Patient-perceived health-related quality of life during recovery after total hip arthroplasty – a 6-month follow-up study

Potilaiden käsitys terveyteen liittyvästä elämänlaadusta lonkan tekonivelleikkauksen jälkeisenä toipumisaikana – kuuden kuukauden seurantatutkimus Tässä kaksivaiheisessa seurantatutkimuksessa tarkasteltiin potilaiden käsitystä terveyteen liittyvästä elämänlaadusta lonkan tekonivelleikkauksen jälkeisenä toipumisaikana. Tutkimuksen ensimmäisessä vaiheessa tarkoituksena oli sekä kuvailla potilaiden kokemuksia potilaana olosta, saamastaan hoidosta ja terveyspalveluorganisaatiosta että analysoida aikaisempien tutkimusten perusteella leikkauksen tuloksia potilaan kannalta. Toisessa vaiheessa tarkoituksena oli arvioida potilaiden kokemaa elämänlaatua leikkauksen jälkeen, ja sitä vaikuttivatko primaaritulokset (fyysinen toimintakyky, kipu, ahdistus) tai taloudelliset seuraukset (potilaiden itsensämaksamat kustannukset, palvelujen käyttö) terveyteen liittyvään elämänlaatuun. Tutkimuksen tavoitteena oli löytää mahdolliset kriittiset ajankohdat tai tekijät, jotka saattavat hidastaa toipumista ja siten huonontaa potilaiden elämänlaatua. Tätä tietoa voidaan käyttää hoitotyössä kun suunnitellaan sopivaa hoitoa ja tukea toipumisajalle. Tutkimuksen ensimmäisessä vaiheessa primaarileikkaukseen tulevat potilaat (n = 17) kuvailivat teemahaastatteluissa kokemuksiaan kahdesti leikkauksen jälkeen. Haastatteluaineisto analysoitiin induktiivisella sisällönanalyysilla. Lisäksi 17 tutkimusartikkelista analysoitiin deduktiivisella sisällönanalyysilla leikkauksen tuloksia potilaalle, tuloksiin vaikuttavia tekijöitä ja käytetyt tutkimusmetodit. Toisessa vaiheessa primaari- tai revisioleikkaukseen tulevat potilaat (n = 100) arvioivat leikkauksen tuloksia kuuden kuukauden ajan leikkauksen jälkeen: terveyteen liittyvää elämänlaatua, primaarituloksia ja taloudellisia seurauksia. Aineisto kerättiin erilaisilla mittareilla: Sickness Impact Profile, Finnish Version, Stait-Trait Anxiety Inventory, ja Numeric Rating Scale. Lisäksi käytettiin tätä tutkimusta varten tehtyjä kyselylomakkeita: Fyysinen toimintakyky-mittari, Palvelujen käyttö-mittari ja Kustannusmittari. Tutkimuksen toiseen vaiheen tulokset analysoitiin tilastollisilla menetelmillä. Potilaiden terveyteen liittyvä elämänlaatu parani ja kipu lievittyi leikkauksen jälkeen ja fyysinen toimintakyky lisääntyi toipumisaikana. Positiivisista muutoksista huolimatta potilaat kokivat ahdistusta samassa määrin kuin ennen leikkaustakin. Palvelujen käyttö vaihteli toipumisajan kuluessa ja potilaiden maksamissa kustannuksissa oli suuria vaihteluita. Fyysisen toimintakyvyn lisääntyminen ja kivun lieveneminen paransivat terveyteen liittyvää elämänlaatua. Sen sijaan huonompi elämänlaatu toipumisaikana oli yhteydessä suurempaan palvelujen käyttöön, kun taas kustannuksilla ei ollut yhteyttä elämänlaatuun. Potilaiden ominaispiirteet tulisi ottaa enemmän huomioon suunniteltaessa sopivaa leikkauksenjälkeistä hoitoa ja tukea. Potilaat tarvitsevat yksilöllisiä ohjeita, sillä monet taustatekijät (esim. ikä, sukupuoli, preoperatiivinen kipu, siviilisääty, ja leikkaustyyppi) vaikuttavat toipumiseen.

Rapid Improvement In Health-Related Quality Of Life In Gouty Arthritis Patients Treated With Canakinumab (Acz885) Compared To Triamcinolone Acetonide

Background : Canakinumab, a fully human anti-IL-1b antibody has been shown to control inflammation in gouty arthritis. This study evaluated changes in health-related quality of life (HRQoL) in patients treated with canakinumab or triamcinolone acetonide (TA).Methods : An 8-wk, dose-ranging, active controlled, single-blind study in patients (_18 to _80 years) with acute gouty arthritis flare, refractory to or contraindicated to NSAlDs and/or colchicine, were randomized to canakinumab 10, 25, 50, 90, 150mg sc or TA 40mg im. HRQoL was assessed using patient reported outcomes evaluating PCS and MCS, and subscale scores of SF-36_ [acute version 2]) and functional disability (HAQ-DI_).Results : In canakinumab 150mg group, the most severe impairment at baseline was reported for physical functioning and bodily pain; levels of 41.5 and 36.0, respectively, which improved in 7 days to 80.0 and 72.2 (mean increases of 39.0 and 35.6) and at 8 wks improved to 86.1 and 86.6 (mean increases of 44.6 and 50.6); these were higher than levels seen in the general US population. TA group, showed less improvement in 7 days (mean increases of 23.3 and 21.3 for physical function and bodily pain). Functional disability scores, measured by the HAQ-DI_ decreased in both treatment groups (Table 1).Conclusions : Gouty arthritis patients treated with canakinumab showed a rapid improvement in physical and mental well-being based on SF-36_ scores. In contrast to the TA group, patients treated with canakinumab showed improvement in 7 days in physical function and bodily pain approaching levels of the general population.Disclosure statement : U.A., A.F., V.M., D.R., P.S. and K.S. are employees and shareholders of Novartis Pharma AG. A.P. has received research support from Novartis Pharma AG. N.S. has received research support and consultancy fees from Novartis Pharmaceuticals Corporation, has served on advisory boards for Novartis, Takeda, Savient, URL Pharma and EnzymeRx, and is/has been a member of a speakers' bureau for Takeda. A.S. has received consultation fees from Novartis Pharma AG, Abbott, Bristol-Myers Squibb, Essex, Pfizer, MSD, Roche, UCB and Wyeth. All other authors have declared no conflicts of interest.

Rapid Improvement in Health-Related Quality of Life (HRQoL) in Gouty Arthritis Patients Treated with Canakinumab (ACZ885) Compared to Triamcinolone Acetonide

Background: Gouty arthritis is a painful inflammatory disease with a significant impact on patients' HRQoL. In gouty arthritis, the inflammatory response is initiated by interleukin-1b (IL-1b) release, due to activation of the NALP3 inflammasome by MSU crystals. Canakinumab, a fully human anti-IL-1b antibody has a long half-life and has been shown to control inflammation in gouty arthritis. This study evaluated changes in HRQoL in gouty arthritis patients following treatment with canakinumab or triamcinolone acetonide (TA).Methods: This was an 8-week, dose-ranging, multi-center, active controlled, single-blind study. Patients (>=18 to <=80 years) experiencing an acute gouty arthritis flare, refractory to or contraindicated to NSAlDs and/or colchicine, were randomized to canakinumab 10, 25, 50, 90, 150 mg sc or TA 40 mg im. HRQoL was assessed as an exploratory endpoint at baseline and different pre-specified time-points using patient reported outcomes evaluating general mental and physical component summary scores and subscale scores of SF-36® (acute version 2) and functional disability (HAQ-DI©). We report HRQoL results for canakinumab 150 mg, the dose that was selected for the Phase III studies.Results: Baseline assessments showed a major impact on the HRQoL during acute gouty arthritis. Compared to TA, canakinumab 150 mg showed greater improvements in SF-36® physical and mental component summary and subscale scores at 7 days post-dose.In the canakinumab 150 mg group, the most severe impairment at baseline was reported for physical functioning and bodily pain; levels of 41.5 and 36.0, respectively, which improved within 7 days to 80.0 and 72.2 (mean increases of 39.0 and 35.6) approaching levels of the general US population (84.2 and 75.2). 8 weeks post-dose patients reached levels of 86.1 and 86.6 (mean increases of 44.6 and 50.6 for physical functioning and bodily pain, respectively) and these were higher than levels seen in the general US population. This was in contrast to patients treated with TA, who showed less improvement within 7 days (mean increases of 23.3 and 21.3 for physical function and bodily pain, respectively). None of the scores reached levels of the general US population 8 weeks post-dose. Functional disability scores, as measured by the HAQ-DI© decreased in both treatment groupsConclusions: All canakinumab doses showed a rapid improvement in physical and mental well-being of gouty arthritis patients based on SF-36® scores, in particular the 150 mg dose. In contrast to the TA group, patients treated with canakinumab showed improvement within 7 days in physical function and bodily pain approaching levels of the general population. The 150 mg dose of canakinumab was selected for further development in Phase III studies.

MOS-SF-36 in evaluating health-related quality of life in alcohol-dependent patients.

Health-related quality of life (HRQoL) was evaluated in a sample of alcohol-dependent patients with the 36-item Medical Outcome Study Short-Form Health Survey (MOS-SF-36). The instrument was administered to 147 patients (77% males), aged 26-78, with a DSM-III-R diagnosis of alcohol dependence. The Hamilton Depression Scale (HDS), the Severity of Alcohol Dependence Questionnaire (SADQ), and the Addiction Severity Index (ASI) were also administered to the first 100 patients included in the study. The reliability and validity of the MOS-SF-36 were evaluated. Test-retest intraclass coefficients for a 10-day interval were in the range .65 to .79, whereas the Cronbach alpha coefficient indicated good internal consistency (range .70 to .89). Compared to scores observed in the general population, MOS-SF-36 scores for alcohol-dependent patients were relatively low (indicating worse perception of HRQoL), especially in the psychological and role dimensions (range 52/100 to 55/100), but were closer to populational values in the physical and functional dimensions (range 61/100 to 75/100)). The highest correlation between MOS-SF-36 dimensions and HDS was found in the MOS-SF-36 &quot;mental health&quot; dimension (r=-.56, p &lt; .001); this dimension was also correlated highly with the psychiatric dimension of the ASI (r=-.73, p &lt; .001). The eight dimensions of the MOS-SF-36 were 21% to 127% lower in patients with HDS greater than or equal to 16 (major depression) compared to those with HDS less than or equal to 7 (absence of depression). The MOS-SF-36 dimensions were 10% to 141% lower in patients with high &quot;ASI alcohol&quot; scores, indicating worse HRQoL profiles with a higher severity of alcohol dependence. The MOS-SF-36 presents good criteria for reliability and validity in alcohol-dependent patients. The results suggested that alcohol-dependent patients perceived their problems more as psychological than physical. The severity of alcohol dependence and depression seemed to influence the perception of HRQoL negatively.

Host- rather than virus-related factors reduce health-related quality of life in hepatitis C virus infection.

BACKGROUND: Hepatitis C virus (HCV) infection is associated with decreased health-related quality of life (HRQOL). Although HCV has been suggested to directly impair neuropsychiatric functions, other factors may also play a role. PATIENTS AND METHODS: In this cross-sectional study, we assessed the impact of various host-, disease- and virus-related factors on HRQOL in a large, unselected population of anti-HCV-positive subjects. All individuals (n = 1736) enrolled in the Swiss Hepatitis C Cohort Study (SCCS) were asked to complete the Short Form 36 (SF-36) and the Hospital Anxiety Depression Scale (HADS). RESULTS: 833 patients (48%) returned the questionnaires. Survey participants had significantly worse scores in both assessment instruments when compared to a general population. By multivariable analysis, reduced HRQOL (mental and physical summary scores of SF-36) was independently associated with income. In addition, a low physical summary score was associated with age and diabetes, whereas a low mental summary score was associated with intravenous drug use. HADS anxiety and depression scores were independently associated with income and intravenous drug use. In addition, HADS depression score was associated with diabetes. None of the SF-36 or HADS scores correlated with either the presence or the level of serum HCV RNA. In particular, SF-36 and HADS scores were comparable in 555 HCV RNA-positive and 262 HCV RNA-negative individuals. CONCLUSIONS: Anti-HCV-positive subjects have decreased HRQOL compared to controls. The magnitude of this decrease was clinically important for the SF-36 vitality score. Host and environmental, rather than viral factors, seem to impact on HRQOL level.

Cannabis Use in Patients with Fibromyalgia: Effect on Symptoms Relief and Health-Related Quality of Life

Background: The aim of this study was to describe the patterns of cannabis use and the associated benefits reported by patients with fibromyalgia (FM) who were consumers of this drug. In addition, the quality of life of FM patients who consumed cannabis was compared with FM subjects who were not cannabis users. Methods: Information on medicinal cannabis use was recorded on a specific questionnaire as well as perceived benefits of cannabis on a range of symptoms using standard 100-mm visual analogue scales (VAS). Cannabis users and non-users completed the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) and the Short Form 36 Health Survey (SF-36). Results: Twenty-eight FM patients who were cannabis users and 28 non-users were included in the study. Demographics and clinical variables were similar in both groups. Cannabis users referred different duration of drug consumption; the route of administration was smoking (54%), oral (46%) and combined (43%). The amount and frequency of cannabis use were also different among patients. After 2 hours of cannabis use, VAS scores showed a statistically significant (p<0.001) reduction of pain and stiffness, enhancement of relaxation, and an increase in somnolence and feeling of well being. The mental health component summary score of the SF-36 was significantly higher (p<0.05) in cannabis users than in non-users. No significant differences were found in the other SF-36 domains, in the FIQ and the PSQI. Conclusions: The use of cannabis was associated with beneficial effects on some FM symptoms. Further studies on the usefulness of cannabinoids in FM patients as well as cannabinoid system involvement in the pathophysiology of this condition are warranted

Glioblastoma in elderly patients: health-related quality of life (hrqol) in a randomized trial comparing 6-weeks of tadiotherapy (rt) vs hypofractionated rt over 2 weeks vs temozolomide chemotherapy (tmz)

BACKGROUND: Despite advances in treatment, survival of patients with GBM over 60 years is still often less than 1 year. In the perspective of a short expected survival, the quality of the remaining life and the effects of therapy on health-related quality of life (HRQoL) should be given special emphasis when recommending treatment for the individual patients. Several studies have focused on survival of the elderly, but few data are available on HRQoL for different treatments. In a randomized trial, we compared survival and HRQoL for 3 treatment options, 6 weeks of RT, vs hypofractionated RT, or chemotherapy with TMZ. MATERIALS AND METHODS: Newly diagnosed GBM patients, age ≥60 years with PS 0-2, were randomized to either standard RT (60 Gy in 2-Gy fractions over 6 weeks), hypofractionated RT (34 Gy in 3.4-Gy fractions over 2 weeks), or 6 cycles of chemotherapy with TMZ (200 mg/m2 day 1-5 every 28 days). QoL was determined by the EORTC QLQ 30 questionnaire and the Brain Cancer Module at inclusion, before start of therapy, at 6 weeks, 3 months, and 6 months after start of treatment. Patients were followed until death. The primary study endpoint was overall survival (OS) and secondary objectives were HRQoL, neurologic symptom control, and safety. RESULTS: A total of 342 patients were included and 292 patients were randomized between the 3 treatment options and 50 patients between hypofractionated RT and TMZ. Median age was 70 years (range 60-92) with 58% being male. Performance status was 0-1 for 75% of patients and 73% had undergone surgical resection. CONCLUSION: The results from the HRQoL analysis of this trial will be presented together with survival data at the upcoming EANO meeting.

Canakinumab Relieves Symptoms of Acute Flares and Improves Health-Related Quality Of Life (HRQoL) in Difficult-To-Treat Gouty Arthritis Patients by Suppressing Inflammation: Results of a Randomized, Dose-Ranging Study

RATIONALE:We investigated the impact of canakinumab, a fully human anti-interleukin-1b monoclonal antibody on inflammation and HRQoL in gouty arthritis patients.METHODS: In this 8-week, single-blind, dose-ranging study, patients with acute gouty arthritis flares, unresponsive/intolerant or contraindicated to NSAIDs and/or colchicine were randomized to single subcutaneous canakinumab (10, 25, 50, 90, or 150mg, N5143) or single intramuscular triamcinolone acetonide (TA, 40mg, N557). Patients assessed pain (Likert scale), physicians assessed clinical signs of joint inflammation, and HRQoL was recorded using SF-36.RESULTS: At baseline, 98% patients had moderate-to-extreme pain, 85% had moderate/severe joint swelling, 64-79% had elevated inflammatory markers and HRQoL scores indicated impaired physical function. Percentage of patients with no/mild pain was numerically greater in most canakinumab groups vs. TA, 24-72h post-dose; difference significant for 150mg group at these time-points (P<0.05). Canakinumab 150mg was associated with significantly lower Likert scores for tenderness [OR, 3.2; 95% CI, 1.27-7.89; P50.014] and swelling (OR, 2.7; 95% CI, 1.09-6.50, P50.032) at 72h vs. TA; erythema was not different. Median CRP and SAA levels normalized by 7 days post-dose in most canakinumab groups, but remained elevated in TA. Physical function improved at 7 days postdose in all groups, highest improvement for canakinumab 150mg. SF-36 scores for physical functioning and bodily pain with canakinumab 150mg approached US general population scores by 7 days post-dose and exceeded normal values by 8 weeks post-dose.CONCLUSION: Canakinumab 150mg produced significantly greater and rapid pain-relief and improvements in HRQoL vs. TAin acute gouty arthritis patients.

An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients.

Aims: The psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study. Methods: QLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N=891), including 12 languages. Experimental treatments were surgery followed by radiotherapy (RT) and adjuvant PCV chemotherapy or surgery followed by concomitant RT plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy. Standard treatment consisted of surgery and postoperative RT alone. The psychometrics of the QLQ-BN20 were examined by means of multi-trait scaling analyses, reliability estimation, known groups validity testing, and responsiveness analysis. Results: All QLQ-BN20 items correlated more strongly with their own scale (r>0.70) than with other QLQ-BN20 scales. Internal consistency reliability coefficients were high (all alpha0.70). Known-groups comparisons yielded positive results, with the QLQ-BN20 distinguishing between patients with differing levels of performance status and mental functioning. Responsiveness of the questionnaire to changes over time was acceptable. Conclusion: The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQOL of brain cancer patients in international studies.

Resident health-related quality of life in Swiss nursing homes.

BACKGROUND: Health-related quality of life (HRQOL) levels and their determinants in those living in nursing homes are unclear. The aim of this study was to investigate different HRQOL domains as a function of the degree of cognitive impairment and to explore associations between them and possible determinants of HRQOL. METHOD: Five HRQOL domains using the Minimum Data Set - Health Status Index (MDS-HSI) were investigated in a large sample of nursing home residents depending on cognitive performance levels derived from the Cognitive Performance Scale. Large effect size associations between clinical variables and the different HRQOL domains were looked for. RESULTS: HRQOL domains are impaired to variable degrees but with similar profiles depending on the cognitive performance level. Basic activities of daily living are a major factor associated with some but not all HRQOL domains and vary little with the degree of cognitive impairment. LIMITATIONS: This study is limited by the general difficulties related to measuring HRQOL in patients with cognitive impairment and the reduced number of variables considered among those potentially influencing HRQOL. CONCLUSION: HRQOL dimensions are not all linearly associated with increasing cognitive impairment in NH patients. Longitudinal studies are required to determine how the different HRQOL domains evolve over time in NH residents.

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide.

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.

Health-Related Quality of Life of Young Adults Treated with Recombinant Human Growth Hormone during Childhood.

BACKGROUND: Since recombinant human growth hormone (rhGH) became available in 1985, the spectrum of indications has broadened and the number of treated patients increased. However, long-term health-related quality of life (HRQoL) after childhood rhGH treatment has rarely been documented. We assessed HRQoL and its determinants in young adults treated with rhGH during childhood. METHODOLOGY/PRINCIPAL FINDINGS: For this study, we retrospectively identified former rhGH patients in 11 centers of paediatric endocrinology, including university hospitals and private practices. We sent a questionnaire to all patients treated with rhGH for any diagnosis, who were older than 18 years, and who resided in Switzerland at time of the survey. Three hundred participants (58% of 514 eligible) returned the questionnaire. Mean age was 23 years; 56% were women; 43% had isolated growth hormone deficiency, or idiopathic short stature; 43% had associated diseases or syndromes, and 14% had growth hormone deficiency after childhood cancer. Swiss siblings of childhood cancer survivors and the German norm population served as comparison groups. HRQoL was assessed using the Short Form-36. We found that the Physical Component Summary of healthy patients with isolated growth hormone deficiency or idiopathic short stature resembled that of the control group (53.8 vs. 54.9). Patients with associated diseases or syndromes scored slightly lower (52.5), and former cancer patients scored lowest (42.6). The Mental Component Summary was similar for all groups. Lower Physical Component Summary was associated with lower educational level (coeff. -1.9). Final height was not associated with HRQoL. CONCLUSIONS/SIGNIFICANCE: In conclusion, HRQoL after treatment with rhGH in childhood depended mainly on the underlying indication for rhGH treatment. Patients with isolated growth hormone deficiency/idiopathic short stature or patients with associated diseases or syndromes had HRQoL comparable to peers. Patients with growth hormone deficiency after childhood cancer were at high risk for lower HRQoL. This reflects the general impaired health of this vulnerable group, which needs long-term follow-up.

Health-related quality of life among patients attending cardiovascular rehabilitation

Purpose: f i rst , an investigation of baseline differences in Health-Related Quality of l i fe (HRQOl) among adhere and non-adhere patients of Phase III cardiac rehabilitation (CR) was examined. Second, among patients who adhered to the program, effectiveness of t reatment based on HRQOl was evaluated. Methods: Data was collected by the Brock University Heart Institute. Participants completed a questionnaire battery at baseline and again at six months i f they were still a client. Results: The physical dimension of HRQOl differed at baseline between the adhere and non-adhere groups. for everyone point increase in physical HRQOl scores there was an associated 1.06 times greater likelihood that an individual would adhere to the program. Second, in those who adhered to the program for six months, physical HRQOl scores improved 3.18 points. Conclusions: Phase III CR significant improves HRQOl in patients suffering f rom cardiovascular disease.