The experiences of people with chronic obstructive pulmonary disease (COPD) using activity monitors in everyday life: an interpretative phenomenological study.

PURPOSE: Understanding the experiences of people with Chronic Obstructive Pulmonary Disease (COPD) using activity monitors in daily life could support the utilisation of technology within healthcare to increase physical activity and support self-management. This qualitative study aimed to explore the experiences of people with COPD using activity monitors at home in everyday life. METHODS: Semi-structured face-to-face or telephone interviews were conducted with seven people with COPD between August 2018 and June 2020. Participants had all used an activity monitor within the last year (Fitbit, Garmin, or Apple Watch). Interviews were analysed in-depth using Interpretative Phenomenological Analysis (IPA). RESULTS: Four themes, developed using IPA, highlight participants' engagement with activity monitors and integrating them into their lives: (1) Motivational features to monitor activity, (2) Importance of setting achievable goals, (3) Developing knowledge and awareness, and (4) Integration into everyday life for self-management. CONCLUSION: Activity monitors were perceived to be beneficial and useful to people with COPD, not just for monitoring their activity, but also helping to self-manage their condition. Activity monitors may be a useful tool within rehabilitation and healthcare services for COPD.

Activity monitors were beneficial for people with Chronic Obstructive Pulmonary Disease (COPD) to monitor their physical activity and support self-management of their COPD.People with COPD could see and make sense of their activity levels, set activity goals and increase their motivation from the objectively monitored activity.Activity monitors can help to support individual goal setting and facilitate ownership, but support is needed to set achievable and realistic goals.Healthcare practitioners need to be aware of the potential negative effects of using activity monitors on mental or physical health and wellbeing and support people with COPD to manage pressure and expectations of meeting their goals.

A Comparison of Physical Activity Between Home-Based and Centre-Based Pulmonary Rehabilitation: A Randomised Controlled Secondary Analysis.

Background: Pulmonary rehabilitation (PR) is a highly effective intervention for individuals with chronic obstructive pulmonary disease (COPD). Physical activity (PA) has been shown to increase after a centre-based programme, yet it is not clear if a home-based programme can offer the same benefit. This study aimed to evaluate the effect of home-based PR compared with the centre-based PR on the PA levels post 7 weeks of PR and 6 months follow-up. Method: In this study, 51 participants with COPD, of them, 36 (71%) men completed physical activity monitoring with a SenseWear Armband, at three time points (baseline, 7 weeks, and 6 months). The participants were randomly assigned to either centre-based supervised PR (n = 25; 69 ± 6 years; FEV1 55 ± 20% predicted) or home-based PR (n = 26; 68 ± 7 years; FEV1 42 ± 19% predicted) programmes lasting 7 weeks. The home-based programme includes one hospital visit, a self-management manual, and two telephone calls. The PA was measured as step count, time in moderate PA (3-6 metabolic equivalent of tasks [METs]) in bouts of more than 10 min and sedentary time (<2 METs). Results: Home-based PR increased step count significantly more than the centre-based PR after 7 weeks (mean difference 1,463 steps: 95% CI 280-2,645, p = 0.02). There was no difference in time spent in moderate PA was observed (mean difference 62 min: 95% CI -56 to 248, p = 0.24). Sedentary behaviour was also significantly different between the centre and home-based groups. The home group spent 52 min less time sedentary compared with the centre-based (CI -106 to 2, p = 0.039). However, after 6 months, the step count and time spent in moderate PA returned to baseline in both the groups. Conclusion: This study provides an important insight into the role of home-based PR which has the potential to be offered as an alternative to the centre-based PR. Understanding who may best respond from the centre or home-based PR warrants further exploration and how to maintain these initial benefits for the long-term. Trial Registry: ISRCTN: No.: ISRCTN81189044; URL: isrctn.com.

Evaluation of multidisciplinary pulmonary rehabilitation education delivered by either DVD or spoken talk.

INTRODUCTION: Pulmonary rehabilitation (PR) is a multidisciplinary program of care for patients with chronic respiratory disease. The educational component is an integral component and represents a large proportion of a program. However, it can be difficult to secure regular multidisciplinary input to PR programs. OBJECTIVES: This service evaluation assessed whether DVD presentations are acceptable to patients and effective as an education medium. METHOD: Two PR groups were compared; one group received education by DVD and the other by spoken talk. Both groups evaluated the content and delivery of each session and their knowledge was measured using the Bristol COPD Knowledge Questionnaire (BCKQ). RESULTS: One hundred and twenty-three patients with Chronic Obstructive Pulmonary Disease (COPD) took part; 58 evaluated the DVD, 75 the talk sessions. There were no differences between the two groups at baseline with respect to age, gender distribution, or FEV1 . Both groups were satisfied with the content (99.46% DVD, 100% talk group) and delivery (100% both DVD and talk groups) of their education sessions. At baseline, there were no between group differences in the mean BCKQ. After PR, significant changes in BCKQ scores were seen within the groups (6.52 points (1.48-11.37) DVD group and 8.96 points (6.50-11.19) talk group), again with no differences between the groups. CONCLUSION: A DVD-based education package is both acceptable to PR patients and effective at improving patients' knowledge of COPD. Using filmed educational talks with PR would have a number of benefits to both the patients and the service and may be a way of increasing the capacity of PR services.

Apps and wearables for monitoring physical activity and sedentary behaviour: A qualitative systematic review protocol on barriers and facilitators.

OBJECTIVE: Monitoring of physical activity and sedentary behaviours by mobile phone applications (apps) and wearable technology (wearables) may improve these health behaviours. This systematic review aims to synthesise the qualitative literature on the barriers and facilitators of using apps and wearables for monitoring physical activity and/or sedentary behaviour in adults. METHODS: This review protocol is registered in PROSPERO (CRD42017070194). Scientific databases including CINAHL Complete, MEDLINE, PsycINFO, SPORTDiscus, Cochrane Library and Scopus will be searched for relevant studies published from 1 January 2012 to the date the searches are conducted. Studies will be included if they incorporated adults who used an app or wearable for monitoring physical activity and/or sedentary behaviour; explored the barriers and/or facilitators of using an app and/or wearable; and were published in English. Following duplicate screening of titles and abstracts, full texts of potentially eligible papers will be screened to identify studies using qualitative approaches to explore barriers and facilitators of using apps and/or wearables for monitoring physical activity and/or sedentary behaviour. Discrepancies will be resolved through consensus or by consulting a third screener. Relevant excerpts (quotes and text) from the included papers will be extracted and analysed thematically. The Critical Appraisal Skills Programme Qualitative Research Checklist will be used to appraise included studies. CONCLUSION: The results of this work will be useful for those intending to monitor physical activity and/or sedentary behaviour using these technologies.

Survival following pulmonary rehabilitation in patients with COPD: the effect of program completion and change in incremental shuttle walking test distance.

Rationale: Pulmonary rehabilitation (PR) in patients with COPD has consistently been shown to produce benefits in exercise capacity, symptoms, and health status. The data surrounding survival following PR are less clear. Our aims were to compare the long-term survival in two cohorts of patients referred for PR; those who successfully completed PR, and a comparator group constructed from patients who either did not complete PR or did not start the program. Additionally, we compared survival between those people who were able to achieve a clinically meaningful improvement in exercise capacity (incremental shuttle walking test) following PR with those who were not. Methods: A retrospective longitudinal analysis of clinical service outcomes was conducted to compare the long-term survival in "completers" and "non-completers" of rehabilitation at two hospitals within the University Hospitals of Leicester NHS Trust from January 1, 2000 to February 23, 2012. For "completers", we also analyzed survival in those meeting (and not meeting) the desired level of change in the incremental shuttle walking test (≥50 m vs <50 m). Results: We present to you the largest dataset on this topic (n=1,515). Survival data were ascertained for 823 (54.3%) patients with COPD who had completed a course of PR and for 692 (45.7%) patients who dropped out. Survival time was significantly greater in "completers" compared to "non-completers" of PR (p<0.001). In addition, PR success (≥50 m change in walking distance) was also associated with improved survival (p<0.05). Conclusion: The data show an association between completion of PR and survival. In addition, PR success (>50 m change in walking distance) was also associated with improved survival.

Comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: a randomised non-inferiority trial.

BACKGROUND: Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD. METHODS: A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units. RESULTS: There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: -0.24, 95% CI -0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks. CONCLUSIONS: The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation. TRIAL REGISTRATION NUMBER: ISRCTN81189044.

Agreement between adherences to four physical activity recommendations in patients with COPD: does the incremental shuttle walk test predict adherence?

INTRODUCTION AND OBJECTIVES: There are various recommendations for physical activity (PA). However agreement between all of these measures has not been established. Furthermore, given the challenges of measuring PA there is interest in evaluating whether a measure of exercise performance can be used as a surrogate measure to identify who is likely to achieve the recommendations. METHODS: A total of 184 people with COPD were recruited, 128 of which had complete data for these analyses. Participants wore the SenseWear Armband for 7 consecutive days and all performed an incremental shuttle walk test (ISWT). We extracted moderate to vigorous physical activity (MVPA) in bouts of ≥10 min using a 3 metabolic equivalent (MET) threshold and an individually prescribed MET threshold (based on performance on the ISWT). Average daily step count and the physical activity level were also calculated. RESULTS: There was poor agreement between the four PA recommendations, with agreement on all four achieved in only 30 participants. People were least likely to be active using MVPA in ≥10 min bouts using 3 MET threshold (21.1% active), and most likely to be active using MVPA in ≥10 min bouts using an individually prescribed threshold (64.9% active). It was not possible to identify a threshold on the ISWT that would reliably predict those that achieved any of the four recommendations. CONCLUSION: Agreement between various physical activity recommendations is poor. This should be considered when measuring and describing physical activity adherence. The ISWT cannot be used to reliably predict adherence to physical activity guidelines.

Socioeconomic deprivation and the outcome of pulmonary rehabilitation in England and Wales.

BACKGROUND: Pulmonary rehabilitation (PR) improves exercise capacity and health status in patients with COPD, but many patients assessed for PR do not complete therapy. It is unknown whether socioeconomic deprivation associates with rates of completion of PR or the magnitude of clinical benefits bequeathed by PR. METHODS: PR services across England and Wales enrolled patients to the National PR audit in 2015. Deprivation was assessed using Index of Multiple Deprivation (IMD) derived from postcodes. Study outcomes were completion of therapy and change in measures of exercise performance and health status. Univariate and multivariate analyses investigated associations between IMD and these outcomes. RESULTS: 210 PR programmes enrolled 7413 patients. Compared with the general population, the PR sample lived in relatively deprived neighbourhoods. There was a statistically significant association between rates of completion of PR and quintile of deprivation (70% in the least and 50% in the most deprived quintiles). After baseline adjustments, the risk ratio (95% CI) for patients in the most deprived relative to the least deprived quintile was 0.79 (0.73 to 0.85), p<0.001. After baseline adjustments, IMD was not significantly associated with improvements in exercise performance and health status. CONCLUSIONS: In a large national dataset, we have shown that patients living in more deprived areas are less likely to complete PR. However, deprivation was not associated with clinical outcomes in patients who complete therapy. Interventions targeted at enhancing referral, uptake and completion of PR among patients living in deprived areas could reduce morbidity and healthcare costs in such hard-to-reach populations.

A strategy to implement a chronic obstructive pulmonary disease discharge care bundle on a large scale.

Care bundles may be an effective tool to standardise care for patients admitted with an exacerbation of chronic obstructive pulmonary disease (COPD). However, it is unclear how care bundles can be implemented without the need for additional resources. We redeployed a respiratory early discharge service (REDS) to deliver a COPD discharge bundle. We audited the effect of this service redesign on length of stay (LOS) and uptake of referrals to smoking cessation and pulmonary rehabilitation services. Of 1,742 patients with COPD, 1,170 received the discharge care bundle. Mean LOS for patients who received the discharge care bundle was 6.17 days versus 7.08 days for patients who did not. Smoking cessation and pulmonary rehabilitation referrals increased during the project year. A COPD discharge care bundle can be implemented on a large scale by redeploying a REDS without an increase on hospital LOS.

Do we need a practice incremental shuttle walk test for patients with interstitial lung disease referred for pulmonary rehabilitation?

BACKGROUND AND OBJECTIVE: Patients with interstitial lung disease (ILD) are increasingly being referred to pulmonary rehabilitation (PR) where exercise capacity is measured, often by an incremental shuttle walk test (ISWT). These patients are frequently limited by severe dyspnoea and exertional desaturation. Available guidelines suggest two ISWT are needed; however, this is time consuming and it has not been reported whether a practice ISWT is necessary in ILD. We aimed to investigate if a practice ISWT is needed for patients with ILD referred to PR. METHODS: Patients with ILD who attended a PR assessment performed two ISWT as per standard protocol. Hospital notes were retrieved and relevant data extracted and validated. Endurance shuttle walk test (ESWT) level was calculated at 85% VO2 peak as estimated from the first ISWT (ISWT 1) and second ISWT (ISWT 2). RESULTS: Forty-three patients were included (18 with idiopathic pulmonary fibrosis). There was a mean change of 28.84 (31.71) m between the two ISWT (P < 0.001) with 72.1% of patients walking further on ISWT 2. A Bland-Altman plot showed good agreement between the ISWTs; however, the limits of agreement were wide. There was a significant difference in ESWT levels (P < 0.001) when calculated from ISWT 1 and ISWT 2. ISWT 1 distance, post-ISWT 1 heart rate and baseline Borg breathlessness score were significant variables (P < 0.05) in linear regression, but this only explained 42.6% of the variance (R(2) 0.426). CONCLUSIONS: A practice ISWT is necessary to accurately assess exercise capacity. It was not possible to predict which patients did not need to complete two ISWT.

Response of the COPD Assessment Tool in Stable and Postexacerbation Pulmonary Rehabilitation Populations.

PURPOSE: The COPD Assessment Tool (CAT) has previously been shown to be a sensitive outcome measure for pulmonary rehabilitation (PR) in a stable population, but its utility in a postexacerbation PR population is unknown. The aim of this study was to investigate any differences in response to the CAT between stable and postexacerbation patients undertaking PR. METHODS: Patients attending a 7-week outpatient PR program completed a CAT questionnaire pre- and postrehabilitation. Patients referred for elective outpatient PR were compared with those who had been referred to PR following a hospital admission for an exacerbation. RESULTS: Two hundred consecutive patients completed the CAT questionnaire: 125 stable patients (74 male, mean age 71.1 ± 8.9 years, forced expiratory volume in 1 second [FEV1] 1.39 L ± 0.6, and body mass index [BMI] 28.5 ± 6.7 kg/m) and 75 postexacerbation patients (23 male, mean age 70.6 ± 8.6 years, FEV1 1.16 L ± 0.5, and BMI 25.8 ± 7.3 kg/m). A statistically significant difference between the stable and postexacerbation patient groups pre-PR CAT score (P = .05) was observed. There was no significant difference in post-PR CAT scores or change in CAT scores between the stable and postexacerbation groups. There was a significant difference in pre- and post-PR walking test results between the groups. The improvement in the Endurance Shuttle Walking Test (ESWT) in the stable group was greater (P < .05). CONCLUSIONS: Postexacerbation PR patients had a worse CAT score prior to PR when compared with a stable PR population, but both groups made improvements in CAT following completion of PR.

Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study.

BACKGROUND: Conventional cardiac rehabilitation (CR) programs are traditionally based on time-constrained, structured, group-based programs, usually set in hospitals or leisure centers. Uptake for CR remains poor, despite the ongoing evidence demonstrating its benefits. Additional alternative forms of CR are needed. An Internet-based approach may offer an alternative mode of delivering CR that may improve overall uptake. Activate Your Heart (AYH) is a Web-based CR program that has been designed to support individuals with coronary heart disease (CHD). OBJECTIVE: The aim of this pilot study was to observe the outcome for participants following the AYH program. METHODS: We conducted a prospective observational trial, recruiting low-risk patients with CHD. Measures of exercise, exercise capacity, using the Incremental Shuttle Walk Test (ISWT), dietary habits, and psychosocial well-being were conducted by a CR specialist at baseline and at 8 weeks following the Web-based intervention. RESULTS: We recruited 41 participants; 33 completed the program. We documented significant improvements in the ISWT distance (mean change 49.69 meters, SD 68.8, P<.001), and Quality of Life (QOL) (mean change 0.28, SD 0.4, P<.001). Dietary habits improved with an increased proportion of patients consuming at least 5 portions of fruit and vegetables per day, (22 [71%] to 29 [94%] P=.01) and an increased proportion of patients consuming at least 2 portions of oily fish per week (14 [45%] to 21 [68%], P=.01). We did not detect changes in anxiety and depression scores or exercise behavior. CONCLUSIONS: We observed important improvements in exercise capacity, QOL, and dietary habits in a group of participants following a Web-based CR program. The program may offer an alternative approach to CR. A mobile version has been developed and we need to conduct further trials to establish its value compared to supervised CR.

A self-management programme for COPD: a randomised controlled trial.

Studies of programmes of self-management support for chronic obstructive pulmonary disease (COPD) have been inconclusive. The Self-Management Programme of Activity, Coping and Education (SPACE) FOR COPD is a 6-week self-management intervention for COPD, and this study aimed to evaluate the effectiveness of this intervention in primary care. A single-blind randomised controlled trial recruited people with COPD from primary care and randomised participants to receive usual care or SPACE FOR COPD. Outcome measures were performed at baseline, 6 weeks and 6 months. The primary outcome was symptom burden, measured by the self-reported Chronic Respiratory Questionnaire (CRQ-SR) dyspnoea domain. Secondary outcomes included other domains of the CRQ-SR, shuttle walking tests, disease knowledge, anxiety, depression, self-efficacy, smoking status and healthcare utilisation. 184 people with COPD were recruited and randomised. At 6 weeks, there were significant differences between groups in CRQ-SR dyspnoea, fatigue and emotion scores, exercise performance, anxiety, and disease knowledge. At 6 months, there was no between-group difference in change in CRQ-SR dyspnoea. Exercise performance, anxiety and smoking status were significantly different between groups at 6 months, in favour of the intervention. This brief self-management intervention did not improve dyspnoea over and above usual care at 6 months; however, there were gains in anxiety, exercise performance, and disease knowledge.

The role of the nurse in pulmonary rehabilitation.

Pulmonary rehabilitation can help patients with chronic obstructive pulmonary disease improve their exercise tolerance and quality of life. Care packages can be devised and managed by respiratory nurses.

An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation.

BACKGROUND: Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease. Since the 2006 American Thoracic Society (ATS)/European Respiratory Society (ERS) Statement on Pulmonary Rehabilitation, there has been considerable growth in our knowledge of its efficacy and scope. PURPOSE: The purpose of this Statement is to update the 2006 document, including a new definition of pulmonary rehabilitation and highlighting key concepts and major advances in the field. METHODS: A multidisciplinary committee of experts representing the ATS Pulmonary Rehabilitation Assembly and the ERS Scientific Group 01.02, "Rehabilitation and Chronic Care," determined the overall scope of this update through group consensus. Focused literature reviews in key topic areas were conducted by committee members with relevant clinical and scientific expertise. The final content of this Statement was agreed on by all members. RESULTS: An updated definition of pulmonary rehabilitation is proposed. New data are presented on the science and application of pulmonary rehabilitation, including its effectiveness in acutely ill individuals with chronic obstructive pulmonary disease, and in individuals with other chronic respiratory diseases. The important role of pulmonary rehabilitation in chronic disease management is highlighted. In addition, the role of health behavior change in optimizing and maintaining benefits is discussed. CONCLUSIONS: The considerable growth in the science and application of pulmonary rehabilitation since 2006 adds further support for its efficacy in a wide range of individuals with chronic respiratory disease.

The development and pilot testing of the self-management programme of activity, coping and education for chronic obstructive pulmonary disease (SPACE for COPD).

PURPOSE: There is no independent standardized self-management approach available for chronic obstructive pulmonary disease (COPD). The aim of this project was to develop and test a novel self-management manual for individuals with COPD. PATIENTS: Participants with a confirmed diagnosis of COPD were recruited from primary care. METHODS: A novel self-management manual was developed with health care professionals and patients. Five focus groups were conducted with individuals with COPD (N = 24) during development to confirm and enhance the content of the prototype manual. The Self-management Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease (SPACE for COPD) manual was developed as the focus of a comprehensive self-management approach facilitated by health care professionals. Preference for delivery was initial face-to-face consultation with telephone follow-up. The SPACE for COPD manual was piloted with 37 participants in primary care. Outcome measures included the Self-Report Chronic Respiratory Questionnaire, Incremental Shuttle Walk Test, and Endurance Shuttle Walking Test (ESWT); measurements were taken at baseline and 6 weeks. RESULTS: The pilot study observed statistically significant improvements for the dyspnea domain of the Self-Report Chronic Respiratory Questionnaire and ESWT. Dyspnea showed a mean change of 0.67 (95% confidence interval 0.23-1.11, P = 0.005). ESWT score increased by 302.25 seconds (95% confidence interval 161.47-443.03, P < 0.001). CONCLUSION: This article describes the development and delivery of a novel self-management approach for COPD. The program, incorporating the SPACE for COPD manual, appears to provoke important changes in exercise capacity and breathlessness for individuals with COPD managed in primary care.

Short outpatient pulmonary rehabilitation programme reduces readmission following a hospitalization for an exacerbation of chronic obstructive pulmonary disease.

BACKGROUND AND OBJECTIVE: The benefits of pulmonary rehabilitation (PR) are now firmly established. However, less is known about the provision and efficacy of PR immediately after an acute exacerbation of chronic obstructive pulmonary disease (COPD). The study aimed to explore the effectiveness of a short outpatient PR programme and the impact upon readmission rates. METHODS: One hundred sixty (87 males) patients, mean (SD) age 70.35 (8.59) years, forced expiratory volume in 1 s 0.99 (0.44) litres were assessed for a 7-week PR programme following a hospital admission for an acute exacerbation of COPD. Patients were assessed and commenced PR within 4 weeks of discharge from hospital. Outcome measures included: Incremental Shuttle Walking Test (ISWT), Endurance Shuttle Walk Test (ESWT), Chronic Respiratory Questionnaire Self-Reported (CRQ-SR). Patients were assessed at baseline and at 7 weeks (after the 4-week supervised and 3-week unsupervised components). Readmission data were collected retrospectively for the 12 months pre and post admission (n = 155). RESULTS: Statistically significant improvements were found in the ISWT, ESWT and CRQ-SR at discharge (P < 0.05). The number of admission was significantly less in the 12-month post-pulmonary rehabilitation compared to the previous 12 months. CONCLUSIONS: A short course of PR showed improvements in exercise capacity and health status in patients who have had an acute exacerbation of COPD. The number of readmissions was also significantly lower in the year following PR.

Development, validation and application of a sensitive LC-MS/MS method for the quantification of thalidomide in human serum, cells and cell culture medium.

A simple, robust, sensitive and selective liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the quantification of thalidomide was developed and validated. The method was applied to thalidomide quantification in three different types of biological samples. Thalidomide was extracted from human serum (100 µL), cells (2.5 × 10(5)), or cell culture media (100 µL) by LLE and separated on a Prodigy C18 (150 mm × 4.0 mm, 5 µm i.d.) column with isocratic elution using water/acetonitrile (70/30, v/v) 0.1% formic acid, at a flow rate of 0.5 mL/min, with umbelliferone (600 ng/mL) as an internal standard. Thalidomide was quantified using a triple quadrupole mass spectrometer operated in multi-reaction-monitoring mode using positive electrospray ionisation. The method was validated in two separate thalidomide concentration ranges; human serum (0.05-20 µg/mL) and in vitro cells (0.78-50 ng) with an inter-day precision of 1.8% and 1.9% and average accuracy of 100% and 101% in serum and cells respectively. Despite the use of small sample volume, the limit of quantification for thalidomide in serum was determined to be 3 ng/mL. The method was successfully employed to measure levels of thalidomide in cancer patient serum and cell culture model systems. Although cellular levels were quantifiable, thalidomide was shown to be unstable under in vitro conditions with a half life of approximately 2 h. In patient samples, circulating serum levels showed a broad correlation with dose and uncovered some patient compliance issues.