scholarly journals Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e051710
Author(s):  
Sze Ling Chan ◽  
Julian Thumboo ◽  
Jacky Boivin ◽  
Seyed Ehsan Saffari ◽  
Shanqing Yin ◽  
...  
Keyword(s):  
Semen Analysis ◽  
Randomised Trial ◽  
Married Couples ◽  
Control Group ◽  
Type I ◽  
Age At First Birth ◽  
Fertility Awareness ◽  
Hybrid Type ◽  
Study Results ◽  
Post Randomisation

IntroductionBirth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural change component targeting modifiable psychological constructs to modify fertility awareness and childbearing intentions. We aim to evaluate the effect of these two interventions on knowledge, attitudes and practice around childbearing compared with a control group among young married couples in Singapore and understand the implementation factors in the setting of an effectiveness-implementation hybrid type 1 three-arm randomised trial.Methods and analysisWe will randomise 1200 young married couples to no intervention (control), Fertility Health Screening group (FHS) or Fertility Awareness Tools (FAT) in a 7:5:5 ratio. Couples in FHS will undergo an anti-Mullerian hormone test and semen analysis, a doctor’s consultation to explain the results and standardised reproductive counselling by a trained nurse. Couples in FAT will watch a standardised video, complete an adapted fertility status awareness (FertiSTAT) tool and receive an educational brochure. The attitudes, fertility knowledge and efforts to achieve pregnancy of all couples will be assessed at baseline and 6 months post-randomisation. Birth statistics will be tracked using administrative records at 2 and 3 years. The primary outcome is the change in the woman’s self-reported intended age at first birth between baseline and 6 months post-randomisation. In addition, implementation outcomes and cost-effectiveness of the two interventions will be assessed.Ethics and disseminationThis study has been reviewed and approved by the Centralized Institutional Review Board of SingHealth (2019/2095). Study results will be reported to the study funder and there are plans to disseminate them in scientific conferences and publications, where authorship will be determined by the International Committee of Medical Journal Editors guidelines.Trial registration numberNCT04647136; ClinicalTrails.gov Identifier.

PP16 Prehospital recognition and antibiotics for 999 patients with sepsis: feasibility study results

2019 ◽  
Vol 36 (10) ◽  
pp. e8.1-e8
Author(s):  
Jenna Bulger ◽  
Susan Allen ◽  
Jan Davies ◽  
Timothy Driscoll ◽  
Gemma Ellis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Early Recognition ◽  
Randomised Trial ◽  
Intervention Group ◽  
Final Diagnosis ◽  
Outcome Data ◽  
Control Group ◽  
Serious Adverse Events ◽  
Study Results ◽  
The Mean

BackgroundSepsis is a common condition which kills approximately 44,000 people annually in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve outcomes. Paramedics frequently attend patients with sepsis, and are well placed to provide early diagnosis and treatment. We aimed to assess whether a multi-centre randomised trial to evaluate pre-hospital antibiotics was feasible.MethodsVolunteer paramedics used scratchcards to allocate patients with ‘Red Flag’ Sepsis at random between experimental and control arms. The primary outcome was mortality at six months. We also measured: adverse events, costs, final diagnosis, length of stay in hospital, and quality of care; and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on: recruitment of paramedics and patients; retrieval of outcome data; safety; acceptability; and diagnostic accuracy.ResultsFifty-four paramedics completed their training and were issued scratchcards to randomly allocate patients to trial arms. Patients were recruited from 1.12.17 to 31.5.18. In total, 118 patients were randomly allocated to trial arms; four patients dissented to be included in the trial, leaving 114 patients to follow-up. Sixty-two patients (54%) were allocated to the intervention arm. The mean age of the control arm was 71.2 years (range 28–97); 33 (65%) control participants were female. In the intervention arm the mean age was 75.6 years (range 30–99) and 38 patients (61%) were female. Nine patients in the control group (18%) and 17 in the intervention group (28%) were already taking antibiotics at the time of their 999 call. Twenty-three questionnaires were received. No serious adverse events were reported.ConclusionsComplete results will be presented at the time of the conference, when routine linked anonymised outcomes are available.

Effect of vitamin D treatment in hypoparathyroid patients: a study on calcium, phosphate and magnesium homeostasis

1997 ◽  
Vol 136 (1) ◽  
pp. 52-60 ◽  
Author(s):  
Lene Mortensen ◽  
Lars Hyldstrup ◽  
Peder Charles
Keyword(s):  
Vitamin D ◽  
Calcium Phosphate ◽  
Control Group ◽  
Type I ◽  
Calcium Balance ◽  
Phosphate Homeostasis ◽  
Balance Study ◽  
Magnesium Homeostasis ◽  
Study Results

Abstract Aim: This study was undertaken to examine the effects of long-term vitamin D treatment on calcium, phosphate and magnesium homeostasis at organ level in hypoparathyroid patients. Methods: Fifteen vitamin D-treated hypoparathyroid patients were studied, eight of the patients in a combined 47Ca kinetic and calcium, phosphate and magnesium balance study. Results were compared with a matched control group of 12 normal individuals. Results: All the patients had normal serum levels of calcium, phosphate and magnesium. Absolute intestinal calcium absorption was increased (P <00001). Urinary calcium excretion was normal, but active tubular calcium reabsorption (TmCa/glomerular filtration rate) was low (P<0·001). Bone resorption rates and bone mineralization rates were very low (P <0001 and P <0·05). Twenty-four-hour urinary hydroxyproline excretion and serum cross-linked carboxyterminal telopeptide of type I were in the upper normal range. Serum alkaline phosphatase was normal, but serum carboxyterminal propeptide of human type I procollagen and serum osteocalcin were significantly reduced (P <0·05). Calcium balance was positive and significantly different from controls (P <0·001). All parameters from phosphate homeostasis were normal. Intestinal magnesium absorption was low though not significantly different from normal (P = 0·06). Urinary excretion of magnesium was not significantly higher than normal, but renal magnesium reabsorption was reduced (P <0·001). Magnesium balance was low, though the difference was not significant (P <0·06). Conclusion: Long-term vitamin D treatment in hypoparathyroid patients resulted in a positive calcium balance. Bone turnover was very low. Results of bone markers and resorption rate were conflicting. Vitamin D treatment apparently normalized the abnormalities previously found in phosphate homeostasis of hypoparathyroid patients. Magnesium homeostasis was disturbed, with a more negative balance compared with normal subjects, implying a state of magnesium deficiency in these patients. European Journal of Endocrinology 136 52–60

scholarly journals Impact of pulse oximetry on hospital referral acceptance in children under 5 with severe pneumonia in rural Pakistan (district Jamshoro): protocol for a cluster randomised trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046158
Author(s):  
Fatima Mir ◽  
Apsara Ali Nathwani ◽  
Suhail Chanar ◽  
Amjad Hussain ◽  
Arjumand Rizvi ◽  
...  
Keyword(s):  
Pulse Oximetry ◽  
Randomised Trial ◽  
Severe Pneumonia ◽  
Sub Saharan Africa ◽  
Control Group ◽  
Danger Sign ◽  
Cluster Randomised ◽  
Hospital Referral ◽  
Study Results ◽  
Children Under 5

BackgroundPneumonia is a leading cause of death among children under 5 specifically in South Asia and sub-Saharan Africa. Hypoxaemia is a life-threatening complication among children under 5 with pneumonia. Hypoxaemia increases risk of mortality by 4.3 times in children with pneumonia than those without hypoxaemia. Prevalence of hypoxaemia varies with geography, altitude and severity (9%–39% Asia, 3%–10% African countries). In this protocol paper, we describe research methods for assessing impact of Lady Health Workers (LHWs) identifying hypoxaemia in children with signs of pneumonia during household visits on acceptance of hospital referral in district Jamshoro, Sindh.Methods and analysisA cluster randomised controlled trial using pulse oximetry as intervention for children with severe pneumonia will be conducted in community settings. Children aged 0–59 months with signs of severe pneumonia will be recruited by LHWs during routine visits in both intervention and control arms after consent. Severe pneumonia will be defined as fast breathing and/or chest in-drawing, and, one or more danger sign and/or hypoxaemia (Sa02 <92%) in PO (intervention) group and fast breathing and/or chest in-drawing and one or more danger sign in clinical signs (control) group. Recruits in both groups will receive a stat dose of oral amoxicillin and referral to designated tertiary health facility. Analysis of variance will be used to compare baseline referral acceptance in both groups with that at end of study.Ethics and disseminationEthical approval was granted by the Ethics Review Committee of the Aga Khan University (4722-Ped-ERC-17), Karachi. Study results will be shared with relevant government and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals.Trial registration numberNCT03588377.

scholarly journals Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030041
Author(s):  
Wei Dai ◽  
Yuanqiang Zhang ◽  
Wenhong Feng ◽  
Xiaoqing Liao ◽  
Yunfei Mu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Symptom Management ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Intervention Group ◽  
Postoperative Recovery ◽  
Control Group ◽  
Oncological Treatment ◽  
Study Results ◽  
Patient Reported

IntroductionSurgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.Methods and analysisThe study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory—lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome—mean symptom threshold events—will be compared between the intervention and control group via independent sample Student’s t-test.Ethics and disseminationThe study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.Trials registration numberChiCTR1900020846.

Penatalaksanaan IMD pada Ibu Postpartum Sectio Caesarea Mempengaruhi Status Gizi dan Kecepatan Produksi ASI

2020 ◽  
Vol 2 (2) ◽  
pp. 112-120
Author(s):  
Nursari Abdul Syukur ◽  
Susi Purwanti
Keyword(s):  
Breast Milk ◽  
Nutritional Status ◽  
Milk Production ◽  
Quantitative Research ◽  
Milk Protein ◽  
Sectio Caesarea ◽  
Control Group ◽  
P Value ◽  
Study Results

Many mothers who give birth to Sectio Caesarea (SC) do not Initiate Early Breastfeeding (IMD), which fails exclusive breastfeeding. This study aimed to determine the effect of IMD management in postpartum SC mothers on nutritional status, speed of milk production, and quality of breast milk protein. Method: quantitative research with quasi approach experiment. The research design used was a pre-post-test control non-equivalent control group. A sampling of this study used the Consecutive method sampling with a sample of 20 mothers who gave birth by cesarean section (SC). Hypothesis testing uses the independent t-test and the Mann-Whitney test. The study results showed an influence on the management of IMD in postpartum SC mothers on the speed of ASI production (p-value=0.004) and nutritional status (p-value=0.028). There was no effect of IMD management on postpartum SC mothers on the quality of breast milk protein (p-value = 0.543). This study recommends that the hospital implement an IMD promotion program before the abdominal wall is closed as a form of intervention to increase milk production and maternal nutritional status

Modern approaches to the treatment of mastitis in women of reproductive age

2016 ◽  
pp. 191-108
Author(s):  
A.A. Sukhanova ◽  
◽  
Yu.M. Melnik ◽  
O.O. Karlova ◽  
◽  
...  
Keyword(s):  
Ultrasound Examination ◽  
Clinical Signs ◽  
Reproductive Age ◽  
Herbal Remedies ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Clinical Method ◽  
Gynecological Examination ◽  
Study Results ◽  
Observation Period

The aim of the study: to study the efficacy and safety of use Mastofemin in the treatment of various forms of mastitis in women of reproductive age. Materials and methods. The study included 62 women of reproductive age (mean age of 33.5±2.3 years) who were screened in the Kiev city center reproductive and perinatal medicine. Women were divided into 2 groups. The first (main) group consisted of 32 patients who received the proposed treatment using herbal remedies Mastofemin 1 capsule 2 times per day for 3 months; 30 patients of the second (control) group were under observation and received no treatment. These groups were representative and homogeneous on age, clinical symptoms and sonographic characteristics. The clinical method included evaluation of complaints of patients, anamnesis, presence of concomitant gynecologic pathology, inspection, palpation of the lymph nodes and the breast and obtaining a discharge from the nipples to conduct cytological examination, which allowed excluding from the study women with suspected malignancy of the process. All the patients were performed ultrasound examination of the breast. The review was supplemented with vaginal gynecological examination and ultrasound examination of small pelvis organs to assess the condition of the uterus and its appendages, the diagnosis of gynecological diseases. Results. Summarizing obtained in this study results one should stress the positive long-term effect of applying Mastofemin for the treatment of proliferative changes of the breast in women of reproductive age. This is manifested by a decrease in the intensity of clinical signs of mastitis, consistent with the results of sonographic control. Established positive dynamics in the treatment of cystic mastitis, dectective and when combined cystic mastopathy with dectective. In the control group of patients for a given observation period (6 months) no significant changes in clinical signs of mastitis and sonographic characteristics. Regression of disease has not occurred in any of the patients, in 2 patients increased sensitivity of the breast after 6 months moved to the soreness. Sonographic characteristics of mastitis during the observation period did not change. Thus, the use of Mastofemin aimed at pathogenetic treatment of mastitis and prevention of breast cancer. Conclusion. Application of Mastofemin during the treatment of mastitis in women of reproductive age significantly improves the clinical condition of patients; reduce the subjective and objective symptoms of the disease. The positive effect of the treatment with Mastofemin proved in the case of the treatment of sonographic following forms of mastitis: cystic mastopathy, cystic mastopathy with dectectasy. Mastofemin may be the drug of choice for complex conservative monotherapy in women of reproductive age with proliferative changes in the breast, and can also be used as part of complex treatment in patients with diffuse changes of the breast when combined with hyperplastic processes of the myometrium and endometrium. Keywords: mastopathy, breast gland, herbal medicine, herbal remedies, Mastofemin.

Brief psycho-education for caregivers of persons with first episode psychosis

2018 ◽  
Vol 9 (01) ◽  
Author(s):  
Praful Prabhuappa Kapse ◽  
Manisha Kiran
Keyword(s):  
First Episode Psychosis ◽  
First Episode ◽  
Control Group ◽  
Episode Psychosis ◽  
Study Results ◽  
Before And After ◽  
Quasi Experimental ◽  
Expressed Emotions ◽  
Experimental Group ◽  
Group Family

Caring for the persons with first episode psychosis is challenging and demanding. It may lead to the increased burden, expressed emotions among the caregivers. The numerous studies have shown that high burden and negative expressed emotions among caregivers can lead to early relapse in the patients with first episode psychosis. To evaluate the effects of the brief psychoeducation on the caregivers burden and expressed emotions. A quasi experimental - before and after with control group research design was adopted for the study. A total of 60 caregivers have participated in the study, of which 30 caregivers in experimental group and 30 caregivers in the control group. Family Burden Interview Schedule (Pai and Kapoor, 1981) and Attitude Questionnaire (Sethi et al., 1981) was used to assess caregiver's burden and expressed emotions. At end of the psychoeducation intervention, burden among caregivers and negative expressed emotions of the caregivers have significantly reduced. The positive expressed emotions have been increased. Study results demonstrates the importance of psychoeducation intervention in reducing the burden and negative expressed emotions.

CARDIOVASCULAR RISK FACTORS PECULIARITIES IN MEN UNDER 60 YEARS OLD WITH MYOCARDIAL INFARCTION AND CHRONIC INFLAMMATORY LUNG DISEASES

2020 ◽  
pp. 21-25
Author(s):  
Tupitsyn V.V. ◽  
Bataev Kh.M. ◽  
Men’shikova A.N. ◽  
Godina Z.N.
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
Heart Disease ◽  
Cardiovascular Risk ◽  
Digestive System ◽  
Control Group ◽  
Study Group ◽  
Type I ◽  
Internal Organs ◽  
History Of

Relevance. Information about the cardiovascular diseases risk factors (CVD RF) for in men with chronic lung inflam-matory pathology (CLID) is contradictory and requires clarification. Aim. To evaluate the peculiarities of CVD RF in men under 60 years of age with CLID in myocardial infarction (MI) to improve prevention. Material and methods. The study included men aged 19-60 years old with type I myocardial infarction. Patients are divided into two age-comparable groups: I - the study group, with CLID - 142 patients; II - control, without it - 424 patients. A comparative analysis of the frequency of observation of the main and additional cardiovascular risk fac-tors in groups was performed. Results. In patients of the study group, more often than in the control group we observed: hereditary burden of is-chemic heart disease (40.8 and 31.6%, respectively; p = 0.0461) and arterial hypertension (54.2 and 44.6%; p = 0.0461), frequent colds (24.6 and 12.0%; p = 0.0003), a history of extrasystoles (19.7 and 12.7%; p = 0.04); chronic foci of infections of internal organs (75.4 and 29.5%; p˂0.0001), non-ulcer lesions of the digestive system (26.1 and 14.6%; p = 0.007), smoking (95.1 and 66.3%; p˂0.0001), MI in winter (40.8 and 25.9%; p = 0.006). Less commonly were observed: oral cavity infections (9.2 and 23.6%; p˂0.0001); hypodynamia (74.5 and 82.5%; p = 0.0358), over-weight (44.4 and 55.2%; p = 0.0136), a subjective relationship between the worsening of the course of coronary heart disease and the season of the year (43.7 and 55.2%; p = 0.0173) and MI - in the autumn (14.1 and 21.9%; p = 0.006) period. Conclusions. The structure of CVD RF in men under 60 years of age with CLID with MI is characterized by the pre-dominance of smoking, non-ulcer pathology of the digestive system, frequent pro-student diseases, meteorological dependence, a history of cardiac arrhythmias and foci of internal organ infections. It is advisable to use the listed factors when planning preventive measures in such patients.

CLINICAL SIGNIFICANCE OF SERUM CAVEOLIN-1 LEVELS IN GASTRIC CANCER PATIENTS

2018 ◽  
Vol 40 (4) ◽  
pp. 323-327 ◽  
Author(s):  
F Tas ◽  
S Karabulut ◽  
K Erturk ◽  
D Duranyildiz
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Histological Grade ◽  
Clinical Importance ◽  
Disease Stage ◽  
Control Group ◽  
Tissue Samples ◽  
Caveolin 1 ◽  
Study Results ◽  
Gastric Cancer Patients

Aim: Caveolin-1 plays a significant role in the pathogenesis of various carcinomas and its expression affects the survival of cancer patients. However, the molecular function of caveolin-1 and its possible clinical importance has remained uncertain in gastric cancer. No clinical trial has examined serum caveolin-1 levels in gastric cancer patients so far, instead all available results were provided from studies conducted on tissue samples. In the current study, we analyzed the soluble serum caveolin-1 levels in gastric cancer patients, and specified its associations with the clinical factors and prognosis. Material and Methods: Sixty-three patients with pathologically confirmed gastric cancer were enrolled into the trial. Serum caveolin-1 concentrations were detected by ELISA method. Thirty healthy subjects were also included in the study. Results: The median age of patients was 62 years, ranging from 28 to 82 years. The serum caveolin-1 levels in gastric cancer patients were significantly higher than those in control group (p < 0.001). The common clinical parameters including patient age, sex, lesion localization, histopathology, histological grade, disease stage, and various serum tumor markers (e.g. LDH, CEA, and CA 19.9) were not found to be associated with serum caveolin-1 levels (p > 0.05). Similarly, no correlation existed between serum caveolin-1 concentration and chemotherapy responsiveness (p = 0.93). Furthermore, serum caveolin-1 level was not found to have a prognostic role (p = 0.16). Conclusion: Even though it is neither predictive nor prognostic, serum caveolin-1 level may be a valuable diagnostic indicator in patients with gastric cancer. Key

PENGARUH PEMBERIAN KOMBINASI EKSTRAK BUAH MENGKUDU (Morinda citrifolia L.) DAN KUNYIT (Curcuma longa) TERHADAP HISTOPATOLOGI GINJAL TIKUS WISTAR YANG DIINDUKSI ALLOXAN

2020 ◽  
Vol 5 (2) ◽  
pp. 319-327
Author(s):  
Pelastri Rahayu ◽  
◽  
Retno Hestiningsih ◽  
Martini Martini ◽  
Dwi Sutiningsih ◽  
...  
Keyword(s):  
Body Weight ◽  
Diabetic Nephropathy ◽  
Blood Glucose ◽  
Curcuma Longa ◽  
Morinda Citrifolia ◽  
Control Group ◽  
Type I ◽  
Turmeric Extract ◽  
Measurement Results ◽  
Diabetes Nephropathy

The prevalence of DM in Riskesdas in 2018 according to the Perkeni consensus in 2015 is higher than according to the Perkeni consensus in 2011, the prevalence was10.9%. The disease can develop into diabetes nephropathy, Increased prevalence of diabetic nephropathy directly proportional with an increase in diabetes prevalence. Diabetic nephropathy is a microvascular complication in diabetics that develops around 30% in patients with type I DM and about 40% in patients with type II DM. Turmeric extract has antioxidant and anti-inflammatory effects to prevent the bad development of diabetes nephropathy. This study looked at the effect of giving a combination of noni and turmeric extract on histopathology of alloxan-induced renal rats. A total of 25 mice were divided into 5 treatment groups, namely the PI group (250 mg / kgBB extract dose), PII group (500 mg / kgBB extract dose), PIII group (750 mg / kgBB extract dose), positive control group (glibenklamid) and negative control group (without extract and glibenklamid). The study used Post Test Only Group. The highest percentage decrease in blood glucose in the PI group was 56.11% and the lowest decrease in the PIII group was 24.12% with p = 0.012. The results of the study were not based on the number of extract doses. The measurement results of rat body weight and glomerular diameter were not affected by blood glucose level with p = 0.700 for body weight and p = 0.187 for glomerular measurement results.

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