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1.
BMJ Open ; 9(10): e026095, 2019 10 03.
Article in English | MEDLINE | ID: mdl-31585968

ABSTRACT

OBJECTIVES: Problem-solving skills training is adaptable, inexpensive and simple to deliver. However, its application with prisoners who self-harm is unknown. The study assessed the feasibility and acceptability of a problem-solving training (PST) intervention for prison staff and prisoners who self-harm, to inform the design of a large-scale study. DESIGN AND SETTING: A mixed-methods design used routinely collected data, individual outcome measures, an economic protocol and qualitative interviews at four prisons in Yorkshire and Humber, UK. PARTICIPANTS: (i) Front-line prison staff, (ii) male and female prisoners with an episode of self-harm in the previous 2 weeks. INTERVENTION: The intervention comprised a 1 hour staff training session and a 30 min prisoner session using adapted workbooks and case studies. OUTCOMES: We assessed the study processes-coverage of training; recruitment and retention rates and adequacy of intervention delivery-and available data (completeness of outcome data, integrity of routinely collected data and access to the National Health Service (NHS) resource information). Prisoner outcomes assessed incidence of self-harm, quality of life and depression at baseline and at follow-up. Qualitative findings are presented elsewhere. RESULTS: Recruitment was higher than anticipated for staff n=280, but lower for prisoners, n=48. Retention was good with 43/48 (89%) prisoners completing the intervention, at follow-up we collected individual outcome data for 34/48 (71%) of prisoners. Access to routinely collected data was inconsistent. Prisoners were frequent users of NHS healthcare. The additional cost of training and intervention delivery was deemed minimal in comparison to 'treatment as usual'. Outcome measures of self-harm, quality of life and depression were found to be acceptable. CONCLUSIONS: The intervention proved feasible to adapt. Staff training was delivered but on the whole it was not deemed feasible for staff to deliver the intervention. A large-scale study is warranted, but modifications to the implementation of the intervention are required.


Subject(s)
Inservice Training , Patient Education as Topic , Prisoners/education , Problem Solving , Self-Injurious Behavior/prevention & control , Adult , Depression/prevention & control , Feasibility Studies , Female , Humans , Inservice Training/economics , Interviews as Topic , Male , Models, Educational , Patient Education as Topic/economics , Prisoners/psychology , Prisons/organization & administration , Process Assessment, Health Care , Quality of Life
2.
PLoS One ; 12(12): e0178918, 2017.
Article in English | MEDLINE | ID: mdl-29211741

ABSTRACT

OBJECTIVES: To assess the cost-effectiveness of acupuncture and usual care, and Alexander Technique lessons and usual care, compared with usual GP care alone for chronic neck pain patients. METHODS: An economic evaluation was undertaken alongside the ATLAS trial, taking both NHS and wider societal viewpoints. Participants were offered up to twelve acupuncture sessions or twenty Alexander lessons (equivalent overall contact time). Costs were in pounds sterling. Effectiveness was measured using the generic EQ-5D to calculate quality adjusted life years (QALYs), as well as using a specific neck pain measure-the Northwick Park Neck Pain Questionnaire (NPQ). RESULTS: In the base case analysis, incremental QALY gains were 0.032 and 0.025 in the acupuncture and Alexander groups, respectively, in comparison to usual GP care, indicating moderate health benefits for both interventions. Incremental costs were £451 for acupuncture and £667 for Alexander, mainly driven by intervention costs. Acupuncture was likely to be cost-effective (ICER = £18,767/QALY bootstrapped 95% CI £4,426 to £74,562) and was robust to most sensitivity analyses. Alexander lessons were not cost-effective at the lower NICE threshold of £20,000/QALY (£25,101/QALY bootstrapped 95% CI -£150,208 to £248,697) but may be at £30,000/QALY, however, there was considerable statistical uncertainty in all tested scenarios. CONCLUSIONS: In comparison with usual care, acupuncture is likely to be cost-effective for chronic neck pain, whereas, largely due to higher intervention costs, Alexander lessons are unlikely to be cost-effective. However, there were high levels of missing data and further research is needed to assess the long-term cost-effectiveness of these interventions.


Subject(s)
Acupuncture/methods , Chronic Pain/therapy , Cost-Benefit Analysis , Movement , Musculoskeletal Manipulations/methods , Neck Pain/therapy , Acupuncture/economics , Age Factors , Female , Humans , Male , Musculoskeletal Manipulations/economics , Primary Health Care
3.
J Altern Complement Med ; 23(3): 180-187, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28253033

ABSTRACT

BACKGROUND: Lifestyle advice is widely considered as an integral component of acupuncture treatment. However, it is unclear whether lifestyle advice and related self-care are important for sustaining benefit over the longer term. In a novel secondary analysis of trial data, this paper explores the nature and impact of acupuncture-related diagnosis, and associated lifestyle advice and self-care, in patients with chronic neck pain. DESIGN: In a three-arm, randomized, controlled multicenter trial with 12 months of follow-up, a total of 517 patients with chronic neck pain were randomized in equal proportions to acupuncture, Alexander technique, or usual care alone. METHODS: For each acupuncture patient, practitioners reported treatment components that included an acupuncture-related diagnosis and provision of associated lifestyle advice. Patients reported at baseline, 3, 6, and 12 months on variables related to treatment, which included aspects of self-care, self-efficacy, and lifestyle advice acted upon, as well as pain and disability scores. Congruence between practitioner advice and patient take-up was assessed using chi-squared test. Impact of lifestyle advice and self-efficacy on outcome was evaluated using regression models. RESULTS: Among patients randomized to acupuncture, the most common diagnostic framework involved the Zang-Fu syndromes for 139/160 (87%) patients. Lifestyle advice was provided by practitioners to 134/160 (84%) of patients, most commonly related to exercise, relaxation, diet, rest, and work. Significant congruence with patient take-up was found for diet, rest, and work. Moreover, patients in the acupuncture group improved their ability to use what they had learnt and increased their self-efficacy. In turn, these characteristics were associated with significant reductions in pain and disability scores at 12 months. CONCLUSION: Acupuncture-related lifestyle advice helped patients improve the way they live and care for themselves and enhanced self-efficacy and ability to use what they had learnt. These changes were associated with reductions in pain and disability at 12 months.


Subject(s)
Acupuncture Therapy , Chronic Pain/therapy , Life Style , Neck Pain/therapy , Self Care , Female , Humans , Male , Professional-Patient Relations
4.
Ann Intern Med ; 163(9): 653-62, 2015 Nov 03.
Article in English | MEDLINE | ID: mdl-26524571

ABSTRACT

BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK.


Subject(s)
Acupuncture Therapy , Chronic Pain/therapy , Neck Pain/therapy , Self Care , Acupuncture Therapy/adverse effects , Acupuncture Therapy/methods , Chronic Pain/economics , Female , Health Expenditures , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Neck Pain/economics , Office Visits/statistics & numerical data , Patient Compliance , Prescription Drugs , Self Care/adverse effects , Self Care/methods , Self Efficacy , Treatment Outcome
5.
Chiropr Man Therap ; 23(1): 3, 2015.
Article in English | MEDLINE | ID: mdl-25628858

ABSTRACT

BACKGROUND: Not enough is understood about patients' views of chiropractic care. The aims of this research were to explore patients' experiences and expectations, their perceptions of benefits and risks, and the implications for chiropractors' continuing fitness to practise. METHODS: Survey questions were formulated from existing literature, published guidance on good practice from the General Chiropractic Council, and from 28 telephone interviews and a small focus group with chiropractic patients using a semi-structured topic guide. In its final form, the survey elicited patients' ratings on expectations regarding 33 aspects of care. In a national cross-sectional survey, a number of sampling methods were required as a consequence of the low practitioner response rate. RESULTS: In total, 544 completed questionnaires were received from chiropractic patients, a lower response rate than expected (8%). The two main benefits that patients reported regarding their chiropractic care were reduced pain (92%) and increased mobility (80%). Of respondents, 20% reported unexpected or unpleasant reactions to their treatment, most commonly tiredness or fatigue (32%), and extra pain (36%). In most cases they expressed low levels of concern about these reactions. Patients' expectations were met for most aspects of care. The four aspects of practice where expectations were least well met comprised: having more information on the cost of the treatment plan at the first consultation (80%); the chiropractor contacting the patient's general practitioner if necessary (62%); having a discussion about a referral to another healthcare practitioner (62%); and providing a method for confidential feedback (66%). CONCLUSIONS: Overall, patients reported a high level of satisfaction with the benefits of their chiropractic care, although there is a likelihood of bias towards patients with a positive experience of chiropractic. There were no serious adverse reactions; however, patients reported concern about pain, tingling and numbness in the limbs after chiropractic. In general, patients' expectations were being well met.

6.
PLoS One ; 9(11): e113726, 2014.
Article in English | MEDLINE | ID: mdl-25426637

ABSTRACT

BACKGROUND: New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources. METHODS AND FINDINGS: The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91. CONCLUSIONS: Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered.


Subject(s)
Acupuncture Therapy/economics , Counseling/economics , Depression/therapy , Depressive Disorder/therapy , Acupuncture Therapy/methods , Cost-Benefit Analysis , Counseling/methods , Depression/economics , Depressive Disorder/economics , Female , Humans , Male , Quality of Life , Quality-Adjusted Life Years , Treatment Outcome
7.
PLoS One ; 9(9): e104077, 2014.
Article in English | MEDLINE | ID: mdl-25198108

ABSTRACT

BACKGROUND: Non-pharmacological interventions for depression may help patients manage their condition. Evidence from a recent large-scale trial (ACUDep) suggests that acupuncture and counselling can provide longer-term benefits for many patients with depression. This paper describes the strategies practitioners reported using to promote longer-term benefits for their patients. METHODS: A qualitative sub-study of practitioners (acupuncturists and counsellors) embedded in a randomised controlled trial. Using topic guides, data was collected from telephone interviews and a focus group, altogether involving 19 counsellors and 17 acupuncturists. Data were audio recorded, transcribed verbatim and analysed using thematic content analysis. RESULTS: For longer-term impact, both acupuncturists and counsellors encouraged insight into root causes of depression on an individual basis and saw small incremental changes as precursors to sustained benefit. Acupuncturists stressed the importance of addressing concurrent physical symptoms, for example helping patients relax or sleep better in order to be more receptive to change, and highlighted the importance of Chinese medicine theory-based lifestyle change for lasting benefit. Counsellors more often highlighted the importance of the therapeutic relationship, emphasising the need for careful "pacing" such that the process and tools employed were tailored and timed for each individual, depending on the "readiness" to change. Our data is limited to acupuncture practitioners using the principles of traditional Chinese medicine, and counsellors using a humanistic, non-directive and person-centred approach. CONCLUSIONS: Long-term change appears to be an important focus within the practices of both acupuncturists and counsellors. To achieve this, practitioners stressed the need for an individualised approach with a focus on root causes.


Subject(s)
Acupuncture Therapy/methods , Depression/therapy , Directive Counseling/methods , Adult , Depression/psychology , Female , Humans , Male
8.
BMJ Open ; 4(6): e005144, 2014 Jun 05.
Article in English | MEDLINE | ID: mdl-24902735

ABSTRACT

INTRODUCTION: Depression and pain frequently occur together and impact on outcomes of existing treatment for depression. Additional treatment options are required. This study aimed to explore patients' experiences of depression, the processes of change within acupuncture and counselling, and the elements that contributed to longer-term change. METHODS: In a substudy nested within a randomised controlled trial of acupuncture or counselling compared with usual care alone for depression, semistructured interviews of 52 purposively sampled participants were conducted and analysed using thematic analysis. RESULTS: Differences were reported by participants regarding their experience of depression with comorbid pain compared with depression alone. Along with physical symptoms often related to fatigue and sleep, participants with depression and comorbid pain generally had fewer internal and external resources available to manage their depression effectively. Those who had physical symptoms and were receiving acupuncture commonly reported that these were addressed as part of the treatment. For those receiving counselling, there was less emphasis on physical symptoms and more on help with gaining an understanding of themselves and their situation. Over the course of treatment, most participants in both groups reported receiving support to cope with depression and pain independently of treatment, with a focus on relevant lifestyle and behaviour changes. The establishment of a therapeutic relationship and their active engagement as participants were identified as important components of treatment. CONCLUSIONS: Participants with and without comorbid pain received acupuncture or counselling for depression, and reported specific identifiable treatment effects. The therapeutic relationship and participants' active engagement in recovery may play distinct roles in driving long-term change. Patients who present with depression and physical symptoms of care may wish to consider a short course of acupuncture to relieve symptoms prior to a referral for counselling if needed. TRIAL REGISTRATION NUMBER: ISRCTN63787732.


Subject(s)
Acupuncture Therapy , Depression/complications , Depression/therapy , Directive Counseling , Pain Management/methods , Pain/complications , Patient Satisfaction , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Qualitative Research , Young Adult
9.
PLoS Med ; 10(9): e1001518, 2013.
Article in English | MEDLINE | ID: mdl-24086114

ABSTRACT

BACKGROUND: Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. METHODS AND FINDINGS: In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥ 20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2.2.1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (-2.46, 95% CI -3.72 to -1.21) and counselling (-1.73, 95% CI -3.00 to -0.45), and over 12 months for acupuncture (-1.55, 95% CI -2.41 to -0.70) and counselling (-1.50, 95% CI -2.43 to -0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported. CONCLUSIONS: In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN63787732 Please see later in the article for the Editors' Summary.


Subject(s)
Acupuncture Therapy , Counseling , Depression/therapy , Primary Health Care , Adolescent , Adult , Aged , Aged, 80 and over , Antidepressive Agents/adverse effects , Antidepressive Agents/therapeutic use , Demography , Depression/drug therapy , Drug Prescriptions , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Treatment Outcome , Young Adult
10.
Trials ; 14: 209, 2013 Jul 10.
Article in English | MEDLINE | ID: mdl-23841901

ABSTRACT

BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354.


Subject(s)
Acupuncture Therapy , Chronic Pain/therapy , Neck Pain/therapy , Physical Therapy Modalities , Research Design , Acupuncture Therapy/economics , Area Under Curve , Chronic Pain/diagnosis , Chronic Pain/economics , Chronic Pain/physiopathology , Clinical Protocols , Cost-Benefit Analysis , England , Health Care Costs , Humans , Neck Pain/diagnosis , Neck Pain/economics , Neck Pain/physiopathology , Pain Measurement , Patient Selection , Physical Therapy Modalities/economics , Predictive Value of Tests , Qualitative Research , Surveys and Questionnaires , Time Factors , Treatment Outcome
11.
PLoS One ; 8(2): e56806, 2013.
Article in English | MEDLINE | ID: mdl-23437246

ABSTRACT

INTRODUCTION: The National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients' positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment. METHODS: The study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis. RESULTS AND DISCUSSION: Three over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient's active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain. CONCLUSION: The acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients' self-efficacy in pain management in the longer term. Unpleasant treatment related effects do not necessarily detract from patients' overall perception of acceptability.


Subject(s)
Acupuncture Therapy , Low Back Pain/psychology , Low Back Pain/therapy , Patient Acceptance of Health Care , Female , Humans , Male , Qualitative Research , Surveys and Questionnaires , Treatment Outcome
12.
Trials ; 13: 209, 2012 Nov 14.
Article in English | MEDLINE | ID: mdl-23151156

ABSTRACT

BACKGROUND: The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. METHODS/DESIGN: Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. PARTICIPANTS: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II).Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. INTERVENTIONS: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. OUTCOME: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. ANALYSIS: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. ANALYSIS of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will compare incremental cost-effectiveness of the three treatment options at 12 months. DISCUSSION: Ethical approval was obtained in October 2009. There were six subsequent protocol amendments, the last of which was approved in January 2012. Recruitment of 755 participants took place over 18 months. Data collection will be completed by June 2012. No interim analyses have been conducted. TRIAL REGISTRATION: ISRCTN63787732.


Subject(s)
Acupuncture Therapy , Clinical Protocols , Counseling , Depression/therapy , Humans , Outcome Assessment, Health Care , Patient Selection , Sample Size
13.
Nurs Older People ; 24(1): 26-30, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22432362

ABSTRACT

Prevention of delirium is an important part of looking after care home residents, however, it can be difficult to detect, especially in those who have dementia. This article explores the perceptions and experiences of care home staff integrating delirium prevention activity in their everyday work. As part of the Stop delirium! feasibility study interviews were carried out and when they were analysed five themes were identified: triggers and knowledge; detection and observation; effect of closest contact; changes in management of care; and communication and teamwork to overcome difficulties. Together these provide insight into how carers identified a potential episode of delirium and indicated the steps that might be taken to manage residents' care. Communication and teamwork were identified as important in delirium prevention and appropriate management.


Subject(s)
Delirium/diagnosis , Dementia/diagnosis , Depression/diagnosis , Nursing Homes , Aged , Diagnosis, Differential , Health Personnel , Homes for the Aged , Humans
14.
Chin J Integr Med ; 17(3): 173-6, 2011 Mar.
Article in English | MEDLINE | ID: mdl-21359917

ABSTRACT

The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism. To determine whether the criticism is justified, in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding, and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain. To conclude we recommend two simple guidelines: the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity, and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.


Subject(s)
Acupuncture Therapy/methods , Acupuncture Therapy/standards , Guidelines as Topic , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Research Design/standards , Double-Blind Method , Humans , Publishing/standards , Single-Blind Method , Time Factors
15.
Age Ageing ; 40(1): 90-8, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20861087

ABSTRACT

BACKGROUND: delirium is likely to be particularly common in care homes, given the clustering of known risk factors in these settings. Preventing delirium should result in significant benefits, including better quality of care and improved outcomes for residents. OBJECTIVE: to test the feasibility of 'Stop Delirium!', an intervention to prevent delirium in care homes for older people, and to optimise parameters to inform the design of a future trial evaluation. METHOD: we delivered Stop Delirium! to six care homes over 10 months, in a mixed methods before and after study. RESULTS: Stop Delirium! was successfully implemented in the study homes. We found evidence supporting positive changes in staff attitudes and practice after the intervention. Although qualitative data suggested it was too early to expect changes in resident outcomes, we also found preliminary evidence suggesting potential improvements in a range of outcomes, including a reduction in the number of falls and prescribed medications. CONCLUSION: a complex intervention for delirium prevention in care homes is feasible and has the potential to improve staff practice and outcomes for residents. This work provides the basis for the next phase of the evaluation to establish its effectiveness and cost-effectiveness.


Subject(s)
Delirium/prevention & control , Homes for the Aged , Nursing Homes , Accidental Falls/prevention & control , Aged , Aged, 80 and over , Delirium/epidemiology , Feasibility Studies , Humans , Inappropriate Prescribing , Outcome Assessment, Health Care , Quality of Health Care , Risk Factors
16.
Nurs Older People ; 22(4): 16-21, 2010 May.
Article in English | MEDLINE | ID: mdl-20503675

ABSTRACT

This article describes delirium and explains why its prevention is important. An enhanced educational package that was developed with care home staff to prevent delirium is outlined. The challenges and successes of the project are highlighted. Case studies and resources to enable healthcare workers to learn about delirium and take action to prevent it are provided.


Subject(s)
Delirium/prevention & control , Education, Nursing, Continuing/organization & administration , Geriatric Nursing , Nursing Staff/education , Aged , Critical Pathways , Delirium/diagnosis , Delirium/etiology , Dementia/diagnosis , Depression/diagnosis , Diagnosis, Differential , Geriatric Assessment , Geriatric Nursing/education , Geriatric Nursing/organization & administration , Humans , Nurse Practitioners , Nursing Assessment , Nursing Homes , Risk Factors , Total Quality Management/organization & administration
17.
Pain Pract ; 10(2): 94-102, 2010.
Article in English | MEDLINE | ID: mdl-20070551

ABSTRACT

OBJECTIVES: There is controversy as to whether or not acupuncture is more effective than placebo. To help clarify this debate, we synthesized the evidence gathered from systematic reviews on the pooled data of high-quality randomized controlled trials comparing acupuncture to sham acupuncture for chronic pain. METHOD: Systematic reviews of acupuncture for the most commonly occurring forms of chronic pain (back, knee, and head) published between 2003 and 2008 were sourced from Ovid databases: Medline, Allied and Complementary Medicine database, Cochrane Library and Web of Science during December 2008. Eight systematic reviews with meta-analyses of pooled data were eligible for inclusion. Data were extracted for short- and longer-term outcomes for the most commonly occurring forms of pain. Two independent reviewers assessed methodological quality. RESULTS: For short-term outcomes, acupuncture showed significant superiority over sham for back pain, knee pain, and headache. For longer-term outcomes (6 to12 months), acupuncture was significantly more effective for knee pain and tension-type headache but inconsistent for back pain (one positive and one inconclusive). In general, effect sizes (standardized mean differences) were found to be relatively small. DISCUSSION: The accumulating evidence from recent reviews suggests that acupuncture is more than a placebo for commonly occurring chronic pain conditions. If this conclusion is correct, then we ask the question: is it now time to shift research priorities away from asking placebo-related questions and shift toward asking more practical questions about whether the overall benefit is clinically meaningful and cost-effective?


Subject(s)
Acupuncture Therapy/methods , Pain Management , Placebo Effect , Chronic Disease , Databases, Factual/statistics & numerical data , Humans , Outcome Assessment, Health Care , Retrospective Studies , Time Factors
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