Datasets:

marianna13
/

litarch

+{"file": "rc0900_NBK519647/context.nxml", "text": "Cigarette smoking during pregnancy can result in serious health risks for pregnant women and their infants.1 Nicotine, carbon monoxide, and other chemicals in the tobacco smoke can cause cancer, still births, preterm births, low birthweight, miscarriages, prenatal deaths, and sudden infant death syndrome.1 In Canada, the prevalence of smoking among pregnant women dropped from 17% in 2000/2001 to 10.5% in 2005/2006,2 and pregnant mothers consumed an average of seven cigarettes per day.2 Smoking rates during pregnancy were most prevalent in the Northern Territories (39.4%) and Prince Edward Island (20.8%) compared to the rest of Canada.2 The prevalence of smoking during pregnancy was higher in women, who were younger than 25 years old, unmarried, limited education, low income, non-immigrants, and poor in overall health.3\nMany different pharmacological (e.g., nicotine replacement therapy [NRT], bupropion and varenicline) and non-pharmacological interventions (e.g., behavioral therapy), given alone or in combination, were effective in helping the adult population to stop smoking.4 Despite an effective smoking cessation profile in the general population, evidence regarding the use of these interventions in pregnant women is less clear. Furthermore, it is uncertain whether there exists a program that is effective in helping pregnant women, who have difficulty to stop smoking, to change their smoking behaviour (i.e., reduce the number of cigarettes smoked per day).\nThe aim of this report is to review the clinical effectiveness of smoking reduction programs and smoking cessation interventions for pregnant women and mothers of infants.", "pairs": [], "interleaved": []}
+{"file": "rc0900_NBK519647/conclusions.nxml", "text": "There was limited evidence on the effectiveness of smoking reduction interventions, and it was unclear if a nurse home visitation program was effective in helping pregnant women to reduce smoking. There was strong to moderate evidence that suggested that psychosocial interventions for promoting smoking cessation during pregnancy can increase the proportion of women who stopped smoking in late pregnancy. Among the psychosocial interventions, counselling, feedback, and incentives appeared to be effective, while the effect of health education and social support was less certain. Counselling and incentives appeared to be effective for continued abstinence during the postpartum period. It was unclear if smoking cessation interventions can help pregnant women to reduce smoking. Pooled results suggested that psychosocial interventions reduced the risk of infants born with low birthweight, increased the mean birthweight, and decreased the risk of NICU admission. Pharmacological interventions, such as NRT and bupropion, appeared to be effective only during treatment or in late pregnancy, but not after pregnancy or during postpartum period. There was no evidence that NRT had any positive or negative effect on infant outcomes and the safety of bupropion was less clear. More evidence is needed, particularly, on the programs promoting smoking reduction for pregnant women, and on the effectiveness and safety of smoking cessation drugs, such as bupropion, varenicline, or other medications for pregnant smokers.", "pairs": [], "interleaved": []}
+{"file": "rc0900_NBK519647/app1.nxml", "text": "", "pairs": [["litarch_figures_62/39/35/rc0900_NBK519647/app1f1.jpg", "", ""]], "interleaved": [["litarch_figures_62/39/35/rc0900_NBK519647/app1f1.jpg", "", ""]]}
+{"file": "rc0900_NBK519647/keyfindings.nxml", "text": "Evidence on the effectiveness of smoking reduction interventions was limited. Psychosocial interventions for smoking cessation appeared to be effective, while the effect of health education and social support was less certain. The results suggested that psychosocial interventions reduced the risk of infants born with low birthweight, increased the mean birthweight, and decreased the risk of neonatal intensive care unit admission. Pharmacological interventions appeared to be effective during treatment or at the end of pregnancy. Nicotine replacement therapy did not seem to have any positive or negative effects on infant outcomes, while the safety of bupropion was inconclusive.", "pairs": [], "interleaved": []}
+{"file": "rc0900_NBK519647/researchquestions.nxml", "text": "What is the clinical effectiveness of smoking reduction programs for pregnant women or mothers of infants?\nWhat is the clinical effectiveness of smoking cessation interventions for pregnant women or mothers of infants?", "pairs": [], "interleaved": []}
+{"file": "rc0900_NBK519647/summary.nxml", "text": "Quantity of Research Available\nA total of 492 citations were identified in the literature search. Following screening of titles and abstracts, 443 citations were excluded and 49 potentially relevant reports from the electronic search were retrieved for full-text review. Two potentially relevant publications were retrieved from the grey literature search. Of these potentially relevant articles, 44 publications were excluded for various reasons, while seven publications, including two SRs and five RCTs, met the inclusion criteria and were included in this report. Appendix 1 describes the PRISMA flowchart of the study selection.\nSummary of Study Characteristics\nThe characteristics of the SRs and MAs7, 8 and RCTs9\u201313 are summarized below and are presented in Appendix 2.\nSRs and MAs\nStudy Design\nOne SR7 included 88 RCTs with 106 study arms involving over 26,000 pregnant smokers and provided data on psychosocial interventions to support pregnant women to stop smoking. Another SR8 included nine RCTs (eight trials with NRT and one trial with bupropion) on pharmacological interventions for promoting smoking cessation during pregnancy of 2,210 pregnant smokers.\nCountry of Origin\nBoth SRs were conducted by authors from the United Kingdom (UK)7, 8 and were published in 20177 and 2015.8\nPopulation\nThe overall populations of the included trials in both SRs7, 8 were in the first or second trimester of pregnancy. Most were healthy women of 16 years or older, with different ethnic backgrounds, education, and socioeconomic status.7, 8 The gestational age ranged from 9 to less than 30 weeks.8\nInterventions and Comparators\nThe psychosocial interventions were categorized as counselling (54 trials), health education (12 trials), feedback (6 trials), incentives (13 trials), social support (7 trials) and exercise (1 trial).7 These interventions were compared with usual care, a less intensive intervention, or an alternative intervention.7 The pharmacological interventions included NRT (8 trials) and bupropion (1 trial) as an adjunct to behavioral support.8 Transdermal nicotine patches were mostly used as an intervention in NRT compared to gum and lozenge. The comparators were either placebo or behavioral support alone.\nOutcomes\nThe primary outcomes in both SRs7, 8 were smoking abstinence rates that were biochemically validated. The secondary outcomes included continued abstinence after childbirth,7 smoking reduction in late pregnancy,7 infant outcomes7, 8 and adverse effects.7, 8 The infant outcomes included low birthweight (under 2,500 g),7, 8 very low birthweight (under 1,500 g),7 preterm birth (under 37 weeks),7, 8 mean birthweight,7, 8 stillbirth,7, 8 perinatal death,7, 8 neonatal death,7 neonatal intensive care unit admissions,7 and congenital abnormalities.8\nFollow-up Period\nThe follow-up periods in the trials included in both SRs7, 8 were conducted during pregnancy and up to two years after childbirth.\nData Analysis and Synthesis\nMeta-analyses were conducted to synthesize data in the both SRs.7, 8 Both clinical and statistical heterogeneity were considered by performing subgroup analyses, metaregressions, or sensitivity analyses.7, 8\nQuality Appraisal\nThe Cochrane risk of bias tool was used to assess the methodological quality of included studies in both SRs.7, 8 The strength of evidence for each body of evidence was assessed using GRADE (the Grading of Recommendations Assessment, Development and Evaluation) approach in one SR.7\nRCTs\nStudy Design\nOf the five included RCTs, one was active-controlled,9 one was double-blind placebo controlled,10 two were single-blinded,11, 13 and one was of a cluster design.12 Three RCTs recruited patients from multiple centres,11\u201313 and two RCTs enrolled patients from a single centre.9, 10\nCountry of Origin\nThe RCTs were conducted in the UK,11 United States,9, 10 Argentina12 and the Netherlands,13 and were published in 2017,9\u201311 201612 and 2014.13\nPopulation\nAll RCTs included pregnant smokers with a mean age ranging from 1913 to 26.5 years.10 One RCT included negative affect pregnant smokers who had emotional issues, such as anxiety, dysthymia, anger, and stress.9 One RCT included young pregnant women with low education levels.13 The mean gestational age ranged from 159, 11 to 20 weeks,13 the average smoking at enrolment ranged from 89, 13 to 1210 cigarettes per day.\nInterventions and Comparators\nThe comparisons were emotional regulation treatment (ERT) versus health and lifestyle intervention (HLS),9 self-help smoking cessation text message (MiQuit) versus usual care,11 counselling (based on the 5As [Ask, Advise, Assess, Assist, and Arrange]) versus control,12 nurse home visitations versus usual care,13 and bupropion sustained release versus placebo.10 The purpose of the nurse home visitations was to help reduce cigarette smoking and promote breastfeeding among young pregnant smokers.13\nOutcomes\nThe outcomes included biochemically validated smoking abstinence rates,9\u201311 the number of cigarettes smoked per day,9, 13 continuous and quit smoking during pregnancy,12 infant outcomes,10, 13 and maternal outcomes.10\nFollow-up Period\nThe follow-up periods in the included RCTs were done both during pregnancy and up to four months after childbirth.\nAnalysis\nThe evaluations of study endpoints in three RCTs10\u201312 were performed on an intention-to-treat (ITT) basis, while the analysis in two RCTs9, 13 was performed on a per-protocol (PP) basis. Three RCTs10\u201312 presented a sample size calculation to obtain sufficient power for the primary outcome, and two RCTs9, 13 did not reported a sample size calculation.\nSummary of Critical Appraisal\nThe summary of the quality assessment for the SRs and RCTs were briefly described below and are presented in Appendix 3.\nSRs and MAs\nThe SRs7, 8 were of high quality as most of the criteria were fulfilled, including an explicit research question, a comprehensive literature search, and at least two people were independently involved in the study selection and data extraction. Also, the publication status was not used as an inclusion criterion, and relevant study characteristics, quality assessment of included studies and a declaration of the conflicts of interest were completed. Appropriate methods of meta-analysis were used to combine the individual study findings. Publication bias was assessed in one SR,7 and was not applicable in the other SR8 as there were eight individual studies included. Both SRs provided a list of excluded studies.\nRCTs\nOne RCT10 was of high quality as all criteria were fulfilled, including an explicit question, a detailed description of methodology on randomization, adequate method of concealment, blinding. As well, there was similarity between treatment groups, relevant outcome measures, an ITT analysis was conducted, and the trial was multi-centric. Four RCTs9, 11\u201313 were of moderate quality as some criteria were partially reported or not fulfilled, such as the method of concealment,9, 11\u201313 blinding9, 11\u201313 and ITT analysis.9, 13 The percentages of dropouts before study completion in both arms were 44% and 53%9 and 49% and 43%10 in two RCTs.9, 10\nSummary of Findings\nThe main findings and conclusions of the included SRs and RCTs are presented in Appendix 4.\nWhat is the clinical effectiveness of smoking reduction programs for pregnant women or mothers of infants?\nOne trial13 was identified that assessed a home visitation program by trained nurses to help young pregnant women with a low education level in reducing cigarette smoking and promoting breastfeeding.\nPercentage of smokers\nThe percentages of smokers in both intervention and control groups were not significantly different at either 32 weeks of pregnancy (33% vs 35%) or at two months after childbirth (48% vs 65%). After conducting the last observation carried forward approach to correct for missing data, the percentages of smokers in the intervention group were significantly lower than those in the control group; 40% versus 48% at 32 weeks of pregnancy, and 49% versus 62% at two months after childbirth.\nNumber of cigarettes smoked per day\nThere was no difference in the number of cigarettes smoked per day between the intervention and control groups (2 versus 3 cigarettes) at 32 weeks of pregnancy, although the numbers of cigarettes smoked in both groups reduced compared to those at enrolment (7 versus 8 cigarettes). At two months after birth, women in the control group increased their daily cigarettes smoked as of at baseline (8 cigarettes), while women in the intervention group smoked an average of 4 cigarettes per day.\nPregnancy outcomes\nBirth weight, gestational age, the prevalence of low birth weight (i.e., <2,500 g), and the prevalence of premature babies (i.e., <37 weeks) were similar in both groups.\nBreastfeeding\nBreastfeeding initiation was similar in both groups (82% versus 78%). The percentage of women, who continued to breastfeed at 6 months after childbirth, was higher than in the intervention group than in the control group (13% versus 6%).\nWhat is the clinical effectiveness of smoking cessation interventions for pregnant women or mothers of infants?\nOne SR7 and three RCTs9, 11, 12 were identified that reported relevant outcomes for the psychosocial interventions, and one SR8 and one RCT10 were identified that reported relevant outcomes for pharmacological interventions.\nPsychosocial Interventions\nSmoking abstinence in late pregnancy\nThere was evidence from the SR7 that counselling was more effective than usual care or less intensive intervention. It was uncertain about the effectiveness of counselling (i.e., cognitive behavioral therapy) compared with alternative intervention (i.e., health education or motivational interview).7\nThere was uncertainty about the effectiveness of health education compared with usual care, less intensive intervention, or alternative interventions.7\nThere was evidence that feedback significantly increased the rate of smoking cessation compared to usual care.7 There was uncertainty if the feedback was more effective when compared to less intensive interventions.7\nThere was evidence that incentives significantly increased the rate of smoking cessation compared to alternative interventions.7 However, it was uncertain about the effectiveness of incentives compared to usual care or less intensive interventions.7\nThere was uncertainty on whether social support (i.e., peer or partner) increased the chance of smoking cessation when compared to less intensive interventions.7 There was also uncertainty whether exercise increased the chance of smoking cessation when compared to usual care.7\nOne RCT12 showed that smoking cessation counselling based on the 5As had no difference in the frequency of women who smoked until the end of pregnancy compared to the control group. One RCT9 showed that the emotional regulation treatment had a higher chance to stop smoking in negative affect pregnant smokers compared to health and lifestyle intervention, but the difference was not statistically significant. One RCT11 showed that a test message intervention program may increase the abstinence rates of smoking compared to usual care, although the difference was not statistically significant.\nContinued abstinence (relapse prevention) in late pregnancy\nThere was no evidence to suggest that counselling could prevent smoking relapse compared to usual care or less intensive interventions.7 There was also uncertainty about the effectiveness of health education compared to usual care, or social support compared to less intensive interventions in smoking relapse prevention.7\nContinued abstinence in the postnatal period\nThere was evidence that counselling increased the rate of smoking abstinence during postpartum periods (i.e., 0 to 5 months, 6 to 11 months and 12 to 17 months), compared to usual care.7 However, there was uncertainty on whether counselling increased postpartum smoking abstinence compared to less intensive interventions or alternative interventions.7\nThere was evidence that health education increased the rate smoking cessation in the early postpartum period (i.e., 0 to 5 months) compared to usual care or less intensive interventions.7\nThere was evidence that incentives increased smoking abstinence during 6 to 11 months postpartum compared to usual care.7 There was also evidence that incentives increased smoking abstinence at 0 to 5 months compared to less intensive interventions.7 However, there was uncertainty if there was an increase in smoking cessation when incentives were compared to usual care at 0 to 5 months, or when incentives were compared to alternative interventions at 0 to 5 months or 6 to 11 months postpartum.14\nThere was no evidence to suggest that social support was more effective than less intensive interventions, or exercise was more effective than usual care in promoting continued smoking abstinence during postnatal period.7\nSmoking reduction in late pregnancy\nIt was uncertain on whether there were differences in smoking reduction that was biochemically validated in different comparisons including counselling versus usual care, counselling versus less intensive interventions, feedback versus usual care, incentives versus usual care, incentives versus alternative interventions, and social support versus less intensive interventions.7\nMean cigarettes smoked per day in late pregnancy\nThere was evidence that health education, feedback and incentives significantly reduced the mean number of cigarettes smoked per day compared to usual care.7 There was uncertainty that counselling and health education could decrease the number of cigarettes smoked per day compared to less intensive interventions.7\nResults from the included RCT9 showed that emotion regulation treatment intervention given to a difficult-to-treat population did not significantly reduce the number of cigarettes smoked per day compared to a healthy lifestyle intervention.\nInfant outcomes\nData from each of the infant outcomes were pooled from \u201call interventions\u201d to increase the detection of rare events.7\nThere was evidence that smoking cessation interventions reduced the risk of infants born with low birthweight (i.e., <2,500 g) by 17%, increased the mean birthweight by 55.6 g, and decreased the risk of neonatal intensive care unit (NICU) admission by 22%.7\nThere was uncertainty whether there was any difference between smoking cessation interventions and controls with respect to the rates of very low birthweight (i.e., <1,500 g), preterm births (i.e., <37 weeks), stillbirths, perinatal deaths, and neonatal deaths.7\nPharmacological Interventions\nSmoking abstinence in late pregnancy\nThere was evidence that NRT increased the rates of biochemically validated smoking cessation by about 40% compared to the control group.8 However, there was no difference in the self-reported smoking abstinence rates between NRT and the control group at 3, 6 or 12 months postpartum.\nBupropion sustained release increased abstinence rates during treatment compared to placebo, but there was no significant difference in the abstinence rates between groups at the end of treatment, at the end of pregnancy, and during the postpartum period.10\nMean cigarettes smoked per day in late pregnancy\nThere was no significant difference in percent reduction in the number of cigarettes smoked per day between bupropion and placebo at the end of treatment, at the end of pregnancy, and during the postpartum period.10\nInfant outcomes\nThere were no significant differences in all infant outcomes between NRT and control8 or between bupropion and placebo.10\nMaternal outcomes\nThere were no significant differences in body mass index, blood pressure, and pulse rate between bupropion and placebo.10 Treatment side effects, such as headaches, difficulty sleeping, running nose, dry mouth, and anxiety, were similar in both groups.10\nLimitations\nThere was limited evidence on the clinical effectiveness of the smoking reduction programs for pregnant women or mothers of infants. One trial on smoking reduction program was identified that used self-reported questionnaires instead of biochemically assessments to measure cigarette smoking behavior of participants. The evidence on pharmacological interventions was derived from a SR published in 2015, has not been updated yet, and was limited to NRT only, with limited or no information on other medications. Given the difficulty in recruitment (i.e., 118 and 6310 participants) and the rate of early withdrawal (i.e., near 50%10) from the bupropion trials, the effectiveness and safety of the medication were questionable.", "pairs": [], "interleaved": []}