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CROaM methods & findings

Method

A mixed methods approach was used. A survey to all UK practising osteopaths was carried out, followed by in-depth interviews of selected osteopaths. Osteopaths also invited patients to provide information about their experience of osteopathic care and its outcomes. Patients were surveyed before treatment, one day and two days after treatment and at six weeks. Selected patients were interviewed. The design employed does not allow conclusions to be made about causal relationships between osteopathic treatment, positive patient outcomes and adverse events.

Findings

1,082 (27.8%) osteopaths completed the practitioner survey. Interviews took place with 24 osteopaths. 2,039 patients, recruited from 212 osteopaths, returned usable baseline questionnaires. Out of 1,782 patients who supplied their contact details, 1,387 (77%) patients returned six week follow up questionnaires. Interviews took place with 19 patients.

  • The majority of osteopathic patients are seen in private dedicated clinical settings. On average osteopaths see 33 patients a week. Patients have mostly back, neck and shoulder problems, with variable duration from acute to chronic.
  • The most commonly used techniques are soft tissue and joint articulation. Near to 43% of patients received HVT, most commonly to the thoracic spine (32%) and lumbar spine (18%) and less frequently to the neck (13%). Visceral techniques are not commonly used. Adjunctive techniques are used by nearly 50% of osteopaths, but only on a small proportion of patients.
  • Fifty per cent of osteopaths describe their main practice setting as being where they are not able to discuss patients with other professionals.
  • On average patients' health status is good, although complaints of pain are common. Just over half of patients report common co morbidities. The majority of which are musculoskeletal.
  • Medication usage is high and analgesic medication usage was reported by over 70% of patients at baseline.
  • Osteopaths express uncertainty about predicting the likely occurrence of adverse events related to HVT, although they are more confident about predicting the benefits. All the major risk factors associated with vertebro basilar stroke were rated as important by osteopaths in the context of treating neck pain.
  • Osteopaths report high levels of receiving consent for new patients and the introduction of new techniques. However, receiving consent from returning patients and for repeated techniques is low in over a third of osteopaths. Osteopaths expressed concern over discussions involving adverse events particularly with new patients regarding treating the cervical spine. There were also differences between the reported frequency that osteopaths described gaining consent with the patients reported experience of being asked permission/consent for examinations and treatments.
  • Patients reported lower levels of consent than did osteopaths. Overall, a small proportion of patients reported that they had received information about risks (36%) and alternative or no treatment options from their osteopaths (38%). The Code of Practice concerning consent for all patients throughout the process of care is at odds with some current practice and to some extent with what patients expect. For patients, consent was perceived to be mediated by the experience of care and their choice to attend treatment. Patients tended to understand risk as a lack of benefit rather than in terms of hazards and harms.
  • Improvement of pain/symptoms was reported by the majority of patients, with around half of patients achieving at least a 30% decrease in pain/symptoms by day two post treatment. Those with widespread troublesome pain/symptoms were least likely to improve. New patients and those returning with a new episode of pain/symptoms improved most. Patients rated their global improvement and satisfaction highly.
  • Immediate increase in pain/symptom intensity was the most frequent reaction post treatment and occurred in around 20% of patients. These treatment reactions were perceived by patients at interview as acceptable and appeared to be well managed. Osteopaths and patients perceived forewarning of likely increases in pain as helpful in their management.
  • To reduce the possible bias due to osteopaths selecting patients known to have good outcomes we carried out a sensitivity analysis on new patients versus returning patients. Only 6 out of 19 comparisons showed significant differences between the two groups. These differences were small in magnitude and involved small numbers of patients and conclude that the threat of bias is small.
  • Comparisons between those that received HVT and those that did not showed that for most outcomes there was no link between HVT and outcome.
  • Four per cent of patients reported temporary incapacity or disability that they attributed to their osteopathic treatment. But only 2 of 10 of these patients described experiences characteristic of a major adverse event at interview. There were no reports of life-threatening events, referral to hospital or other permanent disability in our patient sample.
  • Around 12% of osteopaths reported patients experiencing a major adverse event over the span of their career. Four per cent of osteopaths reported such events within the past twelve months. The most conservative estimate of the rate of major adverse events derived from this data was 1 in 36,000. However the margins of error around this estimate are unknown. It may be more useful to consider the evidence from this study as suggesting that major events are rare, but do occur and that osteopathy can be considered a low risk intervention.
  • The majority of osteopaths favoured the establishment of an adverse events register.