Background: As part of this thesis work, we developed a Shower Technique protocol (‘STP’) for hemodialysis patients with healed central venous catheter (catheter) exit sites, designed to permit showering but not increase infection risk. Research question: Is it feasible to conduct a randomized control trial called the Hemodialysis Infection Prevention using Polysporin Ointment with Shower Technique in Satellite Centres (HIPPO SAT) study comparing the rate of CRB in adult satellite hemodialysis patients using STP versus standard catheter care alone with 6 month follow up? Study Design: The HIPPO SAT pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled catheter exit site. Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, and percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and using aspects of STP (% of contaminated patients in the control arm). Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada. Patient Population: Adult satellite Hemodialysis patients dialyzing via catheter with healed catheter exit sites. Intervention: STP and standard catheter care; or Control: standard catheter care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible. Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination. / Thesis / Master of Science (MSc)

Class of 2012 Abstract / Specific Aims: To explore whether publishing requirements for human-centered randomized control trials, particularly the CONSORT criteria, have any relationship to impact as measured by the Journal Citation Reports TM Impact Factor. Methods: A worksheet was used to evaluate a methodically selected list of journals, including types of articles published, requirements of authors for human-focused randomized control trials, JCR Impact Factor and other JCR metrics for each specific journal title. A worksheet was filled out for each journal by each member of the research team and answers combined for consensus. Group means and SDs were calculated and the Student’s t-Test applied to values for selected journals. Main Results: 50 candidate pharmacy journals were identified and 41 met the criteria for publishing human-centered randomized control trials. Journals were grouped according to whether they required CONSORT or had other reporting requirements for human RCTs, or had no requirements for such studies. Few (6; 15%) pharmacy journals required authors to use CONSORT; and additional 15 (37%) journals provided as least some author guidelines similar to CONSORT. Pharmacy journals using CONSORT or other guidelines had a higher average impact factor (3.5; SD = 1.5) than did journals without guidelines (2.4; SD = 0.9; p = 0.007). Conclusions: There appears to be a statistical difference in average JCR metrics between journals which require specific RCT guidelines and those which do not. The use of reporting guidelines, such as CONSORT, by pharmacy journals is associated with increased impact as represented by JCR influence measures.

Background: Stories may be an effective tool to communicate with and influence patients because of their ability to engage the reader. Objectives: To develop story booklets and evaluate their effectiveness compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods: A systematic process was followed to develop and pilot-test the story booklets. Parents were randomized to receive story booklets or standard information sheets during their ED visit. The primary outcome of change in anxiety during the ED visit was assessed using the State Trait Anxiety Inventory, which was completed upon recruitment and at discharge. Follow-up telephone interviews were conducted at 1 and 3 days post-ED visit to gather information on secondary outcomes: symptoms, expected anxiety for future croup, satisfaction, regret, knowledge, return for medical care, and resource use. Telephone interviews were conducted every other day until symptoms resolved or until day 9. Outcomes were compared using independent-groups t-tests, Mann Whitney tests, or Chi-square tests. Results: There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge. The story group (n=129) showed significantly greater decision regret regarding their decision to go to the ED than the comparison group (n=126) (p<0.001). The story group reported quicker resolution of symptoms: median days to no symptoms 3 versus 5; the survival distributions were significantly different (p=0.032). There were no differences for the remaining outcomes. Conclusions: This study provides preliminary evidence regarding the use of stories in the ED for an acute, self-limiting condition and contributes to a growing evidence matrix identifying when, where, and for whom storytelling may be most effective. Reasons for lack of significance for the primary and other outcomes may relate to choice of outcome, timing of outcome assessment, or disconnect between the intervention and needs of the end-user. Further research is needed to corroborate the significant findings and examine their underlying mechanism. An examination of risk of bias in a sample of pediatric trials demonstrates that there is room for improvement in the design, conduct, and reporting of research related to child health and provides direction for future research.

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.

No description available.

It is widely accepted that breast milk is the optimal source of infant nutrition. Despite the World Health Organization (WHO) recommendation of exclusive breastfeeding for the first 6 months of infant life, many women discontinue breastfeeding as a result of perceived difficulties. Nipple pain is a highly prevalent, significant reason for breastfeeding cessation. Among the numerous interventions for nipple pain, the application of lanolin is commonly recommended, with endorsement by Health Canada, The La Leche League, and International Board Certified Lactation Consultants. The few studies that have evaluated the effectiveness of lanolin on nipple pain have lacked methodologic rigor, and are thus not reliable or generalizable. As such, the purpose of this trial was to rigourously evaluate the effect of lanolin for the treatment of nipple pain among breastfeeding women. This single-site randomized controlled trial (RCT) compared the application of lanolin (treatment) to usual postpartum care (not applying lanolin) for the treatment of nipple pain. The primary outcome for this trial was the effect on pain severity, as measured by a numeric rating scale (NRS) at 4 days post-randomization. Of 186 participants, 93 were randomized to the treatment group and 93 to the usual care group. At 4 and 7 days post-randomization there were no statistically significant differences in pain scores between groups. It is noteworthy that by 7 days post-randomization there were clinically relevant decreases in nipple pain in both groups. However, there were no statistically significant differences between groups for other outcomes, including pain measured with the short-form McGill Pain Questionnaire, breastfeeding duration, breastfeeding exclusivity, and breastfeeding self-efficacy. Despite these findings, women in the treatment group were significantly more satisfied receiving lanolin for their nipple pain than those receiving usual care. Since the use of lanolin is no more effective than applying nothing to the nipples for the management of nipple pain, the widespread use of lanolin is questionable. Further research is required on the role of interventions to prevent nipple pain and damage, and the effect of anticipatory guidance on improving breastfeeding outcomes for those experiencing nipple pain in the early postpartum period.

Falls are a relatively frequent occurrence amongst older people. Rates of falls amongst patients in subacute care are substantially higher than amongst people living in the community. Falls have been reported to cause physical and psychological injury, increase the likelihood of being discharged to nursing home, and are associated with longer lengths of stay in hospital. Thus, minimisation of falls in the subacute hospital setting is of high public health importance. (For complete abstract open document)

Dysarthria describes the impaired speech intelligibility caused by weakness of muscles involved in speech following stroke. This is a common consequence of stroke and can have a detrimental impact on self-confidence leading to social isolation for many. There is limited evidence for dysarthria intervention but we know that research into speech difficulties after stroke is a priority for stroke survivors. An online speech rehabilitation programme was developed, ReaDySpeech, with the potential to offer improved quality of independent practice, increased intensity of practice and the ability to record interaction. The research presented in this thesis aimed to systematically examine the existing evidence base, to carry out some preliminary acceptability work on ReaDySpeech, and implement a feasibility trial. The initial study was a Cochrane systematic review of the effectiveness of interventions for people with non-progressive dysarthria after stroke or other adult-acquired brain injury. This found insufficient evidence to know whether dysarthria intervention is effective or not. This led to a study of early acceptability work for ReaDySpeech and whether there were any technical barriers to use. This found no significant technical barriers other than lack of Wi-Fi and it was acceptable to participants and therapists. This enabled a progression to a feasibility trial following amendments and improvements to the protocol and ReaDySpeech itself. The feasibility trial found recruitment, retention and the intervention were all feasible to carry out during a trial. Further in-depth consideration of the findings indicates more work is needed to widen recruitment and to develop the intervention, comparator and methodology of a future trial for this to be a success with valid clinical implications. This thesis reports this body of work and discusses potential future directions for dysarthria research.

The United States has established breastfeeding as an important health indicator within the Healthy People agenda. Healthy People target goals for breastfeeding initiation, duration, and exclusivity remain unmet. The US Surgeon General's Office reports that lack of knowledge and widespread misinformation about breastfeeding are barriers to meeting Healthy People goals. Breastfeeding mothers are vulnerable to messages that cast doubt on their ability to breastfeed. Very little research has examined specific approaches to help people resist negative messages about health beliefs and behaviors. The objective of this quasi-experimental study was to test an intervention designed to help mothers defend their breastfeeding decisions and resist influences that attempted to persuade them to give formula to their babies. Women attending prenatal breastfeeding classes were recruited and assigned to comparison and intervention groups. The intervention was a board game based on McGuire's inoculation theory of resistance to influence. Controlling for intention to breastfed, intervention and comparison groups were examined for differences in maternal self-efficacy to resist persuasion to give formula and breastfeeding rates for initiation, duration, and exclusivity. Data analyses consisted of analysis of covariance and logistic regression. There was no significant difference between comparison and intervention groups, both groups had high self-efficacy to resist giving formula to their babies; nor were there significant differences regarding breastfeeding initiation, duration and exclusivity. The lack of significant differences may have been influenced by ceiling effects in all of the breastfeeding variables, possibly due to the high socioeconomic level of the sample. The intervention may have worked better in women who were more prone to dissuasive influence, such as those with lower education.

Yes / Objectives To test whether an occupation based lifestyle intervention can sustain and improve the mental wellbeing of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial. Participants 288 independently living adults aged 65 years or over, with normal cognition were recruited from two UK sites between December 2011 and November 2015. Interventions Lifestyle Matters is a NICE recommended multi-component preventive intervention designed to improve the mental wellbeing of community living older people at risk of decline. It involves weekly group sessions over four months and one to one sessions. Main outcome measures The primary outcome was mental wellbeing at 6 months (mental health dimension of the SF-36).Secondary outcomes included physical health dimensions of the SF-36, extent of depression (PHQ-9), quality of life (EQ-5D) and loneliness(de Jong Gierveld Loneliness Scale),assessed at 6 and 24 months. Results Data on 262 (intervention =136; usual care =126) participants were analysed using intention to treat analysis. Mean SF-36 mental health scores at six months differed by 2·3 points (95 CI -1·3 to 5·9; P=0·209) after adjustments. Conclusions Analysis shows little evidence of clinical or cost effectiveness in the recruited population with analysis of the primary outcome revealing that the study participants were mentally well at baseline. The results pose questions regarding how preventive interventions to promote wellbeing in older adults can be effectively targeted in the absence of proactive mechanisms to identify those who at risk of decline. / Primary Care Research Network (PCRN) funding was accessed to support recruitment activity in GP surgeries in Sheffield and NISCHR provided support in North Wales.