Changing Patient and Public Beliefs About Antimicrobials and Antimicrobial Resistance (AMR) Using a Brief Digital Intervention.

Background: A key driver of antimicrobial resistance (AMR) is patient demand for unnecessary antibiotics, which is driven by patients' beliefs about antibiotics and AMR. Few interventions have targeted beliefs to reduce inappropriate demand. Objective: To examine whether a brief, online algorithm-based intervention can change beliefs that may lead to inappropriate antibiotic demand (i.e. perceptions of antibiotic necessity and lack of concern about antibiotic harm). Design: Pre- and post-intervention study. Participants: Participants were 18 years or older, and residing in the United Kingdom, who self-selected to participate via Amazon mTurk, an online survey plaform, and via research networks. Intervention: Participants were presented with a hypothetical situation of cold and flu symptoms, then exposed to the intervention. The online intervention comprised: 1) a profiling tool identifying individual beliefs (antibiotic necessity, concerns, and knowledge) driving inappropriate antibiotic demand; 2) messages designed to change beliefs and knowledge (i.e. reduce antibiotic necessity, and increase antibiotic concerns and knowledge), and 3) an algorithm linking specific messages to specific beliefs and knowledge. Main measures: The profiling tool was repeated immediately after the intervention and compared with baseline scores to assess change in beliefs. A paired samples t-test was used to determine intervention effect. Key Results: A total of 100 respondents completed the study. A significant change in beliefs relating to inappropriate demand was observed after the intervention, with a reduction in beliefs about antibiotic necessity (t = 7.254; p < 0.0001), an increase in antibiotic concerns (t = -7.214; p < 0.0001), and increases in antibiotic and AMR knowledge (t = -4.651; p < 0.0001). Conclusion: This study is the first to demonstrate that patient beliefs about antibiotics and AMR associated with inappropriate demand can be changed by a brief, tailored online intervention. This has implications for the design of future interventions to reduce unnecessary antimicrobial use.

Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets.

INTRODUCTION: Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population. METHODS: We performed subgroup analyses of a recently completed trial in two subsets of individuals: patients aged 65-74 years (low age group) and patients ≥ 75 years (high age group). Pain intensity (PI), onset of pain relief, frequency and duration of BTcP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health status instruments used were the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Short Form 12, version 2 (SF-12v2) questionnaire. RESULTS: Levels of PI at the end of the study improved significantly as compared with baseline in both the low and the high age groups (30.0% and 27.7% reduction, respectively). The onset of analgesia at the end of the study began in < 10 min in 85.0% of young-old subjects and in 62.5% of patients ≥ 75 years, but no significant differences were found. BTcP episodes lasted < 15 min in 75.0% of patients in the low age group and 58.3% in the high age group (p = 0.24). Most of patients in both groups experienced one to five BTcP daily episodes, at all assessment points. HADS-D decreased from 10.78 (± 4.33) to 8.21 (± 3.57) in the low age group, and from 10.96 (± 4.26) to 9.36 (± 3.35) in the high age group (p = 0.02). Significant differences in HADS-A scores from baseline to the end of the study were also observed in both subgroups (p < 0.05). Patients in the low age group had less favorable mental component summary (MCS) and physical component summary (PCS) scores than patients in the high age group. At the end of the study, 10.0% of young-old patients and 29.2% of patients aged ≥ 75 years reported AEs related to their treatment. The most commonly reported AEs included nausea, vomiting, constipation, somnolence, and skin disorders and they were generally mild to moderate in severity. CONCLUSIONS: The results of this study showed that SFTs provided safe and clinically meaningful pain relief in both elderly subgroups. Clinical implications of these findings await validation in large, confirmatory studies to identify age subgroup divergences among elderly cancer patients treated with SFTs.

Mind Matters: Treatment Concerns Predict the Emergence of Antiretroviral Therapy Side Effects in People with HIV.

The aim of this analysis of historical data was to determine whether patients' pre-treatment beliefs about antiretroviral therapy (ART) predict the subsequent reporting of side effects. Data were collected as part of a prospective, 12-month follow-up study. Of 120 people starting ART, 76 completed follow-up assessments and were included in the analyses. Participants completed validated questionnaires assessing their beliefs about ART, beliefs about medicines in general, perceived sensitivity to adverse effects of medicines, depression and anxiety before initiating ART and after 1 and 6 months of treatment. Adherence was assessed at 1, 6 and 12 months. Pre-treatment concerns about ART were associated with significantly more side effects at 1 month (p < 0.05) and 6 months (p < 0.005). Side effects at 6 months predicted low adherence at 12 months (p < 0.005). These findings have implications for the development of interventions to support patients initiating ART by providing a mechanism to pre-empt and reduce side effects.

Theory-Based Digital Interventions to Improve Asthma Self-Management Outcomes: Systematic Review.

BACKGROUND: Asthma is a chronic disease requiring effective self-management to control it and prevent mortality. The use of theory-informed digital interventions promoting asthma self-management is increasing. However, there is limited knowledge concerning how and to what extent psychological theory has been applied to the development of digital interventions, or how using theory impacts outcomes. OBJECTIVE: The study aimed to examine the use and application of theory in the development of digital interventions to enhance asthma self-management and to evaluate the effectiveness of theory-based interventions in improving adherence, self-management, and clinical outcomes. METHODS: Electronic databases (CENTRAL, MEDLINE, EMBASE, and PsycINFO) were searched systematically using predetermined terms. Additional studies were identified by scanning references within relevant studies. Two researchers screened titles and abstracts against predefined inclusion criteria; a third resolved discrepancies. Full-text review was undertaken for relevant studies. Those meeting inclusion criteria were assessed for risk of bias using the Cochrane Collaboration tool. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Study outcomes were classified as medication adherence, self-management, asthma control, clinical markers of health, quality of life, other quality of life outcomes, and health care utilization. Effectiveness was calculated as an average outcome score based on the study's reported significance. The Theory Coding Scheme (TCS) was used to establish the extent to which each intervention had applied theory and which theoretical constructs or behavioral determinants were addressed. Associations between TCS scores and asthma outcomes were described within a narrative synthesis. RESULTS: Fourteen studies evaluating 14 different digital interventions were included in this review. The most commonly cited theories were Social Cognitive Theory, Health Belief Model, and Self-Efficacy Theory. A greater use of theory in the development of interventions was correlated with effective outcomes (r=.657; P=.01): only the 3 studies that met >60% of the different uses of theory assessed by the TCS were effective on all behavioral and clinical outcomes measured. None of the 11 studies that met ≤60% of the TCS criteria were fully effective; however, 3 interventions were partially effective (ie, the intervention had a significant impact on some, but not all, of the outcomes measured). Most studies lacked detail on the theoretical constructs and how they were applied to the development and application of the intervention. CONCLUSIONS: These findings suggest that greater use of theory in the development and application of digital self-management interventions for asthma may increase their effectiveness. The application of theory alone may not be enough to yield a successful intervention, and other factors (eg, the context in which the intervention is used) should be considered. A systematic approach to the use of theory to guide the design, selection, and application of intervention techniques is needed.

Correction to: Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication.

In the Original Publication.

Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication.

OBJECTIVE: Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen. METHODS: Subgroup analyses from a recently completed study were performed according to cancer stage (locally advanced cancer [LAC] vs. metastatic cancer) and most frequent background opioid medication (fentanyl vs. oxycodone/naloxone). The efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset of pain relief, and adverse events (AEs). Health status was assessed with the Short Form 12, version 2 (SF-12v2) questionnaire and the Hospital Anxiety and Depression Scale (anxiety subscale [HADS-A] and depression subscale [HADS-D]). RESULTS: In total, 54 (67.5%) patients had LAC and 26 (32.5%) had metastatic cancer. The oxycodone/naloxone group included 39 patients (48.1%) and the fentanyl group 29 (35.8%). In all subgroups, pain relief was achieved within 5 min in an increasing number of individuals over time; at the end of the study, PI values decreased (PI-end: 44.4% for LAC vs. 57.9% for metastatic cancer; 44.4% for fentanyl vs. 38.6% for oxycodone/naloxone). HADS and mental component summary (MCS) SF-12v2 scores significantly improved in the LAC group (HADS-A 9.44-8.04; HADS-D 10.46-8.15; MCS 44.69-45.94) and in the fentanyl group (HADS-A 10.05-8.33; HADS-D 11.95-8.76; MCS 44.38-47.19). AEs were reported in few patients and were mostly mild. CONCLUSIONS: Exploratory subgroup analyses show the efficacy and safety of SFTs for the treatment of breakthrough pain in patients with cancer, regardless of their cancer stage and background opioid medication.

Breakthrough Pain Management with Sublingual Fentanyl Tablets in Patients with Cancer: Age Subgroup Analysis of a Multicenter Prospective Study.

INTRODUCTION: Breakthrough pain (BTP) management in patients with cancer is challenging, especially in the elderly. However, no studies examining the influence of age on BTP medication have been conducted. The aim of this work was to investigate the effect of sublingual fentanyl tablets (SFTs) in terms of efficacy, safety, and quality of life in two age categories. METHODS: We performed age subgroup analyses (<65 and ≥65 years) from a recently completed study conducted in Spain. Pain intensity (PI), onset of pain relief, frequency and duration of BTP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health-status instruments used were the Short Form 12, version 2 (SF-12v2) questionnaire, and the Hospital Anxiety and Depression Scale (HADS-A and HADS-D). RESULTS: Twenty-six patients were aged <65 years and 54 were aged ≥65 years. SF-12v2 scores did not enhance significantly from baseline. HADS scores and PI decreased significantly at the end of the study, particularly in younger patients (HADS-A: 19.05 vs. 14.41%; HADS-D: 21.35 vs. 18.57%; PI: 67.23 vs. 56.30%). Onset of analgesia began in 2-5 min in 63.3% of subjects aged <65 years and in 36.4% of subjects aged >65 years. Most patients experienced one to five daily episodes after 30 days, and <5% needed a treatment change. AEs were less frequently reported in older individuals (20.5 vs. 36.4%). CONCLUSION: Age subgroup analyses suggest that SFTs are an effective and safe treatment for the management of BTP in cancer patients of all ages. SFTs may offer a well-tolerated and efficient option to control cancer BTP in the elderly.

Pain, disability and health-related quality of life in osteoarthritis-joint matters: an observational, multi-specialty trans-national follow-up study.

The authors aimed to test potential relations between osteoarthritis (OA) features, disability and health-related quality of life (HR-QoL) at different body locations. Outpatients consulting for pain associated to self-reported OA at varied healthcare settings were evaluated in a 3-month observational non-controlled follow-up study. Socio-demographic/anthropometric and medical data were collected at three time points. Lequesne's indices, quick-disabilities of arm, shoulder and hand (DASH) and Oswestry questionnaires provided measures of physical function and disability. HR-QoL measures were obtained with EuroQol-5 Dimensions. Multivariate analyses were used to evaluate the differences of pain severity across body regions and the correlates of disability and HR-QoL. Six thousand patients were evaluated. Pain lasted 2 years or more in 3995 patients. The mean pain severity at baseline was moderate (6.4 points). On average, patients had pain in 1.9 joints/areas. The pain was more severe when OA involved the spine or all body regions. Pain severity explained much of the variance in disability and HR-QoL; this association was less relevant in patients with OA in the upper limbs. There were considerable improvements at follow up. Pain severity improved as did disability, which showed particularly strong associations with HR-QoL improvements. Pain severity is associated with functional limitations, disability and poor HR-QoL in patients with self-reported OA. Functional limitations might have particular relevance when OA affects the upper limbs. Improvements are feasible in many patients who consult because of their pain.

Sublingual Fentanyl Tablets for Relief of Breakthrough Pain in Cancer Patients and Association with Quality-of-Life Outcomes.

BACKGROUND AND OBJECTIVE: Breakthrough pain (BTP) is highly prevalent in patients with cancer and is strongly associated with adverse outcomes related to health status, mood, anxiety and depression. However, studies on the effect of BTP medication on quality of life (QOL) are lacking. The purpose of this study was to provide a qualitative evaluation of the effect of sublingual fentanyl tablets (SFT), a therapy specifically developed for BTP, on the QOL of cancer pain patients. METHODS: We conducted a multicentre, prospective observation post-authorisation, open-label study between March and December 2013. The study consisted of a screening visit and four assessment points at 3, 7, 15 and 30 days. Pain intensity (PI), frequency of BTP, onset of pain relief and adverse events (AEs) were assessed at each visit. Anxiety and depression were evaluated using the validated Hospital Anxiety and Depression Scale (HADS) and health status using the Short Form 12, version 2 (SF-12v2) Health Survey. RESULTS: Of the 102 patients considered eligible, 81 (79.4 %) were enrolled; of these, 69 (85.1 %) completed the study. Significant pain reduction was achieved for average PI (p < 0.001) compared with baseline. At the end of the observational period, HADS scores showed significant improvement in the depression subscale (p = 0.005) and the anxiety subscale (p < 0.001). Similarly, SF-12 scores showed significant improvement, both in the mental component score (p < 0.001) and the physical component score (p = 0.002). SFT was well-tolerated and only one patient withdrew from the study due to drug-related AEs. CONCLUSION: SFT represents an effective, well-tolerated treatment for cancer BTP. Results provide consistent evidence for the positive impact of SFT on health-related QOL and physical functioning as well as other co-morbidities of cancer BTP such as anxiety and depression.

Efficacy and safety of sublingual fentanyl orally disintegrating tablets in patients with breakthrough pain: multicentre prospective study.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting. METHODS: A multicentre, prospective, open-label study was conducted in 19 pain units from Catalonia hospitals (Spain) over a 1-month period. Opioid-tolerant adult patients experiencing episodes of BTP intensity >5 on a visual analogue scale (VAS) during the 12-24 h before screening or AEs related to their previous rescue medication for BTP received sublingual fentanyl ODT in the course of routine clinical practice and completed a 30-day study period consisting of five assessment points: days 0 (baseline), 3, 7, 15 and 30. The efficacy was assessed by collecting pain intensity and pain relief data at baseline and at each assessment. AEs were recorded by investigators throughout the study during clinic visits and telephone follow-ups. For all patients, titration was begun with an initial dose of 100 µg. No more than two doses were allowed to treat an episode and patients might wait at least 4 h before treating another BTP episode with sublingual fentanyl ODT. The dose was increased by 100 µg multiples up to 400 µg as needed; and by 200 µg multiples up from 400 to 800 µg, the maximum titration step. RESULTS: A total of 182 patients were enrolled and 177 (97.2 %) completed the study: 37 had breakthrough cancer pain (BTcP) and 145 had breakthrough non-cancer pain (BTncP). The mean pain intensity showed a statistically significant improvement at the first assessment point and at all assessments thereafter (p < 0.0001). At the end of the study, the time lag between administration and first effect of sublingual fentanyl ODT was ≤10 min in 69.0 % (60 % BTcP and 71.2 % BTncP). The number of daily BTP episodes decreased in both groups, but it was statistically significant in BTcP. 114 patients (62.64 %) experienced AEs during the study. AEs recorded included nausea, vomiting, somnolence and constipation, and seven (4.49 %) were considered severe. No death or discontinuation was considered related to AEs. CONCLUSION: Sublingual fentanyl ODT provided rapid and consistent relief from BTP, both in cancer and non-cancer patients. It was well-tolerated and well-accepted by patients in routine clinical practice.