Pain assessment for people with dementia: a systematic review of systematic reviews of pain assessment tools.

BACKGROUND: There is evidence of under-detection and poor management of pain in patients with dementia, in both long-term and acute care. Accurate assessment of pain in people with dementia is challenging and pain assessment tools have received considerable attention over the years, with an increasing number of tools made available. Systematic reviews on the evidence of their validity and utility mostly compare different sets of tools. This review of systematic reviews analyses and summarises evidence concerning the psychometric properties and clinical utility of pain assessment tools in adults with dementia or cognitive impairment. METHODS: We searched for systematic reviews of pain assessment tools providing evidence of reliability, validity and clinical utility. Two reviewers independently assessed each review and extracted data from them, with a third reviewer mediating when consensus was not reached. Analysis of the data was carried out collaboratively. The reviews were synthesised using a narrative synthesis approach. RESULTS: We retrieved 441 potentially eligible reviews, 23 met the criteria for inclusion and 8 provided data for extraction. Each review evaluated between 8 and 13 tools, in aggregate providing evidence on a total of 28 tools. The quality of the reviews varied and the reporting often lacked sufficient methodological detail for quality assessment. The 28 tools appear to have been studied in a variety of settings and with varied types of patients. The reviews identified several methodological limitations across the original studies. The lack of a 'gold standard' significantly hinders the evaluation of tools' validity. Most importantly, the samples were small providing limited evidence for use of any of the tools across settings or populations. CONCLUSIONS: There are a considerable number of pain assessment tools available for use with the elderly cognitive impaired population. However there is limited evidence about their reliability, validity and clinical utility. On the basis of this review no one tool can be recommended given the existing evidence.

What is traditional acupuncture--exploring goals and processes of treatment in the context of women with early breast cancer.

BACKGROUND: Despite the increasing popularity of acupuncture, there remains uncertainty as to its effectiveness and how it brings about change. Particular questions are posed over whether acupuncture research has sufficient model validity and reflects acupuncture as practised. Exploring traditional acupuncture (TA) in practice should help to expose processes essential to the theory of TA. The aim of this study was to examine what TA practitioners aim to achieve, their rationale and how they follow this through in their practice. METHODS: A longitudinal study of TA for women with early breast cancer (EBC) was performed. Study participants comprised 14 women with EBC and two experienced TA practitioners, all taking part in in-depth interviews, conducted before and after receipt of up to 10 treatment sessions, and analysed using grounded theory methods. Additional data came from practitioner treatment logs and diaries. RESULTS: Practitioners sought long-term goals of increasing strength and enabling coping as well as immediate relief of symptoms. They achieved this through a continuous process of treatment, following through the recursive and individualized nature of TA and adjusted, via differential diagnosis, to the rapidly fluctuating circumstances of individual women. Establishing trust and good rapport with the women aided disclosure which was seen as essential in order to clarify goals during chemotherapy. This process was carefully managed by the practitioners and the resultant therapeutic relationship was highly valued by the women. CONCLUSION: This study provided insight into the interdependent components of TA helping to demonstrate the multiple causal pathways to change through the continuous process of new information, insights and treatment changes. A good therapeutic relationship was not simply something valued by patients but explicitly used by practitioners to aid disclosure which in turn affected details of the treatment. The therapeutic relationship was therefore a vital and integral part of the treatment process.

Enhancing health literacy and behavioural change within a tele-care education and support intervention for people with type 2 diabetes.

BACKGROUND: Behavioural change interventions for persons with chronic illness draw on a variety of theoretical approaches including motivational interviewing and shared decision making. Health literacy provides an additional, potentially powerful explanatory framework to guide research and practice. OBJECTIVE: To examine the changes in the depth and detail of diabetes-related knowledge and confidence for persons with type 2 diabetes. DESIGN: Two-year, prospective, observational study, using questionnaire data at two time points (baseline and 2 years later) and in-depth interviews with a theoretically selected subsample. SETTING AND PARTICIPANTS: A total of 319 patients initially recruited from a deprived urban area in north-west England. INTERVENTION: Dedicated tele-carer education and support, tailored to the individual circumstances of the patient. MAIN OUTCOME MEASURES: Perceptions of confidence, levels of empowerment, learning for self-care and most helpful aspects of the intervention. RESULTS: Over 90% expressed confidence in keeping their blood sugar controlled, and high levels of perceived empowerment (mean = 4.25; 95% CI, 4.17-4.33) were found. Changes in the depth and detail of diabetes-related knowledge and confidence, from the specific to the more general, were observed and enhanced competence in translating knowledge into practice. DISCUSSION AND CONCLUSIONS: The intervention, built within a developed working partnership between tele-carer and patient, operated at two levels: health literacy, enhancing knowledge, developing personal skills and enabling self-control; and socio-psychological behavioural change, tailored to individuals within their socio-economic environments, enabling increased motivation and supportive problem-solving. Both approaches find reflection in the findings and provide powerful explanatory lenses to interrogate the data.

Buyer beware? Does the information provided with herbal products available over the counter enable safe use?

BACKGROUND: Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information. METHODS: Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). RESULTS: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages. CONCLUSIONS: Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.

Exploring the Evidence Base for Acupuncture in the Treatment of Ménière's Syndrome-A Systematic Review.

Ménière's syndrome is a long-term, progressive disease that damages the balance and hearing parts of the inner ear. To address the paucity of information on which evidence-based treatment decisions should be made, a systematic review of acupuncture for Ménière's syndrome was undertaken. The method used was a systematic review of English and Chinese literature, from six databases for randomized, non-randomized and observational studies. All studies were critically appraised and a narrative approach to data synthesis was adopted. Twenty-seven studies were included in this review (9 in English and 18 in Chinese languages): three randomized controlled trials, three non-randomized controlled studies and four pre-test, post-test designs. All but one of the studies was conducted in China. The studies covered body acupuncture, ear acupuncture, scalp acupuncture, fluid acupuncture point injection and moxibustion. The studies were of varying quality. The weight of evidence, across all study types, is of beneficial effect from acupuncture, for those in an acute phase or those who have had Ménière's syndrome for a number of years. The review reinforces the importance of searching for studies from English and Chinese literature. The transferability of the findings from China to a Western context needs confirmation. Further research is also needed to clarify questions around the appropriate frequency and number of treatment/courses of acupuncture. The weight of evidence suggests a potential benefit of acupuncture for persons with Ménière's disease, including those in an acute phase and reinforces the importance of searching for published studies in the Chinese language.

Getting inside acupuncture trials--exploring intervention theory and rationale.

BACKGROUND: Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected) is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture). METHODS: Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. RESULTS: When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. CONCLUSION: Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the intervention. We advocate using this framework to aid reporting, along with further testing and refinement of the framework.

Test-Retest Reliability and Clinical and Research Validity of the 'Quality of Life Impact and Concerns' (QoLI&C) Measure.

Hip dysplasia is a significant public health issue, representing the single largest cause for total hip arthroplasty in young adults. To gain insight into patient concerns and the impact of hip dysplasia on young adults, we developed a patient-centred outcome measure, the 'Quality of Life Impact and Concerns' (QoLI&C) measure. This short report provides additional evidence on test-retest reliability and suggests refinements to the measure to enhance its research and clinical utility.

The use of measurement tools in clinical practice: an observational study of neurorehabilitation.

OBJECTIVE: To explore the way in which standardized measurement tools are used in day-to-day clinical practice. DESIGN: Non-participant observation and semi-structured interviews. SETTING: Hospital-based adult neurorehabilition unit. PARTICIPANTS: The multidisciplinary team delivering rehabilitation in the unit. RESULTS: The multidisciplinary team used the measurement tools internally to establish the presence and severity of patients' impairments and activity limitations; predict recovery and discharge destination; inform treatment planning and monitor progress. They were used externally to demonstrate service effectiveness; communicate with patients, families and external agencies; enable other providers to plan continuing care and resource needs, and inform audit and service development. CONCLUSION: When used in everyday clinical practice by a multidisciplinary neurorehabilitation team, standardized measures were used to support and inform, rather than replace, clinical decision-making.

The outcomes of Perthes' disease.

AIMS: To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. METHODS: The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes' disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes' disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either 'in' or 'out') before a final consensus meeting with representatives of surgeons, patients, and parents. RESULTS: In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). CONCLUSION: Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes' disease. Cite this article: Bone Joint J 2020;102-B(5):611-617.

The potential of complementary and alternative medicine in promoting well-being and critical health literacy: a prospective, observational study of shiatsu.

BACKGROUND: The potential contribution of complementary and alternative medicine (CAM) modalities to promote and support critical health literacy has not received substantial attention within either the health promotion or the CAM literature. This paper explores the potential of one CAM modality, shiatsu, in promoting well-being and critical health literacy. METHODS: Data are drawn from a longitudinal, 6 months observational, pragmatic study of the effects and experience of shiatsu within three European countries (Austria, Spain and the UK). Client postal questionnaires included: advice received, changes made 6 months later, clients 'hopes' from having shiatsu and features of the client-practitioner relationship. RESULT: At baseline, three-quarters of clients (n = 633) received advice, on exercise, diet, posture, points to work on at home or other ways of self-care. At 6 months follow-up, about four-fifths reported making changes to their lifestyle 'as a result of having shiatsu treatment', including taking more rest and relaxation or exercise, changing their diet, reducing time at work and other changes such as increased body/mind awareness and levels of confidence and resolve. Building on the findings, an explanatory model of possible ways that a CAM therapy could contribute to health promotion is presented to guide future research, both within and beyond CAM. CONCLUSION: Supporting individuals to take control of their self-care requires advice-giving within a supportive treatment context and practitioner relationship, with clients who are open to change and committed to maintaining their health. CAM modalities may have an important role to play in this endeavour.

Exploring how to evaluate a qualitative patient-centered outcome measure: literature review and illustrative example - a Perthes child-friendly measure.

PURPOSE: To explore the question of 'how to evaluate a qualitative patient-centred outcome measure', comprising predominantly open-ended items, including perhaps emojis, story writing and/or pictures, in a way that does not compromise the strictures of the qualitative paradigm, doing so in a credible and authoritative manner. The paper aims to promote debate and discussion in the measurement validation community. METHODS: Comprehensive literature review of three electronic databases (PubMed; SCOPUS; Web of Science/Knowledge) and searches of three outcome-focused journals. RESULTS: The vast majority (>90%) of the papers only used qualitative methods in the initial, in particular, content validation of a measure and then used (quantitative) psychometric validation procedures.  The remaining papers comprised articles that were either methodologically or methods focused and the role of qualitative research.  A number of key issues are raised, inter alia: giving primacy to the patient's perspective; exploring the meaning and interpretation respondents place on the concept and possible items in a measure; prioritising maximising meaningful discrimination from the respondent's perspective; ensuring face and content validity and relevance of items in the item content pool; and using appropriate qualitative methods, for example, concept elicitation, "think-aloud" and cognitive interviews and expert respondent panels/judges. This approach is applied to validate a child-friendly outcome measure for children with Perthes disease, a paediatric hip condition presenting primarily amongst male children aged 5-8 years. CONCLUSIONS: The core messages are to: (i) not force validation of a qualitative outcome measure into psychometric validation; but (ii) retain full adherence to the principles of the qualitative paradigm and employ procedures drawn from that paradigm. In this manner, primary emphasis would lie on issues of meaningfulness, face and content validity, the meaning of item and measure scores to respondents and, for a child-friendly measure, the child-friendliness of the measure.

Development and validation of a patient-centered outcome measure for young adults with pediatric hip conditions: the "Quality of Life, Concerns and Impact Measure".

Purpose: To develop and validate a patient-centered, evaluative outcome measure to assess patient-significant and identified impacts of the three pediatric hip conditions (the "Quality of Life, Concerns and Impact Measure" (QoLC&I)), for use by patients and clinicians in discussions over treatment options and the evaluation of treatment and post-operative rehabilitation. Patients and methods: The measure was developed through a qualitative study, via two web-based forums (patient narratives, n=84) and one specialist orthopedic adult hip clinic (conducting interviews, n=38). The draft (1) measure was piloted in an asynchronous web-based discussion group forum; following revision, it was piloted with a group of clinicians and patients to assess its patient and clinical utility, face and content validity. The final, refined prototype measure (QoLC&I, draft 3) was subjected to psychometric evaluation. Results: A total of 230 patients provided useable data for the psychometric analysis: 70% (160) had a confirmed diagnosis of Developmental Dysplasia of the Hip, 15% (35) Perthes, 11% (26) Slipped Upper Femoral Epiphyses; 4% (9) PHC not stated. The scale showed good acceptability (few missing items, good spread, low floor/ceiling effects), relevance (76% stating they would find the measure useful in their discussions with clinicians), and good internal consistency (Cronbach's α=0.98; average ICC=0.98). Hypotheses on convergent validity (with the General Health Questionnaire, to measure depression, and the International Hip Outcome Tool Short Form, to measure quality of life) and divergent validity (with the General Self-Efficacy Scale, to measure coping) were confirmed. Conclusion: The 64-item QoL&CI measure is a practical and valid measure addressing areas of clinical and patient significance and has potential value to assist patients and clinicians in discussions about treatment choices and treatment progress. Future research will address further psychometric testing (test-retest validity and responsiveness to change), in additional sites, and embedding the measure into clinical practice.

Tacit and encoded knowledge in the use of standardised outcome measures in multidisciplinary team decision making: a case study of in-patient neurorehabilitation.

This paper explores how multidisciplinary teams (MDTs) balance encoded knowledge, in the form of standardised outcome measurement, with tacit knowledge, in the form of intuitive judgement, clinical experience and expertise, in the process of clinical decision making. The paper is based on findings from a qualitative case study of a multidisciplinary in-patient neurorehabilitation team in one UK NHS trust who routinely collected standardised outcome measures. Data were collected using non-participant observation of 16 MDT meetings and semi-structured interviews with 11 practitioners representing different professional groups. Our analysis suggests that clinicians drew on tacit knowledge to supplement, adjust or dismiss 'the scores' in making judgements about a patients' likely progress in rehabilitation, their change (or lack of) during therapy and their need for support on discharge. In many cases, the scores accorded with clinicians' tacit knowledge of the patient, and were used to reinforce this opinion, rather than determine it. In other cases, the scores, in particular the Barthel Index, provided a partial picture of the patient and in these circumstances, clinicians employed tacit knowledge to fill in the gaps. In some cases, the scores and tacit knowledge diverged and clinicians preferred to rely on their clinical experience and intuition and adjusted or downplayed the accuracy of the scores. We conclude that there are limits to the advantages of quantifying and standardising assessments of health within routine clinical practice and that standardised outcome measures can support, rather than determine clinical judgement. Tacit knowledge is essential to produce and interpret this form of encoded knowledge and to balance its significance against other information about the patient in making decisions about patient care.

Complementary therapy use by persons with multiple sclerosis: benefits and research priorities.

People with multiple sclerosis (MS) are commonly actively involved in self-care, with many accessing complementary and alternative medicine (CAM) to help in symptom management. To provide increased insight into benefits from CAM use and service user ideas over research priorities, a two-part study, involving a questionnaire and interactive workshop, was undertaken with attendees at a national Congress of the MS Trust in the UK. The six most used therapies were reflexology, massage, yoga, relaxation and meditation, acupuncture and aromatherapy. Each was rated by a quarter to two-fifths as 'extremely helpful'. Insight into the nature of the therapeutic benefit was provided in user comments. Despite the self-selected nature of the sample, the findings point to potential benefits of a set of CAM therapies in helping people with MS. More research on potential benefits of therapies was called for by participants and on the dynamics of the therapeutic effect.

Exploring patient perceptions of movement through the stages of change model within a diabetes tele-care intervention.

Achieving strict control of diabetes is challenging for many patients and most need regularly to depend on ongoing support from health care professionals. One approach that might successfully provide this in a cost-effective and acceptable way is the delivery of advice and support over the telephone (tele-care). To date the process and effects of tele-care have however rarely been studied. This article explores the potential of one behavioural model, the trans-theoretical stages of change model (TTM), to understand and theorize about behaviour change for this chronic disease. Case study data are drawn from a wider randomized controlled trial (RCT) set up to assess the effectiveness of a pro-active call centre-based stepped treatment support to people with type 2 diabetes. The case study demonstrates the relevance and importance of the TTM model in this area. Different experiential and behavioural processes were of particular significance and held different meanings for the various change groups.

Acceptability and satisfaction with a telecarer approach to the management of type 2 diabetes.

OBJECTIVE: To examine patients' views of the acceptability of and satisfaction with telephone care center support provided to improve blood glucose control in type 2 diabetes. RESEARCH DESIGN AND METHODS: The Pro-Active Call-Center Treatment Support (PACCTS) Trial randomized patients from 47 general practices in a deprived urban area in northwest England to usual care or to proactive call center support in addition to usual care. Satisfaction with care was assessed in all 591 patients at baseline and the end of the study using the Diabetes Satisfaction and Treatment Questionnaire (DTSQ). Acceptability was assessed in 394 intervention patients after at least three proactive calls from the call center and at the end of the trial. A purposive sample of 25 patients took part in in-depth semistructured interviews. RESULTS: The response rates to the questionnaires were 79% (DTSQ) and 65% (acceptability). Persons receiving the intervention continued to report high levels of satisfaction with their treatment (95% CI 32.3-33.2 at 1 year), and >90% strongly agreed or agreed that the telecarer approach was acceptable. Qualitative comments pointed to the importance of a personalized service; increased feelings of well-being, including confidence and self-control; help with problem-solving; and patients developing rapport and a strong bond with the telecarers. CONCLUSIONS: A personalized PACCTS approach is acceptable to patients. A service giving priority to the interpersonal dimension leads to increased commitment from patients to improve long-term glycemic control.

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial.

OBJECTIVE: To determine whether Pro-Active Call Center Treatment Support (PACCTS), using trained nonmedical telephonists supported by specially designed software and a diabetes nurse, can effectively improve glycemic control in type 2 diabetes. RESEARCH DESIGN AND METHODS: A randomized controlled implementation trial of 1-year duration was conducted in Salford, U.K. The trial comprised 591 randomly selected individuals with type 2 diabetes. By random allocation, 197 individuals were assigned to the usual care (control) group and 394 to the PACCTS (intervention) group. Lifestyle advice and drug treatment in both groups followed local guidelines. PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c) level. The primary outcome was absolute reduction in HbA(1c), and the secondary outcome was the proportion of patients reducing HbA(1c) by at least 1%. RESULTS: A total of 332 patients (84%) in the PACCTS group and 176 patients (89%) in the control group completed the study. Final HbA(1c) values were available in 374 patients (95%) in the PACCTS group and 180 patients (92%) in the usual care group. Compared with usual care, HbA(1c) improved by 0.31% (95% CI 0.11-0.52, P = 0.003) overall in the PACCTS patients. For patients with baseline HbA(1c) >7%, the improvement increased to 0.49% (0.21-0.77, P < 0.001), whereas in patients with baseline HbA(1c) <7% there was no change. The difference in the proportions of patients achieving a >/=1% reduction in HbA(1c) significantly favored the PACCTS intervention: 10% (4-16, P < 0.001) overall and 15% (7-24, P < 0.001) for patients with baseline HbA(1c) >7%. CONCLUSIONS: In an urban Caucasian trial population with blood glucose HbA(1c) >7%, PACCTS facilitated significant improvement in glycemic control. Further research should extend the validity of findings to rural communities and other ethnic groups, as well as to smoking and lipid and blood pressure control.

A retrospective survey of patients at the University of Salford Acupuncture Clinic.

A retrospective survey was undertaken at the University of Salford Teaching Acupuncture Clinic. A postal questionnaire, exploring patient satisfaction and experience with the treatment and clinic, was sent to all persons who had attended the clinic between September 2001 and 2002. Eighty-four (76%) of the 110 patients returned the questionnaire. Nearly all (88%) gained symptom relief and about a half made changes to their lifestyle. No-one reported any negative effects. More than 90% were satisfied with the treatment given, student practitioners and supervisors, although there were mixed views about the supervisor's role. The study is one of the first studies to explore the satisfaction and experiences in a teaching clinical setting. Further research is needed to provide more in-depth insight into the patient experience and effects of acupuncture in this setting and to explore their experience and effects as the treatment unfolds, and over the longer term.

The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory?

This paper applies a theory-driven approach to explore why the use of patient-reported outcome (PRO) measures in clinical practice, in particular, health-related quality of life (HRQoL) instruments, has little or no apparent influence on clinical decision making. A theory-driven approach involves combining knowledge of whether and how an intervention works. It is argued that such an approach is currently lacking within the literature evaluating the effectiveness of feeding back HRQoL information to clinicians. The paper identifies a number of mechanisms that might give rise to the expected outcomes that are currently implicit within the design of the intervention and hypotheses specified within the trials evaluating the use of HRQoL measures in clinical practice. It then examines how far current clinical practice matches these mechanisms and in doing so, a number of possible explanations for the lack of impact of HRQoL on clinical decision making are reviewed. The influence of HRQoL information on clinical decision making depends on a large number of factors related to the design of the intervention, patients' and clinicians' desire to discuss HRQoL issues within the consultation and the legitimacy that clinicians give to HRQoL instruments. To date, knowledge of how the feedback of HRQoL information to clinicians might improve doctor-patient communication or clinical decision making has yet to sufficiently inform an assessment of whether these aspects of patient care are improved. The paper concludes by specifying how the feedback of HRQoL information to clinicians might be modified to maximise its impact on clinical decision making.

Square pegs and round holes? A review of economic evaluation in complementary and alternative medicine.

INTRODUCTION: Economic evaluation, linking the costs and consequences of an intervention to indicate the potential benefits of alternative interventions, is becoming established as one of the core tools for decision making in health care. As knowledge of the safety and effectiveness of complementary and alternative medicine (CAM) interventions increases, economic evaluation within CAM has a heightened significance. OBJECTIVE: To explore whether the present framework for economic evaluation fits CAM and what modifications if any are needed for its application. DESIGN: Systematic review. METHODS: A comprehensive search of four databases was undertaken (NHS Economic Evaluation Database, AMED, MEDLINE, CINAHL). Studies were included if they took the form of a comparative analysis of costs and consequences of a CAM treatment and were written in English. Each study was reviewed using a set of methodological questions to judge their quality as economic evaluations. RESULTS: A total of 19 studies were identified, of which 9 were cost-effectiveness studies, 7 cost-consequence studies, 2 cost-minimization studies, and 1 cost-benefit analysis. Seventeen (17) of the studies involved CAM treatments being used alongside mainstream or conventional treatments. The majority of the treatments aimed to alleviate pain, including chronic pain, back pain, neck pain, and migraine. Only a small minority of studies addressed wider outcomes of particular relevance to CAM disciplines. Nine (9) adopted a service provider perspective only, 7 included wider sickness absence costs and 3 patient costs. Only 1 study included costs to relatives. The quality of the cost and benefit dimensions of the studies was mixed. CONCLUSIONS: A CAM sensitive approach to economic evaluation is required. This needs to include a focus on outcomes that explore the range of effects of CAM treatment, an exploration of the client's perspective and not just that of the service provider and study designs that facilitate the individualized practitioner approach so central to CAM treatment.