Background The World Health Organization (WHO) defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Despite its importance, mental health provisions are often limited. In 2015, Indonesia had only 773 psychiatrists for 250 million residents. This shortage of specialist mental health professionals is shared by most Low- and Middle-Income Countries (LMICs) and is reflected in the Treatment Gaps in this region indicating the very small proportion of people who receive adequate mental health care for their needs. While the median worldwide Treatment Gap for psychosis is 32.2% (Kohn et al., 2004), in Indonesia it is more than 90%. Experts suggested integrating mental health care into primary care, to help bridge this gap (Mendenhall et al., 2014). The systematic introduction of the World Health Organization Mental Health Gap Action Programme into primary care clinics across Indonesia and the presence of a 15-year-old co-location of Clinical Psychologists in Yogyakarta province's primary care clinics presented an opportunity to assess the clinical and cost-effectiveness of both frameworks. Methods This research ("the trial") set out to develop an approach, and then implement it, to compare the adapted WHO mhGAP framework with the existing specialist framework within primary mental health services in Yogyakarta, Indonesia, through a pragmatic, two-arm cluster randomised controlled non-inferiority trial. This design enabled an examination of patients derived from whole populations in a 'real world' setting. The trial involved two phases: a pilot study in June 2016 with the objectives to refine data collection procedures and to serve as a practice run for clinicians involved in the trial; as well as a substantive trial beginning in December 2016. The 12-item General Health Questionnaire (GHQ-12) was established as a 'fairly accurate' screening tool using a Receiver Operating Curve study. Using the GHQ scoring method of 0-0-1-1, a threshold of 1/2 was identified for use in clinical setting, i.e. the context of the trial. The primary outcome was the health and social functioning of participants as measured by the Health of the Nation Outcome Scale (HoNOS) and secondary outcomes were disability as measured by WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality of life as measured by European Quality of Life Scale (EQ‐5D-3L), and cost of intervention evaluated from a health services perspective, which aimed to determine the clinical effectiveness and cost-effectiveness of both frameworks at six months. Results During the recruitment period, 4944 adult primary care patients attended 27 participating primary care centres. Following screening (n=1484) and in-depth psychiatric interviews (n=394), 174 WHO mhGAP arm and 151 Specialist arm participants received a formal diagnosis and were recruited into the trial. The number of required participants per treatment arm, to provide statistical power of 0.80 and statistical bilateral significance value of 0.05 was estimated to be 96. A total of 153 participants of the WHO mhGAP arm and 141 of the Specialist arm were followed-up at six months, representing 90.8% of all participants diagnosed. At follow-up, 82% (n=126) participants of the WHO mhGAP arm indicated they had attended at least one treatment session during the trial, significantly more than in the Specialist Arm (69%; n=97), 2 = 7.364, p=0.007. The WHO mhGAP arm was proven to be statistically not inferior to the Specialist arm in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Cost-effectiveness analyses show that the Specialist arm was dominant for a unit of improvement in patient outcomes at six months. While the framework is more expensive for the Health System, participants in the Specialist arm were found to have larger improvements. Conclusion Given that both frameworks yielded positive patient outcomes, there is no immediate need to increase the absolute number of specialist mental health professionals in community psychiatry (i.e. replicate the specialist framework outside Yogyakarta). As most psychologists and psychiatrists in Indonesia reside in large cities, the current systematic roll-out of the adapted WHO mhGAP framework might address the need to strengthen non-stigmatising mental health care within community contexts, reflecting the preferences of primary care patients. In districts or provinces which could afford the additional cost, however, the Specialist framework was shown to be better at improving patient outcomes than the adapted WHO mhGAP framework. Existing resources for specialist care can be arranged in a hub-and-spoke (step-up care) model where higher-level interventions are provided for those with greater needs. The proposed model would free-up resources for advanced clinical training of the specialist workforce in key areas of need while keeping specialist services accessible. Trial Registration This trial has been registered with clinicaltrials.gov since 25 February 2016, NCT02700490. Ehical Standards Full ethics approval from the University of Cambridge, UK was received on 15 December 2015 (PRE.2015.108) and from Universitas Gadjah Mada, Indonesia on 14 April 2016 (1237/SD/PL.03.07/IV/2016). A condition of ethics approval from the University of Cambridge is that the investigator is covered by indemnity insurance and that participants are insured for the period of their participation. This was provided by the University of Cambridge Trial Insurance Office (609/M/C/1510). Ethics approval from all the clusters was not required as each cluster (Puskesmas) is a local GP surgery which does not have its own ethics committee. Instead, approval to conduct research at the province of Yogyakarta including all five districts: Kota Yogyakarta, Sleman, Gunung Kidul, Kulon Progo, Bantul Districts was obtained from the Provincial Government Office (070/REG/V/625/5/2016) following ethics approvals. Written consent to participate was obtained from clinicians taking part as well as all patient-participants.

Alcohol misuse and related harm costs money, drains resource and takes lives. Alcohol brief interventional advice forms an important method to moderate alcohol consumption at both individual and population level. Alcohol exerts a significant negative influence on the oral cavity and is implicated in the development of oro-mucosal and dental disease. Alcohol and tobacco smoking are recognised a key aetiological agents in the development of oral cancer which is the 14th most common cancer, accounting for approximately 2% of new cases, killing over 2300 people in the UK every year. A crucial weapon to tackle the disease is prevention through management of those modifiable lifestyle factors. The role of the general dental practitioner (GDP) in providing alcohol advice has received sparse attention, however evidence suggests that GDPs do not routinely engage in this activity. The aim of this research was to identify factors preventing or facilitating GDP engagement and develop strategies to support them to deliver alcohol advice. GDPs salient beliefs were applied, using behaviour change theories (the Theory of Planned Behaviour and Social Cognitive Theory), to formulate a theory based questionnaire. A postal survey (n=300, RR 60%) identified that few (17%) GDPs routinely provide advice to patients exposing potential for improvement. Subsequent exploratory multiple regression analysis identified 5 key items which might act as targets. The resultant five-item model accounted for 41% of the variance in intention [Adjusted R2 for this model is .41; F = 15.34 (.001)].A theoretically informed intervention was administered as a multi-centre, parallel group, three-arm randomized controlled pilot study. The aims were to test the feasibility and acceptability of implementing an alcohol advice intervention in dental primary care. The intervention was not entirely acceptable to patients or dentists. Qualitative analysis revealed factors (not limited) to remuneration, perceived relevance, confidence, embarrassment and fear of consequences mar progress. Modifications to study processes and methods would seem a sensible prior to further study.

Efforts to improve inclusion in research have included mandating the recruitment of ethnic minorities and women into NIH funded studies. However, little research has been completed on who attends such interventions. This is particularly worrisome in populations for which attendance to interventions can have dire consequences. HIV is a public health concern for pregnant women in substance using communities, as pregnant women are much less likely to use condoms during intercourse to prevent HIV. Group modular HIV prevention interventions have long been the standard for HIV prevention. However, little attention in research on HIV prevention interventions RCTs has been focused on attendance to these interventions. This study examined predictors of intervention and control group attendance in a randomized controlled trial comparing a 5-session Safer Sex Skill Building (SSB) intervention to a 1-session HIV education control group in a sample of pregnant women at risk for prenatal substance use. This study identified psychosocial and mental health variables associated with both 1 session control group and 5-session SSB intervention attendance as well as endeavored to identify the number of sessions necessary to attend to achieve an adequate dose in treatment. Findings include younger age and marital status as being predictive of participation in the one session HE control group and having a trade, skill, or profession as being predictive of participation in the five session SSB intervention group. Further research is needed to understand what factors may impact five-session SSB group attendance.

Background: Interest in alternatives to hormone therapy (HT) for menopausal symptoms increased following its association with serious health risks. In terms of phytotherapeutic interventions, while traditional use supports a range of herbs for treating menopausal symptoms, evidence from rigorous scientific trials is limited, and has largely focused on the phytoestrogenic plants. Because of some safety concerns over long-term use of isoflavones, the present study focused on two non-estrogenic herbs, Hypericum perforatum and Vitex agnus-castus, also employed in this context in the Anglo-American and European traditions. Both herbs have shown effectiveness for the alleviation of symptoms of premenstrual syndrome (PMS), which is reported to be more severe during the perimenopause, and may account for many of the so-called 'menopausal symptoms' at this time. Research on menopausal vasomotor symptoms is prone to substantial placebo responses. There has been much interest in increasing our understanding of the placebo response with a view to controlling it in clinical research and harnessing it in clinical practice. Methods & Results: A double-blind, randomised controlled trial (RCT), with a 16-week treatment phase, was conducted on 100 late-perimenopause and early postmenopause women. The herbal combination (Hypericum and Vitex) was not found to be superior to placebo for any of the endpoints - daily weighted flushing scores, overall menopausal symptoms (on the Greene Climacteric Scale) and depression (on the Hamilton Depression Inventory). However, significant improvements across the treatment phase were observed in both arms for all of these outcome measures. No significant change was found for either group on the Utian quality of life scale. The effects of the herbal combination were also examined on PMS-like symptoms in the small sub-population of late-perimenopausal women, and found to be superior to placebo for total PMS-like symptoms and the sub-clusters, PMS-D (depression) and PMS-C (cravings). The active treatment group also showed significant improvements on PMS-A (anxiety) and PMS-H (hydration), although these effects were not superior to placebo. Predictors of the placebo response were investigated and found to include study-entry anxiety for the outcome measures of flushing, depression and overall menopausal symptoms, and improvement during non-treatment run-in for depression and overall symptoms. Because no difference had been found between 'active' and placebo groups in the menopause RCT, it was hypothesised that the same predictors would predict the response to the study treatment. However, low anxiety was significantly associated with improvement in this group. None of the other variables that predicted the placebo response was relevant to the study treatment response. This finding is discussed with reference to the possibility that 'drug' effects and placebo effects are not necessarily additive, and that the same magnitude of effect in both arms might not necessarily imply activity via the same pathways. Conclusions: This research contributes to the growing body of scientific knowledge about evidence-based complementary therapies that informs the community, health-care providers and regulatory authorities. The findings may facilitate identification of potential placebo responders in future research. The need for more research in the area of mechanisms of placebo versus active responses is supported.

Tvångssyndrom består av obsessioner och kompulsioner och drabbar cirka två procent av befolkningen. Efter avslutad behandling är det många patienter som återfaller. Syftet med föreliggande studie är att undersöka huruvida tilläggsbehandling administrerad sex månader efter initial internetadministrerad kognitiv beteendeterapi (KBT) minskar risken för återfall och ökar andelen patienter som uppnår remission, vilket inte tidigare prövats. 97 deltagare, som redan erhållit internetadministrerad KBT, randomiserades till att ingå i behandlingsgrupp eller kontrollgrupp. Tilläggsbehandlingen bestod av tre veckor internetadministrerad KBT med fokus på att fasa ut behandlarens funktion till deltagarens närmaste omgivning. Resultaten visade att deltagarna i behandlingsgruppen hade en signifikant minskad risk att återfalla jämfört med kontrollgruppen. En tendens till ökad andel deltagare i remission i behandlingsgruppen erhölls också. Slutsatsen är att internetadministrerad tilläggsbehandling vid tvångssyndrom är en meningsfull intervention med återfallsprevention som syfte. Framtida forskning bör göra åtskillnad mellan återfallsprevention och ytterligare minskad symtombörda som syfte med tilläggsbehandling.

Policy makers in education and international development have lately gravitated toward the randomized controlled trial (RCT)—an evaluation design that randomly assigns a sample of people or households into an intervention group and a control group in order to measure the differential effect of the intervention—as a means to determine program impact. As part of federal regulations, the U.S. Department of Education and the U.S. Agency for International development explicitly declared a preference for the RCT. When advocating for adopting the RCT model as the preferred evaluation tool, policy makers point to the success story of medical trials and how they revolutionized medicine from Medieval charlatanry to a modern life-saving discipline. By presenting a more nuanced account of the role of the RCT in medical history, however, this study finds that landmark RCTs were accompanied with challenges, Evidence-Based Medicine had rightful critics, and opportunistic biases in drug trials apply equally to education policy and international development. This study also examines the recent privileged role of the RCT in education and international development, concluding that its initial promise was not entirely born out when put into practice, as the national Reading First Initiative exemplifies. From a comparative perspective, the RCT movements also encountered major RCT critics, whose voices were not initially heard. These voices, however, seem to have contributed to a swing of the pendulum away from RCT primacy back towards greater methodological pluralism. A major conclusion of this study is that policy makers should exercise great caution when using RCTs as a policy evaluation tool. This conclusion is arrived at via considering RCT biases, challenges, and limited generalizability; understanding its interpretive-qualitative components; and broadening the overall methodological repertoire to better enable evaluations of macro-policy interventions. / text

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Hip fracture is a global and a growing public health problem. More women than men sustain hip fractures, the incidence increases exponentially with age and mean age is above 80. About one third of hip-fracture patients suffer from dementia and are prone to develop acute confusional state (delirium). Delirium is one of the most common complications after hip-fracture surgery, and seriously impacts on morbidity and mortality. Malnutrition is also common in hip-fracture patients and is associated with postoperative complications, such as delayed healing of the wound, infections and decubitus ulcers. Arthroplasty is usually preferred procedure in displaced femoral neck fractures but is, however, controversial in patients with dementia due to the fear of dislocation of the prosthesis. The aims of this thesis are to identify risk factors for delirium and the impact of delirium on rehabilitation outcome, to evaluate whether a postoperative multi-factorial intervention program could reduce delirium, to investigate the effect of a nutritional intervention and to evaluate complications, functional outcome and mortality regarding two surgical methods, hemiarthroplasty (HAP) and internal fixation (IF), in old patients with femoral neck fracture. Thirty-eight out of 61 consecutive patients (62%) were delirious on admission to hospital or developed postoperative delirium. An increased risk of postoperative delirium was found among hip-fracture patients with dementia and/or depression. Delirious patients were hospitalized longer, were more dependent in their activities of daily living, had poorer psychological well-being and suffered more complications than non-delirious patients. A postoperative multi-factorial and multidisciplinary intervention program reduced the incidence, at 55% vs 75% (p=0.003), and number of days with delirium, 5 vs 10 days (p=0.009). Postoperative complications were also reduced; decubitus ulcers 9% vs 22% (p= 0.010), urinary tract infections 31% vs 51% (p=0.005), falls 12% vs 27% (p=0.007), and the mean hospitalization period was 10 days shorter in the intervention group (p=0.030). Malnutrition was common among all these patients (53 %) and associated with postoperative complications such as decubitus ulcers and delirium. However, the nutritional intervention had no effect on nutritional parameters at four months, nevertheless men had better nutritional outcomes than women. A higher proportion of patients with dementia operated on using HAP had regained their pre-fracture ability to walk independently at the one-year follow up compared with those operated on using IF. Six of 83 patients dislocated their HAP during hospitalization and during an episode of delirium, none had dementia. No difference in mortality between the surgical methods was seen. Dementia per se should not be a reason to disqualify patients from being treated with the most appropriate surgical method. It is clinically important to discriminate between dementia and delirium, since delirium can be prevented and treated even in patients with dementia. Old patients undergoing surgery have special needs that are not always catered for in ordinary orthopaedic or surgical wards. The special care for these patients should include: a combined nursing and medical care based on comprehensive geriatric assessments, systematic prevention, detection and treatment of postoperative complications such as delirium, hypoxemia, urinary tract infections, pain, malnutrition and an active rehabilitation. It is obvious that improved quality of care reduces patient suffering and seemingly the costs for society.

Inom ramen för IVIN- projektet avsåg föreliggande studie att explorativt undersöka vilka variabler som kan moderera behandlingsutfallet i en internetadministrerad KBT-behandling för personer som upplever svårigheter att reglera ilska, aggressioner eller utagerande beteenden i nära relationer. Sextiofem personer inkluderades och randomiserades till de två betingelserna behandlingsgrupp (n=32) och kontrollgrupp (n=33). Aktuell studie baserades på resultaten för de deltagare som fyllt i för- och eftermätning (n = 59). Huvudutfallsmåtten beräknades utifrån individuella värden vid eftermätningen kontrollerat för förmätningen på Multidimensional Measure of Emotional Abuse och Aggression Questionnaire - Revised Swedish Version. För att undersöka valda variablers modererande effekt på respektive utfallsmått användes multipel regression. Resultaten visade att individer med initialt hög frekvens av emotionellt- och fysiskt våld, låg ilskeruminering och hög acceptans av sin partners negativa beteenden drog mest nytta av behandlingen. Resultaten visade även en tendens till att högre motivation, lägre ångest och högre ålder modererade ett bättre behandlingsutfall. Dessa tendenser bör dock utforskas vidare för att bringa ytterligare klarhet till dessa moderatorers påverkan på behandlingsutfallet. / IVIN

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