ABSTRACT
OBJECTIVE: To determine the diagnostic performance of digital palpation of levator ani muscle (LAM) avulsion compared with translabial tomographic ultrasound imaging (TUI). METHODS: A cross-sectional study, incorporating 195 women involved in a longitudinal cohort study. Palpation for levator integrity was performed, followed by a four-dimensional translabial ultrasound. LAM avulsion defects were diagnosed in the presence of puborectalis muscle detachment from its insertion. Post-processing analysis of ultrasound volumes for LAM integrity on TUI was performed blinded against palpation findings. Agreement between methods was assessed using Cohen's κ. RESULTS: In all, 388 paired assessments of LAM bilaterally, were available. Sixteen (8.2%) unilateral avulsion defects were detected on palpation. Sonographically, 31 (16%) were diagnosed with avulsions: 4.6% bilateral and 11.3% unilateral. An overall agreement of 91% was observed between digital palpation and TUI, yielding a Cohen's κ of 0.32 (95% confidence interval 0.15-0.48) demonstrating "fair agreement": and implying 25% sensitivity, 98% specificity, 63% positive predictive value, and 92% negative predictive value. Analysis of the first and last 20 palpations showed no change in performance during the 13-day study period. CONCLUSION: Assessment of LAM avulsion defects by digital palpation is feasible but may require substantial training. Confirmation by imaging is crucial, especially if the diagnosis of avulsion may influence clinical management.
Subject(s)
Palpation , Pelvic Floor , Cross-Sectional Studies , Female , Humans , Longitudinal Studies , Pelvic Floor/diagnostic imaging , UltrasonographyABSTRACT
OBJECTIVE: To evaluate the development of postoperative strabismus causing diplopia in patients who received Molteno implant surgery for the treatment of glaucoma. METHODS: The Otago Glaucoma Surgery Outcome study (OGSOS) was used to select cases who had undergone Molteno implant surgery to examine the effect on the development of strabismus causing diplopia. Information was collected on treatments provided to correct motility disturbance, and their success, in this retrospective non-comparative study. RESULTS: 32 cases (3.3%) were found to have developed diplopia following the Molteno implant surgery from a total of 977 cases. Of these, the strabismus in 23 cases was described in sufficient detail to permit clinical categorization. Most (19/23) demonstrated an exodeviation, hyperdeviation, or a combination thereof, although 2/6 cases with superonasal plate location demonstrated a hypodeviation. Diplopia generally resolved spontaneously (20/32 cases). Treatment was required in eight cases, usually conservative and successful (6/8 cases), but strabismus surgery was required in two cases, and was unsuccessful. CONCLUSIONS: This study found a low incidence of diplopia developing post-Molteno implant surgery. Strabismus features suggested a restrictive etiology, and spontaneous recovery was common (62.5%). Surgical correction proved unsuccessful - confirming persistent postoperative diplopia after Molteno implant surgery to be a rare but surgically challenging complication.
Subject(s)
Diplopia/etiology , Glaucoma/surgery , Molteno Implants/adverse effects , Strabismus/etiology , Adult , Aged , Aged, 80 and over , Diplopia/physiopathology , Female , Glaucoma/physiopathology , Humans , Intraocular Pressure/physiology , Male , Middle Aged , Ophthalmologic Surgical Procedures , Prosthesis Implantation , Retrospective Studies , Strabismus/physiopathology , Visual Acuity/physiology , Young AdultABSTRACT
This observational study was designed to establish whether there is a relationship between intuitive eating and gestational weight gain. Intuitive eating involves eating according to hunger and satiety cues, rather than following diet rules or eating in response to external triggers or emotions. Higher levels of intuitive eating are associated with bodyweight in the normal range in women during young and middle adulthood. Excess gestational weight gain is associated with an increased incidence of adverse health outcomes for mothers and children, including many pregnancy related conditions and, following pregnancy, an increased likelihood of obesity among mothers and children. Pregnant women were recruited at their nuchal translucency scan (11-14â¯weeks gestation), in Dunedin, New Zealand, between 2013 and 2015. A cohort of 218 women completed questionnaires at four times during their pregnancies. Intuitive eating was measured using a version of the Intuitive Eating Scale (IES) adapted for pregnant women and revalidated with this population. Gestational weight gain was calculated at the term visit (>35â¯weeks gestation) and babies' birth weight was established from the electronic maternity system. Mean total IES scores (and all IES subscales) increased across pregnancy. For every one point greater total IES score at baseline, there was a 1.7 (0.5, 2.9) kg lower gestational weight gain. There was no association between babies' birth weight and intuitive eating. Intuitive eating appears to be associated with lower gestational weight gain but not babies' birth weight. It remains to be seen whether intuitive eating can be increased by educational interventions during pregnancy and thus have an impact on gestational weight gain.
Subject(s)
Eating/psychology , Feeding Behavior/psychology , Gestational Weight Gain/physiology , Hunger/physiology , Satiation/physiology , Adult , Cohort Studies , Diet/psychology , Female , Humans , New Zealand , Pregnancy , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Levator ani muscle (LAM) and anal sphincter injuries are common after vaginal birth and are associated with pelvic organ prolapse and anal incontinence. AIMS: Our objective was to investigate long-term association between delivery mode, LAM avulsion and obstetric anal sphincter injuries (OASIS) in women at least 20 years after their first birth. METHODS: All women recruited at 'index birth' of the Dunedin (New Zealand) arm of ProLong (PROlapse and incontinence LONG-term research) Study, were invited to have translabial and transperineal ultrasound assessment of LAM and anal sphincters. Post-processing analysis of imaging data was performed blinded against delivery data. Statistical analysis was performed using the χ2 test and results are expressed as odds ratios (OR). RESULTS: Of the initial 1250 participants, 196 women returned for examination. Mean age was 50.8 years with a mean body mass index of 27.6 and median parity was three. They were seen on average 23 years after their first delivery. Four data sets were unavailable and one declined ultrasound assessment, leaving 191 for analysis. LAM avulsion was diagnosed in 29 (15.2%), and 24 women (12.6%) had significant anal sphincter defect. LAM avulsion was associated with forceps delivery (OR 2.45, 95% CI 1.04-5.80, P = 0.041). Forceps conveyed a greater risk of OASIS (21%) compared to a spontaneous vaginal delivery (11%) but did not reach statistical significance. CONCLUSIONS: Forceps delivery is associated with long-term injurious effect on pelvic floor structures. Discussions of the long-term negative impact of pelvic floor structures and their functions are necessary to achieve an informed consent toward an operative vaginal delivery.
Subject(s)
Anal Canal/injuries , Delivery, Obstetric/adverse effects , Obstetric Labor Complications/epidemiology , Pelvic Floor Disorders/epidemiology , Pelvic Organ Prolapse/epidemiology , Vagina/injuries , Cross-Sectional Studies , Female , Follow-Up Studies , Humans , Middle Aged , New Zealand , Pregnancy , Time FactorsABSTRACT
AIM: To carry out a network meta-analysis of randomised controlled trials (RCTs) of anticholinergic drug treatment for people with overactive bladders. METHODS: Comprehensive searches for relevant RCTs were carried out starting with RCTs included in previous systematic reviews with the last search in February 2017. Searches included terms for the anticholinergic drugs tolterodine, oxybutynin, trospium, propiverine, solifenacin, darifenacin, imidafenacin, and fesoterodine. Data was extracted from the systematic reviews or reports of studies for cure or improvement, voids per 24 hr, leakage episodes per 24 hr and dry mouth. Data was analysed using frequentist network meta-analysis. RESULTS: 128 studies were found. There was no clearly best treatment for cure or improvement. The differences between treatments for voids and leakages were small and unlikely to be of clinical importance. Transdermally delivered oxybutynin was clearly the best treatment for dry mouth but was still worse than placebo. CONCLUSIONS: All the anticholinergic drugs were better than placebo but apart from dry mouth were similar in effect. Transdermal oxybutynin caused less dry mouth than the other treatments, so may be worth considering as the first treatment.
Subject(s)
Cholinergic Antagonists/therapeutic use , Urinary Bladder, Overactive/drug therapy , Benzhydryl Compounds/therapeutic use , Benzilates/therapeutic use , Benzofurans/therapeutic use , Humans , Imidazoles/therapeutic use , Mandelic Acids/therapeutic use , Network Meta-Analysis , Pyrrolidines/therapeutic use , Solifenacin Succinate/therapeutic use , Tolterodine Tartrate/therapeutic use , Treatment OutcomeABSTRACT
OBJECTIVES: This study aimed to ascertain the association between levator avulsion and pelvic organ prolapse (POP). METHODS: This was a cross-sectional study involving 195 women enrolled in a longitudinal cohort study and seen 20 years after an index birth. All had a standardized patient-administered questionnaire, the International Continence Society Pelvic Organ Prolapse Quantification assessment and 4D translabial ultrasound. Main outcome measures were objective POP clinically and on translabial ultrasound. Postimaging assessment of levator integrity and sonographically determined pelvic organ descent was done blinded against other data. RESULTS: Of 195 women who were seen a mean of 23 (range, 19.4-46.2) years after their first birth, one declined ultrasound assessment and was excluded, leaving 194. Mean age was 50.2 (range 36.9-66.5) years with a mean body mass index (BMI) of 27.6 (range, 18.3-54.3) kg/m2 . Median parity was 3 (range 1-14). Ninety-one percent (n = 176) had delivered vaginally. Eighteen percent (n = 34) were symptomatic of prolapse. Clinically, 36% (n = 69) had significant POP. Levator avulsion was diagnosed in 16% (n = 31). Mean levator avulsion defect score was 2.2 (range, 0-12). On univariate analysis, levator avulsion and levator avulsion defect score were associated with clinically and sonographically significant POP, that is, odds ratio 2.6 (1.2-5.7), P = .01; and odds ratio 3.3 (1.4-7.7); P = .003, respectively; Ba (P < .001); bladder (P < .001); uterine (P < .001) and rectal ampulla (P = .009) descent, but not POP symptoms, C, and Bp. Multivariate analysis controlling for potential confounders confirmed our findings. CONCLUSIONS: Levator avulsion is associated with female pelvic organ prolapse, especially of the anterior and central compartments. This association may become stronger with aging.
Subject(s)
Pelvic Floor/injuries , Pelvic Organ Prolapse/diagnostic imaging , Adult , Cohort Studies , Cross-Sectional Studies , Female , Humans , Imaging, Three-Dimensional/methods , Longitudinal Studies , Middle Aged , Time , Ultrasonography/methods , Young AdultABSTRACT
INTRODUCTION AND HYPOTHESIS: Levator ani muscle (LAM) and anal sphincter tears are common after vaginal birth and are associated with female pelvic organ prolapse and anal incontinence. The impact of subsequent births on LAM and external anal sphincter (EAS) integrity is less well defined. The objective of this study was to determine the prevalence of LAM and EAS trauma in primiparous (VP1) and multiparous (VP2+) women who had delivered vaginally to assess if there were differences between the two groups. The null hypothesis was: there is no significant difference in the prevalence of LAM and EAS trauma between the two groups. METHODS: This was a cross-sectional study involving 195 women, participants of the Dunedin arm of the ProLong study (PROlapse and incontinence LONG-term research study) seen 20 years after their index birth. Assessment included a standardized questionnaire, ICS POP-Q and 4D translabial ultrasound. Post-imaging analysis of LAM and EAS integrity was undertaken blinded against other data. Statistical analysis was performed using Fisher's exact test and results were expressed as odds ratios (OR). RESULTS: LAM avulsion and EAS defects were diagnosed in 31 (16%) and 24 (12.4%) women respectively. No significant difference in the prevalence of levator avulsion and EAS defects between primiparous (VP1) and multiparous (VP2+) women who had delivered vaginally (OR 1.9, 95% CI 0.72-5.01, p = 0.26) and (OR 1.2, 95% CI 0.4-3.8, p = 0.76) respectively. CONCLUSIONS: Most LAM avulsions and EAS defects seem to be caused by the first vaginal birth. Subsequent vaginal deliveries after the first were unlikely to cause further LAM trauma.
Subject(s)
Anal Canal/injuries , Anus Diseases/epidemiology , Delivery, Obstetric/adverse effects , Obstetric Labor Complications/epidemiology , Pelvic Floor Disorders/epidemiology , Adult , Anus Diseases/etiology , Birth Order , Cross-Sectional Studies , Delivery, Obstetric/methods , Female , Humans , Longitudinal Studies , Middle Aged , Obstetric Labor Complications/etiology , Odds Ratio , Parity , Pelvic Floor/diagnostic imaging , Pelvic Floor Disorders/etiology , Postpartum Period , Pregnancy , Prevalence , Surveys and Questionnaires , Ultrasonography/methods , Vagina , Vulva/diagnostic imagingABSTRACT
OBJECTIVE: iTaukei women's awareness and practice of family planning methods was investigated in New Zealand and Fiji to ascertain differences in behaviour within the context of changing developmental settings. METHODS: The study was cross-sectional in nature and recruited women aged 18 years and over from three suburbs in Suva, Fiji, and five cities in New Zealand. RESULTS: Overall, 352 women participated in the study, 212 in Fiji and 140 in New Zealand. The study found that living in New Zealand was significantly associated with lower odds of being aware of family planning (OR 0.4, 95%CI 0.2-0.9, p=0.029) and using family planning methods (OR 0.5, 95%CI 0.2-0.9, p=0.027). Tertiary education was found to increase the odds of being aware (OR 2.8, 95%CI 1.3-6.2, p=0.009) and of using (OR 3.9, 95%CI 1.9-7.8, p=0.000) family planning. CONCLUSIONS: Despite the greater availability of services and higher standards of living experienced in New Zealand compared with Fiji, there was no improvement in awareness and use of family planning among New Zealand participants. Implications for public health: Reduced awareness and use of family planning in New Zealand indicates a need for better targeting of services among minority Pacific ethnic groups.
Subject(s)
Contraception Behavior/ethnology , Contraception/statistics & numerical data , Family Planning Services , Health Knowledge, Attitudes, Practice , Reproductive Health/ethnology , Adolescent , Adult , Cross-Sectional Studies , Female , Fiji , Humans , Middle Aged , New Zealand , Socioeconomic Factors , Surveys and QuestionnairesABSTRACT
The objective of this study was to examine the content validity and test-retest reliability of the Intuitive Eating Scale among pregnant women. A qualitative think-aloud study of the Intuitive Eating Scale analysed the content validity. Overall, the Intuitive Eating Scale made sense to pregnant women, but food safety affected the interpretation of some items. A version with instructions modified accounting for food safety, the Intuitive Eating Scale-Pregnancy, was subsequently shown to have stable scores over 5 weeks during the second trimester, mean change = -0.08 (95% limits of agreement: -0.61 to 0.45), r = 0.79, n = 240. The Intuitive Eating Scale-Pregnancy was acceptable for use in this New Zealand pregnant population.
Subject(s)
Feeding Behavior , Intuition , Pregnancy/psychology , Psychometrics/statistics & numerical data , Surveys and Questionnaires , Adult , Female , Food Safety , Humans , New Zealand , Pregnancy Trimester, Second , Young AdultABSTRACT
INTRODUCTION AND HYPOTHESIS: Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. RESULTS: The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. CONCLUSIONS: The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.
Subject(s)
Outcome Assessment, Health Care/standards , Urinary Bladder, Overactive/therapy , Adult , Aged , Consensus , Delphi Technique , Female , Humans , Male , Middle Aged , Quality of Health Care , Quality of Life , Treatment OutcomeABSTRACT
AIM: The aim of the study was to identify unmet need and family planning access among indigenous Fijian or iTaukei women living in New Zealand and Fiji. METHOD: A cross-sectional survey was undertaken between 2012-2013 in five major cities in New Zealand: Auckland, Hamilton, Wellington, Christchurch and Dunedin; and in three suburbs in Fiji. Women who did not want any (more) children but were not using any form of contraception were defined as having an unmet need. Access experiences involving cost and health provider interactions were assessed. RESULTS: Unmet need in New Zealand was 26% and similar to the unmet need found in Fiji (25%). Cost and concern over not being seen by a female provider were the most problematic access factors for women. CONCLUSION: There is a need for better monitoring and targeting of family planning services among minority Pacific groups, as the unmet need found in New Zealand was three times the national estimate overall and similar to the rate found in Fiji. Cost remains a problem among women trying to access family planning services. Gendered traditional roles in sexual and reproductive health maybe an area from which more understanding into cultural sensitivities and challenges may be achieved.
Subject(s)
Family Planning Services , Health Services Accessibility/statistics & numerical data , Health Services Needs and Demand/statistics & numerical data , Adolescent , Adult , Contraception/statistics & numerical data , Cross-Sectional Studies , Female , Fiji , Health Knowledge, Attitudes, Practice , Humans , Middle Aged , New Zealand , Socioeconomic Factors , Young AdultABSTRACT
AIM: To investigate the long-term effect of dietary education on a low fermentable oligosaccharide, disaccharide and polyol (FODMAP) diet on irritable bowel syndrome (IBS) symptoms and quality of life (QoL). METHODS: Participants with IBS (Rome III) were randomized to two groups. Group I commenced a low FODMAP diet at baseline. At three months, group II, so far a comparator group, crossed over to a low FODMAP diet while group I started re-challenging foods. All patients completed the IBS SSS (IBS symptom severity scoring system, 0-500 points increasing with severity), IBS QoL questionnaire (0-100 increasing with QoL), a FODMAP specific food frequency questionnaire and provided a stool sample at baseline, three and six months for microbiome analysis. RESULTS: Fifty participants were enrolled into group I (n = 23) or group II (n = 27). Participants in both groups were similar in baseline values but with more men in group I. There was a significantly lower IBS SSS (275.6 ± 63.6 to 128.8 ± 82.5 vs 246.8 ± 71.1 to 203.6 ± 70.1) (P < 0.0002) and increased QoL (68.5 ± 18.0 to 83 ± 13.4 vs 72.9 ± 12.8 to 73.3 ± 14.4) (P < 0.0001) in group I vs group II at 3 mo. The reduced IBS SSS was sustained at 6 mo in group I (160 ± 102) and replicated in group II (124 ± 76). Fiber intake decreased on the low FODMAP diet (33 ± 17 g/d to 21 ± 8 g/d) (P < 0.01) and after re-introducing FODMAP containing foods increased again to 27 ± 9 g/d. There was no change seen in the intestinal microbiome when participants adopted a low FODMAP diet. CONCLUSION: This study demonstrated that a reduction in FODMAPs improves symptoms in IBS and this improvement can be maintained while reintroducing FODMAPs.
Subject(s)
Diet, Carbohydrate-Restricted/methods , Disaccharides/adverse effects , Gastrointestinal Microbiome , Irritable Bowel Syndrome/diet therapy , Quality of Life , Sugar Alcohols/adverse effects , Adult , Colon/metabolism , Colon/microbiology , Disaccharides/metabolism , Female , Fermentation , Humans , Irritable Bowel Syndrome/microbiology , Male , Middle Aged , Patient Education as Topic , Severity of Illness Index , Sugar Alcohols/metabolism , Surveys and QuestionnairesABSTRACT
OBJECTIVE: International studies have shown that patients want their spiritual needs attended to at the end of life. The present authors developed a project to investigate people's understanding of spirituality and spiritual care practices in New Zealand (NZ) hospices. METHOD: A mixed-methods approach included 52 semistructured interviews and a survey of 642 patients, family members, and staff from 25 (78%) of NZ's hospices. We employed a generic qualitative design and analysis to capture the experiences and understandings of participants' spirituality and spiritual care, while a cross-sectional survey yielded population level information. RESULTS: Our findings suggest that spirituality is broadly understood and considered important for all three of the populations studied. The patient and family populations had high spiritual needs that included a search for (1) meaning, (2) peace of mind, and (3) a degree of certainty in an uncertain world. The healthcare professionals in the hospices surveyed seldom explicitly met the needs of patients and families. Staff had spiritual needs, but organizational support was sometimes lacking in attending to these needs. SIGNIFICANCE OF RESULTS: As a result of our study, which was the first nationwide study in NZ to examine spirituality in hospice care, Hospice New Zealand has developed a spirituality professional development program. Given that spirituality was found to be important to the majority of our participants, it is hoped that the adoption of such an approach will impact on spiritual care for patients and families in NZ hospices.
Subject(s)
Critical Illness/psychology , Family/psychology , Spiritualism/psychology , Terminal Care/psychology , Adult , Aged , Cross-Sectional Studies , Female , Hospices/methods , Hospices/organization & administration , Humans , Male , Middle Aged , New Zealand , Qualitative Research , Surveys and Questionnaires , Terminal Care/methodsABSTRACT
BACKGROUND: Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. METHODS: We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. FINDINGS: Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference -1·01, 95% CI -1·70 to -0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). INTERPRETATION: Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. FUNDING: Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.
Subject(s)
Pelvic Floor , Pelvic Organ Prolapse/rehabilitation , Physical Therapy Modalities , Secondary Prevention , Adult , Female , Humans , Middle Aged , New Zealand , Parity , Treatment Outcome , United KingdomABSTRACT
BACKGROUND: Many countries recommend daily infant vitamin D supplementation during breastfeeding, but compliance is often poor. A monthly, high-dose maternal regimen may offer an alternative strategy, but its efficacy is unknown. OBJECTIVE: The objective of the study was to determine the effect of 2 different monthly maternal doses of cholecalciferol on maternal and infant 25-hydroxyvitamin D [25(OH)D] status during the first 5 mo of breastfeeding. METHODS: With the use of a randomized, double-blind, placebo-controlled design, women who were planning to exclusively breastfeed for 6 mo (n = 90; mean age: 32.1 y; 71% exclusively breastfeeding at week 20) were randomly assigned to receive either cholecalciferol (50,000 or 100,000 IU) or a placebo monthly from week 4 to week 20 postpartum. The treatment effects relative to placebo were estimated as changes in maternal and infant serum 25(OH)D from baseline to week 20 postpartum by using a linear fixed-effects regression model. Additional secondary analyses, adjusted for potential confounders such as season of birth, vitamin D-fortified formula intake, and infant or maternal skin color, were also conducted. RESULTS: After 16 wk of supplementation, changes in maternal serum 25(OH)D were significantly higher in the 50,000-IU/mo (12.8 nmol/L; 95% CI: 0.4, 25.2 nmol/L) and 100,000-IU/mo (21.5 nmol/L; 95% CI: 9.2, 33.8 nmol/L) groups than in the placebo group (P = 0.43 and P < 0.001, respectively). For infants, the unadjusted mean changes in serum 25(OH)D were 4.5 nmol/L (95% CI: -16.2, 25.0 nmol/L) for the 50,000-IU/mo group and 15.8 nmol/L (95% CI: -4.7, 36.4 nmol/L) for the 100,000-IU/mo group, but the changes did not differ from the placebo reference group. However, after adjustment for season of birth, vitamin D-fortified formula intake, and infant skin color, the mean change effect size for the 100,000-IU/mo group was 19.1 nmol/L (95% CI: 2.5, 35.6 nmol/L; P = 0.025) higher than that in the placebo group. CONCLUSIONS: Maternal cholecalciferol supplementation at a dose of 100,000 IU/mo during the first 5 mo of breastfeeding potentially benefits infant vitamin D status. Further studies are required to determine optimum dose and dosing frequency. This trial was registered at www.anzctr.org.au as ACTRN12611000108910.
Subject(s)
Breast Feeding , Cholecalciferol/administration & dosage , Dietary Supplements , Infant Nutritional Physiological Phenomena , Maternal Nutritional Physiological Phenomena , Vitamin D/blood , Adult , Cholecalciferol/blood , Dose-Response Relationship, Drug , Double-Blind Method , Female , Fetal Blood/chemistry , Humans , Infant , Lactation , Postpartum Period/blood , Treatment OutcomeABSTRACT
BACKGROUND: Many randomised trials have count outcomes, such as the number of falls or the number of asthma exacerbations. These outcomes have been treated as counts, continuous outcomes or dichotomised and analysed using a variety of analytical methods. This study examines whether different methods of analysis yield estimates of intervention effect that are similar enough to be reasonably pooled in a meta-analysis. METHODS: Data were simulated for 10,000 randomised trials under three different amounts of overdispersion, four different event rates and two effect sizes. Each simulated trial was analysed using nine different methods of analysis: rate ratio, Poisson regression, negative binomial regression, risk ratio from dichotomised data, survival to the first event, two methods of adjusting for multiple survival times, ratio of means and ratio of medians. Individual patient data was gathered from eight fall prevention trials, and similar analyses were undertaken. RESULTS: All methods produced similar effect sizes when there was no difference between treatments. Results were similar when there was a moderate difference with two exceptions when the event became more common: (1) risk ratios computed from dichotomised count outcomes and hazard ratios from survival analysis of the time to the first event yielded intervention effects that differed from rate ratios estimated from the negative binomial model (reference model) and (2) the precision of the estimates differed depending on the method used, which may affect both the pooled intervention effect and the observed heterogeneity. The results of the case study of individual data from eight trials evaluating exercise programmes to prevent falls in older people supported the simulation study findings. CONCLUSIONS: Information about the differences in treatments is lost when event rates increase and the outcome is dichotomised or time to the first event is analysed otherwise similar results are obtained. Further research is needed to examine the effect of differing variances from the different methods on the confidence intervals of pooled estimates.
Subject(s)
Meta-Analysis as Topic , Models, Biological , Models, Statistical , Research Design , Accidental Falls/prevention & control , Aged , Computer Simulation , Exercise , Humans , Research Design/statistics & numerical dataABSTRACT
OBJECTIVES: Recent network meta-analyses of drug treatments for acute mania have only evaluated the efficacy and acceptability of individual drug treatments. The relative efficacy and acceptability of combined drug treatment has not been assessed. METHODS: Double-blind drug trials in acute mania were identified using a systematic search strategy. We recorded numbers of patients enrolled, endpoints for efficacy (changes in mania rating scales, numbers of responders) and acceptability (numbers of dropouts) and treatment administered (categorized as antipsychotic, mood stabilizer, combined antipsychotic/mood stabilizer or placebo). Data were analyzed using a random effects frequentist network meta-analysis. RESULTS: All three drug categories were more effective than placebo. Antipsychotics and combined antipsychotic/mood stabilizer were significantly more effective than mood stabilizers for changes in mania rating scales. Combined antipsychotic/mood stabilizer was significantly more effective than mood stabilizers and antipsychotics for responder rate. Dropout rates were significantly lower for antipsychotics compared with placebo and mood stabilizers. Combined antipsychotic/mood stabilizer had the highest probability of being the best treatment based on change in mania rating scales (96.1% for all mania scales; 85.5% for Young Mania Rating Scale), and 99.3% for being the best treatment for responders. Antipsychotics had 82.0% probability as the best treatment to minimize dropouts. CONCLUSION: Combined antipsychotic/mood stabilizer appears to have efficacy advantages over antipsychotic or mood stabilizer monotherapy in acute mania, and should be considered as first line therapy.
Subject(s)
Antimanic Agents/therapeutic use , Antipsychotic Agents/therapeutic use , Bipolar Disorder/drug therapy , Acute Disease , Carbamazepine/therapeutic use , Double-Blind Method , Drug Therapy, Combination , Humans , Lithium Compounds/therapeutic use , Randomized Controlled Trials as Topic , Treatment Outcome , Valproic Acid/therapeutic useABSTRACT
AIM: To determine the prevalence of infection with hepatitis C virus (HCV) in those most at risk of advanced liver disease and to identify gaps in knowledge of HCV. METHODS: Questionnaires were mailed to randomly selected residents aged 40-59 to assess the extent of their general knowledge about HCV. The questionnaire assessed demographics, the extent of general knowledge about viral hepatitis, potential risks for infection and the prevalence of risk factors associated with increased progression of liver fibrosis. Anonymised residual laboratory blood samples from 40-59 years old people from Dunedin taken in hospital or in the community, were tested for HCV antibodies and alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (GGT). Linear regression was performed to examine whether the demographics sex, age, socio-economic status, qualification level and occupation sector (categorical variables) were predictors of level of general knowledge about hepatitis. For the demographics that were found to be significant predictors of score outcome, multiple regression analysis was used to determine independent effects. χ (2) tests were used to compare our selected sample and our responder population demographics, to the demographics of the entire 40-59 years old population in Dunedin using the 2006 NZ census data. Exact confidence intervals for the proportion positive for HCV and HBV were calculated using the binomial distribution. RESULTS: The response rate to the mailed questionnaire was 431/1400 (30.8%). On average 59.4% questions were answered correctly. Predictors for higher scores, indicating greater knowledge about symptoms and transmission included sex (female, P < 0.01), higher level of qualification (P < 0.000) and occupation sector (P < 0.000). Sharing intravenous drug utensils was a known risk factor for disease transmission (94.4%), but the sharing of common household items such as a toothbrush was not. 93% of the population were unaware that HCV infection can be asymptomatic. 25% did not know that treatment was available in New Zealand and of those who did know, only 40% assumed it was funded. Six hundred and eighty-two residual anonymised blood samples were tested for HCV antibodies, ALT, AST and GGT. The prevalence for HCV was 4.01%, 95%CI: 2.6%-5.8%. Liver function tests were not useful for identifying likelyhood of HCV infection. CONCLUSION: Prevalence of HCV in our population is high, and the majority have limited knowledge of HCV and its treatment.
Subject(s)
Health Knowledge, Attitudes, Practice , Hepatitis C/epidemiology , Hepatitis C/psychology , Adult , Alanine Transaminase/blood , Antiviral Agents/therapeutic use , Aspartate Aminotransferases/blood , Biomarkers/blood , Chi-Square Distribution , Female , Hepatitis Antibodies/blood , Hepatitis C/diagnosis , Hepatitis C/drug therapy , Hepatitis C/transmission , Humans , Linear Models , Male , Middle Aged , New Zealand/epidemiology , Prevalence , Prospective Studies , Risk Assessment , Risk Factors , Surveys and Questionnaires , gamma-Glutamyltransferase/bloodABSTRACT
OBJECTIVES: To examine the difference in outcome between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), to see if it has changed over the years in diabetics deemed eligible for both treatments; and to contrast the long-term mortality findings with those in non-diabetics. DESIGN: Meta-analyses using data from randomised controlled trials found by searches on MEDLINE, EMBASE and the Cochrane Controlled Trials Register, from their inception until March 2015. SETTING: Studies had to be randomised controlled trials comparing PCI with CABG. PARTICIPANTS: Those taking part in the studies had to have multivessel cardiac or left main artery cardiac disease and be deemed eligible for both treatments. INTERVENTIONS: PCI or CABG. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was all cause mortality. Secondary outcomes were a composite of mortality, stroke and myocardial infarction; cardiovascular death; and MACCE (Major Adverse Cardiac or Cerebrovascular Event). The longest follow-up was used in the analysis. RESULTS: Among 14 studies (4868 diabetics) reported over three decades, meta-regression shows no relationship between the year of publication and the difference in long term all cause mortality between PCI and CABG. CABG has maintained an approximately 30% mortality advantage compared to PCI. The other outcomes used showed the same lack of change over the years. These findings held true among insulin-requiring and non-insulin-requiring diabetics. However, among non-diabetics included in the 14 studies, there was no difference in mortality outcome between PCI and CABG. CONCLUSIONS: The difference in outcome between PCI and CABG in diabetics has not narrowed from the beginning-with balloon angioplasty to current PCI-with the second generation of drug eluting stents. In contrast to the non-diabetics, there is a persistent 30% benefit in all cause mortality favouring CABG in diabetics, and this should be a major factor in treatment recommendation.