Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study

Background
Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in future ventilation trials in mechanically ventilated adults and children.

Methods/design
We will use a mixed methods approach that incorporates a randomised trial nested within a Delphi study and a consensus meeting. Additionally, we will conduct an observational cohort study to evaluate uptake of the core outcome set in published studies at 5 and 10 years following core outcome set publication. The three-round online Delphi study will use a list of outcomes that have been reported previously in a review of ventilation trials. The Delphi panel will include a range of stakeholder groups including patient support groups. The panel will be randomised to one of three feedback methods to assess the impact of the feedback mechanism on subsequent ranking of outcomes. A final consensus meeting will be held with stakeholder representatives to review outcomes.

Discussion
The COVenT study aims to develop a core outcome set for ventilation trials in critical care, explore the best Delphi feedback mechanism for achieving consensus and determine if participation increases use of the core outcome set in the long term.

Survey of new 2007 and 2011 Cochrane reviews found 37% of prespecified outcomes not reported

OBJECTIVES: To survey the outcomes used in Cochrane Reviews, as part of our work within the Core Outcome Measures in Effectiveness Trials Initiative.

STUDY DESIGN AND SETTING: A descriptive survey of Cochrane Reviews, divided by Cochrane Review Group (CRG), published in full for the first time in 2007 and 2011. Outcomes specified in the methods section of each review and outcomes reported in the results section of each review were of interest, in this exploration of the common use of outcomes and core outcome sets (COS).

RESULTS: Seven hundred eighty-eight reviews, specifying 6,127 outcomes, were included. When we excluded specified outcomes from the 86 reviews that did not include any studies, we found that 1,996 (37%) specified outcomes were not reported. Of the 361 new reviews with studies from 2011, 113 (31%) had a "summary of findings" table (SoF). Fifteen broad outcome categories were identified and used to manage the outcome data. We found consistency in the use of these categories across CRGs but inconsistency in outcomes within these categories.

CONCLUSION: COS have been used rarely in Cochrane Reviews, but the introduction of SoF makes the development and application of COS timelier than ever.

Sources of patient knowledge and financing of cataract surgery in rural China: the Sanrao Study of Cataract Outcomes and Up-Take of Services (SCOUTS), report 6.

AIM: To study patient sources of knowledge about cataract surgical services, and strategies for financing surgery in rural China. DESIGN: Cross-sectional case series. METHODS: Patients undergoing cataract surgery by local surgeons in a government, village-level facility in Sanrao, Guangdong between 8 August and 31 December 2005 were examined and had standardised interviews an average of 12 months after surgery. RESULTS: Of 313 eligible patients, 239 (76%) completed the questionnaire. Subjects had a mean (SD) age of 69.9 (10.2) years, 36.4% (87/239) were male, and 87.0% (208/239) had been blind (presenting visual acuity < or = 6/60) before surgery. Word-of-mouth advertising was particularly important: 198 (85.0%) of the subjects knew a person who had undergone cataract surgery, of whom 191 (96.5%) had had cataract surgery at Sanrao itself. Over 70% of subjects (166/239) watched TV daily, whereas 80.0% (188/239) "never" read the newspaper. Nearly two-thirds of suggestions from participants (n = 211, 59.6%) favoured either TV advertisements or word-of-mouth to publicise the programme. While the son or daughter had paid for surgery in over 70% of cases (164/233), the patient's having paid without help was the sole predictor of undergoing second-eye surgery (OR 2.27 (95% CI 1.01 to 5.0, p = 0.04)). DISCUSSION: Strategies to increase uptake of cataract surgery in rural China may benefit from enhancing word-of-mouth advertising (such as with pseudophakic motivators), using television advertising where affordable, and micro-credit or other programmes to enable patients to pay their own fees, thus increasing uptake of second-eye surgery.

The effects of blood pressure lowering on development of cognitive impairment and dementia in patients without apparent prior cerebrovascular disease

BACKGROUND: Hypertension and cognitive impairment are prevalent in older people. It is known that hypertension is a direct risk factor for vascular dementia and recent studies have suggested hypertension also impacts upon prevalence of Alzheimer's disease. The question is therefore whether treatment of hypertension lowers the rate of cognitive decline. OBJECTIVES: To assess the effects of blood pressure lowering treatments for the prevention of dementia and cognitive decline in patients with hypertension but no history of cerebrovascular disease. SEARCH STRATEGY: The trials were identified through a search of CDCIG's Specialised Register, CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL on 27 April 2005. SELECTION CRITERIA: Randomized, double-blind, placebo controlled trials in which pharmacological or non-pharmacological interventions to lower blood pressure were given for at least six months. DATA COLLECTION AND ANALYSIS: Two independent reviewers assessed trial quality and extracted data. The following outcomes were assessed: incidence of dementia, cognitive change from baseline, blood pressure level, incidence and severity of side effects and quality of life. MAIN RESULTS: Three trials including 12,091 hypertensive subjects were identified. Average age was 72.8 years. Participants were recruited from industrialised countries. Mean blood pressure at entry across the studies was 170/84 mmHg. All trials instituted a stepped care approach to hypertension treatment, starting with a calcium-channel blocker, a diuretic or an angiotensin receptor blocker. The combined result of the three trials reporting incidence of dementia indicated no significant difference between treatment and placebo (Odds Ratio (OR) = 0.89, 95% CI 0.69, 1.16). Blood pressure reduction resulted in a 11% relative risk reduction of dementia in patients with no prior cerebrovascular disease but this effect was not statistically significant (p = 0.38) and there was considerable heterogeneity between the trials. The combined results from the two trials reporting change in Mini Mental State Examination (MMSE) did not indicate a benefit from treatment (Weighted Mean Difference (WMD) = 0.10, 95% CI -0.03, 0.23). Both systolic and diastolic blood pressure levels were reduced significantly in the two trials assessing this outcome (WMD = -7.53, 95% CI -8.28, -6.77 for systolic blood pressure, WMD = -3.87, 95% CI -4.25, -3.50 for diastolic blood pressure).Two trials reported adverse effects requiring discontinuation of treatment and the combined results indicated a significant benefit from placebo (OR = 1.18, 95% CI 1.06, 1.30). When analysed separately, however, more patients on placebo in SCOPE were likely to discontinue treatment due to side effects; the converse was true in SHEP 1991. Quality of life data could not be analysed in the three studies. There was difficulty with the control group in this review as many of the control subjects received antihypertensive treatment because their blood pressures exceeded pre-set values. In most cases the study became a comparison between the study drug against a usual antihypertensive regimen. AUTHORS' CONCLUSIONS: There was no convincing evidence from the trials identified that blood pressure lowering prevents the development of dementia or cognitive impairment in hypertensive patients with no apparent prior cerebrovascular disease. There were significant problems identified with analysing the data, however, due to the number of patients lost to follow-up and the number of placebo patients given active treatment. This introduced bias. More robust results may be obtained by analysing one year data to reduce differential drop-out or by conducting a meta-analysis using individual patient data.

Teaching and cognitive outcomes in A-levels and Advanced GNVQ's: Case studies from Science and Business Studies Classrooms

The purpose of the paper is to demonstrate how a research diary methodology, designed to analyse A-level and GNVQ classrooms, can be a powerful tool for examining pedagogy and quality of learning at the level of case study. Two subject areas, science and business studies, are presented as cases. Twelve teachers and thirty-four students were studied over a four-week period in May 1997 and contrasts were drawn between lessons from three A-level physics teachers/three Advanced GNVQ science teachers and two A-level business/economics teachers/four Advanced GNVQ business teachers. Lessons were analysed within a cognitive framework which distinguishes between conceptual and procedural learning and emphasizes the importance of metacognition and epistemological beliefs. Two dimensions of lessons were identified: pedagogical activities (e.g. teacher-led explanation, teacher-led guidance on a task, question/answer sessions, group discussions, working with IT) and cognitive outcomes (e.g. structuring and memorizing facts, understanding concepts and arguments, critical thinking, problem-solving, learning core skills, identifying values). Immediately after each lesson, teachers and students (three per class) completed structured research diaries with respect to the above dimensions. Data from the diaries reveal general and unique features of the lessons. Time-ofyear effects were evident (examinations pending in May), particularly in A-level classrooms. Students in business studies classes reported a wider range of learning activities and greater variety in cognitive outcomes than did students in science classes. Science students self-rating of their ability to manage and direct their own learning was generally low. The phenomenological aspects of the classrooms were consistently linked to teachers' lesson plans and what their teaching objectives were for those particular students at that particular time of the year.

The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]

Background: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland.CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines.

Methods: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.

Using the opinions of coronary heart disease patients in designing a health education booklet for use in general practice consultations.

Objective This study explored how coronary heart disease (CHD) patients’ views would inform the design of an information booklet aimed at providing patients and practitioners with a resource to help influence positively patients’ health behaviour outcomes. Methods Opinions of patients (N=23) with CHD about their information needs, particularly lifestyle advice, were explored using a qualitative approach in four general practices. This information was used in designing a booklet for a pilot study intervention aimed at promoting healthy lifestyle behaviours and medication adherence among people with CHD. Subsequent focus groups explored patients’ (N=17) opinions about the booklet’s ‘fitness for purpose’; semi-structured interviews with practitioners (N=10) examined their views on the booklet’s usefulness. Results In initial focus groups patients identified gaps in their information provision regarding coping with stress, available local community support and medication purpose. A booklet, prepared on the basis of previous literature, was modified to address these gaps. Pilot study patients were satisfied with the re-designed booklet and practitioners reported that its use in consultations enabled change implementation and facilitated patients’ understanding of connections between lifestyle and health outcomes. Conclusion Acknowledging the opinions of CHD patients in producing health information booklets which emphasised a patient centred approach supported practitioner-patient partnerships for choosing healthy lifestyle choices.

Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial

Objective: To test the effectiveness of a complex intervention designed, within a theoretical framework, to improve outcomes for patients with coronary heart disease. Design: Cluster randomised controlled multicentre trial. Setting: General practices in Northern Ireland and the Republic of Ireland, regions with different healthcare systems. Participants: 903 patients with established coronary heart disease registered with one of 48 practices. Intervention: Tailored care plans for practices (practice based training in prescribing and behaviour change, administrative support, quarterly newsletter), and tailored care plans for patients (motivational interviewing, goal identification, and target setting for lifestyle change) with reviews every four months at the practices. Control practices provided usual care. Main outcome measures: The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration, and those admitted to hospital, and changes in physical and mental health status (SF-12). Results: At baseline the numbers (proportions) of patients above the recommended limits were: systolic blood pressure greater than 140 mm Hg (305/899; 33.9%, 95% confidence interval 30.8% to 33.9%), diastolic blood pressure greater than 90 mm Hg (111/901; 12.3%, 10.2% to 14.5%), and total cholesterol concentration greater than 5 mmol/l (188/860; 20.8%, 19.1% to 24.6%). At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers (proportions) of patients above the recommended limits: systolic blood pressure, intervention 98/360 (27.2%) v control, 133/405 (32.8%), odds ratio 1.51 (95% confidence interval 0.99 to 2.30; P=0.06); diastolic blood pressure, intervention 32/360 (8.9%) v control, 40/405 (9.9%), 1.40 (0.75 to 2.64; P=0.29); and total cholesterol concentration, intervention 52/342 (15.2%) v control, 64/391 (16.4%), 1.13 (0.63 to 2.03; P=0.65). The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group: 107/415 (25.8%) v 148/435 (34.0%), 1.56 (1.53 to 2.60; P=0.03). Conclusions: Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease, but no other clinical benefits were shown, possibly because of a ceiling effect related to improved management of the disease. Trial registration: Current Controlled Trials ISRCTN24081411.

Wholeness of healing: an innovative Student-Selected Component introducing United Kingdom medical students to the spiritual dimension in healthcare.

Objective: This Student Selected Component (SSC) was designed to equip United Kingdom (UK) medical students to engage in whole-person care. The aim was to explore students' reactions to experiences provided, and consider potential benefits for future clinical practice.

Methods: The SSC was delivered in the workplace. Active learning was encouraged through facilitated discussion with and observation of clinicians, the palliative team, counselling services, hospital chaplaincy and healing ministries; sharing of medical histories by patients; and training in therapeutic communication. Assessment involved reflective journals, literature appraisal, and role-play simulation of the doctor-patient consultation. Module impact was evaluated by analysis of student coursework and a questionnaire.

Results: Students agreed that the content was stimulating, relevant, and enjoyable and that learning outcomes were achieved. They reported greater awareness of the benefit of clinicians engaging in care of the "whole person" rather than "the disease." Contributions of other professions to the healing process were acknowledged, and students felt better equipped for discussion of spiritual issues with patients. Many identified examples of activities which could be incorporated into core teaching to benefit all medical students.

Conclusion: The SSC provided relevant active learning opportunities for medical students to receive training in a whole-person approach to patient care.

Microarray-based classifiers and prognosis models identify subgroups with distinct clinical outcomes and high risk of AML transformation of myelodysplastic syndrome

The diagnosis of myelodysplastic syndrome (MDS) currently relies primarily on the morphologic assessment of the patient's bone marrow and peripheral blood cells. Moreover, prognostic scoring systems rely on observer-dependent assessments of blast percentage and dysplasia. Gene expression profiling could enhance current diagnostic and prognostic systems by providing a set of standardized, objective gene signatures. Within the Microarray Innovations in LEukemia study, a diagnostic classification model was investigated to distinguish the distinct subclasses of pediatric and adult leukemia, as well as MDS. Overall, the accuracy of the diagnostic classification model for subtyping leukemia was approximately 93%, but this was not reflected for the MDS samples giving only approximately 50% accuracy. Discordant samples of MDS were classified either into acute myeloid leukemia (AML) or

'Murder or Mercy?' an innovative module helping UK medical students to articulate their own ethical standpoints regarding end-of-life decisions

Objectives This student selected component (SSC) was designed to equip United Kingdom (UK) medical students to respond ethically and with sensitivity to requests they might receive as qualified doctors in regard to euthanasia and assisted dying. The aim was to expose students to relevant opinions and experiences and to provide opportunities to explore and justify their own views and rehearse ethical decision making in a safe learning environment. Method The module is delivered by specialists from a number of disciplines including law, theology, medicine and nursing, each providing students with a working knowledge allowing them to actively discuss cases, articulate their own views and practise ethical reasoning through group and individual study. Visits to local intensive care units, palliative care wards and hospices are integrated effectively with theory. Student assessment comprises a dissertation, student-led debate and reflective commentary. Module impact was evaluated by analysis of student coursework and a questionnaire. Results Students found the content stimulating and relevant to their future career and agreed that the module was well-structured and that learning outcomes were achieved. They greatly appreciated the clinical context provided by the visits and opportunities to apply ethical reasoning to real cases and to debate ethical issues with peers. Students reported an increased discernment of the ethical and legal position and practical considerations and a greater awareness of the range of professional and lay viewpoints held. Student perceptions were confirmed on analysis of their submitted coursework. Many participants were less strongly in favour of euthanasia and assisted dying on module completion than at the outset but all felt better equipped to justify their own viewpoint and to respond appropriately to patient requests. Conclusions The multi-disciplinary nature of this course is helpful in preparing students to deal effectively and sensitively with ethical dilemmas they will encounter in their medical career. Use of an integrated, learner-centred approach equips students to actively engage with their peers in discussion of such issues and to formulate and defend their own position.

Blood pressure lowering in patients without prior cerebrovascular disease for prevention of cognitive impairment and dementia

Background: This is an update of a previous review (McGuinness 2006). Hypertension and cognitive impairment are prevalent in older people. Hypertension is a direct risk factor for vascular dementia (VaD) and recent studies have suggested hypertension impacts upon prevalence of Alzheimer's disease (AD). Therefore does treatment of hypertension prevent cognitive decline?
Objectives: To assess the effects of blood pressure lowering treatments for the prevention of dementia and cognitive decline in patients with hypertension but no history of cerebrovascular disease.
Search strategy: The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS as well as many trials databases and grey literature sources were searched on 13 February 2008 using the terms: hypertens$ OR anti-hypertens$. Selection criteria: Randomized, double-blind, placebo controlled trials in which pharmacological or non-pharmacological interventions to lower blood pressure were given for at least six months.
Data collection and analysis: Two independent reviewers assessed trial quality and extracted data. The following outcomes were assessed: incidence of dementia, cognitive change from baseline, blood pressure level, incidence and severity of side effects and quality of life.
Main results: Four trials including 15,936 hypertensive subjects were identified. Average age was 75.4 years. Mean blood pressure at entry across the studies was 171/86 mmHg. The combined result of the four trials reporting incidence of dementia indicated no significant difference between treatment and placebo (236/7767 versus 259/7660, Odds Ratio (OR) = 0.89, 95% CI 0.74, 1.07) and there was considerable heterogeneity between the trials. The combined results from the three trials reporting change in Mini Mental State Examination (MMSE) did not indicate a benefit from treatment (Weighted Mean Difference (WMD) = 0.42, 95%CI 0.30, 0.53). Both systolic and diastolic blood pressure levels were reduced significantly in the three trials assessing this outcome (WMD = -10.22, 95% CI -10.78, -9.66 for systolic blood pressure, WMD = -4.28, 95% CI -4.58, -3.98 for diastolic blood pressure). Three trials reported adverse effects requiring discontinuation of treatment and the combined results indicated no significant difference (OR = 1.01, 95% CI 0.92, 1.11). When analysed separately, however, more patients on placebo in Syst Eur 1997 were likely to discontinue treatment due to side effects; the converse was true in SHEP 1991. Quality of life data could not be analysed in the four studies. Analysis of the included studies in this review was problematic as many of the control subjects received antihypertensive treatment because their blood pressures exceeded pre-set values. In most cases the study became a comparison between the study drug against a usual antihypertensive regimen.
Authors' conclusions: There is no convincing evidence fromthe trials identified that blood pressure lowering in late-life prevents the development of dementia or cognitive impairment in hypertensive patients with no apparent prior cerebrovascular disease. There were significant problems identified with analysing the data, however, due to the number of patients lost to follow-up and the number of placebo patients who received active treatment. This introduced bias. More robust results may be obtained by conducting a meta-analysis using individual patient data.

Gamma Knife stereotactic radiosurgery for idiopathic trigeminal neuralgia. Clinical article

Object
Trigeminal neuralgia pain causes severe disability. Stereotactic radiosurgery is the least invasive surgical option for patients with trigeminal neuralgia. Since different medical and surgical options have different rates of pain relief and morbidity, it is important to evaluate longer-term outcomes.

Methods
The authors retrospectively reviewed outcomes in 503 medically refractory patients with trigeminal neuralgia who underwent Gamma Knife surgery (GKS). The median patient age was 72 years (range 26–95 years). Prior surgery had failed in 205 patients (43%). The GKS typically was performed using MR imaging guidance, a single 4-mm isocenter, and a maximum dose of 80 Gy.

Results
Patients were evaluated for up to 16 years after GKS; 107 patients had > 5 years of follow-up. Eighty-nine percent of patients achieved initial pain relief that was adequate or better, with or without medications (Barrow Neurological Institute [BNI] Scores I–IIIb). Significant pain relief (BNI Scores I–IIIa) was achieved in 73% at 1 year, 65% at 2 years, and 41% at 5 years. Including Score IIIb (pain adequately controlled with medication), a BNI score of I–IIIb was found in 80% at 1 year, 71% at 3 years, 46% at 5 years, and 30% at 10 years. A faster initial pain response including adequate and some pain relief was seen in patients with trigeminal neuralgia without additional symptoms, patients without prior surgery, and patients with a pain duration of = 3 years. One hundred ninety-three (43%) of 450 patients who achieved initial pain relief reported some recurrent pain 3–144 months after initial relief (median 50 months). Factors associated with earlier pain recurrence that failed to maintain adequate or some pain relief were trigeminal neuralgia with additional symptoms and = 3 prior failed surgical procedures. Fifty-three patients (10.5%) developed new or increased subjective facial paresthesias or numbness and 1 developed deafferentation pain; these symptoms resolved in 17 patients. Those who developed sensory loss had better long-term pain control (78% at 5 years).

Conclusions
Gamma Knife surgery proved to be safe and effective in the treatment of medically refractory trigeminal neuralgia and is of value for initial or recurrent pain management. Despite the goal of minimizing sensory loss with this procedure, some sensory loss may improve long-term outcomes. Pain relapse is amenable to additional GKS or another procedure.

The back 2 activity trial: education and advice versus education and advice plus a structured walking programme for chronic low back pain.:education and advice versus education and advice plus a structured walking programme for chronic low back pain

BACKGROUND: Current evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active.

METHODS/DESIGN: The proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial.

DISCUSSION: This paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain.

TRIAL REGISTRATION: [ISRCTN67030896].

General and Respiratory Health Outcomes in Adult Survivors of Bronchopulmonary Dysplasia: A Systematic Review

Background: The purpose of this systematic literature review was to examine current empirical research on general and respiratory health outcomes in adult survivors of bronchopulmonary dysplasia (BPD).

Methods: We searched seven databases up to the end of November 2010 (MEDLINE, PubMed, EMBASE, PsycINFO, Maternity and Infant Care, Cumulative Index of Nursing and Allied Health Literature, and Web of Knowledge). We independently screened and included only those studies concerning the assessment of outcome measures in adult survivors of BPD. Data on methodologic design and findings were extracted from each included study; in addition, the methodologic quality of each study was assessed using the Critical Appraisal Skills Programme checklist.

Results: Fourteen cohort studies met the review criteria. Of those, a total of eight studies were considered to be of high quality (score 9-12), five of moderate quality (score 5-8), and only one was of low quality (score 0-4). In all studies of adult survivors of BPD, differences were found between the index and control groups, suggesting that many adults survivors of BPD who were born preterm or with very low birth weight had more respiratory symptoms and pulmonary function abnormalities compared with their peers. Five studies concerning radiologic findings reported structural changes persisting into adulthood. Findings from three studies suggested impairment in exercise capacity, although firm conclusions were limited by the small sample size in the studies reviewed.

Conclusions: Compared with adults born at term, adult survivors of BPD have more impairment in general and respiratory health, which does not seem to diminish over time.