When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. RESULTS: A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. CONCLUSION: The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

Why are adult women physically active? A systematic review of prospective cohort studies to identify intrapersonal, social environmental and physical environmental determinants.

OBJECTIVE: This study aims to systematically review available evidence from prospective cohort studies to identify intrapersonal, social environmental and physical environmental determinants of moderate-to-vigorous intensity physical activity (MVPA) among working-age women. METHODS: Six databases were searched to identify all prospective cohort studies that reported on intrapersonal (e.g. self-efficacy and socioeconomic status [SES]), social (e.g. crime, area SES and social support) and/or physical (e.g. weather, work and recreation) environmental determinants of MVPA in working-age (mean 18-65 years) women. A qualitative synthesis including harvest plots was completed. PROSPERO: CRD42014009750 RESULTS: Searching identified 17,387 potential articles; 97 were used in the analysis. The majority (n = 87 studies) reported on ≥1 intrapersonal determinant. Very few (n = 34) examined factors in the social or physical environments, and none looked at social policy. Positive and consistent influencers included higher self-efficacy (n = 18/23), self-rated health (n = 8/13) and intentions (n = 10/11) and perceived behavioural control (n = 5/7) to be physically active. Having children in the household was negatively related to MVPA (n = 9/15). CONCLUSIONS: Physical activity intervention studies should consider a woman's level of self-efficacy and perceived behavioural control to be physically active. Additional studies are needed on the impact of children in the household, having a spouse/partner and using group goal setting. More evidence is needed to evaluate the impact of environmental factors.

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

BACKGROUND: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). METHODS/DESIGN: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. DISCUSSION: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

Altered activity of the serratus anterior during unilateral arm elevation in patients with cervical disorders.

Altered activity in the axioscapular muscles is considered to be an important feature in patients with neck pain. The activity of the serratus anterior (SA) and trapezius muscles during arm elevation has not been investigated in these patients. The objectives of this study was to investigate whether there is a pattern of altered activity in the SA and trapezius in patients with insidious onset neck pain (IONP) (n=22) and whiplash associated disorders (WAD) (n=27). An asymptomatic group was selected for baseline measurements (n=23). Surface electromyography was used to measure the onset of muscle activation and duration of muscle activity of the SA as well as the upper, middle, and lower trapezius during unilateral arm elevation in the three subject groups. Both arms were tested. With no interaction, the main effect for the onset of muscle activation and duration of muscle activity for serratus anterior was statistically significant among the groups. Post hoc comparison revealed a significantly delayed onset of muscle activation and less duration of muscle activity in the IONP group, and in the WAD group compared to the asymptomatic group. There were no group main effects or interaction effects for upper, middle and lower trapezius. This finding may have implications for scapular stability in these patients because the altered activity in the SA may reflect inconsistent or poorly coordinated muscle activation that may reduce the quality of neuromuscular performance and induce an increased load on the cervical and the thoracic spine.

School feeding for improving the physical and psychosocial health of disadvantaged elementary school children.

BACKGROUND: Early malnutrition and/or micronutrient deficiencies can adversely affect physical, mental, and social aspects of child health. School feeding programs are designed to improve attendance, achievement, growth, and other health outcomes. OBJECTIVES: The main objective was to determine the effectiveness of school feeding programs in improving physical and psychosocial health for disadvantaged school children. SEARCH STRATEGY: We searched a number of databases including CENTRAL (2006 Issue 2), MEDLINE (1966 to May 2006), EMBASE (1980 to May 2006), PsycINFO (1980 to May 2006) and CINAHL (1982 to May 2006). Grey literature sources were also searched. Reference lists of included studies and key journals were handsearched and we also contacted selected experts in the field. SELECTION CRITERIA: Data from randomized controlled trials (RCTs), non-randomised controlled clinical trials (CCTs), controlled before and after studies (CBAs), and interrupted time series studies (ITSs) were included. Feeding had to be done in school; the majority of participants had to be socio-economically disadvantaged. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all searches and retrieved studies. Data extraction was done by one of four reviewers and reviewed by a second. Two reviewers independently rated quality. If sufficient data were available, they were synthesized using random effects meta-analysis, adjusting for clustering if needed. Analyses were performed separately for RCTs and CBAs and for higher and lower income countries. MAIN RESULTS: We included 18 studies. For weight, in the RCTs and CBAs from Lower Income Countries, experimental group children gained an average of 0.39 kg (95% C.I: 0.11 to 0.67) over an average of 19 months and 0.71 kg (95% C.I.: 0.48 to 0.95) over 11.3 months respectively. Results for weight were mixed in higher income countries. For height, results were mixed; height gain was greater for younger children. Attendance in lower income countries was higher in experimental groups than in controls; our results show an average increase of 4 to 6 days a year. Math gains were consistently higher for experimental groups in lower income countries; in CBAs, the Standardized Mean Difference was 0.66 (95% C.I. = 0.13 to 1.18). In short-term studies, small improvements in some cognitive tasks were found. AUTHORS' CONCLUSIONS: School meals may have some small benefits for disadvantaged children. We recommend further well-designed studies on the effectiveness of school meals be undertaken, that results should be reported according to socio-economic status, and that researchers gather robust data on both processes and carefully chosen outcomes.

Impairment in the cervical flexors: a comparison of whiplash and insidious onset neck pain patients.

There has been little investigation into whether or not differences exist in the nature of physical impairment associated with neck pain of whiplash and insidious origin. This study examined the neck flexor synergy during performance of the cranio-cervical flexion test, a test targeting the action of the deep neck flexors. Seventy-five volunteer subjects participated in this study and were equally divided between Group 1, asymptomatic control subjects, Group 2, subjects with insidious onset neck pain and Group 3, subjects with neck pain following a whiplash injury. The cranio-cervical flexion test was performed in five progressive stages of increasing cranio-cervical flexion range. Subjects' performance was guided by feedback from a pressure sensor inserted behind the neck which monitored the slight flattening of the cervical lordosis which occurs with the contraction of longus colli. Myoelectric signals (EMG) were detected from the muscles during performance of the test. The results indicated that both the insidious onset neck pain and whiplash groups had higher measures of EMG signal amplitude (normalized root mean square) in the sternocleidomastoid during each stage of the test compared to the control subjects (all P<0.05) and had significantly greater shortfalls from the pressure targets in the test stages (P<0.05). No significant differences were evident between the neck pain groups in either parameter indicating that this physical impairment in the neck flexor synergy is common to neck pain of both whiplash and insidious origin.

Is the sagittal configuration of the cervical spine changed in women with chronic whiplash syndrome? A comparative computer-assisted radiographic assessment.

OBJECTIVE: To reveal whether women with chronic whiplash-associated disorder (WAD) symptoms, grade I-II, demonstrate regional and/or segmental radiographic signs of altered cervical lordosis. DESIGN: Case-control study. SETTING: Radiography department at a university hospital. PARTICIPANTS: Three age-balanced groups comprising 120 women. The case group included women with chronic whiplash syndrome (n = 41), and the control group included women with chronic insidious onset neck pain (n = 39) and an asymptomatic group (n = 40), who were given baseline data. The sample was referred from informed doctors and physiotherapists. INTERVENTION: The women sat in a standardized sitting position and radiographs were taken in a lateral position with fluoroscopic control for alignment. OUTCOME MEASURES: Two distinct measurements were taken; 1 of the angles of the upper and lower cervical curvatures, respectively, and 1 of the angles between the inferior borders of each pair of vertebrae in the lower cervical spine. The 3 groups were compared on the ratio of the lower to upper cervical spine angles and on the mean angular values for each segment in the cervical spine. RESULTS: The whiplash group showed a decreased ratio between the lower versus upper cervical spine but comparisons between groups were not statistically significant. The whiplash group was in a significantly more flexed position at the C4-C5 level compared with the asymptomatic group (P =.007). The reliability measures have to be strengthened to render these results definitely conclusive. CONCLUSION: The whiplash group exhibited a different configuration of cervical lordosis. This is clinically important and needs to be studied more closely.

Cervicocephalic kinaesthesia: reliability of a new test approach.

BACKGROUND AND PURPOSE: Relocating either the natural head posture (NHP) or predetermined points in range are clinical tests of impaired neck proprioception but memory might influence these tests. Three new tests, reasoned to be more challenging for the proprioceptive system, were developed. The objectives were to assess the reliability of all tests and whether the three new tests were more challenging for the proprioceptive system. METHOD: A test-retest design was used to assess the reproducibility and errors of all five tests. Twenty asymptomatic volunteers were assessed a week apart, using an electromagnetic movement sensor system, the 3-Space Fastrak. A measure of error magnitude was used to detect kinaesthetic sensibility. Comparison of the means and their corresponding dispersion were analysed descriptively. The between-day intraclass correlation coefficients (ICCs) were calculated and plots of mean differences between days 1 and 2 were conducted to estimate test reliability. Multivariate analysis of variance (MANOVA) and least significant difference (LSD) pairwise comparisons were performed to compare the test accuracy between different target positions. RESULTS: ICCs were between 0.35 and 0.9, but plotting the data modified the interpretation in some tests. Relocating a NHP was easier when the trunk was in a neutral position than when pre-rotated (error 2.46 degrees (+/- 0.2 degree) versus 5.95 degrees (+/- 0.7 degree). Relocating a 30 degrees rotation position (error 5.8 degrees (+/- 0.6 degree) and repeatedly moving through a target (error 4.82 degrees (+/- 0.7 degree) was also difficult. CONCLUSIONS: The new tests were more challenging than relocating the NHP but the reliability of tests relocating uncommon positions was questionable.

Neuropsychological detection of dementia: an overview of the neuropsychological component of the Canadian Study of Health and Aging.

As part of the Canadian Study of Health and Aging (CSHA), a battery of neuropsychological measures was administered to 1879 participants. Participants who received neuropsychological evaluations were selected from an age-stratified random sample on the basis of scores on a cognitive screening tool, the Modified Mini-Mental State Examination (3MS). Seventy-five percent of the sample seen for neuropsychological evaluation scored between 50 and 77 on the 3MS and 25% of the sample scored 78 or over. This paper provides a descriptive summary of the methodological basis of the neuropsychological component of the CSHA. The findings indicated that differences existed between participants administered the battery in English or French in terms of refusal rates and diagnoses of dementia. Cursory examination of the utility of the battery indicated that the battery was tolerated well by both the participants and the psychologists involved with the study and that measures of memory functioning were central to diagnostic decision-making. The relations between neuropsychological, preliminary medical and consensus diagnoses were examined and indicated that neuropsychological information influenced diagnostic decision-making. The neuropsychology component of the CSHA is a rich source of information on persons aged 65 years and older in Canada.

A double-blind comparative multicentre study of remoxipride and haloperidol in schizophrenia.

In a double-blind multicentre study of parallel group design the efficacy and safety of remoxipride and haloperidol were compared in a total of 96 patients with acute episodes of schizophrenic or schizophreniform disorder according to DSM-III. There were 48 patients in each treatment group; 27 men and 21 women in the remoxipride group, 33 men and 15 women in the haloperidol group. The median duration of illness was 7 years in both groups. The mean daily dose was 437 mg for remoxipride and 10.6 mg for haloperidol during the last week of treatment. No statistically significant differences in total BPRS scores were found between remoxipride and haloperidol. The median total BPRS scores at the start of active treatment were 26 in the remoxipride and 27 in the haloperidol group; these were reduced to 16 and 12.5, respectively, at the last rating. According to Clinical Global Impression (CGI), 43% of patients in the remoxipride group and 68% of those in the haloperidol group improved much or very much during treatment. This difference was not statistically significant. Treatment-emergent extrapyramidal side effects such as akathisia, tremor, and rigidity occurred significantly more frequently in the haloperidol group; this group also made more frequent use of anticholinergic drugs. Neither of the trial drugs seriously affected laboratory or cardiovascular variables. It is concluded that remoxipride has an antipsychotic effect in a dose range of 150-600 mg per day comparable to that of haloperidol in doses up to 20 mg per day but with fewer extrapyramidal side effects.

Maternal smoking during pregnancy affects children's vigilance performance.

Aspects of attentional behaviour in 4--7-year-olds, as assessed by auditory and visual vigilance tasks, were related to prenatal exposure to cigarettes. Data on 76--79 children born to healthy, white, predominantly middle-class women were analyzed using multiple regression techniques controlling for potentially confounding variables including postnatal second hand smoke exposure. Cigarette smoking during pregnancy was related to an increased activity level of the children during the tasks and increased errors of commission in the auditory task and, to a lesser degree, in the visual task. After controlling for confounding factors, the relationship between prenatal smoking and errors of omission did not retain significance. The combination of results suggest that the deficits in attention may reflect impulsive responding and increased overall activity.

Risk factors for suicide among patients with schizophrenia.

In order to assess risk factors for suicide among patients with schizophrenia, we compared 32 patients with schizophrenia who committed suicide during an 11 year follow-up with a control group of 64 schizophrenics who did not commit suicide. A history of previous suicide attempts was the factor most strongly related to suicide. In females we found an increased risk for suicide among unmarried, divorced or widowed and among those living alone. In males we found an increased risk among those with a history of alcohol abuse. In contrast to findings in other studies, distribution of age and sex and a history of depressive episodes were factors not associated with an increased risk for suicide. We conclude that suicidal acts among schizophrenics are often impulsive and difficult to predict. Traditional risk scales are of limited value in the clinical assessment of suicidal risk.