Heparin for women with recurrent miscarriage and inherited thrombophilia (ALIFE2): an international open-label, randomised controlled trial.

BACKGROUND: Anticoagulant therapy might reduce the number of miscarriages and adverse pregnancy outcomes in women with recurrent pregnancy loss and inherited thrombophilia. We aimed to assess use of low-molecular-weight heparin (LMWH) versus standard care in this population. METHODS: The ALIFE2 trial was an international open-label, randomised controlled trial undertaken in hospitals in the UK (n=26), the Netherlands (n=10), the USA (n=2), Belgium (n=1), and Slovenia (n=1). Women aged 18-42 years who had two or more pregnancy losses and confirmed inherited thrombophilia, and who were trying to conceive or were already pregnant (≤7 weeks' gestation), were eligible for inclusion. Women were randomly assigned (1:1) to use low-dose LMWH or not (alongside standard care in both groups) once they had a positive urine pregnancy test. LMWH was started at or before 7 weeks' gestation and continued until the end of pregnancy. The primary outcome measure was livebirth rate, assessed in all women with available data. Safety outcomes included bleeding episodes, thrombocytopenia, and skin reactions, and were assessed in all randomly assigned women who reported a safety event. The trial was registered within the Dutch Trial Register (NTR3361) and EudraCT (UK: 2015-002357-35). FINDINGS: Between Aug 1, 2012, and Jan 30, 2021, 10 625 women were assessed for eligibility, 428 were registered, and 326 conceived and were randomly assigned (164 to LMWH and 162 to standard care). 116 (72%) of 162 women with primary outcome data in the LMWH group and 112 (71%) of 158 in the standard care group had livebirths (adjusted odds ratio 1·08, 95% CI 0·65 to 1·78; absolute risk difference, 0·7%, 95% CI -9·2% to 10·6%). 39 (24%) of 164 women in the LMWH group and 37 (23%) of 162 women in the standard care group reported adverse events. INTERPRETATION: LMWH did not result in higher livebirth rates in women who had two or more pregnancy losses and confirmed inherited thrombophilia. We do not advise use of LMWH in women with recurrent pregnancy loss and inherited thrombophilia, and we advise against screening for inherited thrombophilia in women with recurrent pregnancy loss. FUNDING: National Institute for Health and Care Research and the Netherlands Organization for Health Research and Development.

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial.

Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934.

Induction of labour for predicted macrosomia: study protocol for the 'Big Baby' randomised controlled trial.

INTRODUCTION: Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0-38+4 weeks' gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia. METHODS AND ANALYSIS: The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks' gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks' gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included. ETHICS AND DISSEMINATION: The study received a favourable opinion from the South West-Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN18229892.

Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT.

BACKGROUND: Upper limb problems are common after breast cancer treatment. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. DESIGN: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). SETTING: Breast cancer centres, secondary care. PARTICIPANTS: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. INTERVENTIONS: All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). MAIN OUTCOME MEASURES: The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. RESULTS: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. LIMITATIONS: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. CONCLUSIONS: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. FUTURE WORK: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. TRIAL REGISTRATION: This trial is registered as ISRCTN35358984. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 15. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Breast cancer is the most common cancer affecting women. Women now live longer because the detection and treatment of cancer has improved over the last 40 years. The side effects of breast cancer treatments can lead to complications, such as difficulties with arm movements, arm swelling (lymphoedema), pain and poor quality of life. These problems can last for many years after the cancer has been treated. Usual care after breast cancer surgery is to give patients an information leaflet explaining arm exercises that they can undertake after their operation. Offering exercise support from a physiotherapist may be a better way to help those at risk of developing shoulder problems after breast cancer treatment than providing a leaflet only. WHAT DID WE DO?: We compared two strategies to prevent shoulder problems in women having breast cancer treatment: information leaflets and an exercise programme. We invited women with a new diagnosis of breast cancer who were at higher risk of developing shoulder problems than other women with a new diagnosis of breast cancer. We recruited 392 women aged 28­88 years from 17 breast cancer units across England. Women were allocated to one of two groups by chance using a computer. Everyone was given information leaflets that explained what type of exercises to do after surgery. Half of the women (n = 196) were then invited to take part in an exercise programme, supported by a trained physiotherapist. These women followed a programme of shoulder mobility, stretching and strengthening exercises for up to 1 year. We measured changes in arm function, pain, arm swelling (lymphoedema) and physical and mental quality of life, and the cost of treatments during the whole first year of recovery, in everyone. We also spoke to the women and physiotherapists to find out whether or not these treatment strategies were acceptable to them. WHAT DID WE FIND OUT?: Women doing the exercise programme had better arm function, less pain and better quality of life than the women given an information leaflet only. Women said that the exercise programme helped with their recovery during cancer treatment. Exercise was cheap to deliver (£129 per person) and led to improved overall quality of life at 1 year after breast cancer surgery.

Role of immunosuppression in an antibiotic stewardship intervention and its association with clinical outcomes and antibiotic use: protocol for an observational study (RISC-sepsis).

INTRODUCTION: Sepsis is characterised by a dysregulated immune response to infection, with exaggerated pro-inflammatory and anti-inflammatory responses. A predominant immunosuppressive profile affecting both innate and adaptive immune responses is associated with increased hospital-acquired infection and reduced infection-free survival. While hospital-acquired infection leads to additional antibiotic use, the role of the immunosuppressive phenotype in guiding complex decisions, such as those affecting antibiotic stewardship, is uncertain. This study is a mechanistic substudy embedded within a multicentre clinical and cost-effectiveness trial of biomarker-guided antibiotic stewardship. This mechanistic study aims to determine the effect of sepsis-associated immunosuppression on the trial outcome measures. METHODS AND ANALYSIS: RISC-sepsis is a prospective, multicentre, exploratory, observational study embedded within the ADAPT-sepsis trial. A subgroup of 180 participants with antibiotics commenced for suspected sepsis, enrolled in the ADAPT-sepsis trial, will be recruited. Blood samples will be collected on alternate days until day 7. At each time point, blood will be collected for flow cytometric analysis into cell preservation tubes. Immunophenotyping will be performed at a central testing hub by flow cytometry. The primary outcome measures are monocyte human leucocyte antigen-DR; neutrophil CD88; programmed cell death-1 on monocytes, neutrophils and T lymphocytes and the percentage of regulatory T cells. Secondary outcome measures will link to trial outcomes from the ADAPT-sepsis trial including antibiotic days; occurrence of hospital-acquired infection and length of ICU-stay and hospital-stay. ETHICS AND DISSEMINATION: Ethical approval has been granted (IRAS 209815) and RISC-sepsis is registered with the ISRCTN (86837685). Study results will be disseminated by peer-reviewed publications, presentations at scientific meetings and via patient and public participation groups and social media.

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: A multi-centre feasibility randomised controlled trial (COMPRESS-RCT).

BACKGROUND: Mechanical chest compression devices deliver high-quality chest compressions. Early data suggests that mechanical devices may be superior to manual chest compressions in adults following an in-hospital cardiac arrest patients. To determine the feasibility of undertaking an effectiveness trial in this population, we undertook a feasibility randomised controlled trial. METHODS: We undertook a multi-centre parallel group feasibility randomised controlled trial (COMPRESS-RCT). Adult in-hospital cardiac arrest patients that were in a non-shockable rhythm were randomised in a 3:1 ratio to receive mechanical CPR (Jolfe AB/Stryker, Lund, Sweden) or ongoing manual CPR. Recruitment was led by the clinical cardiac arrest team. The primary study outcome was the proportion of eligible participants randomised in the study during site operational recruitment hours. Patients were enrolled under a model of deferred consent. We report data using descriptive statistics, point estimates and 95% confidence intervals. RESULTS: Over a two-year period, we recruited 127 patients across five UK hospitals. We recruited 55.2% (95% CI 48.5%-61.8%) of eligible study participants in site operational recruitment hours. Most participants were male (n = 76, 59.8%) with a mean age of 72 (95% CI: 69.9-74.9) years. Median arrest duration was 18 (IQR 13-29) minutes. In patients randomised to mech-CPR, median time from CPR start to device deployment was 11 (IQR 7-15) minutes. ROSC was achieved in 27.6% (n = 35) participants and 4.7% (n = 6) were alive at 30-days. CONCLUSION: COMPRESS-RCT identified important factors that preclude progression to an effectiveness trial of mechanical CPR in the hospital setting in the UK. Findings will inform the design of future in-hospital intra-arrest intervention trials. ISRCTN38139840, date of registration 9th January 2017.

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting. METHODS: This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions. DISCUSSION: The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH. TRIAL REGISTRATION: ISRCTN no. 10608766, prospectively registered on 18th March 2019.

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

INTRODUCTION: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain. METHODS AND ANALYSIS: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years. ETHICS AND DISSEMINATION: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

What do people talk about during reflexology? Analysis of worries and concerns expressed during sessions for patients with multiple sclerosis.

BACKGROUND: Our previous study evaluated the use of reflexology compared to progressive muscular relaxation in improving the psychological and physical profile associated with multiple sclerosis. In this paper audiotapes from the reflexology sessions have been analysed to give a picture of the nature of interaction between patients and therapists during treatment. METHODS: A crossover design with two groups was chosen. Each participant received six sessions of both interventions. All reflexology sessions were recorded and the tapes transcribed and analysed. RESULTS: Analysis of the available audiotapes (n=245) revealed that reflexology provided opportunities for 48 out of the 50 participants to share worries and concerns. Recurring disclosure themes related to physical symptoms and treatment, psychological concerns, home/family worries, and work/leisure issues. Explorative analysis revealed some differences in the amount of disclosure over the weeks, between for example the participant's type of MS and time living with the diagnosis. CONCLUSIONS: Reflexology appears to have created a space for patients to talk about their worries and concerns, and to receive advice and support from the nurse therapists. This work contributes to the debate about the role of the therapeutic relationship within reflexology practice.

Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial.

PURPOSE: To compare the effects of reflexology and progressive muscle relaxation training for people with multiple sclerosis, provided by nurse therapists, on psychological and physical outcomes. METHODS: A crossover design was chosen with a 4-week break between treatment phases. The Short Form 36 and General Health Questionnaire 28 were completed by patients (n=50) pre and post each of the 6-week treatment phases. Salivary cortisol levels, State Anxiety Inventory, systolic and diastolic blood pressure and heart rate data were collected pre and post the weekly sessions. RESULTS: All of the chosen measures except for three SF-36 scales recorded significant changes, however, despite the 4-week break (washout period), most outcome measures did not return to their pre-treatment baseline levels. This meant that the analysis of the data was complicated by significant effects involving ordering of treatment occurring for eight of the variables (one from SF-36, two from the GHQ, SAI, Salivary Cortisol, Systolic BP and HR). However, there was a difference in the State Anxiety Inventory values between the treatments of the order of 1.092 units (95%CI 0.211-1.976) (p=0.016, Wilks lambda=0.885, df=1, 48) in favour of reflexology. Changes in salivary cortisol comparing levels pre 1st to post 6th session favoured reflexology (95%CI 0.098-2.644) (p=0.037, Wilks lambda=0.912, df=1, 48). A significant difference was found in the way the treatments affected change in systolic blood pressure following sessions; this favoured progressive muscle relaxation training (p=0.002, Wilks lambda=0.812, df=1, 48). CONCLUSION: Positive effects of both treatments following sessions and over the 6 weeks of treatment are reported, with limited evidence of difference between the two treatments, complicated by ordering effects.

A trial of empowerment-based education in type 2 diabetes--global rather than glycaemic benefits.

We have assessed the effect of a structured, empowerment-based educational system ("LAY or "Look After Yourself") for patients with type 2 diabetes. A randomised controlled trial (RCT) was conducted, testing the system against standard support. Using 3 centres, 89 patients participated in the study. Outcome measures included glycated haemoglobin (HbA(1c)), body mass index (BMI) and a variety of quantitative psychological and educational measures. Assessment was made at 6 months ("short-term") and 12 months ("long-term") post-intervention. The educational programme was associated with benefits in HbA(1c) levels (p=0.005), illness attitudes (p=0.04), and perceived treatment effectiveness (p=0.03) at 6 months follow-up compared to controls. At 12 months however, only illness attitudes (p=0.01), and self-monitoring (p=0.002) showed benefit. A combined outcome measure showed positive benefit for the educational programme both at 6 months (p=0.001) and 12 months (p=0.002). This structured educational programme, aimed at encouraging self-help, was associated with only limited benefits in glycaemic control, but there were significant educational and psychological benefits. Diabetes education should be regarded as having broad patient-based positive outcomes, and should not be expected to have lasting benefits on glycaemic control.

The use of the life course paradigm and life course charts to explore referral for family history of breast cancer.

BACKGROUND: Life course research methodologies are used extensively in historical and social science research. In 1998 the life course paradigm was introduced to provide a way of tracing the interplay of person and setting. The method has had a very limited use in nursing research, but in this study it was utilized as a way of capturing dynamic change by placing the individual within a context of four domains; location in time and place, linked lives, human agency and timing of lives. OBJECTIVE: To describe the paradigm, review its use in healthcare research and provide a specific example of its use in healthcare. DESIGN: This paper discusses a novel method of creating life course charts for a qualitative study exploring the differing experiences of women referred from primary care to specialist services due to a family history of breast cancer. SETTING: A nurse-led breast cancer family history clinic in the UK. PARTICIPANTS: Twenty-two women. METHODS: Life charts were used in conjunction with a grounded theory approach to analyse data collected from semi-structured interviews. FINDINGS: Twenty-two life charts were created and the ability to layer the charts of multiple women to visualise similarities and differences aided the analysis. The life charts were a useful tool in the development of theoretical understandings and the psychosocial process of realisation of risk emerged as central to the initiation of referral. This was often apparent when approaching the age of an affected relative (anticipated onset) or when current circumstances emulate past experience (generational transference). CONCLUSIONS: This approach to charting complex psychological, social and contextual factors throughout the life course was methodologically beneficial and could have a wider utility in nursing and healthcare research. As a research tool it enhanced a holistic approach to patient care issues and was helpful as an aid to understanding health behaviours linked to familial risk.

Information needs and decision-making preferences: comparing findings for gynaecological, breast and colorectal cancer.

This study examined information needs and decision-making preferences for women with gynaecological cancers (n=53) using structured interviews and compared findings to previous work involving breast and colorectal cancer patients. Measures of information needs (Information Needs Questionnaire) and decision-making preferences (Control Preferences Scale) were administered to women with gynaecological cancers, consistent with measures previously administered to breast (n=150) and colorectal (n=42) cancer patients. Therefore, statistical comparisons could be made across study groups. Priority information needs were similar across the three cancer groups and related to information about likelihood of cure, spread of disease and treatment options. Patients across study groups preferred to share or delegate decision-making to doctors, rather than make decisions themselves. However, patients with gynaecological and colorectal cancers were more likely to have achieved their preferred role in decision-making than women with breast cancer. There were clear similarities in priority information needs across cancer patients groups. However, decision-making preferences need to be established on an individual basis to ensure that patients are involved in the decision-making process to the extent that they prefer. The research instruments used in this study have potential as clinical guides to enable health professionals to make an individual assessment of needs and preferences.

Obesogenic influences in public housing: a mixed-method analysis.

BACKGROUND: Obesity prevalence is higher among those who live in impoverished environments. This investigation identified obesogenic factors in urban neighborhoods surrounding public housing developments (HDs). DESIGN: Cross-sectional quantitative survey data from 14 HD neighborhoods and qualitative interviews of the HD managers. SETTING: Kansas City, Kansas, and Kansas City, Missouri. SUBJECTS: Environmental data were collected from HDs and surrounding neighborhoods, an area enclosed by an 800-m radius line drawn from the HD centroid. Qualitative data were collected from all 14 HD managers. MEASURES: HDs were rated by a brief environmental audit. HD managers were assessed in a structured 45- to 60-minute interview about neighborhood factors influencing resident obesity. RESULTS: The properties were typically modern and well maintained; however, there were few physical activity (PA) resources and food sources on site. Most HD managers cited the availability of PA resources near the HD; however, there was wide variability in the type and accessibility of the resources. Only two HDs had a store that sold groceries within one block. Interviews identified fast food restaurants as common food sources, with few other food sources available. DISCUSSION: Data suggested that although strides have been made to increase safety and comfort in public housing, there remains poor access to PA resources and healthful food sources. Interventions and policies should consider access to PA resources and food sources.

The Physical Activity Resource Assessment (PARA) instrument: evaluating features, amenities and incivilities of physical activity resources in urban neighborhoods.

BACKGROUND: Neighborhood environment factors may influence physical activity (PA). The purpose of this study was to develop and test a brief instrument to systematically document and describe the type, features, amenities, quality and incivilities of a variety of PA resources. METHOD: The one-page Physical Activity Resource Assessment (PARA) instrument was developed to assess all publicly available PA resources in thirteen urban lower income, high ethnic minority concentration neighborhoods that surrounded public housing developments (HDs) and four higher income, low ethnic minority concentration comparison neighborhoods. Neighborhoods had similar population density and connectivity. Trained field coders rated 97 PA resources (including parks, churches, schools, sports facilities, fitness centers, community centers, and trails) on location, type, cost, features, amenities, quality and incivilities. Assessments typically took about 10 minutes to complete. RESULTS: HD neighborhoods had a mean of 4.9 PA resources (n = 73) with considerable variability in the type of resources available for each neighborhood. Comparison neighborhoods had a mean of 6 resources (n = 24). Most resources were accessible at no cost (82%). Resources in both types of neighborhoods typically had about 2 to 3 PA features and amenities, and the quality was usually mediocre to good in both types of neighborhoods. Incivilities at PA resources in HD neighborhoods were significantly more common than in comparison neighborhoods. CONCLUSION: Although PA resources were similar in number, features and amenities, the overall appearance of the resources in HD neighborhoods was much worse as indicated by substantially worse incivilities ratings in HD neighborhoods. The more comprehensive assessment, including features, amenities and incivilities, provided by the PARA may be important to distinguish between PA resources in lower and higher deprivation areas.

Obesity and the built environment.

Biological, psychological, behavioral, and social factors are unable to fully explain or curtail the obesity epidemic. In this article we review research on the influence of the built environment on obesity. Studies were evaluated with regard to their methods of assessing the environment and obesity, as well as to their effects. Methods used to investigate the relationships between the built environment and obesity were found to be dissimilar across studies and varied from indirect to direct. Levels of assessment between and within studies varied from entire counties down to the individual level. Despite this, obesity was linked with area of residence, resources, television, walkability, land use, sprawl, and level of deprivation, showing promise for research utilizing more consistent assessment methods. Recommendations were made to use more direct methods of assessing the environment, which would include specific targeting of institutions thought to vary widely in relation to area characteristics and have a more influential effect on obesity-related behaviors. Interventions should be developed from the individual to the neighborhood level, specifically focusing on the effects of eliminating barriers and making neighborhood level improvements that would facilitate the elimination of obesogenic environments.

Women's experiences of information, psychological distress and worry after treatment for gynaecological cancer.

Sensitive, appropriate patient information is considered to be an important element in the psychological support of patients. Specialist nurses are seen to have a key responsibility for this work. With regard to gynaecological cancer, evidence suggests that women do not get optimum psychological care. This study set out to explore women's experiences of information, psychological distress and worry after treatment for gynaecological cancer. The study was a survey (not an RCT) and 70 patients from two specialist gynaecological oncology centres were interviewed at the time of diagnosis/initial treatment and again at 6 months. The semi-structured schedule included recognised instruments to assess; sources of information, concerns, and psychological distress. Both initially and at 6 months there was evidence of a considerable burden of worry; over half the women had four or more significant concerns related to their illness experience. However, women who had initial support from a clinical nurse specialist at the time of diagnosis experienced a clinically significant reduction in their level of psychological distress 6 months from diagnosis. Hospital linked professional sources of information were well used at the time of diagnosis, but by 6 months many patients were using non-professional sources such as television, magazines and newspapers. This study suggests that support from a clinical nurse specialist may be able to assist psychological recovery. However, to be effective in this area nurses should be skilled and willing to assess the individual's need for help with information, and managing their worry.

Using combined research methods for exploring diabetes patient education.

This paper explores a trial of an educational intervention designed for people who have Type 2 diabetes. The aim of the trial was to understand how the intervention had influenced outcomes in the context of participants' everyday lives. A randomised-controlled wait-list trial design was used. The study was also informed by a qualitative approach which explored the meanings held by participants for informing their behaviours. Outcomes were measured using diabetes-specific questionnaires and clinical measures of blood glucose control, weight and drug treatment. Alongside these, focus group discussions were held to explore how outcome effects had transpired. Using these different methods resulted in two separate data sets which required diverse methods for analysis. This paper uses examples of compatibilities and contradictions between the data sets to look at how they were combined to produce valid results. Conclusions drawn showed that a combined methods approach was essential to expand the scope and improve the analytic power of trials of patient education. It produced illuminating results which provided guidelines for practice and suggested further areas for research.

Macmillan cancer and palliative care specialists: their practice development support needs.

This study explores the practice development support needs of specialist nurses working in cancer and palliative care, in order to assist in the improvement of cancer and palliative care services. Using a whole population survey, postal questionnaires were sent to 1144 Macmillan post holders in England, Scotland and Wales. There was a 75.7% response rate. Three focus groups consisting of a total of 21 respondents were also used as a secondary form of data collection to supplement and expand upon the questionnaire responses. The findings reveal substantial practice development needs, particularly in relation to organizational support and guidance, education support, resources and access to evidence. The study demonstrates that nurses felt unable to engage in improving care unless initiatives were supported in practical ways by their organizations.

A Prospective Comparison Study of Different Methods of Gathering Self-Reported Family History Information for Breast Cancer Risk Assessment.

Currently there is much debate regarding the ability of mathematical models incorporating epidemiological information or mutation-based risk algorithms to accurately predict a woman's risk of developing breast cancer. Without access to accurate family history information these models have limited use. This study compares different methods of gathering family history information and the impact on subsequent risk assessment. These methods were compared to the "gold standard" interview with a trained genetics' professional. The amount and accuracy of information provided by primary care doctors' letters was found to be poor and better information was obtained by sending a postal questionnaire directly to the patient. Because of the high number of low-risk women referred to clinic a questionnaire (the FCAT) was designed to provide reassurance and piloted as part of this study. This paper highlights the importance of using appropriate methods to gather the family history information. It presents evidence for the importance of a skilled assessor and the need to allow time for women to discuss the importance of this information with their family.