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Background Recurrent Clostridioides difficile infection (rCDI) occurs frequently, and concomitant antibiotic (CA) during the initial episode for treatment of non-CDI is a major risk factor. We sought to address the comparative efficacy of fidaxomicin versus vancomycin in the setting of CA during the initial CDI episode. Methods We conducted a randomized, controlled, open-label trial at 2 hospitals in Ann Arbor, Michigan. We consecutively consented and enrolled hospitalized patients ≥18 years old with diarrhea, a positive test for C. difficile , and ≥1 qualifying CA. Complicated CDI, CDI treatment for >24 hours prior to enrollment, and planned long-term (>12 weeks) CA use were notable exclusions. Clinical cure was defined as resolution of diarrhea for 2 consecutive days maintained until 2 days after therapy, and rCDI as recurrent diarrhea with positive testing ≤30 days after initial treatment. Patients were randomized to fidaxomicin or vancomycin. Results Baseline characteristics were similar in the 2 groups of 144 patients. Rates of clinical cure (73% vs 62.9%, P =.195) and rCDI (3.3% vs 4.0%; P >.99) were similar for fidaxomicin and vancomycin in the intention-to-treat and per-protocol cohorts, respectively. Only 4 patients developed rCDI. Conclusions In this study of patients with CDI receiving CA, a numerically higher proportion were cured with fidaxomicin versus vancomycin, but this result did not reach statistical significance. Overall recurrence was lower than anticipated in both arms compared with previous studies that did not extend duration of CDI treatment during CA. Clinical Trials Registration www.clinicaltrials.gov (NCT02692651). [ABSTRACT FROM AUTHOR]

Background Few studies have focused on the immune response to more recent influenza vaccine formulations such as cell-cultured inactivated influenza vaccine (ccIIV4) or live-attenuated influenza vaccine (LAIV4) in older children and young adults, or differences in immunoglobulin response using newer antibody landscape technology. Methods Participants ages 4–21 were randomized to receive ccIIV4 (n = 112) or LAIV4 (n = 118). A novel high-throughput multiplex influenza antibody detection assay was used to provide detailed IgG, IgA, and IgM antibody isotypes, along with hemagglutination inhibition levels (HAI), measured pre- and 28 days post-vaccination. Results The HAI and immunoglobulin isotype response to ccIIV4 was greater than LAIV4, with significant increases in IgG but not IgA or IgM. The youngest participants had the highest LAIV4 response. Prior LAIV4 vaccination was associated with a higher response to current season ccIIV4. Cross-reactive A/Delaware/55/2019(H1N1)pdm09 antibodies were present pre-vaccination and increased in response to ccIIV4, but not LAIV4. Immunoglobulin assays strongly correlated with and confirmed the findings of HAI titers to measure immune response. Conclusions Age and prior season vaccination may play a role in the immune response in children and young adults to ccIIV4 and LAIV4. While immunoglobulin isotypes provide high-level antigen-specific information, HAI titers alone can provide a meaningful representation of day 28 post-vaccination response. Clinical Trials No NCT03982069 [ABSTRACT FROM AUTHOR]

Aims Tai Chi is a promising exercise option in cardiac rehabilitation to manage coronary heart disease (CHD). Increasing attention was paid on home-based cardiac rehabilitation to improve participation rate, but no study has yet emphasized the effect of home-based Tai Chi. A single-blinded randomized controlled trial is used to examine the effects of a group- plus home-based Tai Chi program on functional health. Methods and results Ninety-eight community-dwelling patients with CHD were randomly assigned to the Tai Chi and control groups. Participants in the Tai Chi group attended 6-week group- plus 6-week home-based Tai Chi program. Outcome measures included physical functions, cardiovascular risk factors, and exercise self-efficacy. Data were collected at baseline, 6-week, 12-week, and 24-week. Intervention effects were analysed using the generalized estimating equation model. Compared with changes in the control group, the intervention group achieved significant improvements in aerobic endurance, lower-body strength, agility and dynamic balance, diastolic blood pressure, and exercise self-efficacy over the 24-week study period (all Ps < 0.05). Intervention adherence was high (79.6% of participants attending >75% of all Tai Chi sessions). Conclusions This Tai Chi program significantly improved the functional health of patients with CHD, indicating that Tai Chi could be taught in group sessions and then continued independently as a home exercise routine for health promotion. [ABSTRACT FROM AUTHOR]

Aims: Medical procedures and hospitalizations can be experienced as traumatic and can lead to post-traumatic stress reactions. Eye movement desensitization and reprocessing (EMDR) shows promising results but very few long-term studies have been published. Therefore, our aim was to test the long-term (8 months post-treatment) effectiveness of EMDR in children and adolescents with medically related subthreshold post-traumatic stress disorder (PTSD). Methods and results: Seventy-four children (including 39 with congenital or acquired heart disease) aged 4–15 (M = 9.6 years) with subthreshold PTSD after previous hospitalization were included into a parallel group randomized controlled trial. Participants were randomized to EMDR (n = 37) or care-as-usual (CAU) (n = 37; medical care only). The primary outcome was PTSD symptoms of the child. Secondary outcomes were symptoms of depression and blood–injection–injury (BII) phobia, sleep problems, and health-related quality of life (HrQoL) of the child. Assessments of all outcomes were planned at baseline and 8 weeks and 8 months after the start of EMDR/CAU. We hypothesized that the EMDR group would show significantly more improvements on all outcomes over time. Both groups showed improvements over time on child's symptoms of PTSD (only parent report), depression, BII phobia, sleep problems, and most HrQoL subscales. GEE analyses showed no significant differences between the EMDR group (nT2 = 33, nT3 = 30) and the CAU group (nT2 = 35, nT3 = 32) on the primary outcome. One superior effect of EMDR over time was found for reducing parent-reported BII phobia of the child. Conclusion: EMDR did not perform better than CAU in reducing subthreshold PTSD up to 8 months post-treatment in previously hospitalized children. Possible explanations and clinical implications are discussed. [ABSTRACT FROM AUTHOR]

Background: Relevant discharge information about the use of analgesic medication and other strategies may help patients to manage their pain more effectively and prevent postoperative persistent pain. Aims: To examine patients’ pain characteristics, analgesic intake and the impact of an educational pain management booklet intervention on postoperative pain control after cardiac surgery. Concerns about pain and pain medication prior to surgery will also be described. Methods: From March 2012 to September 2013, 416 participants (23% women) were consecutively enrolled in a randomized controlled trial. The intervention group received usual care plus an educational booklet at discharge with supportive telephone follow-up on postoperative day 10, and the control group received only usual care. The primary outcome was worst pain intensity (The Brief Pain Inventory – Short Form). Data about pain characteristics and analgesic use were collected at 2 weeks and at 1, 3, 6 and 12 months post-surgery. General linear mixed models were used to determine between-group differences over time. Results: Twenty-nine percent of participants reported surgically related pain at rest and 9% reported moderate to severe pain at 12 months post-surgery. Many participants had concerns about pain and pain medication, and analgesic intake was insufficient post-discharge. No statistically significant differences between the groups were observed in terms of the outcome measures following surgery. Conclusion: Postoperative pain and inadequate analgesic use were problems for many participants regardless of group allocation, and the current intervention did not reduce worst pain intensity compared with control. Further examination of supportive follow-up monitoring and/or self-management strategies post-discharge is required. [ABSTRACT FROM AUTHOR]

Objective. This study aims to assess diaphragmatic excursion and measure pulmonary functions as measures of the degree to which the phrenic nerve is blocked after ISB with two different concentrations of ropivacaine: 0.2% and 0.1%. Design. Randomized, double-blinded study. Setting and Patients. Ambulatory surgical facility. Subjects. Fifty patients undergoing shoulder arthroscopy for rotator cuff repair. Methods. Patients were randomized to receive ultrasound-guided ISB with 20mL of either 0.2% or 0.1% ropivacaine. Diaphragmatic excursion was measured using M-mode ultrasound. Pulmonary functions were assessed by portable spirometer. Additional outcome data included oxygen saturation in post-anesthesia care unit (PACU), pain scores, quality of recovery scores (QOR), and opioid consumption over 72hour period after surgery. Results. Forced vital capacity (FVC) was significantly reduced 30minutes after block placement and in PACU in the 0.2% group when compared with the 0.1% group (P=0.04, P= 0.03, respectively). Forced expiratory volume (FEV1) was also significantly decreased in the 0.2% group in PACU when compared with the 0.1% group (P=0.04). There were no significant differences in pain scores, length of stay, and total opioid consumption in PACU. Patients who received 0.2% ropivacaine had a longer block duration (18 vs 11.9hours, P=0.04) and used less opioid in the 72hours after surgery (55mg vs 102mg codeine equivalents, P=0.02), when they were compared to their counterparts who received 0.1% for their block. Conclusion. 0.1% ropivacaine may impair pulmonary function less than 0.2% ropivacaine. The clinical significance of these differences needs to be further studied. [ABSTRACT FROM AUTHOR]

Background: Impaired emotional well-being has detrimental effects on health outcomes in patients with chronic heart failure (CHF). Aims: To evaluate a nurse-led Coping Effectiveness Training (CET) group intervention for patients with CHF. It was hypothesized that CET would increase emotional well-being (primary outcome) and health-related quality (HRQoL) of life and improve clinical outcomes. Furthermore, changes in appraisal and coping as mediators of the intervention effect were examined. Methods: Participants were randomized to either control group (n=51) receiving standard health care or CET intervention group (n=52). Self-assessments of positive affect, negative affect, depression, anxiety, HRQoL, illness perception, coping strategies and social support were performed pre- and post-intervention and after six weeks, six months and 12 months. Time to death and hospitalizations were measured during the entire follow-up (median 35 months, interquartile range 11 months). Results: No significant improvements for emotional well-being and HRQoL in the intervention group compared with the control group were found. After excluding patients with clinical anxiety and depression at baseline the intervention group had significantly lower negative affect (p = 0.022). There were no significant differences regarding cardiovascular events between the groups. The intervention group had greater sense of control over their illness in the short-term (p = 0.036). Conclusion: CET intervention was found to increase sense of control over the illness in the short term. Psychosocial support programmes, like CET, for patients with CHF is currently lacking evidence for implementing in clinical practice. However, the results provide a basis for future studies with a modified CET intervention design and increased study size. [ABSTRACT FROM AUTHOR]

Introduction. Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. Methods. At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Results. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOLat FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). Conclusion. The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. [ABSTRACT FROM AUTHOR]

Background: Person-centred care (PCC) aims to engage patients as active partners in their care and treatment to improve the management of their illness. Self-efficacy is an important concept and outcome in PCC as it refers to a patient’s belief in their capability to manage the events that affect their lives. Recovery after acute coronary syndrome (ACS) is demanding and a PCC approach may promote self-efficacy and thereby facilitate recovery. Aim: The purpose of this study was to evaluate whether a PCC intervention was able to improve self-efficacy after hospitalization for ACS. Methods: In a randomized controlled trial, patients <75 years of age and hospitalized for ACS were assigned to either a usual care group or a PCC intervention group. Self-efficacy was assessed at baseline and up to six months after discharge using the Swedish Cardiac Self-Efficacy Scale (S-CSES), which consists of three dimensions: control symptoms, control illness and maintain functioning. Results: In total, 177 patients were included in the study: 93 in the usual care group and 84 in the PCC group. At the one-month follow-up the PCC group had improved significantly more (p=0.049) on the control symptoms dimension (mean change 0.81; SD 3.5 versus mean change −0.20; SD 3.0). No difference between groups was seen at the six-month follow-up in any of the S-CSES dimensions. Conclusions: Our results indicate that PCC added to usual care promotes and hastens the development of patients’ confidence in their ability to manage symptoms during recovery after ACS. This underlines the importance of initiating and establishing partnerships between patients and health care professionals as early as possible after ACS. [ABSTRACT FROM AUTHOR]

Process evaluation is valuable in guiding development of effective intervention programmes but rare in adolescent weight management. This paper presents a process evaluation of the Loozit® randomized controlled trial, a community-based behavioural lifestyle intervention for obese 13-16 year olds. Adolescents were randomized to receive the two-phase Loozit® group programme, with (n = 73) or without (n = 78), additional therapeutic contact (telephone coaching, short message service and/or emails) in Phase 2. Quantitative and qualitative process data were collected. Facilitators used a standardized evaluation form to document participant attendance, and comment on lesson adherence and process delivery. Adolescents and parents completed satisfaction questionnaires at 2-, 12- and 24-month follow-ups. Following the intervention, 14 adolescents who provided informed written consent were interviewed about their experience with additional therapeutic contact. Data were analysed using descriptive statistics, parametric and non-parametric tests to compare group means, and thematic analyses. Group attendance rates averaged 85 and 47% during Phases 1 (0-2 months) and 2 (3-24 months), respectively. Facilitators frequently noted that participants reported making healthy lifestyle changes. Elements enjoyed in the sessions included practical activities, fun active games, resistance training and forming new friendships. Adolescents struggled with setting specific, measurable, achievable, realistic and timely (SMART) goals. Overall, participants were satisfied with the help received including the telephone and electronic contact. More than 80% of participants found the programme changed adolescents' eating and physical activity habits, and 89% of parents reported changing parenting strategies. Future adolescent group-based programmes may enhance participant engagement and programme effectiveness by including more interactive and frequent telephone and electronic contact. [ABSTRACT FROM AUTHOR]

Introduction Discogenic low back pain ( LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty ( IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group. Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB. Results Twenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported. Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points. [ABSTRACT FROM AUTHOR]

Objectives The objective of this study was to determine the effects of combining pulsed radiofrequency ( PRF) treatment and transforaminal epidural injection ( TFEI) to treat patients with chronic refractory lumbar radicular pain caused by lumbar spinal stenosis. Study design Randomized control trial. Settings Interventional pain management practice. Method Sixty-two patients were assigned to the study groups ( PRF group = 31; control group = 31). Under fluoroscopic guidance, the RF needle was positioned close to the lumbar dorsal root ganglion. The PRF group received 3 cycles of PRF treatment, and sensory stimulation without RF lesioning was applied to the control group. After PRF or sham lesioning, a local anesthetic with steroid was injected. The primary outcome of a successful response was defined as: 1) ≥50% or 4-point pain reduction in the numerical rating scale ( NRS) without an increase in the Oswestry disability index ( ODI) or medication quantification scale ( MQS), or mean score <4 in the global perceived effect ( GPE) scale; or 2) ≥30% or 2-point pain reduction in NRS with a simultaneous decrease in ODI, MQS, or ≥6 points in the GPE scale. Result The number of patients with successful treatment results was higher in the PRF group at 2 months ( P = 0.032) and 3 months ( P = 0.018). No significant differences were observed in terms of the secondary outcome variables between the 2 groups. Conclusion The TFEI provided significant short-term pain relief and PRF can be applied in conjunction with TFEI to achieve higher treatment efficacy compared with TFEI alone. [ABSTRACT FROM AUTHOR]

Purpose: To describe an intervention promoting benefit-finding in Alzheimer caregivers, to discuss key issues in implementation and ways to resolve them, and to examine whether the intervention reduced burden and depression in a small randomized trial. Design and Methods: Twenty-five caregivers were randomized into benefit-finding and psychoeducation groups. Both groups had eight weekly sessions. Outcome measures including role overload, Zarit Burden Interview, and Hamilton depression scale were collected at baseline and after treatment. Results were analyzed using analysis of covariance. Additionally, the challenges of implementing such interventions, some of which related to cultural issues, were analyzed qualitatively. Results: Controlling for pretest, the benefit-finding group had lower depression than the psychoeducation group at post-test, despite the fact that some caregivers found benefit-finding challenging. The two groups did not differ on overload and burden. However, within-group analysis suggested that both groups showed significant reductions in overload from pretest to post-test. In addition, we discussed participants’ difficulties in grasping the technique of thought modification for benefit-finding, recording such exercises at home, and sharing their thoughts and experiences in groups. We described measures undertaken in the main trial to overcome these issues. Implications: Cognitive approaches focusing on benefit-finding are feasible among Chinese caregivers, with preliminary evidence suggesting an effect on alleviating depression. [ABSTRACT FROM PUBLISHER]

Objective A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). Methods This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20−100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction ( Subject Global Assessment of Medication) were assessed. Results Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Conclusions Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP. [ABSTRACT FROM AUTHOR]

Objective. Anti-inflammatory therapies are effective analgesics for OA. This study determined whether low-dose oral prednisolone (PNL) was an effective analgesic for hand OA.Methods. This was a randomized, double-blind, placebo-controlled trial of people with ACR criteria hand OA and baseline hand pain visual analogue scale (VAS) of >40/100 mm. Participants received 5 mg PNL or placebo daily for 4 weeks. Pain VAS, disease activity VAS, Australian/Canadian Hand Osteoarthritis Index and joint counts were performed at baseline, 4 and 12 weeks. Primary outcome was the change in hand pain VAS at 4 weeks. Analysis of covariance was used for analysis, controlling for baseline values. To explore potential mechanism of action of PNL, non-contrast 0.2 Tesla MRI was performed on the most painful hand at baseline and 4 weeks.Results. A total of 70 participants were recruited (57 women, mean age 61 years, mean baseline pain VAS 61.5 mm); 75% had more than one joint with definite MRI synovitis/effusion. At 4 weeks the adjusted mean reduction in pain VAS was 19.9 mm (PNL group) and 16.8 mm (placebo group) (P = 0.54). There were no statistically significant differences in VAS, Australian/Canadian Hand Osteoarthritis Index or joint counts between placebo and PNL groups at 4 or 12 weeks. A total of 20 participants in each group achieved an Outcome Measures in Rheumatology-Osteoarthritis Research Society International response. Baseline synovitis/effusion did not predict response to treatment.Conclusion. This is the first randomized controlled trial of low-dose corticosteroid alone for painful hand OA, which demonstrated that short-term low-dose oral PNL is not an effective analgesic treatment for hand OA.Trial registration. International Standard Randomised Controlled Trial Number Register, www.isrctn.org, Trial number 99697616. [ABSTRACT FROM PUBLISHER]