Background: It is widely accepted and acknowledged that data harmonization is crucial: in its absence, the co-analysis of major tranches of high quality extant data is liable to inefficiency or error. However, despite its widespread practice, no formalized/systematic guidelines exist to ensure high quality retrospective data harmonization. Methods: To better understand real-world harmonization practices and facilitate development of formal guidelines, three interrelated initiatives were undertaken between 2006 and 2015. They included a phone survey with 34 major international research initiatives, a series of workshops with experts, and case studies applying the proposed guidelines. Results: A wide range of projects use retrospective harmonization to support their research activities but even when appropriate approaches are used, the terminologies, procedures, technologies and methods adopted vary markedly. The generic guidelines outlined in this article delineate the essentials required and describe an interdependent step-by-step approach to harmonization: 0) define the research question, objectives and protocol; 1) assemble pre-existing knowledge and select studies; 2) define targeted variables and evaluate harmonization potential; 3) process data; 4) estimate quality of the harmonized dataset(s) generated; and 5) disseminate and preserve final harmonization products. Conclusions: This manuscript provides guidelines aiming to encourage rigorous and effective approaches to harmonization which are comprehensively and transparently documented and straightforward to interpret and implement. This can be seen as a key step towards implementing guiding principles analogous to those that are well recognised as being essential in securing the foundational underpinning of systematic reviews and the meta-analysis of clinical trials.

Similarities among core symptoms and differences in the expression of symptoms were found across sites. Both biological (menopause status) and cultural (country of residence) variables influence symptomatology.

BackgroundThe proportion of mothers who exclusively breastfeed their babies up to 6 months remains low. Determinants of breastfeeding practices have been largely documented in high-income countries. Little evidence exists on possible predictors of breastfeeding behaviors in the Middle East. Our aim was to assess the prevalence of breastfeeding in Beirut and determine the factors that impact breastfeeding behavior in this population.MethodsData for this longitudinal study is nested within a randomized controlled trial (RCT) assessing the impact of a 24-hour hotline and postpartum support film on postpartum stress. Healthy first-time mothers delivering in the capital Beirut between March and July 2009, were interviewed at 1–3 days and 8–12 weeks post delivery. A multiple logistic regression analysis was used to determine the factors associated with exclusive breastfeeding at 8–12 weeks postpartum.ResultsThe overall breastfeeding rate at 8–12 weeks postpartum was 67%. The exclusive breastfeeding rate was 27.4%. Factors associated with exclusive breastfeeding included maternal work (OR=3.92; p-value<0.001), planned pregnancy (OR=2.42, p-value=0.010), intention to breastfeed (OR=3.28; p-value=0.043), source of maternal emotional support (OR = 1.87, p-value=0.039) and the use the postpartum support video, the hotline service or both (OR=2.55, p-value=0.044; OR=3.87, p-value=0.004 and OR=4.13, p-value=0.003).ConclusionsThe proportion of healthy first-time mothers who exclusively breastfeed in Beirut is extremely low. Factors associated with breastfeeding behavior are diverse. Future research and interventions should target different levels of the maternal-child pair’s ecosystem.Trial registrationClinicalTrials.gov, NCT00857051

The aim of the current study was to triangulate qualitative and quantitative data in order to examine in greater detail the relationship between self-reported headache pain severity, depression and coping styles. Psychosocial scales, headache characteristic scales and in-depth interviews were administered to 71 adults with the diagnosis of primary headache. Regression analyses with the scales showed that greater self-reported headache pain severity was associated with higher levels of depression. A high internal locus of control weakened the relationship between the headache severity and depression variables. The qualitative data supported the relationship between pain severity and internal locus of control and, in addition, revealed that perceived efficacy of pharmacologic intervention might be a related factor. The results suggested that stronger coping skills might reduce depression among headache sufferers.

BackgroundThe postpartum period can be a challenging time particularly for first-time mothers. This study aimed to assess two different interventions designed to reduce stress in the postpartum among first-time mothers.MethodsHealthy first-time mothers with healthy newborns were recruited from hospitals in Beirut, Lebanon after delivery. The two interventions were a 20-minute film addressing common stressors in the postpartum period and a 24-hour telephone support hotline. Participants were randomized to one of four study arms to receive either the postpartum support film, the hotline service, both interventions, or a music CD (control). Participants were interviewed at eight to twelve weeks postpartum for assessment of levels of stress as measured by the Cohen Perceived Stress Scale (PSS-10).ResultsOf the 632 eligible women, 552 (88%) agreed to participate in the study. Of those, 452 (82%) completed the study. Mean PSS-10 scores of mothers who received the film alone (15.76) or the film with the hotline service (15.86) were significantly lower than that of the control group (18.93) (p-value <0.01). Among mothers who received the hotline service alone mean PSS-10 score (16.98) was also significantly lower than that of the control group (p-value <0.05).ConclusionsBoth our postpartum support film and the 24-hour telephone hotline service reduced stress in the postpartum period in first-time mothers. These simple interventions can be easily implemented and could have an important impact on the mental wellbeing of new mothers.Trial registrationThe trial was registered with clinicaltrials.gov (identifier # NCT00857051) on March 5, 2009.