519 results
Search Results
2. The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence.
- Author
-
Russell, Jill, Berney, Lee, Stansfeld, Stephen, Lanz, Doris, Kerry, Sally, Chandola, Tarani, and Bhui, Kamaldeep
- Subjects
QUALITATIVE research ,RANDOMIZED controlled trials ,JOB stress ,EXECUTIVES ,MIXED methods research ,EMPLOYEE well-being ,SICK leave ,PERFORMANCE standards ,PREVENTION of psychological stress ,COMPARATIVE studies ,HEALTH promotion ,LEARNING ,RESEARCH methodology ,MEDICAL cooperation ,MENTAL health ,OCCUPATIONAL health services ,RESEARCH ,PILOT projects ,EVALUATION research - Abstract
Background: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work.Results: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place.Conclusions: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research.Trial Registration: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
3. Reversal Of Arterial Disease by modulating Magnesium and Phosphate (ROADMAP-study): rationale and design of a randomized controlled trial assessing the effects of magnesium citrate supplementation and phosphate-binding therapy on arterial stiffness in moderate chronic kidney disease.
- Author
-
Vermeulen, Emma A., Eelderink, Coby, Hoekstra, Tiny, van Ballegooijen, Adriana J., Raijmakers, Pieter, Beulens, Joline W., de Borst, Martin H., and Vervloet, Marc G.
- Subjects
CHRONIC kidney failure complications ,CHRONIC kidney failure ,RESEARCH ,CARDIOVASCULAR system physiology ,INFLAMMATION ,RESEARCH methodology ,ARTHRITIS Impact Measurement Scales ,CITRATES ,EVALUATION research ,ORGANOMETALLIC compounds ,DIETARY supplements ,COMPARATIVE studies ,RANDOMIZED controlled trials ,CALCINOSIS ,MAGNESIUM ,RESEARCH funding ,VASCULAR diseases ,PHOSPHATES ,DISEASE complications - Abstract
Background: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD.Methods: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m2 without phosphate binder therapy will be recruited. During the 24 weeks intervention, participants will be randomized to one of four intervention groups to receive either magnesium citrate (350 mg elemental magnesium/day) or placebo, with or without the addition of the phosphate binder sucroferric oxyhydroxide (1000 mg/day). Primary outcome of the study is the change of arterial stiffness measured by the carotid-femoral pulse wave velocity over 24 weeks. Secondary outcomes include markers of calcification and inflammation, among others calcification propensity (T50) and high-sensitivity C-reactive protein. As explorative endpoints, repeated 18F-FDG and 18F-NaF PET-scans will be performed in a subset of participants (n = 40). Measurements of primary and secondary endpoints are performed at baseline, 12 and 24 weeks.Discussion: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T50 changes. The results of this combined intervention may contribute to future early interventions for CKD patients to reduce the risk of CVD and mortality.Trial Registration: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019). [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
4. Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse.
- Author
-
Dwyer, Lucy, Bugge, Carol, Hagen, Suzanne, Goodman, Kirsteen, Agur, Wael, Dembinsky, Melanie, Graham, Margaret, Guerrero, Karen, Hemming, Christine, Khunda, Aethele, McClurg, Doreen, Melone, Lynn, Thakar, Ranee, Kearney, Rohna, and TOPSY Team
- Subjects
PELVIC organ prolapse treatment ,RESEARCH ,RESEARCH methodology ,EVALUATION research ,PESSARIES ,VAGINA ,COMPARATIVE studies ,QUALITY of life ,RESEARCH funding ,PELVIC organ prolapse - Abstract
Background: Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alternative to surgery for the management of POP. However, the need for regular follow-up can be burdensome for women and requires significant healthcare resources. The TOPSY study is a randomised controlled trial which aims to determine the clinical and cost-effectiveness of self-management of vaginal pessaries. This paper describes the theoretical and practical development of the self-management intervention.Methods: The intervention was developed using the MRC complex intervention framework, normalisation process theory (NPT) and self-management theory. The intervention aims to boost perceived self-efficacy in accordance with Bandura's social cognitive theory and is guided by the tasks and skills Lorig and Hollman describe as necessary to self-manage a health condition.Results: The TOPSY intervention was designed to support women to undertake the medical management, role management and emotional management of their pessary. The six self-management skills described by Lorig and Hollman: problem-solving, decision-making, resource utilisation, formation of a patient-provider partnership role, action planning and self-tailoring, are discussed in detail, including how women were supported to achieve each task within the context of pessary self-management. The TOPSY intervention includes a self-management support session with a pessary practitioner trained in intervention delivery, a follow-up phone call 2 weeks later and ongoing telephone or face-to-face support as required by the woman initiated by contacting a member of the research team.Conclusions: The TOPSY study intervention was developed utilising the findings from a prior service development project, intervention development and self-efficacy theory, relevant literature, clinician experience and feedback from pessary using women and members of the public. In 2022, the findings of the TOPSY study will provide further evidence to inform this important aspect of pessary management.Trial Registration: ISRCTN Registry ISRCTN62510577 . Registered on June 10, 2017. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
5. Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus.
- Author
-
Backhouse, Michael R., Parker, Daniel J., Morison, Stewart C., Anderson, Jenny, Cockayne, Sarah, and Adamson, Joy A.
- Subjects
FLATFOOT ,RANDOMIZED controlled trials ,ARM exercises ,FOOT orthoses ,MEDICAL personnel ,CHILD care ,STRETCH (Physiology) ,HEALTH education ,RESEARCH ,RESEARCH methodology ,EVALUATION research ,COMPARATIVE studies ,RESEARCH funding ,EXERCISE therapy ,ORTHOPEDIC apparatus - Abstract
Background: Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions.Methods: We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice.Results: In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice.Conclusions: Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
6. Barriers to the conduct of randomised clinical trials within all disease areas.
- Author
-
Djurisic, Snezana, Rath, Ana, Gaber, Sabrina, Garattini, Silvio, Bertele, Vittorio, Ngwabyt, Sandra-Nadia, Hivert, Virginie, Neugebauer, Edmund A. M., Laville, Martine, Hiesmayr, Michael, Demotes-Mainard, Jacques, Kubiak, Christine, Jakobsen, Janus C., and Gluud, Christian
- Subjects
RANDOMIZED controlled trials ,CLINICAL medicine research ,MEDICAL research ,RESEARCH methodology ,INTERNATIONAL cooperation ,RESEARCH & economics ,RESEARCH laws ,CLINICAL trial laws ,SYMPTOMS ,ATTITUDE (Psychology) ,CLINICAL trials ,COOPERATIVENESS ,DIET therapy ,ENDOWMENT of research ,EXPERIMENTAL design ,HEALTH attitudes ,MEDICAL cooperation ,MEDICAL ethics ,MEDICAL personnel ,PRIVACY ,RESEARCH ,SYSTEMATIC reviews ,EVIDENCE-based medicine ,EQUIPMENT & supplies ,RESEARCH personnel ,ECONOMICS ,THERAPEUTICS ,MEDICAL laws - Abstract
Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.Methods: We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.Results: The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.Conclusions: The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
7. MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial.
- Author
-
Andreasson, Kate, Krogh, Jesper, Bech, Per, Frandsen, Hanne, Buus, Niels, Stanley, Barbara, Kerkhof, Ad, Nordentoft, Merete, and Erlangsen, Annette
- Subjects
SUICIDE prevention ,SUICIDAL ideation ,CLINICAL trials ,SUPPORTIVE psychotherapy ,SUICIDAL behavior ,COMPARATIVE studies ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PSYCHOTHERAPY ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,RANDOMIZED controlled trials ,RELATIVE medical risk ,MOBILE apps - Abstract
Background: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper.Methods/design: The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion.Discussion: A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning.Trial Registration: ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
8. The use of qualitative methods to inform Delphi surveys in core outcome set development.
- Author
-
Keeley, T., Williamson, P., Callery, P., Jones, L. L., Mathers, J., Jones, J., Young, B., and Calvert, M.
- Subjects
QUALITATIVE research ,CLINICAL trials ,RHEUMATOLOGY ,NEUROLOGY ,CARDIOPULMONARY system ,PHARMACEUTICAL research ,BIOLOGICAL assay ,COMPARATIVE studies ,CONSENSUS (Social sciences) ,DELPHI method ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,EVALUATION research ,TREATMENT effectiveness - Abstract
Background: Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required.Results: Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified.Conclusions: Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
9. Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT).
- Author
-
Juul, Sophie, Simonsen, Sebastian, Poulsen, Stig, Lunn, Susanne, Sørensen, Per, Bateman, Anthony, and Jakobsen, Janus Christian
- Subjects
BORDERLINE personality disorder ,CLINICAL trials ,SOCIAL adjustment ,QUALITY of life ,GROUP psychotherapy ,OUTPATIENTS ,TREATMENT of borderline personality disorder ,RESEARCH ,RESEARCH methodology ,MEDICAL cooperation ,EVALUATION research ,TREATMENT effectiveness ,COMPARATIVE studies ,RANDOMIZED controlled trials ,RESEARCH funding ,PSYCHOTHERAPY - Abstract
Background: Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown.Methods/design: The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36-mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan.Discussion: We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias.Trial Registration: ClinicalTrials.gov NCT03677037 . Registered on 19 September 2018. [ABSTRACT FROM AUTHOR]- Published
- 2021
- Full Text
- View/download PDF
10. Strategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries
- Published
- 2023
- Full Text
- View/download PDF
11. Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach.
- Author
-
van der Graaf, Rieke, van der Zande, Indira S. E., den Ruijter, Hester M., Oudijk, Martijn A., van Delden, Johannes J. M., Oude Rengerink, Katrien, and Groenwold, Rolf H. H.
- Subjects
PREGNANCY complications ,MATERNAL health ,PREGNANCY & psychology ,FETAL development ,PRENATAL care - Abstract
Background: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach renders research with pregnant women fair. This paper analyzes and evaluates when research with pregnant women can be considered as fair and what constitutes scientific reasons for exclusion.Methods: Conceptual ethical and methodological analysis and evaluation of fair inclusion.Results: Fair inclusion of pregnant women means (1) that pregnant women who are eligible are not excluded solely for being pregnant and (2) that the research interests of pregnant women are prioritized, meaning that they ought to receive substantially more attention. Fairness does not imply that pregnant women should be included in virtually every research project, as including only a few pregnant women in a population consisting only of women will not help to determine the effectiveness and safety of a treatment in pregnant women. Separate trials in pregnant women may be preferable once we assume, or know, that effects of interventions in pregnant women differ from the effects in other subpopulations, or when we assume, or know, that there are no differences. In the latter case, it may be preferable to conduct post-marketing studies or establish registries. If there is no conclusive evidence indicating either differences or equivalence of effects between pregnant and non-pregnant women, yet it seems unlikely that major differences or exact equivalence exist, the inclusion of pregnant women should be sufficient. Depending on the research question, this boils down to representativeness in terms of the proportion of pregnant and non-pregnant women, or to oversampling pregnant women.Conclusions: Fair inclusion of pregnant women in research implies that separate trials in pregnant women should be promoted. Inclusion of pregnant women has to be realized at the earliest phases of the research process. In addition to researchers and research ethics committees, scientific advisory councils, funders, drug regulatory agencies, pharmaceutical companies, journal editors and others have a joint responsibility to further develop the evidence base for drug use in pregnant women. [ABSTRACT FROM AUTHOR]- Published
- 2018
- Full Text
- View/download PDF
12. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.
- Author
-
Ballou, Sarah, Kaptchuk, Ted J., Hirsch, William, Nee, Judy, Iturrino, Johanna, Hall, Kathryn T., Kelley, John M., Vivian Cheng, Kirsch, Irving, Jacobson, Eric, Conboy, Lisa, Lembo, Anthony, Davis, Roger B., and Cheng, Vivian
- Subjects
PLACEBOS ,TRAINING manuals ,RANDOMIZED controlled trials ,IRRITABLE colon ,PEOPLE with visual disabilities ,IRRITABLE colon diagnosis ,COMPARATIVE studies ,EXPERIMENTAL design ,GASTROINTESTINAL agents ,INTERVIEWING ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,RESEARCH ,RESEARCH funding ,TIME ,EVALUATION research ,VEGETABLE oils ,TREATMENT effectiveness ,BLIND experiment ,THERAPEUTICS - Abstract
Background: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.Methods and Design: This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.Discussion: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.Trial Registration: ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
13. Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies.
- Author
-
Crane, Melissa M., Gokee LaRose, Jessica, Espeland, Mark A., Wing, Rena R., Tate, Deborah F., and LaRose, Jessica Gokee
- Subjects
WEIGHT gain prevention ,PATIENT selection ,RANDOMIZED controlled trials ,OBESITY treatment ,HUMAN research subjects ,PREVENTION of obesity ,COMPARATIVE studies ,EXPERIMENTAL design ,HUMAN reproduction ,RESEARCH methodology ,MEDICAL cooperation ,POSTAL service ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,TELEPHONES ,WEIGHT gain ,EVALUATION research - Abstract
Background: Recruiting young adults (ages 18-35 years) into weight gain prevention intervention studies is challenging and men are particularly difficult to reach. This paper describes two studies designed to improve recruitment for a randomized trial of weight gain prevention interventions. Study 1 used a quasi-experimental design to test the effect of two types of direct mailings on their overall reach. Study 2 used a randomized design to test the effect of using targeted messages to increase recruitment of men into the trial.Methods: For Study 1, 60,000 male and female young-adult households were randomly assigned to receive either a recruitment brochure or postcard. Visits to recruitment websites during each mailing period were used to assess response to each mailing. Study 2 focused on postcard recruitment only. These households received either a targeted or generic recruitment postcard, where targeted postcards included the word "Men" in the headline text. Response rates to each type of card were categorized based on participant report of mailing received.Results: The reach of the postcards and brochures were similar (421 and 386 website visits, respectively; P = 0.22). Individuals who received the brochure were more likely to initiate the online screener than those who received a postcard (P = 0.01). In Study 2, of those who completed the telephone screening, 60.9 % of men (n = 23) had received the targeted postcard as compared to the generic postcard (39.1 %, P = 0.30). The reverse was true for women (n = 62, 38.7 vs. 61.3 %, P = 0.08).Conclusions: These studies suggest there was little difference in the reach of postcards versus brochures. However, recipients of brochures were more likely to continue to the next stage of study participation. As expected, men's response to the weight gain prevention messages was lower than women's response; but using targeted messages appears to have modestly increased the proportion of male respondents. These studies add to the limited experimental literature on recruitment messaging and provide further indication for using targeted messages to reach underrepresented populations while providing initial evidence on the effect of mailing type on message reach.Trial Registration: The Study of Novel Approaches to Weight Gain Prevention was registered with ClinicalTrials.gov (identifier: NCT01183689 ) on 13 August 2010. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
14. Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial
- Author
-
Mattock, Holly C., Ryan, Rachael, O’Farrelly, Christine, Babalis, Daphne, and Ramchandani, Paul G.
- Published
- 2020
- Full Text
- View/download PDF
15. Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).
- Author
-
Shepherd, Victoria, Thomas-Jones, Emma, Ridd, Matthew J., Hood, Kerenza, Addison, Katy, and Francis, Nick A.
- Subjects
RANDOMIZED controlled trials ,PRIMARY care ,ACQUISITION of data ,GENERAL practitioners ,QUESTIONNAIRES ,ANTIBIOTICS ,COMMUNICABLE disease diagnosis ,SKIN disease diagnosis ,AGE distribution ,ATTITUDE (Psychology) ,COMMUNICABLE diseases ,COMPARATIVE studies ,ECZEMA ,HEALTH attitudes ,HOME care services ,INFORMED consent (Medical law) ,INTERVIEWING ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL personnel ,NURSES ,PSYCHOLOGY of nurses ,PSYCHOLOGY of parents ,PRIMARY health care ,RESEARCH ,RESEARCH funding ,SKIN diseases ,SAMPLE size (Statistics) ,ELIGIBILITY (Social aspects) ,OCCUPATIONAL roles ,EVALUATION research ,TREATMENT effectiveness ,PATIENT selection ,PSYCHOLOGY of human research subjects ,DIAGNOSIS ,PSYCHOLOGY - Abstract
Background: Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely.Methods: Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes.Results: Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study.Conclusions: GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care through complex studies is to be realised, new approaches to recruitment into primary care trials need to be developed and evaluated.Trial Registration: International Standard Randomised Controlled Trials, ISRCTN96705420 . Registered on 27 June 2012. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
16. Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).
- Author
-
González-González, Ana Isabel, Orrego, Carola, Perestelo-Perez, Lilisbeth, Bermejo-Caja, Carlos Jesús, Mora, Nuria, Koatz, Débora, Ballester, Marta, del Pino, Tasmania, Pérez-Ramos, Jeannet, Toledo-Chavarri, Ana, Robles, Noemí, Pérez-Rivas, Francisco Javier, Ramírez-Puerta, Ana Belén, Canellas-Criado, Yolanda, del Rey-Granado, Yolanda, Muñoz-Balsa, Marcos José, Becerril-Rojas, Beatriz, Rodríguez-Morales, David, Sánchez-Perruca, Luis, and Vázquez, José Ramón
- Subjects
RANDOMIZED controlled trials ,PRIMARY care ,OUTPATIENT medical care ,PRIMARY health care ,FAMILY medicine ,CHRONIC diseases & psychology ,CHRONIC disease treatment ,ATTITUDE (Psychology) ,COMPARATIVE studies ,EXPERIMENTAL design ,HEALTH attitudes ,HEALTH care teams ,INTERNET ,LEARNING ,MATHEMATICS ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL personnel ,NURSE-patient relationships ,PSYCHOLOGY of nurses ,PHYSICIAN-patient relations ,GENERAL practitioners ,QUESTIONNAIRES ,RESEARCH ,STATISTICAL sampling ,HEALTH self-care ,TIME ,PATIENT participation ,GROUP process ,EVALUATION research ,PSYCHOLOGY - Abstract
Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
17. Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled ‘study within a trial’ (SWAT) of a multimedia information resource
- Author
-
Jolly, Kate, Sidhu, Manbinder, on behalf of the PSM COPD Group, Bower, Peter, Madurasinghe, Vichithranie, and MRC START Group
- Published
- 2019
- Full Text
- View/download PDF
18. TIGA-CUB - manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5-11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial.
- Author
-
Edginton, Elizabeth, Walwyn, Rebecca, Burton, Kayleigh, Cicero, Robert, Graham, Liz, Reed, Sadie, Tubeuf, Sandy, Twiddy, Maureen, Wright-Hughes, Alex, Ellis, Lynda, Evans, Dot, Hughes, Tom, Midgley, Nick, Wallis, Paul, and Cottrell, David
- Subjects
PSYCHOANALYSIS ,CHILD psychotherapy ,PARENTING ,EVIDENCE-based medicine ,CHILD psychology ,HEALTH outcome assessment ,AGE distribution ,PSYCHOLOGY of caregivers ,CHILD behavior ,COMPARATIVE studies ,CHILD psychopathology ,COST effectiveness ,EXPERIMENTAL design ,INTERGENERATIONAL relations ,RESEARCH methodology ,MEDICAL care costs ,MEDICAL cooperation ,RESEARCH protocols ,MENTAL health ,PARENT-child relationships ,PSYCHOANALYTIC interpretation ,PSYCHOTHERAPY ,QUALITY of life ,RESEARCH ,TIME ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,ECONOMICS ,DIAGNOSIS ,PSYCHOLOGY - Abstract
Background: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial.Methods and Design: TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and (5) statistical, health economics, process evaluation, and qualitative outcomes.Discussion: TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP.Trial Registration: Current Controlled Trials, ID: ISRCTN86725795 . Registered on 31 May 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
19. Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial.
- Author
-
Gelli, Aulo, Becquey, Elodie, Ganaba, Rasmane, Headey, Derek, Hidrobo, Melissa, Huybregts, Lieven, Verhoef, Hans, Kenfack, Romain, Zongouri, Sita, and Guedenet, Hannah
- Subjects
DIET ,PHYSIOLOGY ,WOMEN'S empowerment ,COMMUNICATION ,NUTRITIONAL status ,CAREGIVERS ,AGRICULTURE ,ANIMAL experimentation ,BIOTIC communities ,CHILD development ,CHILD nutrition ,COMPARATIVE studies ,EXPERIMENTAL design ,HYGIENE ,RESEARCH methodology ,MEDICAL cooperation ,MOTHERS ,NUTRITIONAL assessment ,NUTRITIONAL requirements ,POULTRY ,NUTRITION disorders in children ,POWER (Social sciences) ,RESEARCH ,TIME ,WOMEN'S health ,PSYCHOLOGY of women ,EVALUATION research ,RANDOMIZED controlled trials ,NUTRITIONAL value ,PREVENTION ,DIAGNOSIS - Abstract
Background: The SELEVER study is designed to evaluate the impact of an integrated agriculture-nutrition package of interventions (including poultry value chain development, women's empowerment activities, and a behavior change communications strategy to promote improved diets and feeding, care, and hygiene practices) on the diets, health, and nutritional status of women and children in Burkina Faso. This paper presents the rationale and study design.Methods: The impact evaluation involves a cluster randomized controlled trial design that will be implemented in 120 rural communities/villages within 60 communes supported by SELEVER in the Boucle de Mouhoun, Centre-Ouest, and Haut-Bassins regions of Burkina Faso. Communities will be randomly assigned to one of three treatment arms, including: (1) SELEVER intervention group; (2) SELEVER with an intensive WASH component; and (3) control group without intervention. Primary outcomes include the mean probability of adequacy of diets for women and children (aged 2-4 years at baseline), infant and young child feeding practices of caregivers of children aged 0-2 years, and household poultry production and sales. Intermediate outcomes along the agriculture and nutrition pathways will also be measured, including child nutrition status and development. The evaluation will follow a mixed-methods approach, including a panel of child-, household-, community-, and market-level surveys, and data collection points during post-harvest and lean seasons, as well as one year after implementation completion to examine sustainability.Discussion: To our knowledge, this study is the first to rigorously examine from a food systems perspective, the simultaneous impact of scaling-up nutrition-specific and nutrition-sensitive interventions through a livestock value-chain and community-intervention platform, across nutrition, health, and agriculture domains. The findings of this evaluation will provide evidence to support the design of market-based nutrition-sensitive interventions.Trial Registration: ISRCTN registry, ISRCTN16686478 . Registered on 2 December 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
20. Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial.
- Author
-
Dam, Alieske E. H., de Vugt, Marjolein E., van Boxtel, Martin P. J., and Verhey, Frans R. J.
- Subjects
SOCIAL support ,CAREGIVERS ,DEMENTIA ,RANDOMIZED controlled trials ,SOCIAL isolation ,SOCIAL media ,DIAGNOSIS of dementia ,TREATMENT of dementia ,ADAPTABILITY (Personality) ,PSYCHOLOGY of caregivers ,COMPARATIVE studies ,ECONOMIC aspects of diseases ,EXPERIMENTAL design ,INTERNET ,INTERVIEWING ,LONELINESS ,RESEARCH methodology ,MEDICAL cooperation ,QUALITY of life ,RESEARCH ,SELF-evaluation ,TIME ,EVALUATION research ,BURDEN of care - Abstract
Background: Caregivers of people with dementia (PwD) face burden, feelings of loneliness, and social isolation. Previous studies have shown promising effects of online e-health interventions. Using social media may facilitate support for dementia caregiver networks. In an iterative step-wise approach, a social support tool entitled "Inlife" was developed. This paper describes the design of a study evaluating the effects of Inlife and its process characteristics.Methods: A mixed-method, randomised controlled trial with 122 caregivers of PwD will be conducted. Participants will be assigned to either the Inlife social support intervention or a waiting-list control group. After 16 weeks, the control group will obtain access to the Inlife environment. Data will be collected at baseline (T0) and at 8-week (T1), 16-week (T2) and 42-week follow up (T3). The 16-week follow-up assessment (T2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. The primary outcomes include feelings of caregiver competence and perceived social support. The secondary outcomes include received support, feelings of loneliness, psychological complaints (e.g., anxiety, stress), and quality of life. A process evaluation, including semi-structured interviews, will be conducted to examine the internal and external validity of the intervention.Discussion: Using a mixed-method design, our study will provide valuable insights into the usability, effectiveness, and factors related to implementation of the Inlife intervention. Our study results will indicate whether Inlife could be a valuable social support resource in future routine dementia care.Trial Registration: Dutch trial register, NTR6131 . Registered on 20 October 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
21. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.
- Author
-
Van Dorn, Richard A., Desmarais, Sarah L., Rade, Candalyn B., Burris, Elizabeth N., Cuddeback, Gary S., Johnson, Kiersten L., Tueller, Stephen J., Comfort, Megan L., and Mueser, Kim T.
- Subjects
SUBSTANCE-induced disorders ,PATHOLOGICAL psychology ,RESEARCH protocols ,CLINICAL trials ,HUMAN life cycle ,PSYCHIATRIC diagnosis ,MENTAL illness treatment ,PSYCHIATRIC epidemiology ,SUBSTANCE abuse & psychology ,SUBSTANCE abuse treatment ,SUBSTANCE abuse diagnosis ,MENTAL illness ,COMMUNITY mental health services ,COMMUNITY mental health service administration ,COMPARATIVE studies ,CONTINUUM of care ,EXPERIMENTAL design ,GROUP psychotherapy ,HEALTH care teams ,HEALTH services accessibility ,INTEGRATED health care delivery ,INTERPROFESSIONAL relations ,RESEARCH methodology ,MEDICAL cooperation ,PRISON psychology ,RESEARCH ,RESEARCH funding ,SUBSTANCE abuse ,TIME ,COMORBIDITY ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,MOTIVATIONAL interviewing ,TREATMENT effectiveness - Abstract
Background: Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum.Methods/design: Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated.Discussion: Findings have the potential to improve both jail- and community-based treatment services for adults with CODs as well as inform methods for conducting rigorous pilot implementation and evaluation research in correctional settings and as inmates re-enter the community. Findings will contribute to a growing area of work focused on interrupting the cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among adults with CODs.Trial Registration: ClinicalTrials.gov, NCT02214667 . Registered on 10 August 2014. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
22. COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.
- Author
-
Robinson, Emily J., Goldstein, Laura H., McCrone, Paul, Perdue, Iain, Chalder, Trudie, Mellers, John D. C., Richardson, Mark P., Murray, Joanna, Reuber, Markus, Medford, Nick, Stone, Jon, Carson, Alan, and Landau, Sabine
- Subjects
- *
SEIZURES (Medicine) , *COGNITIVE therapy , *PSYCHOLOGICAL well-being , *MEDICAL care standards , *HEALTH outcome assessment , *RANDOMIZED controlled trials , *THERAPEUTICS , *SPASM treatment , *COMPARATIVE studies , *COST effectiveness , *EXPERIMENTAL design , *RESEARCH methodology , *MEDICAL care costs , *MEDICAL cooperation , *MEDICAL protocols , *RESEARCH , *SPASMS , *STATISTICS , *TIME , *DATA analysis , *EVALUATION research , *TREATMENT effectiveness , *STATISTICAL models , *PSYCHOLOGY - Abstract
Background: Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee.Methods: The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS.Discussion: The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials.Trial Registration: ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014). [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
23. HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients.
- Author
-
Heim, Noor, van Stel, Henk F., Ettema, Roelof G., van der Mast, Roos C., Inouye, Sharon K., and Schuurmans, Marieke J.
- Subjects
DELIRIUM in old age ,CLUSTER randomized controlled trials ,OLDER patients ,HOSPITAL care of older people ,ELECTRONIC health records ,PREVENTION ,DIAGNOSIS of delirium ,AGE distribution ,COMBINED modality therapy ,COMPARATIVE studies ,DELIRIUM ,EXPERIMENTAL design ,HEALTH care teams ,INFORMED consent (Medical law) ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL protocols ,QUALITY of life ,RESEARCH ,TIME ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,RESEARCH bias ,PATIENT selection ,PSYCHOLOGICAL factors - Abstract
Background: A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on the experiences and lessons learned from the conduct of a cluster randomized, stepped wedge trial evaluating the effect of the Hospital Elder Life Program (HELP) in a Dutch hospital setting to prevent older patients from developing delirium.Methods: We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started, as compared to what we actually realized in the different phases of our study. Lessons learned on the design, the timeline, the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges.Results: The start of the trial was delayed which caused subsequent time schedule problems. The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias. Most units experienced major difficulties in including patients, leading to excluding two of the eight units from participation. This resulted in failing to include a similar number of patients in the control condition versus the intervention condition. Data on outcomes routinely collected in the electronic patient records were not accessible during the study, and appeared to be often missing during analyses.Conclusions: The stepped wedge, cluster randomized trial poses specific risks in the design and execution of research in real-life settings of which researchers should be aware to prevent negative consequences impacting the validity of their results. Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial. Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review, flexibility, a spacious time schedule, the availability of substantial capacity in the research team and early checks on the data availability and quality.Trial Registration: Netherlands Trial Register, identifier: NTR3842 . Registered on 24 January 2013. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
24. Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial.
- Author
-
Broberg, Lotte, Backhausen, Mette, Damm, Peter, Bech, Per, Tabor, Ann, and Hegaard, Hanne Kristine
- Subjects
PREGNANT women ,MOTHER-child relationship ,PRENATAL care ,PREMATURE labor ,POSTPARTUM depression ,HEALTH ,MENTAL health ,ANXIETY diagnosis ,ANXIETY treatment ,DIAGNOSIS of mental depression ,MENTAL depression ,THERAPEUTICS ,ANXIETY ,POSTPARTUM depression diagnosis ,ACADEMIC medical centers ,AFFECT (Psychology) ,COMPARATIVE studies ,FUNCTIONAL assessment ,EXERCISE therapy ,RESEARCH methodology ,EVALUATION of medical care ,MEDICAL cooperation ,RESEARCH protocols ,PREGNANCY ,PSYCHOLOGICAL tests ,QUALITY of life ,QUESTIONNAIRES ,RESEARCH ,RISK assessment ,SLEEP ,TIME ,SAMPLE size (Statistics) ,EVALUATION research ,EDINBURGH Postnatal Depression Scale ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,STATE-Trait Anxiety Inventory ,PSYCHOLOGICAL factors ,PREVENTION - Abstract
Background: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/design: The RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016-2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17-22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.Discussion: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial Registration: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
25. Equipoise across the patient population: optimising recruitment to a randomised controlled trial.
- Author
-
Whybrow, Paul, Pickard, Robert, Hrisos, Susan, and Rapley, Tim
- Subjects
DISEASE relapse ,MEDICAL care ,UROLOGISTS ,MEDICAL referrals ,RANDOMIZED controlled trials ,COMPARATIVE studies ,UROLOGICAL surgery ,INTERVIEWING ,RESEARCH methodology ,MEDICAL cooperation ,MEN ,PATIENT satisfaction ,RESEARCH ,RESEARCH ethics ,QUALITATIVE research ,SAMPLE size (Statistics) ,URETHRA stricture ,EVALUATION research ,SEVERITY of illness index ,PATIENT selection ,PSYCHOLOGY of human research subjects ,PSYCHOLOGY ,DIAGNOSIS - Abstract
Background: This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men.Methods: Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability.Results: Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians' relative exposure to different proportions of the patient population.Conclusion: Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached.Trial Registration: ISRCTN Registry, ISRCTN98009168 . Registered on 29 November 2012. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
26. The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial.
- Author
-
Markle-Reid, Maureen, Ploeg, Jenny, Fraser, Kimberly D., Fisher, Kathryn Ann, Akhtar-Danesh, Noori, Bartholomew, Amy, Gafni, Amiram, Gruneir, Andrea, Hirst, Sandra P., Kaasalainen, Sharon, Stradiotto, Caralyn Kelly, Miklavcic, John, Rojas-Fernandez, Carlos, Sadowski, Cheryl A., Thabane, Lehana, Triscott, Jean A. C., and Upshur, Ross
- Subjects
PEOPLE with diabetes ,COMMUNITY involvement ,CAREGIVERS ,HEALTH care intervention (Social services) ,HUMAN services ,PSYCHOLOGICAL aspects of aging ,TYPE 2 diabetes diagnosis ,TYPE 2 diabetes & psychology ,COMMUNITY health services ,AGE distribution ,BEHAVIOR ,PSYCHOLOGY of caregivers ,COMPARATIVE studies ,COST effectiveness ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL care costs ,MEDICAL cooperation ,RESEARCH protocols ,TYPE 2 diabetes ,QUALITY of life ,QUESTIONNAIRES ,RESEARCH ,RESEARCH funding ,TIME ,HEALTH self-care ,SOCIAL support ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,ECONOMICS ,PSYCHOLOGY - Abstract
Background: Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges. This paper presents a protocol for a two-armed, multisite, pragmatic, mixed-methods RCT examining the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP), a new 6-month interprofessional, nurse-led program to promote self-management in older adults (aged 65 years or older) with T2DM and MCC and support their caregivers (including family and friends).Methods/design: The study will enroll 160 participants in two Canadian provinces, Ontario and Alberta. Participants will be randomly assigned to the control (usual care) or program study arm. The program will be delivered by registered nurses (RNs) and registered dietitians (RDs) from participating diabetes education centers (Ontario) or primary care networks (Alberta) and program coordinators from partnering community-based organizations. The 6-month program includes three in-home visits, monthly group sessions, monthly team meetings for providers, and nurse-led care coordination. The primary outcome is the change in physical functioning as measured by the Physical Component Summary (PCS-12) score from the short form-12v2 health survey (SF-12). Secondary client outcomes include changes in mental functioning, depressive symptoms, anxiety, and self-efficacy. Caregiver outcomes include health-related quality of life and depressive symptoms. The study includes a comparison of health care service costs for the intervention and control groups, and a subgroup analysis to determine which clients benefit the most from the program. Descriptive and qualitative data will be collected to examine implementation of the program and effects on interprofessional/team collaboration.Discussion: This study will provide evidence of the effectiveness of a community-based self-management program for a complex target population. By studying both implementation and effectiveness, we hope to improve the uptake of the program within the existing community-based structures, and reduce the research-to-practice gap.Trial Registration: ClinicalTrials.gov, Identifier: NCT02158741 . Registered on 3 June 2014. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
27. Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial).
- Author
-
Cabral Fagundes, Felipe Ribeiro, do Espírito Santo, Caique de Melo, de Luna Teixeira, Francine Mendonça, Tonini, Thaís Vanelli, Nunes Cabral, Cristina Maria, Fagundes, Felipe Ribeiro Cabral, de Melo do Espírito Santo, Caique, and Cabral, Cristina Maria Nunes
- Subjects
THERAPEUTIC alliance ,LUMBAR pain ,PAIN management ,PSYCHOSOCIAL factors ,RANDOMIZED controlled trials ,HEALTH counseling ,CLINICAL trials ,CHRONIC pain & psychology ,CHRONIC pain treatment ,CHRONIC pain ,COMPARATIVE studies ,FUNCTIONAL assessment ,EMPATHY ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PATIENT education ,PHYSICIAN-patient relations ,PSYCHOTHERAPY ,QUESTIONNAIRES ,RESEARCH ,TIME ,EVALUATION research ,PAIN measurement ,TREATMENT effectiveness ,DIAGNOSIS ,PSYCHOLOGY - Abstract
Background: The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain.Methods: Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models.Discussion: This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain.Trial Registration: ClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
28. The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial.
- Author
-
van der Laan, Danielle M., Elders, Petra J. M., Boons, Christel C. L. M., Bosmans, Judith E., Nijpels, Giel, and Hugtenburg, Jacqueline G.
- Subjects
COST effectiveness ,HEALTH care intervention (Social services) ,PATIENT compliance ,ANTIHYPERTENSIVE agents ,DRUGSTORES ,RANDOMIZED controlled trials ,CARDIOVASCULAR system ,COUNSELING ,BLOOD pressure ,COMPARATIVE studies ,DRUGS ,EXPERIMENTAL design ,INTERVIEWING ,HYPERTENSION ,RESEARCH methodology ,MEDICAL care costs ,MEDICAL cooperation ,PHARMACISTS ,RESEARCH ,TIME ,OCCUPATIONAL roles ,EVALUATION research ,TREATMENT effectiveness ,ECONOMICS ,DIAGNOSIS - Abstract
Background: Medication non-adherence is a complex health care problem. Due to non-adherence, substantial numbers of cardiovascular patients benefit from their medication to only a limited extent. In order to improve adherence, a variety of pharmacist-led interventions have been developed. However, even the most effective interventions achieved only a modest positive effect. To be effective, interventions should be targeted at underlying barriers to adherence, developed in a systematic manner and tailored to specific features of a target group and setting. The current paper describes the design of the Cardiovascular medication non-Adherence Tailored Intervention (CATI) study aimed to evaluate the (cost-)effectiveness of a patient-tailored intervention programme in patients using antihypertensive medication.Methods: The CATI study is a randomised controlled trial that will be performed in 13 community pharmacies. Patients aged 45-75 years using antihypertensive medication and considered non-adherent according to pharmacy dispensing data, as well according to a self-report questionnaire, are eligible to participate. Patients in the intervention condition will receive a patient-tailored, pharmacist-led intervention programme. This programme consists of a structured interview at the pharmacy to identify patients' barriers to adherence and to counsel patients in order to overcome these barriers. The primary outcome is self-reported medication adherence measured with the MARS-5 questionnaire. Secondary outcome measures are blood pressure, illness perceptions, quality of life and societal costs. A cost-effectiveness analysis and process evaluation will also be performed.Discussion: This study will provide insight into the (cost-)effectiveness of a patient-tailored, pharmacist-led intervention programme in non-adherent patients using antihypertensive medication. This intervention programme allows community pharmacists to support their patients in overcoming barriers to adherence and improving medication adherence in a structured and patient-tailored manner. An effective intervention will not only enhance medication adherence, but may also improve health outcomes and decrease health care utilisation and costs.Trial Registration: Netherlands Trial Register (identifier: NTR5017), registered on 2 February 2015. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
29. Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial.
- Author
-
Bulteau, Samuel, Sébille, Veronique, Fayet, Guillemette, Thomas-Ollivier, Veronique, Deschamps, Thibault, Bonnin-Rivalland1, Annabelle, Laforgue, Edouard, Pichot, Anne, Valrivière, Pierre, Auffray-Calvier, Elisabeth, Fortin, June, Péréon, Yann, Vanelle, Jean-Marie, Sauvaget, Anne, and Bonnin-Rivalland, Annabelle
- Subjects
DEPRESSED persons ,MENTAL depression ,THERAPEUTICS ,TRANSCRANIAL magnetic stimulation ,ANTIDEPRESSANTS ,NEUROPSYCHOLOGY ,DIAGNOSIS of mental depression ,AFFECT (Psychology) ,BRAIN ,COMPARATIVE studies ,ELECTROENCEPHALOGRAPHY ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PSYCHOLOGICAL tests ,RESEARCH ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment - Abstract
Background: The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.Methods/design: This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).Discussion: The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.Trial Registration: ClinicalTrials.gov, Identifier NCT02376491 . Registered on 17 February 2015 at http://clinicaltrials.gov . [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
30. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.
- Author
-
Fleming, Jennifer, Ownsworth, Tamara, Emmah Doig, Hutton, Lauren, Griffin, Janelle, Kendall, Melissa, Shum, David H. K., and Doig, Emmah
- Subjects
PROSPECTIVE memory ,METACOGNITION ,BRAIN injuries ,RANDOMIZED controlled trials ,SELF-consciousness (Awareness) ,BRAIN ,COGNITION ,COGNITIVE therapy ,COMPARATIVE studies ,CONVALESCENCE ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,MEMORY ,PSYCHOMETRICS ,MEMORY disorders ,QUALITY of life ,RESEARCH ,TIME ,ACTIVITIES of daily living ,EVALUATION research ,TREATMENT effectiveness ,SEVERITY of illness index ,DIAGNOSIS ,PSYCHOLOGY - Abstract
Background: Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI.Methods/design: This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups.Discussion: This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies.Trial Registration: New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement. [ABSTRACT FROM AUTHOR]- Published
- 2017
- Full Text
- View/download PDF
31. Cord pilot trial: update to randomised trial protocol.
- Author
-
Bradshaw, Lucy E., Pushpa-Rajah, Angela, Dorling, Jon, Mitchell, Eleanor J., Duley, Lelia, and Cord Pilot Trial Collaborative Group
- Subjects
RANDOMIZED controlled trials ,UMBILICAL cord clamping ,PREMATURE labor ,RANDOMIZATION (Statistics) ,BAYLEY Scales of Infant Development ,INTRAVENTRICULAR hemorrhage ,UMBILICAL cord ,AGE distribution ,CEREBRAL hemorrhage ,CHILD development ,COMPARATIVE studies ,EXPERIMENTAL design ,GESTATIONAL age ,PREMATURE infants ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,RESEARCH ,STATISTICAL sampling ,TIME ,PILOT projects ,EVALUATION research ,SURGERY - Abstract
Background: The Cord Pilot Trial aimed to assess the feasibility of conducting a large UK randomised trial to compare the effects of alternative polices for timing of cord clamping (immediate within 20 seconds or deferred after at least 2 minutes) for very preterm birth before 32 weeks gestation. Initial recruitment was from March 2013 to February 2014, phase 2 was from March 2014 to February 2015. This paper updates the pilot trial protocol (Trials 15(1):258, 2014) and presents the changes for phase 2.Methods: An electronic randomisation system was introduced at three of the eight pilot sites. For follow-up of children, the Parent Report of Children's Abilities--Revised (PARCA-R) will not be used. For children recruited to the trial during phase 2, follow-up at age 2 years (corrected for gestation at birth) will be by parent completed Ages and Stages Questionnaire (Squire J, Ages and Stages Questionnaires (ASQ), 2009) alone unless funds can be secured for the additional Bayley Scales of Infant Development III (Bayley N, Bayley Scales of Infant and Toddler Development, Third Edition. (Bayley-III), 2005) assessments. To assess accuracy of the cranial ultrasound diagnosis of intraventricular haemorrhage: (i) quality of the scans will be assessed using the British Society of Paediatric Radiology recommendations, and (ii) scan results will be confirmed by independent adjudication. Within and between adjudicator reliability will be assessed. In addition to the analyses planned to assess feasibility of the full trial based on data from the first year of recruitment, data on compliance and outcomes will be presented by allocated group for all women and babies recruited.Trial Registration: ISRCTN21456601, registered on 28 February 2013. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
32. Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial.
- Author
-
Franco Moura, Renata Calhes, Almeida Santos, Cibele, Collange Grecco, Luanda André, Delasta Lazzari, Roberta, Lopes Dumont, Arislander Jonathan, de Almeida Duarte, Natalia Carvalho, Braun, Luiz Alfredo, Palma Lopes, Jamile Benite, dos Santos, Ligia Abram, Souza Rodrigues, Eliane Lopes, Albertini, Giorgio, Cimolin, Veronica, Galli, Manuela, Santos Oliveira, Claudia, Moura, Renata Calhes Franco, Santos, Cibele Almeida, Grecco, Luanda André Collange, Lazzari, Roberta Delasta, Dumont, Arislander Jonathan Lopes, and Duarte, Natalia Carvalho de Almeida
- Subjects
TRANSCRANIAL direct current stimulation ,ARM ,FUNCTIONAL training ,CEREBRAL palsy ,MOTOR cortex ,ARM innervation ,AGE distribution ,CHILD development ,COMPARATIVE studies ,FUNCTIONAL assessment ,ELECTROMYOGRAPHY ,EXPERIMENTAL design ,FRONTAL lobe ,HEMIPLEGIA ,KINEMATICS ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,MOTOR ability ,PHYSICAL therapy ,PLAY ,RESEARCH ,TIME ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,SEVERITY of illness index ,DIAGNOSIS - Abstract
Background: The aim of the proposed study is to perform a comparative analysis of functional training effects for the paretic upper limb with and without transcranial direct current stimulation over the primary motor cortex in children with spastic hemiparetic cerebral palsy.Methods: The sample will comprise 34 individuals with spastic hemiparetic cerebral palsy, 6 to 16 years old, classified at level I, II, or III of the Manual Ability Classification System. Participants will be randomly allocated to two groups: (1) functional training of the paretic upper limb combined with anodic transcranial stimulation; (2) functional training of the paretic upper limb combined with sham transcranial stimulation. Evaluation will involve three-dimensional movement analysis and electromyography using the SMART-D 140® system (BTS Engineering) and the FREEEMG® system (BTS Engineering), the Quality of Upper Extremity Skills Test, to assess functional mobility, the Portable Device and Ashworth Scale, to measure movement resistance and spasticity, and the Pediatric Evaluation of Disability Inventory, to evaluate performance. Functional reach training of the paretic upper limb will include a range of manual activities using educational toys associated with an induced constraint of the non-paretic limb during the training. Training will be performed in five weekly 20-minute sessions for two weeks. Transcranial stimulation over the primary motor cortex will be performed during the training sessions at an intensity of 1 mA. Findings will be analyzed statistically considering a 5 % significance level (P ≤ 0.05).Discussion: This paper presents a detailed description of a prospective, randomized, controlled, double-blind, clinical trial designed to demonstrate the effects of combining transcranial direct current stimulation over the primary motor cortex and functional training of the paretic limb in children with cerebral palsy classified at level I, II, or III of the Manual Ability Classification System. The results will be published and evidence found may contribute to the use of transcranial stimulation for this population.Trial Registration: ReBEC RBR-6V4Y3K . Registered on 11 February 2015. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
33. Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.
- Author
-
Ho, Henry C. Y., Mui, Moses, Wan, Alice, Yin-lam Ng, Stewart, Sunita M., Yew, Carol, Tai Hing Lam, Chan, Sophia S., Ng, Yin-Lam, and Lam, Tai Hing
- Subjects
POSITIVE psychology ,QUALITY of life ,FAMILY relations ,WELL-being ,RANDOMIZED controlled trials ,CONTROL groups ,COMPARATIVE studies ,HAPPINESS ,RESEARCH methodology ,MEDICAL cooperation ,HEALTH outcome assessment ,PSYCHOLOGY ,RESEARCH ,STATISTICAL sampling ,EVALUATION research - Abstract
Background: Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life.Methods: Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention.Results: Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea gathering session in improving subjective happiness (β = .00, p = .990, d = .00) or mental (β = 1.20, p = 1.000, d = -.04) and physical quality of life (β = .15, p = 1.000, d = -.01).Conclusions: The analyses extend previous findings of salutary effects on family well-being by showing that positive psychology family interventions can improve subjective happiness. Suggestions for future research are proposed.Trial Registration: ClinicalTrials.gov NCT01796275 . Retrospectively registered 19 February 2013. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
34. Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.
- Author
-
González-Ortega, Itxaso, Echeburúa, Enrique, García-Alocén, Adriana, Vega, Patricia, and González-Pinto, Ana
- Subjects
PSYCHOSES ,MARIJUANA abuse ,COGNITIVE therapy ,SMOKING cessation ,RANDOMIZED controlled trials ,PATIENTS ,SUBSTANCE abuse & psychology ,SUBSTANCE abuse treatment ,COMPARATIVE studies ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,BLIND experiment ,THERAPEUTICS - Abstract
Background: The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation).Methods/design: This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group.Discussion: This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder.Trial Registration: NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
35. Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project.
- Author
-
Meurer, William J., Legocki, Laurie, Mawocha, Samkeliso, Frederiksen, Shirley M., Guetterman, Timothy C., Barsan, William, Lewis, Roger, Berry, Donald, and Fetters, Michael
- Subjects
CLINICAL trials ,MIXED methods research ,PHARMACEUTICAL industry ,MEDICAL equipment ,FOCUS groups ,VISUAL analog scale ,ATTITUDE (Psychology) ,CULTURE ,EXPERIMENTAL design ,RESEARCH methodology ,RESEARCH funding ,SURVEYS - Abstract
Background: Adaptive designs have been increasingly used in the pharmaceutical and device industries, but adoption within the academic setting has been less widespread - particularly for confirmatory phase trials. We sought to understand perceptions about understanding, acceptability, and scientific validity of adaptive clinical trials (ACTs).Methods: We used a convergent mixed methods design using survey and mini-focus group data collection procedures to elucidate attitudes and opinions among "trial community" stakeholders regarding understanding, acceptability, efficiency, scientific validity, and speed of discovery with adaptive designs. Data were collected about various aspects of ACTs using self-administered surveys (paper or Web-based) with visual analog scales (VASs) with free text responses and with mini-focus groups of key stakeholders. Participants were recruited as part of an ongoing NIH/FDA-funded research project exploring the incorporation of ACTs into an existing NIH network that focuses on confirmatory phase clinical trials in neurological emergencies. "Trial community" representatives, namely, clinical investigators, biostatisticians, NIH officials, and FDA scientists involved in the planning of four clinical trials, were eligible to participate. In addition, recent and current members of a clinical trial-oriented NIH study section were also eligible.Results: A total of 76 stakeholders completed the survey (out of 91 who were offered it, response rate 84 %). While the VAS attitudinal data showed substantial variability across respondents about acceptability and understanding of ACTs by various constituencies, respondents perceived clinicians to be less likely to understand ACTs and that ACTs probably would increase the efficiency of discovery. Textual and focus group responses emerged into several themes that enhanced understanding of VAS attitudinal data including the following: acceptability of adaptive designs depends on constituency and situation; there is variable understanding of ACTs (limited among clinicians, perceived to be higher at FDA); views about the potential for efficiency depend on the situation and implementation. Participants also frequently mentioned a need for greater education within the academic community. Finally, the empiric, non-quantitative selection of treatments for phase III trials based on limited phase II trials was highlighted as an opportunity for improvement and a potential explanation for the high number of neutral confirmatory trials.Conclusions: These data show considerable variations in attitudes and beliefs about ACTs among trial community representatives. For adaptive trials to be fully considered when appropriate and for the research enterprise to realize the full potential of adaptive designs will likely require extensive experience and trust building within the trial community. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
36. GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial.
- Author
-
Wiberg, Sebastian, Hassager, Christian, Hartvig Thomsen, Jakob, Frydland, Martin, Dan Eik Høfsten, Engstrøm, Thomas, Køber, Lars, Schmidt, Henrik, Eifer Møller, Jacob, Kjaergaard, Jesper, Thomsen, Jakob Hartvig, Høfsten, Dan Eik, and Møller, Jacob Eifer
- Subjects
OUTPATIENT medical care ,CARDIAC arrest ,GLUCAGON-like peptide 1 ,HEART failure treatment ,PATIENT compliance ,MANAGEMENT ,CEREBROVASCULAR disease diagnosis ,CEREBROVASCULAR disease prevention ,THERAPEUTIC use of venom ,CEREBROVASCULAR disease ,COMPARATIVE studies ,CARDIOPULMONARY resuscitation ,FUNCTIONAL assessment ,EXPERIMENTAL design ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PEPTIDES ,RESEARCH ,TIME ,VENOM ,PILOT projects ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,NEUROPROTECTIVE agents ,THERAPEUTICS - Abstract
Background: Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous circulation to comatose patients resuscitated from out-of-hospital cardiac arrest.Methods/design: This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling.Discussion: This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results.Trial Registration: 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
37. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.
- Author
-
Asher, Laura, De Silva, Mary, Hanlon, Charlotte, Weiss, Helen A., Birhane, Rahel, Ejigu, Dawit A., Medhin, Girmay, Patel, Vikram, and Fekadu, Abebaw
- Subjects
SCHIZOPHRENIA treatment ,PSYCHIATRIC treatment ,PSYCHOSES ,REHABILITATION -- Social aspects ,RANDOMIZED controlled trials ,THERAPEUTIC environment (Mental health) ,CAREGIVERS ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,MENTAL health ,HEALTH outcome assessment ,RESEARCH ,RESEARCH funding ,STATISTICAL sampling ,SCHIZOPHRENIA ,EVALUATION research - Abstract
Background: Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia.Methods: This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample size will allow us to detect a 20 % difference in WHODAS 2.0 scores between treatment arms with 85 % power. Secondary outcomes include change in symptom severity, economic activity, physical restraint, discrimination and caregiver burden.Discussion: This is the first trial of community-based rehabilitation for schizophrenia and will determine, as a proof of concept, the added value of community-based rehabilitation compared to facility-based care alone in a low-income country with scarce mental health resources.Trial Registration: Clinical Trials.gov Identifier NCT02160249 . Registered on 3 June 2014. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
38. The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial.
- Author
-
Nightingale, Tom E., Walhin, Jean-Philippe, Turner, James E., Thompson, Dylan, and Bilzon, James L. J.
- Subjects
PHYSICAL fitness ,SPINAL cord injuries ,SEDENTARY lifestyles ,BODY composition ,GENE expression ,PHYSIOLOGY ,ADIPOSE tissues ,CHRONIC diseases ,COMPARATIVE studies ,ENERGY metabolism ,EXERCISE therapy ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,HEALTH outcome assessment ,RESEARCH ,STATISTICAL sampling ,SAMPLE size (Statistics) ,EVALUATION research ,RANDOMIZED controlled trials ,OXYGEN consumption - Abstract
Background: Spinal cord injury (SCI) creates a complex pathology that can lead to an increase in sedentary behaviours and deleterious changes in body composition. Consequently, individuals with SCI are at increased risk of developing cardiovascular disease and type-2 diabetes mellitus. While the role of physical activity on the reduction of chronic disease risk is well documented in non-disabled individuals the evidence is less conclusive for persons with SCI. The aim of this methodological paper is to outline the design of a study that will assess the role of a home-based exercise intervention on biomarkers of metabolic and cardiovascular health in persons with SCI: the HOMEX-SCI study.Methods/design: Eligible participants will be inactive (physical activity level ≤1.60) individuals, with a chronic (more than 1 year) spinal cord lesion between the second thoracic and the fifth lumbar vertebrae, and aged between 18 and 65 years. Following baseline laboratory testing and lifestyle monitoring, participants will be randomly allocated to a control (CON) group or a 6-week home-based exercise intervention (INT) group. The INT consists of 45 minutes of moderate-intensity (60-65 % peak oxygen uptake) arm-crank exercise four times per week. Participants assigned to the CON group will be asked to maintain their normal lifestyle. The main outcomes of this study (biomarkers of metabolic and cardiovascular health) are obtained from venous blood samples, collected in the fasted and postprandial state. Eight other measurement categories will be assessed: (1) body composition, (2) physical activity, (3) energy intake, (4) measures of health and wellbeing, (5) resting metabolic rate, heart rate and blood pressure, (6) aerobic capacity, (7) immune function, and (8) adipose tissue gene expression.Discussion: This study will explore the feasibility of home-based moderate-intensity exercise and ascertain its impact on metabolic and cardiovascular health in comparison to a lifestyle maintenance CON group. Findings from this study may help to inform new evidence-based physical activity guidelines and also help to elucidate the physiological mechanisms whereby exercise might exert beneficial effects in persons with chronic SCI. The results will also act as a scientific platform for further intervention studies in other diverse and at-risk populations.Trial Registration: International Standard Randomised Controlled Trial Number: ISRCTN57096451 . Registered on 11 July 2014. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
39. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.
- Author
-
Sánchez, Alvaro, Silvestre, Carmen, Campo, Natalia, Grandes, Gonzalo, and PreDE research group
- Subjects
TYPE 2 diabetes prevention ,PRIMARY care ,PATIENT selection ,INTERVENTION (Social services) ,HEALTH risk assessment ,TYPE 2 diabetes diagnosis ,COMBINED modality therapy ,COMPARATIVE studies ,HEALTH attitudes ,HEALTH promotion ,INTEGRATED health care delivery ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL screening ,TYPE 2 diabetes ,PATIENT education ,PREVENTIVE health services ,RESEARCH ,RISK assessment ,TELEMEDICINE ,TIME ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,EVALUATION of human services programs - Abstract
Background: Process evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recruitment, exposure to the intervention components and baseline characteristics.Methods: An observational descriptive process evaluation study was conducted of the 2.5-year implementation of the Prevention of Diabetes in Euskadi cluster randomized trial in 14 primary care centers of the Basque Health Service (Osakidetza). The clinical intervention consisted of three components: (1) risk screening, (2) an educational intervention promoting healthy lifestyles, and (3) remote support (follow-up). A passive dissemination strategy of providing training and materials was used to translate the intervention into practice. All non-diabetic patients aged 45 to 70 years who were identified as being at high risk of developing T2D were eligible for study inclusion. The RE-AIM framework guided the process evaluation.Results: Overall, 31.4 % of family physicians and 57.6 % of nurses participated in the study, while 4170 out of 67,293 (6.2 %) targeted patients who attended the centers during the implementation period were reached through the screening. Around half of the screened patients were identified as being at high risk of developing T2D (FINDRISC score ≥14). The rate of refusal to participate and the proportion of women were higher in the intervention group. Finally, 634 and 454 non-diabetic 45- to 70-year-old patients who were at high risk of T2D were included in the control and intervention group centers (intervention reach = 48 %). Significant variability in most process indicators was observed at center level.Conclusion: The passive dissemination strategy has produced modest process indicators related to the adoption, reach and implementation of the intervention program, and reduced the possibility of its standardized application in heterogeneous contexts. The resulting different procedures and strategies used by the centers were associated with process outcomes. Context-specific variability and possible confounding will require rigorous procedures for analysis of the intervention effects.Trial Registration: The trial was registered in ClinicalTrials.gov (identifier: NCT01365013 ). Registered on June 2011. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
40. Process-based approach to modeling recurrent-event data explicated on the basis of occurrences of tooth losses in two different prosthetic treatment concepts.
- Author
-
Diebner, Hans H., Marré, Birgit, Roeder, Ingo, and Walter, Michael H.
- Subjects
DENTURES ,DENTAL arch ,DISEASE relapse prevention ,TOOTH loss ,PREVENTION ,THERAPEUTICS ,BRIDGES (Dentistry) ,CLINICAL trials ,COMPARATIVE studies ,DENTAL implants ,JAW diseases ,RESEARCH methodology ,MEDICAL cooperation ,REMOVABLE partial dentures ,RESEARCH ,DENTAL extraction ,TIME ,DISEASE relapse ,EVALUATION research ,TREATMENT effectiveness ,STATISTICAL models ,KAPLAN-Meier estimator ,SURGERY ,EQUIPMENT & supplies - Abstract
Background: In studies comparing different prosthetic treatment concepts the repeated loss of teeth was chosen as the primary outcome. The resulting data appear to represent a data structure of recurrent events. However, the application of an existing method for recurrent events is far from straightforward. Often only the first event or the final state is analyzed using Kaplan-Meier survival statistics, thereby giving a great deal of information away.Methods: The paper presents a strategy for the analysis of recurrent data using a previously published study on the influence of different prosthetic treatment concepts for the shortened dental arch on tooth loss. A method based on cumulative sample history functions of recurrent events was adjusted for tooth loss. The shapes of these cumulative functions suggest a time dependency of the recurrence rate. To keep the model as simple as possible, a tripartite Poisson process (which assumes piecewise time-independent rates) was fitted to the cumulative mean functions stratified by treatment.Results: Within the middle interval of the three-phasic process, the treatment effects differ significantly, which is interpreted as a delay of tooth loss due to the use of one type of prosthesis (fixed) compared with the other (removable).Conclusions: An analysis based on cumulative history functions is based on process, therefore, temporally changing characteristics are better captured than in methods for survival analyses. The presented approach offers useful new insight into the temporal behavior of ongoing tooth loss after prosthetic treatment.Trial Registration: The trial has been registered at controlled-trials.com under ISRCTN97265367 (registration date 4 April 2008). [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
41. Activities and participation of children and adolescents after mild traumatic brain injury and the effectiveness of an early intervention (Brains Ahead!): study protocol for a cohort study with a nested randomised controlled trial.
- Author
-
Renaud, M. Irene, Lambregts, Suzanne A. M., de Kloet, Arend J., Catsman-Berrevoets, Coriene E., van de Port, Ingrid G. L., and van Heugten, Caroline M.
- Subjects
BRAIN injury treatment ,COGNITION disorders in children ,POST-traumatic stress disorder in adolescence ,POST-traumatic stress disorder in children ,RANDOMIZED controlled trials ,BRAIN concussion diagnosis ,AGE distribution ,CHILD behavior ,BRAIN concussion ,COMPARATIVE studies ,FUNCTIONAL assessment ,EMOTIONS ,EXPERIMENTAL design ,HEALTH attitudes ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PAMPHLETS ,PATIENT education ,QUALITY of life ,RESEARCH ,SOCIAL participation ,TEENAGERS' conduct of life ,TIME ,EVALUATION research ,TREATMENT effectiveness ,BLIND experiment ,EARLY medical intervention ,PSYCHOLOGY ,THERAPEUTICS - Abstract
Background: Approximately 20 % of children and adolescents who have sustained mild traumatic brain injuries may experience long-term consequences, including cognitive problems, post-traumatic stress symptoms and reduced load-bearing capacity. The underestimation and belated recognition of these long-term consequences may lead to chronic and disruptive problems, such as participation problems in school and in social relationships. The aim of this study is to examine the level of activities and participation of children and adolescents up to 6 months after a mild traumatic brain injury and to identify possible outcome predictors. Another aim is to investigate the effectiveness of an early psychoeducational intervention and compare the results with those obtained with usual care.Methods/design: This paper presents the Brains Ahead! study design, a randomised controlled trial nested within a multicentre, longitudinal, prospective cohort study. The eligible participants include children and adolescents between 6 and 18 years of age who have experienced a mild traumatic brain injury within the last 2 weeks. The cohort study will include 500 children and adolescents with a mild traumatic brain injury and their caregivers. A subset of 140 participants and their caregivers will be included in the randomised controlled trial. Participants in the randomised controlled trial will be randomly assigned to either the psychoeducational intervention group or the usual care control group. The psychoeducational intervention involves one face-to-face contact and one phone contact with the interventionist, during which the consequences of mild traumatic brain injury and advice for coping with these consequences to prevent long-term problems will be discussed. Information will be provided both verbally and in a booklet. The primary outcome domain is activities and participation, which will be evaluated using the Child and Adolescent Scale of Participation. Participants are evaluated 2 weeks, 3 months and 6 months after the mild traumatic brain injury.Discussion: The results of this study will provide insight into which children with mild traumatic brain injury are at risk for long-term participation problems and may benefit from a psychoeducational intervention.Trial Registration: Netherlands Trial Register identifier NTR5153 . Registered on 17 Apr 2015. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
42. Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial.
- Author
-
Groenen, Carola J. M., Faber, Marjan J., Kremer, Jan A. M., Vandenbussche, Frank P. H. A., and van Duijnhoven, Noortje T. L.
- Subjects
MATERNAL health services ,MEDICAL records ,COOPERATIVE research ,PERINATAL care ,CLINICAL medicine ,COMPARATIVE studies ,EXPERIMENTAL design ,INTERVIEWING ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,PATIENT satisfaction ,QUALITY assurance ,RESEARCH ,TIME ,EVALUATION research ,KEY performance indicators (Management) ,RANDOMIZED controlled trials ,ACQUISITION of data ,EVALUATION of human services programs - Abstract
Background: A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. This paper presents the study protocol.Methods/design: The effects of implementing a PHR in maternity care on patients and professionals will be identified in a stepped-wedge, cluster-randomised, controlled trial. The study will be performed in the region of Nijmegen, a Dutch area with an average of 4,500 births a year and more than 230 healthcare professionals involved in maternity care. Data analyses will describe the effects of MyPregn@ncy on health outcomes in maternity care, quality of care from the patients' perspectives, and collaboration among healthcare professionals. Additionally, a process evaluation of the implementation of MyPregn@ncy will be performed. Data will be collected using data from the Dutch perinatal registry, questionnaires, interviews, and log data.Discussion: The study is expected to yield new information about the effects, strengths, possibilities, and challenges to the implementation and usage of a PHR in routine maternal care settings. Results may lead to new insights and improvements in the quality of maternal and perinatal care.Trial Registration: Netherlands Trial Register: NTR4063. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
43. Investigating the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards (the 'INSITE' trial): study protocol for a randomised controlled trial.
- Author
-
Haddock, Gillian, Davies, Linda, Evans, Emma, Emsley, Richard, Gooding, Patricia, Heaney, Lisa, Jones, Sarah, Kelly, James, Munro, Ailsa, Peters, Sarah, Pratt, Daniel, Tarrier, Nicholas, Windfuhr, Kirsten, and Awenat, Yvonne
- Subjects
MENTAL illness treatment ,SUICIDE prevention ,COGNITIVE therapy ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,HEALTH outcome assessment ,RESEARCH ,RESEARCH funding ,STATISTICS ,DATA analysis ,EVALUATION research ,BLIND experiment ,PATIENT selection ,ACUTE diseases ,PATIENTS' attitudes - Abstract
Background: Suicide is a major cause of preventable death, and suicidal behaviour is prevalent in acute psychiatric wards. People admitted to acute psychiatric wards often experience repeated episodes of suicidal behaviour, causing great distress and heavy use of NHS services. There is little research investigating effective psychological treatments for suicidal patients in inpatient settings although previous research has found support for psychological therapies which specifically target suicidal behaviour. This paper describes the protocol of a single blind RCT to investigate the acceptability and feasibility of a cognitive behavioural intervention targeting suicidality (CBSP) for suicidal people in acute psychiatric wards.Methods/design: A single blind RCT comparing treatment as usual (TAU) to TAU plus Cognitive Behavioural Suicide Prevention (CBSP) therapy (TAU + CBSP). Sixty participants (aged 18-65 years) who are suicidal, or have been within the past 3 months, will be recruited from NHS trusts in the North West of England. Our primary objective is to determine whether CBSP is feasible, acceptable and efficacious when compared to patients who receive TAU alone. Secondary aims are the impact of CBSP on suicidal thinking, behaviours, functioning, quality of life, service use and psychological factors associated with suicide. Assessments take place at baseline, 6 weeks and 6 months (end of treatment). The analysis will report on the feasibility and acceptability of CBSP. Qualitative data from staff and service users will inform feasibility and acceptability data.Discussion: Psychiatric inpatients are a high-risk group and the use of psychological therapies in these settings is rare and requires evaluation. This study is essential to investigate the unique contextual challenges involved in delivering psychological therapy to suicidal inpatients and to identify any necessary modifications required within inpatient settings. The findings will inform a larger, definitive trial.Trial Registration: 15 March 2012, PB-PG-1111-26026, NIHR ISRCTN17890126 . [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
44. Dental practitioner recruitment for a randomized clinical trial in the field to evaluate the performance of a new glass ionomer restoration material.
- Author
-
Klinke, Thomas, Daboul, Amro, Schwahn, Christian, Frankenberger, Roland, Hickel, Reinhard, and Biffar, Reiner
- Subjects
DENTAL glass ionomer cements ,DENTAL fillings ,CURRENT good manufacturing practices ,HEALTH & social status ,UNEMPLOYMENT & health ,EQUIPMENT & supplies ,ACRYLIC resins ,COMPARATIVE studies ,DENTAL materials ,DENTISTS ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,SILICA ,SOCIAL classes ,EVALUATION research ,RANDOMIZED controlled trials ,BLIND experiment ,PATIENT selection - Abstract
Background: In 2009, we began recruiting dental practitioners across Germany to participate in a clinical trial to evaluate the clinical performance of EQUIA, a new glass ionomer restoration material. The aim of this paper is to discuss the outcomes of the dental practitioner recruitment and outline the process of establishing a practice-based research network.Methods: Study proposals were sent to randomly selected dental offices in 29 cities in Germany. The proposals were sent until a minimum of 10 clinics in each city declared participation. Later on, briefing lectures informed the participating practitioners about the design, methods, and material application procedure. Participants were familiarized with the guidelines of Good Manufacturing Practice (GMP) and Good Epidemiological Practice (GEP). A questionnaire describing the characteristics of each dental office was filled out by the participating practitioner. Additionally, participation levels were characterized according to the socioeconomic status and geographic districts of residence in Germany (Regions 0 to 9). The associations between the characteristics were tested by the Kruskal-Wallis Test and Chi-squared test (P < 0.05).Results: A total of 3194 private dental clinics were invited, 1712 clinics refused to participate, 1195 did not respond to the invitation, and 323 agreed to participate. Only 144 clinics participated in the lectures held in their cities and signed the participation agreement. Based on their geographic location, the highest participation was in Region 2 with a participation rate of 14.3%, and the lowest participation was in Region 6 with a participation rate of 1.7%. Regions with the lowest rate of unemployment and relatively higher rates of income (Regions 7 and 8) had the highest rate of refusals (86%).Conclusion: The initial results of the dental practitioner recruitment in this study suggest that the recruitment and pre-randomization design were successful, and by reaching out to a considerable number of private dental clinics to participate, we were able to recruit a smaller number of highly motivated dentists in this clinical study. Regional differences in socioeconomic status, practitioner specialization, and differences in patient health care insurance have to be considered when recruiting dental practitioners for clinical trials.Trial Registration: The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) on 6 September 2012 under DRKS-ID: DRKS00004220. [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
45. Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): study protocol for a randomised controlled trial.
- Author
-
Tallon, Debbie, Wiles, Nicola, Campbell, John, Chew-Graham, Carolyn, Dickens, Chris, Macleod, Una, Peters, Tim J., Lewis, Glyn, Anderson, Ian M., Gilbody, Simon, Hollingworth, William, Davies, Simon, and Kessler, David
- Subjects
MENTAL depression ,THERAPEUTICS ,MIRTAZAPINE ,SEROTONIN uptake inhibitors ,ANTIDEPRESSANTS ,PRIMARY care ,PLACEBOS ,COMPARATIVE studies ,DRUG resistance ,HETEROCYCLIC compounds ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH protocols ,HEALTH outcome assessment ,PRIMARY health care ,PSYCHOLOGICAL tests ,RESEARCH ,RESEARCH funding ,QUALITATIVE research ,SAMPLE size (Statistics) ,EVALUATION research ,RANDOMIZED controlled trials - Abstract
Background: People with depression are usually managed in primary care and antidepressants are often the first-line treatment, but only one third of patients respond fully to a single antidepressant. This paper describes the protocol for a randomised controlled trial (MIR) to investigate the extent to which the addition of the antidepressant mirtazapine is effective in reducing the symptoms of depression compared with placebo in patients who are still depressed after they have been treated with a selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 6 weeks in primary care.Methods/design: MIR is a two-parallel group, multi-centre, pragmatic, placebo controlled, randomised trial with allocation at the level of the individual. Eligible participants are those who: are aged 18 years or older; are currently taking an SSRI/SNRI antidepressant (for at least 6 weeks at an adequate dose); score ≥ 14 on the Beck Depression Inventory (BDI-II); have adhered to their medication; and meet ICD-10 criteria for depression (assessed using the Clinical Interview Schedule-Revised version). Participants who give written, informed consent, will be randomised to receive either oral mirtazapine or matched placebo, starting at 15 mg daily for 2 weeks and increasing to 30 mg daily thereafter, for up to 12 months (to be taken in addition to their usual antidepressant). Participants, their GPs, and the research team will all be blind to the allocation. The primary outcome will be depression symptoms at 12 weeks post randomisation, measured as a continuous variable using the BDI-II. Secondary outcomes (measured at 12, 24 and 52 weeks) include: response (reduction in depressive symptoms (BDI-II score) of at least 50% compared to baseline); remission of depression symptoms (BDI-II <10); change in anxiety symptoms; adverse effects; quality of life; adherence to antidepressant medication; health and social care use, time off work and cost-effectiveness. All outcomes will be analysed on an intention-to-treat basis. A qualitative study will explore patients' views and experiences of either taking two antidepressants, or an antidepressant and a placebo; and GPs' views on prescribing a second antidepressant in this patient group.Discussion: The MIR trial will provide evidence on the clinical and cost-effectiveness of mirtazapine as an adjunct to SSRI/SNRI antidepressants for patients in primary care who have not responded to monotherapy.Trial Registration: EudraCT Number: 2012-000090-23 (Registered January 2012); ISRCTN06653773 (Registered September 2012). [ABSTRACT FROM AUTHOR]- Published
- 2016
- Full Text
- View/download PDF
46. The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials.
- Author
-
Sikander, Siham, Lazarus, Anisha, Bangash, Omer, Fuhr, Daniela C., Weobong, Benedict, Krishna, Revathi N., Ahmad, Ikhlaq, Weiss, Helen A., Price, LeShawndra, Rahman, Atif, and Patel, Vikram
- Subjects
PREGNANT women ,MENTAL depression ,HEALTH programs ,MENTAL health ,MENTAL health services ,POSTPARTUM depression diagnosis ,CLINICAL trials ,COMPARATIVE studies ,COST effectiveness ,EXPERIMENTAL design ,GROUP psychotherapy ,MATERNAL health services ,RESEARCH methodology ,MEDICAL care costs ,MEDICAL cooperation ,RESEARCH protocols ,POSTPARTUM depression ,PSYCHOLOGICAL tests ,QUESTIONNAIRES ,RESEARCH ,RESEARCH funding ,THOUGHT & thinking ,TIME ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,PREDICTIVE tests ,DISEASE remission ,SEVERITY of illness index ,EVALUATION of human services programs ,PSYCHOLOGICAL factors ,ECONOMICS ,THERAPEUTICS - Abstract
Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 ≥ 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.Trial Registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014). [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
47. Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial.
- Author
-
Vickerstaff, Victoria, Ambler, Gareth, Bunce, Catey, Wen Xing, Gazzard, Gus, Xing, Wen, and LiGHT Trial Study Group
- Subjects
CLINICAL trials ,OPEN-angle glaucoma ,GLAUCOMA ,OCULAR hypertension ,MEDICAL statistics ,OPHTHALMOLOGY ,GLAUCOMA diagnosis ,GLAUCOMA treatment ,COMBINED modality therapy ,COMPARATIVE studies ,DRUG administration ,EXPERIMENTAL design ,ANTIHYPERTENSIVE agents ,MEDICAL lasers ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL protocols ,OPHTHALMIC drugs ,QUALITY of life ,QUESTIONNAIRES ,RESEARCH ,STATISTICS ,TIME ,DATA analysis ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,STATISTICAL models ,INTRAOCULAR drug administration ,TRABECULECTOMY ,DIAGNOSIS ,THERAPEUTICS - Abstract
Background: The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study.Methods/design: The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses.Trial Registration: The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 . [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
48. "I never expected that it would happen, coming to ask me such questions":Ethical aspects of asking children about violence in resource poor settings.
- Author
-
Devries, Karen M., Child, Jennifer C., Elbourne, Diana, Naker, Dipak, and Heise, Lori
- Subjects
CHILDREN & violence ,PSYCHOLOGICAL child abuse ,CHILD sexual abuse ,SCHOOL violence ,SCHOOL children ,ATTITUDE (Psychology) ,PREVENTION of child abuse ,PREVENTION of child sexual abuse ,CHILD abuse & psychology ,CHILD abuse ,CHILD behavior ,COMPARATIVE studies ,DEVELOPING countries ,EMOTIONS ,EXPERIMENTAL design ,HEALTH services accessibility ,INFORMED consent (Medical law) ,INTERPERSONAL relations ,INTERVIEWING ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL referrals ,SENSORY perception ,PUBLIC health laws ,PUNISHMENT ,RESEARCH ,RESEARCH funding ,RESEARCH ethics ,RISK assessment ,TEENAGERS' conduct of life ,QUALITATIVE research ,EVALUATION research ,SOCIAL context ,RANDOMIZED controlled trials ,CROSS-sectional method ,ECONOMICS - Abstract
Background: International epidemiological research into violence against children is increasing in scope and frequency, but little has been written about practical management of the ethical aspects of conducting such research in low and middle-income countries. In this paper, we describe our study procedures and reflect on our experiences conducting a survey of more than 3,700 primary school children in Uganda as part of the Good Schools Study, a cluster randomised controlled trial of a school-based violence prevention intervention. Children were questioned extensively about their experiences of physical, sexual, and emotional violence from a range of different perpetrators. We describe our sensitisation and consent procedures, developed based on our previous research experience and requirements for our study setting. To respond to disclosures of abuse that occurred during our survey, we describe a referral algorithm developed in conjunction with local services. We then describe our experience of actually implementing these procedures in our 2012 survey, based on reflections of the research team. Drawing on 40 qualitative interviews, we describe children's experiences of participating in the survey and of being referred to local child protection services.Results: Although we were able to implement much of our protocol in a straightforward manner, we also encountered major challenges in relation to the response of local services to children's disclosures of violence. The research team had to intervene to ensure that children were provided with appropriate support and that our ethical obligations were met.Conclusions: In resource poor settings, finding local services that can provide appropriate support for children may be challenging, and researchers need to have concrete plans and back-up plans in place to ensure that obligations can be met. The merits of mandatory reporting of children's disclosures to local services need to be considered on a case by case basis-in some places this has the potential to do harm. Research teams also must agree on what level of ancillary care will be provided, and budget accordingly. Further practical examples of how to address the challenges encountered in this work are needed, in order to build a consensus on best practices.Trial Registration: NCT01678846 (clinicaltrials.gov), August 24, 2012. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
49. How to assess success of treatment when using multiple doses: the case of misoprostol for medical abortion.
- Author
-
Seuc, Armando H., Shah, Iqbal H., Ali, Moazzam, Diaz-Olavarrieta, Claudia, and Temmerman, Marleen
- Subjects
MISOPROSTOL ,ABORTIFACIENTS ,DRUG dosage ,INFERTILITY treatment ,REPRODUCTIVE technology ,CLINICAL trials ,ABORTION statistics ,ABORTION ,BIOLOGICAL assay ,COMPARATIVE studies ,COMPUTER simulation ,DOSE-effect relationship in pharmacology ,EXPERIMENTAL design ,HIGH performance computing ,LIFE expectancy ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,RESEARCH funding ,STATISTICS ,DATA analysis ,EVALUATION research ,TREATMENT effectiveness ,STATISTICAL models ,KAPLAN-Meier estimator - Abstract
Background: The assessment of treatment success in clinical trials when multiple (repeated) doses (courses) are involved is quite common, for example, in the case of infertility treatment with assisted reproductive technology (ART), and medical abortion using misoprostol alone or in combination with mifepristone. Under these or similar circumstances, most researchers assess success using binomial proportions after a certain number of consecutive doses, and some have used survival analysis. In this paper we discuss the main problems in using binomial proportions to summarize (the overall) efficacy after two or more consecutive doses of the relevant treatment, particularly for the case of misoprostol in medical abortion studies. We later discuss why the survival analysis is best suited under these circumstances, and illustrate this by using simulated data.Methods: The formulas required for the binomial proportion and survival analysis (without and with competing risks) approaches are summarized and analytically compared. Additionally, numerical results are computed and compared between the two approaches, for several theoretical scenarios.Results: The main conceptual limitations of the binomial proportion approach are identified and discussed, caused mainly by the presence of censoring and competing risks, and it is demonstrated how survival analysis can solve these problems. In general, the binomial proportion approach tends to underestimate the "real" success rate, and tends to overestimate the corresponding standard error.Conclusions: Depending on the rates of censored observations or competing events between repeated doses of the treatment, the bias of the binomial proportion approach as compared to the survival analysis approaches varies; however, the use of the binomial approach is unjustified as the survival analysis options are well known and available in multiple statistical packages. Our conclusions also apply to other situations where success is estimated after multiple (repeated) doses (courses) of the treatment. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
50. Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST).
- Author
-
Scutt, Polly, Blackburn, Dan, Krishnan, Kailash, Ballard, Clive, Burns, Alistair, Ford, Gary A., Mant, Jonathan, Passmore, Peter, Pocock, Stuart, Reckless, John, Sprigg, Nikola, Stewart, Rob, Wardlaw, Joanna M., and Bath, Philip M.
- Subjects
STROKE ,COGNITION disorders ,DISEASE complications ,DEMENTIA ,BLOOD pressure ,RANDOMIZED controlled trials ,PREVENTION ,COGNITION disorders diagnosis ,DIAGNOSIS of dementia ,DEMENTIA prevention ,STROKE diagnosis ,ANTILIPEMIC agents ,COGNITION ,COMPARATIVE studies ,ANTIHYPERTENSIVE agents ,LONGITUDINAL method ,LOW density lipoproteins ,NEUROPSYCHOLOGICAL tests ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL protocols ,RESEARCH ,TIME ,SAMPLE size (Statistics) ,PILOT projects ,EVALUATION research ,TREATMENT effectiveness ,PATIENT selection ,STROKE rehabilitation ,PSYCHOLOGICAL factors ,PSYCHOLOGY - Abstract
Background: A common complication after stroke is development of cognitive impairment and dementia. However, effective strategies for reducing the risk of developing these problems remain undefined. Potential strategies include intensive lowering of blood pressure (BP) and/or lipids. This paper summarises the baseline characteristics, statistical analysis plan and feasibility of a randomised control trial of blood pressure and lipid lowering in patients post-stroke with the primary objective of reducing cognitive impairment and dementia.Methods: The Prevention Of Decline in Cognition After Stroke Trial (PODCAST) was a multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial internal pilot trial running in secondary and primary care. Participants without dementia were enrolled 3-7 months post ischaemic stroke or spontaneous intracerebral haemorrhage, and randomised to intensive versus guideline BP lowering (target systolic BP <125 mmHg versus <140 mmHg); patients with ischaemic stroke were also randomised to intensive or guideline lipid lowering (target LDL cholesterol <1.4 mmol/L versus <3 mmol/L). The primary outcome was the Addenbrooke's Cognitive Examination-Revised; a key secondary outcome was to assess feasibility of performing a large trial of one or both interventions. Data are number (%) or mean (standard deviation). The trial was planned to last for 8 years with follow-up between 1 and 8 years. The plan for reporting the main results is included as Additional file 2.Results: 83 patients (of a planned 600) were recruited from 19 UK sites between 7 October 2010 and 31 January 2014. Delays, due to difficulties in the provision of excess treatment costs and to complexity of follow-up, led to few centres taking part and a much lower recruitment rate than planned. Patient characteristics at baseline were: age 74 (SD 7) years, male 64 (77 %), index stroke ischaemic 77 (93 %), stroke onset to randomisation 4.5 [SD 1.3] months, Addenbrooke's Cognitive Examination-Revised 86 (of 100, SD 8), Montreal Cognitive Assessment 24 (of 30, SD 3), BP 147/82 (SD 19/11) mmHg, total cholesterol 4.0 (SD 0.8) mmol/L and LDL cholesterol 2.0 (SD 0.7) mmol/L, modified Rankin Scale 1.1 (SD 0.8).Conclusion: Limited recruitment suggests that a large trial is not feasible using the current protocol. The effects of the interventions on BP, lipids, and cognition will be reported in the main publication.Trial Registration: ISRCTN85562386 registered on 23 September 2009. [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.