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Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented. Trial registration number The trial was assigned ISRCTN02328576 through http://controlled-trials.com/ in June 2006. The first patient was randomised to the pilot in July 2007.

Abstract Background- Hospital acquired infections are a major cause of morbidity and mortality and markedly increased health care costs. Critically ill patients who require management in an Intensive Care Unit are particularly susceptible to these infections which are associated with a very high mortality. Selective decontamination of the digestive tract (SDD) may reduce these infections and improve mortality but it has not been widely adopted into practice. We aim to 1. Clarify reasons why clinicians have avoided implementing SDD into clinical practice despite the current best-evidence 2. Describe barriers to SDD implementation and 3. Identify what further evidence is required before full scale clinical implementation would be considered appropriate and feasible. Methods- We have developed an international 'multi-lens' approach to investigate SDD from several perspectives. In case studies we will identify accounts of implementation of SDD in practice, in terms of the behaviours performed by the full range of individual clinicians, accounts of how SDD was first introduced into the Unit and specific content that may be used to populate the content of behaviour change techniques to be used in an implementation intervention and procedures to consider in order to deliver an implementation trial. In a 4 round Delphi study we will identify the range of stakeholders' beliefs, views and perceived barriers relating to the use of SDD. We will generate hypotheses about key beliefs about SDD and will inform the feasibility of any future randomised controlled trial. In large-scale nationwide postal questionnaire surveys of the state of current practice we will identify the factors predicting acceptability of an effectiveness or implementation trial using, and informed by, the theoretical domains structure. In semi-structured interviews with active international clinical trialists we will assess the feasibility of a randomised controlled trial and identify challenges and barriers to undertaking research in the field of SDD research. Discussion We believe these methods will allow us to determine whether clinical implementation trials or further large effectiveness trials are required before full scale implementation into clinical practice.

Objective: Our objectives were: (1) to examine the association between maternal, fetal, and placental phenotypes of preterm delivery and medically indicated early delivery of singletons during the late preterm and early term periods; and (2) to identify the specific maternal, fetal, and placental conditions associated with these early deliveries.Design: Retrospective study.Setting: City of London and Middlesex County, Ontario, Canada.Sample: Singleton live deliveries, at 34-41 weeks of gestation to women in London and Middlesex.Methods: We obtained data from a city-wide perinatal database (2002-2011; n = 25 699). We used multinomial logistic regression for multivariable analyses.Main Outcome Measure: The outcome was the occurrence of medically indicated late preterm (34-36 weeks of gestation) and early term (37-38 weeks of gestation) delivery, versus delivery at full term (39-41 weeks of gestation).Results: After controlling for confounding factors, all phenotypes were associated with increased odds of medically indicated late preterm and early term delivery. Within the maternal phenotype, chronic maternal medical conditions were associated with increased odds of medically indicated early term delivery (e.g. for gastrointestinal disease, adjusted odds ratio, aOR 1.72, 95% CI 1.47-2.00; for anaemia, aOR 1.40, 95% CI 1.20-1.63), but not late preterm delivery.Conclusions: The aetiology of medically indicated early delivery close to full term is heterogeneous. Patterns of associations suggest slightly different conditions underlying the late preterm and early term phenotypes, with chronic maternal medical conditions being associated with early term delivery but not with late preterm delivery. These results have implications for the prevention of early delivery as well as the identification of high-risk groups among those born early.Tweetable Abstract: The aetiology of medically indicated late preterm and early term delivery is heterogeneous. [ABSTRACT FROM AUTHOR]

Objective Our aim was to examine the association between biological determinants of preterm birth (infection and inflammation, placental ischaemia and other hypoxia, diabetes mellitus, other) and spontaneous late preterm (34-36 weeks) and early term (37-38 weeks) birth. Design Retrospective cohort study. Setting City of London and Middlesex County, Canada. Sample Singleton live births, delivered at 34-41 weeks to London- Middlesex mothers following spontaneous labour. Methods Data were obtained from a city-wide perinatal database on births between 2002 and 2011 (n = 17 678). Multivariable analyses used multinomial logistic regression. Main outcome measure The outcome of interest was the occurrence of late preterm (34-36 weeks) and early term (37-38 weeks) birth, compared with full term birth (39-41 weeks). Results After controlling for covariates, there were associations between infection and inflammation and late preterm birth (aOR = 2.07, 95% CI 1.65, 2.60); between placental ischaemia and other hypoxia and late preterm (aOR = 2.21, 95% CI 1.88, 2.61) and early term (aOR = 1.25, 95% CI 1.13, 1.39) birth; between diabetes mellitus and late preterm (aOR = 3.89, 95% CI 2.90, 5.21) and early term (aOR = 2.66, 95% CI 2.19, 3.23) birth; and between other biological determinants (polyhydramnios, oligohydramnios) and late preterm (aOR = 2.81, 95% CI 1.70, 4.64) and early term (aOR = 1.89, 95% CI 1.32, 2.70) birth. Conclusions Our findings show that delivery following spontaneous labour even close to full term may be a result of pathological processes. Because these biological determinants of preterm birth contribute to an adverse intrauterine environment, they have important implications for fetal and neonatal health. [ABSTRACT FROM AUTHOR]

Purpose: To test whether elevated levels of depressive symptoms affect reports of child outcomes in a sample of mothers of children with new-onset epilepsy.Methods: A sample of 339 mothers from the Health-related Quality of Life in Children with Epilepsy Study was used in the analysis. Mothers' depressive symptoms were measured using the Center for Epidemiological Studies Depression Scale (CES-D). To examine whether maternal mental health status moderated mothers' reports of each core domain of health-related quality of life (functional status, psychological functioning, social functioning, and disease state/symptoms), a series of multiple regression analyses was conducted. Interactions, depicted as product terms between CES-D scores and neurologist-reported measures, were used to determine the presence of depression distortion.Results: Interactions in the regression models were not significant with one exception in the functional status domain of mothers' assessments of their child's energy/fatigue and its impact on daily activities [beta = 0.24 (0.06, 0.41)]. Mothers with high levels of depressive symptoms were shown to have reported higher scores for their child's energy/fatigue and its impact on daily activities.Conclusions: Results from this study do not suggest that the mental health status of mothers affects reporting on the domains of health-related quality of life for their children with new-onset epilepsy. [ABSTRACT FROM AUTHOR]

OBJECTIVES: We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail (arm 3). METHODS: We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire. RESULTS: Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high. CONCLUSIONS: This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions. [ABSTRACT FROM AUTHOR]

Selective episiotomy and the active management of labor have been shown by numerous studies to benefit women's experience of labor as well as its outcomes. However, many Latin American public hospitals have not updated their clinical practices to reflect these findings. Limited access to new knowledge, limited time and physical resources and attitudes resistant to change are factors limiting the adoption of new practices in such hospitals. Interviews were conducted with three department heads, and focus groups were conducted with 31 physicians and midwives working in 10 public hospitals in Argentina and Uruguay. All were asked about facilitators and barriers to making changes in clinical practice. In addition, three focus groups were conducted with 16 pregnant women served by public hospitals. Responses were grouped according to stages of change in incorporating new evidence into practice. Numerous facilitators and barriers were identified by participants, as well as potential strategies for promoting change that could be incorporated into interventions. Barriers included limited access to information, negative attitudes toward changes in practice, lack of skills in performing new practices, lack of medical resources and explicit guidelines and a perceived need to practice defensive medicine. Changing long-standing clinical practice is difficult. Interventions must be adapted to translate evidence-based approaches to new cultures and contexts. Improving information access, use of role models, skill development and improved resources and support may be effective ways to overcome barriers to change in Latin American obstetric care. [ABSTRACT FROM AUTHOR]

Body & Soul has demonstrated effectiveness as a dietary intervention among African American church members. The process evaluation assessed relationships between program exposure and implementation factors and study outcomes and characterized factors important for adoption, implementation, and maintenance. Data sources included participant surveys and qualitative interviews with program staff, church liaisons, and volunteer advisors who conducted motivational interviewing (MI) calls. Outcomes included changes in dietary intake and psychosocial variables. Process variables included program exposure, participation, and dose and perceptions about MI calls. Results showed that attendance at project events, receiving educational materials, and self-reported quality of the MI calls were associated with significantly (p < .05) greater fruit and vegetable intake, decreased fat consumption, and other secondary outcomes. Interviews indicated implementation and sustainability issues and needs including more training to enhance MI implementation as well as ongoing support and resources. The results have implications for future dissemination efforts of Body & Soul. [ABSTRACT FROM AUTHOR]

To address the childhood obesity epidemic, it is necessary to understand parents' and caregivers' concerns and beliefs regarding their children's weight problems and best practices for addressing those concerns. Formative research methods were used to identify obesity-related concerns of Hispanic, Black, and White parents of young children (5-8 years old) in North Carolina. Participants identified challenges at multiple levels of influence. In all groups, participants reported that they had trouble finding enough time to help their children develop healthy lifestyles. Conflicting family priorities and needs often made it difficult to ensure that their children had healthy diets. Children's own diet and activity preferences and their parent or caregiver's inability to adequately guide their choices also contributed to obesigenic behaviors. In addition, many thought that physician and community support for their efforts to manage their children's eating habits was inadequate. Findings from these focus groups suggest that participants would be receptive to positive, multilevel prevention approaches to help their children attain and maintain healthy weights. [ABSTRACT FROM AUTHOR]

Latina women are a growing percentage of the working population, and very little is known about their health needs and interests. The purpose of this article is to share qualitative research results gathered from Latina women with a particular focus on exploring stress and health. This project was a substudy of Health Works in the Community, a 5-year CDC-funded multiple risk-factor reduction trial using participatory action research approaches to address smoking, healthy eating, stress, and physical activity among blue-collar women from 12 manufacturing work sites in rural, eastern North Carolina. Five focus groups were conducted with trained, bilingual facilitators using a vignette-based moderator guide that appeared particularly effective with this population. Results from the focus groups are used to make recommendations for future research with Latinas and for developing effective work-site-based interventions to address issues of stress and health within this population. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine health behaviors (fruit/vegetable intake and physical activity) and their association with social cognitive theory (SCT) constructs among colorectal cancer (CRC) survivors (n=304) and comparable non-CRC-affected participants (n = 521). METHODS: Baseline data were analyzed bivariately and modeled with linear regression. Participants were 48% female, 36% African American (mean age = 67). RESULTS: Behaviors were comparable between groups, but survivors perceived more social support for behaviors (P <.05). Lack of employment was associated with greater frequency of healthy behaviors (P <.05) as were more modifiable factors including higher self-efficacy and lower barriers. CONCLUSIONS: SCT constructs were associated with behavior and may be targets for future interventions, but other variables may be important as well. [ABSTRACT FROM AUTHOR]

With widespread adoption of the Internet, focus groups can now be conducted using Internet-mediated (IM) 'chat' group technology. However, the methodology used for face-to-face groups must be adapted to this new communication medium. This paper presents a case study that describes feasibility issues of the IM 'chat' focus groups, which arose when they were used to collect formative data for the NC STRIDES (STRategies for Improving Diet, Exercise, and Screening) project. This population-based study used the focus group to develop tailored and interactive health communication strategies to reduce the risk of recurrence of colon cancer. In this paper, we describe: (a) the characteristics of IM chat communication, (b) technical implementation of the NC STRIDES 'chat' focus groups, (c) methodological considerations, d) chat focus group formation and management, and (e) participants, satisfaction with their chat focus group experiences. Finally, we offer suggestions for best practice in the use of chat focus groups in health behaviour and social work research. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To determine if positive affect is related to the self-reported health and health behaviors of blue-collar women. METHODS: Analysis of baseline survey data of 1093 women participating in a worksite health promotion intervention at 12 workplaces in 5 rural counties. RESULTS: Positive affect was related to women's self-reported health and exercise. Also, positive coping behaviors were related to exercise. CONCLUSIONS: These findings suggest that incorporating strategies to encourage positive emotional states and positive coping into health promotion interventions might be helpful for improving women's levels of physical activity and overall reported health. [ABSTRACT FROM AUTHOR]

Several lines of evidence indicate an association between omega-3 polyunsaturated fatty acids (PUFAs) and depression. The purpose of this review was to evaluate the evidence to date within the context of the study design and methodology used. In case-control and cohort studies, concentrations of omega-3 PUFAs were lower in participants with unipolar and postpartum depression. Fish are the major dietary source of omega-3 PUFAs, and infrequent fish consumption is associated with depression in epidemiological studies. While these findings do not appear to be the result of confounding, in some studies failure to detect confounding may be due to a lack of power or incomplete control. In four of seven double-blind randomized controlled trials, depression was significantly improved upon treatment with at least 1 g/day of eicosapentaenoic acid, an omega-3 PUFA. While clinical significance was demonstrated, preservation of blinding may be a limitation in this area of research. It remains unclear whether omega-3 supplementation is effective independently of antidepressant treatment, for depressed patients in general or only those with abnormally low concentrations of these PUFAs. The relationship between omega-3 PUFAs and depression is biologically plausible and is consistent across study designs, study groups, and diverse populations, which increases the likelihood of a causal relationship. [ABSTRACT FROM AUTHOR]

BACKGROUND: Evidence is needed for the best long-term diet for weight loss, and improvement in cardiac risk and disease in obese adults. METHODS: We systematically reviewed randomized controlled trials (RCTs) in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted the data and a second checked data extraction. Trial quality was assessed. RESULTS: Low fat diets (LFDs) produced significant weight losses up to 36 months (-3.55 kg; 95% CI, -4.54 to -2.55 kg). Blood pressure, lipids and fasting plasma glucose improved with these diets after 12 months. Four studies found that LFDs may prevent type 2 diabetes and reduce antihypertensive medication for up to 3 years. A very low calorie diet (VLCD, < 4.2 MJ day(-1)) was associated with the most weight loss after 12 months (-13.40 kg; 95% CI, -18.43 to -8.37 kg) in one small study with beneficial effects on asthma. There was no evidence that low carbohydrate protein sparing modified fasts (PSMFs) were associated with greater long-term weight loss than low calorie diets (LCDs, 4.2-6.7 MJ day(-1)) or VLCDs. PSMFs were, however, associated with greater lowering of fasting plasma glucose and HbA1c than LCDs. CONCLUSIONS: Little evidence supports the use of diets other than LFDs for weight reduction. With the increasing prevalence of morbid obesity, long-term follow-up in RCTs is needed to evaluate the effect of LCDs, VLCDs and PSMFs more fully. [ABSTRACT FROM AUTHOR]

BACKGROUND: Evidence is needed for the effectiveness of interventions given with reducing diets for obese adults: drug therapy, exercise, or behaviour therapy. METHODS: We systematically reviewed randomized controlled trials in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted data and a second checked data extraction. Trial quality was assessed. RESULTS: Adding orlistat to diet was associated with weight change for up to 24 months (-3.26 kg, 95% CI, -4.15 to -2.37 kg), and statistically significant beneficial changes were found for total and LDL cholesterol, blood pressure and glycaemic control. Adding sibutramine to diet was associated with a 12 month weight change of -4.18 kg (95% CI, -5.14 to -3.21 kg), and statistically significant beneficial effects on high density lipoprotein cholesterol (HDL) and triglycerides (TGs), but an increase in diastolic blood pressure. Adding exercise to diet, or to diet and behaviour therapy, was associated with improved weight loss for up to 36 months and improvements in HDL, TGs and blood pressure. Adding behaviour therapy to diet, or to diet and sibutramine together, was associated with improved weight loss for up to 18 months. Adding drugs, exercise or behaviour therapy to dietary advice was each associated with similar weight change. CONCLUSIONS: Adding orlistat, sibutramine, exercise, or behaviour modification to dietary advice can improve long-term weight loss. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This article describes the development and randomized evaluation of a tailored nutrition education CD-ROM program for participants in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) in North Carolina. DESIGN: After randomization to intervention or control groups, participants completed a baseline survey and were resurveyed immediately after program use and 1 to 2 months postintervention. SETTING: Two WIC clinics in central North Carolina. PARTICIPANTS: A total of 307 respondents to the follow-up survey (response rate 74.8%) comprised the study sample. Participants were female (96%), 20% were pregnant, and 50% were minorities (African American and other). Intervention: The interactive CD-ROM consisted of a targeted video soap opera, dietary assessment, and individually tailored dietary feedback and strategies for change. MAIN OUTCOME MEASURES: Measures included total fat and fruit and vegetable intake, knowledge of low-fat and infant feeding choices, self-efficacy, and stages of change. ANALYSIS: Descriptive statistics assessed baseline comparability of study groups; analysis of covariance and F tests were used to assess program effects at follow-up. RESULTS: Intervention group members increased self-efficacy (P <.01) and scored significantly higher (P <.05) on both low-fat and infant feeding knowledge compared with controls. No differential effect was observed for dietary intake variables. CONCLUSIONS AND IMPLICATIONS: The findings suggest that one dose of an interactive CD-ROM program can impact mediators of dietary change but may be insufficient to change behavior. [ABSTRACT FROM AUTHOR]

Timely reporting of mammogram results helps to reduce anxiety for women with negative results and speeds up diagnosis or treatment in the case of abnormal results. The goal of this project was to improve the rate at which Virginia mammography centers provide a written report to women in lay terms within 30 days of a mammogram. The project included six intervention and five control mammography centers. The baseline period was prior to when new regulations in the Mammography Quality Standards Act (MQSA) took effect in April 1999. The re-measurement period was after April 1999. Data were obtained from abstraction of mammography reports and patient notification letters from a sample of patients with negative and abnormal mammography results at each mammography center. Each intervention mammography center received a notebook that included numerous tools on systems for patient notification and tracking, baseline notification rates and other abstracted information, biopsy recommendations, sample results letters, and a copy of the MQSA. For negative mammograms, the intervention group in aggregate increased from 24% at baseline to 79% at re-measurement in their rate of notification within 30 days. The control group increased from 25% to 46%. For abnormal mammograms, increases were from 35% to 85% and from 25% to 58%, respectively. The intervention group's increases were considerably higher, suggesting an effect due to the interventions that involved technical assistance, education, and system change. All increases were statistically significant (p < 0.01). At baseline, three intervention centers and two controls had policies for written notification. All 11 had policies at re-measurement. However, only two of the five control centers could provide clear supporting documentation for dates of notification at re-measurement. Mammography centers can benefit from guidance in the form of intervention materials specifically designed to address the MQSA sections that apply to patient notification, tracking, and positive predictive value of biopsy recommendations. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine physical activity among participants in the Wellness for African Americans Through Churches (WATCH) project. METHODS: Both focus-group and survey methodologies were employed. From surveys, frequencies and metabolic equivalents (METs) were calculated for recreational, household, and occupational activity. RESULTS: Half of respondents reported recreational activity > or = 5 days per week; most reported household activity. Women had significantly lower levels of recreational and occupational, but not household activity. Recreational and occupational levels decreased with age. CONCLUSIONS: This sample appears to meet exercise guidelines. Psychosocial factors may be important for intervention in recreational, but not household or occupational activity. [ABSTRACT FROM AUTHOR]

Objective: To determine whether there is a relationship between baseline levels of social support and women's health behaviors. Methods: Baseline surveys for 859 women assessed smoking, diet (fat, fruit, and vegetable consumption), physical activity, breast and cervical cancer screening, and levels of social support. Results: Women had substantial social networks and a high evel of interaction with their coworkers. Social support was associated with physical activity, fruit and vegetable intake, and cervical cancer screening. Conclusion: Findings suggest that work-site health-promotion programs for women could benefit from intervening at the social-network level, especially for some health behaviors. [ABSTRACT FROM AUTHOR]