The relation between measures of health status and quality of life in COPD.

Because quality of life (QoL) and health status (HS) scales contain different kinds of items and are shown not to be equivalent, there is a recommendation to use both types of scales. We investigated the relationship between either type of scale but focusing on the subscales of HS measures. A sample of chronic obstructive pulmonary disease (COPD) patients completed two QoL scales and two HS scales (BPQ and SGRQ), neuroticism, six-minute walk test and FEV1. Factor analysis revealed a two-factor structure (consistent with previous research), and showed that one type of HS subscale is different from QoL but another is equivalent to QoL. If total HS scores are used then it is valuable to include a QoL measure, but if HS subscales are reported, then these cover both latent variables, with the BPQ providing a clearer separation of the latent variables than the SGRQ.

The Lung Information Needs Questionnaire: Development, preliminary validation and findings.

STUDY OBJECTIVES: Many chronic obstructive pulmonary disease (COPD) patients are dissatisfied with the information they are given. A brief questionnaire completed prior to the clinical encounter would assist health professionals identify areas of information need. DESIGN: Ten focus groups of 59 patients assisted in the process of questionnaire construction. Three hundred and four patients (return rate 63%) responded to a postal questionnaire. RESULTS: Twenty-one per cent did not know the name of their disease, 3% reported medication non-compliance and 8% were confused with medicines. Fifty-five per cent of patients were exercising inappropriately, 8% did not know what to do when breathing worsened and 36% did not know when to call an ambulance. All six of the Lung Information Needs Questionnaire domains discriminated significantly as a function of health professional contact. Retest reliability for the six domains varied between .66 and .98, and for the total score was .89. alpha was .62. CONCLUSIONS: Patients can act as experts during the process of questionnaire construction. Information needs vary between patients but tend to be high for non-drug related aspects of self-management COPD. This questionnaire can be used to guide the clinical encounter.

Physical and emotional aspects of self-reported health status: a two-factor model of the short-form Breathing Problems Questionnaire.

The short version of the Breathing Problems Questionnaire (BPQ) is used as an outcome tool in pulmonary assessment. The aim of the study was to establish the validity of scoring BPQ with two subscales, reflecting emotional and physical components of health-related quality of life (HRQoL). Two subscales were suggested by exploratory factor analysis conducted on a data set of 97 patients with chronic obstructive pulmonary disease (COPD). Both subscales were significantly associated with the 6 minute walk test, total quality of life, and emotional stability. Only the physical subscale was significantly associated with FEV1, and only the emotional subscale was significantly associated with happiness. Overall, the sizes of the different correlations are consistent with the conceptual differentiation of the two subscales. We suggest that evaluation of rehabilitation can be made with the two subscales as well as an overall score of the BPQ.

Entanglement and some heretical thoughts about homeopathy.

This paper proposes the emergent entanglement theory of homeopathy. This is based on the lack of evidence that choice of homeopathic medicine is important and predicts links between effectiveness of homeopathic medicines and their manufacturers. It predicts that there will be a consistent variation, in terms of outcome, between homeopaths, and between medicines made by different manufacturers, but not the specific homeopathic medicines prescribed. This theory is potentially testable.

Positivity in illness: self-delusion or existential growth?

OBJECTIVES: This study investigated the relationship between a measure of positivity in illness, the Silver Lining Questionnaire (SLQ), and measures of personality and spirituality/religious beliefs as a way of determining whether positivity in illness is a delusion or existential growth. METHOD: This is a cross-sectional study comparing response to the SLQ, to the Eysenck Personality Questionnaire (EPQ-R), breathlessness, illness type, and spiritual and religious beliefs in a final total sample of 194 respiratory outpatients. RESULTS: The SLQ was associated positively with extraversion (r =.16, p<.05), unrelated to neuroticism (r =.11, n.s.) and repression (r =.10, n.s.) and was positively associated with spiritual and religious beliefs, F(2; 187) = 7.12, p < 001, as predicted by the existential growth but not the delusion interpretation. There was no relationship between positivity and age, r(194) =.09, n.s., or between positivity and gender t(192) = -1.27, n.s., and nor were there relationships with type of illness, F(4, 188) = 2.17, n.s., or breathlessness, F (5, 173) = 0.42, n.s. CONCLUSIONS: The results suggest that positivity in illness is associated with existential growth, though the cross-sectional nature of the study precludes a conclusion of causal direction. The non-significant correlation between the SLQ and neuroticism is in the opposite direction predicted by the delusion explanation, but the non-significant relationship between the SLQ and repression is in the predicted direction. We cannot rule out the possibility that some positivity is delusion.

Methodology for the scientific evaluation of complementary and alternative medicine.

It has been suggested that CAM research should establish efficacy before examining mechanism. This paper shows that the efficacy-mechanism distinction is a false one, as any test of efficacy assumes a particular mechanism and is a test of the theory underlying that mechanism. The term RCT is currently used in medicine for two different sorts of study. The randomised controlled trial (RConT) requires an experimental manipulation that can 'control' for the mechanism under consideration, and therefore tests the efficacy of that mechanism. The randomised comparison trial (RComT) requires only an experimental manipulation creating a therapeutically relevant comparison, and tests the effectiveness of that therapy. The ability to achieve control coupled with an assumed implausibility of hidden moderating variables characterises drug therapy and some CAM therapies where the RConT can be used. However, other CAM researchers assume a variety of holistic mechanisms, where control is necessarily poor and the hypothesis of complex interactions suggest the existence of multiple moderators. In these cases other experimental (e.g. RComT), quasi-experimental or non-experimental designs are needed to evaluate therapeutic practice. Researchers from both communities should make explicit their underlying assumptions and the mechanisms they seek to evaluate when carrying out empirical studies. Research design needs to be appropriate for the mechanism under test.

A brief guide to extended network entanglement theory as a theory of healing and its empirical predictions.

Extended network entanglement theory (ENET) derives from a combination of two theoretical ideas: complexity theory and weak quantum theory. The theory suggests that generalized entanglement evolved initially as a form of communication within the body needed to enable the body to self-organize according to genetically specified patterns, and then as a form of communication between organisms which form social groups. This latter form of communication is at the heart of healing mechanisms. This paper sets out the theory in the form of 16 propositions and then describes 11 research ideas. ENET theory suggests that researchers should focus more on the patient-therapist dyad rather than the technical aspects of the therapy.

Developing a measure of attitudes: the holistic complementary and alternative medicine questionnaire.

We have developed an 11-item scale, the Holistic Complementary and Alternative Medicine Questionnaire (HCAMQ). Six of the HCAMQ items relate to beliefs about the scientific validity of complementary and alternative medicine (CAM), and five to beliefs about holistic health (HH). The HCAMQ was completed by 50 patients attending a CAM clinic and 50 attending rheumatology outpatients; the former completed it twice. Factor analysis (oblique rotation) showed that the CAM and HH items measured distinct but related constructs. The HCAMQ has good test retest reliability (r=0.86, 0.82 and 0.77 for the total, CAM subscale and HH subscale, respectively). The individuals attending CAM clinics were significantly more positive on the CAM but not the HH subscale of the HCAMQ and also used less antibiotics than those attending rheumatology outpatients. Positivity towards CAM on the total HCAMQ and subscales was significantly associated with lower age, increased vitamin use, reduced painkiller use, and, other than on the HH subscale, less antibiotic use. The reason why the HH subscale failed to distinguish between the two patient groups or predict less antibiotic use is unknown. The HCAMQ appears to have good internal validity, but its external validity remains to be established.

Oscillatory effects in a homeopathic clinical trial: an explanation using complexity theory, and implications for clinical practice.

Four double-blind, randomised, placebo-controlled clinical trials of asthma or rhinitis treated with homeopathic immunotherapy (HIT) at a 30C potency have been published. The most recent study, involving house dust mite allergic asthmatics, failed to confirm a therapeutic improvement at the end of the study, but did provide preliminary evidence for an oscillation in outcome (both physiological and subjective) in with verum treatment to placebo. In this paper we show how such an oscillation is consistent with a complexity theory interpretation of how the body functions as a whole, and speculate on why different studies have produced different results. If the complexity theory interpretation is correct, then this will have a significant impact on the design of clinical trials in homeopathy and, possibly, other complementary medical interventions.

Oscillatory effects in a homeopathic clinical trials: an explanation using complexity theory, and implications for clinical practice

Four double-blind, randomised, placebo-controlled clinical trials of asthma or rhinitis treated with homeopathic immunotherapy (HIP) at a 30C potency have been published. The most recent study, involving... (AU)

Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial.

OBJECTIVE: To evaluate the efficacy of homoeopathic immunotherapy on lung function and respiratory symptoms in asthmatic people allergic to house dust mite. DESIGN: Double blind randomised controlled trial. SETTING: 38 general practices in Hampshire and Dorset. PARTICIPANTS: 242 people with asthma and positive results to skin prick test for house dust mite; 202 completed clinic based assessments, and 186 completed diary based assessments. INTERVENTION: After a four week baseline assessment, participants were randomised to receive oral homoeopathic immunotherapy or placebo and then assessed over 16 weeks with three clinic visits and diary assessments every other week. OUTCOME MEASURE: Clinic based assessments: forced expiratory volume in one second (FEV(1)), quality of life, and mood. DIARY BASED ASSESSMENTS: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life, and daily mood. RESULTS: There was no difference in most outcomes between placebo and homoeopathic immunotherapy. There was a different pattern of change over the trial for three of the diary assessments: morning peak expiratory flow (P=0.025), visual analogue scale (P=0.017), and mood (P=0.035). At week three there was significant deterioration for visual analogue scale (P=0.047) and mood (P=0.013) in the homoeopathic immunotherapy group compared with the placebo group. Any improvement in participants' asthma was independent of belief in complementary medicine. CONCLUSION: Homoeopathic immunotherapy is not effective in the treatment of patients with asthma. The different patterns of change between homoeopathic immunotherapy and placebo over the course of the study are unexplained.

A comparison of three disease-specific and two generic health-status measures to evaluate the outcome of pulmonary rehabilitation in COPD.

The use of health status as an outcome measure is becoming more widespread in pulmonary rehabilitation. There are a number of health status measures but the choice remains uncertain. Three disease specific measures and two generic measures of health status were employed to observe their relative sensitivity to a 7-week course of pulmonary rehabilitation. Patients with stable chronic obstructive pulmonary disease (COPD) were recruited into a rehabilitation programme. They completed a shuttle-walking test and three disease-specific questionnaires: the Chronic Respiratory Questionnaire (CRQ), the St. George's Hospital Respiratory Questionnaire (SGRQ) and the Breathing Problems Questionnaire (BPQ). Patients also completed two generic questionnaires: a global quality-of-life scale and an activity checklist. Ninety-seven patients [58 male mean (SD) age 67 (8.7) years] completed the course over a 12-month period. The mean pre-rehabilitation (SD) FEV1 was 1.06 (0.59) l. The shuttle-walking test and the treadmill-endurance test increased significantly after rehabilitation (P<0.001). All three disease-specific questionnaires improved significantly (the CRQ and SGRQ improved beyond minimum clinically important difference). The global score improved significantly whilst the 'things people do' decreased. All three disease-specific measures were responsive to pulmonary rehabilitation. However the operator-led CRQ appears to be the most sensitive short-term outcome measure.

Lichtenstein patch or Perfix plug-and-patch in inguinal hernia: a prospective double-blind randomized controlled trial of short-term outcome.

BACKGROUND: Open mesh used in anterior inguinal hernia repair can be configured as a flat patch (Lichtenstein operation) or as a cone-shaped preformed plug and supplementary patch (plug-and-patch operation; Perfix Plug; Davol Inc, Cranston, RI). METHODS: One hundred forty-one patients were randomly allocated and blinded to receive either a Lichtenstein patch or a Perfix plug-and-patch. Information before the operation and on postoperative days 3 and 14 was recorded by an independent blinded observer to include operating time, postoperative pain, analgesic medication, return to activity and work, and quality of life assessment. RESULTS: Operating time (32 vs 37.6 minutes) was significantly shorter in the plug-and-patch group (P = .01). During days 1 through 8, patients who had undergone the plug-and-patch operation experienced less pain, and their physical functioning on day 3 was significantly better (P = .013). Days of analgesic medication (4.0 vs 4.6 days), return to normal activity (2.8 vs 3.6 days), return to work (17.0 vs 20.8 days), and total days of work missed (14.3 vs 16.1 days) were similar in both groups (P = NS for all comparisons). CONCLUSIONS: Compared with patients who received the Lichtenstein patch for ambulatory inguinal hernia repair, patients who underwent the Perfix plug-and-patch operation experienced less postoperative pain in the first 8 days after the operation but consumed similar postoperative analgesic medication. The rate of return to normal activity and work is similar in both groups, which indicates no superiority for the plug-and-patch operation in overall rehabilitation and societal costs. Overall hospital costs are greater for the plug-and-patch operation ($120 [US]) compared with the Lichtenstein patch ($20 [US]), with a negligible (5.6 minutes) saving of operating room time for the plug-and-patch operation.

Rationale for once-daily therapy in asthma: compliance issues.

Compliance in asthma is known to be poor. Once-daily treatment provides an additional therapeutic option for the clinician whose treatment aims include maximising treatment satisfaction and compliance. Once-daily treatment is preferred by some but not all patients and may lead to greater compliance in patients who are concerned about the effect of corticosteroids on their health. When switching to once-daily treatment, patients should be given a choice as to the time of treatment to minimise the impact of forgetting a dose.

Development of a shortened version of the Breathing Problems Questionnaire suitable for use in a pulmonary rehabilitation clinic: a purpose-specific, disease-specific questionnaire.

One hundred and thirty-eight chronic obstructive pulmonary disease (COPD) patients completed the Breathing Problems Questionnaire (BPQ) before and after a comprehensive programme of rehabilitation. Examination of the changes on individual items showed improvement on 22 items, of which four items were significant at p < 0.05 and deterioration on nine items, of which two were significant at p < 0.01. All deteriorating items were consistent with lifestyle adaptations encouraged as part of the rehabilitation programme. We examined the psychometric properties of a reduced ten item version of the BPQ limited to the items most sensitive to change. We recommend the purpose-specific, disease-specific COPD scale for measuring change in pulmonary rehabilitation assessment in contrast to the longer 33 item questionnaire, which, however, may be more useful for cross-sectional assessment.