The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rationale, implementation and challenges of the ISPY COVID-19 trial during the first phase of trial activity from April 2020 until December 2021.
The ISPY COVID-19 Trial is a multicentre open-label phase 2 platform trial in the USA designed to evaluate therapeutics that may have a large effect on improving outcomes from severe COVID-19. The ISPY COVID-19 Trial network includes academic and community hospitals with significant geographical diversity across the country. Enrolled patients are randomised to receive one of up to four investigational agents or a control and are evaluated for a family of two primary outcomes—time to recovery and mortality. The statistical design uses a Bayesian model with ‘stopping’ and ‘graduation’ criteria designed to efficiently discard ineffective therapies and graduate promising agents for definitive efficacy trials. Each investigational agent arm enrols to a maximum of 125 patients per arm and is compared with concurrent controls. As of December 2021, 11 investigational agent arms had been activated, and 8 arms were complete. Enrolment and adaptation of the trial design are ongoing.
ISPY COVID-19 operates under a central institutional review board via Wake Forest School of Medicine IRB00066805. Data generated from this trial will be reported in peer-reviewed medical journals.
Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection.
The DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs.
The study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences.
ISRCTN Registry: 13164336.
To understand intensivist perceptions of the appropriateness of time-limited trials (TLTs)—a strategy to align life-sustaining care with patient goals and values in the midst of clinical uncertainty.
We conducted a mixed-methods sequential explanatory study of intensive care unit (ICU) intensivists regarding appropriateness of utilising TLTs in three vignettes centred on invasive mechanical ventilation (IMV); continuous renal replacement therapy (CRRT); and heated high-flow nasal cannula (HHFNC). Semistructured interviews were conducted using the Tailored Implementation of Chronic Diseases framework. Data were analysed using thematic and matrix analysis.
Two academic medical centres in the USA participated in the randomised surveys and one centre participated in the semistructured interviews.
Pulmonary and critical care intensivists and fellows.
To understand intensivists perceptions of the appropriateness in using TLTs.
Of 115 physicians surveyed, 71 initiated the survey and 44 completed the entire survey with a response rate of 38% (N=44/115) and a completion rate of 62% (N=44/71). While 35% (N=23/66) of intensivists had never heard of a TLT, of the intensivists who had heard of a TLT, 77% (N=33/43) had participated in one. In response to the vignettes, appropriateness of using a TLT varied (IMV: 74% (N=46/62); CRRT 78% (N=49/63); HHFNC 92% (N=56/61) as did the durations of the TLT. Semistructured interviews with 11 intensivists revealed having clarity about patient goals and clinical endpoints facilitated successful TLTs while lack of an evidenced-based framework was a barrier.
More than half of the physicians who responded had conducted or participated in a TLT. To increase the use of TLTs in the ICU, clinicians desire a more robust, evidence-based framework on how to conduct TLTs.
During and after general anaesthesia, opioids are commonly used for pain treatment. Since preclinical studies underlined the potential immunosuppressive activity of these drugs, it was postulated that their perioperative administration could influence cancer outcomes after surgery. Nevertheless, clinical data have been extrapolated mainly from retrospective analyses. Consequently, the precise link between perioperative opioid use and cancer recurrence/metastasis or cancer-related mortality/morbidity is still an unsolved issue.
This scoping review is planned to follow the Joanna Briggs Institute recommendations. The authors will conduct a literature review through the PRISMA statement using PubMed and EMBASE databases; the Grey literature will be explored using Google Scholar and Conference Proceedings Citation Index (via Web of Science). The search strategy will be limited to articles published in the English language and to human studies. The database searches are planned from the inception to January 2022. Two reviewers will independently screen titles and abstracts, followed by a full-text screening of potentially relevant articles with standardised data extraction. Any disagreement for the inclusion between the two reviewers will be discussed with a third reviewer.
The review aims to map the available literature, focusing on a possible association between perioperative opioid use and cancer outcomes in patients undergoing surgery. The proposed approach will be useful to identify and analyse the knowledge gap in the field and serve as a prerequisite for future research.
Open Science Framework https://osf.io/vfhw6/ DOI 10.17605/OSF.IO/VFHW6
To compare, in a population of women with gestational diabetes mellitus (GDM), the time to diagnosis of Type 2 diabetes in those with and without common mental disorder (CMD) (depression and/or anxiety) during pregnancy.
prospective study of the Born in Bradford cohort in Bradford, UK.
909 women diagnosed with GDM between 2007 and 2010, with linkage to their primary care records until 2017. The exposed population were women with an indicator of CMD during pregnancy in primary care records. The unexposed were those without an indicator.
Time to diagnosis of type 2 diabetes as indicated by a diagnosis in primary care records.
time to event analysis using Cox regression was employed. Multiple imputation by chained equations was implemented to handle missing data. Models were adjusted for maternal age, ethnicity, education, preconception CMD and tobacco smoking during pregnancy.
165 women (18%) were diagnosed with type 2 diabetes over a follow-up period of around 10 years. There was no evidence of an effect of antenatal CMD on the development of type 2 diabetes following GDM (adjusted HR 0.95; 95% CI 0.57 to 1.57).
Women with CMD were not at an increased risk of type 2 diabetes following GDM. This is reassuring for women with these co-morbidities but requires replication in other study populations.
More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%–0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications.
Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7–2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board.
The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants.
Patient safety is a healthcare discipline that aims to prevent and reduce patient harm, risks and errors during the provision of healthcare. Given the size of the nursing workforce in the healthcare system the inclusion of patient safety in the undergraduate nursing curriculum is necessary to enhance a safe culture in the daily work of their future careers. To this end, it is essential to apply effective teaching strategies to develop patient safety competencies. This review will aim to evaluate the effectiveness of educational interventions in developing patient safety knowledge, skills, behaviours and attitudes in undergraduate nursing students within the existing topic areas of the WHO Multi-professional Patient Safety Curriculum Guide.
The databases Medline, CINAHL, Scopus, Education Research Complete, The Cochrane Central Register of Controlled Trials, LILACS, Medes and Grey literature such as ClinicalTrials.gov, Google Scholar, DART-Europe, ProQuest Dissertations, CAPES thesis and dissertations, The Virginia Henderson Global e-Repository, Mednar and Thesis Canada will be searched from July 2011 to January 2022. Two independent reviewers will conduct the search, extract the data and assess the risk of bias for the included studies, using standardised critical appraisal instruments from the Joanna Briggs Institute. The quality of the evidence will be assessed using the Grading of Recommendations, Assessment Development and Evaluation methodology. Studies will be pooled in the meta-analysis. Alternatively, the findings will be presented in narrative form, including tables and figures, to aid in data presentation.
This study raises no ethical issues. The findings will be disseminated through presentations at professional conferences and publications in a peer-reviewed journal.
Hepatocellular adenoma (HCA) is an uncommon, solid and benign liver lesion, mainly occurring in women using oral contraceptives. Patients are advised to stop using oral contraceptives (OC) and, as overweight is frequently observed, dietary restrictions. Metabolic changes are assumed to play a role and it has been suggested that diet may help to reduce tumour size. A low-calorie ketogenic diet (LCKD) has been shown to induce weight loss and multiple metabolic changes, including the reduction of portal insulin concentrations, which downregulates hepatic growth hormone receptors. Weight reduction and an LCKD can potentially reduce the size of HCAs.
We designed a matched, interventional cohort study to determine the effect of an LCKD on the regression of HCA. The study population consists of female subjects with an HCA, 18–50 years of age, body mass index>25 kg/m2, who are entering a surveillance period including cessation of OC. A historical control group will be matched. The intervention consists of an LCKD (approximately 35 g carbohydrate/1500 kcal/day) for 3 months, followed by a less strict LCKD for 3 months (approximately 60 g carbohydrate/1500 kcal/day). Main study endpoint is the diameter of the HCA after 6 months, as compared with the historic control group. Secondary endpoints include adherence, quality of life, change in physical activity, liver fat content, body weight, body composition and resting energy expenditure.
The medical ethical committee has approved the study protocol, patient information files and consent procedure and other study-related documents and procedures.
NL75014.078.20; Pre-results. https://www.trialregister.nl/trial/9092
To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.
Systematic review and meta-analysis.
Medline, Cochrane Central, Embase (and others) from inception to July 2019 and updated on 17 May 2020.
Randomised controlled trials (RCTs) comparing strong non-painful TENS at or close to the site of pain versus placebo or other treatments in adults with pain, irrespective of diagnosis.
Reviewers independently screened, extracted data and assessed risk of bias (RoB, Cochrane tool) and certainty of evidence (Grading and Recommendations, Assessment, Development and Evaluation). Mean pain intensity and proportions of participants achieving reductions of pain intensity (≥30% or
The review included 381 RCTs (24 532 participants). Pain intensity was lower during or immediately after TENS compared with placebo (91 RCTs, 92 samples, n=4841, SMD=–0·96 (95% CI –1·14 to –0·78), moderate-certainty evidence). Methodological (eg, RoB, sample size) and pain characteristics (eg, acute vs chronic, diagnosis) did not modify the effect. Pain intensity was lower during or immediately after TENS compared with pharmacological and non-pharmacological treatments used as part of standard of care (61 RCTs, 61 samples, n=3155, SMD = –0·72 (95% CI –0·95 to –0·50], low-certainty evidence). Levels of evidence were downgraded because of small-sized trials contributing to imprecision in magnitude estimates. Data were limited for other outcomes including adverse events which were poorly reported, generally mild and not different to comparators.
There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.
Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.
Prospective birth cohort.
Pregnancy clinics in New Hampshire and Vermont, USA.
1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.
Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.
Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.
In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.
Addressing the barriers to early breast and cervical cancer diagnosis in low and middle-income countries (LMICs) requires a sound understanding and accurate assessment of diagnostic timeliness. This review aimed to map the current evidence on the time to breast and cervical cancer diagnosis and associated factors in LMICs.
MEDLINE (via PubMed), Cochrane Library, Scopus and CINAHL.
Studies describing the time to diagnosis and associated factors in the context of breast and cervical cancer in LMICs published from 1 January 2010 to 20 May 2021.
Two reviewers independently screened all abstracts and full texts using predefined inclusion criteria. The review was reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Evidence was narratively synthesised using predefined themes.
Twenty-six studies conducted across 24 LMICs were included in the review, most (24/26) of which focused on breast cancer. Studies varied considerably in their conceptualisation and assessment of diagnostic time, events, intervals and delays, with a minority of the studies reporting the use of validated methods and tools. Patient-related intervals and delays were more frequently evaluated and reported than provider-related and health system-related intervals and delays. Across studies, there were variations in the estimated lengths of the appraisal, help-seeking, patient and diagnostic intervals for both cancers and the factors associated with them.
Despite the significant burden of breast and cervical cancer in LMICs, there is limited information on the timeliness of diagnosis of these cancers. Major limitations included variations in conceptualisation and assessment of diagnostic events and intervals. These underscore the need for the use of validated and standardised tools, to improve accuracy and translation of findings to better inform interventions for addressing diagnostic delays in LMICs.
Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation.
IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included.
The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020–075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences.
To quantify and characterise the usage of expanded access (EA) data in National Institute for Health and Care Excellence (NICE) technology appraisals (TAs). EA offers patients who are ineligible for clinical trials or registered treatment options, access to investigational therapies. Although EA programmes are increasingly used to collect real-world data, it is unknown if and how these date are used in NICE health technology assessments.
Cross-sectional study of NICE appraisals (2010–2020). We automatically downloaded and screened all available appraisal documentation on NICE website (over 8500 documents), searching for EA-related terms. Two reviewers independently labelled the EA usage by disease area, and whether it was used to inform safety, efficacy and/or resource use. We qualitatively describe the five appraisals with the most occurrences of EA-related terms.
Number of TAs that used EA data to inform safety, efficacy and/or resource use analyses.
In 54.2% (206/380 appraisals), at least one reference to EA was made. 21.1% (80/380) of the TAs used EA data to inform safety (n=43), efficacy (n=47) and/or resource use (n=52). The number of TAs that use EA data remained stable over time, and the extent of EA data utilisation varied by disease area (p=0.001).
NICE uses EA data in over one in five appraisals. In synthesis with evidence from well-controlled trials, data collected from EA programmes may meaningfully inform cost-effectiveness modelling.
The study aimed to assess the determinants of modern contraceptive method use among young women in Benin.
A mixed-methods design.
We used the Benin 2017–2018 Demographic and Health Survey datasets for quantitative analysis. Data collection was conducted using multiple-cluster sampling method and through household survey. Qualitative part was conducted in the city of Allada, one of the Fon cultural capitals in Benin. The participants were purposively selected.
Contraceptive prevalence rate, unmet need for modern method and percentage of demand satisfied by a modern method for currently married and sexually active unmarried women were measured in the quantitative part. Access barriers and utilisation of modern methods were assessed in the qualitative part.
Overall, 8.5% (95% CI 7.7% to 9.5%) among young women ages 15–24 were using modern contraceptives and 13% (12.1% to 14.0%) among women ages 25 or more. Women 15–24 had a higher unmet need, and a lower demand satisfied by modern contraceptive methods compared with women ages 25 or more. 60.8% (56.9% to 64.7%) of all unmarried young women had unmet need for modern contraceptives. Young women were more likely to use male condoms which they obtain mainly from for-profit outlets, pharmacies and relatives. The factors associated with demand satisfied by a modern method were literacy, being unmarried, knowing a greater number of modern contraceptive methods and experiencing barriers in access to health services. On the other hand, the qualitative study found that barriers to using modern methods include community norms about pre-marital sexual intercourse, perceptions about young women’s fertility, spousal consent and the use of non-modern contraceptives.
Contraceptive use is low among young women in Benin. The use of modern contraceptives is influenced by sociodemographic factors and social norms. Appropriate interventions might promote comprehensive sexuality education, increase community engagement, provide youth-friendly services and address gender inequalities.
Commentary on: Shan Z, Li Y, Baden MY, et al. Association between healthy eating patterns and risk of cardiovascular disease. JAMA Intern Med 2020; 180:1090–100. doi: 10.1001/jamainternmed.2020.2176
Nurses should be aware and open to multiple healthy dietary patterns among diverse groups of people and how they might influence cardiovascular disease (CVD). Further research is required to explore how to increase adherence to healthy diets for diverse population groups within their sociocultural and ecological contexts.
Nurses should be aware and open to multiple healthy dietary patterns among diverse groups of people and how they might influence cardiovascular disease (CVD).
Further research is required to explore how to increase adherence to healthy diets for diverse population groups within their sociocultural and ecological contexts.
Historically, long-term risk management of CVD is composed of healthy dietary recommendations.
Hypertension (HTN) is common in systemic lupus erythematosus (SLE), representing a key risk factor for cardiovascular and renal disease. We described HTN treatment patterns in SLE, evaluated uncontrolled HTN according to Canadian and American guidelines and identified factors associated with uncontrolled HTN.
We performed a cross-sectional study, identifying all McGill Lupus Clinic registry patients with an annual visit between January 2017 and May 2019 who were taking HTN medications. We excluded those taking medications only for another indication (eg, Raynaud’s). We determined the frequency of uncontrolled HTN according to Canadian and American College of Cardiology/American Heart Association guidelines. Multivariate logistic regression (adjusted for age, sex and race/ethnicity) evaluated if uncontrolled HTN was more common with high body mass index (BMI), longer SLE duration, high disease activity, renal damage, multiple concomitant antihypertensives, prednisone and non-steroidal anti-inflammatory drugs.
Of 442 patients with SLE, 108 were taking medications to treat HTN, and 38 took multiple medications concurrently. Angiotensin-receptor blockers were most common, followed by calcium channel blockers, diuretics, angiotensin-converting enzyme inhibitors and beta blockers. Among the 108 patients, 39.8% (n=43) had blood pressure (BP) >140/90 mm Hg, while 66.7% (n=72) had BP >130/80 mm Hg. In multivariate analyses, uncontrolled HTN (>130/80 mm Hg) was more likely in Caucasians (OR 2.72, 95% CI 1.12 to 6.78) and patients with higher BMI (OR 1.08, 95% CI 1.00 to 1.19). Patients with renal damage had better HTN control (OR 0.39, 95% CI 0.16 to 0.97). We could not draw definitive conclusions regarding other variables.
Caucasians and patients with higher BMI had more uncontrolled HTN. The negative association with renal damage is reassuring, as controlled BP is key for renal protection.
The hepatitis C virus (HCV) is a highly infectious and deadly disease, affecting some 58 million people worldwide. Of the 1.13 million people living in the Balearic Islands, Spain, about 1350 individuals have untreated HCV. Of these, about 1120 (83%) are estimated to be people who use drugs (PWUD), who are one of the key at-risk groups for HCV infection globally. Carrying out micro-elimination approaches focused on this population is crucial to achieve the WHO goal of eliminating HCV by 2030. Thus, the primary objective of this study is to validate a model of care that simplifies the screening and linkage to HCV care pathways for PWUD on the Balearic Islands.
This intervention study will be implemented across 17 sites, in 4 different settings: addiction service centres (n=12), non-governmental organisation centres (n=3), a mobile methadone unit and a prison, with an estimated 3725 participants. Together with the healthcare staff at each centre, the intervention protocols will be adapted, focusing on four phases: recruitment and testing; linkage to care; treatment for those who test positive; and monitoring of sustained virological response 12 weeks after treatment and reinfection. The primary outcomes will be the number of tested and treated individuals and the secondary outcomes will include individuals lost at each step in the cascade of care. Descriptive analysis and multivariable logistic regression of the data will be undertaken.
The Hospital Clínic Barcelona, Spain, Ethics Committee approved this study on 18 February 2021 (HCB/2020/2018). Findings will be disseminated through peer-reviewed publications, conference presentations and social media. The results of this study could provide a model for targeting PWUD for HCV testing and treatment in the rest of Spain and in other settings, helping to achieve the WHO HCV elimination goal.
Peripartum cardiomyopathy (PPCM) remains a major contributor to maternal morbidity and mortality worldwide. The disease is associated with various complications, which occur predominantly during the early stages of the disease. Adverse outcomes include decompensated heart failure, thromboembolic complications, arrhythmias and death. We present a protocol for a systematic review and meta-analysis to summarise the available data on the complications and outcomes of women with PPCM.
A comprehensive search of all articles published between 2000 (the year in which the first universal definition of PPCM was used) and 1 June 2021 will be performed on PubMed/MEDLINE, Web of Science, Scopus and EBSCO Host, including Academic Search Premier, Africa-Wide Information, Cumulative Index to Nursing and Allied Health Literature. All cohort and cross-sectional studies, as well as control arms of randomised control trials (RCTs) reporting on the complications and outcomes of PPCM will be included in the review. Methodological quality assessment of included studies will be done by assessing the risk of bias. Heterogeneity of the data will be tested by visual inspection of the forest plot and I2 and 2 tests. This study will report the burden of complications occurring around the time of diagnosis as well as the 6-month or 12-month outcomes of women with PPCM. A summarised description in form of a pooled analysis of across multiple centres, regions and continents would help us to better understand the estimates of complications and outcomes of women with PPCM.
As this research is a systematic review of published literature, ethical approval is not required. The results will be reported according to the latest guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement, and will be submitted to a peer-reviewed journal.
Transdiagnostic cognitive–behavioural therapy (CBT) targets common psychological factors that underlie multiple disorders. While transdiagnostic interventions are a promising new approach, limited research has evaluated these treatments within the alcohol and other drug (AOD) sector for young people with comorbid mental health symptoms. This project will examine the feasibility and preliminary efficacy of FullFix—a new risk-targeted transdiagnostic CBT telehealth programme for comorbid AOD and depression/anxiety disorders in young people. Secondary aims are to identify moderators and mediators of treatment outcomes, to determine how and why treatment is effective and who is most likely to benefit.
Participants will be 130 young people (aged 16–35) accessing AOD services in Queensland, Australia, with comorbid mental health symptoms. They will be randomised to receive either the FullFix intervention plus standard AOD care or standard AOD care alone. Primary outcomes on AOD use and mental health symptoms will be reassessed at 6 weeks, 3 months, 6 months and 12 months, along with secondary outcomes of emotion regulation, social connectedness, perceived self-efficacy, coping skills and quality of life. The trial commenced on October 2018 and expected completion date is September 2021.
Ethical approval for this trial was provided by the University of Queensland (#2018001185). The results of the trial will be disseminated through publication in a peer-reviewed scientific journal, scientific presentations at conferences and distributed via a report and presentations to the partner organisation.
Perinatal depression is common and can often lead to adverse health outcomes for mother and child. Multiple pharmacological and non-pharmacological treatments have been evaluated against usual care or placebo controls in meta-analyses for preventing and treating perinatal depression compared. It is not yet established which of these candidate treatments might be the optimal approach for prevention or treatment.
A systematic review and Bayesian network meta-analyses will be conducted. Eight electronic databases shall be searched for randomised controlled trials that have evaluated the effectiveness of treatments for prevention and/or treatment of perinatal depression. Screening of articles shall be conducted by two reviewers independently. One network meta-analysis shall evaluate the effectiveness of interventions in preventing depression during the perinatal period. A second network meta-analysis shall compare the effectiveness of treatments for depression symptoms in women with perinatal depression. Bayesian 95% credible intervals shall be used to estimate the pooled mean effect size of each treatment, and surface under cumulative ranking area will be used to rank the treatments’ effectiveness.
We shall report our findings so that healthcare providers can make informed decisions on what might be the optimal approach for addressing perinatal depression to prevent cases and improve outcomes in those suffering from depression through knowledge exchange workshops, international conference presentations and journal article publications.