Is a Modified Dialectical Behavior Therapy (DBT) Regimen Effective in Reducing PTSD Symptom Severity in Adult Women with Comorbid PTSD and BPD?

OBJECTIVE: The objective of this selective EBM review is to determine whether or not “a modified dialectical behavior therapy (DBT) regimen is effective in reducing PTSD symptom severity in adult women with comorbid PTSD and BPD?” STUDY DESIGN: Review of two randomized controlled trials (RCTs) and one case study published in English between 2013-2015. DATA SOURCES: Two RCTs and one case study found via PubMed and Google Scholar evaluated the benefit of a modified dialectical behavior therapy (DBT) in reducing PTSD symptom severity in patients with comorbid PTSD and BPD. OUTCOMES MEASURED: PTSD Symptom severity was measured via the Clinician- Administered PTSD Scale (CAPS), PTSD Symptom Scale – Interview (PSS-I), and PTSD Checklist (PCL). RESULTS: Both RCT’s performed by Bohus et al. (Psychother Psychosom. 2013;82(4):221223. doi: 10.1159/000348451) and Harned et al. (Behav Res Ther. 2014;55:7-17. doi: 10.1016/j.brat.2 014.01.008) found a statistically significant relationship between a modified DBT regimen, DBT-PTSD or DBT + DBT PE respectively, and a marked reduction in PTSD symptom severity as compared to the control group. Granato et al. (J. Clin. Psychol. 2015;71:805 -815. doi: 10.100 2/jclp/22207) conducted a case study that descriptively revealed the patient’s reduced PTSD symptomatology after completing DBT + DBT PE yet is deficient in its ability to produce significant data due to their lack of sample size. CONCLUSIONS: The reported evidence in each study supports the efficacy of a modified DBT regimen in the marked reduction of PTSD symptom severity in adult women with co-occurring PTSD and BPD. However, only the two RCTs by Bohus et al and Harned et al. elicited data with statistical significance. Based on the findings from these two trials, it is evident that women who severely suffer from both mental illnesses are capable of reducing their PTSD symptomatology with potential remission from one of the diagnoses after completion of a modified DBT treatment, as compared to traditional DBT that is unable to elicit the same change. These studies prove that it is imperative to simultaneously target both symptomatic manifestations of BPD and PTSD that co-occur and cause significant impairment. Future research should focus on expanding sample sizes and lengthening follow-up measures to assess the treatment’s long-term impact on psychological remission

The effectiveness of continuous positive airway pressure for treating obstructive sleep apnoea in pregnancy: A systematic review

Background: Obstructive sleep apnoea (OSA) occurs in 15–20% of pregnant women living with obesity. As global obesity prevalence increases, OSA in pregnancy is concurrently increasing, yet remains under-diagnosed. The effects of treating OSA in pregnancy are under-investigated. Aim: A systematic review was conducted to determine whether treating pregnant women with OSA using continuous positive airway pressure (CPAP) will improve maternal or fetal outcomes, compared with no treatment or delayed treatment. Materials and Methods: Original studies in English published until May 2022 were included. Searches were conducted in Medline, PubMed, Scopus, the Cochrane Library and clinicaltrials.org. Maternal and neonatal outcome data were extracted, and quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach (PROSPERO registration: CRD42019127754). Results: Seven trials met inclusion criteria. Use of CPAP in pregnancy appears to be well tolerated with reasonable adherence. Use of CPAP in pregnancy may be associated with both a reduction in blood pressure and pre-eclampsia. Birthweight may be increased by maternal CPAP treatment, and preterm birth may be reduced by treatment with CPAP in pregnancy. Conclusion: Treatment of OSA with CPAP in pregnancy may reduce hypertension and, preterm birth, and may increase neonatal birthweight. However, more rigorous definitive trial evidence is required to adequately assess the indication, efficacy, and applications of CPAP treatment in pregnancy

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Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.

BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. METHODS: This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. RESULTS: Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. CONCLUSION: The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake

Study within a trial (SWAT) protocol. Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

INTRODUCTION: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). METHODS: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. DISCUSSION: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants

An Innovative Interprofessional Simulation: Preparing Students to Tackle the Challenge of Care Transitions

INTRODUCTION Transitions of Care (TOC) are associated with communication breakdowns that contribute to medical errors, medication mistakes, and hospital re-admissions. The purpose of this one-day workshop was to teach interprofessional (IP) skills to healthcare students, focusing on verbal and written communication during a TOC of a standardized patient (SP). METHODS Forty-seven students, representing six healthcare disciplines, worked in IP teams to plan a family meeting for a hospitalized SP who had recently experienced a stroke. Students were to communicate pertinent medical, social, and physical issues to the SP, as well as make discharge recommendations. Discharge summaries were entered into an electronic medical record and transmitted to IP teams simulating either a rehabilitation setting or ambulatory care. IP teams utilized these summaries in their family meeting with the SP. After each scenario, students debriefed, focusing on IP competencies. RESULTS Significant improvements were found in nine of fourteen areas measured by the Attitudes Towards Healthcare Teams Scale. Significant improvements were found for confidence in writing an accurate and concise note as well as gleaning information from a discharge summary. CONCLUSIONS This study demonstrated the effectiveness of a short workshop on improving IP verbal and written communication and confidence in TOC scenarios in acute care, rehabilitation, and ambulatory care

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group.  There were no differences in patient understanding between the two methods.  Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting

Study protocol; thyroid hormone replacement for untreated older adults with subclinical hypothyroidism - a randomised placebo controlled trial (TRUST)

Background: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. Methods: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. Discussion: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. Trial registration: Clinicaltrials.gov NCT01660126; registered 8th June 2012