Characteristics of nonparticipants in a randomised colorectal cancer screening trial comparing sigmoidoscopy and faecal immunochemical testing.

Public health systems should guarantee universal access to health care services, including cancer screening. We assessed whether certain population subgroups were underrepresented among participants in colorectal cancer screening with sigmoidoscopy and faecal immunochemical testing (FIT). Between 2012 and 2019, about 140 000 individuals aged 50 to 74 years were randomly invited to once-only sigmoidoscopy or first round of FIT screening. Our study included 46 919 individuals invited to sigmoidoscopy and 70 019 to FIT between 2012 and 2017. We used logistic regression models to evaluate if demographic and socioeconomic factors and use of certain drugs were associated with participation. Twenty-four thousand one hundred and fifty-nine (51.5%) individuals attended sigmoidoscopy and 40 931 (58.5%) FIT screening. Male gender, young age, low education and income, being retired or unemployed, living alone, being an immigrant, long driving time to screening centre, and use of antidiabetic and psychotropic drugs were associated with low participation in both screening groups. Many of these factors also predicted low acceptance of colonoscopy after positive FIT. While male gender, young age and living alone were more strongly associated with nonparticipation in FIT than sigmoidoscopy, low education and income, being retired or immigrant and long driving time were more strongly associated with nonparticipation in sigmoidoscopy than FIT. In conclusion, participation was lower in sigmoidoscopy than FIT. Predictors of nonparticipation were similar between arms. However, low socioeconomic status, being an immigrant and long driving time affected participation more in sigmoidoscopy screening, suggesting that FIT may guarantee more equal access to screening services than sigmoidoscopy.

Impact of a Face-To-Face Versus Smartphone App Versus Combined Breastfeeding Intervention Targeting Fathers: Randomized Controlled Trial.

BACKGROUND: Despite the recognized health and economic benefits of exclusive breastfeeding, few Australian infants are exclusively breastfed beyond 5 months of age. Social support for breastfeeding, in particular the support of an infant's father, has been identified as a crucial element for successful breastfeeding. OBJECTIVE: The objective of this study was to determine the effectiveness of various father-focused breastfeeding interventions in terms of key infant feeding outcomes. METHODS: The study was a 4-arm, factorial, randomized controlled trial conducted in Perth, Australia. The trial arms included a control group and 3 interventions, consisting of a face-to-face father-focused antenatal breastfeeding class facilitated by a male peer facilitator; Milk Man, a breastfeeding smartphone app designed specifically for fathers; and a combination of both interventions. Expecting couples were recruited from hospital-based antenatal classes and block randomized to 1 of the 4 arms. Each partner completed surveys at recruitment and at 6 weeks and 26 weeks postpartum. Primary outcomes were duration of exclusive and any breastfeeding. Secondary outcomes included age of introduction of formula and complementary foods, maternal breastfeeding self-efficacy, and partner postpartum support. RESULTS: A total of 1426 couples were recruited from public (443/1426, 31.1%) and private (983/1426, 68.9%) hospitals. Of these, 76.6% (1092/1426) of fathers completed the baseline questionnaire, 58.6% (836/1426) completed the 6-week follow-up questionnaire, and 49.2% (702/1426) completed the 26-week follow-up questionnaire. The average age of fathers who completed the baseline questionnaire was 33.6 (SD 5.2) years; the majority were born in Australia (76.4%) and had attended university (61.8%). There were no significant differences between the control and any of the intervention groups in any of the infant feeding outcomes or level of breastfeeding self-efficacy and postpartum partner support reported by mothers. CONCLUSIONS: This study did not demonstrate that any intervention was superior to another or that any intervention was inferior to the standard care delivered in routine antenatal classes. Further studies are needed to test the effectiveness of these interventions in more socioeconomically diverse populations that are likely to benefit most from additional partner supports. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000605695; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614000605695. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12884-015-0601-5.

Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial.

BACKGROUND & AIMS: The comparative effectiveness of sigmoidoscopy and fecal immunochemical testing (FIT) for colorectal cancer (CRC) screening is unknown. METHODS: Individuals aged 50-74 years living in Southeast Norway were randomly invited between 2012 and 2019 to either once-only flexible sigmoidoscopy or FIT screening every second year. Colonoscopy was recommended after sigmoidoscopy if any polyp of ≥10 mm, ≥3 adenomas, any advanced adenomas, or CRC was found or, subsequent to, FIT >15 µg hemoglobin/g feces. Data for this report were obtained after complete recruitment in both groups and included 2 full FIT rounds and part of the third round. Outcome measures were participation, neoplasia detection, and adverse events. Age-standardized detection rates and age-adjusted odds ratios (ORs) were calculated. RESULTS: We included 139,291 individuals: 69,195 randomized to sigmoidoscopy and 70,096 to FIT. The participation rate was 52% for sigmoidoscopy, 58% in the first FIT round, and 68% for 3 cumulative FIT rounds. Compared to sigmoidoscopy, the detection rate for CRC was similar in the first FIT round (0.25% vs 0.27%; OR, 0.92; 95% confidence interval [CI], 0.75-1.13) but higher after 3 FIT rounds (0.49% vs 0.27%; OR, 1.87; 95% CI, 1.54-2.27). Advanced adenoma detection rate was lower in the first FIT round compared to sigmoidoscopy at 1.4% vs 2.4% (OR, 0.57; 95% CI, 0.53-0.62) but higher after 3 cumulative FIT rounds at 2.7% vs 2.4% (OR, 1.14; 95% CI, 1.05-1.23). There were 33 (0.05%) serious adverse events in the sigmoidoscopy group compared to 47 (0.07%) in the FIT group (P = .13). CONCLUSIONS: Participation was higher and more CRC and advanced adenomas were detected with repeated FIT compared to sigmoidoscopy. The risk of perforation and bleeding was comparable. Clinicaltrials.gov, Number: NCT01538550.

Process evaluation of a peer-led antenatal breastfeeding class for fathers: perceptions of facilitators and participants.

BACKGROUND: The Parent Infant Feeding Initiative (PIFI) was a factorial, randomised controlled trial that aimed to prolong exclusive breastfeeding by targeting expecting fathers. One of the intervention strategies evaluated was a father-focused breastfeeding class facilitated by a male peer facilitator. The aim of this mixed-methods descriptive study was to 1) evaluate the feedback provided from participants of the class and 2) explore the motivations and experiences of volunteer male peer facilitators trained to deliver the class. METHODS: Father-focused breastfeeding antenatal (FFAB) classes were conducted in six Western Australian hospitals between August 2015 and December 2016. Following each peer facilitated FFAB class, expecting father participants completed an evaluation form to assess their satisfaction with the format, facilitation and content, in addition to whether their expectations and confidence to manage breastfeeding problems had changed. Feedback to open-ended questions was analysed using content analysis to identify learnings and suggestions for improvements. At the completion of PIFI, individual telephone interviews were undertaken with 14 peer facilitators to gain insight into their motivations for volunteering and experiences of conducting the classes. Transcripts from interviews were analysed using Braun and Clarke's six phases for thematic analysis. RESULTS: Participant evaluation forms were completed by 678 of the 697 father participants (98%). Overall satisfaction with class format, facilitation and content was high with 90% or more of fathers either strongly agreeing or agreeing with each positively-phrased evaluation item. Class participants enjoyed interacting with other fathers, appreciated validation of their role, were not always aware of the importance of breastfeeding or potential difficulties, valued the anticipatory guidance around what to expect in the early weeks of parenting and appreciated learning practical breastfeeding support strategies. Peer facilitators indicated they felt well prepared and supported to conduct FFAB classes. Analysis of interview transcripts revealed common experiences of the peer facilitators incorporating four themes: 'Highlights of being a facilitator', 'Challenges', 'Mourning the project completion' and 'Satisfaction with training and support'. CONCLUSION: Father-focused breastfeeding classes supported by volunteer male peer facilitators are a feasible and acceptable way of engaging fathers as breastfeeding supporters. TRIAL REGISTRATION: ACTRN12614000605695 . Registered 6 June 2014.

Endoscopy assistants influence the quality of colonoscopy.

BACKGROUND: Colonoscopy performance varies between endoscopists, but little is known about the impact of endoscopy assistants on key performance indicators. We used a large prospective colonoscopy quality database to perform an exploratory study to evaluate differences in selected quality indicators between endoscopy assistants. METHODS: All colonoscopies reported to the Norwegian colonoscopy quality assurance register Gastronet can be used to trace individual endoscopy assistants. We analyzed key quality indicators (cecum intubation rate, polyp detection rate, colonoscopies rated as severely painful, colonoscopies with sedation or analgesia, and satisfaction with information) for colonoscopies performed between 1 January 2013 and 31 December 2014. Differences between individual assistants were analyzed by fitting multivariable logistic regression models, with the best performing assistant at each participating hospital as reference. All models were adjusted for the endoscopist. RESULTS: 63 endoscopy assistants from 12 hospitals assisted in 15 365 colonoscopies. Compared with their top performing peers from the same hospital, one assistant was associated with cecum intubation failure, four with poor polyp detection, nine with painful colonoscopy, 16 with administration of sedation or analgesics during colonoscopy, and three with patient dissatisfaction about information given relating to the colonoscopy. The number of procedures during the study period or lifetime experience as an endoscopy assistant were not associated with any quality indicator. CONCLUSION: In this exploratory study, there was little variation on important colonoscopy quality indicators between endoscopy assistants. However, there were differences among assistants that may be clinically important. Endoscopy assistants should be subject to quality surveillance similarly to endoscopists.

Assessment of Breast Milk Iodine Concentrations in Lactating Women in Western Australia.

Breast-fed infants may depend solely on an adequate supply of iodine in breast milk for the synthesis of thyroid hormones which are essential for optimal growth and cognitive development. This is the first study to measure breast milk iodine concentration (BMIC) among lactating women in Western Australian (n = 55). Breast milk samples were collected between 2014 and 2015 at a mean (±SD) of 38.5 (±5.5) days post-partum. The samples were analysed to determine median BMIC and the percentage of samples with a BMIC < 100 µg/L, a level considered adequate for breast-fed infants. The influence of (a) iodine-containing supplements and iodised salt use and (b) consumption of key iodine-containing foods on BMIC was also examined. The median (p25, p75) BMIC was 167 (99, 248) µg/L and 26% of samples had a BMIC < 100 µg/L. Overall, BMIC tended to be higher with iodine-containing supplement usage (ratio 1.33, 95% confidence interval (CI) (1.04, 1.70), p = 0.030), cow's milk consumption (ratio 1.66, 95% CI (1.23, 2.23), p = 0.002) and lower for Caucasians (ratio 0.61, 95% CI (0.45, 0.83), p = 0.002), and those with secondary school only education (ratio 0.66, 95% CI (0.46, 0.96), p = 0.030). For most women, BMIC was adequate to meet the iodine requirements of their breast-fed infants. However, some women may require the use of iodine-containing supplements or iodised salt to increase BMIC to adequate levels for optimal infant nutrition.

A study to prolong breastfeeding duration: design and rationale of the Parent Infant Feeding Initiative (PIFI) randomised controlled trial.

BACKGROUND: Very few Australian infants are exclusively breastfed to 6 months as recommended by the World Health Organization. There is strong empirical evidence that fathers have a major impact on their partner's decision to breastfeed and continuation of breastfeeding. Fathers want to participate in the breastfeeding decision making process and to know how they can support their partner to achieve their breastfeeding goals. The aim of the Parent Infant Feeding Initiative (PIFI) is to evaluate the effect on duration of any and exclusive breastfeeding of three breastfeeding promotion interventions of differing intensity and duration, targeted at couples but channelled through the male partner. The study will also undertake a cost-effectiveness evaluation of the interventions. METHODS/DESIGN: The PIFI study is a factorial randomised controlled trial. Participants will be mothers and their male partners attending antenatal classes at selected public and private hospitals with maternity departments in Perth, Western Australia. Fathers will be randomly allocated to either the usual care control group (CG), one of two medium intensity (MI1 and MI2) interventions, or a high intensity (HI) intervention. MI1 will include a specialised antenatal breastfeeding education session for fathers with supporting print materials. MI2 will involve the delivery of an antenatal and postnatal social support intervention delivered via a smartphone application and HI will include both the specialised antenatal class and the social support intervention. Outcome data will be collected from couples at baseline and at six and 26 weeks postnatally. A total of 1600 couples will be recruited. This takes into account a 25% attrition rate, and will detect at least a 10% difference in the proportion of mothers breastfeeding between any two of the groups at 26 weeks at 80% power and 5% level of significance, using a Log-rank survival test. Multivariable survival and logistic regression analyses will be used to assess the effect of the treatment groups on the outcomes after adjusting for covariates. DISCUSSION: The PIFI study will be the first Australian study to provide Level II evidence of the impact on breastfeeding duration of a comprehensive, multi-level, male-partner-focused breastfeeding intervention. Unique features of the intervention include its large sample size, delivery of two of the interventions by mobile device technology, a rigorous assessment of intervention fidelity and a cost-effectiveness evaluation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000605695. Registered 6 June 2014.

"Drop in" gastroscopy outpatient clinic--experience after 9 months.

BACKGROUND: Logistics handling referrals for gastroscopy may be more time consuming than the examination itself. For the patient, "drop in" gastroscopy may reduce uncertainty, inadequate therapy and time off work. METHODS: After an 8-9 month run-in period we asked patients, hospital staff and GPs to fill in a questionnaire to evaluate their experience with "drop in" gastroscopy and gastroscopy by appointment, respectively. The diagnostic gain was evaluated. RESULTS: 112 patients had "drop in" gastroscopy and 101 gastroscopy by appointment. The number of "drop in" patients varied between 3 and 12 per day (mean 6.5). Mean time from first GP consultation to gastroscopy was 3.6 weeks in the "drop in" group and 14 weeks in the appointment group. The half-yearly number of outpatient gastroscopies increased from 696 before introducing "drop in" to 1022 after (47% increase) and the proportion of examinations with pathological findings increased from 42% to 58%. Patients and GPs expressed great satisfaction with "drop in". Hospital staff also acclaimed although it caused more unpredictable working days with no additional staff. CONCLUSIONS: "Drop in" gastroscopy was introduced without increase in staff. The observed increase in gastroscopies was paralleled by a similar increase in pathological findings without any apparent disadvantages for other groups of patients. This should legitimise "drop in" outpatient gastroscopies, but it requires meticulous observation of possible unwanted effects when implemented.

Quality control in colorectal cancer screening: systematic microbiological investigation of endoscopes used in the NORCCAP (Norwegian Colorectal Cancer Prevention) trial.

BACKGROUND: Endoscopic colorectal cancer (CRC) screening is currently implemented in many countries. Since endoscopes cannot be sterilised, the transmission of infectious agents through endoscopes has been a matter of concern. We report on a continuous quality control programme in a large-scale randomised controlled trial on flexible sigmoidoscopy screening of an average-risk population. Continuously, throughout a two-year screening period, series of microbiological samples were taken from cleaned ready-to-use endoscopes and cultured for bacterial growth. RESULTS: 8573 endoscopies were performed during the trial period. Altogether, 178 microbiological samples (2%) were taken from the biopsy channels and surfaces from the endoscopes. One sample (0.5%) showed faecal contamination (Enterobacter cloacae), and 25 samples (14%) showed growth of environmental bacteria. CONCLUSIONS: Growth of bacteria occurs in a clinical significant number of samples from ready-to-use endoscopes. Pathogenic bacteria, however, were found only in one sample. Improvement of equipment design and cleaning procedures are desirable and continuous microbiological surveillance of endoscopes used in CRC screening is recommended.