Trajectories of clinical characteristics, complications and treatment choices in data-driven subgroups of type 2 diabetes.

AIMS/HYPOTHESIS: This study aimed to explore the added value of subgroups that categorise individuals with type 2 diabetes by k-means clustering for two primary care registries (the Netherlands and Scotland), inspired by Ahlqvist's novel diabetes subgroups and previously analysed by Slieker et al. METHODS: We used two Dutch and Scottish diabetes cohorts (N=3054 and 6145; median follow-up=11.2 and 12.3 years, respectively) and defined five subgroups by k-means clustering with age at baseline, BMI, HbA1c, HDL-cholesterol and C-peptide. We investigated differences between subgroups by trajectories of risk factor values (random intercept models), time to diabetes-related complications (logrank tests and Cox models) and medication patterns (multinomial logistic models). We also compared directly using the clustering indicators as predictors of progression vs the k-means discrete subgroups. Cluster consistency over follow-up was assessed. RESULTS: Subgroups' risk factors were significantly different, and these differences remained generally consistent over follow-up. Among all subgroups, individuals with severe insulin resistance faced a significantly higher risk of myocardial infarction both before (HR 1.65; 95% CI 1.40, 1.94) and after adjusting for age effect (HR 1.72; 95% CI 1.46, 2.02) compared with mild diabetes with high HDL-cholesterol. Individuals with severe insulin-deficient diabetes were most intensively treated, with more than 25% prescribed insulin at 10 years of diagnosis. For severe insulin-deficient diabetes relative to mild diabetes, the relative risks for using insulin relative to no common treatment would be expected to increase by a factor of 3.07 (95% CI 2.73, 3.44), holding other factors constant. Clustering indicators were better predictors of progression variation relative to subgroups, but prediction accuracy may improve after combining both. Clusters were consistent over 8 years with an accuracy ranging from 59% to 72%. CONCLUSIONS/INTERPRETATION: Data-driven subgroup allocations were generally consistent over follow-up and captured significant differences in risk factor trajectories, medication patterns and complication risks. Subgroups serve better as a complement rather than as a basis for compressing clustering indicators.

Assessment of weight gain in adult patients living with HIV receiving first-line dolutegravir-based or efavirenz-based ART regimens in routine care clinics in Tshwane district, South Africa: An observational study.

INTRODUCTION: Although dolutegravir (DTG) is deemed stable, safe, cost-effective, and clinically beneficial, it also carries the risk of side effects, including observed weight gain among patients on DTG-based antiretroviral therapy (ART) regimens. We compared weight changes among adults (≥18 years) initiating tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD) or tenofovir disoproxil fumarate, emtricitabine, and efavirenz (TEE) regimens and those switching from TEE to TLD (TEE-to-TLD switchers) in three large primary care facilities in South Africa METHODS: We conducted a retrospective longitudinal record review using patient medical records, extracting relevant demographic and clinical data from October 2018 to June 2021 from randomly selected adults who initiated TLD or TEE (initiators) and adult TEE-to-TLD switchers. We assessed weight, body mass index (BMI), and percentage weight changes for both groups and fitted linear regression and generalized linear models to determine factors associated with weight and BMI change and percentage weight change ≥10%, respectively, among treatment initiators. We fitted linear mixed-effect models among TEE-to-TLD switchers to consider repeated measures. RESULTS: Of 860 initiators, 450 (52.3%) initiated on TEE and 410 (47.7%) on TLD, with median follow-up of 1.4 years and 1.0 year, respectively. At initiation, 43.3% on TEE and 40.8% on TLD were overweight or obese. TLD initiators had an adjusted higher mean weight gain of 1.6 kg (p < 0.001) and mean BMI gain of 0.51 kg/m2 (p < 0.001) than TEE initiators. Independent risk factors for higher mean weight and BMI included age ≥50 years, male, on ART for >12 months, initial BMI of <18.5 kg/m2, and CD4 counts <200 cells/µL. Of 298 TEE-to-TLD switchers, 36.6% were overweight or obese at TEE initiation. Comparing before and after TLD switch, TEE-to-TLD switchers had an adjusted mean weight of 1.2 kg less while on TLD (p = 0.026). Being overweight and CD4 counts >350 cells/µL were independent risk factors for lower weight gain after TLD switch. CONCLUSIONS: We report more weight gain among TLD than among TEE initiators, although to a lesser extent than previously reported. TEE-to-TLD switchers experienced less weight gain after TLD switch; return to health before receiving TLD may be a contributory factor. The current findings are reassuring for those switching to a DTG-based regimen.

The Evaluation of the GET.ON Nationwide Web-Only Treatment Service for Depression- and Stress-Related Symptoms: Naturalistic Trial.

BACKGROUND: GET.ON (HelloBetter) treatment interventions have been shown to be efficacious in multiple randomized controlled trials. OBJECTIVE: This study evaluated the effectiveness of 2 GET.ON interventions, GET.ON Mood Enhancer and GET.ON Stress, in a national digital mental health service implemented across Germany. METHODS: Following an initial web-based questionnaire, participants were allocated to either intervention based on their baseline symptom severity and personal choice and received a semistandardized guided, feedback-on-demand guided, or self-guided version of the treatment. Uncontrolled routine care data from 851 participants were analyzed using a pretest-posttest design. Half of the participants (461/851, 54.2%) were allocated to the stress intervention (189/461, 41% semistandardized; 240/461, 52% feedback on demand; and 32/461, 6.9% self-guided), and almost all participants in the mood intervention (349/352, 99.2%) received semistandardized guidance. RESULTS: Results on depression-related symptom severity indicated a reduction in reported symptoms, with a large effect size of d=-0.92 (95% CI -1.21 to -0.63). Results on perceived stress and insomnia indicated a reduction in symptom severity, with large effect sizes of d=1.02 (95% CI -1.46 to -0.58) and d=-0.75 (95% CI -1.10 to -0.40), respectively. A small percentage of participants experienced deterioration in depression-related symptoms (11/289, 3.8%), perceived stress (6/296, 2%), and insomnia (5/252, 2%). After completing treatment, 51.9% (150/289) of participants showed a clinically reliable change in depression-related symptoms, whereas 20.4% (59/289) achieved a close to symptom-free status. Similar improvements were observed in perceived stress and insomnia severity. Guidance moderated the effectiveness of and adherence to the interventions in reducing depressive symptom severity. Effect sizes on depression-related symptom severity were d=-1.20 (95% CI -1.45 to -0.93) for the semistandardized group, d=-0.36 (95% CI -0.68 to -0.04) for the feedback-on-demand group, and d=-0.83 (95% CI -1.03 to -0.63) for the self-guided group. Furthermore, 47.6% (405/851) of the participants completed all modules of the intervention. Participant satisfaction was high across all patient groups and both interventions; 89.3% (242/271) of participants would recommend it to a friend in need of similar help. Limitations include the assignment to treatments and guidance formats based on symptom severity. Furthermore, part of the differences in symptom change between groups must be assumed to be due to this baseline difference in the measures. CONCLUSIONS: Future digital health implementation and routine care research should focus on monitoring symptom deterioration and other negative effects, as well as possible predictors of deterioration and the investigation of individual patient trajectories. In conclusion, this study supports the effectiveness of tailored digital mental health services in routine care for depression- and stress-related symptoms in Germany. The results highlight the importance of guidance in delivering internet-based cognitive behavioral therapy interventions and provide further evidence for its potential delivered as web-only solutions for increasing access to and use of psychological treatments.

[Indicative prevention programs for mental health promotion in preschool and primary school age: Willingness of pediatricians and families to participate in an innovative care chain]. / Indikative Präventionsprogramme zur Förderung der seelischen Gesundheit im Vor- und Grundschulalter: Teilnahmebereitschaft von Kinderärzt*innen und Familien an einer innovativen Versorgungskette.

BACKGROUND: Mental health problems usually have their onset in childhood. Undiagnosed, they may progress into mental disorders. Despite their effectiveness, existing preventive programs have been rarely used. We aimed to examine to what extent the establishment of a care chain can identify children at high risk at an early stage and assign them to preventive interventions. In addition, prevention program participation was assessed. METHODS: In a prospective implementation study, the Strengths and Difficulties Questionnaire was administered as a screening instrument to families during regular pediatric health examinations (U9-U11, child age 5-10 years). Families received feedback directly from the pediatrician, and in the case of borderline abnormal emotional or behavioral problems, a recommendation for an indicative prevention program. Program indication was additionally determined in an entry examination prior to program participation. RESULTS: In the area of Dresden (Germany), n = 46 (38.7%) pediatricians participated in the project. In n = 28 pediatric practices, n = 3231 (86.4%) families participated in the screening and n = 864 (26.7%) children received a prevention recommendation. Of the families, n = 118/864 (13.7%) self-registered for the prevention programs, n = 215/624 (35.5%) showed interest after being contacted by the study teamn. Through other pathways, n = 139 families requested participation. Clinical evaluation interviews to assess prevention indication were conducted in n = 337 children (n = 461; via all entry pathways). Finally, n = 237 (n = 337) children participated in an indicated prevention program. CONCLUSION: Expanding screening to mental health problems during regular health checkups is feasible, useful, and widely accepted. In order to implement a care chain, a supply structure should be established to enable referral to and uptake of preventive interventions.

Care processes in people in remission from type 2 diabetes: A cohort study using the National Diabetes Audit.

AIMS: People with type 2 diabetes can enter remission but may relapse or develop legacy complications. This analysis assesses whether people with remission from type 2 diabetes continue receiving annual care processes recommended in national guidelines and the potential impacts of formal recognition of remission. METHODS: People with type 2 diabetes with and without formal recognition (diagnostic code) of remission, and with and without evidence of remission (HbA1c < 48 mmol/mol without prescription for glucose-lowering drugs in preceding 26 weeks), included in the 2018/19 National Diabetes Audit (NDA) for England and Wales were followed up to identify care processes received between 1 January 2019 and 31 March 2020. RESULTS: Of the 2,822,145 people with type 2 diabetes in the cohort, 16,460 (0.58%) were coded with remission in the 2018/19 NDA. After adjustment for age, sex, socioeconomic deprivation and ethnicity, people coded with remission were less likely to receive each care process than those without such coding irrespective of HbA1c measurements (relative risk (RR) of receiving all 8 care processes 0.70 (95% CI 0.69-0.72)). For the 339,235 people with evidence of remission, irrespective of diagnostic coding compared to those without such evidence, the RR for receiving all 8 care processes was 0.94 (95% CI 0.93-0.94). CONCLUSIONS: People coded with remission of type 2 diabetes were less likely to receive diabetes care processes than those without such coding. People with evidence of remission had only a slightly reduced likelihood of receiving care processes. Formal recognition of remission may affect the provision or uptake of care processes.

Psychotherapy for Chronic In- and Outpatients with Common Mental Disorders: The "Choose Change" Effectiveness Trial.

INTRODUCTION: Treatment non-response occurs regularly, but psychotherapy is seldom examined for such patients. Existing studies targeted single diagnoses, were relatively small, and paid little attention to treatment under real-world conditions. OBJECTIVE: The Choose Change trial tested whether psychotherapy was effective in treating chronic patients with treatment non-response in a transdiagnostic sample of common mental disorders across two variants of treatment delivery (inpatient and outpatient). METHODS: The controlled nonrandomized effectiveness trial was conducted between May 2016 and May 2021. The study took place in two psychiatric clinics with N = 200 patients (n = 108 inpatients and n = 92 outpatients). Treatment variants were integrated inpatient care versus outpatient care based on acceptance and commitment therapy (ACT) for approximately 12 weeks. Therapists delivered individualized and non-manualized ACT. Main outcome measures were symptoms (Brief Symptom Checklist [BSCL]); well-being (Mental Health Continuum-Short Form [MHC-SF]), and functioning (WHO Disability Assessment Schedule [WHO-DAS]). RESULTS: Both inpatients and outpatients showed decreases in symptomatology (i.e., BSCL: d = 0.68) and increases in well-being and functioning (MHC-SF: d = 0.60 and WHO-DAS: d = 0.70), with more improvement in the inpatients during treatment. Both groups maintained gains 1 year following treatment, and the groups did not significantly differ from each other at this timepoint. Psychological flexibility moderated impact of stress on outcomes. CONCLUSIONS: Psychotherapy as practiced under routine conditions is effective for a sample of patients with common mental disorders, a long history of treatment experience and burden of disease, in both inpatient and outpatient settings. TRIAL REGISTRATION: This study was registered in the ISRCTN registry on May 20, 2016, with the registration number ISRCTN11209732.

Development and validation of a screening questionnaire for early identification of pregnant women at risk for excessive gestational weight gain.

BACKGROUND: Excessive weight gain during pregnancy is associated with adverse health outcomes for mother and child. Intervention strategies to prevent excessive gestational weight gain (GWG) should consider women's individual risk profile, however, no tool exists for identifying women at risk at an early stage. The aim of the present study was to develop and validate a screening questionnaire based on early risk factors for excessive GWG. METHODS: The cohort from the German "Gesund leben in der Schwangerschaft"/ "healthy living in pregnancy" (GeliS) trial was used to derive a risk score predicting excessive GWG. Sociodemographics, anthropometrics, smoking behaviour and mental health status were collected before week 12th of gestation. GWG was calculated using the last and the first weight measured during routine antenatal care. The data were randomly split into development and validation datasets with an 80:20 ratio. Using the development dataset, a multivariate logistic regression model with stepwise backward elimination was performed to identify salient risk factors associated with excessive GWG. The ß coefficients of the variables were translated into a score. The risk score was validated by an internal cross-validation and externally with data from the FeLIPO study (GeliS pilot study). The area under the receiver operating characteristic curve (AUC ROC) was used to estimate the predictive power of the score. RESULTS: 1790 women were included in the analysis, of whom 45.6% showed excessive GWG. High pre-pregnancy body mass index, intermediate educational level, being born in a foreign country, primiparity, smoking, and signs of depressive disorder were associated with the risk of excessive GWG and included in the screening questionnaire. The developed score varied from 0-15 and divided the women´s risk for excessive GWG into low (0-5), moderate (6-10) and high (11-15). The cross-validation and the external validation yielded a moderate predictive power with an AUC of 0.709 and 0.738, respectively. CONCLUSIONS: Our screening questionnaire is a simple and valid tool to identify pregnant women at risk for excessive GWG at an early stage. It could be used in routine care to provide targeted primary prevention measures to women at particular risk to gain excessive gestational weight. TRIAL REGISTRATION: NCT01958307, ClinicalTrials.gov, retrospectively registered 9 October 2013.

[Heart failure with preserved ejection fraction (HFpEF) : Diagnosis and treatment]. / Herzinsuffizienz mit erhaltener Ejektionsfraktion (HFpEF) : Diagnose und Therapie.

Heart failure with preserved ejection fraction (HFpEF) accounts for around half of all hospitalizations associated with heart failure. The prevalence of HFpEF is increasing, mainly due to an aging population and a growing burden of comorbidities, such as hypertension, diabetes, and obesity. Despite increased research efforts, there are still important gaps in terms of the pathophysiological understanding of HFpEF and the practice-related diagnostics. As HFpEF may also be due to rare cardiac diseases, in unclear constellations patients should be referred at an early stage to specialized centers for diagnostics and treatment to facilitate best clinical care. Only recently, evidence has emerged that innovative pharmacological approaches are also able to reduce hard clinical endpoints in HFpEF. These strategies now await implementation into routine care.

Quality of obstetric and newborn care in health centers of Addis Ababa City: using the WHO quality framework.

OBJECTIVE: The study aims to assess the quality of obstetric and newborn care using the WHO quality framework. DESIGN: The study used explanatory sequential mixed methods design. SETTING: This study was conducted in 50 health centers in Addis Ababa city administration from January 25 to December 31, 2021. METHODS: A total of 50 health centers were surveyed using a structured questionnaire and 500 women in the postpartum period were interviewed using a structured questionnaire. Delivery records of the 500 women were reviewed using a structured checklist. A total of 338 midwives were interviewed using a structured questionnaire. The quantitative data was analyzed using Statistical Package for Social Sciences (SPSS). RESULTS: The study revealed that only a third of the 50 health centers were providing good quality care (a quality score ≥ 75%). All the health centers had the physical resources (100%) to deliver obstetric and newborn care. The majority of the health centers had a system for actionable information (92%), functional referral (80%), and providing dignified care (80%). On the other hand, only a few of the health centers met the quality threshold for effective communication (24%), evidence-based practice of routine obstetric and newborn care (36%), and availability of mechanisms to support and motivate skilled birth attendants (24%). None of the health centers met the quality threshold for emotional support during labour and delivery. Obstetric caregivers' high workload and job dissatisfaction were barriers to quality care. CONCLUSION: Ensuring quality obstetric and newborn care needs effective quality improvement interventions that aim to ensure women had effective communication, emotional support, and dignity during labour and delivery. Reducing the workload and increasing motivation of birth attendants play a critical role in improving the quality of care.

The occurrence of multiple treatment switches in axial spondyloarthritis. Results from five Nordic rheumatology registries.

OBJECTIVES: In axial spondyloarthritis (axSpA), switching between multiple biologic or targeted synthetic (b/ts-) DMARDs might indicate difficult-to-treat disease. We aimed to explore the occurrence of multiple switching in routine care axSpA patients using various definitions, and to identify associated clinical characteristics upon start of first b/tsDMARD (baseline). METHODS: Observational cohort study including patients with axSpA starting a first-ever b/tsDMARD 2009-2018 based on data from five biologic registries (Denmark/Sweden/Finland/Norway/Iceland). Comorbidities and extra-articular manifestations were identified through linkage to national registries. Multi-switching was defined in overlapping categories according to b/tsDMARD treatment history: treatment with ≥3, ≥4 or ≥5 b/tsDMARDs during follow-up. We explored the cumulative incidence of patients becoming multi-switchers with ≥3 b/tsDMARDs stratified by calendar-period (2009-2011, 2012-2013, 2014-2015, 2016-2018). In the subgroup of patients starting a first b/tsDMARD 2009-2015, baseline characteristics associated with multi-switching (within 3 years' follow-up) were explored using multiple logistic regression analyses. RESULTS: Among 8398 patients included, 6056 patients (63% male, median age 42 years) started a first b/tsDMARD in 2009-2015, whereof proportions treated with ≥3, ≥4 or ≥5 b/tsDMARDs within 3 years' follow-up were 8%, 3% and 1%, respectively. Calendar-period did not affect the cumulative incidence of multi-switching. Baseline characteristics associated with multi-switching (≥3 b/tsDMARDs) were female gender, shorter disease duration, higher patient global score, comorbidities and having psoriasis but not uveitis. CONCLUSION: In this large Nordic observational cohort of axSpA patients, multiple switching was frequent with no apparent time-trend. Clinical associated factors included gender, but also previous comorbidities and extra-articular manifestations illustrating the ongoing challenge of treating this patient group.

Promise unfulfilled: Implementing web-based psychological therapy in routine cancer care, a qualitative study of oncology health professionals' attitudes.

BACKGROUND: Web-based mental health interventions (e-MhIs) show promise for increasing accessibility and acceptability of therapy for cancer patients. AIM: This study aimed to elicit health professionals' (HPs) views on optimal models for including e-MhIs within standard cancer care. MATERIALS & METHOD: Cancer HPs who worked in a service where an e-MhI was available to patients, and multi-disciplinary HPs interested in supportive care, were invited to participate via email. In semi-structured phone interviews, participants' views on e-MhIs were elicited. They were then presented with five model vignettes varying in local and centralised staff input, and asked to indicate their preference and views on each. A thematic analysis was applied to the data. RESULTS: Twelve nurses, nine psychologists, seven social workers, and three oncologists participated. Four key themes were identified: looking after patients, relationships and multidisciplinary care, trust, and feasibility, all contributing to a meta-theme of tension. Participants were motivated to ensure optimal patient outcomes and thus needed to trust the intervention content and process. They believed personal relationships increased patient engagement while affording greater work satisfaction for HPs. Most participants preferred a fully integrated model of care involving local HP assessment and design of a tailored therapy incorporating some e-MhI components where appropriate, but recognised this gold standard was likely not feasible given current resources. DISCUSSION AND CONCLUSION: Co-design with local staff of optimal models of care for the content and process of implementing e-MhIs is required, with due consideration of the patient group, staffing levels, local workflows and HP preferences, to ensure sustainability and optimal patient outcomes. CLINICAL TRIAL REGISTRATION: The ADAPT Cluster RCT is registered with the ANZCTR Registration number: ACTRN12617000411347.

Identifying health-related quality of life cut-off scores that indicate the need for supportive care in young adults with cancer.

PURPOSE: Using patient-reported outcomes in routine cancer care may improve health outcomes. However, a lack of information about which scores are problematic in specific populations can impede use. To facilitate interpretation of the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), we identified cut-off scores that indicate need for support by comparing each scale to relevant items from the Supportive Care Needs Survey (SCNS-LF59) in a young adult (YA) population. METHODS: We conducted a cross-sectional survey amongst YAs with cancer ages 25-39 at diagnosis. Participants completed the EORTC QLQ-C30 and SCNS-LF59. Patient, clinician and research experts matched supportive care needs from the SCNS-LF59 to quality of life domains of the EORTC QLQ-C30. We evaluated the EORTC QLQ-C30 domain score's ability to detect patients with need using receiver operator characteristic (ROC) analysis, calculating the area under the ROC curve and sensitivity and specificity for selected cut-offs. Cut-offs were chosen by maximising Youden's J statistic and ensuring sensitivity passed 0.70. Sensitivity analyses were conducted to examine the variability of the cut-off scores by treatment status. RESULTS: Three hundred and forty-seven YAs took part in the survey. Six experts matched SCNS-LF59 items to ten EORTC QLQ-C30 domains. The AUC ranged from 0.78 to 0.87. Cut-offs selected ranged from 8 (Nausea and Vomiting and Pain) to 97 (Physical Functioning). All had adequate sensitivity (above 0.70) except the Financial Difficulties scale (0.64). Specificity ranged from 0.61 to 0.88. Four of the cut-off scores differed by treatment status. CONCLUSION: Cut-offs with adequate sensitivity were calculated for nine EORTC QLQ-C30 scales for use with YAs with cancer. Cut-offs are key to interpretability and use of the EORTC QLQ-C30 in routine care to identify patients with supportive care need.

Internet-Delivered Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Nationwide Routine Care: Effectiveness Study.

BACKGROUND: Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficacious for generalized anxiety disorder (GAD), but few studies are yet to report its effectiveness in routine care. OBJECTIVE: In this study, we aim to examine whether a new 12-session iCBT program for GAD is effective in nationwide routine care. METHODS: We administered a specialized, clinic-delivered, therapist-supported iCBT for GAD in 1099 physician-referred patients. The program was free of charge for patients, and the completion time was not predetermined. We measured symptoms with web-based questionnaires. The primary measure of anxiety was the GAD 7-item scale (GAD-7); secondary measures were, for pathological worry, the Penn State Worry Questionnaire and, for anxiety and impairment, the Overall Anxiety Severity and Impairment Scale. RESULTS: Patients completed a mean 7.8 (SD 4.2; 65.1%) of 12 sessions, and 44.1% (485/1099) of patients completed all sessions. The effect size in the whole sample for GAD-7 was large (Cohen d=0.97, 95% CI 0.88-1.06). For completers, effect sizes were very large (Cohen d=1.34, 95% CI 1.25-1.53 for GAD-7; Cohen d=1.14, 95% CI 1.00-1.27 for Penn State Worry Questionnaire; and Cohen d=1.23, 95% CI 1.09-1.37 for Overall Anxiety Severity and Impairment Scale). Noncompleters also benefited from the treatment. Greater symptomatic GAD-7-measured relief was associated with more completed sessions, older age, and being referred from private or occupational care. Of the 894 patients with a baseline GAD-7 score ≥10, approximately 421 (47.1%) achieved reliable recovery. CONCLUSIONS: This nationwide, free-of-charge, therapist-supported HUS Helsinki University Hospital-iCBT for GAD was effective in routine care, but further research must establish effectiveness against other treatments and optimize the design of iCBT for GAD for different patient groups and individual patients.

Outcomes Accountability Systems for Early Childhood Disruptive Behaviors: A Scoping Review of Availability.

Early childhood disruptive behaviors are common mental health problems among American youth, and if poorly-managed, pose costly psychological and societal burdens. Outcomes accountability systems in clinical practice are vital opportunities to optimize early intervention for common mental health problems; however, such systems seem rare. A scoping review was conducted to summarize the current availability of outcomes accountability systems in clinical programs addressing early childhood disruptive behaviors, particularly in the US. We used PsycINFO to identify peer-reviewed literature published in English from 2005 to 2021, from which we selected 23 publications from the US, UK, and Netherlands on outcomes accountability systems within clinical programs treating common childhood mental health problems. Only 3 out of 23 publications described outcomes accountability efforts specifically for early childhood problems. Within the 3 studies, only one UK-based study specifically targeted early childhood disruptive behaviors. We did not find publications specifically describing outcomes accountability efforts in US-based clinical programs to treat early childhood disruptive behaviors. There are multi-level challenges preventing changes to the prevalent US model of paying a fee for each unit of child mental healthcare, with little regard for patient outcomes. However, opportunities exist to improve US-based accountability efforts; from top-down expansion of financial incentives, accountability initiatives, and PDT evidence-based practices to an iterative, bottom-up development of meaningful outcomes measurement by providers. Greater adoption of outcomes monitoring in US clinical practice for common mental health problems can optimize management of early childhood disruptive behaviors and mitigate long-term societal and economic burdens.

Clinician-Identified Factors in Success of Parent-Directed Behavioral Therapy for Children's Tantrums.

Disruptive behavior disorders (DBD) are the most common behavioral health problems in young American children. When not well-managed in early childhood, DBD can progress to lifetime mental health problems with personal, economic, as well as societal impacts. The evidence-based intervention of choice for DBD is outpatient parent-directed behavioral therapy (PDT). However, little is known about clinicians' perspectives on the factors influencing PDT's effectiveness in routine care. The current study directly assesses clinicians' perspectives on factors they believe impact PDT's success for disruptive behavior problems, in particular tantrums, at two outpatient behavioral therapy clinics specializing in PDT. In-depth interviews with 19 clinicians across three experience levels (doctoral intern, post-doctoral, licensed staff psychologist) were conducted and analyzed using qualitative methods. Two major themes were identified as enabling and limiting treatment success: (1) appointment attendance, (2) primary caregiver buy-in to treatment approach. Additional identified factors include caregiver's familial and social support, caregiver's physical and emotional capacities, complexity of the child's behavior problems, the extent to which the home environment can support positive changes, competing family/home demands, and care coordination among hospital programs. The primary factors identified by clinicians highlight the importance of fostering appointment attendance and parental psychoeducation that can be addressed by implementing multi-level administrative, training, and clinical initiatives to improve PDT's real-world effectiveness for DBD.

Long-term outcomes of active surveillance for clinically localized prostate cancer in a community-based setting: results from a prospective non-interventional study.

PURPOSE: To report on long-term outcomes of patients treated with active surveillance (AS) for localized prostate cancer (PCa) in the daily routine setting. METHODS: HAROW (2008-2013) was a non-interventional, health service research study about the management of localized PCa in the community setting, with 86% of the study centers being office-based urologists. A follow-up examination of all patients who opted for AS as primary treatment was carried out. Overall, cancer-specific, and metastasis-free survival, as well as discontinuation rates, were determined. RESULTS: Of 329 patients, 62.9% had very-low- and 21.3% low-risk tumours. The median follow-up was 7.7 years (IQR 4.7-9.1). Twenty-eight patients (8.5%) died unrelated to PCa, of whom 19 were under AS or watchful waiting (WW). Additionally, seven patients (2.1%) developed metastasis. The estimated 10-year overall and metastasis-free survival was 86% (95% CI 81.7-90.3) and 97% (95% CI 94.6-99.3), respectively. One hundred eighty-seven patients (56.8%) discontinued AS changing to invasive treatment: 104 radical prostatectomies (RP), 55 radiotherapies (RT), and 28 hormonal treatments (HT). Another 50 patients switched to WW. Finally, 37.4% remained alive without invasive therapy (22.2% AS and 15.2% WW). Intervention-free survival differed between the risk groups: 47.8% in the very-low-, 33.8% in the low- and 34.6% in the intermediate-/high-risk-group (p = 0.008). On multivariable analysis, PSA-density ≥ 0.2 ng/ml2 was significantly predictive for receiving invasive treatment (HR 2.55; p = 0.001). CONCLUSION: Even in routine care, AS can be considered a safe treatment option. Our results might encourage office-based urologists regarding the implementation of AS and to counteract possible concerns against this treatment option.

The utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) and the facilitator role for introducing patient-reported outcome measures (PROMs) in a medical oncology outpatient department.

PURPOSE: We evaluated the utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) for introducing patient-reported outcome measures (PROMs) into a medical oncology outpatient department. The i-PARIHS framework identifies four core constructs for implementation, including Facilitation, Innovation, Context and Recipients. METHODS: A pilot study used the i-PARIHS framework to identify PROM implementation barriers and enablers to inform facilitation support strategies, such as training clinicians and staff, workflow support, technical support and audit and feedback. Pre- and post-implementation surveys were completed by 83 and 72 staff, respectively, (nurses, doctors and allied health), to assess perceived knowledge, enablers, barriers and utility of PROMs; and acceptability of the PROM intervention was also assessed post-implementation. RESULTS: Important barriers included time constraints and previous experiences with technology. Enablers included good leadership support and a culture of learning. Facilitation strategies were used to overcome barriers identified in the i-PARIHS core domains. Compared to before the intervention, staff surveys showed improvement in perceived usefulness, perceived understanding and interpretation skills for PROMs. Staff perceptions about lack of time to use PROMs during visits remained a major perceived barrier post-implementation. CONCLUSION: The i-PARIHS framework was useful for guiding the implementation of PROMs in routine oncology care. The four core i-PARIHS constructs (Facilitation, Innovation, Context and Recipients) identified factors that directly impacted implementation, with Facilitation having a particularly important role to overcome these barriers. Oncology clinics and health systems considering implementing PROMs should consider having a dedicated Facilitator available during PROM implementation.

Using an implementation science approach to implement and evaluate patient-reported outcome measures (PROM) initiatives in routine care settings.

PURPOSE: Patient-reported outcome and experience measures (PROMs/PREMs) are well established in research for many health conditions, but barriers persist for implementing them in routine care. Implementation science (IS) offers a potential way forward, but its application has been limited for PROMs/PREMs. METHODS: We compare similarities and differences for widely used IS frameworks and their applicability for implementing PROMs/PREMs through case studies. Three case studies implemented PROMs: (1) pain clinics in Canada; (2) oncology clinics in Australia; and (3) pediatric/adult clinics for chronic conditions in the Netherlands. The fourth case study is planning PREMs implementation in Canadian primary care clinics. We compare case studies on barriers, enablers, implementation strategies, and evaluation. RESULTS: Case studies used IS frameworks to systematize barriers, to develop implementation strategies for clinics, and to evaluate implementation effectiveness. Across case studies, consistent PROM/PREM implementation barriers were technology, uncertainty about how or why to use PROMs/PREMs, and competing demands from established clinical workflows. Enabling factors in clinics were context specific. Implementation support strategies changed during pre-implementation, implementation, and post-implementation stages. Evaluation approaches were inconsistent across case studies, and thus, we present example evaluation metrics specific to PROMs/PREMs. CONCLUSION: Multilevel IS frameworks are necessary for PROM/PREM implementation given the complexity. In cross-study comparisons, barriers to PROM/PREM implementation were consistent across patient populations and care settings, but enablers were context specific, suggesting the need for tailored implementation strategies based on clinic resources. Theoretically guided studies are needed to clarify how, why, and in what circumstances IS principles lead to successful PROM/PREM integration and sustainability.

Acceptability and appropriateness of a clinical pathway for managing anxiety and depression in cancer patients: a mixed methods study of staff perspectives.

BACKGROUND: Clinical pathways (CPs) can improve health outcomes, but to be sustainable, must be deemed acceptable and appropriate by staff. A CP for screening and management of anxiety and depression in cancer patients (the ADAPT CP) was implemented in 12 Australian oncology services for 12 months, within a cluster randomised controlled trial of core versus enhanced implementation strategies. This paper compares staff-perceived acceptability and appropriateness of the ADAPT CP across study arms. METHODS: Multi-disciplinary lead teams at each service tailored, planned, championed and implemented the CP. Staff at participating services, purposively selected for diversity, completed a survey and participated in an interview prior to implementation (T0), and at midpoint (6 months: T1) and end (12 months: T2) of implementation. Interviews were recorded, transcribed and thematically analysed. RESULTS: Seven metropolitan and 5 regional services participated. Questionnaires were completed by 106, 58 and 57 staff at T0, T1 and T2 respectively. Eighty-eight staff consented to be interviewed at T0, with 89 and 76 at T1 and T2 (response rates 70%, 66% and 57%, respectively). Acceptability/appropriateness, on the quantitative measure, was high at T0 (mean of 31/35) and remained at that level throughout the study, with no differences between staff from core versus enhanced services. Perceived burden was relatively low (mean of 11/20) with no change over time. Lowest scores and greatest variability pertained to perceived impact on workload, time and cost. Four major themes were identified: 1) Mental health is an important issue which ADAPT addresses; 2) ADAPT helps staff deliver best care, and reduces staff stress; 3) ADAPT is fit for purpose, for both cancer care services and patients; 4) ADAPT: a catalyst for change. Opposing viewpoints are outlined. CONCLUSIONS: This study demonstrated high staff-perceived acceptability and appropriateness of the ADAPT CP with regards to its focus, evidence-base, utility to staff and patients, and ability to create change. However, concerns remained regarding burden on staff and time commitment. Strategies from a policy and managerial level will likely be required to overcome the latter issues. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/ .

Clinicians' knowledge and attitudes towards patient reported outcomes in colorectal cancer care - insights from qualitative interviews.

INTRODUCTION: Patient-reported outcomes (PROs) can be used in cancer care to monitor patients' disease-related symptoms and functional status. However, successful implementation of such instruments is only possible if clinical staff are convinced of the clinical benefits. It is therefore crucial to investigate the attitudes of clinical staff to PROs in routine cancer care. METHODS: Semi-structured, guideline-based interviews were held with 12 clinicians working in certified colorectal cancer centers in Germany who are taking part in an observational study on PROs (five surgeons, two oncologists, one psycho-oncologist, two oncological care nurses, one stoma therapist, and one physician assistant) in order to investigate firstly, how clinicians describe PRO instruments ("wording"); and secondly, the clinicians' general attitude toward PROs. A qualitative content analysis according to Kuckartz was performed. RESULTS: The wording used to describe PROs was not consistent. Statements on attitudes toward PROs were very heterogeneous and were therefore categorized into "(rather) positive" and "(rather) negative." The principal advantages of PROs mentioned by participants included broader, structured knowledge about patients and treatment, as well as relevance for patients. Subcategories for (rather) negative attitudes included statements expressing doubts about the questionnaires and "no need for PROs." DISCUSSION: The clinicians participating mainly expressed fairly positive attitudes toward PROs. However, they had little knowledge about PROs in general and the interviews therefore mainly reflect their expectations and assumptions about them. These initial impressions may be regarded as providing a basis for future implementation strategies and for training of clinicians on how to use PROs in routine cancer care.