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Supporting informed choice in acupuncture: effects of a new person-, evidence- and theory-based website for patients with back pain:

Supporting informed choice in acupuncture: effects of a new person-, evidence- and theory-based... Objectives: To test whether a newly developed person-, theory- and evidence-based website about acupuncture helps patients make informed decisions about whether or not to use acupuncture for back pain. Methods: A randomised online study compared a newly developed ‘enhanced website’ to a ‘standard website’. The enhanced website provided evidence-based information in a person-based manner and targeted psychological con- structs. The standard website was based on a widely used patient information leaflet. In total, 350 adults with recent self-reported back pain were recruited from general practices in South West England. The two primary outcomes were knowledge change and making an informed choice about using acupuncture. Secondary outcomes were beliefs about and willingness to have acupuncture. Results: Participants who viewed the enhanced acupuncture website had a significantly greater increase in knowl- edge about acupuncture (M = 1.1, standard deviation (SD) = 1.7) than participants who viewed the standard website (M = 0.2, SD = 1.1; F(1, 315) = 37.93, p < 0.001, η = .107). Participants who viewed the enhanced acupuncture web- site were also 3.3 times more likely to make an informed choice about using acupuncture than those who viewed the standard website (χ (1) = 23.46, p < 0.001). There were no significant effects on treatment beliefs or willingness to have acupuncture. Conclusion: The enhanced website improved patients’ knowledge and ability to make an informed choice about acu- puncture, but did not optimise treatment beliefs or change willingness to have acupuncture. The enhanced website could be used to support informed decision-making among primary care patients and members of the general public consider- ing using acupuncture for back pain. Keywords acupuncture, attitude, back pain, digital intervention, health education, informed consent Accepted: 10 December 2018 1 5 Centre for Clinical and Community Applications of Health Psychology, Zemedia, Southampton, UK Faculty of Environmental and Life Sciences, University of Southampton, School of Psychological Science, University of Bristol, UK Southampton, UK Corresponding author: Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s Felicity L Bishop, Centre for Clinical and Community Applications College London, London, UK of Health Psychology, Faculty of Environmental and Life Sciences, Centre for Innovation and Leadership in Health Sciences, University of University of Southampton, Building 44, Highfield Campus, Southampton Southampton, Southampton, UK SO17 1BJ, UK. Primary Care and Population Sciences, University of Southampton, Email: F.L.Bishop@southampton.ac.uk Southampton, UK Acupuncture in Medicine, 37(2) Bishop et al. 99 positive expectations of benefitting from acupuncture may Introduction subsequently experience better clinical outcomes, includ- In the United Kingdom alone, approximately 4 million acu- 27,28 ing pain relief and functioning, while presenting infor- puncture treatments are provided annually by over 10,000 mation in a very neutral frame might be detrimental. registered acupuncturists practicing a range of acupuncture Encouraging patients to have positive expectations of acu- styles. Back pain is highly prevalent and burdensome for puncture’s effectiveness might thus enhance clinical out- 2,3 patients and societies, the beneficial effects of acupunc- comes, but is challenging to implement because it would be ture for back pain have been established, and patients com- unethical and potentially harmful to foster unrealistically 1,5 monly seek acupuncture for back pain. While the balance positive expectations. of evidence suggests acupuncture is more beneficial than Two standardised patient information leaflets on acu- usual care, it may not be superior to placebo or sham acu- 30,31 puncture are in use and educational programmes for puncture. This leads to differing interpretations of the evi- medical students have been described. A few formal evalu- 6–9 dence base by policy-makers and in clinical guidelines. ations of these educational programmes have been pub- For example, the UK National Institute for Health and Care lished including, for example, some using digital Excellence recently switched from recommending to not resources. However, we could not locate any published 6,9 recommending acupuncture for back pain, but their inter- studies testing interventions to improve patients’ knowl- pretation of the evidence has been criticised for prioritising edge and/or informed choices about acupuncture. problematic comparisons with sham acupuncture (which We designed a new website to provide scientifically probably has active components) over more clinically accurate evidence-based information about acupuncture, meaningful comparisons with usual care. This situation aiming to increase knowledge, support informed decision- can be confusing for patients and suggests a need for edu- making and encourage realistically positive outcome cational resources to support patients making informed expectancies among people who might be considering choices about acupuncture. using acupuncture. The objectives were to determine When considering trying acupuncture, consumers seek whether, compared to a control website, the new website information from their social networks, print and online could: (1) increase knowledge; (2) improve informed 11,12 media. One study found that many (but not all) of 401 choice; and (3) change beliefs about acupuncture in adults acupuncture patient information leaflets sourced from UK with recent back pain. clinical settings successfully provided ethically sound infor- mation consistent with the scientific evidence base. There is also scope to improve information provided to patients in Methods acupuncture trials. In contrast to leaflets, which provide Interventions limited information and can only provide text and static images, websites can incorporate additional interactive and Two websites about acupuncture were developed: an other features (e.g. quizzes, audio and film) that can: enhanced website and a standard website. The enhanced enhance engagement and effective education; provide website and its development, using a person-, evidence- and more extensive information to those who are interested theory-based approach, have been described elsewhere. In without overwhelming others; and be easily and cheaply brief, the website comprises 11 main pages and addresses disseminated for widespread access. Online health infor- key topics of interest to potential acupuncture patients, 17,18 mation is increasingly important to consumers, but web- including beneficial and adverse effects, mechanisms of 19,20 sites about complementary therapies can be unreliable. action, safety, practicalities and patients’ experiences. Figure Indeed, there is evidence of knowledge gaps, misconcep- 1 shows an example page. The website conveys information tions and concerns about acupuncture among acupuncture through text, written evidence summaries, audio-clips of 11 21 22 patients, trial participants, healthcare providers and the four patients’ stories and two acupuncturists’ descriptions of 23–25 wider community. For example, approximately 50% of their practice, and three short films. The content was based community-dwelling adults with a history of back pain sur- on published scientific evidence, focused on support for acu- veyed did not know that acupuncture is not statutorily regu- puncture providing clinically meaningful pain relief for some lated in the United Kingdom. Lack of knowledge might patients with back pain. This is consistent with the balance of deter use and is important to address. Therefore, people the evidence, including an individual patient data meta-anal- considering acupuncture might benefit from a reliable ysis and a pragmatic view that, as acupuncture is demon- online source of accurate, evidence-based information to strably superior to conventional treatments, patients should support their decision-making. be told about its potential benefits. In addition to supporting decision-making, information The ‘standard’ website was based on an information about acupuncture might also change patients’ beliefs about sheet and consent form designed by consensus among lead- acupuncture and, in doing so, could impact clinical out- ing UK acupuncturists and commonly used in UK clinical comes. Evidence suggests that patients who have more practice. The standard website gives brief information Acupuncture in Medicine, 37(2) 100 Acupuncture in Medicine Figure 1. Example screenshot from enhanced website. (two pages) about acupuncture, its safety, possible side- Measures effects and contraindications. Supplementary Material 1 Participant characteristics. Clinical characteristics were compares the two websites. assessed using items from the recommended minimum data set for back pain. Single items assessed pain duration, fre- quency, intensity, catastrophising, spread to legs and pain- Design related legal claims, disability benefits or compensation. An online study was conducted with a mixed factorial two- Four-item scales assessed pain functioning and interference by-two design, intended to test two new websites, one with excellent internal consistency (Cronbach’s alphas in about acupuncture (the focus of this paper) and one about this sample are 0.96 and 0.92, respectively). Single items placebo. The two factors were topic (acupuncture website measured ethnicity, age, gender and education. vs placebo website) and website (‘enhanced’ vs ‘standard’ website). Each ‘enhanced’ website was compared to a ‘stand- Primary outcomes. Primary outcomes were knowledge and ard’ website on the same topic. Participants were randomised informed choice about acupuncture. Knowledge was automatically by study website to one of the four groups, assessed using a 10-item quiz, comprising true–false ques- representing every combination of the two factors; each par- tions selected from a larger pool of 15 items pilot-tested in ticipant thus viewed one website (enhanced or standard) a community-based sample of 202 adults with recent back about acupuncture and one website (enhanced or standard) pain. The 10 items most commonly answered incorrectly about placebo; the order of which was counterbalanced by the community-based sample were selected (e.g. ‘Acu- within groups. There were no interaction effects between the puncture is never available on the NHS’ – false). The acupuncture and placebo websites and no effects of placebo knowledge score is the total number of items answered cor- website on acupuncture-related outcomes, that is, whether rectly. The quiz was completed before and after viewing the participants viewed the standard or enhanced version of the websites, and a difference-score was calculated. the placebo website had no effect on the acupuncture out- Making an informed choice has been defined as choosing 36,37 come measures. Therefore, here, we report the enhanced ver- based on knowledge and consistent with one’s values. To sus standard comparison for the acupuncture website only, make an informed choice, one needs an accurate under- collapsing across the placebo website conditions. standing of the options, to consider one’s values and to Acupuncture in Medicine, 37(2) Bishop et al. 101 make a decision consistent with one’s knowledge and val- invitation packs (comprising cover letter, information sheet ues. An informed choice to try acupuncture requires knowl- and study website address) to eligible patients. Those with edge about its possible beneficial and adverse effects, a needle phobia or unable to complete questionnaires in positive attitude and a decision to try acupuncture. An English were excluded. Figure 2 shows participant flow. informed choice not to try acupuncture requires knowledge An a priori power calculation was conducted using about its possible beneficial and adverse effects, a negative G*Power. Assuming an effect size f = 0.15 (based on unpub- attitude and a decision not to try acupuncture. lished pilot data), power 0.8 and alpha 0.05 for a factorial The knowledge component of informed choice was analysis of variance (ANOVA), it was estimated that n = 351 measured using the knowledge quiz described above. participants would be required; assuming 5% drop-out, we Attitudes were measured using four items derived from required 369 patients to be randomised. theory-based guidelines for assessing attitudes, for exam- ple, ‘having acupuncture treatment would be good’. Procedure Behavioural intentions were used as a proxy for behaviour and were measured using three items similarly derived, Ethical approval was obtained from the University of for example, ‘if given the opportunity, I intend to have acu- Southampton (reference: 12323) and NHS NRES Committee puncture treatment’. Attitudes and intentions were meas- East of England – Hatfield (reference: 14/EE/1176). ured on 7-point Likert-type scales labelled strongly agree to After reading the online information sheet, participants strongly disagree; scores across constituent items were gave consent by clicking a button. They were then asked summed. The attitude and intention scales had good inter- screening questions assessing age, current or recent back nal consistency (Cronbach’s alphas are .97 and .84, respec- pain (within 3 years), and needle phobia. Those not meeting tively). Participants were categorised as making an the associated inclusion criteria were directed to an exit informed choice or not based on their knowledge score page. Eligible individuals entered their email address and (high/low, based on median split), attitude (positive/nega- created a website password. The acupuncture knowledge tive, split by scale midpoint) and intention (high/low, split quiz then assessed baseline knowledge, after which partici- by scale midpoint). Participants were categorised as mak- pants were presented with two websites sequentially accord- ing an informed choice if they scored above the median on ing to the randomisation. Participants could take breaks, log knowledge and either (1) above the scale midpoint on both out and return to the study later, and stop viewing each web- attitudes and intentions or (2) below the scale midpoint on site whenever they wanted (‘click here when you have fin- both attitudes and intentions. All other score combinations ished looking at the information’ button was on every page). were categorised as not making an informed choice. After viewing the websites, participants completed the par- ticipant characteristics, primary outcome measures and Secondary outcomes. Secondary outcomes were beliefs secondary outcome measures. Finally, participants were about and willingness to have acupuncture. Four dimen- directed to a debriefing page with further information and sions of belief were measured using the four, four-item, links to other resources; those who completed the study subscales of the low back pain treatment beliefs question- were emailed a £10 online shopping voucher. naire: concerns (e.g. ‘I worry that acupuncture could make my back worse’), individual fit (e.g. ‘I think acupunc- Statistical analysis ture could suit me as a treatment for my back pain’), expec- tancy (e.g. ‘Acupuncture can work well for people with The proportion of missing data was small (<5% for any back pain’) and credibility (e.g. ‘Using acupuncture for one variable), but was not missing completely at random, back pain makes a lot of sense’). All items had 5-point Lik- suggesting imputation might be inappropriate, but unlikely ert-type response scales labelled strongly disagree to to alter the results. All analyses were repeated excluding strongly agree. All subscales had good internal consistency missing data and imputing missing values with the expecta- (Cronbach’s alphas for concerns = 0.83, individual fit = 0.91, tion–maximization (EM) algorithm. The results were the expectancy = 0.84 and credibility = 0.84). same; the reported analyses included all available data with One item asked whether participants would be ‘willing no imputation. to have acupuncture treatment’ (yes/no). Supplementary Pearson’s χ compared the number of people making an Material 2 presents the outcome measures. informed choice between the two website groups. ANOVAs tested the effects of website on knowledge change, treat- ment perceptions and willingness to have acupuncture. Participants and recruitment Models were adjusted for possible confounders (previous Adults (aged 18 years and over) who had general practi- acupuncture use and looking up additional information tioner (GP)-documented back pain within 3 years were about acupuncture during study breaks). Unadjusted mod- recruited via 26 general practices in South West England. els are reported for the primary outcomes as the covariates GP staff conducted database searches and mailed study were not significant. Acupuncture in Medicine, 37(2) 102 Acupuncture in Medicine Figure 2. Participant flow diagram. (SD) = 1.7) than participants who viewed the standard acu- Results puncture website (M = 0.2, SD = 1.1). Participant characteristics Table 2 shows how participants were classified as mak- ing or not making an informed choice according to their In total, 350 adults took part; a slight majority were knowledge, attitudes and intentions. The most common female, most were White British and over half had com- pattern of scores (50.8% of participants) was to have posi- pleted college education or higher (see Table 1). tive intentions of using acupuncture and positive attitudes Participants typically had long-standing back pain (45% towards acupuncture, despite low knowledge. There was a had onset over 5 years ago) that affected them on a daily significant association between website and informed or near-daily basis (38%) and was of moderate intensity choice about acupuncture (χ (1) = 23.46, p < 0.001), with (mean = 4.8 on a 1–10 scale). There were no significant 32.9% (52/158) of people who viewed the enhanced web- between-group differences in demographic or clinical site making an informed choice about acupuncture com- measures (all ps > 0.05). pared to 10.1% (15/149) of people who viewed the standard website. Thus, participants who viewed the enhanced web- Primary outcomes: knowledge and informed site were 3.3 times more likely than those who viewed the choice standard website to make an informed choice about acupuncture. There was a significant main effect of website on change in acupuncture knowledge, F(1, 315) = 37.93, p < 0.001, η = 0.107, explaining 10.7% of the variance in knowledge Secondary outcomes: treatment beliefs change. Participants who viewed the enhanced acupuncture website had a significantly greater increase in their knowl- Table 3 shows mean scores on treatment beliefs by website. edge about acupuncture (M = 1.1, standard deviation There was a small non-significant trend for people who Acupuncture in Medicine, 37(2) Bishop et al. 103 Table 1. Participant characteristics by group. Characteristic Category Frequency (%) Whole sample Standard website Enhanced (n = 350) (n = 175) website (n = 175) Demographic characteristics Age Mean ± SD 47.9 ± 15.8 48.0 ± 15.5 47.8 ± 16.1 Gender Female 197 (56.3) 99 (56.6) 98 (56.0) Ethnicity White British 311 (88.9) 150 (85.7) 161 (92.0) White Other 16 (4.6) 8 (4.6) 8 (4.5) Asian or Asian British 4 (1.2) 3 (1.7) 1 (0.6) Mixed 2 (0.6) 0 2 (1.1) Black or Black British 2 (0.6) 2 (1.2) 0 Education Did not complete secondary 19 (5.4) 10 (5.7) 9 (5.1) school Secondary school 89 (25.4) 38 (21.7) 51 (29.1) Sixth form or college 106 (30.3) 51 (29.1) 55 (31.4) Undergraduate study 98 (28.0) 51 (29.1) 47 (26.9) Postgraduate study 35 (10) 24 (13.7) 11 (6.3) Clinical characteristics Time since pain onset Up to 1 year 71 (20.4) 40 (22.9) 31 (17.7) 1–5 years 105 (30.2) 44 (25.1) 61 (34.9) Over 5 years 157 (45.1) 81 (46.3) 76 (43.4) Pain frequency in past 6 months Every day or nearly every day 133 (38.0) 63 (36.0) 70 (40.0) 85 (24.3) 26.3 (26.7) 39 (22.3) >Half the days 102 (29.1) 49 (28.0) 53 (30.3) <Half the days Pain intensity in past week (1–10) Mean ± SD 4.8 ± 2.4 4.7 ± 2.5 4.8 ± 2.4 Pain interference in past week (1–5) Mean ± SD 2.6 ± 1.3 2.6 ± 1.3 2.6 ± 1.2 Current pain functioning (1–5) Mean ± SD 2.0 ± 1.0 2.1 ± 1.1 1.9 ± 0.9 Disability or compensation benefits 16 (4.6) 8 (4.6) 8 (4.6) Legal claim related to back 4 (1.1) 2 (1.1) 2 (1.1) Pain spread to leg(s) in past 2 weeks 142 (40.6) 70 (40.0) 72 (41.1) Pain catastrophising 126 (36.0) 61 (34.9) 65 (37.1) Previous acupuncture 153 (43.7) 79 (45.1) 74 (42.3) viewed the enhanced website to have more positive expec- acupuncture or perceptions that acupuncture offered a good tations of benefit from acupuncture and to rate it as more fit for the individual. credible compared to people who viewed the standard web- Willingness to try acupuncture was very high and not site. There were no effects of website on concerns about affected by website: 85.1% of participants who had viewed Acupuncture in Medicine, 37(2) 104 Acupuncture in Medicine Table 2. Proportion of participants displaying different scores within each informed choice category. Informed Knowledge Attitude Intentions Whole sample Standard website Enhanced website choice (n = 307) (n = 149) (n = 158) Frequency % Frequency % Frequency % No Low Positive Negative 23 7.5 12 8.1 11 7.0 No Low Negative Positive 21 6.8 15 10.1 6 3.8 No Low Positive Positive 156 50.8 87 58.4 69 43.7 No Low Negative Negative 25 8.1 17 11.4 8 5.1 No High Positive Negative 12 3.9 3 2.0 9 5.7 No High Negative Positive 3 1.0 0 0.0 3 1.9 Yes High Positive Positive 64 20.8 14 9.4 50 31.6 Yes High Negative Negative 3 1.0 1 0.7 2 1.3 Table 3. Treatment beliefs by group. a 2 Treatment Standard website Enhanced website Comparison Belief M SD n M SD n Concerns 8.2 2.9 157 8.3 3.2 161 F(1, 314) = 0.02, p = 0.898 <0.001 Individual Fit 14.5 4.0 152 14.8 3.9 151 F(1, 299) = 0.48, p = 0.490 0.002 Expectancy 16.1 2.8 154 16.5 2.5 159 F(1, 309) = 2.81, p = 0.095 0.009 Credibility 15.1 3.3 156 15.6 3.1 161 F(1, 313) = 3.35, p = 0.068 0.011 SD: standard deviation. Models adjusted for previous acupuncture use and looking up additional information about acupuncture during breaks from the study. the enhanced website and 82.8% of those who had viewed willingness to try acupuncture. This might be due to ceiling the standard website were willing to try acupuncture effects (on expectancy, credibility and individual fit) and (χ (1) = .34, p = 0.560). floor effects (on concerns). It would be interesting to test the effects of the enhanced website in a sample of participants less inclined to try acupuncture, although the natural audi- Discussion ence for the website in practice will be participants who are We tested the effects of a new educational website about acu- at least willing to consider acupuncture. Perhaps, attempts to puncture on adults with recent back pain, comparing it to a optimise patients’ beliefs about acupuncture would be more standard website based on existing written patient informa- successful if integrated into the first acupuncture consulta- tion. Participants who viewed the enhanced website had tion and delivered by acupuncturists. greater increases in knowledge about acupuncture and were Strengths of this study include the enhanced website, three times more likely to make an informed choice about developed using an approach based on person-based, evi- acupuncture, compared to participants who viewed the dence-based and theory-based intervention design, and standard website. On average, viewing the enhanced website the use of a control website based on existing standard led participants to answer one more knowledge quiz item patient information. Compared to traditional paper-based correctly (out of 10), while the standard website led to no patient information leaflets, creating a website-enabled additional quiz items being answered correctly. These effects provision of more detailed information in an accessible and are likely to be due, at least in part, to the additional informa- engaging manner, for example, using text, audio and film. tion presented in the enhanced website, but might also be due In 2015, 86% of UK households had internet access and partly to the additional formats (e.g. video and audio) that 78% of adults accessed the Internet daily or almost daily, were used in the enhanced website, but not the standard web- making online health information accessible to a large site. There were no effects on treatment beliefs or majority – but not all – of the population. Acupuncture in Medicine, 37(2) Bishop et al. 105 The generalisability of this study is limited by the largely data, which was analysed by M.G.-H. and F.L.B. All authors pro-acupuncture participants drawn primarily from primary contributed to the interpretation of data. F.L.B. drafted the care. We do not know whether our website might improve work and all authors revised it critically for important intel- acupuncture knowledge among people who hold strong neg- lectual content. All authors gave final approval of the ver- ative attitudes towards it. Our participants were also slightly sion to be published and agreed to be accountable for all younger and more educated than a previous primary care aspects of the work in ensuring that questions related to the sample of adults with back pain from the same region. accuracy or integrity of any part of the work are appropri- However, we are reasonably confident that the website is ately investigated and resolved. accessible to adults with less formal education as we attended to accessibility issues during its development. Information Declaration of conflicting interests about regulation and practicalities of accessing acupuncture The authors declared no potential conflicts of interest with respect is UK-specific and will need revising to reflect ongoing to the research, authorship and/or publication of this article. changes in regulation and provision. The design process for the enhanced website was driven by the person-based Funding approach, in conjunction with the evidence- and theory- The authors disclosed receipt of the following financial support based approaches to intervention design. Our website for the research, authorship and/or publication of this article: This might have had larger effects if it had also been designed as work was supported by Arthritis Research UK, Chesterfield, UK, a traditional patient decision aid, as such aids have been grant number 20113. shown to increase knowledge and improve other decision- making outcomes although to date have shown limited Supplemental material effects on clinical outcomes; future research should explore Supplemental material for this article is available online. whether the person-, evidence- and theory-based approach that guided our website design could beneficially be applied References to traditional patient decision aids. The outcome measures 1. Hopton AK, Curnoe S, Kanaan M, et al. Acupuncture in practice: were previously validated and included assessments of mapping the providers, the patients and the settings in a national objective knowledge and informed choice, which are partic- cross-sectional survey. 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A systematic review of the effect of expec- homeinternetandsocialmediausage/bulletins/internetaccesshouse- tancy on treatment responses to acupuncture. Evid Based Complement holdsandindividuals/2015-08-06 (Archived by WebCite at http:// Alternat Med 2012; 2012: 857804. www.webcitation.org/6g1la5vII). 28. Bishop FL, Yardley L, Prescott P, et al. Psychological covariates of 42. Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing longitudinal changes in back-related disability in patients undergoing health treatment or screening decisions. Cochrane Database Syst Rev acupuncture. Clin J Pain 2015; 31(3): 254–264. 2017; 4: CD001431. Acupuncture in Medicine, 37(2) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Acupuncture in Medicine SAGE

Supporting informed choice in acupuncture: effects of a new person-, evidence- and theory-based website for patients with back pain:

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Copyright © 2022 by British Medical Acupuncture Society
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0964-5284
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10.1177/0964528419827228
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Abstract

Objectives: To test whether a newly developed person-, theory- and evidence-based website about acupuncture helps patients make informed decisions about whether or not to use acupuncture for back pain. Methods: A randomised online study compared a newly developed ‘enhanced website’ to a ‘standard website’. The enhanced website provided evidence-based information in a person-based manner and targeted psychological con- structs. The standard website was based on a widely used patient information leaflet. In total, 350 adults with recent self-reported back pain were recruited from general practices in South West England. The two primary outcomes were knowledge change and making an informed choice about using acupuncture. Secondary outcomes were beliefs about and willingness to have acupuncture. Results: Participants who viewed the enhanced acupuncture website had a significantly greater increase in knowl- edge about acupuncture (M = 1.1, standard deviation (SD) = 1.7) than participants who viewed the standard website (M = 0.2, SD = 1.1; F(1, 315) = 37.93, p < 0.001, η = .107). Participants who viewed the enhanced acupuncture web- site were also 3.3 times more likely to make an informed choice about using acupuncture than those who viewed the standard website (χ (1) = 23.46, p < 0.001). There were no significant effects on treatment beliefs or willingness to have acupuncture. Conclusion: The enhanced website improved patients’ knowledge and ability to make an informed choice about acu- puncture, but did not optimise treatment beliefs or change willingness to have acupuncture. The enhanced website could be used to support informed decision-making among primary care patients and members of the general public consider- ing using acupuncture for back pain. Keywords acupuncture, attitude, back pain, digital intervention, health education, informed consent Accepted: 10 December 2018 1 5 Centre for Clinical and Community Applications of Health Psychology, Zemedia, Southampton, UK Faculty of Environmental and Life Sciences, University of Southampton, School of Psychological Science, University of Bristol, UK Southampton, UK Corresponding author: Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s Felicity L Bishop, Centre for Clinical and Community Applications College London, London, UK of Health Psychology, Faculty of Environmental and Life Sciences, Centre for Innovation and Leadership in Health Sciences, University of University of Southampton, Building 44, Highfield Campus, Southampton Southampton, Southampton, UK SO17 1BJ, UK. Primary Care and Population Sciences, University of Southampton, Email: F.L.Bishop@southampton.ac.uk Southampton, UK Acupuncture in Medicine, 37(2) Bishop et al. 99 positive expectations of benefitting from acupuncture may Introduction subsequently experience better clinical outcomes, includ- In the United Kingdom alone, approximately 4 million acu- 27,28 ing pain relief and functioning, while presenting infor- puncture treatments are provided annually by over 10,000 mation in a very neutral frame might be detrimental. registered acupuncturists practicing a range of acupuncture Encouraging patients to have positive expectations of acu- styles. Back pain is highly prevalent and burdensome for puncture’s effectiveness might thus enhance clinical out- 2,3 patients and societies, the beneficial effects of acupunc- comes, but is challenging to implement because it would be ture for back pain have been established, and patients com- unethical and potentially harmful to foster unrealistically 1,5 monly seek acupuncture for back pain. While the balance positive expectations. of evidence suggests acupuncture is more beneficial than Two standardised patient information leaflets on acu- usual care, it may not be superior to placebo or sham acu- 30,31 puncture are in use and educational programmes for puncture. This leads to differing interpretations of the evi- medical students have been described. A few formal evalu- 6–9 dence base by policy-makers and in clinical guidelines. ations of these educational programmes have been pub- For example, the UK National Institute for Health and Care lished including, for example, some using digital Excellence recently switched from recommending to not resources. However, we could not locate any published 6,9 recommending acupuncture for back pain, but their inter- studies testing interventions to improve patients’ knowl- pretation of the evidence has been criticised for prioritising edge and/or informed choices about acupuncture. problematic comparisons with sham acupuncture (which We designed a new website to provide scientifically probably has active components) over more clinically accurate evidence-based information about acupuncture, meaningful comparisons with usual care. This situation aiming to increase knowledge, support informed decision- can be confusing for patients and suggests a need for edu- making and encourage realistically positive outcome cational resources to support patients making informed expectancies among people who might be considering choices about acupuncture. using acupuncture. The objectives were to determine When considering trying acupuncture, consumers seek whether, compared to a control website, the new website information from their social networks, print and online could: (1) increase knowledge; (2) improve informed 11,12 media. One study found that many (but not all) of 401 choice; and (3) change beliefs about acupuncture in adults acupuncture patient information leaflets sourced from UK with recent back pain. clinical settings successfully provided ethically sound infor- mation consistent with the scientific evidence base. There is also scope to improve information provided to patients in Methods acupuncture trials. In contrast to leaflets, which provide Interventions limited information and can only provide text and static images, websites can incorporate additional interactive and Two websites about acupuncture were developed: an other features (e.g. quizzes, audio and film) that can: enhanced website and a standard website. The enhanced enhance engagement and effective education; provide website and its development, using a person-, evidence- and more extensive information to those who are interested theory-based approach, have been described elsewhere. In without overwhelming others; and be easily and cheaply brief, the website comprises 11 main pages and addresses disseminated for widespread access. Online health infor- key topics of interest to potential acupuncture patients, 17,18 mation is increasingly important to consumers, but web- including beneficial and adverse effects, mechanisms of 19,20 sites about complementary therapies can be unreliable. action, safety, practicalities and patients’ experiences. Figure Indeed, there is evidence of knowledge gaps, misconcep- 1 shows an example page. The website conveys information tions and concerns about acupuncture among acupuncture through text, written evidence summaries, audio-clips of 11 21 22 patients, trial participants, healthcare providers and the four patients’ stories and two acupuncturists’ descriptions of 23–25 wider community. For example, approximately 50% of their practice, and three short films. The content was based community-dwelling adults with a history of back pain sur- on published scientific evidence, focused on support for acu- veyed did not know that acupuncture is not statutorily regu- puncture providing clinically meaningful pain relief for some lated in the United Kingdom. Lack of knowledge might patients with back pain. This is consistent with the balance of deter use and is important to address. Therefore, people the evidence, including an individual patient data meta-anal- considering acupuncture might benefit from a reliable ysis and a pragmatic view that, as acupuncture is demon- online source of accurate, evidence-based information to strably superior to conventional treatments, patients should support their decision-making. be told about its potential benefits. In addition to supporting decision-making, information The ‘standard’ website was based on an information about acupuncture might also change patients’ beliefs about sheet and consent form designed by consensus among lead- acupuncture and, in doing so, could impact clinical out- ing UK acupuncturists and commonly used in UK clinical comes. Evidence suggests that patients who have more practice. The standard website gives brief information Acupuncture in Medicine, 37(2) 100 Acupuncture in Medicine Figure 1. Example screenshot from enhanced website. (two pages) about acupuncture, its safety, possible side- Measures effects and contraindications. Supplementary Material 1 Participant characteristics. Clinical characteristics were compares the two websites. assessed using items from the recommended minimum data set for back pain. Single items assessed pain duration, fre- quency, intensity, catastrophising, spread to legs and pain- Design related legal claims, disability benefits or compensation. An online study was conducted with a mixed factorial two- Four-item scales assessed pain functioning and interference by-two design, intended to test two new websites, one with excellent internal consistency (Cronbach’s alphas in about acupuncture (the focus of this paper) and one about this sample are 0.96 and 0.92, respectively). Single items placebo. The two factors were topic (acupuncture website measured ethnicity, age, gender and education. vs placebo website) and website (‘enhanced’ vs ‘standard’ website). Each ‘enhanced’ website was compared to a ‘stand- Primary outcomes. Primary outcomes were knowledge and ard’ website on the same topic. Participants were randomised informed choice about acupuncture. Knowledge was automatically by study website to one of the four groups, assessed using a 10-item quiz, comprising true–false ques- representing every combination of the two factors; each par- tions selected from a larger pool of 15 items pilot-tested in ticipant thus viewed one website (enhanced or standard) a community-based sample of 202 adults with recent back about acupuncture and one website (enhanced or standard) pain. The 10 items most commonly answered incorrectly about placebo; the order of which was counterbalanced by the community-based sample were selected (e.g. ‘Acu- within groups. There were no interaction effects between the puncture is never available on the NHS’ – false). The acupuncture and placebo websites and no effects of placebo knowledge score is the total number of items answered cor- website on acupuncture-related outcomes, that is, whether rectly. The quiz was completed before and after viewing the participants viewed the standard or enhanced version of the websites, and a difference-score was calculated. the placebo website had no effect on the acupuncture out- Making an informed choice has been defined as choosing 36,37 come measures. Therefore, here, we report the enhanced ver- based on knowledge and consistent with one’s values. To sus standard comparison for the acupuncture website only, make an informed choice, one needs an accurate under- collapsing across the placebo website conditions. standing of the options, to consider one’s values and to Acupuncture in Medicine, 37(2) Bishop et al. 101 make a decision consistent with one’s knowledge and val- invitation packs (comprising cover letter, information sheet ues. An informed choice to try acupuncture requires knowl- and study website address) to eligible patients. Those with edge about its possible beneficial and adverse effects, a needle phobia or unable to complete questionnaires in positive attitude and a decision to try acupuncture. An English were excluded. Figure 2 shows participant flow. informed choice not to try acupuncture requires knowledge An a priori power calculation was conducted using about its possible beneficial and adverse effects, a negative G*Power. Assuming an effect size f = 0.15 (based on unpub- attitude and a decision not to try acupuncture. lished pilot data), power 0.8 and alpha 0.05 for a factorial The knowledge component of informed choice was analysis of variance (ANOVA), it was estimated that n = 351 measured using the knowledge quiz described above. participants would be required; assuming 5% drop-out, we Attitudes were measured using four items derived from required 369 patients to be randomised. theory-based guidelines for assessing attitudes, for exam- ple, ‘having acupuncture treatment would be good’. Procedure Behavioural intentions were used as a proxy for behaviour and were measured using three items similarly derived, Ethical approval was obtained from the University of for example, ‘if given the opportunity, I intend to have acu- Southampton (reference: 12323) and NHS NRES Committee puncture treatment’. Attitudes and intentions were meas- East of England – Hatfield (reference: 14/EE/1176). ured on 7-point Likert-type scales labelled strongly agree to After reading the online information sheet, participants strongly disagree; scores across constituent items were gave consent by clicking a button. They were then asked summed. The attitude and intention scales had good inter- screening questions assessing age, current or recent back nal consistency (Cronbach’s alphas are .97 and .84, respec- pain (within 3 years), and needle phobia. Those not meeting tively). Participants were categorised as making an the associated inclusion criteria were directed to an exit informed choice or not based on their knowledge score page. Eligible individuals entered their email address and (high/low, based on median split), attitude (positive/nega- created a website password. The acupuncture knowledge tive, split by scale midpoint) and intention (high/low, split quiz then assessed baseline knowledge, after which partici- by scale midpoint). Participants were categorised as mak- pants were presented with two websites sequentially accord- ing an informed choice if they scored above the median on ing to the randomisation. Participants could take breaks, log knowledge and either (1) above the scale midpoint on both out and return to the study later, and stop viewing each web- attitudes and intentions or (2) below the scale midpoint on site whenever they wanted (‘click here when you have fin- both attitudes and intentions. All other score combinations ished looking at the information’ button was on every page). were categorised as not making an informed choice. After viewing the websites, participants completed the par- ticipant characteristics, primary outcome measures and Secondary outcomes. Secondary outcomes were beliefs secondary outcome measures. Finally, participants were about and willingness to have acupuncture. Four dimen- directed to a debriefing page with further information and sions of belief were measured using the four, four-item, links to other resources; those who completed the study subscales of the low back pain treatment beliefs question- were emailed a £10 online shopping voucher. naire: concerns (e.g. ‘I worry that acupuncture could make my back worse’), individual fit (e.g. ‘I think acupunc- Statistical analysis ture could suit me as a treatment for my back pain’), expec- tancy (e.g. ‘Acupuncture can work well for people with The proportion of missing data was small (<5% for any back pain’) and credibility (e.g. ‘Using acupuncture for one variable), but was not missing completely at random, back pain makes a lot of sense’). All items had 5-point Lik- suggesting imputation might be inappropriate, but unlikely ert-type response scales labelled strongly disagree to to alter the results. All analyses were repeated excluding strongly agree. All subscales had good internal consistency missing data and imputing missing values with the expecta- (Cronbach’s alphas for concerns = 0.83, individual fit = 0.91, tion–maximization (EM) algorithm. The results were the expectancy = 0.84 and credibility = 0.84). same; the reported analyses included all available data with One item asked whether participants would be ‘willing no imputation. to have acupuncture treatment’ (yes/no). Supplementary Pearson’s χ compared the number of people making an Material 2 presents the outcome measures. informed choice between the two website groups. ANOVAs tested the effects of website on knowledge change, treat- ment perceptions and willingness to have acupuncture. Participants and recruitment Models were adjusted for possible confounders (previous Adults (aged 18 years and over) who had general practi- acupuncture use and looking up additional information tioner (GP)-documented back pain within 3 years were about acupuncture during study breaks). Unadjusted mod- recruited via 26 general practices in South West England. els are reported for the primary outcomes as the covariates GP staff conducted database searches and mailed study were not significant. Acupuncture in Medicine, 37(2) 102 Acupuncture in Medicine Figure 2. Participant flow diagram. (SD) = 1.7) than participants who viewed the standard acu- Results puncture website (M = 0.2, SD = 1.1). Participant characteristics Table 2 shows how participants were classified as mak- ing or not making an informed choice according to their In total, 350 adults took part; a slight majority were knowledge, attitudes and intentions. The most common female, most were White British and over half had com- pattern of scores (50.8% of participants) was to have posi- pleted college education or higher (see Table 1). tive intentions of using acupuncture and positive attitudes Participants typically had long-standing back pain (45% towards acupuncture, despite low knowledge. There was a had onset over 5 years ago) that affected them on a daily significant association between website and informed or near-daily basis (38%) and was of moderate intensity choice about acupuncture (χ (1) = 23.46, p < 0.001), with (mean = 4.8 on a 1–10 scale). There were no significant 32.9% (52/158) of people who viewed the enhanced web- between-group differences in demographic or clinical site making an informed choice about acupuncture com- measures (all ps > 0.05). pared to 10.1% (15/149) of people who viewed the standard website. Thus, participants who viewed the enhanced web- Primary outcomes: knowledge and informed site were 3.3 times more likely than those who viewed the choice standard website to make an informed choice about acupuncture. There was a significant main effect of website on change in acupuncture knowledge, F(1, 315) = 37.93, p < 0.001, η = 0.107, explaining 10.7% of the variance in knowledge Secondary outcomes: treatment beliefs change. Participants who viewed the enhanced acupuncture website had a significantly greater increase in their knowl- Table 3 shows mean scores on treatment beliefs by website. edge about acupuncture (M = 1.1, standard deviation There was a small non-significant trend for people who Acupuncture in Medicine, 37(2) Bishop et al. 103 Table 1. Participant characteristics by group. Characteristic Category Frequency (%) Whole sample Standard website Enhanced (n = 350) (n = 175) website (n = 175) Demographic characteristics Age Mean ± SD 47.9 ± 15.8 48.0 ± 15.5 47.8 ± 16.1 Gender Female 197 (56.3) 99 (56.6) 98 (56.0) Ethnicity White British 311 (88.9) 150 (85.7) 161 (92.0) White Other 16 (4.6) 8 (4.6) 8 (4.5) Asian or Asian British 4 (1.2) 3 (1.7) 1 (0.6) Mixed 2 (0.6) 0 2 (1.1) Black or Black British 2 (0.6) 2 (1.2) 0 Education Did not complete secondary 19 (5.4) 10 (5.7) 9 (5.1) school Secondary school 89 (25.4) 38 (21.7) 51 (29.1) Sixth form or college 106 (30.3) 51 (29.1) 55 (31.4) Undergraduate study 98 (28.0) 51 (29.1) 47 (26.9) Postgraduate study 35 (10) 24 (13.7) 11 (6.3) Clinical characteristics Time since pain onset Up to 1 year 71 (20.4) 40 (22.9) 31 (17.7) 1–5 years 105 (30.2) 44 (25.1) 61 (34.9) Over 5 years 157 (45.1) 81 (46.3) 76 (43.4) Pain frequency in past 6 months Every day or nearly every day 133 (38.0) 63 (36.0) 70 (40.0) 85 (24.3) 26.3 (26.7) 39 (22.3) >Half the days 102 (29.1) 49 (28.0) 53 (30.3) <Half the days Pain intensity in past week (1–10) Mean ± SD 4.8 ± 2.4 4.7 ± 2.5 4.8 ± 2.4 Pain interference in past week (1–5) Mean ± SD 2.6 ± 1.3 2.6 ± 1.3 2.6 ± 1.2 Current pain functioning (1–5) Mean ± SD 2.0 ± 1.0 2.1 ± 1.1 1.9 ± 0.9 Disability or compensation benefits 16 (4.6) 8 (4.6) 8 (4.6) Legal claim related to back 4 (1.1) 2 (1.1) 2 (1.1) Pain spread to leg(s) in past 2 weeks 142 (40.6) 70 (40.0) 72 (41.1) Pain catastrophising 126 (36.0) 61 (34.9) 65 (37.1) Previous acupuncture 153 (43.7) 79 (45.1) 74 (42.3) viewed the enhanced website to have more positive expec- acupuncture or perceptions that acupuncture offered a good tations of benefit from acupuncture and to rate it as more fit for the individual. credible compared to people who viewed the standard web- Willingness to try acupuncture was very high and not site. There were no effects of website on concerns about affected by website: 85.1% of participants who had viewed Acupuncture in Medicine, 37(2) 104 Acupuncture in Medicine Table 2. Proportion of participants displaying different scores within each informed choice category. Informed Knowledge Attitude Intentions Whole sample Standard website Enhanced website choice (n = 307) (n = 149) (n = 158) Frequency % Frequency % Frequency % No Low Positive Negative 23 7.5 12 8.1 11 7.0 No Low Negative Positive 21 6.8 15 10.1 6 3.8 No Low Positive Positive 156 50.8 87 58.4 69 43.7 No Low Negative Negative 25 8.1 17 11.4 8 5.1 No High Positive Negative 12 3.9 3 2.0 9 5.7 No High Negative Positive 3 1.0 0 0.0 3 1.9 Yes High Positive Positive 64 20.8 14 9.4 50 31.6 Yes High Negative Negative 3 1.0 1 0.7 2 1.3 Table 3. Treatment beliefs by group. a 2 Treatment Standard website Enhanced website Comparison Belief M SD n M SD n Concerns 8.2 2.9 157 8.3 3.2 161 F(1, 314) = 0.02, p = 0.898 <0.001 Individual Fit 14.5 4.0 152 14.8 3.9 151 F(1, 299) = 0.48, p = 0.490 0.002 Expectancy 16.1 2.8 154 16.5 2.5 159 F(1, 309) = 2.81, p = 0.095 0.009 Credibility 15.1 3.3 156 15.6 3.1 161 F(1, 313) = 3.35, p = 0.068 0.011 SD: standard deviation. Models adjusted for previous acupuncture use and looking up additional information about acupuncture during breaks from the study. the enhanced website and 82.8% of those who had viewed willingness to try acupuncture. This might be due to ceiling the standard website were willing to try acupuncture effects (on expectancy, credibility and individual fit) and (χ (1) = .34, p = 0.560). floor effects (on concerns). It would be interesting to test the effects of the enhanced website in a sample of participants less inclined to try acupuncture, although the natural audi- Discussion ence for the website in practice will be participants who are We tested the effects of a new educational website about acu- at least willing to consider acupuncture. Perhaps, attempts to puncture on adults with recent back pain, comparing it to a optimise patients’ beliefs about acupuncture would be more standard website based on existing written patient informa- successful if integrated into the first acupuncture consulta- tion. Participants who viewed the enhanced website had tion and delivered by acupuncturists. greater increases in knowledge about acupuncture and were Strengths of this study include the enhanced website, three times more likely to make an informed choice about developed using an approach based on person-based, evi- acupuncture, compared to participants who viewed the dence-based and theory-based intervention design, and standard website. On average, viewing the enhanced website the use of a control website based on existing standard led participants to answer one more knowledge quiz item patient information. Compared to traditional paper-based correctly (out of 10), while the standard website led to no patient information leaflets, creating a website-enabled additional quiz items being answered correctly. These effects provision of more detailed information in an accessible and are likely to be due, at least in part, to the additional informa- engaging manner, for example, using text, audio and film. tion presented in the enhanced website, but might also be due In 2015, 86% of UK households had internet access and partly to the additional formats (e.g. video and audio) that 78% of adults accessed the Internet daily or almost daily, were used in the enhanced website, but not the standard web- making online health information accessible to a large site. There were no effects on treatment beliefs or majority – but not all – of the population. Acupuncture in Medicine, 37(2) Bishop et al. 105 The generalisability of this study is limited by the largely data, which was analysed by M.G.-H. and F.L.B. All authors pro-acupuncture participants drawn primarily from primary contributed to the interpretation of data. F.L.B. drafted the care. We do not know whether our website might improve work and all authors revised it critically for important intel- acupuncture knowledge among people who hold strong neg- lectual content. All authors gave final approval of the ver- ative attitudes towards it. Our participants were also slightly sion to be published and agreed to be accountable for all younger and more educated than a previous primary care aspects of the work in ensuring that questions related to the sample of adults with back pain from the same region. accuracy or integrity of any part of the work are appropri- However, we are reasonably confident that the website is ately investigated and resolved. accessible to adults with less formal education as we attended to accessibility issues during its development. Information Declaration of conflicting interests about regulation and practicalities of accessing acupuncture The authors declared no potential conflicts of interest with respect is UK-specific and will need revising to reflect ongoing to the research, authorship and/or publication of this article. changes in regulation and provision. The design process for the enhanced website was driven by the person-based Funding approach, in conjunction with the evidence- and theory- The authors disclosed receipt of the following financial support based approaches to intervention design. Our website for the research, authorship and/or publication of this article: This might have had larger effects if it had also been designed as work was supported by Arthritis Research UK, Chesterfield, UK, a traditional patient decision aid, as such aids have been grant number 20113. shown to increase knowledge and improve other decision- making outcomes although to date have shown limited Supplemental material effects on clinical outcomes; future research should explore Supplemental material for this article is available online. whether the person-, evidence- and theory-based approach that guided our website design could beneficially be applied References to traditional patient decision aids. The outcome measures 1. Hopton AK, Curnoe S, Kanaan M, et al. Acupuncture in practice: were previously validated and included assessments of mapping the providers, the patients and the settings in a national objective knowledge and informed choice, which are partic- cross-sectional survey. 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Journal

Acupuncture in MedicineSAGE

Published: Mar 21, 2019

Keywords: acupuncture; attitude; back pain; digital intervention; health education; informed consent

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