Models, frameworks and theories in the implementation of programs targeted to reduce formal coercion in mental health settings: a systematic review.

Introduction: Implementation models, frameworks and theories (hereafter tools) provide researchers and clinicians with an approach to understand the processes and mechanisms for the successful implementation of healthcare innovations. Previous research in mental health settings has revealed, that the implementation of coercion reduction programs presents a number of challenges. However, there is a lack of systematized knowledge of whether the advantages of implementation science have been utilized in this field of research. This systematic review aims to gain a better understanding of which tools have been used by studies when implementing programs aiming to reduce formal coercion in mental health settings, and what implementation outcomes they have reported. Methods: A systematic search was conducted using PubMed, CINAHL, PsycINFO, Cochrane, Scopus, and Web of Science. A manual search was used to supplement database searches. Quality appraisal of included studies was undertaken using MMAT-Mixed Methods Appraisal Tool. A descriptive and narrative synthesis was formed based on extracted data. Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines were followed in this review. Results: We identified 5,295 references after duplicates were removed. Four additional references were found with a manual search. In total eight studies reported in nine papers were included in the review. Coercion reduction programs that were implemented included those that were holistic, and/or used professional judgement, staff training and sensory modulation interventions. Eight different implementation tools were identified from the included studies. None of them reported all eight implementation outcomes sought from the papers. The most frequently reported outcomes were acceptability (4/8 studies) and adaptation (3/8). With regards to implementation costs, no data were provided by any of the studies. The quality of the studies was assessed to be overall quite low. Discussion: Systematic implementation tools are seldom used when efforts are being made to embed interventions to reduce coercive measures in routine mental health care. More high-quality studies are needed in the research area that also involves perspectives of service users and carers. In addition, based on our review, it is unclear what the costs and resources are needed to implement complex interventions with the guidance of an implementation tool. Systematic review registration: [Prospero], identifier [CRD42021284959].

Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial.

BACKGROUND: Intimate partner violence constitutes a serious health problem worldwide. To date the evidence is sparse on whether intimate partner violence group interventions could improve mental health outcomes among perpetrators and their partners. OBJECTIVES: To compare the effectiveness of nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy in improving reported mental health outcomes and emotion regulation at 12 months' follow-up amongst perpetrators who voluntarily seek help for violence in intimate partnerships. DESIGN: A randomised controlled trial. PARTICIPANTS: A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study. METHODS: The participants were randomly assigned to cognitive-behavioural group therapy (intervention group, N = 67) or mindfulness-based stress reduction group therapy (comparator group, N = 58). The pre-defined outcomes were symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale at 12 months' follow-up. RESULTS: A reduction of symptoms of anxiety and depression was reported, with no between-group differences (intervention group: coefficient: - 0.17, P = 0.009; comparator group: coefficient: - 0.13, P = 0.036). Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0. 34, P = <0.001). CONCLUSION: Even though there was reduction in symptoms in both groups at 12 months' follow-up with no between-group differences, the total symptom scores remained high in both groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01653860.

Cognitive behavioural group therapy versus mindfulness-based stress reduction group therapy for intimate partner violence: a randomized controlled trial.

BACKGROUND: Violence in close relationships is a global public health problem and there is a need to implement therapeutic programs designed to help individuals who voluntarily seek help to reduce recurrent intimate partner violence. The effectiveness of such interventions in this population remains inconclusive. The aim of the present study was to compare the effectiveness of cognitive-behavioural group therapy (CBGT) vs mindfulness-based stress reduction (MBSR) group therapy in reducing violent behavior amongst individuals who are violent in intimate partnerships and who voluntarily seek help. METHODS: One hundred forty four participants were randomized using an internet-based computer system. Nineteen withdrew after randomization and 125 participants were randomly assigned to the intervention condition (CBGT, n = 67) or the comparator condition (MBSR, n = 58). The intervention condition involved two individual sessions followed by 15 cognitive-behavioural group therapy sessions. The comparator condition included one individual session before and after 8 mindfulness-based group sessions. Participants (N = 125) and their relationship partners (n = 56) completed assessments at baseline, and at three, six, nine and twelve months' follow-up. The pre-defined primary outcome was reported physical, psychological or sexual violence and physical injury as measured by the revised Conflict Tactics Scale (CTS2). RESULTS: The intent-to-treat analyses were based on 125 male participants (intervention group n = 67; comparator group n = 58). Fifty-six female partners provided collateral information. Baseline risk estimate in the CBGT-group was .85 (.74-.92), and .88 (.76-.94) in the MBSR-group for physical violence. At 12-months' follow-up a substantial reduction was found in both groups (CBGT: .08 (.03-.18); MBSR: .19 (.11-.32)). CONCLUSION: Results provide support for the efficacy of both the cognitive-behavioural group therapy and the mindfulness-based stress reduction group therapy in reducing intimate partner violent behavior in men voluntarily seeking treatment. TRIAL REGISTRATION: NCT01653860, registered July 2012.

Control of paratuberculosis: who, why and how. A review of 48 countries.

Paratuberculosis, a chronic disease affecting ruminant livestock, is caused by Mycobacterium avium subsp. paratuberculosis (MAP). It has direct and indirect economic costs, impacts animal welfare and arouses public health concerns. In a survey of 48 countries we found paratuberculosis to be very common in livestock. In about half the countries more than 20% of herds and flocks were infected with MAP. Most countries had large ruminant populations (millions), several types of farmed ruminants, multiple husbandry systems and tens of thousands of individual farms, creating challenges for disease control. In addition, numerous species of free-living wildlife were infected. Paratuberculosis was notifiable in most countries, but formal control programs were present in only 22 countries. Generally, these were the more highly developed countries with advanced veterinary services. Of the countries without a formal control program for paratuberculosis, 76% were in South and Central America, Asia and Africa while 20% were in Europe. Control programs were justified most commonly on animal health grounds, but protecting market access and public health were other factors. Prevalence reduction was the major objective in most countries, but Norway and Sweden aimed to eradicate the disease, so surveillance and response were their major objectives. Government funding was involved in about two thirds of countries, but operations tended to be funded by farmers and their organizations and not by government alone. The majority of countries (60%) had voluntary control programs. Generally, programs were supported by incentives for joining, financial compensation and/or penalties for non-participation. Performance indicators, structure, leadership, practices and tools used in control programs are also presented. Securing funding for long-term control activities was a widespread problem. Control programs were reported to be successful in 16 (73%) of the 22 countries. Recommendations are made for future control programs, including a primary goal of establishing an international code for paratuberculosis, leading to universal acknowledgment of the principles and methods of control in relation to endemic and transboundary disease. An holistic approach across all ruminant livestock industries and long-term commitment is required for control of paratuberculosis.

Infectious diseases in oyster aquaculture require a new integrated approach.

Emerging diseases pose a recurrent threat to bivalve aquaculture. Recently, massive mortality events in the Pacific oyster Crassostrea gigas associated with the detection of a microvariant of the ostreid herpesvirus 1 (OsHV-1µVar) have been reported in Europe, Australia and New Zealand. Although the spread of disease is often viewed as a governance failure, we suggest that the development of protective measures for bivalve farming is presently held back by the lack of key scientific knowledge. In this paper, we explore the case for an integrated approach to study the management of bivalve disease, using OsHV-1 as a case study. Reconsidering the key issues by incorporating multidisciplinary science could provide a holistic understanding of OsHV-1 and increase the benefit of research to policymakers.

Phase II Trial of Preoperative Radiation With Concurrent Capecitabine, Oxaliplatin, and Bevacizumab Followed by Surgery and Postoperative 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX), and Bevacizumab in Patients With Locally Advanced Rectal Cancer: 5-Year Clinical Outcomes ECOG-ACRIN Cancer Research Group E3204.

LESSONS LEARNED: The 5-year oncologic outcomes from the trial regimen were excellent. However, the neoadjuvant and surgical toxicity of this regimen was significant and was the primary reason for the low compliance with adjuvant systemic therapy.Due to the lack of an improvement in the pathologic complete response rate, the substantial associated toxicity, and the negative phase III trials of adjuvant bevacizumab in colon cancer, this regimen will not be pursued for further study. BACKGROUND: The addition of bevacizumab to chemotherapy improves overall survival for metastatic colorectal cancer. We initiated a phase II trial to evaluate preoperative capecitabine, oxaliplatin, and bevacizumab with radiation therapy (RT) followed by surgery and postoperative 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX), and bevacizumab for locally advanced rectal cancer. The purpose of this report is to describe the 5-year oncologic outcomes of this regimen. METHODS: In a phase II Simon two-stage design study, we evaluated preoperative treatment with capecitabine (825 mg/m(2) b.i.d. Monday-Friday), oxaliplatin (50 mg/m(2) weekly), bevacizumab (5 mg/kg on days 1, 15, and 29), and RT (50.4 Gy). Surgery was performed by 8 weeks after RT. Beginning 8-12 weeks after surgery, patients received FOLFOX plus bevacizumab (5 mg/kg) every 2 weeks for 12 cycles (oxaliplatin stopped after 9 cycles). The primary endpoint was a pathologic complete response (path-CR) rate of 30%. Fifty-seven patients with resectable T3/T4 rectal adenocarcinoma were enrolled between 2006 and 2010. RESULTS: Of 57 enrolled patients, 53 were eligible and included in the analysis. Forty-eight (91%) patients completed preoperative therapy, all of whom underwent curative surgical resection. Nine patients (17%) achieved path-CR. There were 29 worst grade 3 events, 8 worst grade 4 events, and 2 patient deaths, 1 of which was attributed to study therapy. Twenty-six patients (54%) began adjuvant chemotherapy. After a median follow-up period of 41 months, the 5-year overall survival (OS) rate for all patients was 80%. Only 2 patients experienced cancer recurrence: 1 distant (liver) and 1 loco-regional (pelvic lymph nodes), respectively. Both of these patients are still alive. The 5-year relapse-free survival rate was 81%. CONCLUSION: Despite the path-CR primary endpoint of this trial not being reached, the 5-year OS and recurrence-free survival rates were excellent. However, the neoadjuvant and surgical toxicity of this regimen was significant and was the primary reason for the low compliance with adjuvant systemic therapy. Because of the lack of an improvement in the path-CR rate, the substantial associated toxicity, and the negative phase III trials of adjuvant bevacizumab in colon cancer, this regimen will not be pursued for further study.

Updated results of a phase I trial of motexafin lutetium-mediated interstitial photodynamic therapy in patients with locally recurrent prostate cancer.

Locally recurrent prostate cancer after treatment with radiation therapy is a clinical problem with few acceptable treatments. One potential treatment, photodynamic therapy (PDT), is a modality that uses laser light, drug photosensitizer, and oxygen to kill tumor cells through direct cellular cytotoxicity and/or through destruction of tumor vasculature. A Phase I trial of interstitial PDT with the photosensitizer Motexafin lutetium was initiated in men with locally recurrent prostate cancer. In this ongoing trial, the primary objective is to determine the maximally tolerated dose of Motexafin lutetium-mediated PDT. Other objectives include evaluation of Motexafin lutetium uptake from prostate tissue using a spectrofluorometric assay and evaluation of optical properties in the human prostate. Fifteen men with biopsy-proven locally recurrent prostate cancer and no evidence of distant metastatic disease have been enrolled and 14 have been treated. Treatment plans were developed using transrectal ultrasound images. The PDT dose was escalated by increasing the Motexafin lutetium dose, increasing the 732 ran light dose, and decreasing the drug-light interval. Motexafin lutetium doses ranged from 0.5 to 2 mg/kg administered IV 24, 6, or 3 hr prior to 732 ran light delivery. The light dose, measured in real time with in situ spherical detectors was 25-100 J/cm2. Light was delivered via optical fibers inserted through a transperineal brachytherapy template in the operating room. Optical property measurements were made before and after light therapy. Prostate biopsies were obtained before and after light delivery for spectrofluorometric measurements of photosensitizer uptake. Fourteen patients have completed protocol treatment on eight dose levels without dose-limiting toxicity. Grade I genitourinary symptoms that are PDT related have been observed. One patient had Grade II urinary urgency that was urinary catheter related. No rectal or other gastrointestinal PDT-related tox-icities have been observed to date. Measurements of Motexafin lutetium demonstrated the presence of photosensitizer in prostate tissue from all patients. Optical property measurements demonstrated substantial heterogeneity in the optical properties of the human prostate gland which supports the use of individualized treatment planning for prostate PDT.

Patient restraint positions in a psychiatric inpatient service.

AIM: The use of physical intervention on psychiatric inpatient units continues to be a source of debate and controversy. Some studies and national clinical guidelines have identified particular restraint positions as both dangerous and undesirable. The following study attempts to identify clinical variables that may make physical restraint in a particular position more likely. METHOD: A cross-sectional survey design was adopted and data was obtained from a violence and aggression audit form used by the trust. This form has 122 items to be completed by staff within 72 hours of an episode of patient aggression or self-harm. Ten variables were selected for scrutiny on the basis of their potential clinical importance. RESULTS: The survey found that prone restraint was significantly associated with others reporting the patient's imminent violence and high-intensity observation after the incident. Supine restraint was significantly associated with the patient being withdrawn and/or refusing to communicate prior to the episode and with a high severity incident rating after the incident. CONCLUSION: If we work on the premise that restraint in the prone position is less desirable than interventions undertaken with the patient in the supine position, this study clearly suggests that we have an opportunity to influence the nature of intervention through quite minimal changes to training programmes. It is important that any change in emphasis around intervention does not create a sense that controlled descent to the floor is inevitable. The principle of its use as a 'last resort in the event of loss of control on the feet' has to be maintained.

Concurrent RT with 5-FU/epirubicin and cisplatin or irinotecan for locally advanced upper GI adenocarcinoma.

From the results of recent studies, it is likely that multimodality therapy with chemotherapy and radiation treatment may improve the overall outcome of locally advanced upper gastrointestinal (GI) malignancies, including esophageal, gastric, pancreatic, and biliary tract carcinomas. However, more effective, more optimal, and less toxic chemotherapy regimen(s) with concomitant radiotherapy are needed beyond the concurrent continuous-infusion fluorouracil (5-FU) with radiation that is commonly applied in general practice. Epirubicin (Ellence), cisplatin, and irinotecan (Camptosar) are all active cytotoxic chemotherapy agents in upper GI cancers. Two phase I studies were designed to test the tolerability of the combination of radiotherapy with infusional 5-FU, epirubicin, and cisplatin (ECF) or 5-FU, irinotecan, and epirubicin (EIF) in the treatment of locally advanced upper GI malignancies.

Rates of unconventional medical therapy use in patients with prostate cancer: standard history versus directed questions.

OBJECTIVES: The use of unconventional medical therapies (UMTs) in the general population has increased dramatically in the past decade. Studies have estimated that 9% to 64% of patients with cancer use UMTs, and many do not disclose this information to their physicians. This study was designed to evaluate the rates of UMT use by patients with prostate cancer revealed by standard versus directed questioning and to identify demographic markers that may predict use. METHODS: A prospective study of 287 consecutive patients with cancer presenting to the Department of Radiation Oncology was performed. The prostate cancer population was 29% (84 of 287) of the total cancer patient population. Each patient underwent the standard history interview, including questions regarding prescription and over-the-counter medication. At the completion of the standard history interview, patients were then asked a set of directed questions regarding the use of UMTs. RESULTS: Of the 84 patients with prostate cancer, 31 (37%) used unconventional therapies. The standard history revealed that 6 (19%) of 31 used UMTs, and directed questioning revealed an additional 25 patients (81%) used UMTs in the study population (P <0.001). Of those using UMTs, 65% used megavitamins, 49% used herbal remedies, 13% used meditation or guided imagery, and 20% used nonherbal natural supplements. CONCLUSIONS: UMT use is prevalent among patients with prostate cancer. Some of these treatments may have a potential biologic impact on tumor behavior, therapeutic endpoints, and measured prostate-specific antigen values. The use of directed questioning during the patient evaluation significantly increases the physician's ability to identify patients with prostate cancer using UMTs.