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1
Newbury, Jonathan. "75+ health assessments : a randomised controlled trial." Title page, contents and abstract only, 2001. http://thesis.library.adelaide.edu.au/adt-SUA/public/adt-SUA20011123.113220.
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Includes bibliographical references. Electronic publication; full text available in PDF format; abstract in HTML format. The aims of this study were to compare preventative care for the elderly, known as 75+ Health Assessment (75+ HA), with usual care in a randomised controlled trial in the elderly living independently in their own home. Further, the study aims to evaluate whether there are measurable differences in defined primary and secondary outcome measures between the control and intervention groups. The results of the trial are discussed and recommendations made. Electronic reproduction.[Australia] :Australian Digital Theses Program,2001. 283, [15] leaves : ill. ; 30 cm.
2
Caldwell, Patrina Ha Yuen. "The Recruitment of Children to Randomised Controlled Trials." University of Sydney. Paediatrics and Child Health, 2003. http://hdl.handle.net/2123/579.
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Abstract Background The randomised-controlled trial (RCT) provides the best evidence for evaluating treatment effects and is accepted as a gold standard for clinical and regulatory decision making (1;2). One of the major challenges to the conduct of RCTs is the recruitment of adequate numbers of participants. Inadequate numbers reduce the power of a study to detect statistically significant treatment effects, and may cause delays, increased costs and failure to complete trials. The need for clinical trials in children has been increasingly recognised by the scientific community, resulting in increased demands for the inclusion of children in trials. For several reasons, recruiting children to trials is more challenging than recruiting adults, as consent issues are more difficult because parents make decisions about trial participation on behalf of their child. Despite general professional and community support for paediatric clinical trials, parents and paediatricians express reluctance when their own child or patient is asked to participate. Although researchers working with children commonly experience difficulty with recruiting children to RCTs, little is known about this very important subject. The method by which potential participants are approached for trial participation, the influence of their health care provider and the attitude of potential participants (or their parents, in the case of children), are critical to the understanding of the decision making process for trial participation. This thesis is one of the first major attempts to explore the issues surrounding the recruitment of children to RCTs, and is divided into four studies which address these issues. Methods Recruitment strategies used to encourage participation in randomised controlled trials (systematic review) Eligible experimental and observational studies comparing methods of recruiting participants for RCTs were identified after a comprehensive search of Medline, Embase, the Cochrane Library and reference lists. Independent data extractions were completed by two reviewers who assessed the studies for eligibility and methodological quality. Outcome measures were consent rates, proportion enrolled by each method and cost of recruitment per participant. Summary estimators of effects were calculated using a random effects model and expressed as relative risk with 95% confidence intervals. Heterogeneity was analysed using the Q statistic. Paediatricians� attitudes to children�s participation in randomised controlled trials (focus group research) Qualitative analysis of focus group discussions involving 16 paediatricians and 5 trainees from a paediatric teaching hospital in Sydney was undertaken. Doctors varied in occupation, experience, research activity, age, gender, ethnicity and parenthood experience. A professional facilitator conducted the semi-structured group discussions. Recruitment ceased when informational redundancy was reached, after 4 focus groups involving 21 participants. The transcribed audiotapes were analysed by theme linkage using the constant comparative method. Australian paediatricians� and adult physicians� attitudes to randomised controlled trials (survey) A 44-item questionnaire was sent to 250 paediatricians and 250 adult physicians randomly selected from the membership list of the Royal Australasian College of Physicians. Questions assessing doctors� treatment philosophies and attitudes to trials were compared with demographic and practice variables. Parents� attitudes to children�s participation in randomised controlled trials (focus group research) Qualitative analysis of focus group discussions involving 33 parents from 5 different settings (representing parents of children with a life threatening, chronic or acute illness, with experience in trials and of healthy children) was undertaken. Parents varied in age, gender, ethnicity, level of education, research experience and their child�s health status. The transcribed discussions were analysed by theme linkage using the constant comparative method. Results Recruitment strategies used to encourage participation in randomised controlled trials (systematic review) Fifty papers were included (out of 8602 titles and abstracts searched) which described 8 RCTs, 2 quasi RCTs, 13 prospective cohort studies, 30 retrospective cohort studies and 2 before-after studies. These studies assessed how over 4 million people were approached for RCT participation using 87 different recruitment strategies, with 103,406 people enrolling in RCTs. Health care provider (HCP) referrals had the highest participant consent rates at the time of exposure to trial information (HCP referral versus target mailing: relative risk (RR) 1.84 (95% confidence interval (95%CI) 1.08, 3.13)). They also had the highest consent rates when potential participants respond to the recruitment material by further enquiry about the trial (HCP referral versus community presentation: RR 1.37 (1.06; 1.78); HCP referral versus worksite approach: RR 25.20 (20.19, 31.45); HCP referral versus general community approach: RR 2.53 (0.46, 14.05); HCP referral versus mailing: RR 3.29 (1.26, 8.60); HCP referral versus media: RR 2.66 (1.31, 5.41)). However, by the time potential participants attend eligibility assessment for trial participation, no difference in consent rates could be distinguished by method of recruitment. Higher proportions of study participants were recruited by methods that exposed larger numbers of potential candidates to trial information (despite their lower consent rates). The stated recruitment cost ranged from US$0 to $1108 per participant, with mailing being the most cost-effective method and community methods (such as community presentations, pamphlets and posters displayed at community sites) the least effective. Paediatricians� attitudes to children�s participation in randomised controlled trials (focus group research) From the focus group discussions, paediatricians thought parents balanced perceived gains and risks when deciding about trial participation. They also believed the child�s condition and parents� health beliefs and personal attributes influenced parents� decisions. Other factors thought to be important by paediatricians were the doctors� beliefs and their relationship with the investigators. Paediatricians perceived gains for trial participation including professional benefits for themselves, improved patient care, convenience for the families and themselves and scientific advancement. Perceived risks included inconvenience, inadequate resources and potential harms to the patient and the doctor-patient relationship. Paediatricians with previous research experience were most knowledgeable about RCTs and perceived greatest gains from trial participation. Paediatricians� personal treatment preferences hindered trial support. Australian paediatricians� and adult physicians� attitudes to randomised controlled trials (survey) Response rate from the paediatricians� and adult physicians� survey was 60% (300/500). Australian paediatricians and adult physicians are very similar in their treatment philosophies, and are clinician-oriented rather than research-oriented in their attitudes, with primary allegiance to their patients and preference for selecting treatment rather than referring for trial participation in the face of treatment uncertainty. Professional activities are clinically focused, with limited time assigned for research. Australian doctors perceive little reward for trial participation and claim that the opinions of referring doctors regarding RCTs does not influence them. Predictors of favourable attitudes to trial participation from the survey were time allocation for research, a history of referring patients to trials in the past and younger age (all p values less than 0.0001). Parents� attitudes to children�s participation in randomised controlled trials (focus group research) When parents were interviewed, they acknowledged balancing risks and benefits when deciding about trial participation for their child. Perceived benefits include the offer of hope, better care of their child, the opportunity to access new treatments, healthcare professionals and health information, meeting others in similar circumstances and helping others. Perceived risks include potential side effects, being randomised to ineffective treatments and the inconvenience of participation. The decision for trial participation is also influenced by parental factors (parents� knowledge, beliefs and emotional response), child factors (the child�s health status and preference about participation), trial factors (the use of placebos and the uncertainties of research) and doctor factors (doctor�s recommendations and communication of trial information). Conclusions There are many challenges to the successful conduct of RCTs. Ways of addressing these include: using effective methods of recruiting potential study participants (such as mailing of recruitment material to potential participants) and abandoning ineffective strategies (such as community methods): fostering greater willingness for trial participation by addressing parents� and paediatricians� concerns including enhancing communication between researchers, paediatricians and parents, and improving the gains-hazard balance (by increasing incentives while decreasing inconveniences); and reforming in the health care system to raise the priority placed on clinical research by restructuring clinical research in a clinically predominant workplace and with a clinically predominant workforce. The findings from this study have implications for researchers planning RCTs for children in the future. Careful consideration of the above will enhance RCTs participation for children improving efficiency, lowering costs and ultimately improving the future health care of children.
3
Finnegan, Olwyn Ava. "Facilitating cardiac rehabilitation behaviours : a randomised controlled trial." Thesis, University of Leeds, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.410935.
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Coskinas, Xanthi. "Changes to design aspects of ongoing randomised controlled trials." Thesis, The University of Sydney, 2022. https://hdl.handle.net/2123/29452.
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Unplanned changes to the research plan of a randomised controlled trial (RCT) may be a necessary response to unforeseen circumstances. Such changes can help ensure the value and relevance of a trial, but also have the potential to introduce a bias if performed inappropriately.
This thesis addresses three broad aims. The first was to highlight the methodological implications of approaches to making various unplanned changes through a series of simulation studies. The second was to estimate the prevalence of such changes to a contemporary sample of published RCTs registered with the Australian New Zealand Clinical Trial Registry (ANZCTR). The third was to assess, and extend as applicable, recommendations for ensuring such changes are performed appropriately and are well documented.
The simulation studies were performed using data from a large RCT of statin therapy for secondary prevention. The first of these demonstrated how unplanned changes (to various aspects of the design such as the primary endpoint) risks introducing a bias if undertaken with knowledge of treatment allocation, but not if made without knowledge of treatment allocation. The second investigated strategies for reacting to an observed imbalance on baseline prognostic factors in an RCT. It demonstrated that: continuing with original plans of unadjusted analyses, provided
valid p-values irrespective of the direction of the prognostic imbalance, and any decisions informed by knowledge of the direction of the prognostic covariate imbalance were prone to bias. The third simulation study investigated strategies for reacting to a lower-than-expected event rate. It showed that switching to an expanded composite endpoint in response to a low pooled event rate does not inflate the type 1 error rate (and is likely to improve the statistical power, provided the expanded composite is sound).
A sample of 181 RCTs that were registered with the ANZCTR and had published a primary result paper were assessed for changes to their research plans, and whether these changes were legitimate or not (that is, made with or without knowledge of treatment allocation). A full audit was conducted on trials with accessible protocols (N=124) and a limited central review on trials without accessible protocols (N=57). The primary results publication was cross-checked with the protocol documents across six methodological aspects for the full audit, and trialists were contacted to resolve queries as necessary. The publication was checked against the registry record for the limited central review, over a subset of three methodological aspects. A key finding of this study was that it was often not possible to reliably assess whether changes had been made or whether changes were made in a blinded manner, based on review of documentation alone. After clarification was sought from the participating trialists, changes were found to be relatively common but typically made in a blinded manner. Improvements to the way unplanned changes to RCT research plans are documented are needed.
A set of recommendations to supplement existing guidelines relating to the documentation of RCT research plans was developed. One key recommendation was that trialists should adopt and implement the principles of the recently developed CONSERVE 2021 Statement to appropriately perform and document substantive changes. A second was that strategies that oblige trialists to upload full protocols (and protocol amendments) to clinical trial registries warrant further investigation and further consideration should be given to including all key methodological aspects in registry records.
The work undertaken provides valuable guidance for trialists (and stakeholders) on how to make and document a methodologically justifiable change to a planned RCT design/analysis and highlights the circumstances under which a change can lead to bias. This is important for ensuring that methodically unsound changes to RCTs are recognised and avoided, and that RCTs that have undergone methodically sound changes are not incorrectly dismissed as potentially biased.
5
Barkun, Jeffrey S. "A randomised controlled trial comparing laparoscopic to mini cholecystectomy /." Thesis, McGill University, 1993. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=68154.
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To better define the differences between laparoscopic (LC) and mini cholecystectomy (MC) in treating cholelithiasis, we conducted a randomized controlled trial with 70 patients (LC:38, MC:32).Both groups were comparable at baseline. The median length of post-operative hospital stay and time to full diet were significantly shorter in LC than MC (p $<$ 0.005 for both). Mean duration of convalescence was 11.9 ($ pm$9.1) days for LC and 20.2 ($ pm$16.5) days for MC (p = 0.04). Kaplan-Meier survival analysis confirmed these results. Using Cox's proportional hazards model, duration of convalescence was only found to be associated with the type of cholecystectomy performed. Three quality of life scores showed that LC patients improved more quickly than MC patients after cholecystectomy.
Surgeons underestimated convalescence on average by 25% (p $<$ 0.01) when compared to nurses' measurements.
In conclusion, even though recovery after MC was shorter than generally anticipated, time to recovery from LC was still shorter and more predictable than MC.
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Schroer, Sylvia. "Developing a randomised controlled trial of acupuncture for depression." Thesis, University of York, 2009. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.538622.
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Woodward, Joanne Lois. "The challenge of conducting a waterbirth randomised controlled trial." Thesis, University of Birmingham, 2012. http://etheses.bham.ac.uk//id/eprint/3392/.
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Waterbirths have been available in the United Kingdom as a method of pain relief for childbirth for over two decades but the neonatal safety of birth in water remains unevaluated. Opponents of a waterbirth randomised controlled trial state randomisation would undermine women’s childbirth experience. In addition, little is known about midwives’ attitudes to waterbirths. This thesis addresses some of the lack of evidence by reporting the findings of two studies which had three aims: to investigate the feasibility of a waterbirth RCT to assess the effects of a waterbirth on the neonate, to explore women’s thoughts about participation and whether randomisation affects women’s satisfaction with their childbirth experience and to assess midwives’ attitudes to waterbirths. The first study involved a RCT with a ‘preference arm’. Eighty women were recruited: 60 in the RCT and 20 in the ‘preference arm’. Women were asked to complete questionnaires to assess their expectations for, and satisfaction with, their childbirth experience: at recruitment, after the birth and 6 weeks after the birth. Women in the randomised arm indicated willingness to partake but questioned midwives’ commitment to offering waterbirths. A Q Methodology study was undertaken to identify factors which influence midwives’ (n=31) attitudes towards waterbirths. Four factors were identified: Motivation, Risk Assessment, Confidence, Safety. Conclusion: It is feasible to organise a larger RCT to assess neonatal safety and women would be supportive. Strategies would be required to ensure midwives are confident and supportive of the waterbirth service.
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Featherstone, Katie. "Patient perspectives of participation in a randomised controlled trial." Thesis, University of Bristol, 2000. http://hdl.handle.net/1983/06229618-6e8d-4764-8c7a-1f0c0d0af307.
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Dakin, Helen A. "Economic evaluation of factorial randomised controlled trials." Thesis, University of Oxford, 2015. http://ora.ox.ac.uk/objects/uuid:77eda1f6-dd8c-439a-8871-75fd57a4c7f5.
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Factorial randomised controlled trials (RCTs) evaluate two or more interventions simultaneously, enabling assessment of interactions between treatments. This thesis presents literature reviews, methodological reviews, simulation studies and applied case studies that explore methods for assessing cost-effectiveness based on factorial RCTs. My systematic review suggests that factorial RCTs account for around 3% of trial-based economic evaluations, although there is currently no guidance or methodological work indicating the most appropriate methods. Around 40% of published studies assumed no interaction between treatments and many were poorly-reported. Various mechanisms are likely to produce large interactions within economic endpoints such as costs, quality-adjusted life-years (QALYs) and net benefits. Failing to take account of interactions can introduce bias and prevent efficient allocation of healthcare resources. I developed the opportunity cost of ignoring interactions as a measure of the implications of this bias. However, allowing for small, chance interactions is inefficient, potentially leading to over-investment in research if trial-based evaluations are used to inform decisions about subsequent research. Nonetheless, analyses on simulated trial data suggest that the opportunity cost of adopting a treatment that will not maximise health gains from the healthcare budget is minimised by including all interactions regardless of magnitude or statistical significance. Different approaches for conducting economic evaluations of factorial RCTs (including regression techniques, extrapolation using patient-level simulation, and considering different components of net benefit separately) are evaluated within three applied studies, including both full and partial factorials with 2x2 and 2x2x2 designs. I demonstrate that within both trial-based and model-based economic evaluation, efficient allocation of healthcare resources requires consideration of interactions between treatments, and joint decisions about interacting treatments based on incremental cost-effectiveness evaluated “inside-the-table” on a natural scale. I make recommendations for the design, analysis and reporting of factorial trial-based economic evaluations based on the results of this thesis.
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Saltvedt, Sissel. "Prenatal diagnosis in routine antenatal care : a randomised controlled trial /." Stockholm, 2005. http://diss.kib.ki.se/2005/91-7140-549-6/.
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Gray, Richard John. "A randomised controlled trial of medication management training for CPNs." Thesis, King's College London (University of London), 2001. https://kclpure.kcl.ac.uk/portal/en/theses/a-randomised-controlled-trial-of-medication-management-training-for-cpns(34bd9a07-da06-41f0-9002-222233ef3eba).html.
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Ussher, Michael Henry. "Randomised controlled trial of an exercise intervention for smoking cessation." Thesis, St George's, University of London, 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.270983.
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Rickard, Claire. "Prolonged use of intravenous administration sets: a randomised controlled trial." Thesis, Queensland University of Technology, 2004. https://eprints.qut.edu.au/15974/1/Claire_Rickard_Thesis.pdf.
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The purpose of this research study was to improve the nursing care of intravenous
catheters by providing evidence on the effects of prolonged duration of intravenous
administration set use.
Intravenous therapy is a vital part of modern health care. However, its invasive nature
can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with
administration sets used beyond this time. Previous research has been limited by the
inadequacy of available definitions for Catheter-Related Infection.
A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and
performance.
Central venous catheters were randomised to have their administration sets used for 4
days (n = 203) or 7 days (n = 201).
Percutaneous central venous catheters were enrolled into the study from two adult
intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were
multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit.
Catheters were cultured for microbial colonisation on removal using the Maki roll-plate
technique. Patients were assessed for CRBSI using the developed definitions consisting
of categories: definite, probable (type I and II), possible and absent. Prior to the clinical
trial, a practice survey questionnaire was administered, and laboratory experimentation
was performed.
Normality of distribution for continuous variables was assessed using the Kolmogorov-
Smirnov statistic. The distribution between groups of variables considered risk factors
for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test.
Logistic regression modelling was performed to analyse the influence of potentially
confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of
administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery.
There were 10 colonised tips in the intervention group and 19 in the control group. This
difference was not statistically significant (Kaplan Meier survival analysis, Log Rank =
0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI.
Prolonged intravenous administration set use of 7 days was found to have no significant
impact on patient infection indicators or physical performance of the sets. This finding is
congruent with previous research and trends in current clinical practice.
In conclusion, the research findings support the use of intravenous administration sets
for 7 days.
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Rickard, Claire. "Prolonged use of intravenous administration sets: a randomised controlled trial." Queensland University of Technology, 2004. http://eprints.qut.edu.au/15974/.
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The purpose of this research study was to improve the nursing care of intravenous catheters by providing evidence on the effects of prolonged duration of intravenous administration set use. Intravenous therapy is a vital part of modern health care. However, its invasive nature can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with administration sets used beyond this time. Previous research has been limited by the inadequacy of available definitions for Catheter-Related Infection. A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and performance. Central venous catheters were randomised to have their administration sets used for 4 days (n = 203) or 7 days (n = 201). Percutaneous central venous catheters were enrolled into the study from two adult intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit. Catheters were cultured for microbial colonisation on removal using the Maki roll-plate technique. Patients were assessed for CRBSI using the developed definitions consisting of categories: definite, probable (type I and II), possible and absent. Prior to the clinical trial, a practice survey questionnaire was administered, and laboratory experimentation was performed. Normality of distribution for continuous variables was assessed using the Kolmogorov- Smirnov statistic. The distribution between groups of variables considered risk factors for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test. Logistic regression modelling was performed to analyse the influence of potentially confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery. There were 10 colonised tips in the intervention group and 19 in the control group. This difference was not statistically significant (Kaplan Meier survival analysis, Log Rank = 0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI. Prolonged intravenous administration set use of 7 days was found to have no significant impact on patient infection indicators or physical performance of the sets. This finding is congruent with previous research and trends in current clinical practice. In conclusion, the research findings support the use of intravenous administration sets for 7 days.
15
Hutchison, Catherine B. "A randomised controlled trial of an audiovisual patient information intervention in cancer clinical trials." Thesis, University of Stirling, 2008. http://hdl.handle.net/1893/442.
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Introduction and background Recruitment to cancer clinical trials needs to be improved, as does patient understanding about clinical trials, to enable patients to make an informed choice about whether or not to take part. The main reason that clinically eligible patients do not take part in clinical trials is because they refuse; poor understanding of the research has been associated with patient refusal. Audiovisual patient information (AVPI) has been shown to improve knowledge/understanding in various areas of practice but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to recruitment rates. Understanding the research is necessary for informed consent, and it was hypothesised that if patient understanding about clinical trials was increased with AVPI, then this could result in a reduction in the number of patients refusing clinical trials, and therefore provide an ethical approach to improving recruitment. This study aimed to test the impact of an audiovisual patient information intervention on recruitment to randomised cancer clinical trials (refusal rates), patient understanding of the information given, and levels of anxiety. Reasons for patients’ decisions about trial participation were also assessed. Method An AVPI intervention was developed that aimed to address the common misconceptions associated with randomisation and clinical equipoise, as well as improve patient understanding generally of randomised cancer trials, and of other core clinical trial informational requirements, such as voluntariness. Patients were randomised to receive either AVPI in addition to the standard trial-specific written information, or the written information alone. A new questionnaire was developed to assess patient understanding (also referred to as knowledge) in the randomised trial setting and, following testing with patients and research nurses, this was shown to be reliable and valid. Patients completed self-report questionnaires to assess their understanding (new knowledge questionnaire) and anxiety (Spielberger State-Trait Anxiety Inventory), at baseline and after they had made their decision about clinical trial entry, when their perceptions of the intervention, as well as factors contributing to their decision were also determined (this tool incorporated Jenkins and Fallowfield’s (2005) questionnaire which assessed reasons for accepting and declining randomised cancer trials). Results A total of 173 patients with breast cancer (65%), colorectal cancer (32%) and lung cancer (3%) were entered into the main study. The median age was 60 (range 37-92 years). There was no difference in clinical trial recruitment rates between the two groups: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores increased more in the intervention group compared to the standard group (U= 2029, p=0.0072). The change in anxiety score between the arms was also statistically significant (p=0.011) with anxiety improving in the intervention arm more than in the no-intervention arm. The estimated difference in the median anxiety change score between the groups is –4.6 (95% ci –7.0 to –2.0). Clinical trial entry was not influenced by tumour type, stage of cancer, age, educational qualifications or previous research experience, however, there was a modest association with deprivation status (p=0.046) where more affluent patients were the least likely to consent to a trial. Educational qualifications and stage of cancer were independently associated with knowledge: patients who were better educated had higher levels of knowledge about randomised trials, and patients who had limited stage of cancer had higher baseline knowledge than patients with advanced cancer. Acceptability of the intervention was high with 93% of those who watched it finding it useful, and 42% stating that it made them want to take part in the clinical trial. Personal benefit and altruism were key motivating factors for clinical trial participation, with reasons for refusal being less clear. Discussion and conclusions Although the potential for AVPI to increase clinical trial recruitment rates was highlighted in the literature, in this study, AVPI was not shown to have any effect on refusal rates to randomised cancer trials. However, by improving patient understanding prior to decision making, AVPI was shown to be a useful addition to the consent process for randomised cancer trials. AVPI addresses the fundamental ethical challenges of informed consent by improving patient understanding, and supports the ethical framework integral to Faden and Beauchamp’s (1986) theory of informed consent. The new knowledge questionnaire was shown to be a sensitive and effective instrument for measuring understanding of randomised clinical trials in the cancer setting, although it would benefit from further testing. The AVPI appears to reduce anxiety at the decision making time point and has been shown to be an acceptable medium for patients. This study confirms existing findings from studies assessing factors affecting decision making, with personal benefit and altruism being key motivating factors, and reasons for refusal being less clear. The need for further qualitative work in this area is highlighted to gain a deeper understanding of what is important to patients, in terms of why they refuse clinical trial participation. Implications for practice and further research Several implications for practice have been identified, including using AVPI as part of the standard information package for patients considering randomised cancer trials, and focussing on patient and staff education in this area. The knowledge questionnaire could be introduced to routine practice as a tool to determine patient understanding prior to decision making, allowing clinicians the opportunity to correct any misconceptions prior to consent. Further research focussing on AVPI specific to individual trials would be helpful, to determine if a more customised approach would be of benefit in terms of clinical trial recruitment. The importance of studying other aspects of the consent process such as the interaction between the clinician and the patient, in addition to more detailed exploration of the factors affecting patients’ decisions were highlighted.
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Zhang, Dalu. "The conduct of randomised controlled trials in China : quality of trial reports and stakeholders’ views." Thesis, University of Birmingham, 2010. http://etheses.bham.ac.uk//id/eprint/885/.
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China is an emerging force in undertaking randomised clinical trials. The quality of trials from China may affect not only its own substantial population but also potentially contribute to health policy throughout the world. However, little is known about the quality of clinical trials conducted there. In this thesis, I will evaluate the quality of published Chinese randomised controlled trials (RCTs) by comparing them with Indian RCTs as well as a set of ‘gold standard’ trials reported in leading European and North American journals. I will also describe and contrast the quality and biases within Chinese RCTs. I then explore the reasons for these differences from the point of view of the major RCT stakeholders: Chinese clinicians and patients. The potential influences from Chinese traditional culture is also evaluated. Chinese medical journal editors need to undertake more training on the reporting of RCTs; all medical societies should take more concern about doctors’ research work; the Chinese public media should help the general population to understand more about RCT principles.
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Kwan, Kwok-loi Queenie. "Randomised controlled trial for early intervention for autism : a pilot study /." View the Table of Contents & Abstract, 2007. http://sunzi.lib.hku.hk/hkuto/record/B3848061X.
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Kwan, Kwok-loi Queenie, and 關幗萊. "Randomised controlled trial for early intervention for autism: a pilot study." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2007. http://hub.hku.hk/bib/B45011230.
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Burgess, Mary. "Postal self-exposure treatment of recurrent nightmares : a randomised controlled trial." Thesis, King's College London (University of London), 2001. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.369056.
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James, Nicola Jayne. "A randomised controlled trial of HIV prevention in a clinic setting." Thesis, University of Nottingham, 1997. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.339550.
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DiGuiseppi, Carolyn Grace. "Cluster-randomised controlled trial of a smoke alarm give-away programme." Thesis, University College London (University of London), 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.269760.
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Singh, Navreen K. "Does colouring promote mindfulness and enhance wellbeing? : a randomised controlled trial." Thesis, University of Surrey, 2018. http://epubs.surrey.ac.uk/849293/.
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Objectives: Colouring books for adults have become increasingly popular. Some of these books are marketed on the basis that they improve mindfulness and promote wellbeing. Using a randomised design, this study aimed to empirically explore whether the provision of guidance on how to colour mindfully is necessary to increase mindfulness, and to reduce worry, perceived stress and work-related rumination. Moreover, the study aimed to assess whether changes in mindfulness predicted changes in worry, perceived stress and work-related rumination. The extent to which trait perfectionism might impact on possible beneficial effects of colouring was also explored. Design: Sixty-four participants (49 female, 15 male, 84% Caucasian, mean age 36) were randomly assigned to either a mindfulness-instructed condition (MI) or non-mindfulness instructed condition (NI). Participants were instructed to colour in designs in a book on 10 occasions over a two-week period. Mindfulness, worry, perceived stress and work-related rumination were measured pre and post the colouring intervention and at one-month follow up. Perfectionism was measured once, prior to the two-week colouring period. Results: Analysis of Covariance indicated no significant differences between conditions in post-colouring and follow up levels of mindfulness, perceived stress, worry or work-related rumination whilst controlling for pre-intervention scores. Oneway Repeated Measures Analysis of Variance for the whole sample indicated significant increases in acting with awareness and nonreacting mindfulness subscales, and a significant decrease in worry, affective rumination and problem-solving pondering pre-to post intervention. Changes in the nonjudging mindfulness facet pre-to post intervention were found to predict changes in worry from pre-intervention to follow up. There was little evidence of a relationship between perfectionism and change in wellbeing variables. Conclusions: Colouring, with or without mindfulness guidance, appears to increase aspects of mindfulness and improve wellbeing. Replication of these results, and further research exploring whether colouring is intrinsically mindful is warranted.
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Drury, Valerie. "Cognitive therapy and recovery from acute psychosis : a randomised controlled trial." Thesis, University of Birmingham, 1999. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.247312.
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Hillsdon, Melvyn. "A randomised controlled trial of physical activity promotion in primary care." Thesis, London School of Hygiene and Tropical Medicine (University of London), 2000. http://researchonline.lshtm.ac.uk/682303/.
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Aim of study: To compare the effectiveness of two contrasting communication styles with a no-intervention control group on self reported physical activity at 12 months follow up. Study Design: 1-year randomised controlled trial. Setting: Two large primary care medical centres in middle England. Subjects: 1, 658, 45-64 year old, insufficiently active men and women. Interventions: Thirty minutes of brief negotiation or direct advice, face-to-face, followed by 6 telephone contacts over 6 months. Main outcome measures: Self reported physical activity at 12 months. Secondary outcome measures were change in blood pressure and body mass index. Results: Both intervention groups and the control group significantly increased their physical activity over baseline (p<0.05). Intention to treat analyses revealed no between group differences for the combined intervention groups vs control and for brief negotiation vs direct advice. In treatment received analysis, the mean proportion change in physical activity for the brief negotiation group was 24% (95% CI 7 to 44) greater than controls with no significant difference between direct advice and controls. There was no change over baseline for body mass index in any group. Both the brief negotiation and the direct advice group reduced systolic blood pressure at 12 months but there were no between group differences. The brief negotiation group produced a -2.3 mmHg (95% CI-3.8 to -0.8) greater reduction in diastolic blood pressure than direct advice. Conclusion: For patients already attending primary care for conditions that might benefit from increased physical activity, it would be worthwhile delivering approximately 20 minutes of brief negotiation to increase their physical activity. It would also be better to avoid instructing them about the need to change. It would seem to be a waste of limited resources to specifically invite patients into primary care for no other reason than to try to intervene in their level of physical activity.
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Nandhra, Sarabijit Singh. "Is a primer needed for orthodontic bonding? : a randomised controlled trial." Thesis, University of Leeds, 2012. http://etheses.whiterose.ac.uk/3229/.
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Is a primer needed for orthodontic bonding? A Randomised controlled trial Objective: To evaluate the clinical performance of APC Victory IITM (3M Unitek) brackets in direct orthodontic bonding with and without the use of primer. Design: A single operator two centre prospective randomised controlled clinical trial. Setting: The orthodontic departments at the Leeds Dental Institute and St.Luke’s hospital, Bradford. Subjects and methods: 92 patients requiring orthodontic treatment with fixed appliances. 46 Patients randomly allocated to control (with primer) or test (without primer). Patients bonded using a standardised procedure. Main outcome measures: Number of bracket failures, time to bond-up appliances and the adhesive remnant index (ARI) when bracket failure occurred, over a six month period Results: Failure rate with primer 8.8%, without primer 13.8%, no statistically significant difference- P value 0.051. Mean difference in bondup time per bracket was 0.068 minutes which was not statistically significant (P =0.402). Statistically significant difference in the ARI – ARI 0 with primer 55.9%, no primer 81.5%, (P= 8.1622e-008). Conclusion: There is no statistically significant difference in the bracket failure rate with or without primer when bonding APC Victory IITM (P=0.051). No significant difference in bond-up times. Statistically significant difference in the ARI, bonding without primer providing a lower ARI.
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Andersson, Henrik, and Mikael Nilsson. "INTERNET-BASED MINDFULNESS-ACCEPTANCE-COMMITMENT IN SPORTS: A RANDOMISED CONTROLLED TRIAL." Thesis, Umeå universitet, Institutionen för psykologi, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-159893.
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The psychological aspects of sports is crucial for performance and important for sustaining good mental health. Despite this, efforts to improve those aspects are surprisingly rare and partly due to stigmatization of help-seeking together with lack of time and economic resources. However, in recent decades much research on internet-based interventions have been conducted. Also, a growing body of empirical support for the Mindfulness-Acceptance-Commitment approach (MAC) related to enhancement in performance and mental health in sports has emerged. This study was the first to explore the effects of internet-based MAC, which was conducted with the digital self-care programme ACTSPORT with or without feedback. Of 193 participants (aged 18 - 71, from 40 different sports on a variety of levels) who were randomly assigned to feedback, non-feedback and waitlist group, 125 completed the study. The results showed that participants who completed ACTSPORT with feedback experienced significantly enhanced performance, reduced performance anxiety and improved mental health, which included higher quality of life and less symptoms of depression. These improvements were predicted by significant improvements in acceptance and dispositional mindfulness. A larger effect was found for participants with feedback which indicated that some support is preferable. In conclusion, the present study indicate that internet-based interventions in sport may be effective, time-saving, cost-effective, flexible and available means for both enhancement in performance and aspects of mental health.De psykologiska faktorerna inom idrott är avgörande för prestation och viktiga för att upprätthålla god mental hälsa. Trots detta är ansträngningar för att förbättra dessa faktorer förvånansvärt sällsynta. Det beror bland annat på att det råder ett stigma kring att söka hjälp samt brist på tid och ekonomiska resurser. De senaste decennierna har det genomförts en stor mängd forskning på internetbaserade interventioner. Dessutom har Mindfulness-Acceptance-Commitment approach (MAC) fått en ökad mängd empiriskt stöd gällande förbättring i prestation och mental hälsa inom idrott. Föreliggande studie är den första i sitt slag att undersöka effekten av internetbaserad MAC, vilken genomfördes med det digitala självhjälpsprogrammet ACTSPORT med eller utan feedback. Av 193 deltagare (ålder 18 - 71, i 40 olika sporter på alla nivåer) som randomiserades till tre grupper med feedback, utan feedback eller väntelista, fullföljde 125 deltagare studien. Resultaten visade att deltagare som fullföljde ACTSPORT med feedback upplevde signifikant förbättrad prestation, minskad prestationsångest såväl som förbättrad mental hälsa vilket inkluderade högre livskvalité och minskade depressionssymtom. Detta visade sig kunna prediceras av signifikanta förbättringar i acceptans och dispositionell mindfulness. En större effekt sågs för deltagarna i gruppen med feedback vilket indikerade att ett visst stöd är fördelaktigt. Slutsatser från studien är att internetbaserade interventioner inom idrott kan vara effektiva, tidsbesparande, kostnadseffektiva, flexibla och tillgängliga medel för att både öka prestation och aspekter av mental hälsa.
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Jennings, Natasha A. "A randomised controlled trial evaluating outcomes of emergency nurse practitioner service." Thesis, Queensland University of Technology, 2015. https://eprints.qut.edu.au/83968/1/Natasha_Jennings_Thesis.pdf.
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The emergency nurse practitioner role was developed as an innovative and cost effective approach to meet increasing patient demand for health care. This thesis is the first contemporary study to evaluate clinical outcomes of the role within a complex systems-intervention framework. Emergency nurse practitioner service effectiveness was demonstrated through superior performance in delivery of timely analgesia for emergency department patients. The results validate nurse practitioner service as being able to demonstrate comparable outcomes. This research provides a much-needed evidence base supporting nurse practitioner service and its role in the changing health system and the reform agenda for service innovation.
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Smyth, Brendan Julian. "Randomised trial evidence in the delivery of haemodialysis." Thesis, University of Sydney, 2020. https://hdl.handle.net/2123/23659.
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The number of people with end-stage kidney disease (ESKD) requiring dialysis is rising around the world. Dialysis sustains life at enormous cost, both in terms of health care spending and, more importantly, in terms of poor quality of life, short life expectancy and high rates of cardiovascular disease. Despite this, the evidence base available to guide treatment decisions is small compared to other internal medicine specialties. This means that key aspects of treatment, such as the optimal amount of dialysis therapy, remain based on evidence that is at significant risk of bias. Even where randomised controlled trials (RCTs) do exist, it is unclear how representative the trial population is compared to the increasingly elderly and co-morbid general dialysis population. This thesis aimed to contribute to the development of a better RCT evidence base in dialysis. This was achieved, firstly, by analysis of the landscape of large RCTs enrolling dialysis patients from the point of view of generalisability and with reference to the global distribution of dialysis recipients. Secondly, current evidence concerning the dose of haemodialysis was reviewed and added to by a series of analyses of the A Clinical Trial of IntensiVE (ACTIVE) Dialysis trial of extended hours, compared to standard hours, haemodialysis. Thirdly, contributions were made to three new RCTs, employing different designs, including cluster randomisation and simplified consent models – which may increase the generalisability of the enrolled study cohort. Finally, two projects were established aiming to foster RCTs in nephrology, particularly in areas underserved by research infrastructure. Collectively, this thesis provides novel evidence for the benefits and limitations of extended hours haemodialysis, and advances our understanding of the state of RCTs in nephrology and of novel RCT designs. It also leaves a legacy of ongoing trials and useful resources for clinical researchers.
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Strange, Vicki. "An investigation into the use of randomised controlled trials to evaluate social interventions : a case study of a randomised controlled trial of peer led sex education." Thesis, University College London (University of London), 2006. http://discovery.ucl.ac.uk/10020508/.
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Walker, Helen. "Increasing attendance at a Hepatitis C screening clinic : a randomised controlled trial." Thesis, University of Sheffield, 2009. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.505338.
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Literature Review: The literature review presents an overview of non-attendance at colorectal cancer screening appointments and evaluates intervention strategies developed for increasing attendance. Although the review suggests that interventions increase attendance rates above baseline rates in services, there still remains a significant problem with non-attendance. Limitations of the studies and directions for future research are discussed. Research report: The study aimed to increase attendance at forthcoming Hepatitis C screening appointments within a substance misuse service. A two-fold intervention (an information leaflet and an implementation intention intervention), was developed and Theory of Planned Behaviour variables were explored. Participants (N = 161) were randomly allocated to one of four groups which received, prior to their appointment: (1) TAU, (2) a Theory of Planned Behaviour questionnaire, (3) an information sheet or (4) a combined intervention of the information sheet and implementation intention induction. Attendance at appointments was monitored; no significant differences in attendance rates were found between groups. Education and employment status were found to be significantly related to attendance. Addressing barriers to attendance through an information leaflet and an implementation intention intervention were not successful in increasing attendance rates in this 'hard to reach' population. Future directions for research in this area are suggested.
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Graffy, Jonathan Peter. "Evaluating breastfeeding support : a randomised controlled trial of support from breastfeeding counsellors." Thesis, University of Birmingham, 2002. http://etheses.bham.ac.uk//id/eprint/696/.
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Two-thirds of UK mothers begin breastfeeding, but many soon stop. Although breastfeeding benefits health, infant feeding is influenced by social and attitudinal factors. Study one prospectively investigated the attitudes and experiences of 514 women. Past experience predicted which multiparae would stop by six weeks. Manual social class and considering bottle feeding did so for primiparae. Perceived insufficient milk was the commonest reason for stopping. Study two, a randomised trial of support from breastfeeding counsellors, recruited 720 women. At four months, 46.1% (143/310) intervention and 42.3% (131/310) control women breastfed (Chi\(^2\)=0.942, P=0.33); 73.9% (229/310) vs 79.4% (246/310) gave bottle feeds (Chi\(^2\)=2.60, P=0.11). Survival analysis confirmed that differences between intervention and control women's partial and full breastfeeding duration were not significant (P=0.45 and 0.15 respectively.) Significantly fewer intervention women felt they had insufficient milk. Qualitative analysis of women’s comments revealed they wanted better information, practical help with positioning, effective advice, encouragement and their feelings acknowledged. Women valued counselling, but their feeding behaviour changed little, which may reflect the strength of social influences and that not all mothers contacted the counsellors postnatally. Practical support in the early postnatal period is important. Counselling may increase women's confidence in breastfeeding and producing enough milk.
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Halsey, Claire. "Randomised controlled trial of an intervention to increase attendance at parent training." Thesis, University of Sheffield, 2009. http://etheses.whiterose.ac.uk/14942/.
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Literature Review: Factors affecting attendance at parent training are presented and consideration is given to theoretical models which might be applied to this field. It is revealed that single parents, those of lower socio-economic status, lower income and experiencing mental health difficulties are less likely to attend. Therapist characteristics including experience, warmth and empathy and the use of administrative strategies all predict increased attendance. Parental motivation and expectations do not have clear roles in affecting parent training attendance. Methodological issues such as inconsistent definitions of attendance and small sample sizes are discussed, as are cautions about generalising findings from specific samples. The health belief model and the theory of planned behaviour are reviewed and considered to have potential for further study concerning attendance at parent training. Research Report: The investigation of a strategy to increase attendance at parent training is presented. One group of parents receive an experimental intervention to develop implementation intention's to overcome barriers to attendance, the control group do not. The two groups are compared on their attendance at parent training. Descriptive statistics indicate that parents in the experimental group do participate in more parent training sessions than the control group, however this trend failed to reach statistical significance. Parents with stronger intents to attend were statistically more likely to complete parent training. The development of implementation intentions prior to attendance was not found to enhance the clinical gains of parents attending parent training. Further research is recommended to explore the relevance of the theory of planned behaviour to parent training. Critical Appraisal: The origins of the project, its organisation and implementation are described. Points of learning are discussed, dissemination plans detailed and areas for continuing professional development expressed.
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Hill, Clare Marie. "'Forging a conviction' : participants' experiences of a western acupuncture randomised controlled trial." Thesis, University of Southampton, 2009. https://eprints.soton.ac.uk/144863/.
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Research into acupuncture has shown that individuals continue to report favourable clinical effects despite the lack of systematic evidence supporting a point specific therapeutic effect for real acupuncture treatment. This thesis presents a qualitative study, nested within a large randomised controlled trial of acupuncture specifically designed to investigate both specific and non-specific effects of western acupuncture for osteoarthritis pain. The aim was to explore the non specific effects of acupuncture in a trial context from the participants’ perspective, in particular the therapeutic relationship and any additional influences on the patient experience that might lead to non-specific effects on outcomes. Participants were recruited from hip or knee joint replacement waiting lists and randomised to one of three treatments (real acupuncture or 2 placebo controls) and one of two consultation conditions (empathic or non- empathic). The qualitative methodology was grounded theory. Data collection combined 27 post trial audio taped, semi structured interviews with post treatment debriefing, participant and non participant observation and personal reflections. The findings of this study identified a core category of ‘forging a conviction’ and a substantive theory of ‘active trial participation’ was developed. Participants gave reasons for entering the trial and for maintaining their commitment to it, despite numerous barriers. These experiences helped to forge convictions about the trial interventions and their effects. As a result a combination of specific and non specific influences appeared to impact on the participants’ reporting of outcomes, leading to discrepancies between the quantitative and qualitative data. This theory of ‘active participation’ in clinical trials challenges some of the basic assumptions of randomized controlled trials, most notably that participants are passive recipients of an intervention and report its effects factually.
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Carpenter, Tyrone Thomas. "A randomised placebo controlled trial of valdecoxib in the treatment of endometriosis." Thesis, University of Surrey, 2005. http://epubs.surrey.ac.uk/843710/.
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Endometriosis is a common condition affecting up to 10% of women of reproductive age. Despite being described nearly 150 years ago its aetiology remains unclear. In addition there is a clear lack of knowledge of the natural history of the condition if left untreated. Numerous medical treatments have been described and are in common use, however the evidence for their efficacy at causing disease regression is limited at best. For endometriotic implants to continue to grow they need to develop additional blood supply and their angiogenic potential has been demonstrated. Vascular endothelial growth factor and prostaglandin E2 are, at least in part, believed to be responsible for this. Both of these require cyclooxygenase 2 for their production. Oestrogen is also essential for the growth of endometriosis and high levels have been demonstrated in endometriotic lesions. Local oestrogen production is predominantly the result of aromatase activity which is potently induced by prostaglandin E2. It is thus hypothesised that if the action of cyclooxygenase 2 is inhibited, endometriosis will regress as a consequence of both inhibition of angiogenesis and reduction in local oestrogen concentration. Based on this theory a randomised double blind placebo controlled trial was undertaken to test the hypothesis that valdecoxib (a cyclooxygenase 2 inhibitor) will cause regression of peritoneal endometriosis in patients with minimal or mild disease over a twelve week period. No significant change in disease quantity was demonstrated compared to placebo. There was a consistent (but statistically insignificant) improvement in pain symptoms in those subjects taking valdecoxib compared to placebo. It is concluded that valdecoxib is ineffective at causing disease regression in minimal and mild endometriosis.
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Reynolds, Heather. "Dressing and Securement of Peripheral Arterial Catheters: A Pilot Randomised Controlled Trial." Thesis, Griffith University, 2014. http://hdl.handle.net/10072/367031.
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The purpose of this research was to assess the feasibility of the trial design and elements for future extensive study to provide evidence of the effectiveness of novel dressing/securement technologies to prevent catheter failure in peripheral arterial catheters in a larger research setting.
Peripheral arterial catheters are a type of intravascular catheter that is widely used in the care of critically ill patients. The catheter insertion site is usually covered with a commercially produced transparent dressing to maintain the position of the catheter, as well as endeavouring to prevent microbial entry to the wound. Arterial catheters may accidentally fall out, become blocked, or become infected, causing catheter failure, interrupted therapy, painful reinsertion, and decreased patient satisfaction. The infection risks of arterial catheters have often been underestimated. Inadequate peripheral intravascular catheter securement remains a poorly researched area of patient care, with a paucity of quality studies. Improved securement would likely prevent many cases of catheter failure.
The aim was to determine initial effectiveness of one dressing and two securement methods with the potential to minimise failure in peripheral arterial catheters compared with usual care, in a pilot study. Specified feasibility objectives for this pilot trial were to be considered successful if 90 out of 120 patients (75%) fulfilled the feasibility criteria regarding recruitment, delivery and adherence, retention, and patient/staff satisfaction with the study products. This would show that the research methods were suitable for use in a larger trial.Thesis (PhD Doctorate)
Doctor of Philosophy (PhD)
School of Nursing and Midwifery
Griffith Health
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Handley, Alicia Katherine. "A randomised controlled trial of group cognitive behavioural therapy for clinical perfectionism." Thesis, Curtin University, 2014. http://hdl.handle.net/20.500.11937/802.
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This thesis consisted of two linked studies. The first study examined the relationship between perfectionism and generalised anxiety disorder symptoms in a clinical sample. Perfectionism demonstrated significant associations with pathological worry and a principal diagnosis of generalised anxiety disorder. The second study examined the efficacy of group cognitive behavioural therapy for clinical perfectionism in a clinical sample. This treatment produced significant reductions in perfectionism and psychopathology and significant increases in self-esteem and quality of life.
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Smith, Caroline Anne. "Acupuncture to treat nausea and vomiting in early pregnancy : a randomised controlled trial." Title page, contents and abstract only, 2000. http://web4.library.adelaide.edu.au/theses/09PH/09phs644.pdf.
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Golley, Rebecca Kirsty, and rebecca golley@gmail com. "FAMILY-FOCUSED MANAGEMENT OF OVERWEIGHT IN PRE-PUBERTAL CHILDREN A RANDOMISED CONTROLLED TRIAL." Flinders University. Medicine, 2006. http://catalogue.flinders.edu.au./local/adt/public/adt-SFU20061018.021848.
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Over a quarter of children and two thirds of adults in Australia are overweight, with these estimates reflecting global trends. The literature review in Chapter 1 highlights that treatment of childhood overweight is an important part of the public health approach required to address the obesity epidemic. Energy moderation, behaviour modification and family support are the cornerstones of treatment of childhood overweight. However the evidence to guide best practice is limited, with a call being made for well designed studies to inform age-appropriate effective, long term child weight management. Studies are needed in a range of populations and to assess a range of health outcomes. This thesis tested the hypothesis that, pre-pubertal children whose parents participate in a parent-led, family-focused child weight management intervention comprising parent skills training and intensive lifestyle education will have adiposity, metabolic profiles and indicators of physical and psychosocial functioning after 12 months that are a) improved compared to children wait listed for intervention and b) no different to children whose parents participate in parenting skills training alone (without intensive lifestyle education).
Methods of the randomised controlled trial undertaken with 111 overweight, pre-pubertal 6-9 year olds to test this hypothesis are detailed in Chapter 2. Parents were defined as the agents of change, responsible for attending intervention sessions and implementing family-focused lifestyle change to support child weight management. Two interventions, both utilising parenting skills training, but differing in the presence or absence of intensive lifestyle eduction were compared to a group waitlisted for intervention with a brief pamphlet. Program effectiveness was defined in terms of adiposity together with broader health and evaluation outcomes.
Chapter 3 describes the study population, their flow through the study, the primary outcome BMI z score and waist circumference z score. With parenting plus intensive lifestyle education there was a 10% reduction in BMI z score over 12 months. However this was not statistically different to the 5% reduction observed with parenting alone or intervention waitlisting. There was a significant reduction in waist circumference between baseline and 12 months with parenting alone and parenting plus lifestyle education, but not waitlisting. There was a group, time and gender interaction, with boys receiving intervention having greater reductions in adiposity. In determining intervention effectiveness, growth, metabolic profile and psychosocial outcomes are presented in Chapter 4. While there were limited improvements in metabolic profile and body dissatisfaction, significant improvements were observed in parent-perceived HR-QOL relating to psychosocial and family functioning. Improvements were confined to the intervention groups, parenting plus lifestyle education more than parenting alone. Chapter 5 presents the study process and impact evaluation. Parents were satisfied with the program and reported that it provided the type of help they wanted. Personal, rather than program factors such as work and family commitments limited intervention attendance to 60%. Child health behaviours and parental weight status show positive change in all groups, but favour intervention. Chapter 6 highlights key findings, study strengths/limitations and areas for further research. In conclusion, a parent-led family-focused intervention utilising parenting skills training and healthy family lifestyle is a promising intervention for young overweight children.
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Sheppard, Sasha. "A randomised controlled trial comparing hospital at home with in-patient hospital care." Thesis, University of Oxford, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.284587.
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Smith, A. J. "Randomised controlled trial of a brief alcohol intervention in a facial injury clinic." Thesis, Cardiff University, 2000. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.540460.
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Hothersall, Eleanor Jane. "Effect of atorvastatin on asthma control and airway inflammation : a randomised controlled trial." Thesis, University of Glasgow, 2008. http://theses.gla.ac.uk/360/.
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Background Statins are inhibitors of the rate-limiting enzyme, 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase, in cholesterol biosynthesis. As such, they have been widely used in clinical practice as cholesterol lowering agents to reduce morbidity and mortality from coronary artery disease. There is evidence from clinical studies and in vitro experiments that statins have additional anti-inflammatory properties in atherosclerotic disease, which are unrelated to their lipid lowering activity. Clinical studies have previously suggested that statins might show a beneficial clinical effect in inflammatory diseases, such as rheumatoid arthritis and multiple sclerosis. Furthermore, preliminary data obtained in models of pulmonary inflammation suggest that the effects manifest in rheumatoid patients can be achieved also in asthma. A proof of concept study was designed to test the hypothesis that atorvastatin improves asthma control and airway inflammation in adults with asthma. Methods Fifty four adults with allergic asthma were recruited to a 22-week crossover randomised controlled trial comparing the effect on asthma control and airway inflammation of oral atorvastatin 40 mg daily with that of a matched placebo. Each treatment was administered for 8 weeks separated by a 6-week washout period. The primary outcome was morning peak expiratory flow. Secondary outcomes included spirometry, asthma control questionnaire (ACQ) score, asthma quality of life questionnaire (AQLQ), provocation concentration to methacholine (PC20) and inflammatory markers: exhaled nitric oxide, sputum differential cell count, sputum supernatant and serum inflammatory markers such as interleukin-6 (IL-6), IL-5, IL-8, sICAM-1, TNF-α, leukotriene B4 (LTB4) and high sensitivity C-reactive protein (hsCRP), and blood lymphocyte proliferation. Results At 8 weeks, the change in mean morning PEF, as compared with baseline, did not differ between the atorvastatin and placebo treatment periods [mean difference -0.5 L/min, 95% CI -10.6 to 9.6, p=0.921]. No statistically significant effect of atorvastatin was seen in evening PEF, or methacholine responsiveness (PC20). Out of all spirometry results, only post-salbutamol FVC showed a statistically significant result, which was slightly lower in the atorvastatin group [treatment difference -0.1L, 95% CI -0.2 to 0.0, p=0.037]. There was also no change in ACQ or AQLQ. No change was seen in exhaled nitric oxide. The total cell counts recovered from sputum were similar after atorvastatin compared to after placebo treatment. After 8 weeks, the mean absolute and relative sputum macrophage count was significantly reduced after atorvastatin compared to placebo [mean absolute difference -44.9x104 cells, 95% CI -80.1 to -9.7, p=0.029]. There was a reciprocal increase in the relative proportion of sputum neutrophils [mean proportion difference 13.1%, 95% CI 1.8 to 24.4, p=0.025], but there were no significant changes in the absolute count of these cells or the counts and proportions of the other sputum cell phenotypes under atorvastatin treatment. The sputum concentrations of inflammatory cytokines and mediators were similar after atorvastatin compared to after placebo treatment other than LTB4 which was significantly reduced [mean difference -88.1 pg/mL, 95% CI -156.4 to -19.9, p=0.014]. No significant difference was seen in the concentration of any serum marker of inflammation between atorvastatin and placebo treatment periods. The change in hsCRP was of borderline significance [mean difference -0.65 mg/L, 95% CI -1.38 to 0.09, p=0.082], but there were no changes in sICAM-1, TNF-α, IL-5, IL-6 and IL-8. There was no significant difference in lymphocyte proliferation. The biochemical effects of atorvastatin therapy were reflected in significant reduction in concentration of serum lipids; cholesterol (mean difference -1.71 mmol/l, 95% CI -1.94 to -1.48 p<0.0001), and HDL-cholesterol (mean difference -0.14 mmol/l, 95% CI -0.26 to -0.02 p=0.026), but not triglycerides. There were significant, albeit modest, increases in mean bilirubin, AST and ALT. There was no difference in compliance, assessed by number of tablets returned and by biochemical results. There was no correlation between changes in LTB4 or IL-8 and sputum macrophage count, sputum neutrophil count, or PEF. The only correlation observed between the variables that were compared was between sputum macrophages and neutrophils. Adverse event rates were similar in patients taking atorvastatin compared with placebo. Equal numbers of patients were lost to follow-up in both arms of the study. One patient died of unrelated causes while taking the placebo medication. Conclusions There were no clinically important improvements in a range of clinical indices of asthma control after eight weeks of treatment with atorvastatin despite expected changes in serum lipids. There were however changes in airway inflammation and in particular, a reduction in the absolute sputum macrophage count after atorvastatin compared to placebo and an associated reduction in sputum LTB4 and a trend towards lower CRP. The lack of any evidence of clinical benefit of atorvastatin in allergic asthma confirms and extends the findings of a smaller randomised placebo controlled crossover trial of simvastatin in 16 subjects with asthma, which showed no change in clinical outcomes or inflammatory markers. It is unlikely that altering duration of treatment, washout period or type of statin used would have changed the outcome of the study. However, as all patients were receiving inhaled corticosteroid as part of their asthma therapy, it is possible that this may have masked any modest anti-inflammatory effects of the statin. Baseline asthma inflammation may also have been too low to show any significant improvement. Despite the postulated anti-inflammatory actions of statins, it seems that they may not be appropriate for the inflammatory phenotype associated with atopic asthma. The reduction in alveolar macrophage count found in patients with allergic asthma may however have relevance to the treatment of chronic lung diseases such as COPD in which alveolar macrophage function has been implicated in the pathogenesis.
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Deale, Alicia Caroline. "Cognitive behaviour therapy for chronic fatigue syndrome : outcome of a randomised controlled trial." Thesis, King's College London (University of London), 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.287944.
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Kaliarntas, Konstantinos T. "Supported treadmill walking for low back pain patients : a biomechanical randomised controlled trial." Thesis, University of Strathclyde, 2011. http://oleg.lib.strath.ac.uk:80/R/?func=dbin-jump-full&object_id=16797.
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Mosleh, Sultan. "Improving attendance at cardiac rehabilitation : a cohort study with nested randomised controlled trial." Thesis, University of Aberdeen, 2010. http://digitool.abdn.ac.uk:80/webclient/DeliveryManager?pid=203472.
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Grant, Mary. "Developing, delivering and evaluating stroke specific vocational rehabilitation : a feasibility randomised controlled trial." Thesis, University of Nottingham, 2016. http://eprints.nottingham.ac.uk/35108/.
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Background: Approximately 152,000 people have a stroke in the UK every year, a quarter are working age and only 40% return to work. Vocational rehabilitation (VR) provision is patchy in the UK and has not been evaluated for the stroke population. Aim: This study aimed to develop, deliver and evaluate stroke specific VR in a feasibility randomised controlled trial (RCT) in one English county. Method: A qualitative interview study with key stakeholders sought to explore barriers to and unmet needs for support for stroke survivors intending to return to work. The findings, two case studies and an expert panel informed the development of a stroke specific VR intervention. Its potential effectiveness in influencing occupational status at 12 months post baseline was measured in a feasibility RCT. Intervention content was analysed and the stroke survivors and employers who received it were interviewed about its usefulness and acceptability. Results: 18 key stakeholders identified barriers to VR in existing service design and delivery. Stakeholders identified the need for individualised, responsive, timely and flexible intervention including support for family members and employers. 46 people, with mainly minor and moderate strokes, were recruited to the feasibility trial and 23 randomised to stroke specific VR. Delivery and compliance with intervention was feasible. Only one participant withdrew. Follow-up was feasible at three, six and 12 months post baseline as indicated by an overall response rate of 73.9%. Twice as many participants returned to work in the intervention group. Data collection on income and benefit status was problematic due to missing data. Secondary measures included quality of life, function, mood and participation. A proforma was successfully used to record and measure intervention content, which showed that stroke specific VR is an individually tailored complex intervention involving cross sector working. 12 stroke survivors and six employers interviewed following the trial, valued this flexible, individualised intervention which positively influenced return to work experiences and outcomes. Discussion: Stroke severity influenced participation and a different model may be needed for those with severe stroke and those unable to return to an existing job. Employer contact was not always possible or desired by the stroke survivor. Funding, targeting and implementing this type of intervention requires further consideration. Conclusion: Early intervention can potentially influence job retention rates in people with mild and moderate stroke but a larger trial is needed to demonstrate effect.
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Vixner, Linda. "Acupuncture for labour pain." Doctoral thesis, Högskolan Dalarna, Medicinsk vetenskap, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:du-17488.
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Background: Acupuncture involves puncturing the skin with thin sterile needles at defined acupuncture points. Previous studies are inconclusive regarding the effect of acupuncture on labour pain, but some studies have found a reduction in the use of pharmacological pain relief when acupuncture is administered. The appropriate dose of acupuncture treatment required to elicit a potential effect on labour pain has not been fully explored. The dose is determined by many different factors, including the number of needles used and the intensity of the stimulation. In Sweden, manual stimulation of the needles is common practice when acupuncture is used for labour pain, but electrical stimulation of the needles, which gives a higher dose, could possibly be more effective. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labour pain, compared with standard care without any form of acupuncture (SC). Methods: The study was designed as a three-armed randomised controlled trial in which 303 nulliparous women with normal pregnancies were randomised to MA, EA, or SC. The primary outcome was labour pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation during labour, use of obstetric pain relief, and associations between maternal characteristics and labour pain and use of epidural analgesia respectively. Also, labour and infant outcomes, recollection of labour pain, and maternal experiences, such as birth experience and experience of the midwife, were investigated two months after the birth. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS. Data were collected during labour before the interventions, the day after birth, and two months later. Besides using the VAS, information was collected by means of study specific protocol, questionnaires and medical records. Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI -1.7 to 6.9, and EA vs. SC 0.6 95% CI -3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7). No statistically significant differences were found in the recollection of labour pain between the three groups two months after birth (mean VAS score: MA 69.3, EA 68.7 and SC 70.1). A few maternal characteristics were associated with labour pain (age, dysmenorrhea, and cervix dilatation), but none of the investigated characteristics predicted the outcome of the acupuncture treatment in MA or EA. Women in the EA group experienced acupuncture as being effective for labour pain to a higher extent than women who received MA, MA 44.4%, EA 67.1% (EA vs. MA OR 2.4 95% CI 1.2 to 4.8). Women in the EA group also spent less time in labour (mean 500 min) than those who received MA (mean 619 min) and SC (mean 615 min) (EA vs. MA HR 1.4 95% CI 1.0 to1.9, EA vs. SC HR 1.4, 95% CI 1.1 to 2.0), and had less blood loss than women receiving SC, (EA vs. SC OR 0.1 95% CI 0.3 to 0.7). The women’s assessment of the midwife as being supportive during labour (MA 77.2%, EA 83.5%, SC 80%), overall satisfaction with midwife care (MA 100%, EA 97.5%, SC 98.7%), and having an overall positive childbirth experience (MA 64.6%, EA 61.0%, SC 54.3%) did not differ statistically. No serious side effects of the acupuncture treatment were reported. Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women’s experience of pain during labour, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labour pain.
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Henderson, Neil James Kerr. "Extending the clinical and economic evaluations of a randomised controlled trial the IONA study /." Connect to e-thesis, 2008. http://theses.gla.ac.uk/418/.
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Thesis (Ph.D.) - University of Glasgow, 2008.Ph.D. thesis submitted to the Department of Statistics, Faculty of Information and Mathematical Sciences, University of Glasgow, 2008. Includes bibliographical references. Print version also available.
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Toth, Benjamin. "Clinical trials in British medicine 1858-1948, with special reference to the development of the randomised controlled trial." Thesis, University of Bristol, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.364843.
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Windrim, Rory. "A randomised controlled trial of oral misoprostol in the induction of labour at term." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape9/PQDD_0006/MQ42461.pdf.
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Henderson, Neil J. K. "Extending the clinical and economic evaluations of a randomised controlled trial : the IONA Study." Thesis, University of Glasgow, 2008. http://theses.gla.ac.uk/418/.
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In modern society people are concerned about their state of health and if they do unfortunately become ill they want the best possible treatment to be made available to them. In order to satisfy these demands new treatments have to be developed. This can be a long and expensive process. Before any new treatment can come to market it has to be proved to be both clinically effective and economically cost-effective. With limited health care resources the cost-effectiveness of treatments is becoming ever more relevant. In order to show whether a treatment is clinically effective a clinical trial is carried out and this is now usually accompanied by an economic evaluation, so that the cost effectiveness of the treatment can be assessed. When a clinical trial aimed at preventing clinical events is analysed, a time-to-first event analysis is often performed together with a cost-effectiveness analysis. These analyses do not always make the best use of the large amounts of patient information recorded during the clinical trial. Using the randomised controlled trial (RCT) the Impact Of Nicorandil in Angina (IONA) as an exemplar, ways in which the clinical and economic evaluations of clinical trials can be expanded are explored. There are three main parts of this thesis. Firstly, following a more detailed introduction in Chapter 1, in Chapters 2 and 3 the IONA Study is introduced and the main clinical results of the study are given. Secondly, in Chapters 4, 5 and 6 the fact that patients could suffer more than one clinical endpoint is considered. The models that can be used to incorporate the recurrent events are introduced and then applied to the data from the IONA Study. Following on from this, through the simulation of recurrent event data, the performance of the models under different known conditions is assessed. Thirdly, in Chapters 7 and 8 an introduction to health economics is given and following this the main results of the economic evaluation of the IONA Study are presented. Areas in which the results of the economic evaluation can be expanded are then investigated. Finally, in Chapter 9 there is a discussion of the work as a whole and areas where there would be the possibility of further work.