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Background Cluster randomised controlled trials (cRCT) present challenges regarding risks of bias and chance imbalances by arm. This paper reports strategies to minimise and monitor biases and imbalances in the ChEETAh cRCT. Methods ChEETAh was an international cRCT (hospitals as clusters) evaluating whether changing sterile gloves and instruments prior to abdominal wound closure reduces surgical site infection at 30 days postoperative. ChEETAh planned to recruit 12,800 consecutive patients from 64 hospitals in seven low-middle income countries. Eight strategies to minimise and monitor bias were pre-specified: (1) minimum of 4 hospitals per country; (2) pre-randomisation identification of units of exposure (operating theatres, lists, teams or sessions) within clusters; (3) minimisation of randomisation by country and hospital type; (4) site training delivered after randomisation; (5) dedicated ‘warm-up week’ to train teams; (6) trial specific sticker and patient register to monitor consecutive patient identification; (7) monitoring characteristics of patients and units of exposure; and (8) low-burden outcome-assessment. Results This analysis includes 10,686 patients from 70 clusters. The results aligned to the eight strategies were (1) 6 out of 7 countries included ≥ 4 hospitals; (2) 87.1% (61/70) of hospitals maintained their planned operating theatres (82% [27/33] and 92% [34/37] in the intervention and control arms); (3) minimisation maintained balance of key factors in both arms; (4) post-randomisation training was conducted for all hospitals; (5) the ‘warm-up week’ was conducted at all sites, and feedback used to refine processes; (6) the sticker and trial register were maintained, with an overall inclusion of 98.1% (10,686/10,894) of eligible patients; (7) monitoring allowed swift identification of problems in patient inclusion and key patient characteristics were reported: malignancy (20.3% intervention vs 12.6% control), midline incisions (68.4% vs 58.9%) and elective surgery (52.4% vs 42.6%); and (8) 0.4% (41/9187) of patients refused consent for outcome assessment. Conclusion cRCTs in surgery have several potential sources of bias that include varying units of exposure and the need for consecutive inclusion of all eligible patients across complex settings. We report a system that monitored and minimised the risks of bias and imbalances by arm, with important lessons for future cRCTs within hospitals.

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Introduction: Parkinsons disease (PD) is the commonest age related motoric neurodegenerative disease. It results from the destruction of dopaminergic cell in the substantial nigra in the midbrain. In addition to the typical motor Parkinsonism symptoms, non -motor manifestations affect multiple organs including the lower urinary tract and contribute to worsening the overall quality of life. The objective of this study is to highlight the bother from lower urinary tract symptoms in patients with PD and determine the relationship between the lower urinary symptoms and severity of PD. Materials and Methods: This is a descriptive cross-sectional study in patients with clinically diagnosed PD that were managed by the Neurology Unit, Neurology Unit, Department of Medicine University of Port Harcourt Teaching Hospital, Port Harcourt, Rivers State, Nigeria. They all filled the International Prostate Symptom Score and Quality of Life form. The severity of PD in each patient was assessed using Unified Parkinsons Disease Rating Scale (UPDRS). The data obtained was analyzed using SPSS Version 20. Results: There were 22 patients aged between 25-87years with a mean age of 59.36 ±15.58years. Nocturia (90.90%), frequency (59.10%) and urgency (59.10%) were the commonest LUTS, while straining was the least frequent (22.70 %). Majority had mild (59.09%)and moderate (27.27%) symptoms. There was a strong association between total IPSSand QoL scores that was statistically significant (p<0.0001 r= +0.859). The degree of bother from LUTS, evaluated with the IPSS questionnaire was associated with worsening of PD symptoms assessed with UPDRS (p=0.012). There was a moderate positive correlation between the severity of PD and the degree of bother from LUTS in PD patients (r=+0.527) Conclusions: Irritative symptoms are very common in Parkinsons disease, with nocturia the commonest. There was a moderate positive correlation between the severity of PD and the degree of bother from LUTS. The IPSS questionnaire could be used in evaluating urinary dysfunction in PD patients in both genders.