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**Past papers Added** CSEC May/June 2016 - Physics - Paper 02 CSEC May/June 2016 - HSB - Paper 02 CSEC May/June 2016 - HSB - Paper 03 CSEC May/June 2016 - English A - Paper 02 CSEC May/June 2016 - Office Management - Paper 02 CSEC May/June 2016 - Office Management - Paper 03 CSEC May/June 2016 - Biology - Paper 02 CSEC May/June 2016 - Geography - Paper 02 CSEC May/June 2016 - Geography - Paper 03 CSEC May/June 2016 - Account Principles - Paper 02 CSEC May/June 2016 - Electrical and Electronic Technology - Paper 02 CSEC May/June 2016 - Social Studies - Work 02 CSEC May/June 2016 - Social Studies - Work 03 CSEC May/June 2016 - Integrated Science - Work 02 CSEC May/June 2016 - Integrated Science - Paper 03 CSEC May/ June 2016 - Principles of Business - Paper 02 CSEC May/June 2016 - Principles of Business - Paper 03 CSEC May/June 2016 - Account Principles Paper 03 CSEC May/June 2016 - EDPM - Paper 01 CSEC May/June 2016 - EDPM - Paper 02 CSEC May/June 2016 - Caribbean History - Paper 03 CSEC May/June 2016 - Additional Maths - Work 03 CSEC May/June 2016 - Mathematics - Work 02 CSEC May/June 2016 - Economics - Paper 02 CSEC May/June 2016 - Economics - Work 0203 CSEC May/June 2016 - Home Economics - Paper 02 Quality of Life Survey 27, 1893-1902(2018)Cite this Article 6940 Approaches 19 Quotes 10 Altmetric Metrics Service involving users in instrument development is increasingly recognized as important, but often does not work and is rarely reported. This has negative consequences for the validity of the content of the measure. The aim of this paper is to identify the types of items that service users felt were important for inclusion or exclusion from the new quality of life recovery measure for people with mental health difficulties. MethodsPotent items are presented to service users in structured individual interviews and face-to-face focus groups. The items were primarily taken or adapted from current measures and covered topics identified as important for quality of life from earlier qualitative work. The content and thematic analysis were carried out to identify the types of items that were important or unacceptable to service users. Results We have identified five key topics of the types of items that service users deemed acceptable or unacceptable; cases should be relevant and meaningful, unambiguous, easy to respond to especially when they are distressed, do not cause further unrest and do not judge. It is worth noting that this was from the perspective of the service user. Conclusions This research underlined the importance of the position of service users on the eligibility and validity of items for use in the development of the new measure. Whether service users favored the item or not was related to their ability or intent to answer accurately and honestly to an item impact on the validity and sensitivity of the measure. There is a growing commitment to outcome measures reported for patients designed to measure health improvements that are most important to service users [1,2]. The methodological quality of PROM's is determined by the extent to which they meet the recognized reliability and validity measurement properties [3,4,5]. A key validity property is the extent to which it covers what is intended for measurement. In the absence of a gold standard measure, researchers often used indirect validity testing methods such as factor analysis, Rasch, or Item Response Theory (IRT). They are important in the development of instruments, but in themselves are not sufficient to fully determine the validity of the outcome measure [6]. It is also important to measure the validity of the content; to what extent does the set of items comprehensively cover the different health components to be measured [3] and face validity; whether the items of each domain are reasonable, appropriate and relevant for people using the measure on a daily basis [7]. The content and validity of many of the outcome measures currently in use are based on the judgements of researchers and healthcare professionals, with a limited contribution from service users [8,9]. However, what a clinician or researcher may consider to be a good outcome may differ from what is considered important for service users [10] and only service users can determine whether the measure records these outcomes favorably [9]. The active contribution of service users at all stages of the measure can improve the acceptability, relevance and quality of the measure and related research [9, 11, 12]. In recent years, there has been a change in mental health policy with a focus on services that focus only on reducing symptoms, according to those with a more holistic and positive approach to recovery and quality of life defined by service users [13:14.15]. This growing movement towards positive mental health has grown internationally on recovery-oriented mental health services [16,17,18,19,20]. It is of particular importance that the PMs used in these services reflect key areas considered relevant to recovery by service users, rather than the traditional focus on reducing symptoms [21]. Aspects of life considered important for recovery have been shown to be consistent with those that are important for quality of life [22,23]. Topics considered by service users to be important for quality of life: well-being, relationships and sense of belonging, activity, self-perception, autonomy, hope and physical health [24:25,26] are similar to those considered important for mental health recovery: connectivity, hope, identity, meaning, and empowerment (CHIME) [27]. The new Quality of Life Recovery (ReQoL) measure in mental health has been developed in four phases: (1) generation and subsequent shortlist of candidates; (2) testing the validity of the face and content of shortlisted items; (3) psychometric assessment; and (4) selection if the final items that included combining qualitative and quantitative phases 2 and 3. It is important to note that the opinion and contribution of the service user at all stages were able with a panel of six professional service users who were included in the selection of shortlisted items from the group of candidate items until decisions on the inclusion of final items. Psychometric testing involved more than 4,000 service users who completed a version of the 60 or 40 item measure before selecting the final items. For details on all stages involved in the development of the measure, see Keetharuth et al. [28]. In this paper, we report in particular on the second of four phases, which included seeking the opinions of service users at a set of cases in order to inform the selection of subjects to be forwarded for psychometric testing. This builds on a systematic review of qualitative research and primary qualitative research involving interviews of service users that identified seven topics that service users considered important for the quality of life listed above [24,25,26]. The set of potential items (n = 1597) that best represented these seven domains was generated from the current quality of life and recovery instruments and from service user interviews. The set of items contained both positive (e.g. I felt happy) and negative (e.g. I felt sad) of the worded item. They were subjected to initial sifting using a set of criteria adapted to those initially proposed by Streiner and Norman [4]. After considering clinicians, researchers and service users who were members of scientific, advisory, stock and expert user groups of the research study, the set of items was reduced to 88 potential items for the new Quality of Life Recovery measure [28]. The aim of this paper is to identify key topics of facial validity that should be taken into account when developing a quality of life instrument, using ReQoL as an example. We also report on the positions of service users on the eligibility and validity of the set of items. A qualitative study was conducted using structured face-to-face interviews and focus groups with service users. EmploymentThere is a requirement that ReQoL be suitable for users of mental health services older than 16 years. Therefore, adults (aged 19-79) and younger adults (aged 16-18) from the National Health Service (NHS) mental health service and a local charity were invited to take part. In order to obtain views from across the spectrum of mental health service users, broad inclusion criteria were applied; the only exclusion concerned people who had experienced acute episodes of their mental health, those who were not well enough to participate and those who could not speak English or give informed consent. This allowed for maximum variation of mental health issues, severity of the problem and current contact with the service. Adult participants were recruited from four UK NHS Trusts mental health services and charities in the UK in the north of the country. Two trusts were located in the south of England and two in the north. North. Young adults (aged 16-18) took place from two other NHS trusts based in the Midlands and the north of England. Recruitment has been undertaken on our behalf by health staff and clinical studies officers within individual trusts. Recruitment procedures followed what is common and practical for each individual trust. This included health personnel approaching service users on hospital wards, attending therapies, those who had previously agreed to be approached for research purposes, participants in the College of Recovery and the Rehabilitation and Recovery Center, and members of established PPI (Public and Patient Involvement) groups. Demographic, care and diagnostic information were taken at the time of the interview. In order to obtain a representative and diverse sample, this information was used to identify recruitment shortcomings, and recruitment staff were subsequently informed and asked to target these groups. A total of 59 users of adult services participated: 40 participated in individual interviews; 11 were attended by two focus groups of seven and four participants respectively; and four interviews were held with the two participants together. A total of 17 young adults participated: 15 participated in individual interviews, and two participants chose to have a joint conversation. Interviews lasted between 20 minutes and 1 hour for 40 minutes. For information on sample demography, see Table 1. Table 1 Features of InterviewsInterviews participants and focus groups were implemented between September 2014 and September 2015. Interviews and focus groups were undertaken at NHS sites known to participants other than one who was on university premises. A fact sheet was provided to participants before the interview. Written consent was obtained at the time of the interview prior to any data collection. Participants were asked to complete a short demographic pattern indicating their gender, age, ethnicity, employment, education level, mental health diagnosis and their own perception of their mental health problem (which may or may not be the same as diagnosis). Interviews and focus groups with users of adult services were conducted by three experienced qualitative researchers, one of whom is a service user (JCo, JCa, AG). Interviews with young adults were conducted by an experienced qualitative researcher and clinician specializing in the mental health of children and adolescents (ETBs). All participants received a ?20 shopping voucher in recognition of their time. The interview process was the same for both adults and young users of adult services. Items are groups by domain, ordered, and represented one domain at a time. To reduce the effect of fatigue, items are represented in a different order starting with another domain for each subsequent interview. In order to determine the validity of each potential item, participants were asked whether it was meaningful and relevant to their quality of life; it was clear, understandable and easy to respond; and the reason they either loved or did not like an object, or preferred it to another. They were also asked to take their preferred item within a group or a pair of items they thought were related to a similar concept (e.g. between I felt relaxed and I felt calm). Alternative formulations on subjects were triggered if participants felt the item was important for their quality of life but not loud or heavily responsible. With interviews, an iterative approach was taken. Adult participants were initially presented with a set of 88 potential items. About halfway through the interviews at the two foundations, 12 items (primarily reformulation of existing issues) were added as a result of feedback provided by the participants interviewed. This raises the item to 100 potential items for the remaining interviews. As a result of the findings of adult participants, a meeting was held with scientific and user group members and decisions were made to remove some items from the set and change others. This reduced the number of items to 61. Young adults are presented with this reduced set of items. Due to the large size of the item set, not all participants provided their view of all items. The average number of items commented on by a group of adults was 68; The smallest number was 5 from a person who was not well at the time, and the interview was interrupted earlier, and also 19 items by a focus group of 7 people. The maximum number of replies was all 100 items. The average number of items commented on by young adults was 34; the minimum number was 21 and the highest was all 61 items. The comfort and enthusiasm of the interlocutors to continue the interview were considered at all times. Most of the interviews were recorded and those tapes were transcribed. The notes were taken for three adult interlocutors who preferred not to have their interview recorded. All identifying information was removed from transcripts and notes prior to analysis. The analysis of interview data took a pragmatic approach to AnalysisA. From the transcripts, each participant's comments for each item are charted in the spreadsheet box with items over the horizontal axis and participants on the vertical axis. The traffic light system was used to highlight negative (red), positive (green) and neutral or ambiguous comments (orange). Items with relatively high levels of acceptability and inconspicuousness have been identified. A thematic analysis of comments was undertaken to determine the underlying reasons for the popularity or lack of popularity of the item. This information was used as a starting point for discussion with scientific, advisory and professional user groups to determine whether the subject should remain a potential item in the reqol measure. In the final stages of the measure's development, this was used in conjunction with other evidence such as psychometrics and clinician feedback [28] to decide on final items. The analysis required the items included in the measure to be relevant and meaningful, to be unequivocal and easy to respond to when they feel distressed, not to cause further distress and not to judge. It is worth noting that this was from the perspective of the service user. Quotes from the interlocutors relating to these questions and relevant items can be found in Table 2. Table 2 Quotes from interview participants about potential items to include in the ReQoL measure Relevance Item Were some items that were universally liked and had few objections. What these items have in common was that service users could connect to the item as something they regularly experienced. As a result, the answers to these questions did not require much thought and the vast majority of participants found them easy to answer. The items that fell into this category were I had difficulty sleeping or sleeping; My health is limited day by day of activity; I felt able to trust others (Quote 1); 'I felt anxious' and 'I felt confident' (Quote 2). These items were considered particularly relevant because of the further impact these experiences or feelings had on other aspects of their quality of life, for example, if you were unable to trust people, then you would never be happy and how self-confidence affected your self-worth. Some items are described by service users as irrelevant or meaningless, either for their own mental health issues or for quality of life. For example, when considering the item I felt accepted as who I am, service users felt that quality of life was more important that they accepted them themselves rather than being accepted by others. It was considered that it was not necessary to 'feel loved' (quote 3) for a good quality of life, and may have been a bit luxurious, but the feeling of 'cared for' was important and less specific to a particular type of relationship. It also felt impractical and elusive to have 'everything under control' or be able to 'do all the things I wanted' (Quote 4). There were objections to some items because they were thought to be overdiagments and not specific to mental health issues. Examples included 'I avoided the things I should have done' - there were thought to be very good reasons to avoid doing things you didn't want to do and this could improve your mental health; I felt irritated that it was considered a normal reaction and not necessarily related to mental health; and 'I felt tired and worn out' (Quote 5) which could be due to physical health as well as mental health. Several young adults felt that being 'confused about who I am' (Quote 6) was a natural thing for individuals in their age group. Some participants found it difficult to respond to the simplicity of objects because they were too abstract, hence the too much thinking. While under normal circumstances this would not be a problem, it was something they felt could be particularly difficult when they are in serious condition after first access to mental health services. This was particularly true in cases which they felt were obliged to consider the thoughts of others, e.g. I felt discriminated against (Quote 7); I felt accepted as who I am; and 'I thought people didn't want to meet me' (quote 8). Instead of considering whether they think people understand them (intent of the item), some will try to think about whether people understood them. There were some items that service users felt might be difficult to provide an honest answer because of their own low level of self-awareness while sick. Sometimes only in retrospect can they realize that they have been 'ignored' (quote 9) or that they have not 'thought clearly' (quote 10). Item ambiguousSome objects can be interpreted in a number of ways, for example, whether it is an object related to physical or emotional health. 'It hurt' Some felt it was emotional rather than physical pain, and there was a certain ambiguity as to whether she 'had self-care, washing or dressing problems' associated with emotional or physical problems, or both. There were also items that should have been negative (i.e. indicative of poor quality of life), but in some circumstances they can be considered positive. For the item I felt guilty (quote 11), several interlocutors indicated that this could be a positive change when they did something regrettable while they were sick. Similarly, cases that should have been positive could be interpreted negatively. For example, clear thinking could be due to a complete lack of emotion, and doing something wrong could be pleasant or useful. For young adults subject I felt that everything was under control (quote 12) was not necessarily indicated to a good quality of life because it meant being in charge, and the subject I could cope with everyday life was preferred because it indicated that they were dealing with it without having to take control. Young people also thought the item 'I feel hopeless' (Quote 13) had two interpretations of 'lack of hope' and 'feeling useless'. Disturbing or sensitive itemsIt is of the most common reason to object to an object, and having the attitude that it should not be included in the measure of quality of life, it was that it would cause upset. Some items were deemed too negative. They were often associated with suicidal thoughts and intentions. It was the extremely negative (and direct) wording within the subject that was disturbing, such as 'I had thoughts of suicide' (Quote 14) and 'I thought I would be better off dying'. The formulation is described as disturbing, sharp and too strong and can actually trigger suicidal thoughts. However, the majority of participants considered that was an important indicator of quality of life, but expressed a preference for cases with a more indirect, sensitive approach. The subjects 'I didn't care about my own life' and 'I thought my life wasn't worth living' are desirable. Some participants consider other subjects to be too extreme and thus described as disturbing, associated with feelings about themselves. Objects I felt humiliated or shamed by other people; I felt useless; I felt ashamed; I felt stupid; and I despised myself (quote 15) they were described as too personal, shameful, not nice and traumatic. One participant stated that such a negative question about himself would make 'voices' prominent. For self-related items, positive items (e.g. 'I felt ok about myself') were preferential. Of the negative items, again a gentler approach is favored, e.g. Due to its sensitive nature, a number of people responded that they would not want to admit certain things and therefore would either not respond to the item or would respond insouidably. The reasons were that they would be embarrassed ['I felt humiliated or ashamed by other people'; I had trouble self-care, washing or dressing (quote 16)] and I was concerned about the consequences of discovering [I had thoughts of suicide; I threatened or intimidated another person (quote 17)]. It was believed that some objects were insensitive because they were too positive, especially objects I felt full of life (quote 18), I felt I could recover from my problems and, to a lesser extent, I felt happy. Participants found these subjects unrealistic, because they felt they would never feel that way even when they were well. Such items are described as patronising and silly, especially when asked when they first approach a mental health service when they will feel particularly distressed. It was believed that the damning itemsSome positively worded items are too damning and reflect the opposite value system. This was especially true of those items that related to doing good things I was able to do things that helped others (quote 19); I felt I had

contributed (quote 19); I did things I thought were valuable; and I felt useful. Some participants felt that helping others was not necessary for quality of life and that people with mental health problems were not necessarily in a position where they could help others or do things that were worthwho, and such activities could make them feel worse. Furthermore, participants noted that if objects were answered truthfully (that they did not do things that helped others) it could result in feelings of guilt. The concept of independence was also considered to be reprehensible for assuming that independence is something to be appreciated (Quote 20). Recent guidelines clear and transparent reporting on the development of measures and the assessment of the properties of the instruments [2]. The reliability and psychometric properties of instruments are often reported, but the key stage of development of any measure is the content and validity of the face. The assessment of the content and validity of the person and the acceptability of items by those people who will ultimately use the measure can only be achieved through qualitative work with service users [6]. This paper demonstrates the importance of considering the views of service users on potential items. Service users provided their opinion on potential items to be taken into account in the ReQoL measure. In short, they expressed concern about sensitive cases that could potentially cause distress; judgements on what was a good outcome; is not relevant to their mental health and quality of life; ambiguous in their interpretation; and difficult to answer because they were too vague or abstract. Service users indicated that the potential consequences of including such items would be that they would not react accurately, truthfully or at all to the item, which in turn would have a detrimental effect on the validity of the measure. This is particularly worrying, as most of the items tested were from or adapted to the measures currently in use. Our findings are consistent with those of Crawford, al. [29] who retrospectively sought views from service users on the suitability of the most commonly used measures in mental health. One of the main concerns expressed in their study was where the subject was damning in its criteria of good outcome: for example, the view that people who got along well with family members had better social functioning or quality of life. Items subject to this criticism in our set of potential items related to the concepts of independence, helping others, and contributing to society by doing things that were useful or valuable. Crawford and Sur. [29] He also recommended that the measure does not cover a long list of questions on mental illness-related difficulties, but should consist of positive and negative items. We found that some objects can be considered too extreme in their negative or positive nature. Those considered too negative by our participants are predominantly associated with suicidal thoughts and those considered too positive about higher levels of well-being (happiness, joy and fun). This posed some concern for the ReQoL team as it was considered important that a valid quality of life measure covered the full spectrum of mental health from worst to best achievable [30]. In addition, polar aspects of recovery phases should also be represented; from a deep sense of loss and hopelessness to living a full and meaningful life [31]. Thus, while the concerns of service users are recognised, a decision has been taken to maintain the next stage of least extreme and least objectionable to service users, but still reflects a sense of hopelessness and positive well-being. A similar dilemma occurred with cases relating to a negative sense of self. The theory of recovery phases begins with the notion of negative identity to a positive sense of self [31]. There were no objections regarding cases that had an overly positive sense of self, but there were some that caused upset because they were unduly negative (e.g. I despised, I felt stupid). Again, in order to cover a wide range of ill health, those who were negative but considered less insensitive were retained. Some participants objected to cases they thought could easily be applied to any member of the general public rather than be specific to those with mental health issues (feeling irritated, avoiding things, fatigue). Following the hearing, it was decided that this did not necessarily require the omission of these cases, as the measure was intended for persons at different stages of their recovery. In order to increase eligibility, validity and reliability, the results of this study informed the development of ReQoL measures at each stage. As a result of feedback from service users, some items were omitted, while others were resussigned. Following a psychometric assessment of the case's performance, the findings were reused to inform the final selection of cases for the ReQoL measure with input from clinicians [28]. For the instrument to measure the terms most significant and relevant to the difficulties of service users, it is important that those providing feedback are representative of the target population [6]. This was considered as much as possible and people with different diagnoses, with varying levels of severity and from hospital, outpatient and recovery services were recruited and interviewed. However, it should be noted that a small part of those with a higher severity of the problem at the time of the interview were less able or motivated to provide a comprehensive response. They happily indicated whether they liked an object or not, but they didn't always articulate why. Greater depth of response was given by those who had milder conditions or those who did relatively well at the time of the interview, although they could look back at a time when they were less well off. Due to time constraints, we have not been able to interview people from primary care services. While the initial selection of subjects took into account the established list of criteria for selecting the best items, this phase made it clear that the responses of service users were not always the ones the researchers expected. This further strengthens the fact that a key component of the development of content validity measures for the target population. Here we have shown that certain questions can be considered irrelevant, reprehensible, disturbing, ambiguous or difficult to answer and should be taken care of when developing to be knew in this. However, items considered undesirable by one population of service users are likely to differ from another. This paper shows that the involvement of service users within this important methodological phase is paramount for the development of a reliable and valid measure that will be acceptable to those who complete it. Further independent research on the acceptance of measures and items of service users compared to other quality of life measures would be welcomed. Data supporting the findings of this study are available from the relevant author. However, the restrictions apply to the availability of these transcripts, as participants only agreed to have their data available to the researchers involved in the project. 1.Ministry of Health (2010); NHS Outcomes Framework 2011-12, London: Department of Health. 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Psychiatric services, 54(11), 1467?1474.Article PubMed Google Scholar 22.Boardman, J., & Shepherd, G. (2013) Estimate Seeking agreement on key domains. Report for the Department of Health. Unpublished (available from authors).23.Shepherd, G., Boardman, J., Rinaldi, M., & Roberts, G. (2014). Support recovery in mental health services: quality and outcomes. Centre for Mental Health and Mental Health Network, NHS Confederation, 34 . Accessed November 18, 2016 Connell, J., Brazier, J., O'Cathain, A., Lloyd-Jones, M., & Paisley, S. (2012). Quality of life of people with mental disorders: Synthesis of qualitative research. Health and Quality of Life Outcomes, 10(1), 138.Article PubMed PubMed Central Google Scholar 25.Brazier, J., Connell, J., Papaioannou, D., Mukuria, C., Mulhern, B., Peasgood, T., et al. (2014). Systematic review, psychometric analysis and qualitative assessment of generic, preference-based health measures in mental health populations and assessment of mapping functions from widely used specific measures. Health Technology Assessment, 18, 34.Article Google Scholar 26.Connell, J., O'Cathain, A., & Brazier, J. (2014). Measuring the quality of life in mental health: Do we ask the right questions? Social Sciences and Medicine, 120, 12?20.Article PubMed PubMed Central Google Scholar 27.Leamy, M., Bird, V., Le Boutillier, C., Williams, J., & Slade, M. (2011). Conceptual framework for personal recovery in mental health: Systematic review and narrative synthesis. British Journal of Psychiatry, 199, 445?452.Article PubMed Google Scholar 28.Keetharuth, A. D., Brazier, J. E., Connell, J., Bjorner, J.B., Carlton, J., Buck, T., E., et al (2018). Quality of Life Recovery (ReQoL): A new generic self-just endpoint for use with people with mental health problems. British Journal of Psychiatry, 212, 42?49.Article PubMed Google Scholar 29.Crawford, M. J., Robotham, D., Thana, L., Patterson, S., Weaver, T., Barber, R., et al. (2011). Selection of mental health outcome measures: attitudes of service users. Journal of Mental Health, 20, 336-346.Article PubMed Google Scholar 30.Huppert, F. A., & Whittington, J. E. (2003). Evidence for the independence of positive and negative well-being: Implications for quality of life assessment. British Journal of Health Psychology, 8(1), 107-122.Article PubMed Google Scholar 31.Andresen, R., Oades, L., & Caputi, P. (2003). Experience of recovery from schizophrenia: According to the empirically confirmed stage of the model. Australia & New Zealand Journal of Psychiatry, 37(5), 586-594.Article Google Scholar Download referencesIda would like to thank all participants in this survey and the staff who participated in the recruitment of participants. Special thanks to Rob Hanlon, Jo Hemmingfield and John Kay for providing us with service user perspectives. The study was conducted by the Department for Policy Research in the Economic Evaluation of Health and Care Interventions (EEPRU) funded by the Ministry of Health It's a research program. The research was partly funded by the National Institute for Health Research Collaboration for leadership in Applied Health Research and Care Yorkshire and the Humber (NIHR CLAHRC YH). . The views and opinions expressed are those of the authors, not necessarily the views of the NHS, NIHR or the Department of Health. All authors declare that they are not in a conflict of interest. Ethical Approval Ethics Approval was obtained from the Edgbaston National Research Ethics Service Committee, West Midlands (14/WM/1062). The management licence was obtained from each of the participating NHS trusts. Informed consent Informed consent was obtained from all participants of the study. Participants agreed to be able to use citations in research reports or other publications, after being anonymized. anonymised.

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