Mindfulness‐based Coping with University Life: A Non‐randomized Wait‐list‐controlled Pilot Evaluation

The aim of this study was to explore the feasibility of implementing a new 8‐week mindfulness‐based programme, ‘Mindfulness‐Based Coping with University Life’ (MBCUL), specifically tailored to the needs and demand of students and to explore its impact in a pilot evaluation. Participants were drawn from the University of Northampton (MBCUL N = 10; control N = 6). A non‐randomized wait‐list‐controlled design was employed. Measures examined anxiety and depression, perceived stress, mindfulness and personally relevant change before and immediately after the programme. The diurnal profile of salivary cortisol and alpha‐amylase level was collected for two consecutive days. No significant intergroup differences were observed on any of the measures at either time point. However, significant change was observed for the MBCUL group in terms of perceived stress (d = 1.06; z = ?2.25, p = 0.03), anxiety (d = 1.04; z = ?2.14, p = 0.03), depression (d = 0.52; z = ?0.69, p = 0.5) and personally relevant change (d = 2.63; z = ?2.68, p = 0.01), along with an increase in mindfulness (d = 1.06; z = ?1.89, p = 0.06). In contrast, no significant change was found in the daily profiles of cortisol and alpha‐amylase. The data from this pilot tentatively suggest that MBCUL appears to be a promising programme that warrants further evaluation using a randomized study with a larger sample size. Copyright © 2011 John Wiley & Sons, Ltd.     

Use of noninvasive positive pressure ventilation in patients with severe obesity undergoing esophagogastroduodenoscopy: a randomized controlled trial

BackgroundPatients with severe obesity being considered for bariatric surgery often undergo preoperative esophagogastroduodenoscopy (EGD). Severe obesity is a risk factor for oxygen desaturation events during EGD. The use of noninvasive positive pressure ventilation (NIPPV) to reduce desaturation events during EGD among patients with severe obesity has not been studied.ObjectiveTo evaluate the use of NIPPV among patients with severe obesity undergoing EGD.SettingCommunity hospital endoscopy suite.MethodsA randomized controlled trial evaluated the use of NIPPV in patients with severe obesity undergoing EGD. Patients were randomized into treatment (NIPPV) and control (nasal cannula, NIPPV for rescue) groups. Primary endpoints were oxygen desaturation events ≤94% and oxygen desaturation events <90% requiring intervention. A secondary endpoint was the use of NIPPV as a rescue maneuver.ResultsFifty-six patients with a body mass index of 40 to 60 were randomized (n = 28 treatment and n = 28 control). A statistically significant difference was noted between the groups for desaturation events ≤94% (14.3% of treatment and 57.1% of control groups, P = .002). There was also a statistically significant difference in the risk of a desaturation event <90% requiring intervention (3.5% of treatment and 28.6% of control groups, P = .025). All patients in the control group who developed desaturation events requiring intervention were rescued with NIPPV.ConclusionsThis study demonstrated the successful use of NIPPV as an adjunct to decrease the incidence of desaturation events in patients with severe obesity undergoing EGD.     

Long-term daily high and low doses of azithromycin in children with cystic fibrosis: A randomized controlled trial

BackgroundLong-term administration of azithromycin (AZM) in children with cystic fibrosis (CF) has improved outcomes. However, the doses and schedule of administration are not very well studied in children with CF.MethodsA randomized controlled trial was conducted to compare the effect of two doses of azithromycin (5 mg/kg/day and 15 mg/kg/day) on FEV₁ and pulmonary exacerbations in children with cystic fibrosis. Enrolled children were randomly allocated to receive daily azithromycin (5 mg/kg/day or 15 mg/kg/day) for 6 months. Clinical assessment and FEV₁ measurement were performed monthly.Results56 children (28 in high dose group and 28 in low dose group) were enrolled. 47 (24 and 23 children in low and high dose groups) completed 12 months of follow up. There was no difference in clinical scores, FEV₁, pulmonary exacerbation rates between two groups at baseline, 6 months and at 12 months. Per protocol analysis revealed that pulmonary exacerbation increased after discontinuing AZM and there was significantly more increase after 12 months of enrolment in children getting high dose azithromycin. There was no improvement in FEV₁ in either group at the end of treatment period. Children tolerated daily low as well as high dose AZM well for 6 months. There was no significant side effect of azithromycin.ConclusionIn this randomized controlled trial, we did not find differences in the effect of 2 doses (5 mg/kg/day or 15 mg/kg/day) of AZM on change in percentage predicted FEV₁, clinical scores, Pseudomonas colonization rates, pulmonary exacerbations and need for antibiotics. There was increase in exacerbations after stopping azithromycin in both the groups. Our results also suggest that the decrease in the incidence of LRTI persists only till 6 months after discontinuing azithromycin.     

High volume peritoneal dialysis vs daily hemodialysis: a randomized, controlled trial in patients with acute kidney injury

There is no consensus in the literature on the best renal replacement therapy (RRT) in acute kidney injury (AKI), with both hemodialysis (HD) and peritoneal dialysis (PD) being used as AKI therapy. However, there are concerns about the inadequacy of PD as well as about the intermittency of HD complicated by hemodynamic instability. Recently, continuous replacement renal therapy (CRRT) have become the most commonly used dialysis method for AKI around the world. A prospective randomized controlled trial was performed to compare the effect of high volume peritoneal dialysis (HVPD) with daily hemodialysis (DHD) on AKI patient survival. A total of 120 patients with acute tubular necrosis (ATN) were assigned to HVPD or DHD in a tertiary-care university hospital. The primary end points were hospital survival rate and renal function recovery, with metabolic control as the secondary end point. Sixty patients were treated with HVPD and 60 with DHD. The HVPD and DHD groups were similar for age (64.2+/-19.8 and 62.5+/-21.2 years), gender (male: 72 and 66%), sepsis (42 and 47%), hemodynamic instability (61 and 63%), severity of AKI (Acute Tubular Necrosis-Index Specific Score (ATN-ISS): 0.68+/-0.2 and 0.66+/-0.2), Acute Physiology, Age, and Chronic Health Evaluation Score (APACHE II) (26.9+/-8.9 and 24.1+/-8.2), pre-dialysis BUN (116.4+/-33.6 and 112.6+/-36.8 mg per 100 ml), and creatinine (5.8+/-1.9 and 5.9+/-1.4 mg per 100 ml). Weekly delivered Kt/V was 3.6+/-0.6 in HVPD and 4.7+/-0.6 in DHD (P<0.01). Metabolic control, mortality rate (58 and 53%), and renal function recovery (28 and 26%) were similar in both groups, whereas HVPD was associated with a significantly shorter time to the recovery of renal function. In conclusion, HVPD and DHD can be considered as alternative forms of RRT in AKI.     

Spray on skin improves psychosocial functioning in pediatric burns patients: a randomized controlled trial

PURPOSE: Microskin is a sprayed on, computer color-matched, skin camouflage which can last for up to 5 days after application. It binds to the epidermis and the patient can sweat and swim with it on. The purpose of the current study was to determine whether Microskin produces psychosocial benefit in pediatric burns patients. PROCEDURE: Twenty children with mature burn scars took part in the study and used Microskin for 5 weeks. Initially, 10 children were randomized to a treatment group while the remaining 10 became a wait-list group for 7 weeks. The wait-list group subsequently received Microskin for 5 weeks. Before and after using Microskin, children completed three psychosocial measures; the Strengths and Difficulties Questionnaire (SDQ), the Family Assessment Device-General Functioning scale (FAD-GF), and the Microskin Questionnaire (MQ-a questionnaire about their experience using Microskin developed specifically for this study). All children were followed up with the same measures 6 months after their completed use of Microskin. RESULTS: After the 5-week Microskin trial there was improvement on all scales of the SDQ for the 10 children in the first treatment group but not for the wait-list group. After the wait-list group used Microskinfor 5 weeks they too improved on all scales. Combining the results for all 20 children from before to after using Microskin there was a statistically significant improvement in the SDQ Emotional Symptoms and Total Difficulties. There was also improved perception of family functioning after using Microskin. Six-month follow-up data showed continued psychosocial improvement. Overall, children felt more confident, happier, and enjoyed social outings more when they had Microskin on, with 95% intending to continue to use Microskin. CONCLUSIONS: Microskin improves psychosocial functioning in pediatric burn patients and is well-tolerated and acceptable. The small sample size precludes sophisticated statistical analyses and generalization of results. There is a need for a full scale randomized controlled study of Microskin with a larger sample size.     

Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis

BackgroundIn Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence.MethodsiCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11–20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months.ResultsEffectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25–100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC.ConclusionsThe IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified.Trial RegistryClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.     

A personalized app to improve quality of life of patients with a stoma: A protocol for a multicentre randomized controlled trial

Aim

Proper education, guidance and support is crucial before and following creation of a stoma. Patients with a stoma and their close relatives need to adapt to and cope with this new – and sometimes unforeseen – situation, which may result in insecurities and a variety of psychosocial problems. Self-efficacy is associated both with a reduction in psychosocial problems and with improved quality of life. The main objective of this study was to investigate whether self-reported quality of life of patients with a stoma can be enhanced by offering personalized and timed guidance, as well as peer contact, in a patient-centred mobile application.

Method

A multicentre, double-blind, randomized controlled trial will be conducted. Consented adults >18 years of age who will receive an ileostomy or colostomy and possess an eligible smartphone will be included. The intervention group will be given the full version of the application (containing personalized and timed guidance, such as operation-specific information and information on the associated care pathway) to install on their smartphone. In addition, the intervention group has access to a protected peer-support platform within the app. The control group will receive a restricted version of the application that contains only generic (non-personalized) stoma-related information. The primary outcome is quality of life, 3 months postoperatively. Secondary outcomes are Patient Reported Outcome Measures (PROMs), such as psychological adaption, as well as number of complications, re-admission and re-operation rates and the length of hospital stay.

Results

Patient enrolment began in March 2021. Data collection was not complete when this protocol was submitted.

Conclusion

We hypothesize that patients with a stoma who are supported by the intervention version of the app will report a significantly higher quality of life than patients with a stoma who are supported by the control version of the app (ie, are not offered personalized and timed guidance and information and do not have access to peer support in the app).     

Treating depression and improving adherence in HIV care with task‐shared cognitive behavioural therapy in Khayelitsha,South Africa: a randomized controlled trial

IntroductionMajor depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study''s aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa.MethodsThis was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time.ResultsAt 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time.ConclusionsTask‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice.Trial RegistrationClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT02696824","term_id":"NCT02696824"}}NCT02696824 https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02696824","term_id":"NCT02696824"}}NCT02696824     

No positive effect of autologous platelet gel after total knee arthroplasty: A double-blind randomized controlled trial: 102 patients with a 3-month follow-up

Background and purpose Activated platelets release a cocktail of growth factors, some of which are thought to stimulate repair. We investigated whether the use of autologous platelet gel (PG) in total knee arthroplasty (TKA) would improve wound healing and knee function, and reduce blood loss and the use of analgesics.Patients and methods 102 patients undergoing TKA were randomly assigned to a PG group (n = 50) or to a control (C) group (n = 52). The primary analysis was based on 73 participants (PG: 32; C: 41) with comparison of postoperative wound scores, VAS, WOMAC, knee function, use of analgesics, and the pre- and postoperative hemoglobin values after a follow-up of 3 months. 29 participants were excluded due to insufficient data.Results The characteristics of the protocol-compliant patients were similar to those of the patients who were excluded. Analysis was per protocol and focused on the remaining 73 patients. At baseline and after 3 months of follow-up, there were no statistically significant differences between both groups regarding age, height, weight, sex, side of operation, platelet count, hemoglobin values, severity of complaints (WOMAC), and level of pain.Interpretation In our patients undergoing TKA, application of PG to the wound site did not promote wound healing. Also, we found that PG had no effect on pain, knee function, or hemoglobin values.     

Your Path to Transplant: A randomized controlled trial of a tailored expert system intervention to increase knowledge,attitudes, and pursuit of kidney transplant

Individually tailoring education over time may help more patients, especially racial/ethnic minorities, get waitlisted and pursue deceased and living donor kidney transplant (DDKT and LDKT, respectively). We enrolled 802 patients pursuing transplant evaluation at the University of California, Los Angeles Transplant Program into a randomized education trial. We compared the effectiveness of Your Path to Transplant (YPT), an individually tailored coaching and education program delivered at 4 time points, with standard of care (SOC) education on improving readiness to pursue DDKT and LDKT, transplant knowledge, taking 15 small transplant-related actions, and pursuing transplant (waitlisting or LDKT rates) over 8 months. Survey outcomes were collected prior to evaluation and at 4 and 8 months. Time to waitlisting or LDKT was assessed with at least 18 months of follow-up. At 8 months, compared to SOC, the YPT group demonstrated increased LDKT readiness (47% vs 33%, P = .003) and transplant knowledge (effect size [ES] = 0.41, P < .001). Transplant pursuit was higher in the YPT group (hazard ratio: 1.44, 95% confidence interval: 1.15-1.79, P = .002). A focused, coordinated education effort can improve transplant-seeking behaviors and waitlisting rates. ClinicalTrials.gov registration: NCT02181114.     

Overall survival in the intervention arm of a randomized controlled screening trial for prostate cancer compared with a clinically diagnosed cohort

OBJECTIVES: This population-based study provides comparisons of prostate cancer characteristics at diagnosis of two cohorts of men from two well-defined geographical areas exposed to different intensities of prostate cancer screening. Overall survival in both cohorts was compared with that in the general population. METHODS: A cohort of 822 men randomized to the intervention arm of a prostate cancer screening trial and subsequently diagnosed with prostate cancer was compared with a nonrandomized cohort of 947 men who were clinically diagnosed with prostate cancer in a geographically neighboring region. In both cohorts, cases were diagnosed with prostate cancer between January 1989 and December 1997. A partitioning of overall survival by variables associated with cancer onset such as age at diagnosis, stage at diagnosis, and grade at diagnosis was performed. RESULTS: Age at diagnosis, tumor extent at diagnosis, and grade at diagnosis were significantly different between the screened and clinically diagnosed cohort. The 5- and 10-yr survival rates were higher in the screened cohort than in the clinically diagnosed cohort (88.8% vs. 52.4%, and 68.4% vs. 29.6%, respectively). Significant differences in survival were evident for all age, stage, and grade subgroups, except for metastatic disease at diagnosis. CONCLUSIONS: Differences in overall survival favoring the screened population were observed for all baseline characteristics (age, stage, and grade of disease), and these variables may all explain differences in overall survival because screening achieves early diagnosis as well as a stage and grade shift. As observed survival rates in the screened population mirrored those within the general population, the contribution of lead time and overdiagnosis to final patient outcome is considered to be large as well.     

A lifestyle intervention randomized controlled trial in obese women with infertility improved body composition among those who experienced childhood adversity

Previous research indicates that tailoring lifestyle interventions to participant characteristics optimizes intervention effectiveness. Our objective was to assess whether the effects of a preconception lifestyle intervention in obese infertile women depended on women's exposure to adversity in childhood. A follow-up of a preconception lifestyle intervention randomized controlled trial (the LIFEstyle study) was conducted in the Netherlands among 577 infertile women (age 18–39 years) with a body mass index (BMI) ≥29 kg/m² at time of randomization; N = 110 (19%) consented to the follow-up assessment, 6 years later. A 6-month preconception lifestyle intervention aimed weight loss through improving diet and increasing physical activity. The control group received care as usual. Outcome measures included weight, BMI, waist and hip circumference, body fat percentage, blood pressure and metabolic syndrome. The potential moderator, childhood adversity, was assessed with the Life Events Checklist-5 questionnaire. Among the 110 women in our follow-up study, n = 65 (59%) reported no childhood adverse events, n = 28 (25.5%) reported 1 type of childhood adverse events and n = 17 (15.5%) reported ≥2 types of childhood adverse events. Regression models showed significant interactions between childhood adversity and effects of lifestyle intervention at the 6-year follow-up. Among women who experienced childhood adversity, the intervention significantly reduced weight (−10.0 [95% CI −18.5 to −1.5] kg, p = 0.02), BMI (−3.2 [−6.1 to −0.2] kg/m², p = 0.04) and body fat percentage (−4.5 [95% CI −7.2 to −1.9] p < 0.01). Among women without childhood adversity, the intervention did not affect these outcomes (2.7 [−3.9 to 9.4] kg, p = 0.42), (0.9 [−1.4 to 3.3] kg/m², p = 0.42) and (1.7 [95% CI −0.3 to 3.7] p = 0.10), respectively. Having a history of childhood adversity modified the effect of a preconception lifestyle intervention on women's body composition. If replicated, it may be important to consider childhood adversity as a determinant of lifestyle intervention effectiveness.     

Use of the ProSeal laryngeal mask airway for pressure-controlled ventilation with and without positive end-expiratory pressure in paediatric patients: a randomized, controlled study

Background. Tracheal intubation and positive end-expiratorypressure (PEEP) are frequently used in children to avoid airwayclosure and atelectasis during general anaesthesia. Also, thelaryngeal mask airway (LMA     

Urinary catheterization in labour with high-dose vs mobile epidural analgesia: a randomized controlled trial

Background: Dense perineal block from epidural analgesia increases the riskof urinary catheterization in labour. Mobile epidurals usinglow-dose local anaesthetic in combination with opioid preservematernal mobility and may reduce the risk of bladder dysfunction.We conducted a three-arm randomized controlled trial to comparehigh-dose epidural pain relief with two mobile epidural techniques. Methods: A total of 1054 primparous women were randomized to receivehigh-dose bupivacaine, epidural analgesia (Control), combinedspinal epidural (CSE), or low-dose infusion (LDI). The requirementfor urinary catheterization during labour and postpartum wasrecorded. Both end points were pre-specified secondary trialoutcomes. Women were evaluated by postnatal interview, whentheir bladder function had returned to normal. Results: Relative to Control, more women who received mobile epiduraltechniques maintained the ability to void urine spontaneouslyat any time (Control 11%, CSE 31% and LDI 32%) and throughoutlabour (Control 3.7%, CSE 13% and LDI 14%), for both mobiletechniques P<0.01. There was no difference in the requirementfor catheterization after delivery. Women in the CSE group reporteda more rapid return of normal voiding sensation, relative tohigh-dose Control (P=0.02). Conclusions: Relative to conventional high-dose block, mobile epidural techniquesencourage the retention of normal bladder function and reducethe risk of urinary catheterization in labour.     

Visually-guided irrigation in patients with early knee osteoarthritis: a multicenter randomized, controlled trial

OBJECTIVE: To determine if visually-guided arthroscopic irrigation is an effective therapeutic intervention in patients with early knee osteoarthritis. DESIGN: Ninety patients with knee osteoarthritis were randomized in a double-blind fashion to receive either arthroscopic irrigation with 3000 ml of saline (treatment group) or the minimal amount of irrigation (250 ml) required to perform arthroscopy (placebo group). The primary outcome variable was aggregate WOMAC score. RESULTS: The study did not demonstrate an effect of irrigation on arthritis severity as measured by aggregate WOMAC scores, the primary outcome variable; the mean change in aggregate WOMAC score at 12 months was 15.5 (95% CI 7.7, 23.4) for the full irrigation group compared to 8.9 (95% CI 4.9, 13.0) for the minimal irrigation group (P=0.10). Full irrigation did have a statistically significant effect on patients' self-reported pain as measured by the WOMAC pain subscale and by a visual analog scale (VAS) (the secondary outcome variables). Mean change in WOMAC pain scores decreased by 4.2 (95% CI -0.9, 9.4) for the full irrigation group compared with a mean decrease of 2.3 (95% CI -0.1, 4.7) in the minimal irrigation group (P=0.04). Mean VAS pain scores decreased by 1.47 (95% CI -1.2, 4.1) in the full irrigation group compared to a mean decrease of 0.12 (95% CI 0.0, 0.3) in the minimal irrigation group (P=0.02). A hypothesis-generating post-hoc analysis of the effect of positively birefrigent intraarticular crystals showed that patients with and without intraarticular crystals had statistically significant improvements in pain assessments and aggregate WOMAC scores at 12 months; patients with crystals had statistically greater improvements in pain. CONCLUSIONS: Visually-guided arthroscopic irrigation may be a useful therapeutic option for relief of pain in a subset of patients with knee OA, particularly in those who have occult intraarticular crystals.