By J. Kor-Shach. Saint Leo University.
TABLE 2 Patient participants per practice Phase discount cipro 500mg online, number of participants GP practice E F G H J – K – Total 113 77 TABLE 3 Demographic characteristics of patients as participants in phase 1 and phase 2 Phase generic 1000mg cipro with visa, n (%) Demographic characteristics 1 (maximum N = 113) 2 (maximum N = 77) Age (years) n = 111 n = 77 Mean (SD) 67 purchase 1000 mg cipro with mastercard. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed buy 250mg cipro mastercard, the full report) may be included in professional journals 39 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. STUDY B: FEASIBILITY STUDY OF A CLUSTER RANDOMISED CONTROLLED TRIAL TABLE 3 Demographic characteristics of patients as participants in phase 1 and phase 2 (continued) Phase, n (%) Demographic characteristics 1 (maximum N = 113) 2 (maximum N = 77) Education n = 109 n = 73 HE/FE/higher school level 32 (29. Note Data completion rates were ≥ 83% and ≥ 78% for phases 1 and 2, respectively. TABLE 4 Demographic characteristics of patients as participants in phase 2 by randomisation group: PCAM vs. CAU Trial arm, n (%) Demographic characteristics PCAM (maximum N = 43) CAU (maximum N = 34) Age (years) n = 43 n = 34 Mean (SD) 68. CAU (continued) Trial arm, n (%) Demographic characteristics PCAM (maximum N = 43) CAU (maximum N = 34) Education n = 40 n = 33 HE/FE/higher school level 15 (37. Note Data completion rates were ≥ 83% and ≥ 78% for phases 1 and 2, respectively. Table 5 shows the self-reported health conditions of patients recruited to both phases. Although there are differences in the proportions having particular conditions, the overall levels of multimorbidity are similar across samples. Table 6 compares the same patient self-reported health conditions for patients in phase 2 by randomisation group (PCAM vs. There was a higher proportion of patients reporting higher levels of multimorbidity in the PCAM cohort. Additional data on the SIMD for the sample are included in additional tables (see Appendix 6, Tables 10 and 11). Patient-reported outcome data (Appendix 6, Tables 13–19) are also presented. This feasibility study was not powered to detect any significant changes in outcomes; its purpose was to estimate data completion rates, including completion rates for different outcome measures. However, if possible, some indication of whether or not an outcome measure was likely to be able to detect any change as a result of the PCAM intervention was also of interest. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 41 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. STUDY B: FEASIBILITY STUDY OF A CLUSTER RANDOMISED CONTROLLED TRIAL TABLE 5 Health-related characteristics of patients as participants in phases 1 and 2 Phase, n (%) Diagnosed with conditiona 1(N = 113) 2 (N = 77) High blood pressure 73 (64. Patients were asked to self-complete questions that were similar to, or reflected the main domains of, the PCAM tool, to see how they might assess themselves in relation to biopsychosocial concerns: these data are reported in Appendix 6, Tables 12 and 13. Table 7 shows the patient-reported biopsychosocial concerns (reflecting the PCAM domains) for participants in both phase 1 and phase 2, and Table 8 shows the same data for participants in phase 2 by randomisation group of PCAM or CAU. Data completion for these sets of questions was around 94%. Participants were most concerned about their health, followed by their lifestyle and their finances. Problems with daily activities and concerns about their social networks were also reported. Participants recruited by nurses in practices allocated to the PCAM arm had higher levels of concerns about daily activities, social networks and finances. CAU Trial arm, n (%) Diagnosed with conditiona PCAM (N = 43) CAU (N = 34) High blood pressure 30 (69. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 43 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. STUDY B: FEASIBILITY STUDY OF A CLUSTER RANDOMISED CONTROLLED TRIAL TABLE 8 Nurse demographic and clinical data by randomisation group: PCAM vs.
In pain management units cheap cipro 250mg visa, assessment involves a doctor (pain specialist) cipro 750 mg discount, a physiotherapist and a psychologist/psychiatrist purchase cipro 1000 mg without a prescription. But cheap 250 mg cipro with mastercard, excellent results can be obtained by a single practitioner with a biopsychosocial mind-set. An assessment approach to low back pain was developed using red and yellow flags. The flags approach is now being applied in chronic pain more generally. They indicate the need for further investigation and possibly, specialist referral. Possible fracture Possible tumor/infection Possible significant neurological deficit * Major trauma * Age <20 or >50 yrs * Severe or progressive * Minor trauma in elderly * History of cancer sensory alteration or of osteoporotic patient * Constitutional symptoms weakness (fever, chills, weight loss) * Bladder or bowl * Recent bacterial infection dysfunction * IV drug use * On examination: evidence * Immunosuppression of neurological deficit * Pain worse at night or when supine Pridmore S. Patients unable to perform their usual functions at work and home, will likely experience loss of income and self-esteem. There may be loss of energy, disinclination to activity. Depressive and anxiety disorders are frequently described as co-morbid conditions. Even when the full diagnostic criteria for anxiety and depressive disorder are not met, some emotional symptoms are frequently present. Until recently, emotional symptoms (anxiety, depression) were conceptualized as secondary to the disability, loss of autonomy, and the frustration of constant pain. Recent studies, however, suggest the emotional symptoms may also have a strong biological component (that the pain and the depression are the result of the same or similar cerebral events). Chronic pain patients, understandably, want a “cure”. They consult various surgeons and seek interventional approaches. As much of the problem lies in the CNS, repeated procedures will worsen rather than improve the situation. A patient who believes intervention will “cure” the pain will not be responsive to conservative (state of the art) management which emphasizes acceptance of some pain and active self-management. Inactivity in chronic pain is a response to 1) avoiding movement as a means to avoiding pain, 2) the mistaken view that pain experienced on movement means that movement will further damage the body. However, inactivity is deleterious, leading to weakness of muscles and stiffness of joints, which leads to further pain, and further inactivity. As part of the physical assessment all appropriate blood and imaging tests will be performed. It may be possible (but this is not often the case) to locate a nociceptive focus i. This chapter deals with chronic pain as a disease entity, and assumes that appropriate treatment of any nonciceptive focus has been provided. However, usually, the following approach should also be offered, as success with a specialist procedures does not have guaranteed or permanent effects, and the major burden of chronic pain disease remains. Where there is significant anxiety or mood disorder, this should be treated using a verbal therapy and, if necessary, medication. Where alcohol and drug problems exist, these need to be addressed. The assistance of appropriate local services may be necessary. Help the patient understand that a “cure” is unlikely, but that with advice and effort, pain can be minimized, and a more active and satisfying life can be achieved. Help the patient understand that in chronic pain conditions, pain associated with movement does not indicate further injury is being done. Help the patient understand that inactivity will make the condition worse.
Digital data were regularly quality checked and an audit trail maintained discount 750 mg cipro with visa. Following acceptance of the study final report to the funder generic 250mg cipro overnight delivery, identifiable patient contact details (used for focus groups and interviews) were destroyed generic cipro 250mg. At this point cheap cipro 750 mg amex, practices were also asked to destroy any identifiable lists of patients approached for the study. All digital and paper data have been archived and managed in accordance with the NHS Ethics Committee, research and development and University of Stirling policies. Qualitative analysis Qualitative data analysis of focus groups and interviews followed the social constructivist version of 47 48, grounded theory, through which themes and subthemes were identified in the data. The social constructivist approach is an iterative process of review that allows for the incorporation of existing 47 48, knowledge and literature that can be drawn upon in the analysis process. NVivo 11 (QSR International, Melbourne, VIC, Australia) software was used to help facilitate the interviews. In an iterative process, all focus group transcripts and interview transcripts were reviewed by multiple team members to identify key themes in relation to our research questions. These themes were discussed and amended until a core set was agreed for use as a final coding frame, which was systematically applied to all data. The research team met throughout the analysis process to review the emerging themes and discuss areas of agreement or divergence until consensus was reached. Additional details on the qualitative data analysis are included in Chapters 3 and 6. The analysis was specifically intended to identify barriers to, and facilitators of, adoption/use, and was informed by the normalisation process theory (NPT). The NPT helps to explain how practices can become embedded in organisational and professional contexts. There are four generative mechanisms to help explain how change can be adopted and embedded: coherence (sense-making), cognitive participation, collective action and reflexive monitoring. The production and reproduction of a practice requires continuous investment by agents (in this case, PNs) over time. NPT mechanisms are constrained (or aided) by the operation of norms (notions of how beliefs, behaviours and actions should be accomplished) and conventions (how beliefs, behaviours and actions are practically accomplished). The NPT generative mechanisms and their constructs have provided a framework for analysis of the qualitative data, to help understand and think through implementation problems and to help identify techniques to solve them. This was drawn on at the start of the project, using the focus group data, to help shape improvements to the implementation process and the training materials. Researcher field notes and post-implementation interviews were then also subsequently used to identify further barriers to, and facilitators of, adoption. Analysis of audio-recorded consultations The analysis of audio-recordings consisted of classifying conversation segments according to whether they attended to physical health, mental well-being or social elements of care. The range of social circumstances attended to were also identified. The PCAM tool should encourage a conversation flow that attends to well-being and social circumstances throughout the consultations (not leaving it until the end, when time may be limited). The analysis, therefore, also included attention to when conversation segments appeared in the consultation. Attending to a mix of physical health, mental well-being and discussion of social circumstances through the consultation, and discussing a range of social circumstances, 14 NIHR Journals Library www. A list of codes by which to classify segments, based on the domains within the PCAM tool, was developed by the research team and consistently applied to all consultation recordings before and after nurse training in the use of the PCAM tool. Integration and synthesis of data sets Overall, the qualitative and quantitative analysis aimed to determine whether or not and how a future cluster trial should proceed. This included assessing whether or not recruitment, retention and data collection were achieved to a sufficient level, and whether or not the outcomes used were sensitive enough to detect change (at what level and for whom), as well as identifying any key methodological issues in converting from a feasibility or pilot trial to a full-scale trial, as established by Shanyinde et al. The ADePT decision aid is described and reported alongside the process evaluation in Chapter 7. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 15 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising.
The trial lasted 16 ranted and are currently ongoing to determine the tolerabil- weeks after a 1-week placebo lead-in phase buy cipro 250mg with mastercard, with subjects ity and efficacy of lithium cipro 750mg generic, particularly in groups of randomized to receive either active medication or placebo individuals with PG and cycling mood disorders cheap cipro 250 mg line. Fifteen subjects treatment of a 37-year-old man with PG has been described meeting the criteria for PG but not for active substance (138) cheap cipro 250mg with visa. The gambler had a 16-year history of significant gam- use disorders or past or present major axis I disorders were bling, with periods of abstinence lasting only 2 to 3 months enrolled, and 10 individuals (all male) completed the study. A placebo-controlled, double-blind trial of in phase, one during placebo treatment in phase I, and two carbamazepine was undertaken, with no improvement during phase I treatment with fluvoxamine (one for non- noted in gambling behavior over the 12-week placebo phase. Study drug dosing was initiated at 50 mg per day, creased to 600 mg per day, with blood levels of 4. Gambling behaviors decreased 2 weeks second and third weeks, respectively. Thereafter, the dose into treatment, and gains were maintained at 30 months. Mean Given the efficacy of SRIs in targeting OC behaviors in endpoint dose of fluvoxamine was 195 50 mg per day OCD (139) and the data supporting 5-HT dysregulation (range, 100 to 250 mg per day). Adverse effects documented in PG, trials of SRIs have been performed. The first of during fluvoxamine treatment were of only mild intensity these studies involved a 31-year-old woman with PG and and were consistent with SSRI treatment, and they were not comorbid social phobia and OC personality traits who had associated with early withdrawal from the study. Outcome been gambling persistently despite multiple prior treatments measures included scores from the PG-CGI and PG- (140). Clomipramine was administered in double-blind, YBOCS, as earlier. Data from the investigation demon- placebo-controlled fashion in a crossover design. Minimal strated active drug to be superior to placebo in targeting improvement was seen after 10 weeks of placebo treatment. Both the groups receiving After initiation of active drug at 25 mg per day with an active medication and placebo showed improvement in con- increase up to 175 mg per day, gambling behavior was dis- trol of gambling behaviors during the first 8 weeks, and the continued at week 3, with absence of gambling remaining most significant difference in response was observed at the at 38 weeks. The adverse effect of increased irritability was end of the second 8-week block (Fig. In other words, effectively treated with a temporary decrease in dose. Sixteen group were more likely to persist over time, whereas initial subjects entered the 16-week trial (8-week placebo lead-in, gains observed in the fluvoxamine-placebo treatment group 8-week active), with seven of ten completers judged to be declined. These findings are consistent with a high initial responders by (a) a score of 'much improved' or 'very rate of placebo responders and suggest that acute trials of much improved' on the Clinical Global Impression score longer duration may be important in better distinguishing for gambling severity (PG-CGI) and (b) greater than 25% response to placebo and active drug. Of the the treatment of PG was reported by an independent group completers, four were female and six were male. In their study, 34 patients were treated for 6 months cation was well-tolerated, and the average dose for complet- with placebo or fluvoxamine at 200 mg per day. Outcome ers was 220 mg per day at endpoint, with responders tend- was measured by quantification of time and money spent ing to be treated with a slightly lower dose (207 mg per on gambling. The authors found no statistically significant day on average). Noncompleters left the study during the differences in response rates to placebo as compared with placebo phase (four for noncompliance, two for lack of re- active drug for the overall sample. Of the three nonresponders, two were the only observing a statistically significant superiority of fluvoxa- completers with histories of cyclothymia, a finding raising mine as compared with placebo in the male and younger- the possibility that individuals with a comorbid cycling aged subgroups of individuals with PG in the study. Strik- Chapter 120: Pathologic Gambling and Impulse Control Disorders 1733 FIGURE 120. Changes in gambling symptom severity of patients with pathologic gambling (PG) in response to fluvoxamine. Changes in PG–Clinical Global Impression (CGI) scores are shown for subjects completing a 16-week pla- cebo-controlled, double-blind study of fluvoxa- mine for the treatment of PG. Measures are shown for individuals receiving placebo in phaseIfollowedbyfluvoxamine inphaseII(dia- monds) or fluvoxamine in phase I followed by placebo in phase II (squares). The study com- promising results and to define better the short- and long- pared the results of treatment with fluoxetine at 20 mg per term efficacies and tolerabilities of specific SRIs in groups day with support psychotherapy (n 11) as compared of individuals with PG. Measures of outcome included scores on the CGI and Ludo-Cage test.