Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study.

BACKGROUND: The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts. OBJECTIVE: The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC95) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser. METHODS: We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC95. RESULTS: We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (-1 to 5), 13 (9 to 17) and 7 (-12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as "stable" and "about the same" using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC95 of 4 and 5, 0.31 (95% CI -0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC95 of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC95 of 4 and 3 for the eNRS. CONCLUSIONS: The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures' metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

Patients' expectations of osteopathic care: a qualitative study.

BACKGROUND: Research has shown that patients' expectations of health care and health-care practitioners are complex and may have a significant impact on outcomes of care. Little is known about the expectations of osteopathic patients. OBJECTIVES: To explore osteopathic patients' expectations of private sector care. DESIGN: Focus groups and individual interviews with purposively selected patients; this was the qualitative phase of a mixed methods study, the final phase being a patient survey. SETTING AND PARTICIPANTS: A total of 34 adult patients currently attending for treatment at private osteopathic practices across the United Kingdom. INTERVENTION: Focus group discussions and individual interviews around expectations before, during and after osteopathic care. OUTCOME MEASURES: Thematic analysis of text data to identify topics raised by patients and to group these into broad themes. RESULTS: Many components of expectation were identified. A preliminary conceptual framework describing the way the therapeutic encounter is approached in osteopathy comprised five themes: individual agency, professional expertise, customer experience, therapeutic process and interpersonal relationship. DISCUSSION AND CONCLUSION: The components of expectation identified in this phase of the study provided potential question topics for the survey questionnaire in the subsequent phase of the investigation. The model developed in this study may add a new perspective to existing evidence on expectations. Further research is recommended to test the findings both within private practice and the National Health Service.

Patients' expectations of private osteopathic care in the UK: a national survey of patients.

BACKGROUND: Patients' expectations of osteopathic care have been little researched. The aim of this study was to quantify the most important expectations of patients in private UK osteopathic practices, and the extent to which those expectations were met or unmet. METHODS: The study involved development and application of a questionnaire about patients' expectations of osteopathic care. The questionnaire drew on an extensive review of the literature and the findings of a prior qualitative study involving focus groups exploring the expectations of osteopathic patients. A questionnaire survey of osteopathic patients in the UK was then conducted. Patients were recruited from a random sample of 800 registered osteopaths in private practice across the UK. Patients were asked to complete the questionnaire which asked about 51 aspects of expectation, and post it to the researchers for analysis.The main outcome measures were the patients-perceived level of expectation as assessed by the percentage of positive responses for each aspect of expectation, and unmet expectation as computed from the proportion responding that their expectation "did not happen". RESULTS: 1649 sets of patient data were included in the analysis. Thirty five (69%) of the 51 aspects of expectation were prevalent, with listening, respect and information-giving ranking highest. Only 11 expectations were unmet, the most often unmet were to be made aware that there was a complaints procedure, to find it difficult to pay for osteopathic treatment, and perceiving a lack of communication between the osteopath and their GP. CONCLUSIONS: The findings reflected the complexity of providing osteopathic care and meeting patients' expectations. The results provided a generally positive message about private osteopathic practice. The study identified certain gaps between expectations and delivery of care, which can be used to improve the quality of care. The questionnaire is a resource for future research.

Osteopathic practice in the United Kingdom: A retrospective analysis of practice data.

BACKGROUND: This study describes osteopathic practise activity, scope of practice and the osteopathic patient profile in order to understand the role osteopathy plays within the United Kingdom's (UK) health system a decade after our previous survey. METHOD: We used a retrospective questionnaire survey design to ask about osteopathic practice and audit patient case notes. All UK registered osteopaths were invited to participate in the survey. The survey was conducted using a web-based system. Each participating osteopath was asked about themselves, their practice and asked to randomly select and extract data from up to 8 random new patient health records during 2018. All patient related data were anonymised. RESULTS: The survey response rate was 500 osteopaths (9.4% of the profession) who provided information about 395 patients and 2,215 consultations. Most osteopaths were self-employed (81.1%; 344/424 responses) working alone either exclusively or often (63.9%; 237/371) and were able to offer 48.6% of patients an appointment within 3 days (184/379). Patient ages ranged from 1 month to 96 years (mean 44.7 years, Std Dev. 21.5), of these 58.4% (227/389) were female. Infants <1 years old represented 4.8% (18/379) of patients. The majority of patients presented with musculoskeletal complaints (81.0%; 306/378). Persistent complaints (present for more than 12 weeks before appointment) were the most common (67.9%; 256/377) and 41.7% (156/374) of patients had co-existing medical conditions. The most common treatment approaches used at the first appointment were soft-tissue techniques (73.9%; 292/395), articulatory techniques (69.4%; 274/395) and high velocity low amplitude thrust (34.4%; 136/395). The mean number of treatments per patient was 7 (mode 4). CONCLUSION: Osteopaths predominantly provide care of musculoskeletal conditions, typically in private practice. To better understand the role of osteopathy in UK health service delivery, the profession needs to do more research with patients in order to understand their needs and their expected outcomes of care, and for this to inform osteopathic practice and education.

Patient reported outcomes in a large cohort of patients receiving osteopathic care in the United Kingdom.

OBJECTIVE: The use of Patient Reported Outcome Measures (PROMs) to evaluate care is being advocated increasingly in clinical settings. Electronic data capture is both resource and environmentally friendly and convenient. This purpose of this study was to test and implement a nationwide system to collect routine PROM data from osteopathic patients using a web and mobile app. METHODS: A prospective study design was used to monitor outcomes of care for patients attending osteopathic clinics. Demographic and service data were collected, the primary outcomes were the Bournemouth Questionnaire and a Global Rating of Change score. Data concerning patients' satisfaction and experience of care were collected also. Data were collected at baseline, one week, and six weeks post-treatment. RESULTS: A total of 1721 patients completed the PROM app questionnaire. The majority (65.8%) of patients who used the PROM app were between 40 and 69 years old with 11% being 70 years and over. At baseline 39.8% of patients reported they'd had their symptoms for 13 weeks or more. Low back pain was the most common symptom (55.8%). Patients reported high scores for both satisfaction and experience of osteopathic care: 88.1% were very satisfied at six weeks post-baseline and 93.5% reported very good experience at six weeks post-baseline. Data from the Global Rating of Change scale indicated that at one week post-baseline 89.1% of patients reported some measure of improvement, and at six weeks this figure rose to 92.8%. The mean sum score for the Bournemouth Questionnaire went from 30.8 at baseline to 13.3 at six weeks post-baseline. This represented a significant and clinically meaningful positive change score of 56.8%. CONCLUSION: The app was well-completed and the data very encouraging. These data will help to form the basis for standards of care for patients attending osteopathic practices.

Direct and mediated effects of treatment context on low back pain outcome: a prospective cohort study.

OBJECTIVES: Contextual components of treatment previously associated with patient outcomes include the environment, therapeutic relationship and expectancies. Questions remain about which components are most important, how they influence outcomes and comparative effects across treatment approaches. We aimed to identify significant and strong contextual predictors of patient outcomes, test for psychological mediators and compare effects across three treatment approaches. DESIGN: Prospective cohort study with patient-reported and practitioner-reported questionnaire data (online or paper) collected at first consultation, 2 weeks and 3 months. SETTING: Physiotherapy, osteopathy and acupuncture clinics throughout the UK. PARTICIPANTS: 166 practitioners (65 physiotherapists, 46 osteopaths, 55 acupuncturists) were recruited via their professional organisations. Practitioners recruited 960 adult patients seeking treatment for low back pain (LBP). PRIMARY AND SECONDARY OUTCOMES: The primary outcome was back-related disability. Secondary outcomes were pain and well-being. Contextual components measured were: therapeutic alliance; patient satisfaction with appointment systems, access, facilities; patients' treatment beliefs including outcome expectancies; practitioners' attitudes to LBP and practitioners' patient-specific outcome expectancies. The hypothesised mediators measured were: patient self-efficacy for pain management; patient perceptions of LBP and psychosocial distress. RESULTS: After controlling for baseline and potential confounders, statistically significant predictors of reduced back-related disability were: all three dimensions of stronger therapeutic alliance (goal, task and bond); higher patient satisfaction with appointment systems; reduced patient-perceived treatment credibility and increased practitioner-rated outcome expectancies. Therapeutic alliance over task (ηp2=0.10, 95% CI 0.07 to 0.14) and practitioner-rated outcome expectancies (ηp2=0.08, 95% CI 0.05 to 0.11) demonstrated the largest effect sizes. Patients' self-efficacy, LBP perceptions and psychosocial distress partially mediated these relationships. There were no interactions with treatment approach. CONCLUSIONS: Enhancing contextual components in musculoskeletal healthcare could improve patient outcomes. Interventions should focus on helping practitioners and patients forge effective therapeutic alliances with strong affective bonds and agreement on treatment goals and how to achieve them.

Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study.

INTRODUCTION: Components other than the active ingredients of treatment can have substantial effects on pain and disability. Such 'non-specific' components include: the therapeutic relationship, the healthcare environment, incidental treatment characteristics, patients' beliefs and practitioners' beliefs. This study aims to: identify the most powerful non-specific treatment components for low back pain (LBP), compare their effects on patient outcomes across orthodox (physiotherapy) and complementary (osteopathy, acupuncture) therapies, test which theoretically derived mechanistic pathways explain the effects of non-specific components and identify similarities and differences between the therapies on patient-practitioner interactions. METHODS AND ANALYSIS: This research comprises a prospective questionnaire-based cohort study with a nested mixed-methods study. A minimum of 144 practitioners will be recruited from public and private sector settings (48 physiotherapists, 48 osteopaths and 48 acupuncturists). Practitioners are asked to recruit 10-30 patients each, by handing out invitation packs to adult patients presenting with a new episode of LBP. The planned multilevel analysis requires a final sample size of 690 patients to detect correlations between predictors, hypothesised mediators and the primary outcome (self-reported back-related disability on the Roland-Morris Disability Questionnaire). Practitioners and patients complete questionnaires measuring non-specific treatment components, mediators and outcomes at: baseline (time 1: after the first consultation for a new episode of LBP), during treatment (time 2: 2 weeks post-baseline) and short-term outcome (time 3: 3 months post-baseline). A randomly selected subsample of participants in the questionnaire study will be invited to take part in a nested mixed-methods study of patient-practitioner interactions. In the nested study, 63 consultations (21/therapy) will be audio-recorded and analysed quantitatively and qualitatively, to identify communication practices associated with patient outcomes. ETHICS AND DISSEMINATION: The protocol is approved by the host institution's ethics committee and the NHS Health Research Authority Research Ethics Committee. Results will be disseminated via peer-reviewed journal articles, conferences and a stakeholder workshop.