Suzanne Parsons

Advice to use topical or oral ibuprofen for chronic knee pain in older people: randomised controlled trial and patient preference study

Objective To determine whether older patients with chronic knee pain should be advised to use topical or oral non-steroidal anti-inflammatory drugs (NSAIDs). Design Randomised controlled trial and patient preference study. Setting 26 general practices. Participants People aged ≥50 with knee pain: 282 in randomised trial and 303 in preference study. Interventions Advice to use topical or oral ibuprofen. Primary outcome measures WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, major and minor adverse effects. Results Changes in global WOMAC scores at 12 months were equivalent. In the randomised trial the difference (topical minus oral) was two points (95% confidence interval −2 to 6); in the preference study, it was one point (−4 to 6). There were no differences in major adverse effects in the trial or study. The only significant differences in secondary outcomes were in the randomised trial. The oral group had more respiratory adverse effects (17% v 7%,95% confidence interval for difference −17% to −2%), the change in serum creatinine was 3.7 mmol/l less favourable (0.9 µmol/l to 6.5 µmol/l); and more participants changed treatments because of adverse effects (16% v 1%, −16% to −5%). In the topical group more participants had chronic pain grade III or IV at three months, and more participants changed treatment because of ineffectiveness. Conclusions Advice to use oral or topical preparations has an equivalent effect on knee pain over one year, and there are more minor side effects with oral NSAIDs. Topical NSAIDs may be a useful alternative to oral NSAIDs. Trial registration ISRCTN 79353052.

Influences on older people’s decision making regarding choice of topical or oral NSAIDs for knee pain: qualitative study

Objective To explore the factors that influence older people’s decision making regarding use of topical or oral ibuprofen for their knee pain. Design Qualitative interview study nested within a randomised controlled trial and a patient preference study that compared advice to use oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) for knee pain in older people. Setting 11 general practices. Participants 30 people aged ≥50 with knee pain. Results Participants’ decision making was influenced by their perceptions of the associated risk of adverse effects, presence of other illness, nature of their pain, advice received, and practicality. Although participants’ understanding of how the medications worked was sometimes poor their decision making about the use of NSAIDs seemed logical and appropriate. Participants’ model for treatment was to use topical NSAIDs for mild, local, and transient pain and oral NSAIDs for moderate to severe, generalised, and constant pain (in the absence of other more serious illness or risk of adverse effects). Participants showed marked tolerance and normalisation of adverse effects. Conclusion Participants had clear ideas about the appropriate use of oral and topical NSAIDs. Taking such views into account when prescribing may improve adherence, judgment of efficacy, and the doctor-patient relationship. Tolerance and normalisation of adverse effects in these patients indicate that closer monitoring of older people who use NSAIDs might be needed.

The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

BackgroundThe OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale.Methods/designQuantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control).DiscussionAlthough process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation.Trial RegistrationISRCTN No: ISRCTN43769277

British pain clinic practitioners' recognition and use of the bio-psychosocial pain management model for patients when physical interventions are ineffective or inappropriate: results of a qualitative study

BackgroundTo explore how chronic musculoskeletal pain is managed in multidisciplinary pain clinics for patients for whom physical interventions are inappropriate or ineffective.MethodsA qualitative study was undertaken using semi-structured interviews with twenty five members of the pain management team drawn from seven pain clinics and one pain management unit located across the UK.ResultsAll clinics reported using a multidisciplinary bio-psychosocial model. However the chronic pain management strategy actually focussed on psychological approaches in preference to physical approaches. These approaches were utilised by all practitioners irrespective of their discipline. Consideration of social elements such as access to social support networks to support patients in managing their chronic pain was conspicuously absent from the approaches used.ConclusionPain clinic practitioners readily embraced cognitive/behavioural based management strategies but relatively little consideration to the impact social factors played in managing chronic pain was reported. Consequently multidisciplinary pain clinics espousing a bio-psychosocial model of pain management may not be achieving their maximum potential.

Did local enhancement of a national campaign to reduce high antibiotic prescribing affect public attitudes and prescribing rates

Objectives: Due to concerns about both costs and drug resistance, reducing antibiotic prescribing is a strategic aim for the UK National Health Service. A nationwide public education campaign launched in October 1999 (CATNAP) addressed this. The objectives were 1) to assess public attitudes to antibiotic use in a district with high antibiotic prescribing where a nationwide public education campaign was locally enhanced, 2) to assess the impact of the campaign on prescribing of antibiotics locally. Design: 1) Questionnaire survey to test the hypothesis that public attitudes would be equivalent before and after local enhancement of the national campaign. 2) Prescribing data analysis to assess the impact of the campaign on prescribing of antibiotics. Setting: London Borough of Barking and Dagenham. Outcome measures: 1) Differences in public attitudes to antibiotic prescribing pre and post the locally enhanced campaign. 2) Changes in prescribing rates pre and post the locally enhanced campaign Results: 1) Response rates in questionnaire study: 45% (442/982) initially, 42% (815/1941) at follow-up. Responses to all general questions were equivalent in both surveys. There was considerable misunderstanding amongst the population about the effectiveness of antibiotics, particularly in relation to viral infections, colds, sore throats and coughs. The proportion of responders who believed that children should be prescribed antibiotics for a fever was not equivalent in the two surveys, it decreased from 56 to 49%, the limit of the one-sided confidence interval was 13.5%. 2) The rate of change in prescriptions dispensed between 1998/9 and 1999/2000 was not significantly different from that expected, based on the previous four years, in either England and Wales or Barking and Dagenham. Conclusion: Using this study design and this method of locally enhancing a public education campaign, the locally enhanced campaign did not appear to influence the publics attitudes towards antibiotic prescribing in an area of high prescribing. Assessment of the attitudes of those who had definitely been exposed to the campaign and greater promotion of the campaign and its messages to, and by, GPs might be more likely to produce a demonstrable change in attitudes.

Methodological challenges and approaches to improving response rates in population surveys in areas of extreme deprivation.

BACKGROUND Achieving good response rates to population surveys from hard to reach groups in deprived areas can be challenging. AIM To explore and compare different approaches to improving response rates in an economically deprived multicultural area. METHOD Following a lower than anticipated response rate in a pilot study for a postal questionnaire survey of chronic pain (79/653 (12%)), we conducted a second pilot involving a shorter postal survey and separate collection of more detailed information in a waiting room survey. The second postal survey used a shorter questionnaire, telephone data collection from non-responders by study team members rather than telephone reminders from practice receptionists, and involved a nested randomised-controlled trial (RCT) of hand-addressed versus printed-address envelopes. Both pilots involved subjects randomly selected from the practice registers. RESULTS The second pilot postal survey using shorter questionnaires yielded considerably more responses (240/642 (37%)). Our RCT showed that hand-addressed envelopes achieved a slightly higher response rate although not large enough to justify its use in our main study. The waiting room survey was successful in collecting more detailed data from lengthy questionnaires. CONCLUSION A range of methods of questionnaire administration may be required when conducting a survey with a hard to reach group in a deprived and ethnically diverse population. Postal and telephone administration can be used to collect a small amount of data. Face-to-face administration and recruitment can be successful for longer questionnaires.

TOIB Study. Are topical or oral ibuprofen equally effective for the treatment of chronic knee pain presenting in primary care: a randomised controlled trial with patient preference study. [ISRCTN79353052]

BackgroundMany older people have chronic knee pain. Both topical and oral non- steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat this. Oral NSAIDS are effective, at least in the short term, but can have severe adverse effects. Topical NSAIDs also appear to be effective, at least in the short term. One might expect topical NSAIDs both to be less effective and to have fewer adverse effects than oral NSAIDs. If topical NSAIDs have fewer adverse effects this may outweigh both the reduction in effectiveness and the higher cost of topical compared to oral treatment. Patient preferences may influence the comparative effectiveness of drugs delivered via different routes.MethodsTOIB is a randomised trial comparing topical and oral ibuprofen, with a parallel patient preference study. We are recruiting people aged 50 or over with chronic knee pain, from 27 MRC General Practice Research Framework practices across the UK. We are seeking to recruit 283 participants to the RCT and 379 to the PPS. Participants will be followed up for up to two years (with the majority reaching one year). Outcomes will be assessed by postal questionnaire, nurse examination, laboratory tests and medical record searches at one and two years or the end of the study.DiscussionThis study will provide new evidence on the overall costs and benefits of treating chronic knee pain with either oral or topical ibuprofen. The use of a patient preference design is unusual, but will allow us to explore how preference influences response to a medication. In addition, it will provide more information on adverse events. This study will provide evidence to inform primary care practitioners, and possibly influence practice.

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study

Objectives To explore European-based pharmaceutical industry professionals’ beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Setting Pharmaceutical companies in the UK, Poland and Spain. Participants 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Method Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. Results 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Conclusions Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the publics lack of knowledge and interest in medicines R&D, and the pharmaceutical industrys lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships.

Study protocol: Determining what young people with rheumatic disease consider important to research (the Young People’s Opinions Underpinning Rheumatology Research - YOURR project)

Plain English summaryInvolving young people in research about their health is increasingly recognized as being important to make sure that research is focused more on the needs of young people. However, at present, ideas about what should be researched and found out mainly come from researchers and health professionals like doctors and nurses rather than young people. Therefore, in the past, young people’s ideas about what should be researched in terms of rheumatic problems have not been explored. In this study, we will talk with groups of young people with rheumatic problems across the UK to explore what they think research into their health should focus on. We will also discuss with young people, if and how, they would like to be involved in shaping research into rheumatic problems. The findings from this work will help make sure that the views of young people with rheumatic problems influence the work of a group of researchers and health professionals who concentrate on rheumatology research. This group is called the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR). A national young person’s advisory group will be set up to make sure that the beliefs and ideas of young people with rheumatic disease inform the work of the BANNAR.AbstractBackground The involvement of people of all ages (including young people) in health-related research is now widely advocated but research priorities are still largely driven by professional agendas, with evidence from the adult literature reporting a mismatch between researcher and patient generated lists of research topics. To date, there have been no studies exploring the research priorities of young people with long term conditions including rheumatic disease. In this study, we will explore young people’s beliefs about their research priorities for rheumatic conditions and whether and how young people would like to become involved in the research process. Methods/Design We will hold up to 16 focus group discussions with young people (11–24 years) across England, Northern Ireland, Scotland and Wales. Two age groups will be recruited to the study, 11–15 year olds to represent early and mid-adolescence and 16–24 year olds to reflect late adolescence and emerging adulthood. Focus groups will be as interactive and engaging as possible, using a mixture of statement sorting and a research prioritization exercise to stimulate the discussion. Young people will be recruited via members of the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR) and relevant national charities. Focus groups will be audiotaped and transcribed for analysis. Discussion This project will help ensure full representation from young people with rheumatic diseases in the development of a research strategy for BANNAR and will ultimately inform a young person’s led involvement strategy to facilitate the future ethical and meaningful involvement of young people in BANNAR members’ future research programmes. In addition, a national young persons’ advisory group will be established, the constitution and format of which will be determined by the young people themselves.

What the public knows and wants to know about medicines research and development: a survey of the general public in six European countries

Objectives To explore public knowledge of, and interest in, learning more about medicines R&D in six European countries. Design Online survey of 6931 members of the public across Europe. Methods The survey formed part of a public omnibus survey. A quota sampling approach was used with quotas set according to national census data on age, gender and government region. The survey explored the publics knowledge and awareness of medicines R&D, their interest in learning more and the perceived influences on this. Results The survey was completed by 6931 members of the public, over 75% of whom reported having no or less than good knowledge of medicines R&D. Males were more likely than females to report good knowledge (17% vs 15%), and knowledge appeared to decrease with age. Those who were currently or had previously been involved in medical research were almost five times more likely to report good knowledge of medicines R&D overall (43% vs 13%). Participants reported good knowledge of medicines safety and clinical trials but little knowledge of pharmacoeconomics. They were most interested in learning more about medicines safety and personalised and predictive medicine and least interested in pharmacoeconomics. Older people, women and respondents with current good knowledge of medicines R&D were most interested in learning more about medicines R&D. Conclusions Experience of medical research appears to play a key role in increasing public awareness of and future interest in medicines R&D. Some groups may need to be specifically targeted to increase their awareness of medicines R&D, for example, women expressed great interest in learning more but reported less knowledge than men. It may be useful to explore further the views of those who are currently uninterested in learning more.