The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment

Background: Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. Methods/Design: In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring. Discussion: Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment. Trial registration: The study is registered at the Clinical Tials.gov (NCT01701011)

The impact of a self-administered coping intervention on emotional wellbeing in women awaiting the outcome of IVF treatment: a randomised controlled trial

STUDY QUESTION What is the effect of the positive reappraisal coping intervention (PRCI) on anxiety in women awaiting the outcome of an IVF/ICSI cycle? SUMMARY ANSWER Women reported significantly more anxiety during the waiting period than before treatment, but the use of the PRCI did not significantly reduce anxiety during the waiting period. WHAT IS KNOWN ALREADY Waiting for the outcome of IVF/ICSI treatment after embryo transfer is one of the most stressful periods of fertility treatments. At present, no evidence-based coping interventions are available to assist women though this waiting period. The PRCI has been designed to address this unmet need by promoting positive reappraisal coping. STUDY DESIGN, SIZE, DURATION A three-armed randomized controlled trail (RCT) was designed to evaluate the PRCI in women undergoing IVF/ICSI. Data were collected between October 2010 and June 2012. A total of 377 participants were randomized to receive either the PRCI and emotional monitoring, emotional monitoring only, or routine care. Only the PRCI-monitoring group received the coping intervention, comprising an explanatory leaflet and ten statements to be read at least once in the morning and once in the evening. PARTICIPANT, MATERIALS, SETTING, METHODS To capture the general impact of the PRCI, all three groups completed questionnaires at three time points: just before the waiting period (time 1: stimulation phase), on Day 10 of the 14-day waiting period (time 2: waiting period) and 6 weeks after the start of the waiting period (time 3: 6-week follow-up). In addition, to capture the specific impacts of the PRCI on the days of the waiting period, the PRCI-monitoring group and the monitoring-control group also rated their emotions and reactions daily, for the 14-day waiting period. MAIN RESULTS AND THE ROLE OF CHANCE Of the women who agreed to participate and who met eligibility criteria, 377 were randomized. All study participants reported significantly more anxiety and depression during the waiting period than before treatment (P < 0.001). The mean difference in anxiety between time 1 versus time 2 was 1.465 (95% CI 1.098–1.832). The mean difference in depression between time 1 versus time 2 was 0.514 (95% CI 0.215–0.813). Use of the PRCI did not significantly reduce anxiety or depression, or daily negative emotions during the waiting period. However, patients randomized to the PRCI reported significantly more positive emotions during the waiting period (P < 0.001) than the monitoring-control group, and reported the intervention to be easy to use, and as having a positive psychological effect. No significant differences were found between the groups in treatment outcome. LIMITATIONS, REASONS FOR CAUTION The lack of difference observed in the present study for anxiety levels between the PRCI and the monitoring-control group could have been due to the effects of monitoring itself or its ability to attenuate or obscure the effects of the PRCI intervention in unknown ways. A randomized group of women who used only the PRCI without daily monitoring would provide more insight. WIDER IMPLICATIONS OF THE FINDINGS The PRCI was shown to help women reinterpret the demands of the waiting period in a more positive way. These results are consistent with previous studies showing that positive reappraisal coping is a useful strategy for unpredictable and uncontrollable situations represented by a medical waiting period. This simple low cost self-help coping intervention increases positive affect during the waiting period in an IVF/ICSI treatment

Effectiveness of mechanical bowel preparation versus no preparation on anastomotic leakage in colorectal surgery : a systematic review and meta-analysis

It has been a standard practice to perform mechanical bowel preparation (MBP) prior to colorectal surgery to reduce the risk of colorectal anastomotic leakages (CAL). The latest Cochrane systematic review suggests there is no benefit for MBP in terms of decreasing CAL, but new studies have been published. The aim of this systematic review and meta-analysis is to update current evidence for the effectiveness of preoperative MBP on CAL in patients undergoing colorectal surgery. Consequently, PubMed, MEDLINE, Embase, CENTRAL and CINAHL were searched from 2010 to March 2017 for randomised controlled trials (RCT) that compared the effects of MBP in colorectal surgery on anastomotic leakages. The outcome CAL was expressed in odds ratios and analysed with a fixed-effects analysis in a meta-analysis. Quality assessment was performed by the cochrane risk of bias tool and grades of recommendation, assessment, development and evaluation (GRADE) methodology. Eight studies (1065 patients) were included. The pooled odds ratio showed no significant difference of MBP in colorectal surgery on CAL (odds ratio (OR) = 1.15, 95% CI = 0.68–1.94). According to GRADE methodology, the quality of the evidence was low. To conclude, MBP for colorectal surgery does not lower the risk of CAL. These results should, however, be interpreted with caution due to the small sample sizes and poor quality. Moreover, the usefulness of MBP in rectal surgery is not clear due to the lack of stratification in many studies. Future research should focus on high-quality, adequately powered RCTs in elective rectal surgery to determine the possible effects of MBP

Exploring a self-help coping intervention for pregnant women with a miscarriage history

Pregnant women with a history of miscarriages experience symptoms of anxiety and depression in a subsequent pregnancy and are in need of support in the period after miscarriage, when trying to get pregnant again and during the first phase of pregnancy.The aim of this study was to investigate whether a Positive Reappraisal Coping Intervention (PRCI) and Daily Record Keeping (DRK) chart, developed for use in assisted conception treatment, are also appropriate for use in pregnant women with a history of miscarriage(s).In this convergent parallel mixed method study, thirteen women visiting an Early Pregnancy Unit and/or Recurrent Miscarriage Clinic in a university medical center in the Netherlands were selected on the basis of the number of miscarriages and age. Exclusion criteria were not speaking the Dutch language, pregnancy after fertility treatment and having a medical cause identified for the miscarriages. Women used the PRCI and DRK for 3. weeks in a subsequent pregnancy. Quantitative data were obtained from the DRK and were analyzed by reporting frequencies and means for each case. Qualitative data were collected by semi-structured interviews and were analyzed by using thematic analysis.The majority of the women were able to use the PRCI and DRK for 3. weeks. Women adapted the way in which they used the PRCI and DRK based on their judgment about the effect, the intensity of the emotions they experienced, or whether they felt the effort to use these instruments to be worthwhile or not

Coping after recurrent miscarriage: uncertainty and bracing for the worst

BACKGROUND: The aim of this study was to understand how women with single or recurrent miscarriages cope during the waiting periods after miscarriage - waiting for pregnancy or waiting for pregnancy confirmation - and to investigate their perception of a 'positive reappraisal' coping intervention designed for these waiting periods. Positive reappraisal is a cognitive strategy to change the meaning of a situation, specifically reinterpreting the situation in a more positive way.METHODS: A qualitative methodology was used. Data were obtained from two focus groups comprising nine women with one or more miscarriages.RESULTS: Two core categories, 'uncertainty' and 'bracing', were highlighted during the waiting period for confirmation of an ongoing pregnancy. Women who had experienced a single miscarriage appraised this waiting period as benign and used distraction and coping by social support. Women with recurrent miscarriages could not confidently appraise the waiting period as one that would bring hope or joy and used bracing for the worst as their coping strategy to manage this ambivalence. With this strategy, women tried to control their current emotions, and looked into the future to try to minimise their distress if a further miscarriage occurred. Although all women thought that a 'positive reappraisal' coping intervention would be practical and applicable during waiting periods, only women with recurrent miscarriages actually wanted to use such an intervention.CONCLUSIONS: Coping interventions targeting reappraisal of the waiting period stressor situation could help women to cope as they wait for a subsequent pregnancy to be confirmed as ongoing. Coping interventions may need to be tailored, but before any strategy is introduced, further study is needed to identify the most appropriate approach