A Randomized Controlled Trial of Topical Analgesia Posthemorrhoidectomy (TAPH Trial).

BACKGROUND: Postoperative pain remains the greatest problem after hemorrhoidectomy. Pain is hypothesized to arise from bacterial infection, sphincter spasm, and local inflammation. OBJECTIVE: This trial was conducted to assess the effects of metronidazole, diltiazem, and lidocaine on posthemorrhoidectomy pain. DESIGN: A double-blinded randomized controlled factorial trial. SETTINGS: This multicenter trial was conducted in Auckland, New Zealand. PATIENTS: A total of 192 participants were randomly assigned (1:1:1:1) into 4 parallel arms. INTERVENTIONS: Participants were randomly assigned into 1 of 4 groups receiving topical treatment with 10% metronidazole, 10% metronidazole + 2% diltiazem, 10% metronidazole + 4% lidocaine, or 10% metronidazole + 2% diltiazem + 4% lidocaine. Participants were instructed to apply treatment to the anal verge 3 times daily for 7 days. MAIN OUTCOME MEASURES: The primary outcome was pain on the visual analog scale on day 4. The secondary outcomes included analgesia usage, pain during bowel movement, and functional recovery index. RESULTS: There was no significant difference in the pain and recovery scores when diltiazem or lidocaine was added to metronidazole (score difference between presence and absence of diltiazem in the formulation: -3.69; 95% CI, -13.3 to 5.94; p = 0.46; between presence and absence of lidocaine: -5.67; 95% CI, -15.5 to 3.80; p = 0.24). The combination of metronidazole + diltiazem + lidocaine did not further reduce pain. Secondary analysis revealed a significant difference between the best (metronidazole + lidocaine) and worst (metronidazole + diltiazem + lidocaine) groups in both pain and functional recovery scores. There were no significant differences in analgesic usage, complications, or return to work between the groups. No clinically important adverse events were reported. The adverse event rate did not change in the intervention groups. LIMITATIONS: Topical metronidazole was used in the control group rather than a pure placebo. CONCLUSIONS: There was no significant difference in pain when topical diltiazem, lidocaine, or both were added to topical metronidazole. See Video Abstract . CLINICALTRIALSGOV IDENTIFIER: NCT04276298. ENSAYO CONTROLADO ALEATORIZADO DE ANALGESIA TPICA POSTERIOR A HEMORROIDECTOMA ENSAYO TAPH: ANTECEDENTES:El dolor postoperatorio sigue siendo el mayor problema tras hemorroidectomía. La hipótesis es que el dolor se debe a infección bacteriana, el espasmo esfínteriano e inflamación local.OBJETIVO:Se realizó un ensayo factorial aleatorizado y controlado para evaluar los efectos del metronidazol, el diltiazem y la lidocaína en el dolor posthemorroidectomía.DISEÑO:Ensayo factorial controlado aleatorizado doble ciego.ESCENARIO:Se realizó un ensayo multicéntrico en Auckland, Nueva Zelanda.PACIENTES:Se aleatorizó a 192 participantes (1:1:1:1) en cuatro brazos paralelos.INTERVENCIONES:Los participantes se asignaron aleatoriamente a uno de los cuatro grupos que recibieron tratamiento tópico con metronidazol al 10% (M), metronidazol al 10% + diltiazem al 2% (MD), metronidazol al 10% + lidocaína al 4% (ML), o metronidazol al 10% + diltiazem al 2% + lidocaína al 4% (MDL). Se indicó a los participantes que lo aplicaran en el margen anal 3 veces al día durante 7 días.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el dolor en la escala analógica visual en el día 4. Los resultados secundarios incluyeron el uso de analgesia, el dolor al defecar y el índice de recuperación funcional.RESULTADOS:No hubo diferencias significativas en las puntuaciones de dolor y recuperación cuando se añadió diltiazem o lidocaína al metronidazol (diferencia de puntuación entre la presencia y la ausencia de D en la formulación: -3.69; IC del 95%: -13.3; 5.94; p = 0.46; entre la presencia y la ausencia de L: -5.67; IC del 95%: -15.5; 3.80; p = 0.24). La combinación de MDL no redujo más el dolor. El análisis secundario reveló una diferencia significativa entre los grupos mejor (ML) y peor (MDL) tanto en las puntuaciones de dolor como en las de recuperación funcional. No hubo diferencias significativas en el uso de analgésicos, las complicaciones o la reincorporación al trabajo entre los grupos. No se notificaron eventos adversos clínicamente importantes. La tasa de eventosadversos no cambió en los grupos de intervención.LIMITACIONES:Se utilizó metronidazol tópico en el grupo de control, en lugar de un placebo puro.CONCLUSIONES:No hubo diferencias significativas en el dolor cuando se añadió diltiazem tópico o lidocaína, o ambos, al metronidazol tópico. ( Traducción-Dr. Jorge Silva Velazco )Identificador de registro del ensayo clínico:NCT04276298.

Frailty and Long-Term Mortality Following Emergency Laparotomy: A Comparison Between the 11-Item and 5-Item Modified Frailty Indices.

INTRODUCTION: Emergency laparotomy (EL) is a high-risk operation which is increasingly performed on an aging patient population. Objective frailty assessment using a validated index has the potential to improve preoperative risk stratification. This study aimed to assess the correlation between frailty and long-term mortality and morbidity outcomes for older EL patients. Secondary aims were to compare the 11-item and shortened five-item modified frailty indices (mFIs) in terms of value and predictive validity. METHODS: A prospective multicenter observational study of patients aged ≥55 y undergoing EL was conducted across five hospitals in New Zealand between 2017 and 2022. Frailty was measured using the 11-item and abbreviated five-item mFIs. Multivariable logistic regression was used to determine whether frailty was independently associated with one-year postoperative mortality and other morbidity outcomes. Correlation between the two frailty indices were assessed with the Spearman's correlation coefficient (P). RESULTS: Frailty assessments were performed in 861 participants, with the prevalence being 18.7% and 29.8% using the 11-item and five-item mFIs, respectively. Both frailty indices demonstrated similar associations with one-year mortality (two-fold increased risk), major complications, admission to intensive care unit, rehabilitation, and 30-d readmission. The 11-item mFI demonstrated a greater association with early mortality (four-fold increased risk), reoperations, and increased length of stay compared with the five-item frailty index. Spearman P was 0.6 (P < 0.001). CONCLUSIONS: Frailty, as identified by the 11-item and five-item mFIs, was associated with one-year mortality and other important morbidity outcomes for older EL patients. These forms of frailty assessment provide important information that may aid in risk assessment and patient-centered decision-making.

Association between frailty, long-term mortality and functional outcomes for older adults undergoing emergency laparotomy.

BACKGROUND: An increasing number of older patients are undergoing emergency laparotomy (EL). Frailty is thought to contribute to adverse outcomes in this group. The best method to assess frailty and impacts on long-term mortality and other important functional outcomes for older EL patients have not been fully explored. METHODS: A prospective multicenter study of older EL patients was conducted across four hospital sites in New Zealand from August 2017 to September 2022. The Clinical Frailty Scale (CFS) was used to measure frailty-defined as a CFS of ≥5. Primary outcomes were 30-day and one-year mortality. Secondary outcomes were postoperative morbidity, admission for rehabilitation, and increased care level on discharge. A multivariate logistic regression analysis was conducted, adjusting for age, sex, and ethnicity. RESULTS: A total of 629 participants were included. Frailty prevalence was 14.6%. Frail participants demonstrated higher 30-day and 1-year mortality-20.7% and 39.1%. Following adjustment, frailty was directly associated with a significantly increased risk of short- and long-term mortality (30-day aRR 2.6, 95% CI 1.5, 4.3, p = <0.001, 1-year aRR 2.0, 95% CI 1.5, 2.8, p < 0.001). Frailty was correlated with a 2-fold increased risk of admission for rehabilitation and propensity of being discharged to an increased level of care, complications, and readmission within 30 days. CONCLUSION: Frailty was associated with increased risk of postoperative mortality up to 1-year and other functional outcomes for older patients undergoing EL. Identification of frailty in older EL patients aids in patient-centered decision-making, which may lead to improvement in outcomes.

Low dialysate sodium levels for chronic haemodialysis.

BACKGROUND: Cardiovascular (CV) disease is the leading cause of death in dialysis patients and is strongly associated with fluid overload and hypertension. It is plausible that low dialysate sodium ion concentration [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension and ultimately reducing CV morbidity and death. This is an update of a review first published in 2019. OBJECTIVES: This review evaluated the harms and benefits of using a low (< 138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 1 October 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs), both parallel and cross-over, of low (< 138 mM) versus neutral (138 to 140 mM) or high (> 140 mM) dialysate [Na+] for maintenance HD patients were included. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for inclusion and extracted data. Statistical analyses were performed using the random-effects model, and results expressed as risk ratios (RR) for dichotomous outcomes, and mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI). Confidence in the evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). MAIN RESULTS: We included 17 studies randomising 509 patients, with data available for 452 patients after dropouts. All but three studies evaluated a fixed concentration of low dialysate [Na+], with one using profiled dialysate [Na+] and two using individualised dialysate [Na+]. Five were parallel group studies, and 12 were cross-over studies. Of the latter, only six used a washout between intervention and control periods. Most studies were short-term with a median (interquartile range) follow-up of 4 (4 to 16) weeks. Two were of a single HD session and two of a single week's HD. Seven studies were conducted prior to 2000, and six reported the use of obsolete HD practices. Other than for indirectness arising from older studies, risks of bias in the included studies were generally low. Compared to neutral or high dialysate [Na+] (≥ 138 mM), low dialysate [Na+] (< 138 mM) reduces interdialytic weight gain (14 studies, 515 participants: MD -0.36 kg, 95% CI -0.50 to -0.22; high certainty evidence) and antihypertensive medication use (5 studies, 241 participants: SMD -0.37, 95% CI -0.64 to -0.1; high certainty evidence), and probably reduces left ventricular mass index (2 studies, 143 participants: MD -7.65 g/m2, 95% CI -14.48 to -0.83; moderate certainty evidence), predialysis mean arterial pressure (MAP) (5 studies, 232 participants: MD -3.39 mm Hg, 95% CI -5.17 to -1.61; moderate certainty evidence), postdialysis MAP (5 studies, 226 participants: MD -3.17 mm Hg, 95% CI -4.68 to 1.67; moderate certainty evidence), predialysis serum [Na+] (11 studies, 435 participants: MD -1.26 mM, 95% CI -1.81 to -0.72; moderate certainty evidence) and postdialysis serum [Na+] (6 studies, 188 participants: MD -3.09 mM, 95% CI -4.29 to -1.88; moderate certainty evidence). Compared to neutral or high dialysate [Na+], low dialysate [Na+] probably increases intradialytic hypotension events (13 studies, 15,764 HD sessions: RR 1.58, 95% 1.25 to 2.01; moderate certainty evidence) and intradialytic cramps (10 studies, 14,559 HD sessions: RR 1.84, 95% 1.29 to 2.64; moderate certainty evidence). Effect size for important outcomes were generally greater with low dialysate [Na+] compared to high compared with neutral dialysate [Na+], although formal hypothesis testing identifies that the difference was only certain for postdialysis serum [Na+]. Compared to neutral or high dialysate [Na+], it is uncertain whether low dialysate [Na+] affects intradialytic or interdialytic MAP, and dietary salt intake. It is also uncertain whether low dialysate [Na+] changed extracellular fluid status, venous tone, arterial vascular resistance, left ventricular volumes, or fatigue. Studies did not examine CV or all-cause death, CV events, or hospitalisation. AUTHORS' CONCLUSIONS: Low dialysate [Na+] reduces intradialytic weight gain and probably blood pressure, which are effects directionally associated with improved outcomes. However, the intervention probably increases intradialytic hypotension and probably reduces serum [Na+], effects that are associated with an increased risk of death. The effect of the intervention on overall patient health and well-being is unknown. Further evidence is needed in the form of longer-term studies in contemporary settings, evaluating end-organ effects in small-scale mechanistic studies using optimal methods, and clinical outcomes in large-scale multicentre RCTs.

Improving Golden Hour Care Coordination: Using Defined Roles to Improve Nurse Confidence and Care Coordination of Neonates Following Admission.

STUDY AIM: To investigate whether use of admission lanyards improves nurse confidence, care coordination, and infant health outcomes during neonatal emergency admissions. METHODS: Admission lanyards that defined team roles, tasks, and responsibilities were evaluated in a mixed-methods, historically controlled, and nonrandomized intervention study. Methods included (i) 81 pre- and postintervention surveys to explore nurse confidence, (ii) 8 postintervention semistructured interviews to elicit nurse perceptions of care coordination and nurse confidence, and (iii) a quantitative comparison of infant care coordination and health outcomes for 71 infant admissions before and 72 during the intervention. RESULTS: Nurse participants reported that using lanyards during neonatal admissions improved clarity of roles and responsibilities, communication, and task delegation, contributing to better admission flow, team leadership, accountability, and improved nurse confidence. Care coordination outcomes showed significantly improved time to stabilization for intervention infants. Radiographies for line placement were performed 14.4 minutes faster, and infants commenced intravenous nutrition 27.7 minutes faster from time of admission. Infant health outcomes remained similar between groups. CONCLUSION: Admission lanyards were associated with improved nurse confidence and care coordination during neonatal emergency admissions, significantly reducing time to stabilization for infants, shifting outcomes closer to the Golden Hour.

Tiotropium treatment for bronchiectasis: a randomised, placebo-controlled, crossover trial.

BACKGROUND: Tiotropium via the HandiHaler device is an established long-acting, anticholinergic bronchodilator that prevents exacerbations and improves lung function in patients with chronic obstructive pulmonary disease. We hypothesised that tiotropium would reduce pulmonary exacerbations and improve lung function in patients with stable bronchiectasis and airflow limitation, and assessed the effect of tiotropium on these outcomes. METHODS: In a randomised, double-blind, two-period crossover trial, we recruited adult patients from three hospitals in New Zealand. Patients were excluded if they had a smoking history of >20 pack-years. Patients were assigned to either the tiotropium-placebo or placebo-tiotropium sequence in a 1:1 ratio, using randomly permuted blocks stratified by centre. Participants and investigators were masked to treatment allocation. Eligible patients received tiotropium 18 µg via HandiHaler daily for 6 months followed by 6 months of placebo, or vice versa, with a washout period of 4 weeks. The primary end-point was rate of event-based exacerbations during the 6-month period. Primary analyses were carried out in an intention-to-treat set. RESULTS: 90 patients were randomly assigned and 85 completed both treatment cycles. The rate of exacerbations was 2.17 per year under the tiotropium treatment and 2.27 per year under placebo (rate ratio 0.96, 95% CI 0.72-1.27; p=0.77). Tiotropium, compared with placebo, improved forced expiratory volume in 1 s by 58 mL (95% CI 23-92 mL; p=0.002). Adverse events were similar under both treatments. CONCLUSIONS: Tiotropium via HandiHaler over 6 months significantly improved lung function but not frequency of exacerbations. Further research is required to understand the clinical context and significance of these findings.

Development of a Bronchoscopy-Radiologic Skills and Task Assessment Tool (BRadSTAT): A Tool for Evaluating the Radiological Skills of Bronchoscopists with Different Experience.

BACKGROUND: Competency using radiologic images for bronchoscopic navigation is presumed during subspecialty training, but no assessments objectively measure combined knowledge of radiologic interpretation and ability to maneuver a bronchoscope into peripheral airways. OBJECTIVES: The objectives of this study were (i) to determine whether the Bronchoscopy-Radiology Skills and Tasks Assessment Tool (BRadSTAT) discriminates between bronchoscopists of various levels of experience and (ii) to improve construct validity using study findings. METHODS: BRadSTAT contains 10 questions that assess chest X-ray and CT scan interpretation using multiple images per question and 2 technical skill assessments. After administration to 33 bronchoscopists (5 Beginners, 9 Intermediates, 10 Experienced, and 9 Experts), discriminative power was strengthened using differential weighting on CT-related questions, producing the BRadSTAT-CT score. Cut points for both scores were determined via cross-validation. RESULTS: Mean BRadSTAT scores for Beginner, Intermediate, Experienced, and Expert were 74 (±13 SD), 78 (±14), 86 (±9), and 88 (±8), respectively. Statistically significant differences were noted between Expert and Beginner, Expert and Intermediate, and Experienced and Beginner (all p ≤ 0.05). Mean BRadSTAT-CT scores for Beginner, Intermediate, Experienced, and Expert were 63 (±14), 74 (±15), 82 (±13), and 90 (±9), respectively, all statistically significant (p ≤ 0.03). Cut points for BRadSTAT-CT had lower sensitivity but greater specificity and accuracy than for BRadSTAT. CONCLUSION: BRadSTAT represents the first validated assessment tool measuring knowledge and skills for bronchoscopic access to peripheral airways, which discriminates between bronchoscopists of various experience levels. Refining BRadSTAT produced the BRadSTAT-CT, which had higher discriminative power. Future studies should focus on their usefulness in competency-based bronchoscopy programs.

Outcomes of patients with delayed surveillance colonoscopy.

BACKGROUND: Surveillance colonoscopy has been shown to be an effective tool for prevention of colorectal cancer (CRC) in high-risk populations, if adhered to. AIM: To discover the sequelae of late surveillance in a cohort of patient's overdue for colonoscopy. METHODS: We conducted a retrospective cohort study on all patients from the Bay of Plenty District Health Board region, New Zealand, placed on the colonoscopy surveillance waitlist from 2006 onwards who had their procedure completed between 1 November 2016 and 31 January 2018. Patients with overdue surveillance, defined as done later than 90 days after the recommended due date, were compared with patients who were done either early or on time. RESULTS: A total of 786 patients was recorded as overdue for surveillance colonoscopy and 386 were completed early or on time. The median time overdue was 22 months. Three (0.4%) cases of CRC were found in overdue patients compared with four (1%) cases for those done on time (adjusted P = 0.24). There were 86 (11%) advanced adenomas (AA) in patients overdue compared with 27 (7%) in those not overdue (odds ratio (OR) 1.6; 95% confidence interval (CI) 1.0-2.5; P = 0.04). Surveillance of 180 high-risk post-polypectomy patients identified 2 CRC and 8/43 AA in those overdue compared with no CRC and 9/137 AA (18.6% vs 6.6%; OR 1.79; 95% CI 1.07-2.0; unadjusted P = 0.03) in those done on time. CONCLUSION: While overdue surveillance is not predictive of increased CRC, it is associated with an increase in expected number of AA, particularly in patients having surveillance for previous high-risk polypectomy.

Effects of worn and new footwear on plantar pressure in people with gout.

BACKGROUND: In clinical trials, good quality athletic shoes offer short-term improvements (two-months) in foot pain and disability in people with gout, but these improvements are not sustained over time. This may be due to wear and subsequent changes to the structural integrity of the shoe. The aim of this study was to examine the effects of wear on plantar pressures and footwear characteristics in shoes over six-months in people with gout. METHODS: Forty people with gout participated in a cross-sectional repeated measures study. Participants wore a pair of commercially available athletic footwear for six-months. Participants then attended a study visit where the worn footwear was compared with a new pair of the same model and size of footwear. Wear characteristics (upper, midsole, outsole) and plantar pressure were measured in the two footwear conditions. Wear characteristics were analysed using paired t-tests and Fisher's exact tests. Plantar pressure data were analysed using linear mixed models. RESULTS: Increases in medial midsole (P < 0.001), lateral midsole (P < 0.001) and heel midsole (P < 0.001) hardness were observed in the worn shoes. Normal upper wear patterns (P < 0.001) and outsole wear patterns (P < 0.001) were observed in most of the worn shoes. No differences in peak plantar pressures (P < 0.007) were observed between the two footwear conditions. Reduced pressure time integrals at the first metatarsophalangeal joint (P < 0.001), second metatarsophalangeal joint (P < 0.001) and hallux (P = 0.003) were seen in the worn shoes. CONCLUSIONS: The study found signs of wear were observed at the upper, midsole and outsole in the worn footwear after six-months. These changes to the structural properties of the footwear may affect forefoot loading patterns in people with gout.

Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.

BACKGROUND: Fluid overload in patients undergoing hemodialysis contributes to cardiovascular morbidity and mortality. There is a global trend to lower dialysate sodium with the goal of reducing fluid overload. METHODS: To investigate whether lower dialysate sodium during hemodialysis reduces left ventricular mass, we conducted a randomized trial in which patients received either low-sodium dialysate (135 mM) or conventional dialysate (140 mM) for 12 months. We included participants who were aged >18 years old, had a predialysis serum sodium ≥135 mM, and were receiving hemodialysis at home or a self-care satellite facility. Exclusion criteria included hemodialysis frequency >3.5 times per week and use of sodium profiling or hemodiafiltration. The main outcome was left ventricular mass index by cardiac magnetic resonance imaging. RESULTS: The 99 participants had a median age of 51 years old; 67 were men, 31 had diabetes mellitus, and 59 had left ventricular hypertrophy. Over 12 months of follow-up, relative to control, a dialysate sodium concentration of 135 mmol/L did not change the left ventricular mass index, despite significant reductions at 6 and 12 months in interdialytic weight gain, in extracellular fluid volume, and in plasma B-type natriuretic peptide concentration (ratio of intervention to control). The intervention increased intradialytic hypotension (odds ratio [OR], 7.5; 95% confidence interval [95% CI], 1.1 to 49.8 at 6 months and OR, 3.6; 95% CI, 0.5 to 28.8 at 12 months). Five participants in the intervention arm could not complete the trial because of hypotension. We found no effect on health-related quality of life measures, perceived thirst or xerostomia, or dietary sodium intake. CONCLUSIONS: Dialysate sodium of 135 mmol/L did not reduce left ventricular mass relative to control, despite improving fluid status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: The Australian New Zealand Clinical Trials Registry, ACTRN12611000975998.

Feasibility and Provisional Efficacy of Embedding High-Intensity Interval Training Into Physical Education Lessons: A Pilot Cluster-Randomized Controlled Trial.

PURPOSE: The aim of this study was to determine the feasibility of generalist school teachers delivering curriculum connected high-intensity interval training in a school's physical education class time. METHOD: Two schools volunteered to participate. A total of 84 students (11.9 [0.5] y, M = 64 and F = 19) volunteered to participate. Four classes from 2 schools were randomized to either intervention (n = 53) or control (n = 31) for one school term (8 wk). Intervention class teachers participated in a 1-day workshop instructing them how to deliver twice weekly, high-intensity interval training sessions. The control classes continued with their usual physical education curriculum. Recruitment, intervention fidelity, and program satisfaction were assessed. Preliminary efficacy (primary outcome cardiorespiratory fitness) was quantified using generalized linear mixed models, expressed as effect size. A range of secondary outcomes was also assessed. RESULTS: The recruitment rate was 88%. About 84% of the sessions were delivered. The heart rate peak over all sessions was 89.6% (13%) of the predicted maximum. The intervention teachers reported high levels of satisfaction. Almost all student participants were positive about participating. No adverse events occurred. The adjusted between-group difference for cardiorespiratory fitness was trivial (effect size 0.02). CONCLUSIONS: This teacher-delivered high-intensity interval training program was feasible and acceptable to both teachers and student participants. It is therefore potentially scalable.

Low dialysate sodium levels for chronic haemodialysis.

BACKGROUND: Cardiovascular (CV) disease is the leading cause of death in dialysis patients, and strongly associated with fluid overload and hypertension. It is plausible that low dialysate [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension, and ultimately reducing CV morbidity and mortality. OBJECTIVES: This review evaluated harms and benefits of using a low (< 138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 7 August 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs), both parallel and cross-over, of low (< 138 mM) versus neutral (138 to 140 mM) or high (> 140 mM) dialysate [Na+] for maintenance HD patients were included. DATA COLLECTION AND ANALYSIS: Two investigators independently screened studies for inclusion and extracted data. Statistical analyses were performed using random effects models, and results expressed as risk ratios (RR) for dichotomous outcomes, and mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI). Confidence in the evidence was assessed using GRADE. MAIN RESULTS: We included 12 studies randomising 310 patients, with data available for 266 patients after dropout. All but one study evaluated a fixed concentration of low dialysate [Na+], and one profiled dialysate [Na+]. Three studies were parallel group, and the remaining nine cross-over. Of the latter, only two used a washout between intervention and control periods. Most studies were short-term with a median (interquartile range) follow-up of 3 (3, 8.5) weeks. Two were of a single HD session, and two of a single week's HD. Half of the studies were conducted prior to 2000, and five reported use of obsolete HD practices. Risks of bias in the included studies were often high or unclear, lowering confidence in the results.Compared to neutral or high dialysate [Na+], low dialysate [Na+] had the following effects on "efficacy" endpoints: reduced interdialytic weight gain (10 studies: MD -0.35 kg, 95% CI -0.18 to -0.51; high certainty evidence); probably reduced predialysis mean arterial blood pressure (BP) (4 studies: MD -3.58 mmHg, 95% CI -5.46 to -1.69; moderate certainty evidence); probably reduced postdialysis mean arterial BP (MAP) (4 studies: MD -3.26 mmHg, 95% CI -1.70 to -4.82; moderate certainty evidence); probably reduced predialysis serum [Na+] (7 studies: MD -1.69 mM, 95% CI -2.36 to -1.02; moderate certainty evidence); may have reduced antihypertensive medication (2 studies: SMD -0.67 SD, 95% CI -1.07 to -0.28; low certainty evidence). Compared to neutral or high dialysate [Na+], low dialysate [Na+] had the following effects on "safety" endpoints: probably increased intradialytic hypotension events (9 studies: RR 1.56, 95% 1.17 to 2.07; moderate certainty evidence); probably increased intradialytic cramps (6 studies: RR 1.77, 95% 1.15 to 2.73; moderate certainty evidence).Compared to neutral or high dialysate [Na+], low dialysate [Na+] may make little or no difference to: intradialytic BP (2 studies: MD for systolic BP -3.99 mmHg, 95% CI -17.96 to 9.99; diastolic BP 1.33 mmHg, 95% CI -6.29 to 8.95; low certainty evidence); interdialytic BP (2 studies:, MD for systolic BP 0.17 mmHg, 95% CI -5.42 to 5.08; diastolic BP -2.00 mmHg, 95% CI -4.84 to 0.84; low certainty evidence); dietary salt intake (2 studies: MD -0.21g/d, 95% CI -0.48 to 0.06; low certainty evidence).Due to very low quality of evidence, it is uncertain whether low dialysate [Na+] changed extracellular fluid status, venous tone, arterial vascular resistance, left ventricular mass or volumes, thirst or fatigue. Studies did not examine cardiovascular or all-cause mortality, cardiovascular events, or hospitalisation. AUTHORS' CONCLUSIONS: It is likely that low dialysate [Na+] reduces intradialytic weight gain and BP, which are effects directionally associated with improved outcomes. However, the intervention probably also increases intradialytic hypotension and reduces serum [Na+], effects that are associated with increased mortality risk. The effect of the intervention on overall patient health and well-being is unknown. Further evidence is needed in the form of longer-term studies in contemporary settings, evaluating end-organ effects in small-scale mechanistic studies using optimal methods, and clinical outcomes in large-scale multicentre RCTs.

Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.

BACKGROUND: Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS: We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Maori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Maori and 0.76 (95% CI -5.57 to 7.09) for non-Maori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Maori and 1.36 (-3.16 to 5.88) for non-Maori. No study-related adverse events were reported. CONCLUSIONS: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Maori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).

Vitamin D3 supplementation in adults with bronchiectasis: A pilot study.

Vitamin D supplementation prevents acute respiratory infections and, through modulating innate and adaptive immunity, could have a potential role in bronchiectasis management. The primary aims of this pilot study were to assess serum 25-hydroxyvitamin D (25(OH)D) levels in New Zealand adults with bronchiectasis, and their 25(OH)D levels after vitamin D3 supplementation. Adults with bronchiectasis received an initial 2.5 mg vitamin D3 oral loading dose and 0.625 mg vitamin D3 weekly for 24 weeks. The primary outcome was serum 25(OH)D levels before and after vitamin D3 supplementation. Secondary outcomes (time to first infective exacerbation, exacerbation frequency, spirometry, health-related quality of life measures, sputum bacteriology and cell counts and chronic rhinosinusitis) were also assessed. This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12612001222831). The initial, average 25(OH)D level was 71 nmol/L (95% confidence interval (CI): [58, 84]), rising to 218 nmol/L (95% CI: [199, 237]) at 12 weeks and 205 nmol/L (95% CI: [186, 224]) at 24 weeks. The initial serum cathelicidin level was 25 nmol/L (95% CI: [17, 33]), rising to 102 nmol/L (95% CI: [48, 156]) at 12 weeks and 151 nmol/L (95% CI: [97, 205]) at 24 weeks. Over the 24-week study period, we observed statistically significant changes of 1.11 (95% CI: [0.08, 2.14]) in the Leicester Cough Questionnaire and -1.97 (95% CI: [-3.71, -0.23]) in the Dartmouth COOP charts score. No significant adverse effects were recorded. Many New Zealand adults with bronchiectasis have adequate 25(OH)D levels. Weekly vitamin D3 supplementation significantly improved 25(OH)D levels.

Cluster-randomised controlled trial of an occupational therapy intervention for children aged 11-13 years, designed to increase participation to prevent symptoms of mental illness.

BACKGROUND: The impact of occupational therapy on mental health outcomes for children is largely unexplored. The aim of this study was to investigate an evidence-based occupational therapy intervention designed to increase participation in daily occupations to prevent symptoms of mental illness for children and run in schools. METHODS: The study used a pragmatic, cluster-randomised controlled trial design with two arms. Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile-rank category and block randomised. Blinding of participants post-randomisation was not feasible; however, outcomes assessors were blinded. Outcomes were measured at baseline, after the parallel and crossover phases, and at follow-up; and were anxiety symptoms (primary), depression symptoms, self-esteem, participation and wellbeing. Intention-to-treat analysis was applied and mixed linear modelling was used to account for clusters and repeated measures, and to adjust for covariates identified. RESULTS: This trial found significant positive effects of the intervention on child-rated satisfaction with their occupational performance and teacher-rated child anxiety. No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing. CONCLUSIONS: This was the first known cluster-randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non-clinical sample of children. No compelling evidence was found to support the use of the intervention in schools in its current format, however, results were promising that the focus on occupations influenced participation. Recommendations are made to redesign the intervention as an embedded intervention in the classroom, cotaught by teachers and including parental involvement.

The first metatarsophalangeal joint in gout: a systematic review and meta-analysis.

BACKGROUND: The aim of this review was to qualitatively synthesise studies that have investigated characteristics of the first metatarsophalangeal joint (1(st) MTP) in gout and to undertake a meta-analysis to estimate the average prevalence of acute 1(st) MTP arthritis across studies in people with gout. METHODS: Studies published in English were included if they involved participants who had a diagnosis of gout and presented original findings relating to the following outcome measures associated with the 1(st) MTP: epidemiology; clinical features; structural and functional characteristics; and microscopic and imaging features. RESULTS: Forty-five studies were included in the qualitative synthesis. 1(st) MTP pain was a prominent feature in people with gout. People with 1(st) MTP gout reported walking- and general-disability. Structural and functional characteristics of 1(st) MTP gout included hallux valgus, osteoarthritis, and restricted joint motion. Successful crystal aspiration ranged from 81 to 91 % and positive crystal identification via microscopy ranged from 83 to 93 % in patients with a history of 1(st) MTP gout. Imaging features were common at the 1(st) MTP including the double contour sign, tophi and erosions. Eleven studies involving 2,325 participants were included in the meta-analysis, providing an estimate of the average prevalence of acute 1(st) MTP arthritis across studies of 73 % (95 % prediction interval 40-92 %; range 48-97 %; I(2) = 93 %). CONCLUSIONS: 1(st) MTP acute arthritis is highly prevalent in people with gout and has a substantial impact on patient-reported pain and disability. Gout affects the structure and function of the 1(st) MTP. Microscopic and imaging studies have demonstrated crystal deposition and joint damage at the 1(st) MTP in people with gout.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

BACKGROUND: Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. OBJECTIVE: The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. METHODS: In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. RESULTS: The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were accrued (completed baseline assessments). The majority (n=52, 58%) of the 89 women who dropped out between enrollment and accrual never logged in to the allocated isafe website. Of every 4 accrued women, 3 (314/412, 76.2%) identified the classified ad as their referral source, followed by friends and family (52/412, 12.6%). Women recruited through a friend or relative were more likely to self-identify as indigenous Maori and live in the highest-deprivation areas. Ads increased the accrual rate by a factor of 74 (95% CI 49-112). CONCLUSIONS: Print advertisements, website links, and networking were costly and inefficient methods for recruiting participants to a Web-based eHealth trial. Researchers are advised to limit their recruitment efforts to Web-based online marketplace and classified advertising platforms, as in the isafe case, or to social media. Online classified advertising in "Jobs-Other-volunteers" successfully recruited a diverse sample of women experiencing intimate partner violence. Preintervention recruitment data provide critical information to inform future research and critical analysis of Web-based eHealth trials. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by WebCite at http://www.webcitation/6lMGuVXdK).

The effectiveness of the levonorgestrel intrauterine system in obese women with heavy menstrual bleeding.

INTRODUCTION: To evaluate the effectiveness of the levonorgestrel intrauterine system (LNG-IUS) in obese women with heavy menstrual bleeding in Counties Manukau Auckland area, New Zealand. METHODS: Prospective observational study in a tertiary teaching hospital. Twenty women with heavy menstrual bleeding (HMB) who agreed to treatment with the LNG-IUS and had a body mass index (BMI) of >30 kg/m2 were recruited between May and December 2014. The women completed two validated tools (Menstrual Impact Questionnaire and the Pictorial Bleeding Assessment Chart) at recruitment, 6 and 12 months follow-up. Demographic, medical and laboratory variables were obtained from the relevant CMH databases. Data on side effects and satisfaction were obtained from the women at 12 months. RESULTS: The median age (range) and BMI of the 20 women were 40.5 years (27-52 years) and 40.6 kg/m2 (30-68), respectively. Three LNG-IUS were removed due to infection and pain and these women were subsequently booked for a hysterectomy. The reduction in menstrual loss was estimated at 19.7% per month (95% CI (12.5%, 26.2%); P < 0.001), which translates to 73.2% per period of 6 months (95% CI (55.3%, 83.9%)) and 92.8% per period of 12 months (95% CI (80.0%, 97.4%)). The six items in the quality of life measure improved significantly in 14 women but only 12 women were satisfied with the treatment. CONCLUSION: The LNG-IUS was an effective treatment for 67% of obese women with heavy menstrual bleeding over a 12-month period, as assessed by the reduction in menstrual bleeding and the improvement in the quality of life measures.

Update: Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass.

After the publication of our paper Dunlop et al. "Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass", we became aware of further data correlating left ventricular (LV) mass index at baseline and their corresponding mass at 12 months, using cardiac magnetic resonance imaging (MRI) in patients on hemodialysis. The original published sample size for the SoLID trial of 118 was a conservative estimate, calculated using analysis of covariance and a within person Pearson's correlation for LV mass index of 0.75. New data communicated to the SoLID trial group has resulted in re-calcuation of the sample size, based upon a within person Pearson's correlation of 0.8 but otherwise unchanged assumptions. As a result, the SoLID trial will now recruit 96 participants.

A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

BACKGROUND: Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent. METHODS/DESIGN: In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship. DISCUSSION: This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures. TRIAL REGISTRATION: Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .