Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.

OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.

Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

Self-perceived barriers to healthcare access for patients with post COVID-19 condition.

BACKGROUND: Many patients with post COVID-19 condition (PCC) require healthcare services. However, qualitative studies indicate that patients with PCC encounter many barriers to healthcare access. This cross-sectional study aimed to determine how many PCC patients report barriers to healthcare access and which barriers are reported, and to explore differences between subgroups. METHODS: Data were collected via an online survey from 10,462 adult patients with a confirmed or suspected COVID-19 infection in the Netherlands, who experienced persisting symptoms ≥ 3 months after the initial infection. To study self-perceived barriers, a list of eleven possible barriers was used, covering multiple aspects of healthcare access. Differences between subgroups based on sociodemographic characteristics, medical characteristics, PCC symptoms (fatigue, dyspnoea, cognitive problems, anxiety and depression), and healthcare use (general practitioner, paramedical professional, medical specialist, occupational physician and mental health professional) were studied through multivariable multinomial (0 vs. 1 vs. > 1 barrier) and binomial regression analyses (for each individual barrier). RESULTS: A total of 83.2% of respondents reported at least one barrier to healthcare access. Respondents reported a median of 2.0 (IQR = 3.0) barriers. The barriers "I didn't know who to turn to for help" (50.9%) and "No one with the right knowledge/skills was available" (36.8%) were most frequently reported. Respondents with younger age, higher educational level, not hospitalized during acute COVID-19 infection, longer disease duration, who had more severe PCC symptoms, and who did not consult an occupational physician or paramedical professional, were more likely to report barriers. Analyses per barrier showed that women were more likely to report financial and help-seeking barriers, while men were more likely to report barriers related to availability of care. Hospitalized respondents were less likely to report barriers related to availability of care, but not less likely to report financial or help-seeking barriers. CONCLUSIONS: This study shows that the majority of patients with PCC experiences barriers to healthcare access. Particular attention should be paid to younger, non-hospitalized patients with a long disease duration and severe PCC symptoms. Efforts to remove barriers should focus not only on improving availability of care, but also on helping patients navigate care pathways.

Heterogeneous outcome reporting in adult slow-transit constipation studies: Systematic review towards a core outcome set.

BACKGROUND AND AIM: Standardizing evaluative outcomes and their assessment facilitates comparisons between clinical studies and provides a basis for comparing direct effects of different treatment options. The aim of this study was to systematically review types of outcomes and measurement instruments used in studies regarding treatment options for slow-transit constipation (STC) in adults. METHODS: In this systematic review of the literature, we searched MEDLINE, Embase, and PsycINFO from inception through February 2018, for papers assessing any STC treatment in adult patients. Outcomes were systematically extracted and categorized in domains using the conceptual framework of the Outcome Measures in Rheumatology filter 2.0. Outcome reporting was stratified by decade of publication, intervention, and study type. RESULTS: Forty-seven studies were included in this systematic review. Fifty-nine different types of outcomes were identified. The outcomes were structured in three core areas and 18 domains. The most commonly reported domains were defecation functions (94%), gastrointestinal transit (53%), and health-care service use (51%). The most frequently reported outcomes were defecation frequency (83%), health-related quality of life (43%), and adverse events and complications (43%). In 62% of the studies, no primary outcome was defined, whereas in two studies, more than one primary outcomes were selected. A wide diversity of measurement instruments was used to assess the reported outcomes. CONCLUSION: Outcomes reported in studies on STC in adults are heterogeneous. A lack of standardization complicates comparisons between studies. Developing a core outcome set for STC in adults could contribute to standardization of outcome reporting in (future) studies.

Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study.

INTRODUCTION: The variety, time patterns and long-term prognosis of persistent COVID-19 symptoms (long COVID-19) in patients who suffered from mild to severe acute COVID-19 are incompletely understood. Cohort studies will be combined to describe the prevalence of long COVID-19 symptoms, and to explore the pathophysiological mechanisms and impact on health-related quality of life. A prediction model for long COVID-19 will be developed and internally validated to guide care in future patients. METHODS AND ANALYSIS: Data from seven COVID-19 cohorts will be aggregated in the longitudinal multiple cohort CORona Follow Up (CORFU) study. CORFU includes Dutch patients who suffered from COVID-19 at home, were hospitalised without or with intensive care unit treatment, needed inpatient or outpatient rehabilitation and controls who did not suffer from COVID-19. Individual cohort study designs were aligned and follow-up has been synchronised. Cohort participants will be followed up for a maximum of 24 months after acute infection. Next to the clinical characteristics measured in individual cohorts, the CORFU questionnaire on long COVID-19 outcomes and determinants will be administered digitally at 3, 6, 12, 18 and 24 months after the infection. The primary outcome is the prevalence of long COVID-19 symptoms up to 2 years after acute infection. Secondary outcomes are health-related quality of life (eg, EQ-5D), physical functioning, and the prevalence of thromboembolic complications, respiratory complications, cardiovascular diseases and endothelial dysfunction. A prediction model and a patient platform prototype will be developed. ETHICS AND DISSEMINATION: Approval was obtained from the medical research ethics committee of Maastricht University Medical Center+ and Maastricht University (METC 2021-2990) and local committees of the participating cohorts. The project is supported by ZonMW and EuroQol Research Foundation. Results will be published in open access peer-reviewed scientific journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER: NCT05240742.

Cost-effectiveness of interventions for treating anxiety disorders: A systematic review.

BACKGROUND: Anxiety disorders are highly prevalent mental disorders that constitute a major burden on patients and society. As a consequence, economic evaluations of the interventions have become increasingly important. However, no recent overview of these economic evaluations is currently available and the quality of the published economic evaluations has not yet been assessed. Therefore, the current study has two aims: to provide an overview of the evidence regarding the cost-effectiveness of interventions for anxiety disorders, and to assess the quality of the studies identified. METHODS: A systematic review was conducted using PubMed, PsycINFO, NHS-EED, and the CEA registry. We included full economic evaluations on interventions for all anxiety disorders published before April 2016, with no restrictions on study populations and comparators. Preventive interventions were excluded. Study characteristics and cost-effectiveness data were collected. The quality of the studies was appraised using the Consensus on Health Economic Criteria. RESULTS: Forty-two out of 826 identified studies met the inclusion criteria. The studies were heterogeneous and the quality was variable. Internet-delivered cognitive behavioural therapy (iCBT) appeared to be cost-effective in comparison with the control conditions. Four out of five studies comparing psychological interventions with pharmacological interventions showed that psychological interventions were more cost-effective than pharmacotherapy. LIMITATIONS: Comparability was limited by heterogeneity in terms of interventions, study design, outcome and study quality. CONCLUSIONS: Forty-two studies reporting cost-effectiveness of interventions for anxiety disorders were identified. iCBT was cost-effective in comparison with the control conditions. Psychological interventions for anxiety disorders might be more cost-effective than pharmacological interventions.