digital interventions may reduce asthma exacerbations. Subgroup analyses show that EMDs may improve adherence by 23% and SMS interventions by 12%, and interventions with an in-person element and adherence feedback may have greater benefits for asthma control and adherence, respectively. Future studies should include percentage adherence as a routine outcome measure to enable comparison between studies and meta-analysis, and use validated questionnaires to assess adherence and outcomes.

A Network Analysis of Selected Psychosocial Factors in Vulvodynia and Its Subtypes.

OBJECTIVE: Psychosocial factors are related to pain and sex-related outcomes in provoked vulvodynia and possibly in mixed and spontaneous vulvodynia. However, a broader behavioral framework, such as the psychological flexibility model, has received limited attention in this context. Recently, additional psychosocial variables have also emerged that appear relevant to vulvodynia, including perceived injustice, body-exposure anxiety during intercourse, and unmitigated sexual communion. The present study applied network analysis to explore relations between psychological flexibility, newly emerging psychosocial variables relevant to vulvodynia, and their associations with vulvodynia outcomes. The study also explored potential differences across vulvodynia subtypes. DESIGN: An online cross-sectional study of 349 participants with vulvodynia (112 provoked, 237 spontaneous/mixed) was carried out. METHODS: Participants completed self-report questionnaires, including questions on pain and sexual outcomes, depression, facets of psychological flexibility, body-exposure anxiety during intercourse, unmitigated sexual communion, and perceived injustice. Networks were computed for the total sample and for provoked and mixed/spontaneous vulvodynia subsamples. RESULTS: Perceived injustice, pain acceptance, and depression were "central" factors among the included variables, in all models. Psychological flexibility processes were relevant for all networks. Depression was more central in the network for mixed/spontaneous vulvodynia; body-exposure anxiety during intercourse was most central for the provoked subtype. CONCLUSIONS: Among the included variables, perceived injustice, pain acceptance, depression, and psychological flexibility appear to be important in vulvodynia. As different factors are significant across subtypes, tailored treatment approaches are suggested.

The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence.

AIMS: This study aimed to establish the psychometric properties of a questionnaire measure of patients' adherence to medications to elicit patients' report of medication use in a variety of clinical samples. The reliability and validity were assessed in patients with hypertension. Additional analyses were performed on other patient groups. METHODS: Using a cross-sectional study design, a 10-item version of the Medication Adherence Report Scale (©Professor Rob Horne) was piloted in two samples of patients receiving treatment for hypertension (n = 50 + 178), asthma (n = 100) or diabetes (n = 100) at hospital outpatient or community clinics in London and the south-east of England. Following principal components analysis, five items were retained to form MARS-5 (©Professor Rob Horne). Evaluation comprised internal reliability, test-retest reliability, criterion-related validity (relationship with blood pressure control) and construct validity (relationship with patients' beliefs about medicines). RESULTS: The MARS-5 demonstrated acceptable reliability (internal and test-retest) and validity (criterion-related and construct validity) in these patient groups. Internal reliability (Cronbach's α) ranged from 0.67 to 0.89 across all patient groups; test-retest reliability (Pearson's r) was 0.97 in hypertension. Criterion-related validity was established with more adherent hypertension patients showing better blood-pressure control (χ2 = 4.24, df = 1, P < .05). Construct validity with beliefs about medicines was demonstrated with higher adherence associated with stronger beliefs in treatment necessity and lower treatment concerns. CONCLUSIONS: The MARS-5 performed well on several psychometric indicators in this study. It shows promise as an effective self-report tool for measuring patients' reports of their medication use across a range of health conditions.

Self-reported symptom burden in postural orthostatic tachycardia syndrome (POTS): A narrative review of observational and interventional studies.

BACKGROUND AND OBJECTIVE: Postural Orthostatic Tachycardia Syndrome (POTS) is a chronic health condition affecting mostly women of childbearing age, and significantly impacting their health and quality of life. It is currently poorly understood with no approved licensed treatments. The aim of this systematic review was to contextualize the symptom burden of POTS, and review factors associated with this burden that may guide future treatments. The specific questions were (1) How does symptom burden in POTS compare to the burden in other long term conditions (LTCs), (2) Which factors are associated with POTS symptom burden, and (3) Which interventions show promise in reducing symptom burden in POTS. DATABASES AND DATA TREATMENT: Electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, APA PsycArticles, OpenGrey) were searched from inception to January 2022 for observational studies reporting on the association between any biological, psychological or social factors and symptom burden, and randomized controlled trials reporting on interventions for symptom burden in adults with POTS. Two reviewers independently conducted eligibility screening, data extraction and quality assessment. A narrative synthesis was undertaken. RESULTS/CONCLUSION: 5159 entries were screened for eligibility. Twenty-nine studies were included (1372 participants with POTS of a total sample size of 2314, 17 High-, 12 Medium-quality), seventeen were observational and twelve were randomized controlled experimental and intervention trials. Overall methodological quality of the evidence was medium-high but heterogeneity was high and sample sizes modest, allowing moderately robust conclusions. Orthostatic symptom burden was higher in POTS than other LTCs. Serum activity against adrenergic α1 receptors, physical functioning, depression, catastrophizing, prolonged cognitive stress testing and anxiety were significantly associated with symptom burden in medium-high quality studies. Preliminary medium-high quality evidence from predominantly proof-of-concept (n = 11) studies and one 3-month 2 × 2 factorial design trial suggest that compression garments, propranolol, pyridostigmine, desmopressin, and bisoprolol may hold promise in reducing symptom burden. Directions for future research include investigating associated factors over time, the development of complex interventions which address both biological and psychosocial factors associated with symptom burden, and effectiveness trials of these interventions. SIGNIFICANCE: POTS symptom burden is high, particularly in relation to orthostatic intolerance when compared to other long-term conditions (LTCs). Despite this burden, there are no effectiveness randomized controlled trials of treatment to reduce symptoms in POTS. This review provides a starting point to understanding researched biological and psychosocial factors associated with this burden. There was however inconsistency in the measurement of symptom burden, lowering the confidence of cross-study inferences. A coherent definition of POTS symptom range, severity and impact along with a validated and reliable POTS-specific instrument is currently lacking. A standardized questionnaire to assess POTS symptom burden as a core outcome measure will help clarify future research and clinical practice.

Psychosocial factors associated with pain and health-related quality of life in Endometriosis: A systematic review.

BACKGROUND AND OBJECTIVE: Endometriosis is associated with pain and impaired health-related quality of life (HRQoL). Psychosocial factors have been associated with pain and HRQoL in other conditions, suggesting their potential relevance in Endometriosis. However, the role of psychosocial factors in this population has not been systematically explored yet. This systematic review aims to explore the association of psychosocial factors with pain intensity/severity and HRQoL in women with Endometriosis. DATABASES AND DATA TREATMENT: Observational and experimental studies that explored the association of psychosocial factors with pain and HRQoL in women with Endometriosis were eligible. The following databases were searched: Medline, Embase, Cochrane library, Web of Science, PsychInfo and Cumulative index of nursing and allied health literature. The methodological quality was assessed, and findings were synthesized using narrative synthesis. RESULTS: Twenty-seven studies were eligible for inclusion, which included 5419 women with Endometriosis. Catastrophising and anxiety were the factors most consistently associated with greater pain, whilst depression, anxiety and stress were related to worse HRQoL. Findings regarding depression and pain were mixed, and research on social factors was limited. CONCLUSIONS: This systematic review highlights the role of psychosocial factors in Endometriosis. Anxiety, depression and catastrophising are suggested as potential treatment targets. The review also indicates the lack of research on other potentially important psychosocial factors, such as avoidance, perceived injustice and social support. SIGNIFICANCE: This systematic review explored the role of psychosocial factors in Endometriosis, suggesting that these are associated with pain and health-related quality of life (HRQoL). Among the psychosocial factors included, anxiety, depression and catastrophising were the factors most often associated with pain and HRQoL in Endometriosis. These findings highlight the need to target psychological factors in the treatment of women with Endometriosis.

The role of psychological flexibility, perceived injustice and body image in Vulvodynia: A longitudinal study.

BACKGROUND: Women with Vulvodynia experience pain, related impacts on sex and daily functioning, and depression. While psychosocial factors are associated with outcomes in Vulvodynia, longitudinal data are limited, especially in mixed/spontaneous Vulvodynia. Broad psychological models such as psychological flexibility (PF) and content-specific factors, such as body-exposure anxiety (BEA) and avoidance during sexual activities and perceived injustice, have not been adequately investigated in Vulvodynia. The aim of this study was to explore whether these factors assessed at baseline predict pain severity, pain interference, sexual functioning and satisfaction and depression 3 months later. METHODS: A longitudinal study of 349 women with Vulvodynia was conducted. Participants completed online self-report measures of pain-related and sexual outcomes, depression, BEA, perceived injustice and facets of PF (present moment awareness, pain acceptance, committed action) at baseline and after 3 months, overlapping with the Coronavirus disease 2019 (COVID-19) pandemic. RESULTS: Seventy percent of women responded at both assessments (n = 244). There were significant decreases in pain severity, pain interference, present moment awareness, committed action and a significant increase in depression at 3 months. All the baseline psychosocial factors significantly correlated with at least one outcome at 3 months. When adjusting for baseline outcome and demographics, committed action significantly positively predicted depression at 3 months and pain acceptance significantly positively predicted pain interference at 3 months. CONCLUSIONS: Among women with Vulvodynia, pain acceptance and committed action are prospectively associated with pain interference and depression. The reliability and generalizability of these results needs to be established given the overlap with the COVID-19 pandemic. Future studies should investigate whether targeting these factors enhances outcomes in Vulvodynia. SIGNIFICANCE: This longitudinal study explored the role of PF, perceived injustice and body image during sexual activities in predicting pain severity, pain interference, sexual functioning, sexual satisfaction and depression in women with Vulvodynia. The study findings reveal that two facets of PF (committed action and pain acceptance) predicted pain interference and depression over time. It may be important to incorporate these processes in treatments developed for Vulvodynia.

Psychosocial factors associated with pain and sexual function in women with Vulvodynia: A systematic review.

BACKGROUND AND OBJECTIVE: Vulvodynia is a prevalent chronic vulval pain condition affecting 10%-28% of women, and significantly impacting their health and quality of life. It is currently poorly understood and biomedical treatments achieve only modest benefits for pain and sexual functioning. A wider psychosocial conceptualization of this condition may improve outcomes. There is currently no coherent understanding of how psychosocial factors may contribute to outcomes in Vulvodynia. The aim of this review is to identify and systematically review psychosocial factors associated with pain and sexual outcomes and to inform a psychosocial model of Vulvodynia. DATABASES AND DATA TREATMENT: Observational/experimental studies reporting on the association between psychosocial factors and pain/sexual outcomes in adult women with Vulvodynia were eligible. Two reviewers independently conducted eligibility screening, data extraction and quality assessment. Twenty-one studies were included, all focused on women with Provoked Vestibulodynia (PVD). Most of the studies were low-to-medium quality. RESULTS/CONCLUSION: A range of general/pain-related distress and avoidance processes, and sex/intimacy avoidance or engagement processes were significantly associated with pain, sexual functioning or sexual distress and sexual satisfaction, supporting the role of a psychosocial approach to PVD. Depression, anxiety, catastrophizing, pain-anxiety, pain acceptance, body-exposure anxiety, attention to sexual cues, partner hostility and solicitousness, self-efficacy and penetration cognitions are highlighted as potentially important treatment targets in PVD. Due to the limited data available, developing a psychosocial model was not possible. Directions for future research include examining the replicability and generalizability of the factors identified, exploring differences/similarities across Vulvodynia subsets and testing tailored theoretically based treatments. SIGNIFICANCE: The systematic review highlights the role of psychosocial factors associated with pain and sexual functioning in Vulvodynia. The review findings reveal that Vulvodynia presents both similar and unique cognitive, behavioural and interpersonal features compared to other chronic pain conditions. There may be important roles for negative sexual cues, body image-related factors during intercourse, partner factors, self-efficacy beliefs and penetration cognitions, in relation to pain and sexual functioning.

The experience of pain severity and pain interference in vulvodynia patients: The role of cognitive-behavioural factors, psychological distress and fatigue.

OBJECTIVE: Vulvodynia is a chronic pain condition characterised by severe pain affecting the vulva. Biopsychosocial models have revealed the importance of illness perceptions, cognitive-behavioural variables and psychological distress in explaining the experience of pain and disability across several conditions. These factors have never been collectively examined in vulvodynia. We predicted that distress, fatigue, illness perceptions, and cognitive-behavioural factors would be associated with pain severity and interference among women with vulvodynia. METHODS: This online cross-sectional study recruited 335 vulvodynia patients from an Italian charity association (Vulvodiniapuntoinfo.com), who completed pain severity and interference measures in addition to the Hospital Anxiety and Depression scale, Revised Illness Perception Questionnaire, Chalder Fatigue Questionnaire, Cognitive-Behavioural Symptom Questionnaire and a demographic questionnaire. RESULTS: Hierarchical regression models controlling for demographic and illness characteristics, revealed that lower treatment control beliefs, greater illness identity, catastrophizing and psychological distress, were significant predictors of pain severity, explaining 35% of the variance. A second adjusted hierarchical regression model revealed that low treatment-control, higher fatigue, distress, and avoidance/resting behaviours were significant predictors of pain interference, explaining 48% of the variance. CONCLUSION: Distress, illness perceptions, fatigue, and cognitive-behavioural factors are associated with pain severity and interference in patients with vulvodynia, highlighting the importance of adopting a biopsychosocial approach in this setting. Future research should examine these factors over time to inform the development of future tailored interventions to help support women better manage vulvodynia.