scholarly journals Accuracy and efficacy of diagnosis via integrated with metabolomics in patients with PCOS: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Cheng-Ming Ni ◽  
Wen-Long Huang ◽  
Yan-min Jiang ◽  
Juan Xu ◽  
Ru Duan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Characteristics ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Individual Therapy ◽  
Diagnosis And Treatment ◽  
Laboratory Evaluation ◽  
Future Research ◽  
Control Group ◽  
Randomized Controlled

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome and the mechanisms underlying its various clinical signs and symptoms are still poorly understood, brings huge difficulties for clinical diagnosis and treatment. General agreement based on several clinical guideline[1, 2] suggest that it is critical to precisely diagnose the phenotypes of PCOS and give them an individual therapy. However, the criteria for different phenotypes remains unclear, mostly based on symptoms, physical examination and laboratory evaluation. The aim of this study is to compare the accuracy and preciseness of metabolomics markers with common clinical characteristics to find a more effective way to diagnose and treat these two subgroups (based on our basic study[3]) of PCOS patients. What’s more, the effects of different interventions according to two subgroups will also be observed. Methods/design This is a prospective, multicenter, analyst-blinded and randomized controlled trial. One healthy control group and two parallel experiment arms will be proposed in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed mainly based on clinical indexes (group one); (3) PCOS patients diagnosed mainly based on metabolomics indexes (group two). A total of 276 eligible people will be recruited, which includes 60 healthy people and 216 PCOS patients, which will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in two different diagnosis groups will be divided into two different subgroups according to their clinical characteristics (group one based on clinical indexes, group two based on metabolomics indexes) and receive a 6-month corresponding treatment. The primary outcome for experiment groups will be the condition of PCOS. All data will be analyzed periodically. This trial will help us to clarify the value of metabolomics integrated with clinical characteristics in diagnosis and treatment of two PCOS subgroups. It will also highlight any differences in the accuracy and efficacy of these two techniques and it may provide a new specific direction of integrated method for the PCOS therapy. Discussion The purpose of this trial is to determine whether integrated metabolomics indexes is more accuracy and effective than clinical characteristics in diagnose the phenotypes of reproductive females with PCOS. This trial will, therefore, contribute to providing a solid foundation for clinical precise diagnosis of two PCOS subgroups, as well as future research in PCOS individual therapy.

scholarly journals The challenge of improving boiling: lessons learned from a randomized controlled trial of water pasteurization and safe storage in Peru

2016 ◽  
Vol 144 (10) ◽  
pp. 2230-2240 ◽  
Author(s):  
K. HEITZINGER ◽  
C. A. ROCHA ◽  
R. E. QUICK ◽  
S. M. MONTANO ◽  
D. H. TILLEY ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Drinking Water ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Future Research ◽  
Control Group ◽  
Drinking Water Contamination ◽  
Storage Container ◽  
Safe Storage ◽  
Randomized Controlled

SUMMARYBoiling is the most common method of household water treatment in developing countries; however, it is not always effectively practised. We conducted a randomized controlled trial among 210 households to assess the effectiveness of water pasteurization and safe-storage interventions in reducingEscherichia colicontamination of household drinking water in a water-boiling population in rural Peru. Households were randomized to receive either a safe-storage container or a safe-storage container plus water pasteurization indicator or to a control group. During a 13-week follow-up period, households that received a safe-storage container and water pasteurization indicator did not have a significantly different prevalence of stored drinking-water contamination relative to the control group [prevalence ratio (PR) 1·18, 95% confidence interval (CI) 0·92–1·52]. Similarly, receipt of a safe-storage container alone had no effect on prevalence of contamination (PR 1·02, 95% CI 0·79–1·31). Although use of water pasteurization indicators and locally available storage containers did not increase the safety of household drinking water in this study, future research could illuminate factors that facilitate the effective use of these interventions to improve water quality and reduce the risk of waterborne disease in populations that boil drinking water.

scholarly journals Accuracy and efficacy of diagnosis using clinical characteristics integrated with metabolomics in patients with polycystic ovary syndrome: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Cheng-Ming Ni ◽  
Wen-Long Huang ◽  
Yan-min Jiang ◽  
Juan Xu ◽  
Ru Duan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Clinical Characteristics ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Control Group ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Group 2 ◽  
Group 1

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome, and the mechanisms underlying its various clinical signs and symptoms are still poorly understood. It is critical to precisely diagnose the phenotypes of PCOS in order to provide patients with individualized therapy[1, 2] . However, the criteria by which to diagnose different phenotypes, which are mostly based on symptoms, physical examination, and laboratory evaluation, remain unclear. The aim of this study is to compare the accuracy and precision of metabolomic markers with common clinical characteristics to determine a more effective way to diagnose and treat two subgroups, one based on clinical indexes and another based on metabolomic indexes[3], of PCOS patients. The effects of different the interventions based on the two subgroups will also be observed. Methods This is a prospective, multicenter, analyst-blinded, randomized controlled trial. There will be one healthy control group and two parallel experimental arms in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed based on clinical indexes (group 1); (3) PCOS patients diagnosed based on metabolomic indexes (group 2). A total of 276 eligible people will be recruited, including 60 healthy people and 216 PCOS patients, who will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in the two different diagnosis groups will be divided into two different subgroups based on their clinical characteristics (group 1 based on clinical indexes, group 2 based on metabolomic indexes); thereafter, they will receive a 6-month different treatment. The primary outcome for experimental groups will be the treatment effect of PCOS. Discussion The purpose of this trial is to determine whether integrated metabolomic indexes are more accurate and effective than clinical characteristics in the diagnosis of the phenotypes of reproductive females with PCOS. This trial will therefore contribute to the provision of a solid foundation for the precise clinical diagnosis of two PCOS subgroups, as well as for future research on individualized PCOS therapy.

scholarly journals Enhanced self-efficacy after a self-management programme in pituitary disease: a randomized controlled trial

2017 ◽  
Vol 177 (1) ◽  
pp. 59-72 ◽  
Author(s):  
Cornelie D Andela ◽  
Han Repping-Wuts ◽  
Nike M M L Stikkelbroeck ◽  
Mathilde C Pronk ◽  
Jitske Tiemensma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Illness Perceptions ◽  
Social Issues ◽  
Controlled Trial ◽  
Self Management ◽  
Future Research ◽  
Control Group ◽  
Randomized Controlled ◽  
Pituitary Disease

ContextPatients with pituitary disease report impairments in Quality of Life (QoL) despite optimal biomedical care. Until now, the effects of a self-management intervention (SMI) addressing psychological and social issues for these patients and their partners have not been studied.ObjectiveTo examine the effects of a SMI i.e. Patient and Partner Education Programme for Pituitary disease (PPEP-Pituitary).Design and subjectsA multicentre randomized controlled trial included 174 patients with pituitary disease, and 63 partners were allocated to either PPEP-Pituitary or a control group. PPEP-Pituitary included eight weekly sessions (90 min). Self-efficacy, bother and needs for support, illness perceptions, coping and QoL were assessed before the intervention (T0), directly after (T1) and after six months (T2). Mood was assessed before and after each session.ResultsPatients in PPEP-Pituitary reported improved mood after each session (except for session 1). In partners, mood only improved after the last three sessions. Patients reported higher self-efficacy at T1 (P = 0.016) which persisted up to T2 (P = 0.033), and less bother by mood problems directly after PPEP-Pituitary (P = 0.01), but more bother after six months (P = 0.001), although this increase was not different from baseline (P = 0.346). Partners in PPEP-Pituitary reported more vitality (P = 0.008) which persisted up to T2 (P = 0.034). At T2, partners also reported less anxiety and depressive symptoms (P ≤ 0.014).ConclusionThis first study evaluating the effects of a SMI targeting psychosocial issues in patients with pituitary disease and their partners demonstrated promising positive results. Future research should focus on the refinement and implementation of this SMI into clinical practice.

Evaluation of a Decision Aid for Women with Epilepsy Who Are Considering Pregnancy: A Randomized Controlled Trial

2017 ◽  
Vol 37 (5) ◽  
pp. 589-599 ◽  
Author(s):  
Amanda McGrath ◽  
Louise Sharpe ◽  
Suncica Lah ◽  
Kaitlyn Parratt
Keyword(s):  
Randomized Controlled Trial ◽  
Decision Aid ◽  
Controlled Trial ◽  
Future Research ◽  
Control Group ◽  
Childbearing Age ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cohen’S D ◽  
Cohen's D

Background. For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. Objective. This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families. Methods. Seventy-nine WWE of childbearing age were recruited from Epilepsy Action Australia between October and November 2013 and randomized to receive the intervention (the DA) or not, and to complete a set of questionnaires pre- and post- intervention. The DA, delivered as a PDF booklet, provided balanced evidence-based information about options, risks and benefits, including probabilities; as well as steps for clarifying values and considering options within one’s personal situation. Results. Compared with the control group, the DA group had statistically significant improvements in knowledge about pregnancy and epilepsy (Cohen’s d = 1.24; 95%CI = 0.77 to 1.83) and reduced decisional conflict (Cohen’s d = 0.59; 95%CI = 0.21 to 0.99). Changes in decision self-efficacy, certainty of choice, patient-practitioner communication abilities and value congruence with choice were comparable between the DA and control group. Importantly, women’s decisions about motherhood were not biased towards either direction, and there were no adverse effects on depression or anxiety. All women who received the DA indicated they would recommend it to other WWE. Conclusions. The DA has the potential to serve as a useful support tool for WWE who are considering motherhood. Future research is needed to test the DA in clinical settings with guidance from a health professional. The trial was registered with the Australian New Zealand Clinical Trials Registry (ID ACTRN12613001082796).

scholarly journals Effectiveness and sustainability of a motor-cognitive stepping exergame training on stepping performance in older adults: a randomized controlled trial

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Klaus Hauer ◽  
Elena Litz ◽  
Michaela Günther-Lange ◽  
Caroline Ball ◽  
Eling D. de Bruin ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Future Research ◽  
Control Group ◽  
Randomized Controlled ◽  
Balance Exercises

Abstract Background Training effects reported for stepping exergames on stepping performances in older adults often based on not comprehensively validated outcomes measures, and follow-up data on their sustainability are lacking. The aim of this study is to evaluate the effectiveness and sustainability of a motor-cognitive stepping exergame training on the stepping performance in older adults. Methods Fifty-eight older adults (78.3 ± 6.5 years) participated in the randomized controlled trial with a 10-week intervention and 10-week follow-up period. The intervention group (IG: n = 29) took part in a once-weekly exercise program including strength and balance exercises supplemented with an additional stepping exergame training. The control group (CG: n = 29) only performed the strength and balance exercises. Outcome measures included stepping reaction times (SRTs) and games scores for individual stepping exergame levels and for the overall exergame performance, as measured by an assessment strategy previously validated in older adults. Results SRTs and/or games scores for 7 out of 10 levels and the overall exergame performance significantly improved in the IG compared to the CG during the intervention (p ≤ 0.001–0.039, ηp2 = 0.090–0.445). Training gains were sustained for 2 levels and for the overall exergame performance (p = 0.017–0.033, ηp2 = 0.127–0.193). Conclusion The study demonstrates that the additional stepping exergame training effectively and sustainably improves the performance in complex motor-cognitive stepping exergame tasks in older adults, which can be relevant for preventing falls. Future research is needed to evaluate the effectiveness of such training on reducing the number of falls. Trial registration ISRCTN registry, ISRCTN14855620, 06/06/2019 (retrospectively registered).

scholarly journals A Randomized Controlled Trial to Evaluate Interventions Designed to Improve University Students' Subjective Financial Wellness in the United Kingdom

2020 ◽  
Vol 31 (2) ◽  
pp. 296-312
Author(s):  
Kelly Ann Schmidtke ◽  
Antony Elliott ◽  
Krishane Patel ◽  
Derek King ◽  
Ivo Vlaev
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Future Research ◽  
Control Group ◽  
Financial Behaviors ◽  
Randomized Controlled ◽  
Financial Wellness ◽  
Subjective Perceptions ◽  
The United Kingdom

This article describes a randomized controlled trial to evaluate the effectiveness of intervention tools designed to help people save more or spend less money by enhancing their capabilities, motivations, and opportunities. The participants included 177 students from an English University who were randomly allocated to either the Control, Savings-Tool, or Savings+Habit-Tools group. Participants provided with the intervention tool(s) for 4 weeks were more likely to experience improvements in both their financial satisfaction and subjective perceptions than those in the Control group not asked to use either tool. The tools did not significantly affect financial behaviors or objective financial wellness. The discussion examines limitations of the study and discusses avenues for future research such as including a longer follow-up period.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

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