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.

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).

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.

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.

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 .

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.

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.