Deaths and cardiopulmonary events following colorectal cancer screening-A systematic review with meta-analyses.

BACKGROUND: Colorectal cancer screening programmes (CRCSPs) are implemented worldwide despite recent evidence indicating more physical harm occurring during CRCSPs than previously thought. Therefore, we aimed to review the evidence on physical harms associated with endoscopic diagnostic procedures during CRCSPs and, when possible, to quantify the risk of the most serious types of physical harm during CRCSPs, i.e. deaths and cardiopulmonary events (CPEs). METHODS: Systematic review with descriptive statistics and random-effects meta-analyses of studies investigating physical harms following CRCSPs. We conducted a systematic search in the literature and assessed the risk of bias and the certainty of the evidence. RESULTS: We included 134 studies for review, reporting findings from 151 unique populations when accounting for multiple screening interventions per study. Physical harm can be categorized into 17 types of harm. The evidence was very heterogeneous with inadequate measurement and reporting of harms. The risk of bias was serious or critical in 95% of assessments of deaths and CPEs, and the certainty of the evidence was very low in all analyses. The risk of death was assessed for 57 populations with large variation across studies. Meta-analyses indicated that 3 to 23 deaths occur during CRCSPs per 100,000 people screened. Cardiopulmonary events were assessed for 55 populations. Despite our efforts to subcategorize CPEs into 17 distinct subtypes, 41% of CPE assessments were too poorly measured or reported to allow quantification. We found a tendency towards lower estimates of deaths and CPEs in studies with a critical risk of bias. DISCUSSION: Deaths and CPEs during CRCSPs are rare, yet they do occur during CRCSPs. We believe that our findings are conservative due to the heterogeneity and low quality of the evidence. A standardized system for the measurement and reporting of the harms of screening is warranted. TRIAL REGISTRATION: PROSPERO Registration number CRD42017058844.

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses.

INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening. DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses. METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses. RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy. DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.

Racial Analysis of Clinical and Biochemical Outcomes in Patients With Prostate Cancer Treated With Low-Dose-Rate Brachytherapy.

PURPOSE: Black men in the United States experience significantly higher incidence of and mortality from prostate cancer (PCa) than non-Black men. The cause of this disparity is multifactorial, though inequitable access to curative radiation modalities, including low-dose-rate (LDR) brachytherapy, may contribute. Despite this, there are few analyses evaluating the potential of different radiation therapies to mitigate outcome disparities. Therefore, we examined the clinical outcomes of Black and non-Black patients treated with definitive LDR brachytherapy for PCa. METHODS: Data were collected for all patients treated with definitive LDR brachytherapy between 2005 and 2018 on a retrospective institutional review board approved protocol. Pearson χ2 analysis was used to assess demographic and cancer differences between Black and non-Black cohorts. Freedom from biochemical failure (FFBF) was calculated using Kaplan-Meier analysis. Univariate and multivariate analyses were used to identify factors predictive of biochemical failure. RESULTS: One hundred and sixty-seven patients were included in the analysis (Black: n = 81; 48.5%) with a median follow-up of 88.4 months. Black patients were from lower income communities (P < .01), had greater social vulnerability (P < .01), and had a longer interval between diagnosis and treatment (P = .011). Overall cumulative FFBF was 92.3% (95% confidence interval [CI], 87.8%-96.8%) at 5 years and 87.7% (95% CI, 82.0%-93.4%) at 7 years. There was no significant difference in FFBF in Black and non-Black patients (P = .114) and Black race was not independently predictive of failure (hazard ratio, 1.51; 95% CI, 0.56-4.01; P = .42). Overall survival was comparable between racial groups (P = .972). Only nadir prostate-specific antigen was significantly associated with biochemical failure on multivariate (hazard ratio, 3.57; 95% CI, 02.44-5.22; P < .001). CONCLUSIONS: Black men treated with LDR brachytherapy achieved similar FFBF to their non-Black counterparts despite poorer socioeconomic status. This suggests that PCa treatment with brachytherapy may eliminate some disparities in clinical outcomes.

Association of ferritin and transferrin saturation with all-cause mortality, and the effect of concurrent inflammation: a danish cohort study.

The association between ferritin and transferrin saturation (TS), respectively, and all-cause mortality is unclear. Furthermore, the influence of concurrent inflammation has not been sufficiently elucidated. We investigated these associations and the effect of concurrently elevated C-reactive protein (CRP), and accordingly report the levels associated with lowest all-cause mortality for females and males with and without inflammation.Blood test results from 161,921 individuals were included. Statistical analyses were performed in sex-stratified subpopulations, with ferritin or TS level as continuous exposure variables, and were adjusted for age, co-morbidity and inflammation status using CRP. An interaction was used to investigate whether the effect of ferritin or TS on all-cause mortality was modified by inflammation status (CRP ≥ 10 mg/L or CRP < 10 mg/L). Low and high ferritin and TS levels were respectively associated with increased all-cause mortality in females and in males. These associations persisted with concurrent CRP ≥ 10 mg/L. The ferritin level associated with lowest mortality was 60 µg/L for females and 125 µg/L for males with CRP < 10 mg/L. It was 52 µg/L for females and 118 µg/L for males with CRP ≥ 10 mg/L. The TS level associated with lowest mortality was 33.9% for females and 32.3% for males with CRP < 10 mg/L. It was 28.7% for females and 30.6% for males with CRP ≥ 10 mg/L.Our findings can nuance clinical interpretation and further aid in defining recommended ranges for ferritin and TS.

Development and implementation of a tool for measuring the training effectiveness of the patient-centered consultation model.

Background: The patient-centered consultation model comprises four elements: exploring health, illness and disease experiences, understanding the whole person, finding common ground, and enhancing the patient-doctor relationship. This method is taught at the course in general practice at Copenhagen University. The aim of the study was to develop a simple tool consisting of a questionnaire about the patient-centered elements and a test video consultation. The outcome is the change in the students' ability to identify these elements. Used as a pre-course and post-course test it can inform the teachers which elements of the patient-centered consultation need intensifying in the teaching. Methods: The students from a course in general practice volunteered to participate in all steps of the development. They took part in individual interviews to select items from an already existing questionnaire (DanSCORE). The preliminary questionnaire was tested for face and content validity, pilot-tested and tested for test-retest reliability. All video consultations were transcribed and assessed for patient-centered elements through a conversation analysis. The videos showed medical students seeing real patients. Results: The preliminary version of the questionnaire (called DanOBS) had 23 items. In the subsequent interviews, items were reduced to 17, each with three response options. After a pilot test, the questionnaire was further reduced to 13 items, all strictly relevant to the model and with two response options. The final questionnaire had acceptable test-retest reliability. The number of test consultation videos underwent a reduction from six videos to one. Conclusions: The DanOBS combined with a test video consultation, used as a pre-and post-course test demonstrates for teachers which elements in the patient-centered consultation need to be intensified in the teaching.

Effects of Heavy Slow Resistance Training Combined With Corticosteroid Injections or Tendon Needling in Patients With Lateral Elbow Tendinopathy: A 3-Arm Randomized Double-Blinded Placebo-Controlled Study.

BACKGROUND: Lateral elbow tendinopathy is a disabling tendon overuse injury. It remains unknown if a corticosteroid injection (CSI) or tendon needling (TN) combined with heavy slow resistance (HSR) training is superior to HSR alone in treating lateral elbow tendinopathy. PURPOSE/HYPOTHESIS: The purpose was to investigate the effects of HSR combined with either (1) a CSI, (2) TN, or (3) placebo needling (PN) as treatment for lateral elbow tendinopathy. We hypothesized that 12 weeks of HSR in combination with a CSI or TN would have superior effects compared with PN at 12, 26, and 52 (primary endpoint) weeks' follow-up on primary (Disabilities of the Arm, Shoulder and Hand [DASH] score) and secondary outcomes in patients with chronic unilateral lateral elbow tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 60 patients with chronic unilateral lateral elbow tendinopathy were randomized to perform 12 weeks of home-based HSR with elastic band exercises combined with either (1) a CSI, (2) TN, or (3) PN, and at 12, 26, and 52 weeks, we assessed the primary outcome, the DASH score, and secondary outcomes: shortened version of the DASH (QuickDASH) score, pain (numerical rating scale [NRS] score), pain-free grip strength, and hypervascularization (power Doppler area). RESULTS: A CSI, TN, and PN improved patient outcomes equally based on the DASH (Δ20 points), QuickDASH (Δ21 points), and NRS (Δ2.5 points) scores after 12 weeks. Further, after 12 weeks, a CSI also resulted in decreased hypervascularization (power Doppler area) compared with PN (Δ-2251 pixels, P = .0418). Except for the QuickDASH score (CSI increased score by Δ15 points compared with PN; P = .0427), there were no differences between the groups after 52 weeks. CONCLUSION: These results suggest that 12 weeks of HSR improved symptoms in both the short and the long term and that a CSI or TN did not amplify this effect. In addition, a CSI seemed to impair patient-reported outcomes compared with HSR alone at long-term follow-up. REGISTRATION: NCT02521298 (ClinicalTrials.gov identifier).

Influence of Antimicrobial Resistance on the Course of Symptoms in Female Patients Treated for Uncomplicated Cystitis Caused by Escherichia coli.

BACKGROUND: Resistance to the prescribed antibiotic causes a longer duration of symptoms in patients with urinary tract infection. Yet, a study found that patients infected with trimethoprim-resistant Escherichia coli (E. coli) had a prolonged duration of symptoms even if treated with an antibiotic to which the strain was susceptible. The purpose of this study was to attempt to reproduce this finding in a different cohort. METHODS: We analyzed data from two studies from general practice in the Capital Region of Denmark including patients from 2014 to 2016. The primary outcome was the severity of frequency and dysuria. The secondary outcome was the number of days until symptoms had disappeared. RESULTS: We included 180 women treated for uncomplicated cystitis caused by E. coli. We found that 16.11% (n = 29) of the E. coli strains were resistant to all of the three selected antibiotics (ampicillin, sulfamethizole and trimethoprim). There was no significant difference in severity or time until the symptoms had disappeared between women infected with resistant or susceptible E. coli. CONCLUSIONS: Strains of E. coli resistant to ampicillin, sulfamethizole and trimethoprim causing uncomplicated cystitis do not result in more severe symptoms or a longer symptom duration if treated with an antibiotic to which they are susceptible.

Short and long-term psychosocial consequences of participating in a colorectal cancer screening programme: a matched longitudinal study.

OBJECTIVES: To investigate the psychosocial consequences of receiving a false-positive (no abnormalities) result or being diagnosed with polyps compared with receiving a negative result in a colorectal cancer (CRC) screening programme. DESIGN AND SETTING: This was a longitudinal study nested in the roll-out of the Danish CRC screening programme that targets all individuals aged 50-74 years. PARTICIPANTS: In the inclusion period (April-September 2017), all positive screenees (n=1854) were consecutively enrolled and matched 2:1:1 on sex, age (±2 years), municipality and screening date with negative screenees (n=933) and individuals not yet invited to screening (n=933).Questionnaires were sent by mail to all eligible participants in Region Zealand, Denmark, after the screening result, 2 months and 12 months after the final result.Positive screenees who did not receive the follow-up procedure were excluded. MAIN OUTCOME MEASURES: The primary outcomes were psychosocial consequences. Outcomes were measured with the CRC screening-specific questionnaire Consequences of screening in CRC with 11 outcomes after the screening result and with 21 outcomes at the two later assessments. RESULTS: After receiving the screening result, individuals with no abnormalities, low-risk and medium-risk and high-risk polyps scored significantly worse on 8 of 11 outcomes compared with the negative screenee group. At the 12-month follow-up, the differences were still significant in 8 of 21 outcomes (no abnormalities), 4 of 21 outcomes (low-risk polyps) and 10 of 21 outcomes (medium-risk and high-risk polyps). The negative screenee group and the group not yet invited to screening differed psychosocially on 5 of 11 outcomes after the screening result, but on none of the 21 outcomes at the 2 months and 12 months follow-up. CONCLUSIONS: The study showed that there are both short-term and long-term psychosocial consequences associated with receiving a no abnormalities result or being diagnosed with polyps. The consequences were worst for individuals diagnosed with medium-risk and high-risk polyps.

Psychosocial consequences of screening-detected abdominal aortic aneurisms: a cross-sectional study.

OBJECTIVE: In Sweden, an abdominal aortic aneurysm (AAA) screening programme was gradually implemented from 2009 to reduce the incidence of rupture and thereby mortality. AAA screening introduces a variety of unintended, but generally unavoidable, harms, e.g. stress and worry. Such psychosocial consequences have previously only been investigated with generic measures. Therefore, the aim of this study was to describe and compare the psychosocial consequences in men with a screening detected AAA to men with a normal screening result after they participated in the Swedish national AAA-screening programme using a validated psychometric instrument. MATERIAL AND METHODS: This study was a cross-sectional survey. Data were originally collected to validate the COS-AAA and has previously been published in details. The Consequences of Screening in Abdominal Aortic Aneurysm (COS-AAA) questionnaire was sent to 250 men with a screening detected AAA and 500 with a normal screening result who were randomly selected from a Swedish population-based screening register. RESULTS: In total, 158 (63%) men with a screening detected AAA and 275 (55%) men with a normal screening result completed the COS-AAA. We found that men with a screening detected AAA reported negative psychosocial consequences to a greater extent in 10 of 13 COS-AAA Part 1 scales, all statistically significant except three (behaviour, sleep and negative experiences from examination). For COS-AAA Part 2, there was a statistically significant difference between groups in four of five scales. CONCLUSIONS: Men diagnosed with a screening detected AAA, reported more negative psychosocial consequences compared to men with a normal result. Screening for abdominal aorta aneurism (AAA) introduces intended benefits and unintended harms. Adequate measures are necessary to determine the balance between them.Key points:This study applied a condition-specific questionnaire with high content validity and adequate psychometric properties to measure psychosocial consequences in men participating in AAA screening.We found that men with a screening detected AAA reported more negative psychosocial consequences than men with a normal aorta size.The risk of negative psychosocial consequences is important to include in the decision making on whether to participate in screening or not.

Trend in antibiotic prescription to children aged 0-6 years old in the capital region of Denmark between 2009 and 2018: Differences between municipalities and association with socioeconomic composition.

BACKGROUND: To curb future antibiotic resistance it is important to monitor and investigate current prescription patterns of antibiotics. OBJECTIVES: To examine trends in antibiotic prescription to children aged 0-6 years old and the association with socioeconomic status of municipalities in the Capital region of Denmark between 2009 and 2018. METHODS: This is a register-based study combining data on antibiotic treatments from 2009 to 2018, inhabitant-data and socioeconomic municipality scores. Subjects were children aged 0-6 years, residing in the Capital Region of Denmark. The study quantifies the use of antibiotics as number of antibiotic treatments/1000 inhabitants/year (TIY), inhabitants defined as children aged 0-6. Socioeconomic status of the municipalities is evaluated by a score from 3 to 12. RESULTS: The average TIY of the municipalities decreased from 741.2 [95%CI 689.3-793.2] in 2009 to 348.9 [329.4-368.4] in 2018. The difference between the highest and lowest prescribing municipalities was reduced from 648.3 TIY in 2009-212.5 TIY in 2018. The average increase in TIY per unit increase in socioeconomic municipality score changed from 20.05 [7.69-31.06] in 2009 to -4.58 [-16.02-5.60] in 2018, representing a decreasing association between socioeconomic municipality score and use of antibiotic in the respective municipalities. CONCLUSION: The trend in antibiotic prescription to children aged 0-6 years old decreased substantially in all the investigated municipalities in the 10-year study period. Local differences in prescription rates declined towards a more uniform prescription pattern across municipalities and association with socioeconomic status of the municipalities was reduced.

Criteria-based dispatch of emergency medical services in non-traumatic subarachnoid haemorrhage.

INTRODUCTION: Timely admission to a facility capable of providing highly specialised treatment is key in patients with spontaneous subarachnoid haemorrhage. We aimed to determine the time elapsed from the initial emergency telephone call to arrival at a neurosurgical department. Also, we aimed to determine the ambulance dispatch criteria used and the activated prehospital responses. METHODS: This was a retrospective study. Patients admitted in the Capital Region of Denmark within a 3.5-year period were identified in the Danish National Patient Register. Data were extracted from medical records and from automated telephone logs at the Emergency Medical Dispatch Centre. RESULTS: Time intervals were available in 124 out of 262 patients and ambulance dispatch criteria in 98 patients. The median time from call to neurosurgical admission was 207.5 minutes. The dispatch criterion sudden severe headache had a sensitivity of 17.4%. An ambulance with lights and sirens was dispatched to 77% of patients and 28% were brought directly to a hospital with neurosurgical facilities. CONCLUSIONS: The median time from emergency call to neurosurgical admission was 3.5 hours. No single dispatch criterion detected the condition with an acceptable sensitivity. A high proportion of patients received an ambulance with lights and sirens, but more than two out of three were not initially brought to a hospital with neurosurgical facilities. FUNDING: the non-profit organisation Trygfonden Trial registration: NCT03786068 - www.clinicaltrials.gov.

Effectiveness of a tailored intervention to reduce antibiotics for urinary tract infections in nursing home residents: a cluster, randomised controlled trial.

BACKGROUND: When suspecting a urinary tract infection (UTI), the nursing home staff contacts a physician with clinical information on behalf of the resident; hence, poor understanding of UTI or a lack of clinical communicative skills can cause overtreatment with antibiotics. We investigated whether a tailored intervention that improves knowledge about UTI and communication skills in nursing home staff influences antibiotic prescriptions for UTI. METHODS: This open-label, parallel-group, cluster randomised controlled trial was done at 22 participating nursing homes in Denmark. Patients were eligible if they were nursing home residents aged 65 years or older, had the nursing home listed as their permanent address, and resided in a living space designated for those with dementia or somatic health-care needs. We included nursing homes that were not participating in other UTI projects and those in which staff were present at all hours. Using computer-generated random numbers and stratification by municipality, a statistician randomised the nursing homes (1:1) to receive either interactive educational sessions and use of a dialogue tool or to continue standard practice. The statistical analysis was blinded. Staff attended 75 min sessions over 8 weeks to learn how to distinguish between UTIs and asymptomatic bacteriuria, evaluate non-specific symptoms, and use the dialogue tool. The primary outcome was the number of antibiotic prescriptions for acute UTI per resident per days at risk, defined as the number of days the resident had been present at the nursing home during the trial period. The trial is registered at ClinicalTrials.gov, NCT03715062. FINDINGS: Between June 1, 2017, and June 1, 2018, 22 of 68 invited nursing homes were recruited. Of 22 randomised nursing homes (n=1625 residents), 11 received the intervention (770 [92·2%] of 835 allocated residents) and 11 were in the control group (705 [89·2%] of 790 allocated residents). The standardised number of nursing home staff was 572 in the intervention group and 535 in the control group. All nursing homes completed the trial. 65 residents were excluded from data collection in the intervention group and 85 were excluded in the control group. 1470 residents (intervention n=765; control n=705) were analysed for the primary endpoint. The number of antibiotic prescriptions for UTI per resident was 134 per 84 035 days at risk in the intervention group and 228 per 77817 days at risk in the control group. The rate ratio (RR) of receiving an antibiotic for UTI was 0·51 (95% CI 0·37-0·71) in the unadjusted model and 0·42 (0·31-0·57) in the adjusted model. Of 140 diary entries of suspected UTIs, no deaths were reported. 421 (28·5%) of 1475 residents were admitted to hospital. The risk of all-cause hospitalisation increased in the intervention group (adjusted model RR 1·28, 95% CI 0·95-1·74), whereas all-cause mortality was lower in the intervention group (0·91, 0·62-1·33). INTERPRETATION: The intervention effectively reduced antibiotic prescriptions and inappropriate treatments for UTI without substantially influencing all-cause hospitalisations and mortality. FUNDING: Danish Ministry of Health and the Velux Foundation.

Chronic hyperglycemia, hypercholesterolemia, and metabolic syndrome are associated with risk of tendon injury.

Tendon injury is a considerable problem affecting both physically active and sedentary people. The aim of this study was to examine the relationship between markers for metabolic disorders (hyperglycemia, hypercholesterolemia, and metabolic syndrome) and the risk of developing tendon injuries requiring referral to a hospital. The Copenhagen City Heart Study is a prospective study of diabetic and non-diabetic individuals from the Danish general population with different physical activity levels. The cohort was followed for 3 years via national registers with respect to tendon injuries. Data from 5856 individuals (median age 62 years) were included. The overall incidence of tendon injury in both upper and lower extremities that required an out-patient or in-house visit to a hospital was ~5.7/1000 person years. Individuals with elevated HbA1c (glycated hemoglobin) even in the prediabetic range (HbA1c>5.7%) had a ~3 times higher risk of tendon injury in the lower extremities only, as compared to individuals with normal HbA1C levels. Hypercholesterolemia (total cholesterol>5 mmol/L) increased risk of tendon injury in the upper extremities by ~1.5 times, and individuals with metabolic syndrome had ~2.5 times higher risk of tendon injury in both upper and lower extremities. In conclusion, these data demonstrate for the first time in a large cohort with different physical activity levels that the indicators for metabolic syndrome are a powerful systemic determinant of tendon injury, and two of its components, hyperglycemia and hypercholesterolemia, each independently make tendons susceptible for damage and injury.

Breaking potentially bad news of cancer workup to well-informed patients by telephone versus in-person: A randomised controlled trial on psychosocial consequences.

BACKGROUND: The use of telephone in delivering cancer care increases, but not in cancer workup. Current protocols for breaking bad news assume a single in-person meeting. Cancer workup involves multiple opportunities for patient information. We investigated the psychosocial consequences in gradually informed patients of receiving lung cancer workup results by telephone versus in-person. METHODS: A randomised, controlled, open-label, assessor-blinded, single-centre trial including patients referred for invasive workup for suspected malignancy (clinical trials no. NCT04315207). Patients were informed on probable cancer at referral, after imaging, and on the day of invasive workup (Baseline visit). Primary endpoint: change (Δ) from baseline to follow-up (4 weeks after receiving workup results) in scores of a validated, sensitive, condition-specific questionnaire (COS-LC) assessing consequences on anxiety, behaviour, dejection and sleep. RESULTS: Of 492 eligible patients, we randomised 255 patients (mean age: 68 years; female: 38%; malignancy diagnosed: 68%) to the telephone (n = 129) or in-person (n = 126) group. Groups were comparable at baseline and follow-up, and no between-groups difference in ΔCOS-LC was observed in the intention-to-treat population, or in subgroups diagnosed with or without malignancy. CONCLUSION: Breaking final result of cancer workup by telephone is not associated with adverse psychosocial consequences compared to in-person conversation in well-informed patients.

Psychosocial consequences of invitation to colorectal cancer screening: a matched cohort study.

BACKGROUND: Psychosocial consequences of colorectal cancer (CRC) screening can arise anywhere in the screening cascade. Previous studies have investigated the consequences of participating in CRC screening; however, we have not identified any studies investigating the psychosocial consequences of receiving the invitation. Therefore, the objective of this study was to investigate psychosocial consequences of invitation to CRC screening. METHODS: The study was a longitudinal study performed in Region Zealand, Denmark. Participants included in this study were a random sample of 1000 CRC screening invitees and 1000 control persons, not invited to screening, matched in a 1:1 design on sex, age and municipality. We assessed psychosocial consequences before and after invitation in both study groups concurrently. The primary outcomes were psychosocial consequences measured with the condition-specific questionnaire Consequences of Screening in ColoRectal Cancer. RESULTS: Preinvitation response rates were 575 (57.5%) and 610 (61.0%) for the invitation group and control group, respectively. Postinvitation response rates were 442 (44.2%) for the invitation group and 561 (56.1%) for the control group.No differences in mean change in scale score were seen except for the scale 'Change in body perception'. The invitation group had a 0.39 lower change (99% CI (-0.78 to -0.004), p=0.009) in mean score than the control group in the direction of a less negative body perception after invitation. CONCLUSIONS: This study did not identify an association between invitation to CRC screening and negative psychosocial consequences.

Consequences of screening in colorectal cancer (COS-CRC): development and dimensionality of a questionnaire.

BACKGROUND: Harms of colorectal cancer (CRC) screening include psychosocial consequences. We have not identified studies using a participant-relevant questionnaire with adequate measurement properties to investigate these harms. However, Brodersen et al. have previously developed a core questionnaire consequences of screening (COS) for use in screening for life-threatening diseases. Therefore, the objectives were: (1) To investigate content validity of COS in a CRC screening setting and in case of gaps in content coverage (2) generate new items and themes and (3) test the possibly extended version of COS for dimensionality and differential item functioning (DIF) using Rasch Models. METHODS: We performed two-part-focus-groups with CRC screenees. Screenees were recruited by strategic sampling. In the first part 16 screenees with false-positive results (n = 7) and low-risk polyps (n = 9) were interviewed about their CRC screening experiences and in the second part COS was examined for content validity. When new information was developed in the focus groups, new items covering this topic were generated. Subsequently, new items were, together with COS, tested in the subsequent interviews. A random subsample (n = 410) from a longitudinal questionnaire study, not yet published, was used to form the data for this paper. We analysed multidimensionality and uniform DIF with Andersen's conditional likelihood ratio test. We assessed individual item fit to the model. We also analysed Local Dependence (LD) and DIF by partial gamma coefficients using Rasch Models. RESULTS: COS was found relevant in a CRC screening setting. However, new information was discovered in the focus groups, covered by 18 new CRC screening-specific items. The Rasch analyses only revealed minor problems in the COS-scales. The 18 new items were distributed on four new CRC screening-specific dimensions and one single item. CONCLUSION: An extended version of COS specifically for use in a CRC screening setting has been developed. The extended part encompasses four new scales and one new single item. The original COS with the CRC-screening specific extension is called consequences of screening in colorectal cancer (COS-CRC). COS-CRC possessed reliability, unidimensionality and invariant measurement.

Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms.

BACKGROUND: Little is known about factors associated with a clinically relevant reduction in menopausal symptoms through a brief acupuncture approach for women with moderate-to-severe menopausal symptoms. METHODS: Post hoc analysis of a randomized controlled trial where participants were allocated to early versus late standardized acupuncture. Both the early group and the late group are included in this study. The late group got an identical intervention parallel staged by 6 weeks. By means of the relative importance, the effect was evaluated for both early versus late women with a 6-week follow-up. We included four symptom subscales from the validated MenoScores Questionnaire: hot flushes, day and night sweats, general sweating, menopausal-specific sleeping problems, as well as an overall score, which is the sum of the four outcomes in the analysis. RESULTS: 67 women with moderate to severe menopausal symptoms were included of whom 52 (77.6%) experienced a clinically relevant reduction in any of the four surveyed symptom subscales or overall score. 48 (71.6%) women experienced a clinically relevant reduction in any of the vasomotor symptom subscales: hot flushes, day and night sweats, general sweating. Women with vocational education were most likely to experience improvement compared to women with higher education. Beyond education, other factors of some importance for a clinically relevant reduction were no alcohol consumption, two or more births and urinary incontinence. CONCLUSIONS: Level of education was the most consistent factor associated with improvement. Beyond education, other factors of some importance were no alcohol consumption, two or more births and urinary incontinence. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov at April 21, 2016. The registration number is NCT02746497 .

What factors are most important for the development of the maternal-fetal relationship? A prospective study among pregnant women in Danish general practice.

BACKGROUND: Development of the maternal antenatal attachment (MAA) constitutes an important aspect of the transition into motherhood. Early identification of women at risk of developing a poor MAA provides possibilities for preventive interventions targeting maternal mental health and the emerging mother-infant relationship. In this study, we investigate the relative importance of an extensive set of psychosocial, pregnancy-related, and physiological factors measured in the first trimester of pregnancy for MAA measured in third trimester. METHODS: A prospective study was conducted among pregnant women in Danish general practice (GP). Data were obtained in the first and the third trimester from pregnancy health records and electronic questionnaires associated with routine GP antenatal care visits. The Maternal Antenatal Attachment Scale (MAAS) was used to assess maternal antenatal attachment. The relative importance of potential determinants of maternal antenatal attachment was assessed by the relative contribution of each factor to the fit (R2) calculated from multivariable regression models. RESULTS: The sample consisted of 1328 women. Low antenatal attachment (Total MAAS ≤ 75) was observed for 513 (38.6%) women. Perceived social support (having someone to talk to and having access to practical help when needed) emerged as the most important determinant. Furthermore, scores on the MAAS decreased with worse self-rated health, poor physical fitness, depression, increasing age, having given birth previously, and higher education. CONCLUSION: Pregnant women reporting lack of social support and general low physical and mental well-being early in pregnancy may be at risk for developing a poor MAA. An approach targeting both psychosocial and physiological well-being may positively influence expectant mothers' successful adaptation to motherhood.

Life expectancy estimates for patients diagnosed with prostate cancer in the Veterans Health Administration.

PURPOSE: Accurate life expectancy estimates are required to inform prostate cancer treatment decisions. However, few models are specific to the population served or easily implemented in a clinical setting. We sought to create life expectancy estimates specific to Veterans diagnosed with prostate cancer. MATERIALS AND METHODS: Using national Veterans Health Administration electronic health records, we identified Veterans diagnosed with prostate cancer between 2000 and 2015. We abstracted demographics, comorbidities, oncologic staging, and treatment information. We fit Cox Proportional Hazards models to determine the impact of age, comorbidity, cancer risk, and race on survival. We stratified life expectancy estimates by age, comorbidity and cancer stage. RESULTS: Our analytic cohort included 145,678 patients. Survival modeling demonstrated the importance of age and comorbidity across all cancer risk categories. Life expectancy estimates generated from age and comorbidity data were predictive of overall survival (C-index 0.676, 95% CI 0.674-0.679) and visualized using Kaplan-Meier plots and heatmaps stratified by age and comorbidity. Separate life expectancy estimates were generated for patients with localized or advanced disease. These life expectancy estimates calibrate well across prostate cancer risk categories. CONCLUSIONS: Life expectancy estimates are essential to providing patient-centered prostate cancer care. We developed accessible life expectancy estimation tools for Veterans diagnosed with prostate cancer that can be used in routine clinical practice to inform medical-decision making.

Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial.

BACKGROUND: Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). METHOD: This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. RESULTS: Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. CONCLUSION: This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.