Factors affecting recruitment and attrition in randomised controlled trials of Complementary and Alternative Medicine for pregnancy-related issues

Background. Randomised controlled trials (RCTs) investigating Complementary and Alternative Medicine (CAM) for pregnancy-related issues have encountered issues with recruitment and attrition. Little is known about the cause of these issues. Methods. Data was gathered from an antenatal CAM randomised controlled trial. During foetal anomaly appointments, women meeting inclusion criteria were invited to participate in the trial. Numbers of women invited and eligible were recorded. Reasons for noninterest were noted and analysed. Focus groups exploring trial experience of participants were also conducted. Findings. Of the 428 women invited to participate, 376 were eligible and just under a quarter participated. Reasons for nonparticipation included concerns about CAM and lack of interest in participation in research. Other factors negatively affecting recruitment included recruitment timing, competition for participants, limited support from staff, and inadequate trial promotion. Factors encouraging recruitment included being interested in research and seeking pain relief. Reasons for dropping out were time constraints, travel issues, work commitments, and pregnancy issues. Several women in the sham and usual care group dropped out due to dissatisfaction with treatment allocation. Conclusion. CAM researchers must explore problems encountered with recruitment and attrition so that evidence-based implementation strategies to address the issues can be developed

The Watching Pregnancy Project: an exploration of low back pain occurrence, symptoms and healthcare use in pregnant women

Introduction Many women experience low back pain (LBP) during pregnancy, which often persists after birth. Those affected have reported frustration that their symptoms are not taken seriously, along with limited availability of treatments to meet their needs. To our knowledge, no UK-based studies have prospectively investigated the extent of LBP as a problem for women both during pregnancy and after birth. Therefore, this study aimed to explore the extent and current management of this problem in a UK healthcare setting over four pre-defined study time points; two during pregnancy and two after birth. Materials and Methods A prospective observational cohort study followed a sample of pregnant women living in the UK, from 20 to 22-weeks’ gestation until six months after birth. All women attending their routine anomaly scan were informed of the study. Those with red flags, inflammatory / neurological disease, urinary tract infection (UTI) or otherwise deemed ineligible by their treating midwife, were excluded. A bespoke online questionnaire was distributed to consenting women to remotely collect demographic data and self-reported LBP history, symptom presentation, healthcare use and outcomes at four pre-defined study time-points, (i) 20 to 22-weeks’ and (ii) 31 to 34-weeks’ gestation, (iii) six weeks and (iv) six months after birth. At the end of the study women provided feedback about their experiences and an evaluation of the methods of recruitment and online data collection was carried out to inform a future, fully powered study. Results 307 women, from middle and upper socioeconomic groups, consented to participate and completed the first questionnaire. Women found the study procedures easy to follow with 50% completing the final questionnaire and 121 completing all four questionnaires. In the first questionnaire, 43% of women (N=132) reported having a history of LBP, with 46% of these currently experiencing LBP. Average composite pain scores ranged from 6.4 to 7.1/10 over the course of the study and were highest during the third trimester. Between 20 and 34 weeks´ gestation women reported a clinically important deterioration in health-related quality of life and back-specific function, along with high fear-avoidance beliefs between 31 to 34 weeks’ gestation. Women with a history of LBP were more likely to report symptoms 6-weeks after birth. Over 50% did not receive any treatment for their LBP. A significant proportion opted to self-medicate with painkillers, and many of those receiving physiotherapy for their LBP chose to self-refer. Conclusions Pregnant women, predominantly from affluent socioeconomic groups, were interested in taking part in this study and found the procedures easy to follow. A significant proportion had a history of LBP. The deterioration observed in function and health-related quality of life, along with high fear-avoidance beliefs about physical activity when pain symptoms were at their worst, could be contributing to the increasing socioeconomic burden of LBP. In addition, women’s use of over-the-counter painkillers for their LBP is concerning, given the considerable uncertainty about the effects of these on the unborn child. These findings would suggest that more research should be directed at ways of preventing LBP from becoming a problem for pregnant women, in particular reducing the risk factors for chronicity that may be perpetuating this often ‘trivialised’ problem

Reducing the Decline in Physical Activity during Pregnancy: A Systematic Review of Behaviour Change Interventions

Purpose: Physical activity (PA) typically declines throughout pregnancy. Low levels of PA are associated with excessive weight gain and subsequently increase risk of pre-eclampsia, gestational diabetes mellitus, hypertension disorders, delivery by caesarean section and stillbirth. Systematic reviews on PA during pregnancy have not explored the efficacy of behaviour change techniques or related theory in altering PA behaviour. This systematic review evaluated the content of PA interventions to reduce the decline of PA in pregnant women with a specific emphasis on the behaviour change techniques employed to elicit this change. Search and Review Methodology: Literature searches were conducted in eight databases. Strict inclusion and exclusion criteria were employed. Two reviewers independently evaluated each intervention using the behaviour change techniques (BCT) taxonomy to identify the specific behaviour change techniques employed. Two reviewers independently assessed the risk of bias using the guidelines from the Cochrane Collaboration. Overall quality was determined using the GRADE approach. Findings: A total of 1140 potentially eligible papers were identified from which 14 studies were selected for inclusion. Interventions included counselling (n = 6), structured exercise (n = 6) and education (n = 2). Common behaviour change techniques employed in these studies were goal setting and planning, feedback, repetition and substitution, shaping knowledge and comparison of behaviours. Regular face-to-face meetings were also commonly employed. PA change over time in intervention groups ranged from increases of 28% to decreases of 25%. In 8 out of 10 studies, which provided adequate data, participants in the intervention group were more physically active post intervention than controls. Conclusions and Implications: Physical activity interventions incorporating behaviour change techniques help reduce the decline in PA throughout pregnancy. Range of behaviour change techniques can be implemented to reduce this decline including goals and planning, shaping knowledge and comparison of outcomes. A lack of high quality interventions hampers conclusions of intervention effectiveness

Application of objective physical activity measurement in an antenatal physical activity consultation intervention:a randomised controlled trial

Background Physical Activity (PA) during pregnancy has many health benefits, however, inactivity in this population is common and PA often declines with increasing gestation. PA consultations have been useful in promoting PA in the general population, however their use for addressing PA in pregnancy is unknown. This study aimed to examine if a theory-based intervention using PA consultations would reduce the magnitude of decline in objectively measured PA between the first and third trimesters of pregnancy. Methods A RCT was carried out in an urban maternity unit in Northern Ireland between September 2012 and June 2013. 109 low-risk, primigravida pregnant women were randomised to a control (n = 54) or intervention group (n = 55). Intervention participants received three face-to-face individual PA consultations. Daily PA was measured in each trimester using seven day accelerometry. The study was approved by a NHS trust (12/NI/0036). PA data in counts per minute (CPM) were categorised into intensity using Freedson cut points and mean minutes of PA were compared between groups using repeated measures ANOVA with a sub-analysis stratifying participants per PA level in trimester one. Results Intention to treat analysis was performed on data from 97 participants. Time in moderate, vigorous and moderate-vigorous intensity PA (MVPA) significantly declined between trimesters one and three in both groups (P < 0.001). There were no statistically significant differences in PA between groups in any trimester. Women in the intervention group who were less active in trimester one did not demonstrate a significant decline in MVPA throughout pregnancy (in contrast with the decline identified in the more active participants). Conclusions The findings indicate that PA consultations were not effective in reducing the decline of MVPA in throughout pregnancy, however, women who were less active in trimester one and received PA consultations had a lesser decrease in MVPA. It is possible that pregnant women, specifically those who are more active at the start of pregnancy, have differing needs for PA behaviour change and maintenance, requiring more intense interventions than less active women

Does physical activity change predict functional recovery in low back pain? Protocol for a prospective cohort study

Background: Activity advice and prescription are commonly used in the management of low back pain (LBP). Although there is evidence for advising patients with LBP to remain active, facilitating both recovery and return to work, to date no research has assessed whether objective measurements of free living physical activity (PA) can predict outcome, recovery and course of LBP. Methods: An observational longitudinal study will investigate PA levels in a cohort of community-dwelling working age adults with acute and sub-acute LBP. Each participant's PA level, functional status, mood, fear avoidance behaviours, and levels of pain, psychological distress and occupational activity will be measured on three occasions during for 1 week periods at baseline, 3 months, and 1 year. Physical activity levels will be measured by self report, RT3 triaxial accelerometer, and activity recall questionnaires. The primary outcome measure of functional recovery will be the Roland Morris Disability Questionnaire (RMDQ). Free living PA levels and changes in functional status will be quantified in order to look at predictive relationships between levels and changes in free living PA and functional recovery in a LBP population. Discussion: This research will investigate levels and changes in activity levels of an acute LBP cohort and the predictive relationship to LBP recovery. The results will assess whether occupational, psychological and behavioural factors affect the relationship between free living PA and LBP recovery. Results from this research will help to determine the strength of evidence supporting international guidelines that recommend restoration of normal activity in managing LBP. Trial registration. [Clinical Trial Registration Number, ACTRN12609000282280]. © 2009 Hendrick et al; licensee BioMed Central Ltd