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Biomedical subjects

Andrew J Vickers

Publications and source records attributed to Andrew J Vickers.

14 recordsLinked to original sources
PubMed2004

Acupuncture for postchemotherapy fatigue: a phase II study.

PURPOSE: To determine whether improvement in postchemotherapy fatigue following acupuncture treatment is substantial enough to warrant a controlled trial. PATIENTS AND METHODS: We accrued patients at Memorial Sloan-Kettering Cancer Center who had completed cytotoxic chemotherapy but experienced persisting fatigue. Patients with severe anemia, clinical depression, or Karnofsky performance status score less than 70 were excluded. Thirty-seven patients were registered in two cohorts; 31 provided follow-up data. Patients received acupuncture either twice per week for 4 weeks (25 patients) or once per week for 6 weeks (12 patients). The primary end point was change in score on the Brief Fatigue Inventory between baseline and 2 weeks after the final treatment. A baseline Brief Fatigue Inventory score of four or greater was an eligibility requirement for the trial. RESULTS: Patients had completed cytotoxic chemotherapy an average of more than 2 years previously. Baseline fatigue scores were high, with approximately half of the sample scoring in the "severe" range. Mean improvement following acupuncture was 31.1% (95% CI, 20.6% to 41.5%), meeting our prespecified criterion for declaring acupuncture worthy of further study. Increasing age was associated with poorer response and failure to complete the study. There was no important difference in improvement following once-weekly and twice-weekly treatments. CONCLUSION: Acupuncture is worthy of further study in the treatment of postchemotherapy fatigue.

Acupuncture Therapy↗
PubMed2004

Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial.

OBJECTIVE: To determine the effects of a policy of "use acupuncture" on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of "avoid acupuncture." DESIGN: Randomised, controlled trial. SETTING: General practices in England and Wales. PARTICIPANTS: 401 patients with chronic headache, predominantly migraine. Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months or to a control intervention offering usual care. MAIN OUTCOME MEASURES: Headache score, SF-36 health status, and use of medication were assessed at baseline, three, and 12 months. Use of resources was assessed every three months. RESULTS: Headache score at 12 months, the primary end point, was lower in the acupuncture group (16.2, SD 13.7, n = 161, 34% reduction from baseline) than in controls (22.3, SD 17.0, n = 140, 16% reduction from baseline). The adjusted difference between means is 4.6 (95% confidence interval 2.2 to 7.0; P = 0.0002). This result is robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year (8 to 38). SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy, and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication (P = 0.02), made 25% fewer visits to general practitioners (P = 0.10), and took 15% fewer days off sick (P = 0.2). CONCLUSIONS: Acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. Expansion of NHS acupuncture services should be considered.

Acupuncture Therapy↗
PubMed2004

Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care.

OBJECTIVE: To evaluate the cost effectiveness of acupuncture in the management of chronic headache. DESIGN: Cost effectiveness analysis of a randomised controlled trial. SETTING: General practices in England and Wales. PARTICIPANTS: 401 patients with chronic headache, predominantly migraine. Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months from appropriately trained physiotherapists, or to usual care alone. MAIN OUTCOME MEASURE: Incremental cost per quality adjusted life year (QALY) gained. RESULTS: Total costs during the one year period of the study were on average higher for the acupuncture group (403 pounds sterling; 768 dollars; 598 euros) than for controls (217 pounds sterling) because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the one year of the trial was 0.021 quality adjusted life years (QALYs), leading to a base case estimate of 9180 pounds sterling per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial. CONCLUSIONS: Acupuncture for chronic headache improves health related quality of life at a small additional cost; it is relatively cost effective compared with a number of other interventions provided by the NHS.

Acupuncture Therapy↗
PubMed2004

Statistical considerations for use of composite health-related quality-of-life scores in randomized trials.

BACKGROUND: Quality of life instruments are frequently used as outcomes in randomized trials. Instruments that consist of several subscales present researchers with a choice of whether to combine some or all scales into a single composite score. There may be several clinically and scientifically reasonable alternative combinations of subscales for the primary outcome measure. MAJOR FINDINGS: The statistical efficiency of different combinations of subscales depends on the relative effect size of the intervention on each subscale and the correlation between the subscales. Simple equations can be derived for determining the relative statistical efficiency of each clinically reasonable combination of subscales. Hypothetical scenarios show that the number of patients needed in a clinical trial can be twice as great for some combinations of subscales as for others. CONCLUSIONS: There are often compelling clinical or scientific reasons to use a particular subscale or composite in a randomized trial. In the case where a number of different alternatives would be reasonable, statistical efficiency can help guide the choice of endpoint.

Data Interpretation, Statistical↗
PubMed2003

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial.

BACKGROUND: High-dose therapy with autologous stem cell transplantation (HDT/ASCT) is a commonly used treatment for hematologic malignancies. The procedure causes significant psychological distress and no interventions have been demonstrated to improve mood in these patients. Music therapy has been shown to improve anxiety in a variety of acute medical settings. In the current study, the authors determined the effects of music therapy compared with standard care on mood during inpatient stays for HDT/ASCT. METHODS: Patients with hematologic malignancy admitted for HDT/ASCT at two sites (Memorial Sloan-Kettering Cancer Center and Ireland Cancer Center in Cleveland, Ohio) were randomized to receive music therapy given by trained music therapists or standard care. Outcome was assessed at baseline and every 3 days after randomization using the Profile of Mood States. RESULTS: Of 69 patients registered in the study, follow-up data were available for 62 (90%). During their inpatient stay, patients in the music therapy group scored 28% lower on the combined Anxiety/Depression scale (P = 0.065) and 37% lower (P = 0.01) on the total mood disturbance score compared with controls. CONCLUSIONS: Music therapy is a noninvasive and inexpensive intervention that appears to reduce mood disturbance in patients undergoing HDT/ASCT.

Amyloidosis↗
PubMed2003

How many repeated measures in repeated measures designs? Statistical issues for comparative trials.

BACKGROUND: In many randomized and non-randomized comparative trials, researchers measure a continuous endpoint repeatedly in order to decrease intra-patient variability and thus increase statistical power. There has been little guidance in the literature as to selecting the optimal number of repeated measures. METHODS: The degree to which adding a further measure increases statistical power can be derived from simple formulae. This "marginal benefit" can be used to inform the optimal number of repeat assessments. RESULTS: Although repeating assessments can have dramatic effects on power, marginal benefit of an additional measure rapidly decreases as the number of measures rises. There is little value in increasing the number of either baseline or post-treatment assessments beyond four, or seven where baseline assessments are taken. An exception is when correlations between measures are low, for instance, episodic conditions such as headache. CONCLUSIONS: The proposed method offers a rational basis for determining the number of repeat measures in repeat measures designs.

Controlled Clinical Trials as Topic↗
PubMed2003

Use of a single global assessment to reduce missing data in a clinical trial with follow-up at one year.

We conducted a randomized controlled trial (ISRCTN96537534) to assess the effects of acupuncture on migraine and chronic tension headache. Patients (n=401) completed a diary of headache severity four times a day for 4 weeks at baseline, immediately following a 3-month treatment period and 1 year after randomization. During the trial, it appeared that dropout might be higher than expected. We therefore obtained a rapid global assessment of headache from participants to aid imputation of missing data. Patients were contacted by telephone and asked to rate current and baseline headache on a 0-10 scale. Use of global assessment reduced the number of patients from whom we obtained no follow-up headache data from 69 (17%) to 24 (6%). Analysis of patients who provided both a diary and a global assessment demonstrated excellent properties of global assessment, with very similar results to the full diary. We therefore used the global assessment to help impute missing 1-year diary scores. Rapid global assessment can be easily implemented in any trial and aids imputation of missing data, though it should not be used instead of more intensive methods of assessment. Further research might usefully examine the value of global assessment for imputation of missing data in a variety of different settings.

Acupuncture↗
PubMed2003

Complementary and alternative therapies.

Patients with prostate cancer increasingly use complementary and alternative therapies. A well-informed oncologist can guide patients to use such treatments to maximize their benefits and reduce the risk of harm. Patients should be dissuaded from using alternative therapies instead of mainstream care to treat cancer. Preliminary evidence suggests that botanical medicines such as PC-SPES may be of benefit, but comparative human trials are yet to be conducted and problems of contamination resolved. Some complementary therapies help reduce symptoms in early-stage prostate cancer, but botanical remedies must be treated with caution because of the possibility of adverse effects and interactions with conventional medicine.

Complementary Therapies↗
PubMed2003

Underpowering in randomized trials reporting a sample size calculation.

OBJECTIVE: The objective of this study was to determine whether standard deviations (SDs) used in sample size calculations are smaller than those found in the resulting study sample, thereby leading to underpowered studies. METHOD: The predicted SD used in the sample size calculation and the actual SD of the study sample were recorded for randomized trials recently published in one of four major journals. RESULTS: Sample SD was greater than predicted SD for 80% of endpoints. About one quarter of trials required five times as many patients as specified in the sample size calculation. CONCLUSION: Trials reporting sample size calculations for continuous endpoints published in the most reputable medical journals are often underpowered. There seems to be insufficient understanding that the SD of a sample of patients is a random variable, associated with imprecision, that cannot easily be extrapolated from one population to another.

Data Interpretation, Statistical↗
PubMed2002

Immediate effects of dry needling and acupuncture at distant points in chronic neck pain: results of a randomized, double-blind, sham-controlled crossover trial.

To evaluate immediate effects of two different modes of acupuncture on motion-related pain and cervical spine mobility in chronic neck pain patients compared to a sham procedure. Thirty-six patients with chronic neck pain and limited cervical spine mobility participated in a prospective, randomized, double-blind, sham-controlled crossover trial. Every patient was treated once with needle acupuncture at distant points, dry needling (DN) of local myofascial trigger points and sham laser acupuncture (Sham). Outcome measures were motion-related pain intensity (visual analogue scale, 0-100 mm) and range of motion (ROM). In addition, patients scored changes of general complaints using an 11-point verbal rating scale. Patients were assessed immediately before and after each treatment by an independent (blinded) investigator. Multivariate analysis was used to assess the effects of true acupuncture and needle site independently. For motion-related pain, use of acupuncture at non-local points reduced pain scores by about a third (11.2 mm; 95% CI 5.7, 16.7; P = 0.00006) compared to DN and sham. DN led to an estimated reduction in pain of 1.0 mm (95% CI -4.5, 6.5; P = 0.7). Use of DN slightly improved ROM by 1.7 degrees (95% CI 0.2, 3.2; P = 0.032) with use of non-local points improving ROM by an additional 1.9 degrees (95% CI 0.3, 3.4; P = 0.016). For patient assessment of change, non-local acupuncture was significantly superior both to Sham (1.7 points; 95% CI 1.0, 2.5; P = 0.0001) and DN (1.5 points; 95% CI 0.4, 2.6; P = 0.008) but there was no difference between DN and Sham (0.1 point; 95% CI -1.0, 1.2; P = 0.8). Acupuncture is superior to Sham in improving motion-related pain and ROM following a single session of treatment in chronic neck pain patients. Acupuncture at distant points improves ROM more than DN; DN was ineffective for motion-related pain.

Acupuncture Analgesia↗
PubMed2002

Placebo controls in randomized trials of acupuncture.

Considerable intellectual and practical effort has been expended on designing and evaluating placebo controls in acupuncture studies. Somewhat less attention has been paid to the question: Why use a placebo in a randomized trial of acupuncture? This is partly because placebo controls have generally been seen as an inherent part of randomized trial methodology. As a result, most acupuncture trials have included a placebo-control group. A large number of different placebo techniques have been used in these trials. The design and choice of placebo techniques has typically depended on purely theoretical considerations, without empirical validation of physiological inactivity and psychological credibility. Principles can be developed for deciding whether to use placebo or another form of control in a randomized trial. These include issues of ethics, practicality and methodology. Such principles apply regardless of the intervention; they can and should be applied to acupuncture research.

Acupuncture Therapy↗
PubMedDate not supplied

Incorporating predictions of individual patient risk in clinical trials.

A risk prediction model is a statistical technique that gives a predicted probability of a certain event for an individual patient. Prediction models outperform the traditional risk classification systems that work by assigning patients into risk groups based on the presence or absence of particular risk factors, such as stage of disease. As such, risk prediction models have a number of important possible uses in clinical trials. For Phase II studies, prediction models can help adjust comparisons with historical control groups for differences in case mix. For Phase III studies, prediction models can ensure that accrued patients are at sufficiently high risk. This improves statistical power and avoids unethical inclusion of low-risk patients. We also propose that prediction models could potentially be used for applying the results of Phase III trials to individual patients. Clinical decisions could be informed by individualized estimates of treatment benefit, rather than by average treatment effects.

Clinical Trials, Phase III as Topic↗
PubMedDate not supplied

Statistical reanalysis of four recent randomized trials of acupuncture for pain using analysis of covariance.

OBJECTIVES: Acupuncture has been promoted for the treatment of chronic pain. Though many randomized trials have been conducted, these have been criticized for deficiencies of methodology, acupuncture technique, and sample size. Somewhat less emphasis has been placed on methods of statistical analysis. This paper describes 4 recent randomized trials of acupuncture for musculoskeletal or headache pain. Each trial used statistical methods that did not adjust for baseline pain scores and were thus of suboptimal power. The objective of this study is to reanalyze the trials using analysis of covariance (ANCOVA). METHODS: Raw data for the 4 trials were obtained from the original authors. Data were reanalyzed by ANCOVA. RESULTS: For 2 trials--acupuncture versus placebo for chronic headache and acupuncture versus transcutaneous electric nerve stimulation for back pain--reanalysis did not change the conclusion of no difference between groups, but showed that clinically significant differences between groups could not ruled out. Reanalysis of a trial of acupuncture versus placebo for shoulder pain slightly strengthened the evidence of acupuncture effectiveness. Reanalysis of the fourth trial, which compared acupuncture to placebo acupuncture and massage for neck pain, reversed the results of the original paper: reanalysis found acupuncture to be effective and that its effectiveness could not be ascribed to a placebo effect. DISCUSSION: Future trials of acupuncture and other modalities for pain should use efficient statistical methods. ANCOVA is more efficient than unadjusted analysis where used appropriately.

Acupuncture↗