Acute infectious conjunctivitis is a common condition most frequently caused by viruses or bacteria. Clinical outcome assessments have been used to assess signs and symptoms of bacterial and viral conjunctivitis, but have not been evaluated for content validity. We aimed to develop content-valid patient- (PRO) and observer-reported outcome (ObsRO) instruments to assess symptoms of ocular discomfort associated with viral or bacterial conjunctivitis in adult and pediatric patients.Draft items were developed from a previous review of published studies from 2001 to 2015. Patients and caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the past 6 months were recruited. Concept elicitation with open-ended questions explored signs and symptoms, followed by cognitive interviewing to assess clarity and relevance of the draft items. Patients aged ≥8 years were interviewed for the PRO; parents/caregivers of children aged 1–10 years were interviewed for the ObsRO. Interviews were conducted in three rounds to allow changes. Concept saturation was documented using a saturation grid. Cognitive interview data were analyzed iteratively and focused on clarity, relevance and inconsistent interpretation of the instrument’s content.n = 10; round 2, n = 6; round 3, n = 7). Data saturation was reached by the 16th interview. The most frequent spontaneously reported signs/symptoms were: discharge, red/pink eyes, itchiness, swelling/puffiness, watery eyes, pain, burning and foreign body sensation. Itching, pain/burning/stinging and foreign body sensation were most commonly reported as the top three most bothersome symptoms. Interview results indicated that items on pain, itching and foreign body sensation for the PRO and pain or discomfort for the ObsRO were relevant to the patients’ experience of conjunctivitis and were clear and easy to understand.Overall, 23 patients or parents/caregivers participated (round 1, PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key viral and bacterial conjunctivitis symptoms in adult and pediatric patients. Acute infectious conjunctivitis is a commonly encountered disorder in children and adults in both primary care and specialty eye care settings. The predominant causes of infectious conjunctivitis are viral and bacterial pathogens; other causes are much rarer . InfectiClinical outcome assessments (COAs) are used to measure symptoms, overall mental state and patient functioning in drug development programs to capture treatment benefit and support regulatory approval . COAs usGiven that published COAs for acute infectious conjunctivitis captured in our literature search lacked documentation of their development according to FDA guidelines for reliability and content validity, we intended to develop a content-valid PRO and ObsRO for use in clinical trials of adenoviral and bacterial conjunctivitis to assess changes in symptoms of ocular discomfort. In this study, two instruments were developed to assess ocular discomfort symptoms associated with acute infectious conjunctivitis: a PRO for adults and children aged ≥8 years and an ObsRO for children aged < 8 years. This paper describes the qualitative evaluation of the novel PRO and ObsRO to support their content validity and potential application to clinical research conducted in children and adults with acute infectious conjunctivitis.The study flow for the development of the PRO and ObsRO instruments are summarized in Fig. Draft items were developed based on a previous review of the published literature for articles from 2001 to 2015 to identify relevant patient-focused concepts  for assessing treatment benefit in patients with viral and bacterial conjunctivitis. Results from the literature review showed that ocular discomfort and pain were common patient-reported concepts in bacterial and viral conjunctivitis .The final instrument was intended to assess ocular pain and discomfort during periodic study visits in clinical trials of adenoviral and bacterial conjunctivitis. The initial draft instrument utilized an 11-point numeric rating scale, a commonly used scale to capture pain, and was developed as a current assessment rather than incorporating a recall period. An adaptation of the instrument was developed for use by parents and/or other caregivers (henceforth referred to as “caregivers”) in patients aged < 8 years (ObsRO). For the PRO, multiple draft items were developed for exploration during patient interviews to evaluate different options for capturing symptoms, such as whether pain and discomfort should be combined into one item or separated into different items. For the ObsRO, one item was drafted to capture eye pain or discomfort based on observable behaviors. These candidate items were tested during the combined concept elicitation and cognitive interviews.Written informed consent and assent were obtained from adult patients/caregivers and child/adolescent patients, respectively. The study involved one-time, one-on-one, face-to-face interviews with patients and/or caregivers of patients with bacterial or viral conjunctivitis. The interviews combined both concept elicitation and cognitive interviewing. In the concept elicitation portion, participants were asked to recall their experience of conjunctivitis (focusing on ocular discomfort) that occurred within the prior 6 months in order to identify key concepts  important to patients with conjunctivitis. The cognitive interviewing portion was used to assess the clarity and relevance of the draft items. All interviews lasted ~ 60 min and were conducted in three rounds, each of which had unique participants. After each round, changes were made to the PRO and ObsRO (caregiver-reported) items, and the revised instrument was tested in the subsequent round. There were no prespecified rules guiding revision of the instruments after each round; decisions were based on the data findings and the judgment of the study team. Three drafts of the questionnaires (one per round) were written before the PRO and ObsRO instruments were finalized. The PRO and ObsRO were developed concurrently but independently of each other.Patients and/or caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the prior 6 months were recruited from the Baltimore, MD metropolitan area of the United States. Patients were required to be free of symptoms of conjunctivitis for ≥1 week before the interview and to have oral and written fluency in English. Patients aged ≥8 years completed the PRO; caregivers of children aged 1–10 years completed the ObsRO. A total of 25 patients were targeted, with the aim of including ≥5 patients within each of the following subgroups: (1) caregivers of infants/toddlers aged 1–3 years; (2) caregivers of children aged 4–7 years; (3) dyads of children aged 8–10 years and their caregivers; (4) children/adolescents aged 11–17 years; and (5) adults aged ≥18 years.n = 2), discharge documents or visit summaries (n = 6), copies of the paper prescription (n = 13), physician notes (n = 1) or diagnosis information from a participant’s health insurance or pharmacy online portal (n = 1). Best efforts were made to recruit a diverse sample based on sex and race/ethnicity.Individuals with any serious psychiatric disorder or other condition that could interfere with providing informed consent/assent or participating in an interview to discuss health were excluded from the study. Potential patients were identified using a patient database provided by the firm Global Perspectives , through social media and/or via direct referral solicitation. Potentially eligible patients or caregivers of patients were screened by Global Perspectives. Diagnosis was based on a physician-completed diagnosis form , watery eyes and discharge. Interviewers then asked each patient to rank the top three most bothersome signs or symptoms. Caregivers were asked to rank the top three most bothersome signs and symptoms based on what they had observed and/or heard from their child. This was followed by questions on the impact of conjunctivitis on the patient. If a symptom/sign was reported by both parent and child in a dyad, it was counted once. If only one individual in the dyad reported a sign/symptom, that was also counted once.In round 1 of the PRO, items on current pain and discomfort were tested. These included a question asking about eye discomfort or eye pain, 2 questions querying eye pain and discomfort separately and separate questions on eye discomfort and eye pain with additional descriptions for pain  and discomfort . In round 2, patients completed the same questions as in round 1 but with the addition of one question based on feedback from the round 1 interviews. In round 3, five additional questions were added based on feedback from round 2 and a decision by the investigators to test the items with a 24-h recall period. The 5 additional items focused on the symptom “at its worst” over the past 24 h.Caregivers in round 1 of the ObsRO were asked to complete one item asking if their child was currently showing observable signs of pain or discomfort, such as eye rubbing, tearing or child expressing pain or discomfort. Only one item was included for the ObsRO because these signs would likely be relevant to all symptoms associated with pain or discomfort. In round 2, caregivers were asked to complete the same item used in round 1. In round 3, the ObsRO was revised to include a 24-h recall.All interviews were audio recorded and transcribed verbatim; transcripts were reviewed to remove identifying data and correct any transcription errors. All transcripts were coded using MaxQDA v.11 . For the concept elicitation portion of the interviews, the data were assessed to document concept saturation, the point at which no new concepts arose during the course of the interviews. A saturation grid was developed to document concept saturation. Signs and symptoms mentioned by patients or caregivers when responding to open-ended questions were coded as spontaneous reports. For the cognitive interviewing portion, the draft PRO and ObsRO items were evaluated for the clarity of their instructions, applicability of their response options and understanding of item content. Cognitive interview data were analyzed iteratively, with data organized by question to allow for identification of issues of clarity, relevance or inconsistency in interpretation. Descriptive statistics  were used to describe patients’ sociodemographic information.n = 5), and the majority (n = 3/5) were black. One-half (n = 2/4) of all child/adolescent patients were black and one-half were female. The majority of caregivers were female (n = 9/10) and black (n = 6/10), and all cared for a child aged 1–6 years. The caregivers in the dyads were all female and most (n = 3/4) were white, while the children in the dyads were aged 9–10 years and had completed the fourth grade. The duration of conjunctivitis experienced by patients ranged from 2 days to a week and a half. The majority (n = 14) of patients had bilateral conjunctivitis, while 9 developed conjunctivitis in only one eye.Overall, 23 patients or caregivers were recruited across three rounds of interviews Table . Almost N = 23) reported a total of 17 signs and symptoms, with an average of 7.8 signs/symptoms per patient. The most frequently reported signs and symptoms experienced by patients are shown in Table n = 22/23), red/pink eyes (n = 21/23), itchiness (n = 15/23), swelling/puffiness (n = 12/23), watery eyes (n = 7/23), pain (n = 7/23), burning (n = 5/23), and foreign body sensation (n = 5/23). When participants were asked to rank the top three most bothersome signs or symptoms, the most frequently reported symptoms were itching, pain/burning/stinging and foreign body sensation; the most frequently reported signs were discharge, pink/red eyes and bump/stye  and child/adolescent (n = 7/8) patients reported impacts of conjunctivitis on daily activities, including missing work/school and social interactions with family and friends. Emotional impacts, such as feeling annoyed, irritated, bored and lonely, were also reported by patients. All 14 caregivers reported impacts of conjunctivitis on their child with respect to daily activities and/or emotional impacts.Data saturation was reached by the 16th participant. Overall, patients and caregivers N = 2 reportedA summary of the issues and solutions during the cognitive interviews is shown in Table Overall, the response options  in the three PRO rounds were found to be clear, easy to understand and appropriate. Results from the round 1 interviews suggested that eye pain and discomfort were relevant to the experience of conjunctivitis in these patients. When they were asked what they thought about the examples of eye pain provided , the patients generally found the examples to be helpful and appropriate and this was also the result in rounds 2 and 3. However, definitions of eye discomfort were highly variable across patients, and there was disagreement as to whether pain and discomfort represented the same concept or should be assessed separately. Round 1 interviews also showed that itching was an important and common symptom for conjunctivitis patients. Therefore, an item on itching was added to the PRO and tested in round 2. When the patients were asked what they thought about the examples of eye discomfort provided , the patients generally found the descriptions to be helpful and appropriate, with the same result in rounds 2 and 3.Round 2 interviews confirmed the importance of itching. Data in round 2 also suggested that foreign body sensation and discharge were relevant and important concepts; therefore additional items on these two concepts were added in round 3 for further exploration. When patients were asked to explain the meaning of the question “how bad is your eye pain or discomfort from your pink eye?” there were mixed interpretations. Three of the 6 patients defined the questions as asking about both discomfort and pain, 1 patient defined the question as how the eye felt overall, 1 patient discussed discomfort only and another discussed pain only.After round 2, it was decided not to remove any items so these could be tested further in round 3. In addition, five items were added on pain, discomfort, itching, discharge and foreign body discharge “at their worst” in the “past 24 h.” The 24-h recall and “symptoms/signs at their worst” wording were added to account for any variability in symptom severity over the course of the day. Discharge was introduced in round 3 because it was a common concept often mentioned during the concept elicitation interviews in rounds 1 and 2. Round 3 results provided further support for the key concepts of pain, itching and foreign body sensation. Items in round 3 were considered clear and easy to answer using the 24-h recall. After round 3, it was decided to focus on symptoms only as clinicians would evaluate signs. As a result, discharge was removed. To improve clarity, the pain item was retained and defined as hurting, burning or stinging. The discomfort item was removed due to inconsistent interpretation by patients.n = 6/7) of caregivers reported the question to be easy to understand, and all caregivers correctly interpreted the question and found it relevant to their child’s experience with conjunctivitis. In round 2, the 2 caregivers reported the question as easy to understand and correctly interpreted its meaning, and found the question relevant. In round 3, all 5 caregivers understood the meaning of the question and found it relevant when asked with a 24-h recall. As with the PRO, the 24-h recall period had been added at round 3 to account for variability over the course of the day.In round 1 and 2, caregivers were asked if their child was showing observable signs of pain or discomfort, such as eye rubbing, tearing or child expressing pain or discomfort. In round 1, the majority  response on observable signs of pain or discomfort is suitable for the ObsRO. The term “discomfort” was removed from the PRO due to inconsistent interpretation by patients, but “ocular discomfort” can still be used to collectively describe these symptoms. Overall, the PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key symptoms of viral and bacterial conjunctivitis in adult and pediatric patients.To our knowledge, this is the first study to develop an ObsRO and to assess content validity of a PRO and an ObsRO for acute infectious conjunctivitis in both adult and pediatric patients. The results of a systematic literature search suggest that the symptoms of viral and bacterial conjunctivitis are generally similar , so the The instruments developed in this study are intended to be used to evaluate ocular discomfort symptoms in patients with adenoviral and bacterial conjunctivitis. For the PRO, patients are asked to think only about what they are feeling because of the conjunctivitis itself and not about what they have experienced from taking the drops. This also applies to caregivers administered the ObsRO when thinking about their child’s experience with conjunctivitis. The PRO and ObsRO take < 5 min to administer and respondent burden is minimal, making it easier to implement in trials or real-world clinical practice. In addition, for patients that are not able to read or write, versions of the PRO and ObsRO that can be administered entirely by interviewers have also been developed. Analyses from clinical trial data will help to examine the measurement properties of the instruments as well as estimate the minimum clinically important differences and responder thresholds for the PRO and ObsRO instruments.There are a number of notable limitations to this study. First, participants were chosen from one metropolitan area only, which could limit generalizability of the study findings. In addition, the diagnosis of conjunctivitis was not confirmed by cultures. In clinical practice, a lack of effective antiviral treatments and the self-resolving nature of bacterial infection limit the value of routine cultures or other diagnostic testing to establish the underlying cause of infection and potential treatment response. Thus, clinicians often rely on signs and symptoms for diagnosis and/or may prescribe antibacterial agents on an empiric basis for suspected or equivocal cases, which can lead to inappropriate use of antibiotics. Another limitation of this study is that conclusions drawn are based on a small sample size. In particular, there were only 4 children in the dyads (aged 9–10 years). Despite this, concept saturation was achieved well within the sample size; similar terms were used by children, adolescents and adults to describe their symptoms; and interpretation of the questions was consistent across rounds. In addition, the participants aged 9–10 years had no difficulties in understanding or answering the questions during the cognitive interviews. While there were no participants aged 8 years in our study sample, the literature suggests that children aged ≥8 years are able to self-report on symptoms such as pain , 15. We Participants were asked to recall their experiences retrospectively in this study. Future research to evaluate these instruments prospectively is needed and would help to track changes in symptoms over the course of the illness. Research to validate incremental changes of symptoms using the instruments and their correlation with clinician-graded objective signs would also be useful. Results from the use of the instruments in clinical trials should provide information to address these questions and validate the instruments in the context of clinical trials of infectious conjunctivitis. Further development of the instruments should also include psychometric evaluation in a larger sample of patients with infectious conjunctivitis.This study supports the inclusion of items on pain, itching and foreign body sensation for a PRO and a general item on eye pain or discomfort for an ObsRO to evaluate ocular symptoms associated with viral or bacterial conjunctivitis in adult and pediatric patients.


Since the start of out-of-hours (OOH) primary care clinics, the number of patient consultations has been increasing. Triage plays an important role in patient selection for a consultation, and in providing reassurance and self-management advice.We aimed to investigate whether the smartphone application “Should I see a doctor?” (in Dutch:”moet ik naar de dokter?”) could guide patients in appropriate consultation at OOH clinics by focusing on four topics: 1) app usage, 2) user satisfaction, 3) whether the app provides the correct advice, and 4) whether users intend to follow the advice.A prospective, cross-sectional study amongst app users in a routine primary care setting.The app is a self-triage tool for acute primary care. A built-in questionnaire asked users about the app’s clarity, their satisfaction and whether they intended to follow the app’s advice (n = 4456). A convenience sample of users was phoned by a triage nurse (reference standard) to evaluate whether the app’s advice corresponded with the outcome of the triage call (n = 126). Suggestions of phoned participants were listed.The app was used by patients of all ages, also by parents for their children, and mostly for abdominal pain, skin disorders and cough. 58% of users received the advice to contact the clinic, 34% a self-care advice and 8% to wait-and-see. 65% of users intended to follow the app’s advice. The app was rated as ‘neutral’ to ‘very clear’ by 87%, and 89% were ‘neutral’ to ‘very satisfied’. In 81% of participants the app’s advice corresponded to the triage call outcome, with sensitivity, specificity, positive- and negative predictive values of 84%, 74%, 88% and 67%, respectively.The app “Should I see a doctor?” could be a valuable tool to guide patients in contacting the OOH primary care clinic for acute care. To further improve the app’s safety and efficiency, triaging multiple symptoms should be facilitated, and more information should be provided to patients receiving a wait-and-see advice. Since the start of out-of-hours (OOH) primary care clinics, the number of patient consultations has been increasing . PatientTelephone triage by a nurse using standardized protocols plays a crucial role in the organization of OOH care in the Netherlands, and in many other countries. During a phone call, the nurse selects patients for a consultation. If a consultation is not deemed necessary, she provides reassurance, advises appropriate self-management, and communicates red-flag symptoms.The internet is increasingly being used to research health concerns and has the potential to change healthcare behavior ,7. NHS CSelf-triage tools, based on computerized clinical algorithms, have been described for abdominal pain, influenza-like-illness, sexual health problems, pediatric emergency care, and also for primary care –15. A reThe app “Should I see a doctor?” was developed to advise patients whether or not to contact the OOH service for acute care, as well as to provide reassurance, information and self-care options. It could be a practical, safe and efficient tool if: 1) the app is regarded clear and users are satisfied; 2) the app provides the correct advice; 3) users follow this advice. We conducted a cohort study to obtain feedback from users on utility, and did a pilot assessment of safety and efficiency in a routine primary health care setting.www.trialregister.nl) under number: NTR4361.We performed a prospective, cross-sectional cohort study between July 2014 and 2015, using a built-in questionnaire and contacting a convenience sample of app users by telephone. From the routine Dutch primary care setting, 6194 app users voluntarily and anonymously participated in this study. The study was approved by the Ethical Committee of the University Medical Center Utrecht, and was exempted by the Committee from obtaining patients’ consent and full protocol delivery (reference number: METC 14-061/C). The study was conducted according to the principles outlined in the Declaration of Helsinki. The study is registered at the Dutch Trial Register (The “Should I see a doctor?” (in Dutch:”moet ik naar de dokter?”) app is a self-triage tool for acute care. It was developed in 2012 by the Apeldoorn OOH GP clinic and Van Campen Consulting, in collaboration with the NHG (Dutch College of GPs) . The apphttps://itunes.apple.com/nl/app/moet-ik-naar-de-dokter/id527929945?mt=8), and Google play store (https://play.google.com/store/apps/details?id=nl.moetiknaardedokter.app&hl=nl) and can be used offline, as well as online. Through a public health campaign all Dutch general practices received flyers and posters about the app for distribution in their waiting rooms, and additionally, the app was endorsed via the media. Assistance in downloading the app was not provided in clinics, so, users found and decided to download and use the app on their own. After downloading, sex and year of birth need to be entered.Since October 2012, the app can be downloaded on smartphones for free via the Appstore How satisfied are you with the app? very unsatisfied, unsatisfied, neutral, satisfied, very satisfied Do you give permission to an OOH clinic triage nurse to phone you and check the advice of the app? yes/no . If yes: What is your phone number?Users who answered question 1 with yes were included in the study (group 1). All users who gave permission in question 5 were called by a nurse as soon as possible, preferably the same day, but within 24 hours (group 2). With these group 2 patients, the nurse performed a routine telephone triage according to the NTS and classified the patient’s problem as: call GP (U1-U4), or wait-and-see (U5)  and addiHow satisfied are you with the advice of the app? Only if the participant indicated to feel ‘unsatisfied’ or ‘very unsatisfied’, they were asked for a verbal explanation.Do you intend to follow the advice of the app? Only if the participant did not intend to follow the app’s advice, they were asked for a verbal explanation.Do you have suggestions to improve the app?All data the participants entered were registered anonymously in Google Analytics. These included a unique user number, sex, age, date and time of use, location of the symptom, main symptom, the app’s triage route, the advice of the app, and the answers to the 5 questions of the built-in questionnaire. In the start-up phase sex, age and symptom data were not registered. For the phoned participants, date and time of the phone call, the triaged complaint/symptom, the triage outcome , or wait-and-see), and the verbal explanations and suggestions -in short sentences and catchwords- were entered by the nurse in Excel. Names were not registered and telephone numbers were not stored.Continuous variables are reported as mean values with a standard deviation and dichotomous data as percentages. To assess differences in user-rated clarity, satisfaction and their intention to follow the advice, subgroups, based on age, sex and the app’s advice, were analyzed. Factors related to ‘intention to follow the advice’ and ‘satisfaction’ were investigated using multivariate logistic regression analysis (stepwise backward) using determinants with a p-value less than 0.1 (as determined by Chi Square testing), with a cut-off value of 0.05 for expulsion from the model. For Chi Square testing and multivariate regression analysis the following continuous and ordinal data was dichotomized: age as 0–12 and >12 years, satisfaction as (very) satisfied and the other three options, clarity as (very) clear and the other three options. Additional variables were: advice  and sex. SPSS version 22 was used for the analyses. Sensitivity, specificity, positive- and negative predictive values and likelihood ratios were calculated with 95% confidence intervals (CI). Telephone triage was regarded as the reference standard. To further assess safety, we compared the triaged symptoms by the app and the nurse for those cases where the app under-triaged.A semi-qualitative approach was used to analyze the phoned participants’ responses. Two reviewers (NV and AvdV) read the comments and suggestions and defined three overarching themes with various sub-themes; these were mutually agreed. These (sub-)themes were manually assigned to the responses independently by two reviewers; discrepancies were reviewed and jointly agreed. Absolute numbers are reported .The app “Should I see a doctor?” was developed as a self-triage decision support tool for acute primary care in the Netherlands. Nowadays, it has been downloaded over 200,000 times.In the study period, all app users in the Netherlands received a pop-up asking whether they wanted to participate in a short survey. A total of 4456 out of 6194 respondents answered to have used the app for a current medical problem and were included in the study (group 1). During one month participants could provide their phone number for a routine triage call. Of these, 143 participants could be contacted within 24 hours, and 126 were triaged for the same disease entity as they consulted the app for (group 2).The app was used by participants of all ages and also by parents for their children, but most often by adults 19 to 45 years of age. The majority of users were female (66%). Overall, the app was most often used for abdominal pain, skin disorders and cough . More spOf all users, 87% rated the app as ‘neutral’ to ‘very clear’. No differences were found in clarity per triaged symptom . 89% of users were ‘neutral’ to ‘very satisfied’ with the app . Being  and their experiences with the app were statistically not different from those of group 1. Group 2, however, contained more males .Overall, the app’s advice corresponded to the outcome of the triage call for 81% of phoned participants . For 11%To obtain insight in potential reasons for the discrepancies between both outcomes leading to under-triaging, the symptoms of these 14 patients were further analyzed . First, Of the participants contacted by phone, 19 answered to be dissatisfied with the app and provided a total of 21 explanations for this. The majority (62%) related to a perceived inability to enter the (complete) story of their illness; the specific issues that were mentioned are listed in A total of 65 suggestions were communicated to further improve the app, which are listed in The app is used by patients of all ages, also for children, and for a wide variety of symptoms. For adolescents and young adults, it seems to be an easily accessible tool to evaluate genital organ complaints. The app is most often used in the evening/night and weekend, fitting with its aim to evaluate whether an OOH contact is needed. The majority of users were (very) satisfied with the app and 65% intended to follow its advice. The app under-triaged 11% of patients, but not for life-threatening symptoms. Users provided good suggestions for improvements of the app.To our knowledge, our study is the first to have evaluated the performance -utility, safety and efficiency- of a self-triage tool in a routine primary care setting. This provides insight into whether such a tool has the potential to decrease pressure at OOH clinics in a safe and patient-friendly way. Furthermore, we’ve compared the app’s performance with a routine telephone triage. First, as this is the normal patient route, and second, they use the same underlying clinical algorithms.Some limitations should be acknowledged. First, we were only able to question the user’s intention to follow the advice, but couldn’t measure real behaviour. For complete insight in the efficiency of gatekeeping tools, research how patients interpret the advice and how this changes healthcare seeking behaviour would be needed. Second, calls with 126 users were available for diagnostic accuracy determination; more calls could have provided more precision. Patients who agreed to be phoned by a nurse could have introduced selection bias. However, comparing their characteristics with group 1 did not reveal important differences. We therefore don’t expect that selection bias limits generalizability. Third, 9% of phoned users were contacted the day after they had used the app. Symptoms might have settled, worsened and/or changed, and it was not clear whether patients reported their current, or earlier symptoms to the nurse. This delay has probably resulted in mismatches, as when these cases were removed from the accuracy analysis figures improved to a sensitivity of 87%, specificity of 73%, PPV of 87% and NPV of 73%. Finally, the phone triages were not recorded as we did not want to interfere with the routine procedure of these calls. Therefore, a detailed analysis of the specific questions and responses causing discrepancies was not possible.Several studies support the potential of medical apps ,8,20, hoNHS Choices users reported to have reduced primary care consultation due to using the website . Other sThe app’s safety and efficiency can and should be improved, and our study has provided direction to this aim. For six of the under-triaged patients the app triaged another symptom than the nurse. For example, the app was used for ‘throat complaints’ and the nurse triaged ‘cough’, ‘cough’ versus ‘sick child’, or ‘stomach ache’ versus ‘malaise’ . These sThe efficiency of the app is at stake when a wait-and-see advice is not adhered to. Intended non-adherence to a wait-and-see advice was 44% in our study. Participants commented that they weren’t fully reassured, the advice was not extensive enough, and that more information was needed. We therefore recommend extending the advices, and more linkage to a website endorsed by the national GP organization. The patient website of the Dutch College of GPs (thuisarts.nl) provides such extended advice . Better Undoubtedly, e-health will get a more prominent place in healthcare . Given tS1 Text(DOCX)Click here for additional data file.S1 TableIn total, 65 suggestions were provided by the phoned participants.(DOCX)Click here for additional data file.


The prevalence of chronic pain is between 33% to 64% and is due to cancer pain, but it has also been observed in non-cancer patients. Chronic pain is associated with lower quality of life and higher psychological distress and depressive/anxiety disorders in patients without a history of disorder.In this study we evaluated in clinical practice the effectiveness of the intrathecal pump in 140 patients who underwent pain therapy at our Center. These patients were consecutively enrolled from January 2010 to July 2018.Follow-up was carried out over these eight years regarding the infusion modalities. Pain relief was obtained in 71  patients out of the 140 that experienced satisfactory pain control globally.Intrathecal therapy is one of the best options for chronic severe refractory pain. The greatest advantage of this therapy is due to the possibility of treating the pain with minimal dosages of the drug, avoiding the appearance of troublesome side effects. It can take on different aspects both from a clinical and biological/ physiological point of view, and present itself as an epiphenomenon of a pathophysiological process, until it becomes a real pathological entity in its own right. Pain is defined as chronic when it is continuous for more than three tosix months . It is aIL-6, TNF-α and IL1-β, produced by macrophages, are cytokines that amplify chronic pain. According to some studies, the administration of TNF-α is associated with thermal hyperalgesia, mechanical allodynia and hypersensitivity associated with pain. In the electrophysiological field, TNF-α can also increase the conductivity of K+ ions of the membrane in a non-voltage dependent manner, resulting in overall neuronal hyperexcitability and therefore neuropathic pain. TNF-α induce the release of glial mediators TNF-α-induced glial mediators cause endocytosis of GABA receptors with consequent reduction of inhibitory modulation of the GABAergic system. Longterm potentiation (LTP) is a physiological mechanism for strengthening a neuronal circuit and is involved in numerous nerve functions. Intrathecal therapy (IT) is a good choice to improve therapeutic results in chronic pain.The aim of this study was to evaluate in clinical practice the effectiveness of the intrathecal pump in 140 patients consecutively enrolled from January 2010 to July 2018 who underwent pain therapy at our Center.2One hundred and forty patients who underwent pain therapy at our Center were consecutively enrolled from January 2010 to July 2018. All procedures conducted in the study were in accordance with international guidelines, with the standards of human experimentation of the local Ethics Committees and with the Helsinki Declaration of 1975, revised in 1983.At the baseline visit, each patient signed their informed consent for the use of their data in clinical research.All 140 patients underwent complete physical examination. Their pain was evaluated with the McGill Pain Questionnaire (MPQ), recording the Numerical Rating Scale (NRS) of average pain, minimum pain, maximum pain and pain during exertion . All patients were evaluated for HBV, and HCV serum markers. Serum samples were tested for HBsAg, anti-HCV, total anti-HBc, and anti-hepatitis B surface antibody (HBs) using commercial immunoenzymatic assays  M/S for HBsAg, AxSYM® HCV (v3) for anti-HCV, AxSYM® CORE™ (v2) for total anti-HBc, and AxSYM® AUSAB® for anti-HBs), as described in previous studies , 27, 28.Epidemiological, clinical, and immunological data recorded at the baseline visit included patients’ age and sex and risk factors for the acquisition of pain as stated by the patients.All cases were followed-up in these 8 years with complete physical examinations, laboratory tests were carried out and pain was re-evaluated.3The demographic and clinical data obtained at enrolment are shown in The 140 patients were predominantly male: 98 (70%), with a media age of 51.2 years old (range: 42-63). Of 140 patients, 99 cases had been subjected to a system for the treatment of chronic cancer pain; 41 patients were diagnosed with non-cancer pain. In non-cancer pain patients, the main diagnoses were neuropathic or mixed pain, chronic, not responsive to conventional drug therapy and / or burdened by the incidence of significantly elevated side effects with high doses. Some patients were not responders to spinal cord stimulation .Morphine was administered as the first intrathecal continuous infusion in 120 cases, in three patients ziconotide was used alone as the primary infusion, and 11 patients received primary Baclofen infusion alone. Ziconotide and Bupivacaine are analgesic adjuvants to morphine. In three patients, Ziconotide had been used in association with morphine as a secondary infusion, and three patients had a secondary infusion of Bupivacaine used in association with morphine. The patient was then given an intrathecal continuous infusion of one of the following: ziconotide 2.5 mL (2.5 μg at 1 μg per mL) daily, morphine 0.1-8 mg daily, baclofen 250-1000 μg daily or bupivacaine 3-8 mg daily.From the follow-up carried out over these 8 years regarding the infusion modalities and the titration of the described drugs, the following data concerning pain relief was obtained: 71  patients out of 140 experienced satisfactory pain control globally, settling on a percentage of pain relief variable from 50 to 70%.Only one patient, followed by oncologist, showed pain relief less than 30%.In patients on follow-up with baclofen infusion for a diagnosis other than chronic pain, a variable reduction of the painful physiological symptomatology in spasticity was observed.4Intrathecal therapy is a good choice to improve therapeutic results in patients with chronic pain. In fact, the morbidity and mortality of IT opioids are lower than those of systemic administration of opioids. A trial on 6398 patients in over a period of ten years , showed Regarding the algorithm for IT management in patients with cancer pain, the prognosis, the probable disease progression in anatomical regions, features of tumors and findings of peri-procedural imaging are useful considerations for the selection of the device. Patients with cancer pain deserve special attention, in terms of implementation of IT and selection of drugs, together with the sustainability of a regime. Therefore, patients are stratified into 3 main categories by stage of disease and life expectancy. In the last PACC update, IT is used to treat related/unrelated cancer pain, and chronic-severe refractory pain . The focThe need to resort to the continuous infusion of subarachnoid drugs occurs when pharmacological, neurostimulation or surgical therapies have been unsuccessful. The main indications are: chronic non-cancer pain with a strong neuropathic component; chronic cancer pain with more than 6 months of life expectancy, and spasticity of degenerative and traumatic origin.The procedure is completely reversible, the catheter can be removed if the expectations in terms of reduction / disappearance of the symptomatology are not met; the greatest advantage is the possibility of treating the symptoms  with minimal doses of effective drug, avoiding the appearance of troublesome side effects. Fixed-flow pumps have an indefinite duration, while programmable flow pumps are constrained to when the battery runs out, so they must be replaced before the battery expires.The implant procedure involves positioning the catheter in the subarachnoid space, connecting it to the pump through a second catheter (extension) that is tunneled to the abdomen where the subcutaneous pocket containing the pump is packaged. Both the first and second phases of the operation are performed under local anesthesia, possibly paired with a mild analgosedation. In addition to the risks associated with the completion of a surgical procedure, the implants and / or the use of IT devices may also entail the following risks and complications: the displacement or disconnection of the catheter may occur; insertion of a catheter into the subarachnoid space may result in epidural bleeding, headache, hematoma, infection, spinal cord compression and/ or paresis; loss of cerebrospinal fluid (fluid that bathes nerve structures), with possible headache; persistent pain at the site of implantation of the catheter or pump; serum collection at the pump site just under the skin, which can be evacuated with a simple puncture; catheter migration, which can cause changes in the analgesic effect; allergic reaction or rejection of implanted materials;and pain localized at the implant site.Our study demonstrates the effectiveness of intrathecal therapy in reducing severe chronic refractory pain compared to intravenous (i.v.) therapies. The importance of specialized staff dedicated to these procedures can drastically reduce adverse events and complications. It is a safe and manageable solution in pain management and can be considered for chronic refractory pain from all sources. Our data shows a longer follow up and case study than the others in the literature , 61, 62 5Chronic pain is correlated with lower quality of life and depressive/anxiety disorders (15.5%) in patients without a history of these disorders. Depression and anxiety are associated with more severe pain.Intrathecal therapy is one of the best options in the treatment of chronic/severe refractory pain. The costs associated with therapy in terms of safety are significantly better than those of systemic opioids.The greatest advantage of this therapy is due to the possibility of treating the pain with minimal dosages of the drug, avoiding the appearance of troublesome side effects. Non-responsive patients represent the ideal category to be addressed with “niche” techniques such as cordotomy.Our results confirm that intrathecal therapy is one of the best choices in the management and treatment of severe chronic refractory pain. This therapy, overall, is safer than systemic opioids, which often need higher dosages to be effective. With systemic opioid therapy, the higher dosages and possible interferences with other drugs used in this type of complex patient allow an increase in the possibility of serious adverse events. Intrathecal therapy has demonstrated superiority in the management of dosages of these drugs which can be reduced to the minimum effective with this technique.The use of minimum effective dosages of opioids in pain therapy allows a reduction in serious adverse events, and for this reason also a considerable reduction in the overall costs of treatment of chronic patients.The need to resort to the continuous infusion of subarachnoid drugs occurs when pharmacological, neurostimulation or surgical therapies have been unsuccessful. The catheter can be removed calmly, if the expectations in terms of symptomatic reduction are not met.


The Back Beliefs Questionnaire (BBQ) is a 14-item patient-reported questionnaire that measures attitudes and beliefs about the consequences of back pain. The BBQ has recently been translated into Norwegian, but its psychometric properties have not yet been tested. The aim of this study is to evaluate the reliability and construct validity of the BBQ when used on elderly patients with back pain.> 55 years of age) seeking primary care for a new episode of back pain. Test-retest, standard error of measurement (SEM), minimal detectable change (MDC), internal consistency and construct validity by a priori hypotheses (Spearman’s- and Pearson correlation coefficient) were tested.A prospective cohort study with a test-retest design among 116 elderly patients  67.7 (8.3), were included and 63 patients responded to the test-retest assessment. The mean (SD) BBQ sum scores (range 9–45) were 29.8 (7.0) and 29.2 (6.7) for the test and retest respectively. The test-retest was acceptable with an intraclass correlation coefficient of 0.71 , SEM was 3.8 and MDC 10.5. Internal consistency with Cronbach’s alpha was good (0.82) and acceptable construct validity was supported by the confirmation of 75% of the a priori hypotheses.The Norwegian version of the BBQ demonstrated acceptable test-retest reliability and good construct validity and can be used to assess pessimistic beliefs in elderly patients with back pain. Back pain is among the most common musculoskeletal complaints seen in primary care . The preBeliefs and attitudes towards back pain can be measured with questionnaires. The Back Beliefs Questionnaire (BBQ) was developed by Symonds et al., with the aim to make a new instrument to measure beliefs and attitudes related to back pain . The autThe BBQ has recently been translated into Norwegian, but assessment of test-retest reliability and validity has not yet been performed. The psychometric properties of any scale may be affected by translation into another language, hence, it is important for the scale to be evaluated psychometrically. Therefore, the aim of this study was to evaluate the psychometric properties of the Norwegian version of the BBQ in terms of test-retest reliability, construct validity and internal consistency when used on elderly patients with a new episode of back pain.> 55 years) patients with back pain. The protocol has been published   .The internal consistency of the questionnaire was assessed with Cronbach’s Alpha. Values ranging from 0 to 1 are considered good when above 0.8, moderate between 0.7 and 0.8, and low when under 0.7 .Construct validity for the BBQ total score was assessed by comparing the BBQ for association to concurrent measures. Predefined hypotheses of association were established based on the construct of the measures and former correlations in similar studies. The BBQ was hypothesized to have moderate to high correlation with the FABQ-PA, moderate correlation with the RMDQ, high correlation with the PCS, and low to moderate correlation with the NRS. A high score in reference scales indicates more fear avoidance, catastrophizing, disability and pain, and a low score in BBQ reflects pessimistic beliefs and attitudes, meaning that all correlations were expected to have negative values. The Pearson’s correlation coefficient was used if values were normally distributed and the Spearman’s correlation coefficient if values were not normally distributed. Correlation between scales was interpreted as high when r was 0.50 and above, moderate when between 0.30 and 0.49, and low when between 0.10 and 0.29 .The prefinal version of the Norwegian BBQ was tested on the first ten participants at baseline, with similar characteristics as the whole sample. The ten participants included 6 women and 4 men, with a mean age of 69.1, all with a history of back pain and a mean (SD) BBQ score of 27.6 (4.9). The main study included 116 patients from primary care with back pain in the validation (T0), 71 women and 45 men. Of those included, 10 patients had missing items in the BBQ and were excluded from the analysis, resulting in a total of 106 participants with valid data. Sixty-three participants had valid data at retest (T1). The 10 incomplete responses had a total of 25 missing items, within which every item on the scale was represented. Items 13 (“Back trouble must be rested”) and 14 (“Later in life back trouble gets progressively worse”) had five missing values each, and the other items each had 1–3 missing values. Among the distractors, item 7 had four missing values, and item 4,5,9 and 11 had 1–2 missing values. The mean (SD) BBQ total score at T0 was 29.8 (7.03). The lowest (9) and highest (45) possible scores were each achieved by one participant, indicating no floor- or ceiling effects for the BBQ total score. Patient characteristics and clinical variables are presented in Table The median time between test and retest was 3 days range 1–13). There was an acceptable agreement between the test and retest total score, with an ICC  of 0.71 . The SEM of the BBQ total score was 3.8, the MDC was 10.5 and MDC% was 23.3. The Bland-Altman plot  and, moderate correlation to both PCS (rho = − 0.45) and RMDQ (r = − 0.49). Moreover, the BBQ demonstrated a weak correlation to the NRS (rho = − 0.14). In total, the correlation coefficients confirmed 75% of the a priori hypotheses.Evaluation of normality with Kolmogorov-Smirnov tests and the visual inspection of distribution plots suggested that BBQ, FABQ-PA and RMDQ, were normally distributed, while PCS and NRS were non-normally distributed. Table The Norwegian version of the BBQ shows acceptable psychometric properties in elderly patients with a new episode of back pain. Our results indicate that BBQ can be used in both clinical settings and research with the purpose of assessing beliefs about back pain. This is in line with former assessments of BBQ in other languages , 15, 31.Fears and beliefs leading to avoidance have been shown to negatively influence the prognosis of back pain and increases the risk of developing chronic disability , 33. Wit. The ICC is influenced by the variation between the patients – heterogeneity resulting in a high ICC value – and substantiates the importance of assessing measurement errors [Our study sample completed the BBQ with a mean score of approximately 30 on a scale ranging from 9 to 45; this is a relatively high score, reflecting optimistic beliefs. This score is higher than some other studies which report a mean score ranging from 21 to 26 , 18, 34,t errors . MDC, wht errors . Due to A high internal consistency was found for BBQ, even though the Cronbach’s alpha coefficient is sensitive to the number of items in the scale, and questionnaires with fewer than 10 items can result in a value that is too low , 39. TheConstruct validity is an important element of the validity of a questionnaire. As there were no comparable questionnaires for evaluating back beliefs in our prospective cohort, construct validity was assessed by testing predefined hypotheses about expected correlations to other measurements in our study. The hypotheses were based on existing literature on the BBQ and its assumed relation to similar or non-similar constructs. As expected, a good correlation between the BBQ and the FABQ-PA was found, similar to the original study by Symonds et al., in Britain . Other sOne limitation of this study is that we could not prohibit participants from seeking medical advice or treatment between recruitment, baseline testing and retesting, and their back beliefs may therefore have been influenced by healthcare or alternative care practitioners. Furthermore, participants were recruited in primary care, and due to practical and economic considerations, there are no data on potential study participants that declined to participate.This study indicates that the Norwegian version of the BBQ had acceptable test-retest reliability, internal consistency and construct validity when used on elderly patients in primary care with a new episode of back pain. Further investigations on the importance and consequences of back beliefs are recommended. Research should also explore how to influence irrational attitudes and beliefs about back pain.Additional file 1. The Norwegian version of the Back Beliefs Questionnaire.


However, there were no significant differences (p>0.05) in the treatment effects between TBMT and CBMT, except for ‘vitality’ (p=0.011) scale in the GHS where TBMT led to significantly higher mean score. Mobile-app platform of the McKenzie extension protocol has comparable clinical outcomes with the traditional clinic-based McKenzie Therapy, and thus is an effective supplementary platform for care of patients with low-back pain.Studies on validation of telerehabilitation as an effective platform to help manage as well as reduce burden of care for Low-Back Pain (LBP) are sparse. This study compared the effects of Telerehabilitation-Based McKenzie Therapy (TBMT) and Clinic-Based McKenzie Therapy (CBMT) among patients with LBP. Forty-seven consenting patients with chronic LBP who demonstrated ‘directional preference’ for McKenzie Extension Protocol (MEP) completed this quasi experimental study. The participants were assigned into either the CBMT or TBMT group using block permuted randomization. Participants in the CBMT and TBMT groups received MEP involving a specific sequence of lumbosacral repeated movements in extension aimed to centralize, decrease, or abolish symptoms, thrice weekly for eight weeks. TBMT is a comparable version of CBMT performed in the home with the assistance of a mobile phone app. Outcomes were assessed at the 4th and 8th weeks of the study in terms of Pain Intensity (PI), Back Extensors Muscles’ Endurance (BEME), Activity Limitation (AL), Participation Restriction (PR), and General Health Status (GHS). Data were analyzed using descriptive and inferential statistics. Alpha level was set at p< 0.05. Within-group comparison across baseline, 4 Chronic Low-Back Pain (LBP) is more resistant to therapeutic intervention than the other forms of back pain , as a reConsequent to the foregoing, exercise has become the central element in the physical therapy management of patients with chronic non-specific LBP . Still, The McKenzie method is a classification-based treatment for LBP  with subTelerehabilitation is considered as a potential solution to bridge service delivery gap, especially in geographically remote areas with shortage of health care personnel and lack of access to physical therapy rehabilitation services . Telereh2 , Osogbo and the State Hospital, Ejigbo were invited into this quasi-experimental study. However, only 56 of the consenting patients were found eligible for the study, and 47 completed the study. CONSORT showing the progression of patients through the study is presented in 2 , where cThe following instruments were used in this studyQuadruple Visual Analogue Scale (QVAS): This was used to assess pain intensity experienced by the participants at the time of assessment, typical or average pain, pain at its best, and pain at its worst, respectively . A YorubOswestry Disability Index (ODI): This was used to assess participation restriction . A YorubRoland Morris Disability Questionnaire (RMDQ): This was used to assess activity limitation in activity of daily living among the participants. Similarly, a Yoruba translated version of the 24 item RMDQ  was used in the study.SF-12 General Health Status Questionnaire: This was used to assess the general health status (GHS) or the Health-related Quality of Life (HRQoL) of the participants. A Yoruba version of the SF-12 was also used in this study (2015).All translations of the tools used in this study were done by language experts from the Department of Linguistics and African Languages, Obafemi Awolowo University, Ile Ife, Nigeria.Ethical approval for this study was obtained from the Health Research Ethical Committee of the Institute of Public Health, Obafemi Awolowo University Research and Ethical Committee before the commencement of the study. The purpose of the research was explained to each consenting participant. A Yoruba-translated informed consent form was also used in the study. Participants were consecutively recruited but randomly assigned to the two treatment groups until they had all completed the 8-week treatment program. In order to introduce blinding and reduce bias, a research assistant recorded the number of patients who were invited to participate, the number who declined to participate, and the number of screened patients who were ineligible and their reasons for declining participation or ineligibility. Participants who volunteered to participate and satisfied the eligibility criteria were randomly allocated to group A or B by the same assistant who was not involved in the assessment and treatment of the patient. In order to ensure equal-sized treatment groups, random permuted blocks were used  and a blBaseline assessment was carried out for each participant in the study. Anthropometric variables involving weight and height were measured. The participants were screened for their eligibility to participate in the study using the McKenzie Institute’s Lumbar Spine Assessment Algorithm (MILSAA). The MILSAA sought information on demographics and LBP-specific characteristics including onset of back pain, recurrence, duration of complaint, and previous intervention received. The MILSAA is a well-defined algorithm that leads to the simple classification of spinal-related disorders. This is based on a consistent “cause and effect” relationship between historical pain behaviour as well as the pain response to repeated test movements, positions, and activities during the assessment process. The participants were assessed for directional preference. This involved repeated movements, between 5–10 sets of each movement and included movements in standing and lying and in sagittal and frontal planes while the participants’ symptomatic and mechanical responses were assessed. Following the repeated-movement testing, the participants returned to the same standing position and following standardized instructions in the MILSAA, they were asked whether pain was centralizing or peripheralizing during and after movements, or if there was no effect. The participants’ mechanical responses to repeated movements was used to establish their directional preferences. Flexion, lateral, and no responders to repeated movements were excluded from the study. Only extension responders from the MILSAA assessment were eligible for the study. None of the participants reported positively to the specific questions in the MILSAA indicative of red flags. None of the participants reported a current episode of constant symptoms of LBP. Among all the participants, test movements in flexion in standing produced pain, while repeated movements in flexion increased pain in either standing or lying. On the other hand, test movements and repeated movements in extension in standing and/or lying decreased and/or centralized pain among the participants. Following their qualification to participate in the study, each participant was requested to complete the outcome measures before the commencement of the exercise protocol and subsequently at weeks 4 and 8 of the study.Static back extensors endurance was conducted prior the commencement of intervention using the modified Biering-Sørensen test of Static Muscular Endurance (BSME). The BSME was preceded by a warm-up phase of low-intensity self-pace walking and active stretching of the trunk and the extremities for about five minutes. During the BSME, the participant lay on a plinth in prone position with the upper edge of the iliac crests aligned with the edge of the plinth, and with hands held by the sides. The lower body (the lower extremities) was fixed to the plinth by two non-elastic straps located around the pelvis and ankles. Horizontality in the test position was ensured by asking the participant to maintain contact between his/her back and a hanging ball. Once a loss of contact for more than 10 seconds was noticed, the participant was encouraged once to immediately maintain contact again. Once the participant could not immediately correct or hold the position or claimed to be fatigued, the test was terminated .The CBMT group received the McKenzie extension protocol. The protocol involves a course of specific lumbosacral repeated movements in extension that cause the symptoms to centralize, decrease, or abolish . The extTelerehabilitation-based McKenzie therapy is a comparable version of CBMT performed in the home with the assistance of a mobile phone app. The TBMT app is a combination of the McKenzie extension protocols and back care education developed and enabled to run on a smartphone or android phone with Operating System of 3.0. The app is exclusively a product of the authors and not that of the McKenzie Institute International. It incorporated personalized and guided self-therapy using the same protocols in the McKenzie protocol . Thus, the TBMT is a mobile phone video app designed for patients with chronic LBP based on McKenzie therapy principles.The app has moderate to high usability and functionality features based on the findings on its development and feasibility . This futh and 8th weeks of the study. During these assessment sessions, participants underwent the modified BSME, as well as, completed all the outcome tools. All outcome assessments were done in the clinic.Treatment outcome assessments were carried out at the 4th and 8th week for continuous variables, while Friedman’s ANOVA was used for categorical variables. Alpha level was set at 0.05. The data analysis was carried out using IBM Statistics SPSS 22.0 version software .Descriptive statistics of mean and standard deviation were used to summarize the data. Comparing between the two groups, independent t-tests were used to compare demographic characteristics and patients outcomes that were continuous variables , while Mann Whitney U-tests were used for the categorical variables (ODI and SF-12 scores). For within groups effects, repeated measure ANOVA was used to determine the effects of the different treatment regimen across baseline, 4Participants in the two groups were comparable in general characteristics (p>0.05) . A majorth and 8th week. Results shows that there were significant differences (p<0.05) in the outcome parameters across the three time points of the study.th week of the study  , except for items ‘vitality’ (p=0.011) on the SF-12 where the TBMT had significantly higher mean change (Between groups comparison of effects showed no significant differences (p>0.05) in the treatment outcome (mean change) at the end of the 4 values) . Similarn change .This study compared the effect of CBMT and TBMT on pain intensity, back extensors muscles’ endurance, activity limitation, participation restriction, general health status, and cost-utility in patients with chronic non-specific LBP. The participants in this study were on the average 48.8±11.1years old. The age category of participants in this study fell within the age bracket of 40–80 years within which LBP is prevalent . Also, mThe clinical characteristics profile of the patients in this study, showed that the patients’ pain was longstanding (about nine months), with the majority having recurrent episodes of LBP. LBP is reported to run a recurrent course in the majority of patients . In esseThere were reports that LBP disturbed sleep among some patients in this study, consistent with the findings of prior studies that chronic LBP significantly affects quality of sleep . It has None of the patients in this study reported positively to specific questions in the McKenzie Institute Lumbar Spine Assessment Algorithm that were indicative of red flags. Also, none of the patients reported a current episode of constant symptoms of LBP. For all participants, test movements in flexion in standing produced pain, while repeated movements in flexion increased pain in either standing or lying. On the other hand, test movements and repeated movements in extension in standing and/or lying decreased and/or centralized pain among the participants.The patients in this study were comparable in their general characteristics, except for weight. Similarly, their baseline clinical measures were comparable, except for ‘vitality’ on the SF-12 health survey. Baseline characteristics are believed to be predictors of response to treatment in clinical trials for LBP . Hence, The within-group comparison of participants in CBMT and TBMT groups across the three time points of the study revealed that McKenzie extension therapy plus back hygiene conducted via the traditional clinic-based approach or performed in the home with the assistance of a mobile phone app had significant effects on pain intensity, back extensors muscles’ endurance, activity limitation, participation restriction, and general health status. These findings are consistent with previous reports that demonstrated evidence for use of the McKenzie protocol . Thus, iThe mechanism by which the McKenzie protocol achieves its therapeutic effects is largely dependent on patients’ differences and pathologic conditions as per the type of McKenzie syndrome. For example, derangement syndrome is believed to result in obstructed range of motion . McKenziIn addition to the foregoing, previous studies have shown that extension movements cause an anterior migration of nuclear tissue, which conversely displaces posteriorly during flexion . Therefoth and 8th weeks of the study, except for vitality composite of the SF-12 where the TBMT group had significantly higher mean change. It was also observed that the CBMT had a higher mean change margin in the mental health domain of the SF-12 but was not statistically significant (p=0.053). The significant difference in vitality observed between both interventions may not be unconnected with the significant difference that existed in the baseline between both groups. In addition, the significant difference in the weight, with the app-based group being significantly heavier than the clinic-based group, may explain the subsequent difference in fatigue/vitality.The findings of this study showed that there were no significant differences in the treatment outcome (mean change) between the CBMT and TBMT groups at the end of the 4There are earlier claims that telerehabilitation enhances the psychological functioning of patients and their intrinsic motivation . There aGenerally, there are more studies on the use of telerehabilitation to aid in the assessment of patients with LBP  than forThere is a wide range of heterogeneity between studies with respect to methodologies, population samples, clientele, settings, and outcomes measured. Many of the studies reported similar or better clinical outcomes for telerehabilitation when compared to conventional interventions , while nth and 8th week from this study, supports the assertion that mobile technology will not completely replace the traditional in-person interaction with a health-care professional (The McKenzie therapy approach propagates the principle of extension in the management of LBP and also advocates self-care. Although the efficacy of McKenzie method has been established by several studies, it is yet to be proven whether the method will produce similar results if self-administered outside the conventional clinic-based approach. The comparability in findings between the CBMT and TBMT at 4essional . Howeveressional . In partessional .McKenzie extension protocol conducted via a telerehabilitation platform has comparable outcomes with clinic-based McKenzie therapy. Thus, telerehabilitation application of the McKenzie extension is effective in management of patients with chronic non-specific low-back pain. Hence, telerehabilitation-based McKenzie therapy may help bridge the gap in the non-availability of clinic-based McKenzie therapy facilities, especially in remote settings.


Although pain management in EDs has been fully addressed in clinical trials, prehospital settings have rarely been investigated.The present study was conducted to compare the effectiveness of intravenous acetaminophen with that of ketorolac in pre-hospital pain control.This randomized clinical trial (RCT) was performed at a prehospital setting during EMS missions in Tehran, Iran. The eligible candidates comprised all patients over the age of 7 years with a complaint of moderate to severe pain. The patients were randomly assigned to two groups, one receiving 30 mg of intravenous (IV) ketorolac and the other 1 g of IV acetaminophen. The pain intensity was measured using a visual analog scale (VAS) before administering the analgesic and upon admission to the ED.The present study was conducted on 150 patients aged 8–81 years with a mean age of 40.4 ± 17.7, including 84 (56%) males. The mean reduction in the pain score was 14.9±8.6 in the acetaminophen group and 16.0±8.8 in the ketorolac group. Univariate analyses suggested no statistically significant differences between the two groups in terms of delta pain score (pain reduction) (P=0.429).Based on the obtained findings, both ketorolac and acetaminophen could be administered for pain management in prehospital settings in both traumatic and non-traumatic patients in case their contraindications are considered. Emergency patients always complain about the unpleasant sensation of pain. It is believed that, the earlier the pain control is started, the more successful it appears to be. So, starting pain management by emergency medical service (EMS) technicians can help with the better control of pain in the emergency department (ED) , 2. DespThis randomized clinical trial (RCT) was performed at a prehospital setting during EMS missions in Tehran, Iran. After approving the study protocol by ethics committee of Iran University of Medical Sciences, sampling was performed from September 2011 until March 2012. After signing informed consent forms, the patients were included in the study. The Declaration of Helsinki was also followed throughout the study by the researchers.The eligible candidates comprised all patients over the age of 7 years with a complaint of moderate to severe pain and able to respond to the research questions. The exclusion criteria consisted of altered levels of consciousness, pain with cardiac origins, gastrointestinal bleeding and a history of allergy to acetaminophen or ketorolac.A checklist was prepared in two parts; the first part included variables associated with demographic characteristics of the patients, i.e. age and gender, and the second involved pain characteristics, i.e. the pain cause and intensity before and after the intervention. The patients were randomly assigned to two groups, one receiving 30 mg of intravenous (IV) ketorolac and the other 1 g of IV acetaminophen. The pain intensity was measured using a visual analog scale (VAS) before administering the analgesic and upon admission to the ED.A pain reduction of over 13 mm was considered acceptable and a reduction of over 30 mm clinically significant. A VAS pain intensity of 0–35 was considered mild, 36–65 moderate and 66–100 severe .To analyze the data, the Chi-square test was used to compare the categorical variables, and the independent t-test and Pearson correlation to compare the numerical variables. ANCOVA was also used for the association of delta pain reduction with type of drug and another covariate. Moreover, the Shapiro–Wilk test was used to test the normality assumption. P<0.05 was set as the level of statistical significance. The statistical analysis was performed in SPSS.The present study was conducted on 150 patients aged 8–81 years with a mean age of 40.4 ± 17.7, including 84 (56%) males. Moreover, ketorolac was found to be more effective in reducing the intensity of severe pains than moderate pains. Ketorolac was also found to be more effective in reducing the pain score (P=0.083) and the rate of pain reduction (P=0.040) in case of severe pains compared to acetaminophen .Delta pain reduction was found to be more significantly correlated with age in the ketorolac group  compared to in the acetaminophen group .ANCOVA suggested that pain intensity  and gender  were statistically significant and age  marginally significant for delta pain score as the dependent variable, although the type of medicine was insignificant .The present research found both ketorolac and acetaminophen to clinically relieve pain in pre-hospital settings, and to be more effective in relieving traumatic pains than non-traumatic pains. In severe pains, ketorolac was found to cause a higher reduction in the pain score compared to acetaminophen. Conversely, acetaminophen was more effective in managing moderate pains than sever pains. These medicines were found to be more effective in pain reduction in younger ages, and this finding was more significant in the ketorolac group compared to in the acetaminophen group. These medicines were also more effective in men than in women.A systematic review on prehospital pain management of trauma patients by Dijkstra et al. found paracetamol to be an effective analgesic both orally and intravenously, which is consistent with the present findings . The effIn contrast to the obtained results for the effectiveness and safety of acetaminophen, Dijkstra et al. and Macintyre et al. found that non-steroidal anti-inflammatory drugs to cause mixed effects in terms of effectiveness, as they cause many contraindications and serious side effects. They did not therefore recommend these drugs for prehospital settings given the restricted possibilities for adequate risk assessment on potential contraindications and side effects , 11; nevGiven pain measurement as a subjective criterion in subjects, factors such as a desire for more pain relief by using higher doses of painkillers, the patient’s failure to comprehend the questionnaire’s items and a childish fear of reinjections can influence the reliability of these criteria, the actual pain reduction and its associated outcomes. Given that possible side-effects during and after hospitalization were not investigated in the present study, the findings are recommended to be interpreted and analyzed cautiously.Based on the obtained findings, both ketorolac and acetaminophen could be administered for pain management in prehospital settings in both traumatic and non-traumatic patients in case their contraindications are considered. The effectiveness of both drugs also appear to decrease with age.


Poststroke shoulder pain occurs very frequently and compromises function and quality of life. Because treatment depends on a multidisciplinary approach, it is desirable to optimize effectiveness. Myofascial pain syndrome is defined by the presence of trigger points that can also be found in spastic stroke patients. The aim of this study was to evaluate the frequency of myofascial pain in the shoulder girdle muscles in patients with poststroke shoulder pain and to document the clinical and functional results obtained with specific treatment for this condition.Spastic stroke hemiplegic patients undergoing rehabilitation at the Rehabilitation Center of the Hospital das Clínicas of the Ribeirão Preto Medical School of the University of São Paulo were evaluated regarding the intensity and characteristics of shoulder pain, previous therapeutic interventions, shoulder goniometry and the presence of trigger points. Patients underwent trigger point blockade by intramuscular infiltration of 1% lidocaine. The evaluation and treatment procedures were repeated in the subsequent 3 weeks as long as the pain intensity was greater than 5 on a visual analog scale (VAS). In the fourth week, the evaluation procedures were repeated. Patients who were in a multiprofessional rehabilitation program were instructed to continue the treatment, and the others received complementary therapeutic advice if necessary to initiate it. The evaluations were performed at 0, 1, and 3 weeks and after 4 months.p<0.05) through the end of the third week , but not at the end of four months . Good responders had significantly lower pain levels after the third week and presented with a larger range of motion for passive abduction by the end of 4 months. These results demonstrate that the myofascial component of pain should be considered in poststroke shoulder pain and that its treatment may be a pathway for the rapid and long-lasting relief of symptoms.Twenty-one patients  participated in the study, and there was a reduction in pain assessed by VAS from baseline (7.6±2.7) to the first week (5.8±3.6; Trigger point blockade with lidocaine can reduce pain perception in spastic hemiplegic shoulder in as much as 50% of stroke survivors for four months. Poststroke shoulder pain (PSSP) is defined by musculoskeletal pain in the weakened shoulder of hemiplegic individuals due to stroke. The clinical features of PSSP vary from mild discomfort to disabling pain, often acting as a precursor factor for secondary anatomical deformities. Pain is most often referred to as heavy, continuous or triggered by passive or active mobilization, is associated with decreased range of motion and increased disability in activities of daily living or care, and can lead to immobility and progressively worsening function. Thus, PSSP interferes with adequate participation in rehabilitation programs The etiology of PSSP is still controversial and multifactorial Usually, the condition develops 2-3 months after the stroke, in some cases as early as 2 weeks MPS is a regional pain condition associated with the presence of trigger points (TP). Trigger points are regions of the body surface over the muscles that are painful to palpation and reproduce the patients' complaints, and when properly treated, lead to the improvement of symptoms This study aimed to evaluate whether TP blockade is effective in reducing pain assessed by VAS and improving shoulder goniometry in spastic subjects with PSSP.This paper describes a series of twenty-one patients with stable cerebral lesions who were enrolled from an outpatient rehabilitation clinic at the Rehabilitation Center at the Ribeirão Preto General Hospital. After adequate explanations, those who agreed to participate in the study signed the informed consent form recommended by the institutional ethical review board. We based sample size calculations on data from a single study in the literature The inclusion criteria were as follows: either sex; older than 18 years of age; spastic upper limb weakness due to ischemic or hemorrhagic hemispheric stroke; and diagnosis of PSSP, regardless of motor dominanceThe exclusion criteria were as follows: previous shoulder pain in the hemiplegic side of the body; pregnant or nursing women; diagnosis of reflex sympathetic dystrophy; presence of pain of central origin; cognitive impairment that impeded assessment and collaboration with treatment; previous adverse reactions to lidocaine; structured joint deformity in the painful shoulder; and uncontrolled coagulation condition.1/4” (30 x 0.7 mm) were also used for deeper layers or more obese subjects. Needling was intended to elicit the ‘twitch response', which refers to the localized contraction of part of the muscle fibers that is visible to the naked eye in the superficial muscles. In the deeper muscles, this muscle response is not visible but may be noticed by a movement of the needle for more experienced injectors, and the patient may feel a sharp and subtle sensation that is accompanied by a ‘jump sign’. The mean volume injected was 8.0 ml, and for safety reasons, the maximal volume was not more than 10.0 ml. The therapeutic sessions were repeated for up to 3 consecutive weeks in those patients who indicated pain levels above 5 in the VAS; however, even without this pain level, the subjects were invited to return for all the scheduled evaluations.Procedures: Evaluations occurred at the initial consultation, after one and three weeks and finally after 4 months. The main outcomes were VAS ratings of pain intensity, which ranged from 0 to 10 Statistical analysis: Qualitative variables were described as percentages in each category, while the quantitative variables were analyzed for normality by the Kolmogorov-Smirnov test and described with adequate measures of central tendency and dispersion. Missing values were imputed using the last observation carried forward technique, and subjects' data were evaluated according to an intention to treat analysis. We used two-way repeated measures ANOVA to test the group*time effect.Outcomes: Patients who improved at least 4 points on the VAS at any moment after the first TP block were classified as “good responders”, all others as “no response”, and both groups were analyzed separately with the same statistical procedures. The significance level was 5%, with correction for multiple comparisons.p=0.119). All patients had spasticity in the weakened upper limb, classified as grade 2 or above on the modified Ashworth scale, and 8 had hemiparesis on the right side  were men, the mean age was 66.2±10.5 years and the median time since the stroke was 9.0±6.8 months  and through the end of the third week  but not at the end of four months . Both good responders and those with no response had similar pain levels at baseline, but by the third week, pain levels were significantly lower in the good responder group  and remained so after 4 months  (p<0.03). Five subjects were completely asymptomatic with only 2 sessions of TP blocks.Regarding the pain assessments, the whole group of patients experienced some relief in the period from the baseline assessment to the end of the first week  . Figure The aim of the study was to evaluate the effects of PSSP treatment by blocking TPs. In agreement with the clinical experience of the researchers, it was possible to confirm the hypothesis that this local inactivation of the TP attenuated the PSSP indicated by improvements in the VAS mean values in the first week after the procedure, with more pronounced results in the third week, and maintenance of pain relief by the end of 4 months. Additionally, when analyzing individual cases, some patients maintained complete abolition or very low pain values throughout the follow-up period. We did not observe any side effects, such as drowsiness, arrhythmia or hypotension, since the administered dose was less than 0.1 g.It may be argued that other causes of PSSP should have been assessed. Shoulder subluxation is often associated with shoulder pain in stroke survivors, but unless it is a clearly flaccid extremity where the subacromial sulcus is evident, and there is substantial relief with limb support, the literature fails to associate any radiological findings with PSSP. Additionally, adhesive capsulitis is a diagnostic alternative that requires contrast arthrographic findings of a reduction in capsular volume. This condition is clinically suspected when the subject fails to either passively or actively abduct the shoulder, sometimes because of pain. In the spastic hemiplegic patient, failure to abduct the shoulder is usually caused by an increased tone in the adductors, i.e., the pectoralis major, subscapularis, teres major and latissimus dorsi, but it must be stressed that the taut bands in a TP are also associated with reduced range of motion (ROM), thus these three conditions share this same symptomatology. The improvement in ROM in the good responder group in this sample indicated that MPS rather than the other two conditions should be considered, or at least be considered as one component of the pain-related impairment.The hypotheses of the pathophysiological mechanisms of MPS involve the accumulation of extracellular material that is not reabsorbed after the occurrence of micro- and macro-muscle lesions Microlesions rupture the sarcoplasmic reticulum and promote the release and accumulation of Ca++ in the sarcoplasm, which interacts with ATP, initiating the interaction of actin and myosin and resulting in the segmental shortening of the sarcomere, which explains the localized hypertonia identified by palpable nodules within the muscle. The exacerbated contraction amplifies the energy consumption that cannot be supplied by the local microcirculation due to the mechanical compression of the capillaries. Consequently, the region starts to work in ischemic conditions, depleting the local ATP and further damaging the active Ca++ uptake. In this way, TPs are associated with prolonged and exaggerated contraction of muscle fibers, causing muscle fatigue. The sum of localized ischemia with extracellular abnormalities and release of algiogenic substances is responsible for the self-sustained vicious cycle of contraction-ischemia-contraction that is responsible for central and peripheral pain sensitization.Nociceptors linked to nerve fibers III and IV are stimulated and protrude into the posterior horn of the gray matter of the spinal cord, then signals ascend via the rostral projection tracts to supraspinal units. Painful stimuli induce several secondary and CNS-sensitizing alterations contributing to the clinical picture of MPS Some of the side effects described for TP inactivation with lidocaine infiltration are arrhythmia and hypotension, which are dose-dependent and were not expected to be present in doses as low as those used in this study. Allergic reactions were not observed either. None of the subjects presented adverse events from the needling itself, such as bruises or postprocedure soreness.Support and proper movement of the shoulder joint depend substantially on the harmony of muscle contraction, which can be severely compromised by the change in strength and tone in stroke individuals. All participants in this study had spastic hemiparesis as the motor sequelae of the brain injury, which may have triggered the onset of TPs due to muscle imbalance and lack of regional harmonic coordination. Considering the reduction in abduction and external rotation in both active and passive mobilization in the initial evaluation, the suspected involved muscles preferentially fell on those with an adductor role and internal rotation, that is, the subscapular, teres major, major dorsal and major pectoral muscles, which share very close insertions in the smaller tubercle and intertubercular groove.The treatment of MPS can be performed in several ways, all based on the inactivation of TPs: among these treatment modalities are manual inactivation, although there is no evidence of its efficacy We succeeded in demonstrating the presence of MPS in as many as half of the studied sample, and the proper inactivation of TPs resulted in a reduction in pain and an improvement in ROM. This subgroup of patients with substantial and prolonged therapeutic responses can motivate the clinician to always consider MPS on the list of possible etiologic diagnoses and to master this examination and therapeutic technique, considering the impact that can be quickly obtained to improve functioning, care and quality of life with very little investment.Liporaci FM and Mourani MM were the evaluators and the performers of the trigger point blockade and contributed to the manuscript preparation. Riberto M suggested the study, trained the other authors, selected the participants, performed the statistical analysis and supervised the manuscript preparation.