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Background | The World Health Organization recommends birth companionship for all women in labor. There is insufficient evidence on birth companionship in low-income settings and it is not clear if role orientation impacts effectiveness. The aim of this study was to assess the efficacy of midwife-led role orientation of birth compa... | PMC10506214 | ||
Methods | A stepped wedge cluster randomized trial conducted (control | PMC10506214 | ||
Results | Mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period ( | PMC10506214 | ||
Conclusion | birth companions | Midwife-led role orientation of birth companions increased maternal satisfaction. Nevertheless, no significant effect was noted in the mode of delivery, length of labor, Apgar score, and need to augment labor. Findings could inform the integration of birth companions in the admission process of the woman in labor in si... | PMC10506214 | |
Trial registration number | NCT04771325. | PMC10506214 | ||
Keywords | PMC10506214 | |||
Background | There has been progress in the maternal and neonatal mortality rates in Uganda. This has been mainly attributed to skilled birth attendance [The World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice to promote a positive childbirth experience [Se... | PMC10506214 | ||
Methods | PMC10506214 | |||
Study setting | The study was carried out in the Bugisu sub-region located in the Eastern part of Uganda. The Bugisu sub-region consists of six districts, including Manafwa, Mbale, Bududa, Sironko, Namisindwa, and Bulambuli. According to the Uganda National Bureau of Statistics, the sub-region is home mainly to the Gisu people with an... | PMC10506214 | ||
Control (usual care) | Women are escorted to the health facilities by one or more family members or friends. One person is allowed besides her to provide support. The support persons do not receive any orientation sessions and have no designated roles. Information is provided on the need arise basis. That is; when the midwife needs anything ... | PMC10506214 | ||
Outcomes | birth companions, anxiety | DILATION, SECONDARY | The primary outcome was the chance of having a spontaneous vaginal delivery. The secondary outcomes were; the incidence of having a spontaneous vaginal delivery, length of labor, Apgar score, coping, anxiety and maternal satisfaction. Maternal anxiety and coping during labor are reported in another article and can be a... | PMC10506214 |
Data management and analysis | Data was entered using excel and imported to STATA 14 for analysis [ | PMC10506214 | ||
Results | PMC10506214 | |||
Discussion | birth companions, anxiety | In this study, we assessed the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and labor outcomes. Results from our study showed that the mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period. And, there were no statis... | PMC10506214 | |
Strengths and limitations of the study | The selected study design had the following strengths; Firstly, the facilities were their own controls hence buffering the effects of heterogeneity. Secondly, the stepped wedge design limited contamination of the intervention arm considering the socio nature of the intervention. Also, subgroup analysis of treatment eff... | PMC10506214 | ||
Acknowledgements | The authors recognize the Swedish International development Agency for funding the study and the participants of this study who voluntarily agreed to take part in this research. | PMC10506214 | ||
Authors’ contributions | GN | SIDA | EWW conceived and designed the study. EWW, GN and NMT implemented the study and conducted data analysis. GN, JKB, and NMT supervised the study. EWW, GN, JKB, and NMT interpreted study results: EWW wrote the first draft of the manuscript. EWW, GN, JKB and NMT reviewed and corrected the draft manuscript. All authors read... | PMC10506214 |
Funding | SIDA | This study is part of EWW’s doctoral research funded by the Swedish International development Agency (SIDA) through a Makerere-Sweden Research collaboration. | PMC10506214 | |
Availability of data and materials | The data that support the findings of this study are available from the first and corresponding author, Eva Wodeya Wanyenze. | PMC10506214 | ||
Declarations | PMC10506214 | |||
Ethics approval and consent to participate | This study was approved by the Makerere School of Health Sciences Research Ethics Committee (SHSREC REF: 2017–54) and the Uganda National Council for Science and Technology (HS377ES). Administrative clearance was also obtained from the health facility (UG-REC-011). Written informed consent was sought from participants ... | PMC10506214 | ||
Consent for publication | Not applicable. | PMC10506214 | ||
Competing interests | The authors declare no competing interests. | PMC10506214 | ||
References | PMC10506214 | |||
Purpose | OBSTRUCTIVE SLEEP APNEA SYNDROME | The aim of the present study was to assess the efficacy of the Ronch®AP palatal device in treating patients with moderate and severe forms of obstructive sleep apnea syndrome. | PMC10066138 | |
Methods | Daytime sleepiness, apnea | In a randomized controlled trial 22 patients were examined with the Ronch®AP palatal device after 4 weeks of usage. Their results were compared to a control group of 30 patients who did not receive any treatment during this time. All patients included did not tolerate CPAP therapy. Among other parameters the apnea–hypo... | PMC10066138 | |
Results | Using the Ronch®AP palatal device AHI was reduced from an average of 35.34 ± 14.9/h to 19.18 ± 14.93/h, whereas the control group only showed a minimal mean reduction from 31.32 ± 12.76/h to 29.37 ± 17.11/h. The difference in reduction between the two randomized groups was highly significant ( | PMC10066138 | ||
Conclusions | OBSTRUCTIVE SLEEP APNEA SYNDROME | The Ronch®AP device is an effective alternative treatment option for patients suffering from moderate and severe forms of obstructive sleep apnea syndrome and not tolerating CPAP therapy. | PMC10066138 | |
Trial registration number | DER | 407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München). | PMC10066138 | |
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10066138 | ||
Introduction | chronic disorder, hypopneas, fatigue, choking, airway obstruction, hypopnea, OSA, apnea, daytime sleepiness, Apnea, snoring, arousals, impaired cognition or cardiovascular events, OSAS, collaps, hypopnea inspiratory airflow | CHRONIC DISORDER, CHOKING, OBSTRUCTIVE SLEEP APNEA SYNDROME, AIRWAY OBSTRUCTION, COLLAPSE, EVENTS, EXCESSIVE SLEEPINESS | Obstructive sleep apnea syndrome (OSAS) is a common chronic disorder caused by repetitive pharyngeal collapse during sleep leading to complete or partial airway obstruction during inspiratory airflow. It is characterized by frequent reoccurrences of hypopneas and apneas resulting in strongly compromised blood oxygenati... | PMC10066138 |
Materials and methods | PMC10066138 | |||
Patients and features | OSAS, daytime sleepiness | CAVITY | From October 2016 to August 2019, 60 patients were evaluated at the Department of Otorhinolaryngology of the Ludwig-Maximilians-University Clinic in Munich. The study examining the effectiveness of the Ronch®AP palatal device in treating OSAS was designed as a randomized and controlled trial. The functional principle o... | PMC10066138 |
Randomization | Afterward, patients were randomized into one group set to receive therapeutic intervention by Ronch®AP and a control group. For randomization an envelope containing equal amounts of batches for both groups was used. Each group consisted of 30 patients. | PMC10066138 | ||
Statistical analysis | Program R (Version 4.0.1, R Core Team, 2020) was applied for statistical evaluation. For descriptive analysis of parameters absolute values as well as margins were used. Mean value, standard deviation, minimum and maximum were calculated. Two sample | PMC10066138 | ||
Results | sleepiness, OSAS, daytime sleepiness | After the adjustment period was completed, 22 out of 30 patients tolerated Ronch®AP and were approved for polysomnographic testing. In accordance with the study’s protocol 30 patients of the control group did not receive any treatment. 14 women (23.3%) and 46 men (76.75) were included in the study. 32 patients suffered... | PMC10066138 | |
Discussion | hypopneas, respiratory effort-related arousals, obstructive apneas, hypopnea, apnea, daytime sleepiness, snoring, arousals, OSAS, AHI reduction, Daytime sleepiness | MINOR, RESPIRATORY EFFORT-RELATED AROUSAL, POSITIVE | The presented study examined the Ronch®AP palatal device as an alternative conservative treatment option in OSAS therapy. Even though the therapeutic approach to treat OSAS by stenting the retropalatinal space is not novel, little research has been published [The effectiveness of Ronch®AP was examined in a randomized c... | PMC10066138 |
Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10066138 | ||
Data, materials and/or code availability | Data are available by the authors. | PMC10066138 | ||
Declarations | PMC10066138 | |||
Conflict of interest | The authors have no relevant financial or non-financial interests to disclose. | PMC10066138 | ||
Ethical approval | DER | This study was performed in line with the principles of the Declaration of Helsinki. Trial registration number: 407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München). | PMC10066138 | |
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10066138 | ||
References | PMC10066138 | |||
Background | disability, chronic mental illness, Obsessive-compulsive disorder, OCD | Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability. Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients and has been shown to be effective. However, 3-arm trials on ICBT, face-to-face cognitive behavioral group therapy (C... | PMC10248767 | |
Objective | OCD | This study is a randomized, controlled, assessor-blinded trial of 3 groups for OCD: ICBT combined with medication, CBGT combined with medication, and conventional medical treatment (ie, treatment as usual [TAU]). The study aims to investigate the efficacy and cost-effectiveness of ICBT related to CBGT and TAU for adult... | PMC10248767 | |
Methods | Obsessive-Compulsive, OCD | SECONDARY | In total, 99 patients with OCD were selected and randomly assigned to the ICBT, CBGT, and TAU groups for treatment for 6 weeks. The primary outcomes were the Yale-Brown Obsessive-Compulsive Scale (YBOCS) and the self-rating Florida Obsessive-Compulsive Inventory (FOCI), compared at baseline, during treatment (3 weeks),... | PMC10248767 |
Results | Repeated-measures ANOVA was used for data analysis, and the final effective sample size was 93 (ICBT: n=32, 34.4%; CBGT: n=28, 30.1%; TAU: n=33, 35.5%). After 6-week treatment, the YBOCS scores of the 3 groups significantly decreased ( | PMC10248767 | ||
Conclusions | OCD | Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults wi... | PMC10248767 | |
Trial Registration | Chinese Clinical Trial Registry ChiCTR1900023840; https://www.chictr.org.cn/showproj.html?proj=39294 | PMC10248767 | ||
Introduction | obsessive-compulsive, Obsessive-compulsive disorder, depressive, OCD, chronic mental illness, disability | Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability [Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients. ICBT is divided into therapist-guided ICBT and self-guided ICBT. ICBT has the advantages of convenience and time sav... | PMC10248767 | |
Methods | PMC10248767 | |||
Trial Design | OCD | SECONDARY, RECRUITMENT | The study was a 6-week, assessor-blinded, clinical RCT with patients with OCD allocated 1:1:1 to the ICBT, CBGT, and TAU groups. Primary and secondary outcomes were measured 3 times: at baseline (0 weeks), during treatment (3 weeks), and after treatment (6 weeks). The study was carried out at the Shanghai Mental Health... | PMC10248767 |
Ethical Considerations | The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) and was approved by the Shanghai Ethical Review Committee (2018-57). | PMC10248767 | ||
Participants | psychiatric, OCD | The study subjects were 99 patients with OCD who were consecutively enrolled from a public psychiatric hospital. Information about the trial was sent to clinicians and advertised on posters in the clinic lobby and the online WeChat public account. Participation was referred by psychiatrists or via self-referral, and bo... | PMC10248767 | |
Interventions | All patients in the 3 groups had taken medication before the start of the experiment, 84.9% (n=79) of the patients had taken medication stably for more than 8 weeks, most of the remaining patients had taken medication stably for less than 8 weeks, and a few patients had discontinued medication before enrollment. The ty... | PMC10248767 | ||
CBGT Intervention | The CBGT group was headed by a nationally registered therapist who had received systematic training. The group was closed and homogeneous, and all face-to-face sessions were audio-recorded to ensure that therapists adhered to the treatment manual. Each subgroup included 6-8 patients, who were treated twice a week for a... | PMC10248767 | ||
TAU Intervention | sleep disorders, OCD | The TAU group was treated with only medication. The medication interventions of the 3 groups were under the charge of an associate chief psychiatrist, who was unaware of the grouping of patients. The medicines used for the treatment of OCD in this study were SSRIs approved by the State Food and Drug Administration (SFD... | PMC10248767 | |
Outcome Measures | Obsessive-compulsive | ADVERSE EVENTS | The demographic data of the 3 groups were collected during the enrollment assessment. Obsessive-compulsive symptoms, the quality of life, and costs were collected 3 times: at baseline, during treatment (3 weeks), and after treatment (6 weeks). All assessments at baseline were offline, and subsequent assessments in the ... | PMC10248767 |
Primary Outcome | Obsessive-compulsive | Obsessive-compulsive symptoms were measured using a masked assessor–rated YBOCS [ | PMC10248767 | |
Secondary Outcome | The quality of life was measured using the EQ-VAS score of the EQ-5D [ | PMC10248767 | ||
Cost Data | confusion | The study designed the Sinicized Cost Questionnaire based on Trimbos and the Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry [Direct costs included registration, psychological treatment, medication, and rehabilitation. Indirect costs included transportation expenses, accommodation expenses,... | PMC10248767 | |
Sample Size | The statistical method suitable for this study was 2-way (1 within-subject and 1 between-subject factor) repeated-measures ANOVA. According to the theoretical considerations [and the minimum sample size was nl=n2=n3=23. Considering the dropout rate and clinical operability, the TAU, ICBT, and CBGT groups should each ha... | PMC10248767 | ||
Randomization and Blinding | BLIND | Random sequences were generated in Microsoft Excel with the RAND function, and all eligible patients were randomized 1:1:1 to the ICBT, CBGT, and TAU groups. The evaluators were blind to the patients’ treatment. At the same time, patients were asked not to mention the psychotherapeutic conditions to the evaluator durin... | PMC10248767 | |
Statistical Analysis | SD | DISEASE | Statistical data were analyzed with SPSS 25.0 (IBM Corporation). All outcome analyses were conducted according to the intention-to-treat principle, and the missing data were dealt with using conditional mean imputation [The study repeated the analysis for the primary outcome using 2 different approaches as sensitivity ... | PMC10248767 |
Results | PMC10248767 | |||
Feasibility and Safety | anxiety, vertigo | ADVERSE EVENTS | In the ICBT group, 7 (21.2%) of 33 patients dropped out (n=3, 42.9%, men): 1 (14.3%) patient lost contact before the start of treatment, 3 (42.9%) patients discontinued the medication because their condition improved, and 3 (42.9%) patients withdrew because they could not receive online treatment. In the CBGT group, 7 ... | PMC10248767 |
Secondary Outcome | OCD, obsessive-compulsive disorder | The VAS scores in the EQ-5D scale for the 3 groups had no significant differences at baseline (Secondary outcome of VAS in a study of the effect of ICBT vs CBGT vs TAU on OCD symptoms in adults. CBGT: cognitive behavioral group therapy; ICBT: internet-based cognitive behavioral therapy; OCD: obsessive-compulsive disord... | PMC10248767 | |
Health Economics Analyses | PMC10248767 | |||
Therapist Time Consumption | This study did not include the time of therapists for cost calculation but collected the total time of the therapists occupied by the 3 groups of interventions. The results showed that patients in the ICBT group consumed a total of 1078 minutes of the therapist’s time during the 6-week treatment, with an average of 32.... | PMC10248767 | ||
Sensitivity Analysis | The study performed complete case analysis (n=80, 86.0%) and analysis with the addition of covariates, and the results of the 2 sensitivity analyses were consistent with those of the primary analyses, suggesting the robustness of our conclusions. | PMC10248767 | ||
Discussion | PMC10248767 | |||
Principal Findings | YBOCS, anxiety, vertigo, obsessive-compulsive symptoms, assessor-rated, OCD | ADVERSE EVENTS, BLIND | This study was an RCT of ICBT, CBGT, and conventional medical treatment for OCD in China, which aimed to evaluate the efficacy and cost-effectiveness of therapist-guided ICBT for Chinese patients with OCD. All 3 groups had curative effects and improved quality of life after treatment for 6 weeks, and the ICBT group was... | PMC10248767 |
Limitations | This study has a few limitations. First, the dose and duration of patients’ SSRI treatment before enrollment were not clearly recorded, which were variables that could be included in the analysis. In addition, 8 weeks should be used as a standard for stable medication to screen subjects to reduce the impact of medicati... | PMC10248767 | ||
Conclusion | Psychotic Disorders, OCD | Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults wi... | PMC10248767 | |
Abbreviations | Obsessive-Compulsive | cognitive behavioral group therapycognitive behavioral therapyCognitive Behavioral Therapy Chinacost-effectiveness ratioEuroQol 5D QuestionnaireEuroQol Visual Analogue Scaleexposure and response preventionface-to-face CBTFlorida Obsessive-Compulsive Inventoryinternet-based cognitive behavioral therapyincremental cost-e... | PMC10248767 | |
Background | depression | The prevalence of depression is increasing in Japan. Pharmacists play an important role in helping patients use medicines effectively. Several studies had investigated the impact of community pharmacists on patient adherence to antidepressant therapy, and their results indicated that further study was warranted. | PMC9951417 | |
Methods | Depressive, adverse drug reactions, unipolar depression | MAY, ADVERSE DRUG REACTIONS | This study was conducted from June 2019 to May 2020 using a cluster non-randomized, open-label, parallel-group design. Four community pharmacy stores in Osaka and Hyogo Prefectures, Japan, participated in the study, and enrolled patients with unipolar depression. In the intervention group (IG), patients received cognit... | PMC9951417 |
Results | Four pharmacies (two in IG and two in CG) completed the intervention period. Results were obtained from 19 patients in the IG and 12 patients in the CG. In the IG, the mean DAI-10 score increased from 4.941 at baseline to 6.105, the mean PHQ-9 score decreased from 9.263 to 8.625, and the mean patient satisfaction score... | PMC9951417 | ||
Conclusion | depressed | CBT-based medication support provided by community pharmacists may improve patient medication adherence to antidepressant therapy and symptoms. Such support can be expected to facilitate better treatment of depressed patients and may also allow the duration of treatment to be shortened. | PMC9951417 | |
Trial registration | UMIN000037954, Date of first registration: 17/06/2019. | PMC9951417 | ||
Supplementary information | The online version contains supplementary material available at 10.1186/s12888-023-04602-5. | PMC9951417 | ||
Introduction | major depression, cognitive distortions, depressed, depression, Depression | ADVERSE DRUG REACTIONS | The World Health Organization estimated that 264 million people had depression worldwide in 2017, and the global burden of depression is on the rise [Depression generally require a long-term treatment. Treatment of major depression typically consists of three distinctive phases: acute, continuation, and maintenance [Pa... | PMC9951417 |
Objectives | unipolar depression | The objective of this study was to investigate whether CBT-based medication support by the community pharmacist would improve the medication adherence, medical status, satisfaction towards the services of pharmacy of patients with unipolar depression. Another objective was to observe changes in pharmacists’ confidence ... | PMC9951417 | |
Methods | PMC9951417 | |||
Study design | MAY | This study was a cluster non-randomized, open-label, parallel-group, controlled study, based on the transparent reporting of evaluations with nonrandomized designs statement. This study was conducted from June 2019 to May 2020. Four community pharmacies in Osaka and Hyogo Prefectures, Japan, participated. This study wa... | PMC9951417 | |
Participants | PMC9951417 | |||
Pharmacists inclusion criteria | depressive | The inclusion criteria for pharmacists included (i) employed at a community pharmacy that accepts prescriptions mainly from psychosomatic medicine and psychiatry, (ii) routinely provides medication to depressive patients, and (iii) has received an explanation of the purpose of the research from the Investigator, unders... | PMC9951417 | |
Patients inclusion criteria | unipolar depression | RECRUITMENT | Patients were eligible for inclusion if they were (i) diagnosed with unipolar depression, (ii) currently receiving antidepressant prescriptions, and (iii) visiting the participating pharmacy for prescription refills. As part of the patient recruitment process, the participating pharmacist contacted the prescribing phys... | PMC9951417 |
Patients exclusion criteria | dementia, schizophrenia, maniac | Exclusion criteria included (i) patients suspected of having maniac episodes, (ii) diagnosis of schizophrenia, (iii) diagnosis of dementia, and (iv) patients not visiting the pharmacy in person. Patients were eligible if their pharmacy visit was accompanied by a helper. | PMC9951417 | |
Allocation | This was a non-randomized study. One of the study investigators (AF) allocated the participating pharmacies to the intervention and control groups. For this purpose, the prescribing practitioners’ receptiveness for the pharmacist interventions, the personal relationship between the pharmacist and patients, and similari... | PMC9951417 | ||
Intervention group | adverse drug reactions | ADVERSE DRUG REACTIONS | In the intervention group, patients received CBT-based medication support, and their medication adherence and adverse drug reactions were monitored by telephone calls. | PMC9951417 |
Control group | Control-group pharmacists used their routine interactions with their patients. | PMC9951417 | ||
Educational program | depressed | Before participating in this study, pharmacists attended a 5-hour training course on CBT-based medication support. This training program was developed by Tanuma et al. with a focus on community pharmacists [
The commentary on building basic communication with patients was shortened.The role-playing cases were limited t... | PMC9951417 | |
Outcomes | PMC9951417 | |||
Primary outcome | The primary outcomes of this study were medication adherence. Medication adherence was evaluated using the Drug Attitude Inventory (DAI)-10 questionnaire (Japanese version).The DAI-10 questionnaire is a 10-item self-report scale widely used to evaluate patients’ attitudes towards medication. Respondents answer each que... | PMC9951417 | ||
Secondary outcomes | SECONDARY | The secondary outcomes of this study were assessed using the Patient Health Questionnaire (PHQ)-9, patient satisfaction [ | PMC9951417 | |
Statistical analysis | REGRESSION | The differences in the study variables between the start (baseline) and end of the study (6-months post-baseline) were evaluated in the per-protocol set. The Between-group differences in the 6-month changes in DAI-10, PHQ-9, and EQ-5D-5 L and PCMCD scores were compared using the unpaired t-test. To examine the factors ... | PMC9951417 | |
Risk management | We had cognited following latent risks in this study;
worsening the relationship between the patients-pharmacist or physician-pharmacist due to the failure or wrong way of CBT-based medication support.1 might worsen the patient’s symptoms.We explained these to the pharmacist in advance, and instructed to exclude the pa... | PMC9951417 | ||
Results | PMC9951417 |
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