Rates of Reproductive Counseling and Contraception Use in Patients with Heart Failure at a Tertiary Care Center.

BACKGROUND: Increasing numbers of women of childbearing age have cardiac disease, including heart failure (HF). In these women, pregnancy can cause significant morbidity and mortality. Contraceptive use and pregnancy counseling in women with HF is an essential part of their medical care. Here, we assess contraceptive use and pregnancy counseling of patients with HF at a single tertiary care center. METHODS AND RESULTS: This was a retrospective, single-center cohort study of female patients with HF with reduced ejection fraction, left ventricular assist devices (LVADs), and heart transplants who were seen in the adult advanced HF outpatient clinics. Patients were identified in the electronic health care record system, and records were reviewed to assess for documentation of contraception and pregnancy counseling. We identified 156 women of childbearing age (aged >18 to <45), seen in the HF clinics between 2018 and 2023. Patients were subdivided by their most recent diagnosis and therapy: HF with reduced ejection fraction (83 [53.2%]), LVAD (18 [11.5%]), and heart transplant (55 [35.3%]). Contraception was documented for 74% of women with HF, 56% of women with LVAD, and 85% of women with heart transplants. Pregnancy counseling was documented for 18.00% of women with HF, 0.06% of women with LVAD, and 29.00% of women with heart transplants. CONCLUSIONS: In our study, many women with HF, LVAD, or transplant have documented contraceptive therapy; however, pregnancy counseling seems to be limited. This vital aspect of medical care should be available for all patients given potential pregnancy-associated risks.

Effectiveness of Very Brief Advice on Tobacco Cessation: A Systematic Review and Meta-Analysis.

BACKGROUND: Very brief advice (VBA; ≤ 3 min) on quitting is practical and scalable during brief medical interactions with patients who smoke. This study aims to synthesize the effectiveness of VBA for smoking cessation and summarize the implementation strategies. METHODS: We searched randomized controlled trials aiming at tobacco abstinence and comparing VBA versus no smoking advice or no contact from Medline, Embase, CINAHL, Cochrane Library, PsycInfo databases, six Chinese databases, two trial registries ClinicalTrials.gov and WHO-ICTRP from inception to September 30, 2023. Grading of Recommendations, Assessment, Development, and Evaluations framework was used to assess the certainty of the evidence of the meta-analytic findings. The outcomes were self-reported long-term tobacco abstinence at least 6 months after treatment initiation, earlier than 6 months after treatment initiation, and quit attempts. Effect sizes were computed as risk ratio (RR) with 95% CI using frequentist random-effect models. DATA SYNTHESIS: Thirteen randomized controlled trials from 15 articles (n = 26,437) were included. There was moderate-certainty evidence that VBA significantly increased self-reported tobacco abstinence at ≥ 6 months in the adjusted model (adjusted risk ratio ARR 1.17, 95% CI: 1.07-1.27) compared with controls. The sensitivity analysis showed similar results when abstinence was verified by biochemical validation (n = 6 studies, RR 1.53, 95% CI 0.98-2.40). There was high-certainty evidence that VBA significantly increased abstinence at < 6 months (ARR 1.22, 95% CI: 1.01-1.47). Evidence of effect on quit attempts (ARR 1.03, 95% CI 0.97-1.08) was of very low certainty. DISCUSSION: VBA delivered in a clinical setting is effective in increasing self-reported tobacco abstinence, which provides support for wider adoption in clinical practice.

Perioperative and Postoperative Continuous Nutritional Counseling Improves Quality of Life of Gastric Cancer Patient Undergoing Gastrectomy.

Post-gastrectomy syndrome (PGS) and body weight loss (BWL) decrease quality of life (QOL) and survival of the patient undergoing gastrectomy. We have introduced perioperative and post-discharge continuous nutritional counseling (CNC) to prevent BWL and improve QOL after gastrectomy. In the present study, we evaluated the effect of CNC on QOL using the Post-gastrectomy Syndrome Assessment Scale-45 (PGSAS-45). Eighty-three patients with gastric cancer (GC) who underwent curative gastrectomy between March 2018 and July 2019 were retrospectively analyzed. Patients received either pre-discharge nutritional counseling alone (control group, n = 45) or CNC (CNC group, n = 38) after gastrectomy. QOL at 12 months after gastrectomy was compared between the two groups. In QOL assessment, change in body weight (-7.98% vs. -12.77%, p = 0.0057), ingested amount of food per meal (7.00 vs. 6.07, p = 0.042) and ability for working (1.89 vs. 2.36, p = 0.049) were significantly better in CNC group than control group. Multiple regression analysis showed that CNC was a significantly beneficial factor for abdominal pain subscale (p = 0.028), diarrhea subscale (p = 0.047), ingested amount of food per meal (p = 0.012), Ability for working (p = 0.031) and dissatisfaction at the meal (p = 0.047). Perioperative and postoperative CNC could improve QOL in the patient undergoing gastrectomy in addition to preventing postoperative BWL.

Sexual counseling for female sexual interest/arousal disorders: a randomized controlled trial based on the "good enough sex" model.

BACKGROUND: Female sexual interest/arousal disorder (FSIAD) is the most common female sexual disorder with adverse effects on women's health and interpersonal relationships. AIM: This survey evaluated the effects of sexual counseling based on the "good enough sex" (GES) model on the sexual health variables of women with FSIAD. METHODS: A randomized clinical trial with a 1:1 allocation ratio was conducted among 80 women with FSIAD in Iran in 2021. Eligible participants were randomly assigned to group A (women) and group B (couples). Women attended 4 weekly online group sexual counseling sessions based on the GES model, each lasting 120 minutes. In group B, husbands participated in sessions 2 and 3. OUTCOMES: Women's sexual health parameters-including sexual desire, sexual satisfaction, sexual function, sexual distress, sexual communication, frequency of sexual intercourse, and dysfunctional beliefs-were evaluated before and 3 months after counseling. The significance threshold considered P < .007 due to Bonferroni correction. RESULTS: After the intervention, all sexual parameters except sexual dysfunctional beliefs showed significant improvement (P < .001) in both groups. During the follow-up period, the average scores for all sexual variables were slightly higher in group B vs group A. The between-group difference was significant only for frequency of sexual intercourse (P < .01). CLINICAL IMPLICATIONS: This study reaffirms the impact of the GES model as biopsychosocial therapy in managing female sexual problems. Considering men's reluctance to accompany their wives to sex clinics, counseling for women alone can play a significant role in solving sexual problems, especially in the case of FSIAD. Online sexual consultation offers cost and time savings, provides a secure space for discussing sensitive topics, and facilitates group program coordination. It ensures universal access to counseling, thereby addressing gender incompatibility issues. It is a powerful, interactive, and acceptable alternative to in-person visits, providing convenience and confidentiality for clients seeking sexual health support. STRENGTHS AND LIMITATIONS: The following were among the survey strengths: conducting a randomized controlled trial on women with FSIAD by applying an appropriate model and scales, involving spouses, and evaluating online group sexual counseling. However, the results of this study may not be generalizable to women without partners. CONCLUSION: The GES model, emphasizing intimacy and sexual dialogue, reduces unrealistic sexual expectations and improves women's sexual desire and overall health. Our results showed that instead of insisting on the physical presence of husbands in counseling sessions, clinicians should emphasize their emotional support and companionship during the treatment process.

Predictors of Nicotine Replacement Therapy Adherence: Mixed-Methods Research With a Convergent Parallel Design.

BACKGROUND: Few studies have examined the effect of baseline attitudes toward nicotine replacement therapy (NRT) on its actual adherence in a smoking cessation intervention. PURPOSE: This study (i) examined the predictability of baseline variables (quantitative data) on NRT adherence and (ii) explored the congruence of participants' statements about NRT products (qualitative data) during counseling sessions with their baseline attitudes. METHODS: This is a mixed-methods research study using a convergent parallel design. Participants included 74 individuals in the treatment group who received behavioral counseling and combination NRT. A Poisson regression analysis was performed to identify baseline variables predicting NRT adherence. Thematic analysis was completed with a subset of participants (n = 38) who varied in NRT attitude scores and adherence. A joint display was created to integrate quantitative and qualitative data and discover convergence. RESULTS: Approximately 59% of the participants (41/74) used NRT continuously for ≥5 weeks. Having negative attitudes toward NRT and depressive symptoms predicted NRT adherence even after controlling for education and anxiety symptoms. Thematic analysis revealed that NRT adherence is a learning process that consists of the following three distinctive but interrelated phases: (i) information needs, (ii) comprehensive readiness, and (iii) experiential learning. Of the 38 participants, 34 (89.5%) showed convergence between baseline attitude scores and statements about NRT made during counseling sessions. CONCLUSIONS: Individuals who have negative attitudes toward NRT are less likely to use the products in a smoking cessation intervention. Counselors should assess attitudes toward NRT at baseline and address them proactively during counseling sessions.

Few research studies have explored how attitudes toward nicotine substitutes (nicotine patches, gum, and lozenges) affect people's adherence to those substitutes (using them consistently as directed). This study examined (i) whether age, gender, education, attitudes toward the substitutes, and depressive and anxiety symptoms would predict peoples' adherence to these nicotine substitutes during a study to help stop smoking and (ii) whether peoples' statements about their experiences with the substitutes would reveal any patterns. The study was conducted with 74 individuals who received behavioral counseling and combination nicotine substitutes. Having negative attitudes toward the substitutes and depressive symptoms predicted adherence. Age, gender, education, positive attitudes, and anxiety symptoms did not. Statements from a subset of participants (n = 38) revealed that adherence to the substitutes is a learning process that consists of the following three phases: (i) needing more information assuring the safety of the substitutes, (ii) being mentally and situationally ready, and (iii) learning while being involved in the process such as "trial and error." Individuals who have negative attitudes toward the substitutes are less likely to use them, and counselors should assess attitudes toward nicotine replacement therapy before suggesting their use and address these attitudes proactively during smoking cessation counseling sessions.

Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial.

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts.Clinical Trials Number: NCT02054780.

Empirical Development of a Behavioral Intervention for African American/Black and Latino Persons with Unsuppressed HIV Viral Load Levels: An Application of the Multiphase Optimization Strategy (MOST) Using Cost-Effectiveness as an Optimization Objective.

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments.

Smoking Cessation Support in Social and Community Service Organizations: Potential Activities, Barriers, and Facilitators.

INTRODUCTION: Social and Community Service Organizations (SCSOs) are a potential setting to reach and support people with a low socioeconomic position who smoke, yet smoking cessation is not widely supported by SCSO professionals. AIMS AND METHODS: This study aims to identify SCSO professionals' (1) potential activities to support smoking cessation and (2) barriers and facilitators in undertaking these activities. Between July and November 2022, semi-structured interviews were conducted with 21 professionals recruited through SCSOs in Amsterdam North, including participation workers, welfare workers, parent and child counselors, budget coach, debt counselor, welfare work, community sports, and community center coordinators. Data were analyzed using a thematic approach. RESULTS: Eight activities were identified that could support the client either directly (ie, recognizing smoking clients, discussing smoking and smoking cessation, referring clients, providing smoking cessation counseling, offering help around services) or indirectly (ie, collaboration with relevant network partners, implementing smoke-free environments, enhancing professional skills). Various barriers and facilitators were identified related to the (1) client and their environment (ie, clients' readiness and social environment), (2) interaction between professional and client (ie, topic sensitivity), (3) professional (ie, professional is non-smoker, knowledge, and self-efficacy), (4) professionals' work environment (ie, necessity, responsibility, priority, and time), and (5) smoking cessation services (ie, availability of appropriate services and referral process). CONCLUSIONS: There is potential for SCSO professionals to support smoking cessation, but several barriers hinder their efforts. To address these barriers, it is essential to take into account the factors that SCSO professionals believe facilitate the provision of smoking cessation support. IMPLICATIONS: This study provides insight into how the potential of SCSOs in Amsterdam North to support smoking cessation efforts among people with a low socioeconomic position can be harnessed. Barriers were found at multiple levels (client, professional, client-professional interaction, and organizational) and these findings imply that stakeholders across these levels will need to prioritize smoking cessation to facilitate and stimulate SCSO professionals in supporting smoking cessation. A concrete action would be to offer SCSO professionals additional training in conversational skills to discuss smoking. As a prerequisite, easily accessible and suitable smoking cessation services should be available in the neighborhood.

Cross-Cultural Patient Counseling and Communication in the Integrative Medicine Setting: Respecting the Patient's Health Belief Model of Care.

PURPOSE OF REVIEW: Communicating effectively with patients having a traditional, alternative or complementary medicine-related health-belief model is challenging in today's cross-cultural society. This narrative review explores the integrative medicine setting of care, focusing on insights from the integrative oncology daily practice, while addressing the relevance to the mental health setting. The way in which healthcare providers can enhance cultural-sensitive communication with patients and informal caregivers; recognize and respect health-beliefs to bridge cultural gaps; and generate an open, non-judgmental and mindful dialogue are discussed. RECENT FINDINGS: Identifying cross-cultural barriers to healthcare provider-patient communication is important in order to address the potential for conflict between conventional and "alternative" health beliefs; difficulties in creating a shared-decision making process; disagreement on therapeutic goals and treatment plan; and finally, the potential for non-compliance or non-adherence to the conventional oncology treatment. Acquiring intercultural competencies is needed at all stages of medical education, and should be implemented in medical and nursing curricula, as well as during specialization and sub-specialization. As with patient-centered paradigms of care, integrative medicine entails a dual patient-centered and sensitive-cultural approach, based on a comprehensive bio-psycho-social-spiritual model of care.

The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled type 2 diabetes mellitus (T2DM): a randomised controlled trial.

BACKGROUND: Many patients with T2DM on insulin are not optimally controlled despite receiving standard diabetes education counselling. Poor insulin adherence may be a contributing factor. We developed and evaluated a new module [Universiti Sains Malaysia-Insulin Adherence Module (USM-IAM)] on insulin-treated patients with poorly controlled diabetes. METHODS: Eligibility criteria are those diagnosed with T2DM, aged between 18 and 65 years, with HbA1c between 8 and 15% and on insulin therapy for 1 year. Patients were randomly allocated to receive either the USM-IAM-based counselling or the standard counselling (SC) at baseline and the second visit. Patients were instructed to adjust insulin doses based on blood glucose levels. Outcomes were changes in adherence score, FBS and HbA1c levels from baseline to 3 months and baseline to sixth month. RESULTS: Ninety patients were randomised to each group. The baseline sociodemographic and clinical characteristics were homogenous among groups. Ninety patients were analysed for each group. Adherence score changes between baseline to 3 months were - 8.30 (- 11.47, - 5.14) in USM-IAM-based counselling group (USM-IAM) and - 7.64 (- 10.89, - 4.40) in standard counselling group (SCG), between baseline to sixth month were - 10.21 (- 13.40, - 7.03) in USM-IAM and - 10.79 (- 14.64, - 6.97) in SCG. FBS changes between baseline to 3 months were 1.374 (0.25, 2.50) in USM-IAM and 0.438 (- 0.66, 1.54) in SCG, and between baseline to sixth month were 1.713 (0.473, 2.95) in USM-IAM and 0.998 (- 0.02, 2.01) in SCG. HbA1c changes between baseline to 3 months were 1.374 (0.25, 2.50) in USM-IAM and 0.547 (0.12, 0.98) in SCG, and between baseline to sixth month were 1.03 (0.65, 1.41) in USM-IAM and 0.617 (0.20, 1.03) in SCG. Between-subjects effects for all outcomes were not statistically significant. CONCLUSION: Both groups had significant improvements in adherence score and HbA1c with time, with higher improvement in patients receiving the USM-IAM. FBS reductions were significant in the intervention group but not in the control group. TRIAL REGISTRATION: This study protocol is registered with Clicaltrials.gov with ID NCT05125185 dated 17th November 2021.

Application of different counseling strategies for better adult asthma control.

OBJECTIVE: We aimed to compare the effectiveness of three distinct counseling methods to determine the most effective approach. METHODS: In this prospective cohort study with a two-month follow-up, A group of non-smoking adults, aged 19-60 years, were randomly collected at outpatients clinic with prior asthma diagnosis, based on the forced expiratory volume in one seconds to forced vital capacity ratio (FEV1/FVC) and the guidelines outlined by the Global Initiative for Asthma (GINA), At the baseline assessment, all patients, underwent FEV1/FVC measurements, asthma symptom evaluations using Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), and GINA symptoms control assessment questionnaire, and assessment of pressurized metered-dose inhaler (pMDI) usage. The patients were divided into three groups, each assigned a distinct counseling strategy: traditional verbal counseling, advanced counseling utilizing the Asthma smartphone-application, and a combination of advanced-verbal counseling. We conducted a two-month monitoring period for all three groups. RESULTS: Significant differences (p < .001) were observed among the three counseling groups in ACT, FEV1/FVC ratio, and GINA symptoms control assessment scores from the first month to the second month visit. Regarding ACQ, the study unveiled a noteworthy disparity in ACQ scores during the second week, with a significant difference (p = .025) observed between the verbal and advanced-verbal counseling groups. Similarly, a significant difference (p = .016) was noted between the advanced counseling group and the advanced-verbal counseling groups. CONCLUSION: The study findings indicate that the combining advanced-verbal counseling by incorporating the Asthma smartphone-application alongside traditional verbal counseling is a more effective approach for improving asthma control in adults.

Effect of logotherapy counseling program on chronic sorrow, dignity, and meaning in life of palliative care patients: a randomized controlled trial.

PURPOSE: Palliative care patients experience chronic sorrow with loss in dignity and meaning in life. Logotherapy is an effective way to cope with loss. This study aimed to evaluate the effect of logotherapy on chronic sorrow, dignity, and meaning in life of palliative care patients. METHODS: This study was conducted with 58 adults hospitalized due to advanced cancer and assigned to either intervention or control group by simple randomization. Data were collected with descriptive information form, Palliative Performance Scale, Patient Dignity Inventory (PDI), Prolonged Grief Disorder Scale-Patient Form (PGDS-PF), and Meaning in Life Questionnaire (MIL) on admission, at the 4th and 8th weeks. The intervention group received eight sessions of logotherapy. The control group received routine care. RESULTS: The mean scores of PGDS-PF (p = 0.01), PDI (p = 0.01), and searched meaning subdimension of MIL (MIL-SM) (p = 0.11) decreased in the intervention group compared to controls, both at the 4th and 8th week evaluation. The mean score of the present meaning subdimension of MIL (MIL-PM) (p = 0.02) increased at the 4th week evaluation but decreased at a non-statistically significant level at the 8th week. The mean scores of PGDS-PF and PDI increased in the control group while MIL-PM and MIL-SM decreased, both at the 4th and 8th week evaluation. CONCLUSIONS: Logotherapy was found effective in decreasing the sorrow and dignity-related distress of palliative care patients, while increasing finding meaning in life. Logotherapy is recommended to be used by palliative care professionals to empower patients. TRIAL REGISTRATION: Clinicaltrials registration number and date: NCT05129059, 19/01/2021.

A theoretical explanation for how a nutrition counseling and medically tailored meal delivery program benefitted participants living with lung cancer.

PURPOSE: The purpose of this study was to assess participants' perceptions and experiences while participating in a Food is Medicine medically tailored meal plus intensive nutrition counseling intervention to create a theoretical explanation about how the intervention worked. METHODS: This interpretive qualitative study included the use of semi-structured interviews with active participants in a randomized controlled trial aimed at understanding how a medically tailored meal plus nutrition counseling intervention worked for vulnerable individuals with lung cancer treated at four cancer centers across the USA. During the 8-month long study, participants in the intervention arm were asked to be interviewed, which were recorded, transcribed verbatim, and analyzed using conventional content analysis with principles of grounded theory. RESULTS: Twenty individuals participated. Data analysis resulted in a theoretical explanation of the intervention's mechanism of action. The explanatory process includes three linked and propositional categories leading to patient resilience: engaging in treatment, adjusting to diagnosis, and active coping. The medically tailored meals plus nutrition counseling engaged participants throughout treatment, which helped participants adjust to their diagnosis, leading to active coping through intentional self-care, behavior change, and improved quality of life. CONCLUSIONS: These findings provide evidence that a Food is Medicine intervention may buffer some of the adversity related to the diagnosis of lung cancer and create a pathway for participants to experience post-traumatic growth, develop resilience, and change behaviors to actively cope with lung cancer. Medically tailored meals plus intensive nutrition counseling informed by motivational interviewing supported individuals' adjustment to their diagnosis and resulted in perceived positive behavior change.

A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers.

CONTEXT: Many cancer survivors and their informal caregivers experience multiple symptoms during the survivor's treatment. OBJECTIVE: Test relative effectiveness and optimal sequencing of two evidence-based interventions for symptom management. METHODS: In this sequential multiple assignment randomized trial (SMART), survivors of solid tumors with elevated depression or anxiety and their caregivers as dyads were initially randomized after baseline assessment in a 3:1 ratio to the Symptom Management and Survivorship Handbook (SMSH, N = 277 dyads) intervention or SMSH plus 8 weeks of telephone interpersonal counseling (TIPC, N = 97 dyads). After 4 weeks, survivors who were not responding (no improvement or worsening score on depression and/or anxiety item) to SMSH only and their caregivers were re-randomized to continue with SMSH alone (N = 44 dyads) to give it more time or to SMSH + TIPC (N = 44 dyads). Mixed effects and generalized linear models compared severity of depression, anxiety, and a summed index of 16 other symptoms over weeks 1-13 and week 17 between randomized groups and among three dynamic treatment regimes (DTRs). Dyads received SMSH only for 12 weeks (DTR1); SMSH for 12 weeks with 8 weeks of TIPC added from week 1 (DTR2); and SMSH for 4 weeks followed by the combined SMSH + TIPC for 8 weeks if no response at 4 weeks (DTR3). RESULTS: Survivors randomized initially to SMSH alone had significantly lower anxiety over weeks 1-13 compared to those randomized to the combined SMSH + TIPC. In comparing DTRs, survivor's anxiety was significantly lower at week 13 for DTR1 compared to DTR2 with no other main effects for survivors or caregivers. Exploratory moderation analyses indicated a potential benefit of adding TIPC for caregivers of non-responders with elevated baseline symptoms. CONCLUSION: SMSH + TIPC did not result in better symptom outcomes at week 17 than SMSH alone. Lower intensity SMSH may improve depression and anxiety symptoms for most survivors and their caregivers. TRIAL REGISTRATION: Clinicaltrails.gov ID number, NCT03743415; approved and posted on 11/16/2018.

A comprehensive approach to lifestyle intervention based on a calorie-restricted diet ameliorates liver fat in overweight/obese patients with NAFLD: a multicenter randomized controlled trial in China.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a globally increasing health epidemic. Lifestyle intervention is recommended as the main therapy for NAFLD. However, the optimal approach is still unclear. This study aimed to evaluate the effects of a comprehensive approach of intensive lifestyle intervention (ILI) concerning enhanced control of calorie-restricted diet (CRD), exercise, and personalized nutrition counseling on liver steatosis and extrahepatic metabolic status in Chinese overweight and obese patients with NAFLD. METHODS: This study was a multicenter randomized controlled trial (RCT) conducted across seven hospitals in China. It involved 226 participants with a body mass index (BMI) above 25. These participants were randomly assigned to two groups: the ILI group, which followed a low carbohydrate, high protein CRD combined with exercise and intensive counseling from a dietitian, and a control group, which adhered to a balanced CRD along with exercise and standard counseling. The main measure of the study was the change in the fat attenuation parameter (FAP) from the start of the study to week 12, analyzed within the per-protocol set. Secondary measures included changes in BMI, liver stiffness measurement (LSM), and the improvement of various metabolic indexes. Additionally, predetermined subgroup analyses of the FAP were conducted based on variables like gender, age, BMI, ethnicity, hyperlipidemia, and hypertension. RESULTS: A total of 167 participants completed the whole study. Compared to the control group, ILI participants achieved a significant reduction in FAP (LS mean difference, 16.07 [95% CI: 8.90-23.25] dB/m) and BMI (LS mean difference, 1.46 [95% CI: 1.09-1.82] kg/m2) but not in LSM improvement (LS mean difference, 0.20 [95% CI: -0.19-0.59] kPa). The ILI also substantially improved other secondary outcomes (including ALT, AST, GGT, body fat mass, muscle mass and skeletal muscle mass, triglyceride, fasting blood glucose, fasting insulin, HbA1c, HOMA-IR, HOMA-ß, blood pressure, and homocysteine). Further subgroup analyses showed that ILI, rather than control intervention, led to more significant FAP reduction, especially in patients with concurrent hypertension (p < 0.001). CONCLUSION: In this RCT, a 12-week intensive lifestyle intervention program led to significant improvements in liver steatosis and other metabolic indicators in overweight and obese Chinese patients suffering from nonalcoholic fatty liver disease. Further research is required to confirm the long-term advantages and practicality of this approach. TRIAL REGISTRATION: This clinical trial was registered on ClinicalTrials.gov (registration number: NCT03972631) in June 2019.

Enhancing parental understanding of congenital heart disease through personalized prenatal counseling with 3D printed hearts.

OBJECTIVES: In addition to a correct prenatal diagnosis of congenital heart disease (CHD), comprehensive parental counseling is crucial to ensure that parents are well-informed about the condition of the fetus. This study aims to investigate whether there is a significant difference in the information acquired by parents through traditional counseling, utilizing 2-dimensional (2D) illustrations and images, compared to an advanced approach utilizing personalized three-dimensional (3D) printed models of the fetal heart developed from 3D ultrasound imaging. METHODS: This study, designed as a pilot randomized control trial, enrolled pregnant women with gestational ages greater than 18 weeks, whose fetuses were diagnosed with CHD and referred to our center between November, 2020 and June, 2021. Two groups of patients were included in the study. The first group received standard medical counseling with 2D images and illustrations, while the second group underwent advanced counseling with 3D-printed patient-specific heart models. Both groups were then required to complete the same survey in which the knowledge of the CHD was investigated. The 3D models were created from 3D ultrasound imaging and printed using resin materials in both 1:1 and 5:1 scale. RESULTS: A comparison of the scores obtained from the two groups revealed that 3D visualization of the fetus's heart has the potential to increase parental knowledge about CHD and the required surgical procedures. Furthermore, all couples expressed interest in receiving a 1:1 scale model of their baby's heart. CONCLUSION: Personalized prenatal counseling with 3D-ultrasound-based heart models positively impacts parents' understanding of CHD. The use of 3D models provides a more comprehensive and accessible representation of the condition, contributing to an increased knowledge gain, and potentially helping to support informed decisions regarding their child's care.

Interventions for smoking cessation in hospitalised patients.

BACKGROUND: In 2020, 32.6% of the world's population used tobacco. Smoking contributes to many illnesses that require hospitalisation. A hospital admission may prompt a quit attempt. Initiating smoking cessation treatment, such as pharmacotherapy and/or counselling, in hospitals may be an effective preventive health strategy. Pharmacotherapies work to reduce withdrawal/craving and counselling provides behavioural skills for quitting smoking. This review updates the evidence on interventions for smoking cessation in hospitalised patients, to understand the most effective smoking cessation treatment methods for hospitalised smokers. OBJECTIVES: To assess the effects of any type of smoking cessation programme for patients admitted to an acute care hospital. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 7 September 2022. SELECTION CRITERIA: We included randomised and quasi-randomised studies of behavioural, pharmacological or multicomponent interventions to help patients admitted to hospital quit. Interventions had to start in the hospital (including at discharge), and people had to have smoked within the last month. We excluded studies in psychiatric, substance and rehabilitation centres, as well as studies that did not measure abstinence at six months or longer. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcome was abstinence from smoking assessed at least six months after discharge or the start of the intervention. We used the most rigorous definition of abstinence, preferring biochemically-validated rates where reported. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 82 studies (74 RCTs) that included 42,273 participants in the review (71 studies, 37,237 participants included in the meta-analyses); 36 studies are new to this update. We rated 10 studies as being at low risk of bias overall (low risk in all domains assessed), 48 at high risk of bias overall (high risk in at least one domain), and the remaining 24 at unclear risk. Cessation counselling versus no counselling, grouped by intensity of intervention Hospitalised patients who received smoking cessation counselling that began in the hospital and continued for more than a month after discharge had higher quit rates than patients who received no counselling in the hospital or following hospitalisation (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.24 to 1.49; 28 studies, 8234 participants; high-certainty evidence). In absolute terms, this might account for an additional 76 quitters in every 1000 participants (95% CI 51 to 103). The evidence was uncertain (very low-certainty) about the effects of counselling interventions of less intensity or shorter duration (in-hospital only counselling ≤ 15 minutes: RR 1.52, 95% CI 0.80 to 2.89; 2 studies, 1417 participants; and in-hospital contact plus follow-up counselling support for ≤ 1 month: RR 1.04, 95% CI 0.90 to 1.20; 7 studies, 4627 participants) versus no counselling. There was moderate-certainty evidence, limited by imprecision, that smoking cessation counselling for at least 15 minutes in the hospital without post-discharge support led to higher quit rates than no counselling in the hospital (RR 1.27, 95% CI 1.02 to 1.58; 12 studies, 4432 participants). Pharmacotherapy versus placebo or no pharmacotherapy Nicotine replacement therapy helped more patients to quit than placebo or no pharmacotherapy (RR 1.33, 95% CI 1.05 to 1.67; 8 studies, 3838 participants; high-certainty evidence). In absolute terms, this might equate to an additional 62 quitters per 1000 participants (95% CI 9 to 126). There was moderate-certainty evidence, limited by imprecision (as CI encompassed the possibility of no difference), that varenicline helped more hospitalised patients to quit than placebo or no pharmacotherapy (RR 1.29, 95% CI 0.96 to 1.75; 4 studies, 829 participants). Evidence for bupropion was low-certainty; the point estimate indicated a modest benefit at best, but CIs were wide and incorporated clinically significant harm and clinically significant benefit (RR 1.11, 95% CI 0.86 to 1.43, 4 studies, 872 participants). Hospital-only intervention versus intervention that continues after hospital discharge Patients offered both smoking cessation counselling and pharmacotherapy after discharge had higher quit rates than patients offered counselling in hospital but not offered post-discharge support (RR 1.23, 95% CI 1.09 to 1.38; 7 studies, 5610 participants; high-certainty evidence). In absolute terms, this might equate to an additional 34 quitters per 1000 participants (95% CI 13 to 55). Post-discharge interventions offering real-time counselling without pharmacotherapy (RR 1.23, 95% CI 0.95 to 1.60, 8 studies, 2299 participants; low certainty-evidence) and those offering unscheduled counselling without pharmacotherapy (RR 0.97, 95% CI 0.83 to 1.14; 2 studies, 1598 participants; very low-certainty evidence) may have little to no effect on quit rates compared to control. Telephone quitlines versus control To provide post-discharge support, hospitals may refer patients to community-based telephone quitlines. Both comparisons relating to these interventions had wide CIs encompassing both possible harm and possible benefit, and were judged to be of very low certainty due to imprecision, inconsistency, and risk of bias (post-discharge telephone counselling versus quitline referral: RR 1.23, 95% CI 1.00 to 1.51; 3 studies, 3260 participants; quitline referral versus control: RR 1.17, 95% CI 0.70 to 1.96; 2 studies, 1870 participants). AUTHORS' CONCLUSIONS: Offering hospitalised patients smoking cessation counselling beginning in hospital and continuing for over one month after discharge increases quit rates, compared to no hospital intervention. Counselling provided only in hospital, without post-discharge support, may have a modest impact on quit rates, but evidence is less certain. When all patients receive counselling in the hospital, high-certainty evidence indicates that providing both counselling and pharmacotherapy after discharge increases quit rates compared to no post-discharge intervention. Starting nicotine replacement or varenicline in hospitalised patients helps more patients to quit smoking than a placebo or no medication, though evidence for varenicline is only moderate-certainty due to imprecision. There is less evidence of benefit for bupropion in this setting. Some of our evidence was limited by imprecision (bupropion versus placebo and varenicline versus placebo), risk of bias, and inconsistency related to heterogeneity. Future research is needed to identify effective strategies to implement, disseminate, and sustain interventions, and to ensure cessation counselling and pharmacotherapy initiated in the hospital is sustained after discharge.

Promoting Alcohol Reduction in Non-Treatment Seeking parents (PAReNTS): a pilot feasibility cluster randomized controlled trial of brief alcohol interventions with parents in contact with child safeguarding services.

Many parents who come into contact with early help and children's social care services are risky drinkers. This study aimed to investigate the feasibility and acceptability of conducting a trial of brief alcohol interventions within this setting. We conducted a three-arm pilot feasibility cluster randomised controlled trial in the North-East of England. The additive interventions were: i) screening and a healthy lifestyle leaflet (control); ii) brief advice; iii) extended brief intervention. The trial was later reduced to two-arm due to the extended brief intervention being infeasible. Of the 1769 parents that were approached, 429 consented to be screened (24%), the majority were eligible to participate (n = 415; 97%), 147 of which (35%) scored ≥5 on the AUDIT-C screening tool. There were 108 parents (74%) who consented to participate in the trial (n = 50 control; n = 58 brief advice). Follow-up rates at 6 and 12-months were 61% and 43%. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking. Qualitative data showed that parents and practitioners largely found trial procedures to be acceptable, however, care should be taken when discussing alcohol risk with parents in this setting. Most of the a-priori success criteria were met in this pilot feasibility trial. The findings suggest that it may be feasible to conduct a two-arm randomised controlled trial of brief alcohol interventions to parents in contact with early help and social care. The TLFB30 was found to be a suitable tool to measure the primary outcome of heavy episodic drinking.

Experiences and impacts of psychological support following adverse neonatal experiences or perinatal loss: a qualitative analysis.

BACKGROUND: Poor parental mental health in the perinatal period has detrimental impacts on the lives and relationships of parents and their babies. Parents whose babies are born premature and/or sick and require neonatal care or those who experience perinatal loss are at increased risk of adverse mental health outcomes. In 2021 a North-West charity received funding to offer psychological support to service users of infants admitted to neonatal care or those who had experienced perinatal loss, named the Family Well-being Service (FWS). The FWS offered three different types of support - ad hoc support at the neonatal units or specialist clinics; one-to-one person-centred therapy; or group counselling. Here we report the qualitative findings from an independent evaluation of the FWS. METHODS: Thirty-seven interviews took place online or over the phone with 16 service users (of whom two took part in a follow-up interview), eight FWS providers and 11 healthcare professionals. Interviews were coded and analysed using thematic analysis. RESULTS: The analysis revealed two themes. 'Creating time and space for support' detailed the informational, contextual, and relational basis of the service. This theme describes the importance of tailoring communications and having a flexible and proactive approach to service user engagement. Service users valued being listened to without judgement and having the space to discuss their own needs with a therapist who was independent of healthcare. Communication, access, and service delivery barriers are also highlighted. The second theme - 'making a difference' - describes the cognitive, emotional, and interpersonal benefits for service users. These included service users being provided with tools for positive coping, and how the support had led to enhanced well-being, improved relationships, and confidence in returning to work. CONCLUSION: The findings complement and extend the existing literature by offering new insights into therapeutic support for service users experiencing adverse neonatal experiences or perinatal loss. Key mechanisms of effective support, irrespective of whether it is provided on a one-to-one or group basis were identified. These mechanisms include clear information, flexibility (in access or delivery), being independent of statutory provision, focused on individual needs, active listening, the use of therapeutic tools, and positive relationships with the therapist. Further opportunities to engage with those less willing to take up mental health support should be developed.

Assessing the validity of maternal report on breastfeeding counselling in Kosovo's primary health facilities.

BACKGROUND: Improving the quality of breastfeeding counselling delivered by primary care providers can improve breastfeeding outcomes and ultimately reduce mortality and morbidity of children and mothers. Accurate data on coverage and quality of primary care breastfeeding counselling is essential for monitoring progress; however, global and national indicators are limited. To help address this gap, this study validated indicators of receipt and quality of breastfeeding counselling during routine consultations for infant care at seven primary health facilities across Kosovo. METHODS: Mothers' reports of breastfeeding counselling received during routine consultations for their infants (0-12 months of age) were collected by exit interview in 2019 and 2021 (n = 609). Responses were compared against direct observation of their consultation using a structured checklist (reference standard) by a trained third-party observer at the primary care facility. We assessed 13 indicators; ten were related to the receipt and content of breastfeeding counselling, and three were specific to the provider's interpersonal skills. We calculated sensitivity, specificity, and area under the receiver operating curve (AUC) to determine individual-level reporting accuracy. RESULTS: Ten indicators had an agreement rate above 70% and seven indicators had high overall individual-level validity (AUC ≥ 0.7). High prevalence indicators recorded high sensitivity and low specificity, and the inverse for low prevalence indicators. More subjective indicators were less reliable, e.g., mothers over-reported the prevalence of all three indicators related to providers' interpersonal skills. CONCLUSIONS: This study offers evidence on breastfeeding counselling quality by validating maternal reports of whether a provider discussed breastfeeding, the clinical content of that counselling, and how it was delivered. It is also situated in a primary care setting within a fragile state of which there is limited evidence. We observed that mothers reported accurately when asked directly to recall breastfeeding counselling services received. However, there is a need to further validate subjective questions about interpersonal skills and other measures for the 'experience of care' quality dimension.