scholarly journals Clinically, what ought we to believe?

2018 ◽  
Vol 27 (1) ◽  
pp. 72-74 ◽  
Author(s):  
John D Little ◽  
Lorraine Davison ◽  
Robert D Little
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relevant Information ◽  
Evidence Base ◽  
Social Interventions ◽  
Hierarchy Of Evidence ◽  
Differences Of Opinion ◽  
The Status ◽  
Randomised Controlled ◽  
Clinical Strategy

Objective: To question the status of the randomised controlled trial (RCT) in the hierarchy of evidence. Conclusions: The RCT provides important and clinically relevant information, particularly in psychopharmacology. However, and as with other methodologies, RCTs too are flawed and automatic abdication to their conclusions, especially in complex social interventions, is unwise. A clinical example with conflicting and polarising views, each with their evidence base, is described alongside a suggested clinical strategy for resolving differences of opinion.

scholarly journals Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA—Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mairead Furlong ◽  
Sinead McGilloway ◽  
Christine Mulligan ◽  
Colm McGuinness ◽  
Nuala Whelan
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomised Controlled Trial ◽  
Psychosocial Functioning ◽  
Controlled Trial ◽  
Evidence Base ◽  
Parental Mental Illness ◽  
Research And Innovation ◽  
Mental Health Settings ◽  
Randomised Controlled

Abstract Background Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed method evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness. Methods The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost-effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5–18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are as follows: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention and at 6- and 12-month follow-up. Discussion Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings. Trial registration ISRCTN Registry, ISRCTN13365858. Registered 5th February 2019.

A randomised controlled trial of clinical supervision: selected findings from a novel Australian attempt to establish the evidence base for causal relationships with quality of care and patient outcomes, as an informed contribution to mental health nursing practice development

2010 ◽  
Vol 15 (2) ◽  
pp. 151-167 ◽  
Author(s):  
Edward White ◽  
Julie Winstanley
Keyword(s):  
Mental Health ◽  
Clinical Practice ◽  
Randomised Controlled Trial ◽  
Clinical Supervision ◽  
Controlled Trial ◽  
Evidence Base ◽  
Mental Health Nursing ◽  
Health Nursing ◽  
Randomised Controlled ◽  
Practice Development

This paper reports on selected findings from a novel randomised controlled trial (RCT) conducted in mental health settings in Queensland, Australia. Several national and state reports recently revealed the sub-optimal state of Australian mental health service provision which have direct implications for mental health nursing, including the privately experienced cost of working and coping in these settings. Clinical supervision (CS), a structured staff support arrangement, has shown promise as a positive contribution to the clinical practice development agenda and is now found reflected in health policy themes elsewhere in the world. However, CS is underdeveloped in Australia and the empirical evidence base for the informed implementation of CS, per se, has remained elusive. Within the overall context of a RCT design, therefore, and supplemented by other data collection methods, this large and generously funded study attempted to make an incremental contribution to better understanding this demanding substantive domain. Whilst the substantive insights and theoretical propositions reported here were derived from, and may be limited by, a sub-specialty of nursing and a single geographic location, they were earthed in the personal self-reported experience of those directly involved with a clinical practice innovation. They may resonate with counterparts beyond mental health nursing and Queensland, Australia, respectively, therefore, and may assist in both conceptualising and operationalising CS research, education, management, policy and clinical practice development decision making in the future.

Evaluating evidence for stoma care nursing: appraising a randomised controlled trial of ostomy skin barriers

2019 ◽  
Vol 17 (7) ◽  
pp. 38-42
Author(s):  
Jackie McPhail
Keyword(s):  
Randomised Controlled Trial ◽  
Adaptive Design ◽  
Controlled Trial ◽  
Skin Barrier ◽  
Evidence Base ◽  
Skin Condition ◽  
Peristomal Skin ◽  
Critical Appraisal Skills ◽  
Randomised Controlled ◽  
Stoma Care

Background: Nursing practice should be evidence-based. As such, nurses should be able to rank sources according to a hierarchy of evidence and critically appraise the validity of studies. This is especially important in stoma care, where high-quality evidence is limited. Methods: Evidence appraisal is made easier by tools, such as the Critical Appraisal Skills Programme (CASP) for Randomised Controlled Trials (RCT). CASP was used to critique the ADVOCATE Trial, ( Colwell et al 2018 ), A Randomised Controlled Trial Determining Variance in Ostomy Skin Condition and the Economic Impact (ADVOCATE Trial), which had an adaptive design and compared the cost efficiency and efficacy of a ceramide-infused two-piece skin barrier with a comparator. The participants were randomised, and the trial was double blinded. Results: The trial addressed clearly focused issues. The improvement in cost efficacy for the trial group was statistically significant (p=0.017); in addition, three of six tertiary objectives were also statistically significant. Improvement in peristomal skin health was noticeable but not statistically significant. The results can be applied to other ostomy patient populations, and all clinically important outcomes were considered. Conclusion: CASP provided a staged and structured approach to review an RCT. It can help specialist nurses to find and apply relevant study findings to practice. CASP assessment found the ADVOCATE trial to be a reliable evidence base on which stoma care nurse could adjust their practice to optimise costs and peristomal skin health.

scholarly journals An external pilot study to test the feasibility of a randomised controlled trial comparing eye muscle surgery against active monitoring for childhood intermittent exotropia [X(T)]

2015 ◽  
Vol 19 (39) ◽  
pp. 1-144 ◽  
Author(s):  
Michael Clarke ◽  
Vanessa Hogan ◽  
Deborah Buck ◽  
Jing Shen ◽  
Christine Powell ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Health Technology ◽  
Evidence Base ◽  
Intermittent Exotropia ◽  
Active Monitoring ◽  
Randomised Controlled

IntroductionThe evidence base for the treatment of strabismus (squint) is poor. Our main aim is to improve this evidence base for the treatment of a common type of childhood squint {intermittent exotropia, [X(T)]}. We conducted an external pilot study in order to inform the design and conduct of a future full randomised controlled trial (RCT).MethodsChildren of between 6 months and 16 years with a recent diagnosis of X(T) were eligible for recruitment. Participants were recruited from secondary care at the ophthalmology departments at four UK NHS foundation trusts. Participants were randomised to either active monitoring or surgery. This report describes the findings of the Pilot Rehearsal Trial and Qualitative Study, and assesses the success against the objectives proposed.Recruitment and retentionThe experience gained during the Pilot Rehearsal Trial demonstrates the ability to recruit and retain sites that are willing to randomise children to both trial arms, and for parents to agree to randomisation of their children to such a study. One child declined the group allocation. A total of 231 children were screened (expected 240), of whom 138 (60%) were eligible (expected 228: 95%) and 49 (35% of eligible) children were recruited (expected 144: 63% of eligible). Strategies that improved recruitment over the course of the trial are discussed, together with the reasons why fewer children were eligible for recruitment than initially anticipated. Attrition was low. Outcome data were obtained for 47 of 49 randomised children.Trial processes and data collectionThe Trial Management processes proved effective. There were high levels of completion on all of the data collection forms. However, the feedback from the treatment orthoptists revealed that some modifications should be made to the length and frequency of the health service assessment and travel assessment questionnaires, thus reducing the burden on participants in the main trial. Modifications to the wording of the questions also need to be made.Monitoring of biasChildren who recruited to the trial were older and had more severe strabismus than those children eligible but declining participation. Strategies to account for this in a full trial are proposed.Reasons for participation or declining studyThese were identified using qualitative interviews. The principal reasons for declining entry into the study were strong preferences for and against surgical treatment.HarmsThere were no serious unexpected adverse events. Two children had overcorrection of their X(T) with reduction in binocular vision following surgery, which is in line with previous studies. No children in the active monitoring arm developed a constant strabismus although two showed some reduction in control.ConclusionsThe SamExo study has demonstrated that it is possible to recruit and retain participants to a randomised trial of surgery compared with active monitoring for X(T). For longer-term full RCTs, in order to maximise the generalisability of future studies, consideration needs to be given to planning more time and clinic appointments to assess eligibility and to allow consideration of participation; the greater use of research nurses for recruitment; and accommodating the strong preferences of some parents both for and against surgical intervention.Trial registrationCurrent Controlled Trials ISRCTN44114892.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 39. See the NIHR Journals Library website for further project information.

scholarly journals Family Talk Versus Usual Services In Improving Child And Family Psychosocial Functioning In Families With Parental Mental Illness (PRIMERA - Promoting Research And Innovation In Mental Health Services For Families And Children): Study Protocol For A Randomised Controlled Trial

2021 ◽  
Author(s):  
Mairead Furlong ◽  
Sinead McGilloway ◽  
Christine Mulligan ◽  
Colm McGuinness ◽  
Nuala Whelan
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomised Controlled Trial ◽  
Psychosocial Functioning ◽  
Controlled Trial ◽  
Evidence Base ◽  
Service Utilisation ◽  
Parental Mental Illness ◽  
Mental Health Settings ◽  
Randomised Controlled

Abstract Background: Parental mental illness is common and can lead to dependent children incurring a high risk of developing mental disorders, physical illness, and impaired educational and occupational outcomes. Family Talk is one of the better known interventions designed to prevent the intergenerational transmission of mental illness. However, its evidence base is small, with few robust independent randomised controlled trials, and no associated process or cost evaluations. The PRIMERA (Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children) research programme involves a mixed methods evaluation of Family Talk which is being delivered in mental health settings in Ireland to improve child and family psychosocial functioning in families with parental mental illness.Methods: The study comprises a multi-centre, randomised controlled trial (RCT), with nested economic and process evaluations, to assess the clinical and cost effectiveness and implementation mechanisms of Family Talk compared to usual services. The study is being conducted in 15 adult and child mental health settings in Ireland. Families with a parent with mental illness, and children aged 5-18 years (n = 144 families) will be randomised to either the 7-session Family Talk programme (n = 96) or to standard care (n = 48) using a 2:1 allocation ratio. The primary outcomes are child psychosocial functioning and family functioning. Secondary outcomes are: understanding and experience of parental mental illness, parental mental health, child and parental resilience, partner wellbeing and service utilisation. Blind assessments will take place at pre-intervention, and at 6-, 12-month follow up.Discussion: Given the prevalence and burden of intergenerational mental illness, it is imperative that prevention through evidence-based interventions becomes a public health priority. The current study will provide an important contribution to the international evidence base for Family Talk whilst also helping to identify key implementation lessons in the scaling up of Family Talk, and other similar interventions, within routine mental health settings.Trial registration: ISRCTN Registry, ISRCTN13365858. Registered 5th February 2019. http://www.isrctn.com/ISRCTN13365858

Filmed versus Live Social Contact Interventions to Reduce Stigma: A Randomised Controlled Trial

2012 ◽  
Author(s):  
Sarah Clement ◽  
Adrienne van Nieuwenhuizen ◽  
Aliya Kassam ◽  
Ian Norman ◽  
Clare Flach ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Social Contact ◽  
Randomised Controlled
Sign in / Sign up

Export Citation Format

Share Document