Arne Johan Norheim

Evaluating Complex Healthcare Systems: A Critique of Four Approaches

The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced); the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.

Acupuncture adverse effects are more than occasional case reports: Results from questionnaires among 1135 randomly selected doctors, and 197 acupuncturists

Summary The aim of the present paper is to describe what kind of adverse effects of acupuncture Norwegian doctors and acupuncturists have encountered, and to indicate how often these adverse effects occur. The questionnaire was sent to an unweighted, stratified, random sample of 1466 working Norwegian doctors under the age of 71. A similar questionnaire was sent to all 311 acupuncturists found in the Yellow Pages of the telephone directory. A total of 1135 (77%) and 197 acupuncturists (68%) responded. The myth of acupuncture as a therapy without adverse effects has not been substantiated. Pneumothorax, the most common serious adverse effect of acupuncture was reported in 33 patients. Local skin infections (n = 66), perichondritis on the auricle (n = 6), arthritis and osteomyelitis (n = 4), are reported from doctors, but not from the acupuncturists. Fainting during treatment is relatively common among acupuncturists (n = 140), while the doctors report more cases of psychiatric problems (n = 20) and increased pain after acupuncture treatment (n = 56). The study indicates that the acupuncture adverse effects rate is at least 0.21 per year of practice as an acupuncturist. This paper presents a broad panorama of adverse effects of acupuncture. The study should imply more focus on who should practise acupuncture, and when to use the method. Despite the reported adverse effects, acupuncture can still be presented as a relatively safe therapeutic measure.

Perioperative acupuncture and postoperative acupressure can prevent postoperative vomiting following paediatric tonsillectomy or adenoidectomy: a pragmatic randomised controlled trial

Objective To investigate the effectiveness of acupuncture and acupressure as supplements to standard treatment for postoperative vomiting in children undergoing tonsillectomy and/or adenoidectomy. Methods A pragmatic, open, block-randomised controlled trial. The results were analysed according to the intention-to-treat principle. The study was conducted without extra resources in a normal setting at the day-surgery department of Lovisenberg Diakonale Hospital in Oslo. 154 children with an American Society of Anesthesiologists grade 1–2, weighing at least 10 kg, were included. Children with concomitant gastrointestinal diseases, emesis or antiemetic treatment <24 h preoperatively, rash or local infection over the actual acupuncture points were excluded together with patients whose parents’ informed consent could not be obtained. The intervention group received acupuncture at pericardium 6 bilaterally, at a depth of approximately 0.7 cm with a median of 21 min during anaesthesia, followed by acupressure wristbands for 24 h and standard treatment. The control group received standard treatment. The primary end point was the occurrence of vomiting or retching during 24 h postoperatively. Results Children in the acustimulation group experienced less retching and vomiting than the control group—46.8% versus 66.2% (p=0.015). The effect of acustimulation was specifically pronounced in girls and children aged 1–3 years. Conclusion This trial indicates the effectiveness of acustimulation as an adjunct to standard treatment. The results should encourage and promote the implementation of acustimulation for postoperative vomiting in children undergoing adenoidectomy or tonsillectomy.

Acupressure treatment of morning sickness in pregnancy. A randomised, double-blind, placebo-controlled study

Objective - To find out whether acupressure wristband can alleviate nausea and vomiting in early pregnancy. Design - Double-blind, placebo-controlled study. Subjects - 97 women with mean gestational length completed 8-12 weeks. Main outcome measures - Symptoms were recorded according to intensity, duration and nature of complaints. Results - 71% of women in the intervention group reported both less intensive morning sickness and reduced duration of symptoms. The same tendency was seen in the placebo group, with 59% reporting less intensity and 63% shorter duration of symptoms. However, a significance level of 5% was reached only in the case of duration of symptoms, which was reduced by 2.74 hours in the intervention group compared to 0.85 hours in the placebo group (p = 0.018). Conclusions ? Acupressure wristband might be an alternative therapy for morning sickness in early pregnancy, especially before pharmaceutical treatment is considered.OBJECTIVE To find out whether acupressure wristband can alleviate nausea and vomiting in early pregnancy. DESIGN Double-blind, placebo-controlled study. SUBJECTS 97 women with mean gestational length completed 8-12 weeks. MAIN OUTCOME MEASURES Symptoms were recorded according to intensity, duration and nature of complaints. RESULTS 71% of women in the intervention group reported both less intensive morning sickness and reduced duration of symptoms. The same tendency was seen in the placebo group, with 59% reporting less intensity and 63% shorter duration of symptoms. However, a significance level of 5% was reached only in the case of duration of symptoms, which was reduced by 2.74 hours in the intervention group compared to 0.85 hours in the placebo group (p = 0.018). CONCLUSIONS Acupressure wristband might be an alternative therapy for morning sickness in early pregnancy, especially before pharmaceutical treatment is considered.

Any difference? Use of a CAM provider among cancer patients, coronary heart disease (CHD) patients and individuals with no cancer/CHD

BackgroundAlthough use of complementary and alternative medicine (CAM) among cancer patients has been described previously, prevalence of use has not commonly been compared to other disease groups in a true population sample where CAM use or cancer is not the main focus. The aims of the present study are to (1) examine how CAM use in cancer patients differs from people with a previous CHD diagnosis and people with no cancer or CHD diagnosis in an unselected general population and (2), investigate the use of a CAM provider among individuals with a previous cancer diagnosis.MethodsA total of 8040 men and women aged 29 to 87 in the city of Tromsø, Norway filled in a questionnaire developed specifically for the Tromsø V study with questions on life style and health issues. Visits to a CAM provider within the last 12 months and information on cancer, heart attack and angina pectoris (heart cramp) were among the questions. 1449 respondents were excluded from the analyses.ResultsAmong the 6591 analysed respondents 331 had a prior cancer diagnosis, of whom 7.9% reported to have seen a CAM provider within the last 12 months. This did not differ significantly from neither the CHD group (6.4%, p = 0.402) nor the no cancer/CHD group (9.5%, p = 0.325).ConclusionAccording to this study, the proportion of cancer patients seeing a CAM provider was not statistically significantly different from patients with CHD or individuals without cancer or CHD.

Do Cancer Patients with a Poor Prognosis Use Complementary and Alternative Medicine More Often than Others

INTRODUCTION One reason for patients with cancer to use complementary and alternative medicine (CAM) is that their cancer cannot be cured by conventional therapy. The aim of the present study is to explore whether use of CAM is associated with survival prognosis in long-term survivors of cancer. MATERIALS AND METHODS Cancer patients who were alive 5 years or more after diagnosis were chosen to participate in the study, one group with less than 20% and another group with 40%-60% expected five-year survival at the time of diagnosis. A total of 735 patients received a four-page postal questionnaire about CAM use; 397 questionnaires were returned (response rate = 54%). RESULTS The results are reported at five levels of CAM use. The poor prognosis group reported CAM use more often than the better prognosis group; however, only significantly higher at CAM level 2 (use of a CAM provider) (p = 0.021) and in use of self-support/CAM techniques (p < 0.001). Use of over-the-counter (OTC) dietary supplements and use of diet as treatment were not significantly different between the groups. DISCUSSION This study supports the suggestion that use of a CAM therapist and use of self-support/CAM techniques might be associated with less hope of cure given by the physician.

Doctors' attitudes to acupuncture -- a Norwegian study

1466 Norwegian working doctors under 71 y of age were surveyed in February 1994 on their attitudes to acupuncture and experience as acupuncture patients. 1135 doctors responded (response rate: 77%). More than 8% had undergone acupuncture treatment and 38% of these reported benefit from the treatment. Over 53% would realistically consider acupuncture if they got problems or diseases where acupuncture treatment could be an alternative. More than 38% recommend acupuncture treatment to their migraine patients. More than four out of five doctors would not try to interfere with a patients wish to try acupuncture treatment for cancer. 81% said that acupuncture is, or should be integrated in the national health care system. More general practitioners held this view than other doctors (p < 0.001). Positive attitudes were strongest among doctors who either had already undergone acupuncture treatment or intended to do so. If this development continues, acupuncture could be an integrated part of the national Norwegian health care system in the near future.

Complementary and Alternative Medicine Use among Norwegian Cancer Survivors: Gender-Specific Prevalence and Associations for Use

The associations for CAM use are only occasionally differentiated by gender in populations where both male and female cancer survivors occur. The aim of this study is to describe the prevalence of CAM use in individuals with a previous cancer diagnosis and to investigate gender differences regard to factors associated with use. A total of 12982 men and women filled in a questionnaire with questions about life style and health issues. Eight hundred of those had a previous cancer diagnosis of whom 630 answered three questions concerning CAM use in the last 12 months. A total of 33.8% of all cancer survivors reported CAM use, 39.4% of the women and 27.9% of the men (P < 0.01). The relationship between the demographic variables and being a CAM user differed significantly between men and women with regard to age (P = 0.03), education (P = 0.04), and income (P < 0.01). Female CAM users were more likely to have a university degree than the nonusers, while male CAM users were more likely to have a lower income than the nonusers. According to this study, prevalence and factors associated with CAM use differ significantly between male and female survivors of cancer.

Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicenter, double-blinded, randomized trial

Objectives To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. Methods A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012–2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1–11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5–45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. Results This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. Conclusions The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. Trial Registration Number ClinicalTrials.gov NCT01729052.

Implementation of acupuncture and acupressure under surgical procedures in children: a pilot study

Objective To test the feasibility of research on acupuncture and acupressure for children undergoing tonsillectomy and/or adenoidectomy. Methods During January and February 2008, 20 patients from the ordinary waiting list at Lovisenberg Diakonale Hospital in Oslo were randomised to either acupuncture while under anaesthesia or standard care as control. The authors gave acupuncture at Pericardium 6 (P6) at a depth of approximately 0.7 cm on both forearms. The needles were removed when the patient was transferred to the recovery unit and replaced with acupressure wristbands. The outcome measure in the pilot study was to explore if acupuncture and acupressure could be implemented without extending the anaesthesia time and surgical time. This pilot study also tested the feasibility of the research protocol for future investigation in the field, with postoperative nausea, vomiting and retching as the primary end points for effect. Results The study showed no delay in the surgical procedure and no additional anaesthesia time attributable to the introduction of acupuncture. The protocol was found to be feasible with regard to performance of the main study. Vomiting occurred in five patients in the treatment group and 10 patients in the control group. The total numbers of vomiting events were 13 in the treatment group and 19 in the control group. Conclusion The results encouraged performance of the main study according to the research protocol.