Framework Convention on Tobacco Control 2030-A Program to Accelerate the Implementation of World Health Organization Framework Convention for Tobacco Control in Low- and Middle-Income Countries: A Mixed-Methods Evaluation.

BACKGROUND: Framework Convention on Tobacco Control (FCTC) 2030 Program (2017-2021) was launched to accelerate World Health Organization (WHO) FCTC implementation in 15 low- and middle-income countries (LMICs). We evaluated the Program in six domains: Governance; Smoke-Free Policies; Taxation; Packaging and Health Warnings; Tobacco Advertising, Promotion, and Sponsorship (TAPS) bans; and International and Regional Cooperation. AIMS AND METHODS: Following a mixed-methods design, we surveyed (June-September 2020) FCTC focal persons in 14 of the 15 countries, to understand the Program's financial and technical inputs and progress made in each of the six domains. The data were coded in terms of inputs (financial = 1, technical = 1, or both = 2) and progress (none = 1, some = 2, partial = 3, or strong = 4) and a correlation was computed between the inputs and progress scores for each domain. We conducted semi-structured interviews with key stakeholders in five countries. We triangulated between the survey and interview findings. RESULTS: FCTC 2030 offered substantial financial and technical inputs, responsive to country needs, across all six domains. There was a high positive correlation between technical inputs and progress in five of the six domains, ranging from r = 0.61 for taxation (p < .05) to r = 0.91 and for smoke-free policies (p < .001). The interviews indicated that the Program provided timely and relevant evidence and created opportunities for influencing tobacco control debates. CONCLUSIONS: The FCTC 2030 Program might have led to variable, but significant progress in advancing FCTC implementation in the 15 countries. As expected, much of the progress was in augmenting existing structures and resources for FCTC implementation. The resulting advances are likely to lead to further progress in FCTC policy implementation. IMPLICATIONS: What this study adds: In many LMICs, WHO FCTC policies are not in place; and even when enshrined in law, they are poorly enforced. It is not clear how financial and technical assistance to high tobacco-burden LMICs can most effectively accelerate the implementation of WHO FCTC policies and offer value for money. Bespoke and responsive assistance, both financial and technical, to LMICs aimed at accelerating the implementation of WHO FCTC policies are likely to lead to progress in tobacco control.

'Oral Cancer is a Punishment for my Sins': Oral Histories of Oral Cancer, Fatalism and Islamic Religious Beliefs in Pakistan.

This paper explores how Islamic religious beliefs; spiritual practices and fatalism may act as barriers to a diagnosis of oral cancer in Rawalpindi/Islamabad Pakistan. The qualitative methodology is oral history and interviews took place with fifteen women diagnosed with oral cancer and receiving treatment in hospital. The research provides a model illustrating how religiosity, fatalism and the social determinants of health exist on a continuum and influence the perspectives of women in Pakistan, contributing to their late presentation and diagnosis of oral cancer. Analysis of the patients' oral histories, suggests improved communication between medical professionals and integration of spiritual/traditional healers into the existing health care system of Pakistan which may assist in reducing oral health inequalities.

Pakistan Oral Cancer Collaborative: analyzing barriers and obstacles to oral cancer diagnosis, treatment, and prevention in Pakistan.

Oral cancer is a global health problem with increasing case numbers worldwide and no significant improvement in prognosis over the last few decades. It is one of the most common cancers and a leading cause of death in Pakistan, although the number reported is significantly underreported owing to the lack of a national cancer repository, and the true magnitude of this challenge is not known. Bilateral discussions and workshops funded by the Global Challenges Research Fund brought together a number of like-minded researchers and clinicians from the United Kingdom and Pakistan to analyze the status quo and plan the future course. This article reviews some of these discussions as well as barriers to oral cancer diagnosis in Pakistan and makes recommendations to investigate the magnitude and develop measures that may help tackle this devastating disease.

Monitoring oral health of people in Early Intervention for Psychosis (EIP) teams: The extended Three Shires randomised trial.

BACKGROUND: The British Society for Disability and Oral Health guidelines made recommendations for oral health care for people with mental health problems, including providing oral health advice, support, promotion and education. The effectiveness of interventions based on these guidelines on oral health-related outcomes in mental health service users is untested. OBJECTIVE: To acquire basic data on the oral health of people with or at risk of serious mental illness. To determine the effects of an oral health checklist in routine clinical practice. DESIGN: Clinician and service user-designed cluster randomised trial. SETTINGS AND PARTICIPANTS: The trial compared a simple form for monitoring oral health care with standard care (no form) for outcomes relevant to service use and dental health behaviour for people with suspected psychosis in Mid and North England. Thirty-five teams were divided into two groups and recruited across 2012-3 with one year follow up. RESULTS: 18 intervention teams returned 882 baseline intervention forms and 274 outcome sheets one year later (31%). Control teams (n=17) returned 366 baseline forms. For the proportion for which data were available at one year we found no significant differences for any outcomes between those allocated to the initial monitoring checklist and people in the control group (Registered with dentist (p=0.44), routine check-up within last year (p=0.18), owning a toothbrush (p=0.99), cleaning teeth twice a day (p=0.68), requiring urgent dental treatment (p=0.11). CONCLUSION: This trial provides no clear evidence that Care Co-ordinators (largely nursing staff) using an oral health checklist improves oral health behaviour or oral health state in those thought to be at risk of psychosis or with early psychosis.

Intensive case management for severe mental illness.

BACKGROUND: Intensive Case Management (ICM) is a community-based package of care aiming to provide long-term care for severely mentally ill people who do not require immediate admission. Intensive Case Management evolved from two original community models of care, Assertive Community Treatment (ACT) and Case Management (CM), where ICM emphasises the importance of small caseload (fewer than 20) and high-intensity input. OBJECTIVES: To assess the effects of ICM as a means of caring for severely mentally ill people in the community in comparison with non-ICM (caseload greater than 20) and with standard community care. We did not distinguish between models of ICM. In addition, to assess whether the effect of ICM on hospitalisation (mean number of days per month in hospital) is influenced by the intervention's fidelity to the ACT model and by the rate of hospital use in the setting where the trial was conducted (baseline level of hospital use). SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (last update search 10 April 2015). SELECTION CRITERIA: All relevant randomised clinical trials focusing on people with severe mental illness, aged 18 to 65 years and treated in the community care setting, where ICM is compared to non-ICM or standard care. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected trials, assessed quality, and extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses.We performed a random-effects meta-regression analysis to examine the association of the intervention's fidelity to the ACT model and the rate of hospital use in the setting where the trial was conducted with the treatment effect. We assessed overall quality for clinically important outcomes using the GRADE approach and investigated possible risk of bias within included trials. MAIN RESULTS: The 2016 update included two more studies (n = 196) and more publications with additional data for four already included studies. The updated review therefore includes 7524 participants from 40 randomised controlled trials (RCTs). We found data relevant to two comparisons: ICM versus standard care, and ICM versus non-ICM. The majority of studies had a high risk of selective reporting. No studies provided data for relapse or important improvement in mental state.1. ICM versus standard careWhen ICM was compared with standard care for the outcome service use, ICM slightly reduced the number of days in hospital per month (n = 3595, 24 RCTs, MD -0.86, 95% CI -1.37 to -0.34,low-quality evidence). Similarly, for the outcome global state, ICM reduced the number of people leaving the trial early (n = 1798, 13 RCTs, RR 0.68, 95% CI 0.58 to 0.79, low-quality evidence). For the outcome adverse events, the evidence showed that ICM may make little or no difference in reducing death by suicide (n = 1456, 9 RCTs, RR 0.68, 95% CI 0.31 to 1.51, low-quality evidence). In addition, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment due to very low-quality evidence (n = 1129, 4 RCTs, RR 0.70, 95% CI 0.49 to 1.0, very low-quality evidence).2. ICM versus non-ICMWhen ICM was compared with non-ICM for the outcome service use, there was moderate-quality evidence that ICM probably makes little or no difference in the average number of days in hospital per month (n = 2220, 21 RCTs, MD -0.08, 95% CI -0.37 to 0.21, moderate-quality evidence) or in the average number of admissions (n = 678, 1 RCT, MD -0.18, 95% CI -0.41 to 0.05, moderate-quality evidence) compared to non-ICM. Similarly, the results showed that ICM may reduce the number of participants leaving the intervention early (n = 1970, 7 RCTs, RR 0.70, 95% CI 0.52 to 0.95,low-quality evidence) and that ICM may make little or no difference in reducing death by suicide (n = 1152, 3 RCTs, RR 0.88, 95% CI 0.27 to 2.84, low-quality evidence). Finally, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment as compared to non-ICM (n = 73, 1 RCT, RR 1.46, 95% CI 0.45 to 4.74, very low-quality evidence).3. Fidelity to ACTWithin the meta-regression we found that i.) the more ICM is adherent to the ACT model, the better it is at decreasing time in hospital ('organisation fidelity' variable coefficient -0.36, 95% CI -0.66 to -0.07); and ii.) the higher the baseline hospital use in the population, the better ICM is at decreasing time in hospital ('baseline hospital use' variable coefficient -0.20, 95% CI -0.32 to -0.10). Combining both these variables within the model, 'organisation fidelity' is no longer significant, but the 'baseline hospital use' result still significantly influences time in hospital (regression coefficient -0.18, 95% CI -0.29 to -0.07, P = 0.0027). AUTHORS' CONCLUSIONS: Based on very low- to moderate-quality evidence, ICM is effective in ameliorating many outcomes relevant to people with severe mental illness. Compared to standard care, ICM may reduce hospitalisation and increase retention in care. It also globally improved social functioning, although ICM's effect on mental state and quality of life remains unclear. Intensive Case Management is at least valuable to people with severe mental illnesses in the subgroup of those with a high level of hospitalisation (about four days per month in past two years). Intensive Case Management models with high fidelity to the original team organisation of ACT model were more effective at reducing time in hospital.However, it is unclear what overall gain ICM provides on top of a less formal non-ICM approach.We do not think that more trials comparing current ICM with standard care or non-ICM are justified, however we currently know of no review comparing non-ICM with standard care, and this should be undertaken.

Droperidol for psychosis-induced aggression or agitation.

BACKGROUND: People experiencing acute psychotic illnesses, especially those associated with agitated or violent behaviour, may require urgent pharmacological tranquillisation or sedation. Droperidol, a butyrophenone antipsychotic, has been used for this purpose in several countries. OBJECTIVES: To estimate the effects of droperidol, including its cost-effectiveness, when compared to placebo, other 'standard' or 'non-standard' treatments, or other forms of management of psychotic illness, in controlling acutely disturbed behaviour and reducing psychotic symptoms in people with schizophrenia-like illnesses. SEARCH METHODS: We updated previous searches by searching the Cochrane Schizophrenia Group Register (18 December 2015). We searched references of all identified studies for further trial citations and contacted authors of trials. We supplemented these electronic searches by handsearching reference lists and contacting both the pharmaceutical industry and relevant authors. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) with useable data that compared droperidol to any other treatment for people acutely ill with suspected acute psychotic illnesses, including schizophrenia, schizoaffective disorder, mixed affective disorders, the manic phase of bipolar disorder or a brief psychotic episode. DATA COLLECTION AND ANALYSIS: For included studies, we assessed quality, risk of bias and extracted data. We excluded data when more than 50% of participants were lost to follow-up. For binary outcomes, we calculated standard estimates of risk ratio (RR) and the corresponding 95% confidence intervals (CI). We created a 'Summary of findings' table using GRADE. MAIN RESULTS: We identified four relevant trials from the update search (previous version of this review included only two trials). When droperidol was compared with placebo, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 227, RR 1.18, 95% CI 1.05 to 1.31, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for the droperidol group (1 RCT, N = 227, RR 0.55, 95% CI 0.36 to 0.85, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 227, RR 0.34, 95% CI 0.01 to 8.31, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 227, RR 0.62, 95% CI 0.15 to 2.52, low-quality evidence) than placebo. For 'being ready for discharge', there was no clear difference between groups (1 RCT, N = 227, RR 1.16, 95% CI 0.90 to 1.48, high-quality evidence). There were no data for mental state and costs.Similarly, when droperidol was compared to haloperidol, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 228, RR 1.01, 95% CI 0.93 to 1.09, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for participants in the droperidol group (2 RCTs, N = 255, RR 0.37, 95% CI 0.16 to 0.90, high-quality evidence). There was no evidence that droperidol caused more cardiovascular hypotension (1 RCT, N = 228, RR 2.80, 95% CI 0.30 to 26.49,moderate-quality evidence) and cardiovascular hypotension/desaturation (1 RCT, N = 228, RR 2.80, 95% CI 0.12 to 67.98, low-quality evidence) than haloperidol. There was no suggestion that use of droperidol was unsafe. For mental state, there was no evidence of clear difference between the efficacy of droperidol compared to haloperidol (Scale for Quantification of Psychotic Symptom Severity, 1 RCT, N = 40, mean difference (MD) 0.11, 95% CI -0.07 to 0.29, low-quality evidence). There were no data for service use and costs.Whereas, when droperidol was compared with midazolam, for the outcome of tranquillisation or asleep by 30 minutes we found droperidol to be less acutely tranquillising than midazolam (1 RCT, N = 153, RR 0.96, 95% CI 0.72 to 1.28, high-quality evidence). As regards the 'need for additional medication by 60 minutes after initial adequate sedation, we found an effect (1 RCT, N = 153, RR 0.54, 95% CI 0.24 to 1.20, moderate-quality evidence). In terms of adverse effects, we found no statistically significant differences between the two drugs for either airway obstruction (1 RCT, N = 153, RR 0.13, 95% CI 0.01 to 2.55, low-quality evidence) or respiratory hypoxia (1 RCT, N = 153, RR 0.70, 95% CI 0.16 to 3.03, moderate-quality evidence) - but use of midazolam did result in three people (out of around 70) needing some sort of 'airway management' with no such events in the droperidol group. There were no data for mental state, service use and costs.Furthermore, when droperidol was compared to olanzapine, for the outcome of tranquillisation or asleep by any time point, we found no clear differences between the older drug (droperidol) and olanzapine (e.g. at 30 minutes: 1 RCT, N = 221, RR 1.02, 95% CI 0.94 to 1.11, high-quality evidence). There was a suggestion that participants allocated droperidol needed less additional medication after 60 minutes than people given the olanzapine (1 RCT, N = 221, RR 0.56, 95% CI 0.36 to 0.87, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 221, RR 0.32, 95% CI 0.01 to 7.88, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 221, RR 0.97, 95% CI 0.20 to 4.72, low-quality evidence) than olanzapine. For 'being ready for discharge', there was no difference between groups (1 RCT, N = 221, RR 1.06, 95% CI 0.83 to 1.34, high-quality evidence). There were no data for mental state and costs. AUTHORS' CONCLUSIONS: Previously, the use of droperidol was justified based on experience rather than evidence from well-conducted and reported randomised trials. However, this update found high-quality evidence with minimal risk of bias to support the use of droperidol for acute psychosis. Also, we found no evidence to suggest that droperidol should not be a treatment option for people acutely ill and disturbed because of serious mental illnesses.

Oral health education (advice and training) for people with serious mental illness.

BACKGROUND: People with serious mental illness not only experience an erosion of functioning in day-to-day life over a protracted period of time, but evidence also suggests that they have a greater risk of experiencing oral disease and greater oral treatment needs than the general population. Poor oral hygiene has been linked to coronary heart disease, diabetes, and respiratory disease and impacts on quality of life, affecting everyday functioning such as eating, comfort, appearance, social acceptance, and self esteem. Oral health, however, is often not seen as a priority in people suffering with serious mental illness. OBJECTIVES: To review the effects of oral health education (advice and training) with or without monitoring for people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (5 November 2015), which is based on regular searches of MEDLINE, EMBASE, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: All randomised clinical trials focusing on oral health education (advice and training) with or without monitoring for people with serious mental illness. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. MAIN RESULTS: We included three randomised controlled trials (RCTs) involving 1358 participants. None of the studies provided useable data for the key outcomes of not having seen a dentist in the past year, not brushing teeth twice a day, chronic pain, clinically important adverse events, and service use. Data for leaving the study early and change in plaque index scores were provided. Oral health education compared with standard careWhen 'oral health education' was compared with 'standard care', there was no clear difference between the groups for numbers leaving the study early (1 RCT, n = 50, RR 1.67, 95% CI 0.45 to 6.24, moderate-quality evidence), while for dental state: no clinically important change in plaque index, an effect was found. Although this was statistically significant and favoured the intervention group, it is unclear if it was clinically important (1 RCT, n = 40, MD - 0.50 95% CI - 0.62 to - 0.38, very low quality evidence).These limited data may have implications regarding improvement in oral hygiene. Motivational interview + oral health education compared with oral health educationSimilarly, when 'motivational interview + oral health education' was compared with 'oral health education', there was no clear difference for the outcome of leaving the study early (1 RCT, n = 60 RR 3.00, 95% CI 0.33 to 27.23, moderate-quality evidence), while for dental state: no clinically important change in plaque index, an effect favouring the intervention group was found (1 RCT, n = 56, MD - 0.60 95% CI - 1.02 to - 0.18 very low-quality evidence). These limited, clinically opaque data may or may not have implications regarding improvement in oral hygiene. Monitoring compared with no monitoringFor this comparison, only data for leaving the study early were available. We found a difference in numbers leaving early, favouring the 'no monitoring' group (1 RCT, n = 1682, RR 1.07, 95% CI 1.00 to 1.14, moderate-quality evidence). However, these data are problematic. The control denominator is implied and not clear, and follow-up did not depend only on individual participants, but also on professional caregivers and organisations - the latter changing frequently resulting in poor follow-up, but not a good reflection of the acceptability of the monitoring to patients. For this comparison, no data were available for 'no clinically important change in plaque index'. AUTHORS' CONCLUSIONS: We found no evidence from trials that oral health advice helps people with serious mental illness in terms of clinically meaningful outcomes. It makes sense to follow guidelines and recommendations such as those put forward by the British Society for Disability and Oral Health working group until better evidence is generated. Pioneering trialists have shown that evaluative studies relevant to oral health advice for people with serious mental illness are possible.