Effectiveness of the Walking in ScHools (WISH) Study, a peer-led walking intervention for adolescent girls: results of a cluster randomised controlled trial.

BACKGROUND: Most adolescent girls fail to meet current physical activity guidelines. Physical activity behaviours track from childhood into adulthood and providing adolescent girls with opportunities to be physically active may have health benefits beyond childhood. The effects of walking interventions on adult cardiometabolic health are known, however less is understood about the potential of walking to promote physical activity in adolescents. Following the Walking In ScHools (WISH) feasibility study, this definitive trial aimed to evaluate the effectiveness of a novel, low-cost, school-based walking intervention at increasing physical activity levels of adolescent girls (aged 12-14 years). METHODS: Female pupils were recruited from eighteen schools across the border region of Ireland and in Northern Ireland. In intervention schools (n = 9), girls aged 15-18 years, were trained as walk leaders, and led the younger pupils in 10-15 min walks before school, at break and lunch recess. All walks took place in school grounds and pupils were encouraged to participate in as many walks as possible each week. The primary outcome measure was accelerometer determined total physical activity (counts per minutes, cpm). RESULTS: In total, 589 pupils were recruited to the study. At baseline, pupils engaged in a median (interquartile range (IQR)) 35.7 (21.2) mins moderate-vigorous physical activity (MVPA) per day and only 12% (n = 66) of participants met physical activity guidelines (60 min MVPA per day). The intervention was delivered for a mean (standard deviation (SD)) 19.9 ± 0.97 weeks. The mean post-intervention total physical activity for the intervention group was 676 cpm and 710 cpm in the control group. Post-intervention total physical activity did not statistically differ between groups when adjusted for age, body mass index z-scores and baseline physical activity (mean difference, -33.5, 95% CI = -21.2 to 88.1; p = 0.213). CONCLUSIONS: 'Scaling-up' physical activity interventions is challenging and despite a promising feasibility study, the results of this fully powered trial suggest that in this context, the WISH intervention did not increase device measured physical activity. Since the COVID-19 pandemic, school environments have changed and although pupils enjoyed the programme, attendance at walks was low, indicating that there is a need to better understand how to implement interventions within schools. TRIAL REGISTRATION: ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.

BACKGROUND: Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls. METHODS: In this cluster-randomised controlled trial, female pupils aged 12-14 years were recruited from 18 (mixed or single-sex) schools across the border region of Ireland and Northern Ireland. Schools were randomly assigned to either the control group (usual physical activity; n=9) or the intervention group (n=9) by independent faculty staff using an online randomisation tool (randomization.com). In intervention schools, female pupils aged 15-18 years were trained as walk leaders and led the younger pupils in 10-15 min walks before school, at break, and at lunchtime. Walks were in school grounds and pupils were encouraged to join as many walks as possible. The intervention was delivered for a full school year excluding holidays (for a total of 18-21 weeks). Accelerometers measured PA, and the primary outcome was total PA (counts per minute [cpm]). Ethics approval was granted by Ulster University Research Ethics Committee and written informed consent (parent or guardian) and assent (pupils) was obtained. This study is registered with the ISRCTN Registry, 12847782. FINDINGS: The study took place from Sept 1, 2021, to May 31, 2023. In total, 589 pupils were recruited (n=286 in intervention group; n=303 in control group). Median moderate-vigorous PA (MVPA) at baseline was 36·1 min/day (IQR 23·0) for the intervention group and 35·3 min/day (19·8) for the control group. Only 37 (15%) girls in the intervention group and 29 (10%) girls in the control group met PA guidelines (60 min/day of MVPA). The mean total PA after intervention was 676 cpm (SD 18·7) for the intervention group and 710 cpm (SD 17·7) for the control group. Post-intervention total PA did not differ between groups when adjusted for age, body-mass index, z-scores, and baseline PA (mean difference -33·5, 95% CI -21·2 to 88·1; p=0·213). INTERPRETATION: Scaling up PA interventions is challenging. Despite a promising feasibility study, the results of this fully powered trial indicate that in this context, the walking programme did not increase PA. Since the COVID-19 pandemic, school environments have changed, and although pupils enjoyed the programme, attendance at walks was low. There is a need to better understand the implementation of interventions such as this within schools. FUNDING: Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN).

'Including us, talking to us and creating a safe environment'-Youth patient and public involvement and the Walking In ScHools (WISH) Study: Lessons learned.

BACKGROUND: Young people have the right to be informed and consulted about decisions affecting their lives. Patient and public involvement (PPI) ensures that research is carried out 'with' or 'by' young people rather than 'to', 'about' or 'for' them. The aim of this paper is to outline how youth PPI can be embedded within a physical activity intervention, reflect on the impact of PPI and provide recommendations for future PPI in a similar context. METHODS: A Youth Advisory Group (YAG) was set up within the Walking In ScHools (WISH) Study to involve adolescent girls in the delivery, implementation and dissemination of a physical activity intervention targeted at adolescents. Schools invited pupils aged 12-14 years and 15-18 years to YAG meetings (n3, from 2019 to 2023). Participative methods were used to inform recruitment strategies and data collection methods for the WISH Study. RESULTS: Across the three YAG meetings, n51 pupils from n8 schools were involved. Pupils enjoyed the YAG meetings, felt that their feedback was valued and considered the meetings a good way to get young people involved in research. The YAG advised on specific issues and although measuring impact was not the primary aim of the YAG meetings, over the course of the study there were many examples of the impact of PPI. Recruitment targets for the WISH Study were exceeded, the attrition rate was low and pupils were engaged in data collection. CONCLUSION: Youth PPI is a developing field and there are few physical activity studies that report the PPI work undertaken. Within the WISH Study, three YAG meetings were held successfully, and the views of adolescent girls were central to the development of the study. Considering the specific issues that the YAG advised on (study recruitment, attrition and data collection), there was evidence of a positive impact of PPI. PATIENT OR PUBLIC CONTRIBUTION: Pupils from post-primary schools interested/participating in the WISH Study were invited to attend YAG meetings. YAG meetings were set up to consult adolescent girls on the delivery, implementation and dissemination of the WISH intervention.

Harms of exercise training in patients with cancer undergoing systemic treatment: a systematic review and meta-analysis of published and unpublished controlled trials.

Background: Exercise is recommended for people with cancer. The aim of this study was to evaluate the harms of exercise in patients with cancer undergoing systemic treatment. Methods: This systematic review and meta-analysis included published and unpublished controlled trials comparing exercise interventions versus controls in adults with cancer scheduled to undergo systemic treatment. The primary outcomes were adverse events, health-care utilization, and treatment tolerability and response. Eleven electronic databases and trial registries were systematically searched with no date or language restrictions. The latest searches were performed on April 26, 2022. The risk of bias was judged using RoB2 and ROBINS-I, and the certainty of evidence for primary outcomes was assessed using GRADE. Data were statistically synthesised using pre-specified random-effect meta-analyses. The protocol for this study was registered in the PROESPERO database (ID: CRD42021266882). Findings: 129 controlled trials including 12,044 participants were eligible. Primary meta-analyses revealed evidence of a higher risk of some harms, including serious adverse events (risk ratio [95% CI]: 1.87 [1.47-2.39], I2 = 0%, n = 1722, k = 10), thromboses (risk ratio [95% CI]: 1.67 [1.11-2.51], I2 = 0%, n = 934, k = 6), and fractures (risk ratio [95% CI]: 3.07 [3.03-3.11], I2 = 0%, n = 203, k = 2) in intervention versus control. In contrast, we found evidence of a lower risk of fever (risk ratio [95% CI]: 0.69 [0.55-0.87], I2 = 0% n = 1109, k = 7) and a higher relative dose intensity of systemic treatment (difference in means [95% CI]: 1.50% [0.14-2.85], I2 = 0% n = 1110, k = 13) in intervention versus control. For all outcomes, we downgraded the certainty of evidence due to imprecision, risk of bias, and indirectness, resulting in very low certainty of evidence. Interpretation: The harms of exercise in patients with cancer undergoing systemic treatment are uncertain, and there is currently insufficient data on harms to make evidence-based risk-benefits assessments of the application of structured exercise in this population. Funding: There was no funding for this study.

Parathyroidectomy for adults with primary hyperparathyroidism.

BACKGROUND: Primary hyperparathyroidism (PHPT), a disorder in which the parathyroid glands produce excessive amounts of parathyroid hormone, is most common in older adults and postmenopausal women. While most people with PHPT are asymptomatic at diagnosis, symptomatic disease can lead to hypercalcaemia, osteoporosis, renal stones, cardiovascular abnormalities and reduced quality of life. Surgical removal of abnormal parathyroid tissue (parathyroidectomy) is the only established treatment for adults with symptomatic PHPT to prevent exacerbation of symptoms and to be cured of PHPT. However, the benefits and risks of parathyroidectomy compared to simple observation or medical therapy for asymptomatic and mild PHPT are not well established. OBJECTIVES: To evaluate the benefits and harms of parathyroidectomy in adults with PHPT compared to simple observation or medical therapy. SEARCH METHODS: We searched CENTRAL, MEDLINE, LILACS, ClinicalTrials.gov and WHO ICTRP from their date of inception until 26 November 2021. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing parathyroidectomy with simple observation or medical therapy for the treatment of adults with PHPT. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. cure of PHPT, 2. morbidity related to PHPT and 3. serious adverse events. Our secondary outcomes were 1. all-cause mortality, 2. health-related quality of life and 3. hospitalisation for hypercalcaemia, acute renal impairment or pancreatitis. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We identified eight eligible RCTs that included 447 adults with (mostly asymptomatic) PHPT; 223 participants were randomised to parathyroidectomy. Follow-up duration varied from six months to 24 months. Of the 223 participants (37 men) randomised to surgery, 164 were included in the analyses, of whom 163 were cured at six to 24 months (overall cure rate 99%). Parathyroidectomy compared to observation probably results in a large increase in cure rate at six to 24 months follow-up: 163/164 participants (99.4%) in the parathyroidectomy group and 0/169 participants in the observation or medical therapy group were cured of their PHPT (8 studies, 333 participants; moderate certainty).  No studies explicitly reported intervention effects on morbidities related to PHPT, such as osteoporosis, osteopenia, kidney dysfunction, urolithiasis, cognitive dysfunction or cardiovascular disease, although some studies reported surrogate outcomes for osteoporosis and cardiovascular disease. A post-hoc analysis revealed that parathyroidectomy, compared to observation or medical therapy, may have little or no effect after one to two years on bone mineral density (BMD) at the lumbar spine (mean difference (MD) 0.03 g/cm2,95% CI -0.05 to 0.12; 5 studies, 287 participants; very low certainty). Similarly, compared to observation, parathyroidectomy may have little or no effect on femoral neck BMD after one to two years (MD -0.01 g/cm2, 95% CI -0.13 to 0.11; 3 studies, 216 participants; very low certainty). However, the evidence is very uncertain for both BMD outcomes. Furthermore, the evidence is very uncertain about the effect of parathyroidectomy on improving left ventricular ejection fraction (MD -2.38%, 95% CI -4.77 to 0.01; 3 studies, 121 participants; very low certainty). Four studies reported serious adverse events. Three of these reported zero events in both the intervention and control groups; consequently, we were unable to include data from these three studies in the pooled analysis. The evidence suggests that parathyroidectomy compared to observation may have little or no effect on serious adverse events (RR 3.35, 95% CI 0.14 to 78.60; 4 studies, 168 participants; low certainty).  Only two studies reported all-cause mortality. One study could not be included in the pooled analysis as zero events were observed in both the intervention and control groups. Parathyroidectomy compared to observation may have little or no effect on all-cause mortality, but the evidence is very uncertain (RR 2.11, 95% CI 0.20 to 22.60; 2 studies, 133 participants; very low certainty). Three studies measured health-related quality of life using the 36-Item Short Form Health Survey (SF-36) and reported inconsistent differences in scores for different domains of the questionnaire between parathyroidectomy and observation. Six studies reported hospitalisations for the correction of hypercalcaemia. Two studies reported zero events in both the intervention and control groups and could not be included in the pooled analysis. Parathyroidectomy, compared to observation, may have little or no effect on hospitalisation for hypercalcaemia (RR 0.91, 95% CI 0.20 to 4.25; 6 studies, 287 participants; low certainty). There were no reported hospitalisations for renal impairment or pancreatitis. AUTHORS' CONCLUSIONS: In accordance with the literature, our review findings suggest that parathyroidectomy, compared to simple observation or medical (etidronate) therapy, probably results in a large increase in cure rates of PHPT (with normalisation of serum calcium and parathyroid hormone levels to laboratory reference values). Parathyroidectomy, compared with observation, may have little or no effect on serious adverse events or hospitalisation for hypercalcaemia, and the evidence is very uncertain about the effect of parathyroidectomy on other short-term outcomes, such as BMD, all-cause mortality and quality of life. The high uncertainty of evidence limits the applicability of our findings to clinical practice; indeed, this systematic review provides no new insights with regard to treatment decisions for people with (asymptomatic) PHPT. In addition, the methodological limitations of the included studies, and the characteristics of the study populations (mainly comprising white women with asymptomatic PHPT), warrant caution when extrapolating the results to other populations with PHPT. Large-scale multi-national, multi-ethnic and long-term RCTs are needed to explore the potential short- and long-term benefits of parathyroidectomy compared to non-surgical treatment options with regard to osteoporosis or osteopenia, urolithiasis, hospitalisation for acute kidney injury, cardiovascular disease and quality of life.

Diagnostic Test Accuracy of Urine C-peptide Creatinine Ratio for the Correct Identification of the Type of Diabetes: A Systematic Review.

Objective: To examine the accuracy of urine c-peptide creatinine ratio (UCPCR) for identifying the type of diabetes in appropriate clinical settings. Design: Systematic review of test accuracy studies on patients with different forms of diabetes. Data sources: Medline, Embase and Cochrane library databases from 1 January 2000 to 15 November 2020. Eligibility criteria: Studies reporting the use of UCPCR for diagnosing patients with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) and monogenic forms of diabetes (categorized as maturity-onset diabetes of the young [MODY]). Study selection and data synthesis: Two reviewers independently assessed articles for inclusion and assessed the methodological quality of the studies using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, with input from a third reviewer to reach consensus when there was a dispute. Meta-analysis was performed with the studies reporting complete data to derive the pooled sensitivity, specificity and diagnostic odds ratio (DOR), and narrative synthesis only for those with incomplete data. Results: Nine studies with 4,488 patients were included in the qualitative synthesis, while only four of these (915 patients) had complete data and were included in the quantitative synthesis. All the studies had moderate risk of bias and applicability concerns. Meta-analysis of three studies (n=130) revealed sensitivity, specificity and DOR of 84.4% (95% confidence interval [CI] 68.1-93.2%), 91.6% (82.8-96.1%) and 59.9 (32.8-106.0), respectively, for diagnosing T1DM using a UCPCR cut-off of <0.2 nmol/mmol. For participants with T2DM (three studies; n=739), UCPCR >0.2 nmol/mmol was associated with sensitivity, specificity and DOR of 92.8% (84.2-96.9%), 81.6% (61.3-92.5%) and 56.9 (31.3-103.5), respectively. For patients with MODY in the appropriate clinical setting, a UCPCR cut-off of >0.2 nmol/mmol showed sensitivity, specificity and DOR of 85.2% (73.1-92.4%), 98.0% (92.4-99.5%) and 281.8 (57.5-1,379.7), respectively. Conclusions: Based on studies with moderate risk of bias and applicability concerns, UCPCR confers moderate to high sensitivity, specificity, and DOR for correctly identifying T1DM, T2DM and monogenic diabetes in appropriate clinical settings. Large multinational studies with multi-ethnic participation among different age groups are necessary before this test can be routinely used in clinical practice. Study registration: Protocol was registered as PROSPERO CRD42017060633.

Changes in Physical Activity, Sleep, Mental Health, and Social Media Use During COVID-19 Lockdown Among Adolescent Girls: A Mixed-Methods Study.

BACKGROUND: To suppress the transmission of coronavirus, many governments, including that of the island of Ireland, implemented a societal lockdown, which included school closures, limits on social gatherings, and time outdoors. This study aimed to evaluate changes in physical activity (PA), mental health, sleep, and social media use among adolescent girls during lockdown. METHODS: 281 female pupils (12-14 y) taking part in the ongoing Walking In Schools study on the island of Ireland self-reported PA, mental health, sleep, and social media use before (September-October 2019) and during lockdown (May-June 2020), via questionnaires. These were supplemented with open-ended structured interviews conducted with 16 girls during lockdown. RESULTS: During the period of lockdown and school closures, pupils tried new forms of PA and undertook PA with family, but there was no significant change in self-reported PA. There was a decline in health-related quality of life and motivation for exercise; however, self-efficacy for walking and happiness with appearance increased. There was no change in sleep quality or social media usage. CONCLUSIONS: Despite the many challenges that schools face as they reopen, there is a need to continue to prioritize PA and motivation for exercise to support health and well-being in adolescent girls.

Non-functioning pituitary macroadenomas: factors affecting postoperative recurrence, and pre- and post-surgical endocrine and visual function.

BACKGROUND: Non-functioning pituitary macroadenomas (NFPAs) with visual field defects are ideally managed by transsphenoidal tumour resection to improve vision, and long-term postsurgical follow up is necessary to monitor for tumour recurrence. Regular updates from global data are necessary for developing optimal management strategies of these tumours. METHODS: Pre- and postoperative visual and endocrine profile, imaging characteristics and details of surgical interventions among patients with NFPAs managed between 2008 and 2019 in a UK regional centre were assessed. The radiological and surgical outcomes including postoperative complications, recurrence risk and the factors influencing outcomes also were assessed. RESULTS: 105 cases with mean (SD) age 60.1 (14.3) years and follow-up duration 60 (37) months were studied. 67 (64%) patients were male. Five-year recurrence-free survival rate was 71.5% (95% confidence interval [CI] 62.7% to 81.6%) with 33 (31%) tumour recurrences of whom 20 (60%) received radiotherapy and 9 (27%) underwent further surgery. Younger age, tumour volume, and bilateral cavernous sinus extension were the predictors of recurrence on univariate analysis, while younger age was the only factor on multivariate analysis (Hazard ratio 0.95; 95% CI: 0.92, 0.97). 72/78 patients (92%) with preoperative visual field defects improved after surgery, of whom 27 (35%) had full recovery. 20 (24%) patients had recovery of an abnormal hormone axis. 15 patients (16%) developed perioperative complications such as cerebrospinal fluid leak (12 cases), meningitis (2 cases), and bleeding (2 cases). CONCLUSIONS: Five-year recurrence-free survival after transsphenoidal resection for NFPAs was 71.5% with older age at surgery conferring lower risk of recurrence. Visual recovery/ improvement occurred in 92% of cases with preoperative visual defects following surgery.

Seasonal variation in trauma admissions to a level III trauma unit over 10 years.

INTRODUCTION: Major trauma centres have improved morbidity and mortality for moderate and severely injured patients. Less injured patients may be treated in facilities less resourced for trauma care. In these units, understanding the variations in injury presentation and treatment over time allows service delivery to be tailored to demand. This study set out to describe seasonal variations in trauma over a 10-year period at a level III trauma unit. MATERIALS AND METHODS: Patient demographics, admission frequency, site of injury, season of admission, management, complications, onward transfers, and length of stay were extracted on consecutive patients admitted with traumatic injuries between January 2009 and December 2018 and recorded on a prospectively maintained database. Analysis was undertaken to determine if there were reproducible patterns in trauma presentation across seasons, based on the patient's age and gender, type of injury, management and length of stay. RESULTS: There were 13,007 'first admissions' over 10 years, with a mean (SD) age of 55.6 (27.7) years. Admissions were higher in summer (27%) and lower in winter (23.6%) and patients were on average younger in the summer (52.8 years) and older in winter (59.2 years). The proportion of female and male patients remained relatively constant across seasons (CV=6% and 8%, respectively). There was seasonal variation in the incidence of forearm (36%) elbow (19%), and multi-sites injuries (17%) compared with hip and wrist injuries (CV=5% for both). A lower proportion of patients underwent operations in summer (72%) compared with other seasons with winter having the highest at 77%. More patients aged less than 60 years stayed in hospital during winter than summer (13.2% vs. 11.6-12.4%) although often for a day. Patients aged 60 years stayed longer in spring and winter. CONCLUSION: The results of this study demonstrate trends in the admission and management of trauma patients to a level III trauma unit. Some of the patterns in admission, treatment and length of stay had not been identified previously. The results can be used to enhance patient care and minimise health care costs by reducing unwarranted variations and enabling service delivery to match the demand in all trauma units.

Rising to the challenge: designing, implementing and reporting exercise oncology trials in understudied populations.

Exercise can improve cancer-related fatigue, quality of life and physical fitness, but is understudied in less common cancers such as multiple myeloma. Studying less common cancers and the adoption of novel study designs and open-science practices would improve the generalisability, transparency, rigour, credibility and reproducibility of exercise oncology research.

A study protocol for a clustered randomised controlled trial to evaluate the effectiveness of a peer-led school-based walking intervention on adolescent girls' physical activity: the Walking In ScHools (WISH) study.

BACKGROUND: Adolescent girls in the UK and Ireland are failing to meet current physical activity guidelines. Physical activity behaviours track from childhood to adulthood and it is important that adolescent girls are provided with opportunities to be physically active. Walking has been a central focus for physical activity promotion in adults and may effectively increase physical activity levels among younger people. Following on from a pilot feasibility trial, the purpose of this cluster randomised controlled trial (c-RCT) is to evaluate the effectiveness of a novel, low-cost, peer-led school-based walking intervention delivered across the school year at increasing physical activity levels of adolescent girls. METHODS: The Walking In ScHools (WISH) Study is a school-based c-RCT conducted with girls aged 12-14 years from eighteen schools across the Border Region of Ireland / Northern Ireland. Following baseline data collection, schools will be randomly allocated to intervention or control group. In intervention schools, female pupils aged 15-18 years will be invited to train as walk leaders and will lead younger pupils in 10-15 min walks before school, at break and lunch recess. All walks will take place in school grounds and pupils will be encouraged to participate in as many walks as possible each week. The intervention will be delivered for the whole school year (minimum 20-22 weeks). The primary outcome measure is accelerometer-measured total physical activity (counts per minute) (end of intervention). Secondary outcomes will include time spent in sedentary behaviour, light, moderate and vigorous intensity physical activity, anthropometry measures, social media usage and sleep. A mixed-methods process evaluation will also be undertaken. DISCUSSION: The WISH Study will examine the effectiveness of a low-cost, school-based, peer-led walking intervention in increasing physical activity in adolescent girls when delivered across the school year. If the intervention increases physical activity, it would benefit adolescent girls in the defined target area with potential for wider adoption by schools across the UK and Ireland. TRIAL REGISTRATION: ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

Survival at 10 years following lower extremity amputations in patients with diabetic foot disease.

BACKGROUND: Amputations are associated with markedly reduced long-term survival in patients with diabetic foot disease. However, there is paucity of long-term survival data in published literature. METHODS: We searched the electronic case records and laboratory details of patients who underwent amputations between 1997 and 2006 to obtain at least 10 years of follow up data after the surgery to assess the survival rates and possible risk factors reducing survival in the year 2016. Amputation level below ankle was considered as minor and above ankle as major amputations. RESULTS: Of the 233 cases (159 males; median age 68 years), 161 had major amputations. Of the 72 cases who had minor amputations initially, 63 needed a further amputation or contralateral amputation on follow up. One hundred seventy-seven patients (76%) were not alive after 10 years of follow up. The survival rates at 1, 3, 5, 7, and ≥10 years were 64%, 50%, 40%, 34%, and 24%, respectively. Maximum number of deaths occurred within 4 months of amputations. There was no difference between survival rates following major or minor amputations and among males or females. The only statistically significant parameter affecting lower survival rate was age ≥70 years, with each additional year of age increasing the hazard by a factor of 1.039 (95% CI: 1.024-1.054) or 3.9% (2.4-5.4%). CONCLUSIONS: Five-year and 10-year survival rates were 40% and 24%, respectively, following diabetic foot amputations. Higher age ≥70 years was associated with lower survival rate compared with younger age groups after lower extremity amputations.

Moving Sport and Exercise Science Forward: A Call for the Adoption of More Transparent Research Practices.

The primary means of disseminating sport and exercise science research is currently through journal articles. However, not all studies, especially those with null findings, make it to formal publication. This publication bias towards positive findings may contribute to questionable research practices. Preregistration is a solution to prevent the publication of distorted evidence resulting from this system. This process asks authors to register their hypotheses and methods before data collection on a publicly available repository or by submitting a Registered Report. In the Registered Report format, authors submit a stage 1 manuscript to a participating journal that includes an introduction, methods, and any pilot data indicating the exploratory or confirmatory nature of the study. After a stage 1 peer review, the manuscript can then be offered in-principle acceptance, rejected, or sent back for revisions to improve the quality of the study. If accepted, the project is guaranteed publication, assuming the authors follow the data collection and analysis protocol. After data collection, authors re-submit a stage 2 manuscript that includes the results and discussion, and the study is evaluated on clarity and conformity with the planned analysis. In its final form, Registered Reports appear almost identical to a typical publication, but give readers confidence that the hypotheses and main analyses are less susceptible to bias from questionable research practices. From this perspective, we argue that inclusion of Registered Reports by researchers and journals will improve the transparency, replicability, and trust in sport and exercise science research. The preprint version of this work is available on SportR[Formula: see text]iv: https://osf.io/preprints/sportrxiv/fxe7a/.

Postdiagnosis sedentary behavior and health outcomes in cancer survivors: A systematic review and meta-analysis.

BACKGROUND: High levels of sedentary behavior may negatively affect health outcomes in cancer survivors. A systematic review and meta-analysis was performed to clarify whether postdiagnosis sedentary behavior is related to survival, patient-reported outcomes, and anthropometric outcomes in cancer survivors. METHODS: The Ovid MEDLINE, EMBASE, CINAHL (The Cumulative Index to Nursing and Allied Health Literature), and SPORTDiscus databases were searched from study inception to June 2019. Studies of adults who had been diagnosed with cancer that examined the association between sedentary behavior and mortality, patient-reported outcomes (eg, fatigue, depression), or anthropometric outcomes (eg, body mass index, waist circumference) were eligible for inclusion. Meta-analyses were performed to estimate hazard ratios for the highest compared with the lowest levels of sedentary behavior for all-cause and colorectal cancer-specific mortality outcomes. The ROBINS-E (Risk of Bias in Nonrandomized Studies-of Exposures tool) and the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system were used to assess the risk of bias and the strength of evidence, respectively. RESULTS: Thirty-three eligible publications from a total of 3569 identified articles were included in the review. A higher level of postdiagnosis sedentary behavior was associated with an increased risk of all-cause mortality (hazard ratio, 1.22; 95% CI, 1.06-1.41; heterogeneity [I2 statistic], 33.8%) as well as colorectal cancer-specific mortality (hazard ratio, 1.53; 95% CI, 1.14-2.06; I2 , 0%). No clear or consistent associations between sedentary behavior and patient-reported or anthropometric outcomes were identified. The risk of bias in individual studies ranged from moderate to serious, and the strength of evidence ranged from very low to low. CONCLUSIONS: Although avoiding high levels of sedentary behavior after a cancer diagnosis may improve survival, further research is required to help clarify whether the association is causal.

Exercise, or exercise and diet for the management of polycystic ovary syndrome: a systematic review and meta-analysis.

BACKGROUND: Typically, management of PCOS focuses on lifestyle changes (exercise and diet), aiming to alleviate symptoms, and lower the associated risk of type 2 diabetes and cardiovascular disease. Our objective was to analyse evidence on the effectiveness of exercise in the management of PCOS, when compared to (i) usual care, (ii) diet alone, and (iii) exercise combined with diet, and also exercise combined with diet, compared to (i) control or usual care and (ii) diet alone. METHODS: Relevant databases were searched (June 2017) with no time limit for trial inclusion. Eligible trials employed a randomised or quasi-randomised design to measure the chronic effects of exercise, or exercise and diet in women with PCOS. RESULTS: Searches returned 2390 articles; of those, 27 papers from 18 trials were included. Results are presented as mean difference (MD) and 95% confidence intervals (95% CI). Compared with control, exercise had a statistical effect on change from baseline fasting insulin (MD - 2.44 µIU/mL, 95% CIs - 4.24 to - 0.64; very low-quality evidence), HOMA-IR (- 0.57, - 0.99 to - 0.14; very low-quality evidence), total cholesterol (- 5.88 mg/dL, - 9.92 to - 1.83; low-quality evidence), LDL cholesterol (- 7.39 mg/dL, - 9.83 to - 4.95; low-quality evidence), and triglycerides (- 4.78 mg/dL, - 7.52 to - 2.05; low-quality evidence). Exercise also improved VO2 max (3.84 ml/kg/min, 2.87 to 4.81), waist circumference (- 2.62 cm, - 4.13 to - 1.11), and body fat percentage (- 1.39%, - 2.61 to - 0.18) when compared with usual care. No effect was found for change value systolic/diastolic blood pressure, fasting glucose, HDL cholesterol (all low-quality evidence), or waist-to-hip ratio. Many favourable change score findings were supported by post-intervention value analyses: fasting insulin (- 2.11 µIU/mL, - 3.49 to - 0.73), total cholesterol (- 6.66 mg/dL, - 11.14 to - 2.17), LDL cholesterol (- 6.91 mg/dL, - 12.02 to - 1.80), and VO2 max (5.01 ml/kg/min, 3.48 to 6.54). Statistically lower BMI (- 1.02 kg/m2, - 1.81 to - 0.23) and resting heart rate (- 3.26 beats/min - 4.93 to - 1.59) were also revealed in post-intervention analysis. Subgroup analyses revealed the greatest improvements in overweight/obese participants, and more outcomes improved when interventions were supervised, aerobic in nature, or of a shorter duration. Based on limited data, we found no differences for any outcome between the effects of exercise and diet combined, and diet alone. It was not possible to compare exercise vs diet or exercise and diet combined vs diet. CONCLUSION: Statistically beneficial effects of exercise were found for a range of metabolic, anthropometric, and cardiorespiratory fitness-related outcomes. However, caution should be adopted when interpreting these findings since many outcomes present modest effects and wide CIs, and statistical effects in many analyses are sensitive to the addition/removal of individual trials. Future work should focus on rigorously designed, well-reported trials that make comparisons involving both exercise and diet. SYSTEMATIC REVIEW REGISTRATION: This systematic review was prospectively registered on the Prospero International Prospective Register of Systematic Reviews ( CRD42017062576 ).

Do I focus on the process of cycling or try to put my mind elsewhere? A comparison of concentration strategies for use in pacing by novice riders.

The ability to hold a pace is a key skill for endurance athletes. The present study compared the influence of different strategies on how athletes learn to pace at 80% of their maximum performance for a 3-min cycle time trial. Participants first completed three maximal 3-min tests to establish maximal performance. During subsequent visits we asked participants to ride at 80% of their average maximal 3-min power output for four 3-min efforts under different conditions. Participants were blinded to feedback for three of the four conditions with participants (a) riding on feel (all feedback blinded), (b) associating on the task by focusing attention on the skills needed for efficient cycling, and (c) dissociating from the task by intentionally focusing concentration elsewhere (d) and finally, participants rode with full feedback where pace could be regulated via observation. All participants completed the blind condition first, the full feedback condition last, with association focus and dissociation focus rides being alternated. As expected, results showed participants rode close to the 80% goal when observing full feedback. Participants rode at 82% of maximum in the blind "ride on feel" condition, 79% in the associative condition, and 70% in the dissociative condition. We suggest results show that simple strategies related to concentration can influence the accuracy of pacing efforts. The difference in the ability to pace while using an associative or dissociative attentional focus was consistent with theory. The differences we observed occurred with minimal input from participants in terms of actively learning psychological skills. Future research is needed to investigate how athletes learn to use pacing strategies to help performance.

Primary hyperparathyroidism: findings from the retrospective evaluation of cases over a 6-year period from a regional UK centre.

BACKGROUND: Although there are international guidelines on diagnosis and management of primary hyperparathyroidism (PHPT), clinical practice varies in different centres. Periodic review of diagnostic work-up, surgical treatment by parathyroidectomy (PTX) and clinical surveillance in nonsurgical treatment group among patients with PHPT is expected to improve the quality of care. We report a retrospective study of cases with PHPT managed at a regional centre in the United Kingdom. METHODS: Clinical data of cases with calcium ≥2.6 mmol/L and parathyroid hormone (PTH) ≥9.0 pmol/L was procured from biochemistry database from January 2011 to December 2016. Laboratory parameters, imaging studies for renal stones, osteoporosis and localisation of parathyroid adenomas, type of treatment received (PTX or nonsurgical), complications of treatment, other medical co-morbidities and mortality during follow-up was recorded in each case to examine the outcomes of care of patients with PHPT. RESULTS: The study included 160 patients: 127 (79%) females and 33 (21%) males. Median age was 70 years in females and 74 in males. Thirty cases (19% of 159) had renal stones and 47 (37.3% of 126) had osteoporosis. Eighty-one cases (51%) received PTX. Logistic regression analysis showed that higher calcium levels (odds ratio (OR) = 73.991; p < 0.001), peak PTH (OR = 1.023; p = 0.025), peak alkaline phosphatase (OR = 0.985, p < 0.001), lower age (OR = 0.985, p < 0.001) and male gender (OR = 0.209, p < 0.002) as statistically significant predictors for patients receiving PTX. Higher age at diagnosis of PHPT was associated with increased risk of co-existent hypertension (OR = 10.904, p = 0.001) and fractures (OR = 1.067, p = 0.004). Higher peak calcium concentration was an independent predictor of acute kidney injury (OR = 9.631, p = 0.011). PTX cured 76 cases (94%) with only 7 (9%) postoperative complications. Twenty-four cases (15%) died from the entire cohort (only one from PTX group) during a median follow-up period of 3.6 years (interquartile range = 1.5). CONCLUSIONS: PTX treatment is associated with cure of disease in patients with PHPT with acceptable risk of complications. Improvements in diagnostic work-up and follow-up care should improve the morbidity from PHPT.

The effects of different passive static stretching intensities on recovery from unaccustomed eccentric exercise - a randomized controlled trial.

Effects of passive static stretching intensity on recovery from unaccustomed eccentric exercise of right knee extensors was investigated in 30 recreationally active males randomly allocated into 3 groups: high-intensity (70%-80% maximum perceived stretch), low-intensity (30%-40% maximum perceived stretch), and control. Both stretching groups performed 3 sets of passive static stretching exercises of 60 s each for hamstrings, hip flexors, and quadriceps, over 3 consecutive days, post-unaccustomed eccentric exercise. Muscle function (eccentric and isometric peak torque) and blood biomarkers (creatine kinase and C-reactive protein) were measured before (baseline) and after (24, 48, and 72 h) unaccustomed eccentric exercise. Perceived muscle soreness scores were collected immediately (time 0), and after 24, 48, and 72 h postexercise. Statistical time × condition interactions observed only for eccentric peak torque (p = 0.008). Magnitude-based inference analyses revealed low-intensity stretching had most likely, very likely, or likely beneficial effects on perceived muscle soreness (48-72 h and 0-72 h) and eccentric peak torque (baseline-24 h and baseline-72 h), compared with high-intensity stretching. Compared with control, low-intensity stretching had very likely or likely beneficial effects on perceived muscle soreness (0-24 h and 0-72 h), eccentric peak torque (baseline-48 h and baseline-72 h), and isometric peak torque (baseline-72 h). High-intensity stretching had likely beneficial effects on eccentric peak torque (baseline-48 h), but likely had harmful effects on eccentric peak torque (baseline-24 h) and creatine kinase (baseline-48 h and baseline-72 h), compared with control. Therefore, low-intensity stretching is likely to result in small-to-moderate beneficial effects on perceived muscle soreness and recovery of muscle function post-unaccustomed eccentric exercise, but not markers of muscle damage and inflammation, compared with high-intensity or no stretching.

Physical activity for women with breast cancer after adjuvant therapy.

BACKGROUND: Women with a diagnosis of breast cancer may experience short- and long-term disease and treatment-related adverse physiological and psychosocial outcomes. These outcomes can negatively impact prognosis, health-related quality of life (HRQoL), and psychosocial and physical function. Physical activity may help to improve prognosis and may alleviate the adverse effects of adjuvant therapy. OBJECTIVES: To assess effects of physical activity interventions after adjuvant therapy for women with breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group (CBCG) Specialised Registry, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Physiotherapy Evidence Database (PEDro), SPORTDiscus, PsycINFO, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform, on 18 September 2015. We also searched OpenGrey and Healthcare Management Information Consortium databases. SELECTION CRITERIA: We searched for randomised and quasi-randomised trials comparing physical activity interventions versus control (e.g. usual or standard care, no physical activity, no exercise, attention control, placebo) after adjuvant therapy (i.e. after completion of chemotherapy and/or radiation therapy, but not hormone therapy) in women with breast cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data. We contacted trial authors to ask for additional information when needed. We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome and used GRADE to assess the quality of evidence for the most important outcomes. MAIN RESULTS: We included 63 trials that randomised 5761 women to a physical activity intervention (n = 3239) or to a control (n = 2524). The duration of interventions ranged from 4 to 24 months, with most lasting 8 or 12 weeks (37 studies). Twenty-eight studies included aerobic exercise only, 21 involved aerobic exercise and resistance training, and seven used resistance training only. Thirty studies described the comparison group as usual or standard care, no intervention, or control. One-fifth of studies reported at least 20% intervention attrition and the average physical activity adherence was approximately 77%.No data were available on effects of physical activity on breast cancer-related and all-cause mortality, or on breast cancer recurrence. Analysis of immediately postintervention follow-up values and change from baseline to end of intervention scores revealed that physical activity interventions resulted in significant small-to-moderate improvements in HRQoL (standardised mean difference (SMD) 0.39, 95% CI 0.21 to 0.57, 22 studies, 1996 women; SMD 0.78, 95% CI 0.39 to 1.17, 14 studies, 1459 women, respectively; low-quality evidence), emotional function (SMD 0.21, 95% CI 0.10 to 0.32, 26 studies, 2102 women, moderate-quality evidence; SMD 0.31, 95% CI 0.09 to 0.53, 15 studies, 1579 women, respectively; low-quality evidence), perceived physical function (SMD 0.33, 95% CI 0.18 to 0.49, 25 studies, 2129 women; SMD 0.60, 95% CI 0.23 to 0.97, 13 studies, 1433 women, respectively; moderate-quality evidence), anxiety (SMD -0.57, 95% CI -0.95 to -0.19, 7 studies, 326 women; SMD -0.37, 95% CI -0.63 to -0.12, 4 studies, 235 women, respectively; low-quality evidence), and cardiorespiratory fitness (SMD 0.44, 95% CI 0.30 to 0.58, 23 studies, 1265 women, moderate-quality evidence; SMD 0.83, 95% CI 0.40 to 1.27, 9 studies, 863 women, respectively; very low-quality evidence).Investigators reported few minor adverse events.Small improvements in physical activity interventions were sustained for three months or longer postintervention in fatigue (SMD -0.43, 95% CI -0.60 to -0.26; SMD -0.47, 95% CI -0.84 to -0.11, respectively), cardiorespiratory fitness (SMD 0.36, 95% CI 0.03 to 0.69; SMD 0.42, 95% CI 0.05 to 0.79, respectively), and self-reported physical activity (SMD 0.44, 95% CI 0.17 to 0.72; SMD 0.51, 95% CI 0.08 to 0.93, respectively) for both follow-up values and change from baseline scores.However, evidence of heterogeneity across trials was due to variation in intervention components (i.e. mode, frequency, intensity, duration of intervention and sessions) and measures used to assess outcomes. All trials reviewed were at high risk of performance bias, and most were also at high risk of detection, attrition, and selection bias. In light of the aforementioned issues, we determined that the evidence was of very low, low, or moderate quality. AUTHORS' CONCLUSIONS: No conclusions regarding breast cancer-related and all-cause mortality or breast cancer recurrence were possible. However, physical activity interventions may have small-to-moderate beneficial effects on HRQoL, and on emotional or perceived physical and social function, anxiety, cardiorespiratory fitness, and self-reported and objectively measured physical activity. The positive results reported in the current review must be interpreted cautiously owing to very low-to-moderate quality of evidence, heterogeneity of interventions and outcome measures, imprecision of some estimates, and risk of bias in many trials. Future studies with low risk of bias are required to determine the optimal combination of physical activity modes, frequencies, intensities, and durations needed to improve specific outcomes among women who have undergone adjuvant therapy.