Stephanie L. Prady

A Systematic Evaluation of the Impact of STRICTA and CONSORT Recommendations on Quality of Reporting for Acupuncture Trials

Background We investigated whether there had been an improvement in quality of reporting for randomised controlled trials of acupuncture since the publication of the STRICTA and CONSORT statements. We conducted a before-and-after study, comparing ratings for quality of reporting following the publication of both STRICTA and CONSORT recommendations. Methodology and Principal Findings Ninety peer reviewed journal articles reporting the results of acupuncture trials were selected at random from a wider sample frame of 266 papers. Papers published in three distinct time periods (1994–1995, 1999–2000 and 2004–2005) were compared. Assessment criteria were developed directly from CONSORT and STRICTA checklists. Papers were independently assessed for quality of reporting by two assessors, one of whom was blind to information which could have introduced systematic bias (e.g. date of publication). We detected a statistically significant increase in the reporting of CONSORT items for papers published in each time period measured. We did not, however, find a difference between the number of STRICTA items reported in journal articles published before and 3 to 4 years following the introduction of STRICTA recommendations. Conclusions and Significance The results of this study suggest that general standards of reporting for acupuncture trials have significantly improved since the introduction of the CONSORT statement in 1996, but that quality in reporting details specific to acupuncture interventions has yet to change following the more recent introduction of STRICTA recommendations. Wider targeting and revision of the guidelines is recommended.

The association between green space and depressive symptoms in pregnant women: moderating roles of socioeconomic status and physical activity

Background The current study explored the association between green space and depression in a deprived, multiethnic sample of pregnant women, and examined moderating and mediating variables. Method 7547 women recruited to the ‘Born in Bradford’ cohort completed a questionnaire during pregnancy. A binary measure of depressive symptoms was calculated using a validated survey. Two green space measures were used: quintiles of residential greenness calculated using the normalised difference vegetation index for three neighbourhood sizes (100, 300 and 500 m buffer zones around participant addresses); access to major green spaces estimated as straight line distance between participant address and nearest green space (>0.5 hectares). Logistic regression analyses examined relationships between green space and depressive symptoms, controlling for ethnicity, demographics, socioeconomic status (SES) and health behaviours. Multiplicative interactions explored variations by ethnic group, SES or activity levels. Mediation analysis assessed indirect effects via physical activity. Results Pregnant women in the greener quintiles were 18–23% less likely to report depressive symptoms than those in the least green quintile (for within 100 m of green space buffer zone). The green space-depressive symptoms association was significant for women with lower education or who were active. Physical activity partially mediated the association of green space, but explained only a small portion of the direct effect. Conclusions Higher residential greenness was associated with a reduced likelihood of depressive symptoms. Associations may be stronger for more disadvantaged groups and for those who are already physically active. Improving green space is a promising intervention to reduce risk of depression in disadvantaged groups.

Psychological distress during pregnancy in a multi-ethnic community: findings from the born in Bradford cohort study.

Purpose Antenatal anxiety and depression are predictive of future mental distress, which has negative effects on children. Ethnic minority women are more likely to have a lower socio-economic status (SES) but it is unclear whether SES is an independent risk factor for mental health in pregnancy. We described the association between maternal mental distress and socio-demographic factors in a multi-ethnic cohort located in an economically deprived city in the UK. Methods We defined eight distinct ethno-language groups (total N = 8,454) and classified a threshold of distress as the 75th centile of within-group GHQ-28 scores, which we used as the outcome for univariate and multivariate logistic regression for each ethnic group and for the sample overall. Results Financial concerns were strongly and independently associated with worse mental health for six out of the eight ethnic groups, and for the cohort overall. In some groups, factors such as working status, education and family structure were associated with worse mental health, but for others these factors were of little importance. Conclusions The diversity between and within ethnic groups in this sample underlines the need to take into consideration individual social, migration and economic circumstances and their potential effect on mental health in ethnically diverse areas.

The psychometric properties of the subscales of the GHQ-28 in a multi-ethnic maternal sample: results from the Born in Bradford cohort

BackgroundPoor maternal mental health can impact on children’s development and wellbeing; however, there is concern about the comparability of screening instruments administered to women of diverse ethnic origin.MethodsWe used confirmatory factor analysis (CFA) and exploratory factor analysis (EFA) to examine the subscale structure of the GHQ-28 in an ethnically diverse community cohort of pregnant women in the UK (N = 5,089). We defined five groups according to ethnicity and language of administration, and also conducted a CFA between four groups of 1,095 women who completed the GHQ-28 both during and after pregnancy.ResultsAfter item reduction, 17 of the 28 items were considered to relate to the same four underlying concepts in each group; however, there was variation in the response to individual items by women of different ethnic origin and this rendered between group comparisons problematic. The EFA revealed that these measurement difficulties might be related to variation in the underlying concepts being measured by the factors.ConclusionsWe found little evidence to recommend the use of the GHQ-28 subscales in routine clinical or epidemiological assessment of maternal women in populations of diverse ethnicity.

Measuring expectations of benefit from treatment in acupuncture trials: A systematic review ☆

OBJECTIVES We conducted a systematic review that aimed to document and describe how (1) expectation of benefit from treatment (response expectancies) were measured and reported in acupuncture trials, and (2) examine any effect on outcomes. DESIGN We searched MEDLINE, EMBASE, AMED, CIHAHL, CENTRAL and Science and Technology Proceedings up to November 2007 for randomised (RCT) and quasi-randomised (CCT) controlled trials and prospective controlled cohorts of acupuncture as treatment for a medical or psychological condition in adults. An update citation search was conducted in April 2010. We included studies that mentioned soliciting response expectancies. RESULTS We found 58 RCTs that fulfilled our inclusion criteria. Around half referenced one of five published instruments, most of which were designed to measure sham credibility and included one question on response expectancy. A wide range of question phrasing and response scales was used. There was some evidence that response scales may influence the measurement of expectations. Eight trials analysed the association between pre-randomisation expectations for assigned treatment and outcomes, and six the effect of pre-randomisation expectations across all patients independent of treatment allocation. Some showed associations but others did not. CONCLUSIONS There is some evidence that response expectancies interact with outcomes in acupuncture trials however the variety of question phrasing and analysis methods precludes drawing a firm conclusion about for whom and under which circumstance. To further our understanding of expectations, more methodological work is needed to standardise the questions and response scales that are used.

Evaluation of ethnic disparities in detection of depression and anxiety in primary care during the maternal period: combined analysis of routine and cohort data

Background There are limited data on detection disparities of common mental disorders in minority ethnic women. Aims Describe the natural history of common mental disorders in primary care in the maternal period, characterise women with, and explore ethnic disparities in, detected and potentially missed common mental disorders. Method Secondary analyses of linked birth cohort and primary care data involving 8991 (39.4% White British) women in Bradford. Common mental disorders were characterised through indications in the electronic medical record. Potentially missed common mental disorders were defined as an elevated General Health Questionnaire (GHQ-28) score during pregnancy with no corresponding common mental disorder markers in the medical record. Results Estimated prevalence of pre-birth common mental disorders was 9.5%, rising to 14.0% 3 years postnatally. Up to half of cases were potentially missed. Compared with White British women, minority ethnic women were twice as likely to have potentially missed common mental disorders and half as likely to have a marker of screening for common mental disorders. Conclusions Common mental disorder detection disparities exist for minority ethnic women in the maternal period.

Insufficient evidence to determine the impact of patient preferences on clinical outcomes in acupuncture trials: a systematic review.

OBJECTIVE To review reporting of preferences in acupuncture studies and their effect on clinical outcomes. STUDY DESIGN AND SETTING Systematic review of published randomized and quasi-randomized controlled trials of acupuncture reporting participant preferences for randomization or treatment or using a preference design. RESULTS Of the 31 included trials, 5 reported on randomization preference, 18 on treatment preference, and 1 reported on both. Seven used a preference design. Four out of seven trials noted that the group with preferences had different baseline characteristics (less education, worse baseline measure score, and greater or fewer years with pain). There was a tendency for greater attrition in nonpreference arms at 6 months but not earlier. Around three-quarters of participants turned down randomization in favor of nontrial treatment, and preference for acupuncture was around 20% when offered multiple treatments. Questions used to elicit preferences varied across trials and were poorly reported. Ten trials reported the effects of preferences on outcomes; only one detected a statistically (but not clinically) significant difference. CONCLUSION There is little evidence that preferences cause detectable effects on outcomes in acupuncture trials; however, trials use inconsistent methods and poorly report these data. Monitoring the level and effect of preferences in trials is recommended.

The effect of post‐natal mental distress amongst Indian and Pakistani mothers living in England on children's behavioural outcomes

BACKGROUND Low socio-economic status (SES), post-natal mental distress and parenting impact child mental health and future well-being. There are unexplained differences in child mental health between South Asian ethnic minority groups living in the UK that may be due to variation in, and differential mediation of, these factors. METHODS We used multivariate multiple regression analysis of the effect of symptoms of mental distress, socio-demographic variables and warmth of parenting on child internalizing and externalizing scores at age seven (measured in 2010) in a population cohort of English children whose mothers were of Indian (n = 211) and Pakistani (n = 260) origin. RESULTS In the fully adjusted models the legacy of mental distress was visible for both internalizing (β coefficient 1.52, P = 0.04) and externalizing (1.68, P = 0.01) behaviour in the Pakistani children, and on the Indian childrens internalizing (2.08, P = 0.008) but not externalizing (0.84, P = 0.204) behaviour. Lower SES was associated with worse behavioural scores for the Pakistani children, and warmth of parenting on Indian childrens externalizing scores. CONCLUSIONS Symptoms of post-natal mental distress are associated with Indian and Pakistani child outcomes at age seven. The finding that warmth of parenting had a stronger association on Indian childrens externalizing scores than mental distress might be explained by differences in the expression of SES on family characteristics and functioning between the two ethnic groups.

Antidepressants in Inflammatory Bowel Disease: A Systematic Review

Background: Antidepressants are commonly used to treat symptoms of anxiety and depression in inflammatory bowel disease (IBD). Recent studies suggest a link between IBD activity and an individuals emotional state which raises the possibility that antidepressants may potentially modify the disease course of IBD. This systematic review thus primarily aims to evaluate the efficacy of antidepressants on IBD activity, and secondarily, on anxiety and depression. Methods: MEDLINE, EMBASE, Cochrane (IBD Group), CINAHL, AMED, PsycINFO, and OpenGrey were searched from 1990 onward with no restrictions on study design. A quality appraisal was conducted using several scales as appropriate for each study design. A narrative synthesis was also conducted. Results: Fifteen eligible studies included in the review (1 randomized controlled trial, 2 cohorts, 1 case–control, 1 cross-sectional survey, 1 qualitative, 2 audits, 1 case series, and 6 case reports) examined a range of antidepressants. Twelve studies suggested that antidepressants have a positive impact on IBD course. Nine studies reported anxiety and depression as an outcome, of these 8 reported beneficial effects of antidepressants. Most of the studies were deemed to be at low risk of bias, apart from the case reports, which were at high risk of bias. Conclusions: This research indicates that antidepressants may have a beneficial effect on IBD course. However, it is currently not possible to determine their efficacy for certain because of the lack of randomized trials. Further trials using objective measures of IBD activity, longer follow-up periods, and larger sample sizes are needed.

Using intervention mapping to develop a home-based parental-supervised toothbrushing intervention for young children

BackgroundDental caries in young children is a major public health problem impacting on the child and their family in terms of pain, infection and substantial financial burden on healthcare funders. In the UK, national guidance on the prevention of dental caries advises parents to supervise their child’s brushing with fluoride toothpaste until age 7. However, there is a dearth of evidence-based interventions to encourage this practice in parents. The current study used intervention mapping (IM) to develop a home-based parental-supervised toothbrushing intervention to reduce dental caries in young children.MethodsThe intervention was developed using the six key stages of the IM protocol: (1) needs assessment, including a systematic review, qualitative interviews, and meetings with a multi-disciplinary intervention development group; (2) identification of outcomes and change objectives following identification of the barriers to parental-supervised toothbrushing (PSB), mapped alongside psychological determinants outlined in the Theoretical Domains Framework (TDF); (3) selection of methods and practical strategies; (4) production of a programme plan; (5) adoption and implementation and (6) Evaluation.ResultsThe comprehensive needs assessment highlighted key barriers to PSB, such as knowledge, skills, self-efficacy, routine setting and behaviour regulation and underlined the importance of individual, social and structural influences. Parenting skills (routine setting and the ability to manage the behaviour of a reluctant child) were emphasised as critical to the success of PSB. The multi-disciplinary intervention development group highlighted the need for both universal and targeted programmes, which could be implemented within current provision. Two intervention pathways were developed: a lower cost universal pathway utilising an existing national programme and an intensive targeted programme delivered via existing parenting programmes. A training manual was created to accompany each intervention to ensure knowledge and standardise implementation procedures.ConclusionsPSB is a complex behaviour and requires intervention across individual, social and structural levels. IM, although a time-consuming process, allowed us to capture this complexity and allowed us to develop two community-based intervention pathways covering both universal and targeted approaches, which can be integrated into current provision. Further research is needed to evaluate the acceptability and sustainability of these interventions.