Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness

AbstractObjectivesTo determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children.DesignPragmatic randomised open label superiority trial with two parallel groups.Setting96 general practices in Wales and western and southern England.Participants483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded.InterventionsParticipants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.Main outcome measuresThe primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.Results483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score over the 16 week period was 7.5 (SD. 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group. No statistically significant difference was found in weekly POEM scores between groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additives group were 0.41 points higher than in the bath additives group (95% confidence interval −0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects.ConclusionsThis trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.

Download Full-text

Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-050627 ◽

2021 ◽

Vol 11 (12) ◽

pp. e050627

Author(s):

Domenico Giacco ◽

Agnes Chevalier ◽

Megan Patterson ◽

Thomas Hamborg ◽

Rianna Mortimer ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Social Activities ◽

Social Contacts ◽

Coaching Intervention ◽

Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

Download Full-text

The effect of group-based education on gastrointestinal symptoms and quality of life in patients with celiac disease: randomized controlled clinical trial

BMC Gastroenterology ◽

10.1186/s12876-022-02096-1 ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Zahra Akbari Namvar ◽

Reza Mahdavi ◽

Masood Shirmohammadi ◽

Zeinab Nikniaz

Keyword(s):

Quality Of Life ◽

Celiac Disease ◽

Gastrointestinal Symptoms ◽

Control Group ◽

Post Intervention ◽

Sf 36 ◽

Gi Symptoms ◽

Significant Difference ◽

The Mean

Abstract Background In this trial, we investigated the effect of a group-based education program on gastrointestinal (GI) symptoms and quality of life (QOL) in patients with celiac disease (CD). Method In the present study, 130 patients with CD who were on a GFD for at least 3 months, randomly assigned to receive group-based education (n = 66) or routine education in the celiac clinic (n = 64) for 3 months. We assessed gastrointestinal symptoms and quality of life using the gastrointestinal symptom rating scale (GSRS) questionnaire and SF-36 questionnaire at baseline and 3 months after interventions. Results The mean age of the participants was 37.57 ± 9.59 years. There were no significant differences between the two groups regarding the baseline values. Results showed that the mean score of total GSRS score in the intervention group was significantly lower compared with the control group 3 months post-intervention (p = 0.04). Also, there was a significant difference in the mean score of SF-36 between the two groups 3 months post-intervention (p = 0.02). Conclusion Results showed that group-based education was an effective intervention in patients with celiac disease to improve gastrointestinal symptoms and quality of life. Trial registration IRCT code: IRCT20080904001197N21; registration date: 5/23/2019.

Download Full-text

Relationship between Quality of Life and Occupational Accidents in South-East of Iran (Zahedan)

Global Journal of Health Science ◽

10.5539/gjhs.v9n2p112 ◽

2016 ◽

Vol 9 (2) ◽

pp. 112 ◽

Cited By ~ 1

Author(s):

Fereydoon Laal ◽

Mohammad Jafari Modrek ◽

Davoud Balarak ◽

Mahdi Mohammadi ◽

Mahdieh Rakhshani ◽

...

Keyword(s):

Quality Of Life ◽

Psychological Health ◽

Statistical Significance ◽

Occupational Accidents ◽

Control Group ◽

Life Questionnaire ◽

Significant Difference ◽

The Mean ◽

And Control

<p>With the development of science and technology, occupational accidents, as one of the most important problems in the world, result in negative effects on physical and psychological health, and also the quality of life of workers. The aim of this study was to compare the quality of life among workers with and without accident. In a cross-sectional study, 93 workers were selected, 31 who experienced accident and 62 as control group. To gather the data, a researcher-made questionnaire for demographic characteristics and the quality of life questionnaire (SF-36) were used. Mann-Whitney and Chi-square tests were used for data analysis. The mean and standard deviation of age was 30.81±7.29 and 30.56±7.19 in workers with accident (case group) and control group, respectively. Homogeneity was ensured in terms of age and work experience and the two groups had no significant difference in this regard (p>0.05). Most of the participants were high school graduates (67.7%). The majority of accidents (68.8%) had occurred in the manufacturing sections. The most common accident type was sprayed chemical substances (19.4%) and the less frequent was electrocution (3.2%). The mean total score for the quality of life was 37.61±14.29 and 74.92±12.95 in the case and control groups with a statistical significance difference (p<0.001). The results of this study indicate that the incident could affect the quality of life of workers. Therefore, promoting the safety culture can help to reduce the occupational accidents.</p>

Download Full-text

THE EFFECT OF ANTICONVULSANT DRUGS ON SERUM THYROID-STIMULATING HORMONE

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2021.v14i5.41329 ◽

2021 ◽

pp. 144-146

Author(s):

NEETHU T T ◽

SYAM S ◽

BEENA V ◽

DHANYA S P

Keyword(s):

Quality Of Life ◽

Thyroid Function ◽

Sodium Valproate ◽

Thyroid Stimulating Hormone ◽

Control Group ◽

Significant Difference ◽

Epileptic Patients ◽

The Mean ◽

Stimulating Hormone

Objective: Antiepileptic (AED) drugs are an integral component of the management of seizure disorder; however, they have a wide spectrum of adverse effects. It is important to be aware of these side effects as they have a major impact on the quality of life and are sometimes partially reversible after drug discontinuation. Among them, the influence of AED on thyroid function is an important one. However, there is only limited data available. The objective of this study is to evaluate the effect of AED on thyroid-stimulating hormone (TSH). Methods: A cross-sectional study of 1-year duration (march 2017 – march 2018) was conducted among 150 epileptic patients receiving phenytoin, carbamazepine, and sodium valproate for more than 6 months in a tertiary care center in central Kerala. Serum levels of TSH of patients on AED were compared with that of 50 healthy age- and sex-matched control groups. Data regarding the same were analyzed using SPSS version 16 with the Chi-square test, ANOVA, and independent t-test. Results: A total of 150 epileptic patients with a mean age of 35.54 + 10.72, including 66 males (44%) and 84 females (56%) were enrolled in this study. Fifty adults of mean age 36.5+ 8.4 and male to female ratio 1.10:1 formed the control group. It was found that the mean TSH value of patients on phenytoin (3.97+ 1.47), carbamazepine (3.57+ 1.44), and sodium valproate 3.03 + 1.41 significantly higher than that of the control group (1.91 + 0.72). On comparing the mean serum TSH of the drug group significant difference noted between phenytoin and sodium valproate treated group. Among the 12 patients develop subclinical hypothyroidism 65% taking drugs for more than 5 years. Conclusion: There is a positive correlation between the use of anticonvulsants and thyroid dysfunction and the association increases with the duration of therapy. The clinicians should be encouraged for regular monitoring of thyroid function test to impart a better quality of life to the patients.

Download Full-text

Endoscope-assisted (with robotic guidance and using a hybrid technique) interhemispheric transcallosal hemispherotomy: a comparative study with open hemispherotomy to evaluate efficacy, complications, and outcome

Journal of Neurosurgery Pediatrics ◽

10.3171/2018.8.peds18131 ◽

2019 ◽

Vol 23 (2) ◽

pp. 187-197 ◽

Cited By ~ 4

Author(s):

P. Sarat Chandra ◽

Heri Subianto ◽

Jitin Bajaj ◽

Shabari Girishan ◽

Ramesh Doddamani ◽

...

Keyword(s):

Quality Of Life ◽

Blood Loss ◽

Hospital Stay ◽

Primary Outcome ◽

Operating Time ◽

First Episode ◽

Hybrid Technique ◽

The Mean ◽

Secondary Outcomes

OBJECTIVEEndoscope-assisted hemispherotomy (EH) has emerged as a good alternative option for hemispheric pathologies with drug-resistant epilepsy.METHODSThis was a prospective observational study. Parameters measured included primary outcome measures (frequency, severity of seizures) and secondary outcomes (cognition, behavior, and quality of life). Blood loss, operating time, complications, and hospital stay were also taken into account. A comparison was made between the open hemispherotomy (OH) and endoscopic techniques performed by the senior author.RESULTSOf 59 cases (42 males), 27 underwent OH (8 periinsular, the rest vertical) and 32 received EH. The mean age was 8.65 ± 5.41 years (EH: 8.6 ± 5.3 years; OH: 8.6 ± 5.7 years). Seizure frequency per day was 7 ± 5.9 (EH: 7.3 ± 4.6; OH: 15.0 ± 6.2). Duration of disease (years since first episode) was 3.92 ± 1.24 years (EH: 5.2 ± 4.3; OH: 5.8 ± 4.5 years). Number of antiepileptic drugs per patient was 3.9 ± 1.2 (EH: 4.2 ± 1.2; OH: 3.8 ± 0.98). Values for the foregoing variables are expressed as the mean ± SD. Pathologies included the following: postinfarct encephalomalacia in 19 (EH: 11); Rasmussen’s syndrome in 14 (EH: 7); hemimegalencephaly in 12 (EH: 7); hemispheric cortical dysplasia in 7 (EH: 4); postencephalitis sequelae in 6 (EH: 2); and Sturge-Weber syndrome in 1 (EH: 1). The mean follow-up was 40.16 ± 17.3 months. Thirty-nine of 49 (79.6%) had favorable outcomes (International League Against Epilepsy class I and II): in EH the total was 19/23 (82.6%) and in OH it was 20/26 (76.9%). There was no difference in the primary outcome between EH and OH (p = 0.15). Significant improvement was seen in the behavioral/quality of life performance, but not in IQ scores in both EH and OH (p < 0.01, no intergroup difference). Blood loss (p = 0.02) and hospital stay (p = 0.049) were less in EH.CONCLUSIONSEH was as effective as the open procedure in terms of primary and secondary outcomes. It also resulted in less blood loss and a shorter postoperative hospital stay.

Download Full-text

Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial

BMC Geriatrics ◽

10.1186/s12877-020-01870-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Stefan Zechmann ◽

Oliver Senn ◽

Fabio Valeri ◽

Stefan Essig ◽

Christoph Merlo ◽

...

Keyword(s):

Quality Of Life ◽

Primary Care ◽

Patient Safety ◽

Mean Difference ◽

Control Group ◽

Cluster Randomised ◽

Significant Difference ◽

The Mean ◽

Multimorbid Patients

Abstract Background Management of patients with polypharmacy is challenging, and evidence for beneficial effects of deprescribing interventions is mixed. This study aimed to investigate whether a patient-centred deprescribing intervention of PCPs results in a reduction of polypharmacy, without increasing the number of adverse disease events and reducing the quality of life, among their older multimorbid patients. Methods This is a cluster-randomised clinical study among 46 primary care physicians (PCPs) with a 12 months follow-up. We randomised PCPs into an intervention and a control group. They recruited 128 and 206 patients if ≥60 years and taking ≥five drugs for ≥6 months. The intervention consisted of a 2-h training of PCPs, encouraging the use of a validated deprescribing-algorithm including shared-decision-making, in comparison to usual care. The primary outcome was the mean difference in the number of drugs per patient (dpp) between baseline and after 12 months. Additional outcomes focused on patient safety and quality of life (QoL) measures. Results Three hundred thirty-four patients, mean [SD] age of 76.2 [8.5] years participated. The mean difference in the number of dpp between baseline and after 12 months was 0.379 in the intervention group (8.02 and 7.64; p = 0.059) and 0.374 in the control group (8.05 and 7.68; p = 0.065). The between-group comparison showed no significant difference at all time points, except for immediately after the intervention (p = 0.002). There were no significant differences concerning patient safety nor QoL measures. Conclusion Our straight-forward and patient-centred deprescribing procedure is effective immediately after the intervention, but not after 6 and 12 months. Further research needs to determine the optimal interval of repeated deprescribing interventions for a sustainable effect on polypharmacy at mid- and long-term. Integrating SDM in the deprescribing process is a key factor for success. Trial registration Current Controlled Trials, prospectively registered ISRCTN16560559 Date assigned 31/10/2014. The Prevention of Polypharmacy in Primary Care Patients Trial (4P-RCT).

Download Full-text

Efficacy and Safety of Electro-Acupuncture (EA) on Insomnia in Patients with Lung Cancer: Study Protocol of a Randomized Controlled Trial

10.21203/rs.3.rs-20546/v1 ◽

2020 ◽

Author(s):

Hongyu Yue ◽

Shuang Zhou ◽

Huangan Wu ◽

Xuan Yin ◽

Shanshan Li ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Cancer Survivors ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Secondary Outcomes

Abstract Background : Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients’ quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. Method : This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). The primary outcome will be assessed at baseline, week 4, week 8, week 12 and week 20. The secondary outcomes will only be assessed at baseline and week 8. Discussion : This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. Trial registration: ChiCTR, ChiCTR1900026395, Registered 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068

Download Full-text

Effect of an Educational Intervention on Quality of Life and Sexual Function in Women with Endometriosis

International Journal of Studies in Nursing ◽

10.20849/ijsn.v3i2.452 ◽

2018 ◽

Vol 3 (2) ◽

pp. 127 ◽

Cited By ~ 1

Author(s):

Hend Abdallah EL Sayed ◽

Samia Abdel Hakeem Hanseen Aboud

Keyword(s):

Quality Of Life ◽

Sexual Function ◽

Educational Intervention ◽

University Hospital ◽

Control Group ◽

Study Group ◽

Significant Difference ◽

Quasi Experimental ◽

The Mean

Aim of the study was to investigate the effect of an educational intervention on quality of life and sexual function in women with endometriosis. Design: Quasi experimental time series research design. Setting: obstetrics and gynecology outpatient clinic affiliated to Benha University Hospital and Benha teaching Hospital. Sample: A purposive sample of 138 women diagnosed with endometriosis was eligible in the study and assigned equally into study and control groups. Tools for data collection: A structured interviewing questionnaire, Endometriosis Health Profile Questionnaire-30 and Sexual Health Outcomes in Women Questionnaire. Results: There was no statistically significant difference between both groups regarding demographic and obstetrical characteristics (p ˃ 0.05). Before implementation of educational intervention, the mean scores of total EHP-30 and SHOW-Q showed impaired quality of life and sexual function in the both groups (p ˃ 0.05). After one and two months of educational intervention implementation, mean total score of EHP-30 was significantly lowered in the study group compared with the control group. The mean scores of satisfaction, orgasm, and desire subscales were significantly higher in study group compared with control group. Whereas, the mean score of the pelvic problem interference subscale was significantly lower in study group compared with control group (p ≤ 0.001). Conclusion: The educational intervention about endometriosis has significant effect on the improvement of women's quality of life and sexual function. Recommendation: Provide health educational program for women with endometriosis to improve quality of life as well as sexual function.

Download Full-text

The Effect of Capsella bursa-pastoris Extract on Heavy Menstrual Bleeding and Quality of Life in Patients with Uterine Leiomyoma: A Double-blind Randomized Clinical Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v31i330303 ◽

2019 ◽

pp. 1-10

Author(s):

Atieh Sadat Danesh ◽

Faraz Mojab ◽

Abolfazl Mohammadbeigi ◽

Soodabeh Bioos ◽

Zahra Siaghati ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Uterine Leiomyoma ◽

Intervention Group ◽

Menstrual Bleeding ◽

Control Group ◽

Double Blind ◽

Significant Difference ◽

The Mean

Objectives: Heavy Menstrual Bleeding (HMB) is the most important problems of Uterine Leiomyoma (UL). This study aimed to assess the effect of the extract of the Capsella bursa-pastoris (CBP) on the control of HMB and quality of life in patients with uterine leiomyoma. Design: In a double-blind randomized, clinical trial 54 women with uterine leiomyoma were randomly assigned to the intervention/control groups by block randomization. Setting: Gynecology outpatient clinics. Intervention: The intervention group received 350 mg of alcoholic extract of Capsella bursa-pastoris and the control group received placebo twice daily for three months. Main Outcome Measures: Amount of bleeding by Pictorial blood loss assessment chart (PBAC), quality of life by menstrual quality of life questionnaires (MQ) and bleeding duration by calendar were evaluated. Results: The mean of PBAC decreased from 464.00± 283.61 at baseline to 323.82±207.66 in the intervention group and decreased from 445.92±362.64 to 214.36±137.68 in control group in the third month. The improvement trend was significant in the two groups, but there was no significant difference between groups. The mean of bleeding duration and menstrual quality of life showed improvement in patients of two groups without significant difference between the two groups. Conclusion: Despite the effectiveness of CBP in the intervention group in decreasing of PBAC score and menstrual bleeding duration and improvement of menstrual quality of life in patients who suffered from UL, it did not show a significant effect compared to the control group. Future studies with a larger sample size in one specific type of UL suggested.

Download Full-text

Evaluating the Effectiveness of Planned Discharge Program in the Quality of Life of Gastrointestinal Cancer Patients Undergoing Chemotherapy: A Clinical Trial Study

Medical - Surgical Nursing Journal ◽

10.5812/msnj.101442 ◽

2020 ◽

Vol 9 (1) ◽

Author(s):

Somaye Chare Joo ◽

Ali Navidian ◽

Simin Sharifi

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Gastrointestinal Cancer ◽

Intervention Group ◽

Home Visits ◽

Routine Care ◽

Control Group ◽

Significant Difference ◽

The Mean

Background: Considering recent economic challenges, the short-term hospitalization of cancer patients for routine chemotherapy, and the lack of routine home visits for cancer patients in Iran, the quality of life of these patients after discharge can be a source of concern. Objectives: This study aimed to determine the effect of a planned discharge program on the quality of life of gastrointestinal cancer patients undergoing chemotherapy in hospitals of Zahedan University of Medical Sciences. Methods: This clinical trial was conducted in 2018 on gastrointestinal cancer patients undergoing chemotherapy in hospitals affiliated to the Zahedan University of Medical Sciences. The sample was selected by convenience sampling, and the participants were randomly assigned into two groups of intervention (n = 45) and control (n = 45). The intervention was performed in three 45 to 60-minute sessions and sending text messages, which were based on the patients’ identified problems and needs for the intervention group. Data collection tools included the QLQ-C30 questionnaire and a demographic characteristics form. Data were analyzed by SPSS V. 21 software using descriptive and analytical statistical tests. Results: The mean scores of the patients’ quality of life increased on most of the functional subscales and global health/quality of life in the intervention group. In the control group (routine care), however, no significant difference was observed in most functional subscales of quality of life. There was a significant change in the mean severity of symptoms in the intervention group so that the severity of symptoms decreased after the intervention. In the control group, there was a significant difference in the mean severity of symptoms before and after the intervention so that the severity of symptoms increased in most cases. Conclusions: Home visits of cancer patients are not in routine care after discharge in Iran, and they are not covered by insurance companies. Thus, home visits are expensive. However, in areas where the economic index is low, and patients have little access to smartphones, the planned discharge program can be a suitable method to increase the quality of life of cancer patients.

Download Full-text