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1.  Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults 
JAMA  2017;317(15):1535-1543.
Key Points
Question
Does a single dose of dexamethasone in the absence of antibiotics provide symptom relief for acute sore throat in adults presenting to primary care?
Findings
In this randomized clinical trial including 565 adults, the proportion of participants in the dexamethasone group achieving complete symptom resolution at 24 hours was not significantly different from those taking placebo. But at 48 hours significantly more in the dexamethasone group experienced complete resolution than did those in the placebo group.
Meaning
Among adults presenting to primary care practices with acute sore throat, a single dose of oral dexamethasone did not increase the likelihood of symptom resolution at 24 hours but did increase the likelihood at 48 hours.
This randomized controlled trial compared the effects of a single dose of dexamethasone vs placebo on sore throat symptoms among adults with acute sore throat not requiring immediate antibiotics.
Importance
Acute sore throat poses a significant burden on primary care and is a source of inappropriate antibiotic prescribing. Corticosteroids could be an alternative symptomatic treatment.
Objective
To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics.
Design, Setting, and Participants
Double-blind, placebo-controlled randomized trial (April 2013-February 2015; 28-day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolled 576 adults recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy.
Interventions
Single oral dose of 10 mg of dexamethasone (n = 293) or identical placebo (n = 283).
Main Outcomes and Measures
Primary: proportion of participants experiencing complete resolution of symptoms at 24 hours. Secondary: complete resolution at 48 hours, duration of moderately bad symptoms (based on a Likert scale, 0, normal; 6, as bad as it could be), visual analog symptom scales (0-100 mm; 0, no symptom to 100, worst imaginable), health care attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events.
Results
Among 565 eligible participants who were randomized (median age, 34 years [interquartile range, 26.0-45.5 year]; 75.2% women; 100% completed the intervention), 288 received dexamethasone; 277, placebo. At 24 hours, 65 participants (22.6%) in the dexamethasone group and 49 (17.7%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 4.7% (95% CI, −1.8% to 11.2%) and a relative risk of 1.28 (95% CI; 0.92 to 1.78; P = .14). At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. At 48 hours, 102 participants (35.4%) in the dexamethasone group vs 75 (27.1%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 8.7% (95% CI, 1.2% to 16.2%) and a relative risk of 1.31 (95% CI, 1.02 to 1.68; P = .03). This difference also was observed in participants not offered delayed antibiotic prescription, for a risk difference of 10.3% (95% CI, 0.6% to 20.1%) and a relative risk of 1.37 (95% CI, 1.01 to 1.87; P = .046). There were no significant differences in any other secondary outcomes.
Results
Of 565 eligible randomized participants (median age, 34 years [interquartile range, 26.0-45.5 years]; 75.2% women; 100% completed the intervention), 288 received dexamethasone and 277, placebo. At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. Results were similar among those who were not offered an antibiotic prescription and those who were offered a delayed antibiotic prescription. At 48 hours, more participants receiving dexamethasone than placebo had complete symptom resolution. This difference also was observed in patients not offered delayed antibiotics. There were no significant differences in any other secondary outcomes.
Conclusions and Relevance
Among adults presenting to primary care with acute sore throat, a single dose of oral dexamethasone compared with placebo did not increase the proportion of patients with resolution of symptoms at 24 hours. However, there was a significant difference at 48 hours.
Trial Registration
isrctn.org Identifier: ISRCTN17435450
doi:10.1001/jama.2017.3417
PMCID: PMC5470351  PMID: 28418482
2.  Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial 
Trials  2017;18:421.
Background
Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use.
Methods/design
Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below:Group 1 – Uva-ursi + advice to take ibuprofenGroup 2 – Placebo + advice to take ibuprofenGroup 3 – Uva-ursi + no advice to take ibuprofenGroup 4 – Placebo + no advice to take ibuprofen
Patients and physicians will be blinded to the randomised group for the herb.
The main outcome is symptom severity at days 2–4 recorded in a validated, self-report diary used in previous studies.
Secondary outcomes include antibiotic use and symptom duration.
In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint.
In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package.
Discussion
The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics.
Trial registration
ISRCTN registry, ID: ISRCTN43397016. Registered on 11 February 2015.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-017-2145-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-017-2145-7
PMCID: PMC5591533  PMID: 28886751
Antibiotic resistance; Urinary tract infection; Uva-ursi; NSAID; Ibuprofen
3.  Cost effectiveness of amoxicillin for lower respiratory tract infections in primary care: an economic evaluation accounting for the cost of antimicrobial resistance 
The British Journal of General Practice  2016;66(650):e633-e639.
Background
Lower respiratory tract infections (LRTIs) are a major disease burden and are often treated with antibiotics. Typically, studies evaluating the use of antibiotics focus on immediate costs of care, and do not account for the wider implications of antimicrobial resistance.
Aim
This study sought to establish whether antibiotics (principally amoxicillin) are cost effective in patients with LRTIs, and to explore the implications of taking into account costs associated with resistance.
Design and setting
Multinational randomised double-blinded trial in 2060 patients with acute cough/LRTIs recruited in 12 European countries.
Method
A cost-utility analysis from a health system perspective with a time horizon of 28 days was conducted. The primary outcome measure was the quality-adjusted life year (QALY). Hierarchical modelling was used to estimate incremental cost-effectiveness ratios (ICERs).
Results
Amoxicillin was associated with an ICER of €8216 (£6540) per QALY gained when the cost of resistance was excluded. If the cost of resistance is greater than €11 (£9) per patient, then amoxicillin treatment is no longer cost effective. Including possible estimates of the cost of resistance resulted in ICERs ranging from €14 730 (£11 949) per QALY gained — when only multidrug resistance costs and health care costs are included — to €727 135 (£589 856) per QALY gained when broader societal costs are also included.
Conclusion
Economic evaluation of antibiotic prescribing strategies that do not include the cost of resistance may provide misleading results that could be of questionable use to policymakers. However, further work is required to estimate robust costs of resistance.
doi:10.3399/bjgp16X686533
PMCID: PMC5198702  PMID: 27402969
amoxicillin; antibiotic resistance; cost-effectiveness; economic costs; lower respiratory tract infection; quality-adjusted life years
4.  Nappy pad urine samples for investigation and treatment of UTI in young children: the ‘DUTY’ prospective diagnostic cohort study 
The British Journal of General Practice  2016;66(648):e516-e524.
Background
The added diagnostic utility of nappy pad urine samples and the proportion that are contaminated is unknown.
Aim
To develop a clinical prediction rule for the diagnosis of urinary tract infection (UTI) based on sampling using the nappy pad method.
Design and setting
Acutely unwell children <5 years presenting to 233 UK primary care sites.
Method
Logistic regression to identify independent associations of symptoms, signs, and urine dipstick test results with UTI; diagnostic utility quantified as area under the receiver operator curves (AUROC). Nappy pad rule characteristics, AUROC, and contamination, compared with findings from clean-catch samples.
Results
Nappy pad samples were obtained from 3205 children (82% aged <2 years; 48% female), culture results were available for 2277 (71.0%) and 30 (1.3%) had a UTI on culture. Female sex, smelly urine, darker urine, and the absence of nappy rash were independently associated with a UTI, with an internally-validated, coefficient model AUROC of 0.81 (0.87 for clean-catch), which increased to 0.87 (0.90 for clean-catch) with the addition of dipstick results. GPs’ ‘working diagnosis’ had an AUROC 0.63 (95% confidence intervals [CI] = 0.53 to 0.72). A total of 12.2% of nappy pad and 1.8% of clean-catch samples were ‘frankly contaminated’ (risk ratio 6.66; 95% CI = 4.95 to 8.96; P<0.001).
Conclusion
Nappy pad urine culture results, with features that can be reported by parents and dipstick tests, can be clinically useful, but are less accurate and more often contaminated compared with clean-catch urine culture.
doi:10.3399/bjgp16X685873
PMCID: PMC4917055  PMID: 27364678
antibacterial agents; diagnosis; infant; paediatrics; primary health care; urinary tract infections
5.  World Congress Integrative Medicine & Health 2017: Part one 
Brinkhaus, Benno | Falkenberg, Torkel | Haramati, Aviad | Willich, Stefan N. | Briggs, Josephine P. | Willcox, Merlin | Linde, Klaus | Theorell, Töres | Wong, Lisa M. | Dusek, Jeffrey | Wu, Darong | Eisenberg, David | Haramati, Aviad | Berger, Bettina | Kemper, Kathi | Stock-Schröer, Beate | Sützl-Klein, Hedda | Ferreri, Rosaria | Kaplan, Gary | Matthes, Harald | Rotter, Gabriele | Schiff, Elad | Arnon, Zahi | Hahn, Eckhard | Luberto, Christina M. | Martin, David | Schwarz, Silke | Tauschel, Diethard | Flower, Andrew | Gramminger, Harsha | Gupta, Hedwig H. | Gupta, S. N. | Kerckhoff, Annette | Kessler, Christian S. | Michalsen, Andreas | Kessler, Christian S. | Kim, Eun S. | Jang, Eun H. | Kim, Rana | Jan, Sae B. | Mittwede, Martin | Mohme, Wiebke | Ben-Arye, Eran | Bonucci, Massimo | Saad, Bashar | Breitkreuz, Thomas | Rossi, Elio | Kebudi, Rejin | Daher, Michel | Razaq, Samaher | Gafer, Nahla | Nimri, Omar | Hablas, Mohamed | Kienle, Gunver Sophia | Samuels, Noah | Silbermann, Michael | Bandelin, Lena | Lang, Anna-Lena | Wartner, Eva | Holtermann, Christoph | Binstock, Maxwell | Riebau, Robert | Mujkanovic, Edin | Cramer, Holger | Lauche, Romy | Michalsen, Andres | Ward, Lesley | Cramer, Holger | Irnich, Dominik | Stör, Wolfram | Burnstock, Geoffrey | Schaible, Hans-Georg | Ots, Thomas | Langhorst, Jost | Lauche, Romy | Sundberg, Tobias | Falkenberg, Torkel | Amarell, Catherina | Amarell, Catherina | Anheyer, Melanie | Eckert, Marion | Eckert, Marion | Ogal, Mercedes | Eckert, Marion | Amarell, Catherina | Schönauer, Annette | Reisenberger, Birgit | Brand, Bernhard | Anheyer, Dennis | Dobos, Gustav | Kroez, Matthias | Martin, David | Matthes, Harald | Ammendola, Aldo | Mao, Jun J. | Witt, Claudia | Yang, Yufei | Dobos, Gustav | Oritz, Miriam | Horneber, Markus | Voiß, Petra | Reisenberger, Birgit | von Rosenstiel, Alexandra | Eckert, Marion | Ogal, Mercedes | Amarell, Catharina | Anheyer, Melanie | Schad, Friedemann | Schläppi, Marc | Kröz, Matthias | Büssing, Arndt | Bar-Sela, Gil | Matthes, Harald | Schiff, Elad | Ben-Arye, Eran | Arnon, Zahi | Avshalomov, David | Attias, Samuel | Schönauer, Annette | Haramati, Aviad | Witt, Claudia | Brinkhaus, Benno | Cotton, Sian | Jong, Miek | Jong, Mats | Scheffer, Christian | Haramati, Aviad | Tauschel, Diethard | Edelhäuser, Friedrich | AlBedah, Abdullah | Lee, Myeong Soo | Khalil, Mohamed | Ogawa, Keiko | Motoo, Yoshiharu | Arimitsu, Junsuke | Ogawa, Masao | Shimizu, Genki | Stange, Rainer | Kraft, Karin | Kuchta, Kenny | Watanabe, Kenji | Bonin, D | Büssing, Arndt | Gruber, Harald | Koch, Sabine | Gruber, Harald | Pohlmann, Urs | Caldwell, Christine | Krantz, Barbara | Kortum, Ria | Martin, Lily | Wieland, Lisa S. | Kligler, Ben | Gould-Fogerite, Susan | Zhang, Yuqing | Wieland, Lisa S. | Riva, John J. | Lumpkin, Michael | Ratner, Emily | Ping, Liu | Jian, Pei | Hamme, Gesa-Meyer | Mao, Xiaosong | Chouping, Han | Schröder, Sven | Hummelsberger, Josef | Wullinger, Michael | Brodzky, Marc | Zalpour, Christoff | Langley, Julia | Weber, Wendy | Mudd, Lanay M. | Wayne, Peter | Witt, Clauda | Weidenhammer, Wolfgang | Fønnebø, Vinjar | Boon, Heather | Steel, Amie | Bugarcic, Andrea | Rangitakatu, Melisa | Steel, Amie | Adams, Jon | Sibbritt, David | Wardle, Jon | Leach, Matthew | Schloss, Janet | Dieze, Helene | Boon, Heather | Ijaz, Nadine | Willcox, Merlin | Heinrich, Michael | Lewith, George | Flower, Andrew | Graz, Bertrand | Adam, Daniela | Grabenhenrich, Linus | Ortiz, Miriam | Binting, Sylvia | Reinhold, Thomas | Brinkhaus, Benno | Andermo, Susanne | Sundberg, Tobias | Falkenberg, Torkel | Nordberg, Johanna Hök | Arman, Maria | Bhasin, Manoj | Fan, Xueyi | Libermann, Towia | Fricchione, Gregory | Denninger, John | Benson, Herbert | Berger, Bettina | Stange, Rainer | Michalsen, Andreas | Martin, David D. | Boers, Inge | Vlieger, Arine | Jong, Miek | Brinkhaus, Benno | Teut, Michael | Ullmann, Alexander | Ortiz, Miriam | Rotter, Gabriele | Binting, Sylvia | Lotz, Fabian | Roll, Stephanie | Canella, Claudia | Mikolasek, Michael | Rostock, Matthias | Beyer, Jörg | Guckenberger, Matthias | Jenewein, Josef | Linka, Esther | Six, Claudia | Stoll, Sarah | Stupp, Roger | Witt, Claudia M. | Chuang, Elisabeth | Kligler, Ben | McKee, Melissa D. | Cramer, Holger | Lauche, Romy | Klose, Petra | Lange, Silke | Langhorst, Jost | Dobos, Gustav | Chung, Vincent C. H. | Wong, Hoi L. C. | Wu, Xin Y. | Wen, Grace Y. G. | Ho, Robin S. T. | Ching, Jessica Y. L. | Wu, Justin C. Y. | Coakley, Amanda | Flanagan, Jane | Annese, Christine | Empoliti, Joanne | Gao, Zishan | Liu, Xugang | Yu, Shuguang | Yan, Xianzhong | Liang, Fanrong | Hohmann, Christoph D. | Steckhan, Nico | Ostermann, Thomas | Paetow, Arion | Hoff, Evelyn | Michalsen, Andreas | Hu, Xiao-Yang | Wu, Ruo-Han | Logue, Martin | Blonde, Clara | Lai, Lily Y. | Stuart, Beth | Flower, Andrew | Fei, Yu-Tong | Moore, Michael | Liu, Jian-Ping | Lewith, George | Hu, Xiao-Yang | Wu, Ruo-Han | Logue, Martin | Blonde, Clara | Lai, Lily Y. | Stuart, Beth | Flower, Andrew | Fei, Yu-Tong | Moore, Michael | Liu, Jian-Ping | Lewith, George | Jeitler, Michael | Zillgen, Hannah | Högl, Manuel | Steckhan, Nico | Stöckigt, Barbara | Seifert, Georg | Michalsen, Andreas | Kessler, Christian | Khadivzadeh, Talat | Bashtian, Maryam Hassanzadeh | Aval, Shapour Badiee | Esmaily, Habibollah | Kim, Jihye | Kim, Keun H. | Klocke, Carina | Joos, Stefanie | Koshak, Abdulrahman | Wie, Li | Koshak, Emad | Wali, Siraj | Alamoudi, Omer | Demerdash, Abdulrahman | Qutub, Majdy | Pushparaj, Peter | Heinrich, Michael | Kruse, Sigrid | Fischer, Isabell | Tremel, Nadine | Rosenecker, Joseph | Leung, Brenda | Takeda, Wendy | Liang, Ning | Feng, Xue | Liu, Jian-ping | Cao, Hui-juan | Luberto, Christina M. | Shinday, Nina | Philpotts, Lisa | Park, Elyse | Fricchione, Gregory L. | Yeh, Gloria | Munk, Niki | Zakeresfahani, Arash | Foote, Trevor R. | Ralston, Rick | Boulanger, Karen | Özbe, Dominik | Gräßel, Elmar | Luttenberger, Katharina | Pendergrass, Anna | Pach, Daniel | Bellmann-Strobl, Judit | Chang, Yinhui | Pasura, Laura | Liu, Bin | Jäger, Sven F. | Loerch, Ronny | Jin, Li | Brinkhaus, Benno | Ortiz, Miriam | Reinhold, Thomas | Roll, Stephanie | Binting, Sylvia | Icke, Katja | Shi, Xuemin | Paul, Friedemann | Witt, Claudia M. | Rütz, Michaela | Lynen, Andreas | Schömitz, Meike | Vahle, Maik | Salomon, Nir | Lang, Alon | Lahat, Adi | Kopylov, Uri | Ben-Horin, Shomron | Har-Noi, Ofir | Avidan, Benjamin | Elyakim, Rami | Gamus, Dorit | NG, Siew | Chang, Jessica | Wu, Justin | Kaimiklotis, John | Schumann, Dania | Buttó, Ludovica | Langhorst, Jost | Dobos, Gustav | Haller, Dirk | Cramer, Holger | Smith, Caroline | de Lacey, Sheryl | Chapman, Michael | Ratcliffe, Julie | Johnson, Neil | Lyttleton, Jane | Boothroyd, Clare | Fahey, Paul | Tjaden, Bram | van Vliet, Marja | van Wietmarschen, Herman | Jong, Miek | Tröger, Wilfried | Vuolanto, Pia | Aarva, Paulina | Sorsa, Minna | Helin, Kaija | Wenzel, Claudia | Zoderer, Iris | Pammer, Patricia | Simon, Patrick | Tucek, Gerhard | Wode, Kathrin | Henriksson, Roger | Sharp, Lena | Stoltenberg, Anna | Nordberg, Johanna Hök | Xiao-ying, Yang | Wang, Li-qiong | Li, Jin-gen | Liang, Ning | Wang, Ying | Liu, Jian-ping | Balneaves, Lynda | Capler, Rielle | Bocci, Chiara | Guffi, Marta | Paolini, Marina | Meaglia, Ilaria | Porcu, Patrizia | Ivaldi, Giovanni B. | Dragan, Simona | Bucuras, Petru | Pah, Ana M. | Badalica-Petrescu, Marius | Buleu, Florina | Hogea-Stoichescu, Gheorghe | Christodorescu, Ruxandra | Kao, Lan | Cho, Yumin | Klafke, Nadja | Mahler, Cornelia | von Hagens, Cornelia | Uhlmann, Lorenz | Bentner, Martina | Schneeweiss, Andreas | Mueller, Andreas | Szecsenyi, Joachim | Joos, Stefanie | Neri, Isabella | Ortiz, Miriam | Schnabel, Katharina | Teut, Michael | Rotter, Gabriele | Binting, Sylvia | Cree, Margit | Lotz, Fabian | Suhr, Ralf | Brinkhaus, Benno | Rossi, Elio | Baccetti, Sonia | Firenzuoli, Fabio | Monechi, Maria V. | Di Stefano, Mariella | Amunni, Gianni | Wong, Wendy | Chen, Bingzhong | Wu, Justin | Amri, Hakima | Haramati, Aviad | Kotlyanskaya, Lucy | Anderson, Belinda | Evans, Roni | Kligler, Ben | Marantz, Paul | Bradley, Ryan | Booth-LaForce, Cathryn | Zwickey, Heather | Kligler, Benjamin | Brooks, Audrey | Kreitzer, Mary J. | Lebensohn, Patricia | Goldblatt, Elisabeth | Esmel-Esmel, Neus | Jiménez-Herrera, Maria | Ijaz, Nadine | Boon, Heather | Jocham, Alexandra | Stock-Schröer, Beate | Berberat, Pascal O. | Schneider, Antonius | Linde, Klaus | Masetti, Morgana | Murakozy, Henriette | Van Vliet, Marja | Jong, Mats | Jong, Miek | Agdal, Rita | Atarzadeh, Fatemeh | Jaladat, Amir M. | Hoseini, Leila | Amini, Fatemeh | Bai, Chen | Liu, Tiegang | Zheng, Zian | Wan, Yuxiang | Xu, Jingnan | Wang, Xuan | Yu, He | Gu, Xiaohong | Daneshfard, Babak | Nimrouzi, Majid | Tafazoli, Vahid | Alorizi, Seyed M. Emami | Saghebi, Seyed A. | Fattahi, Mohammad R. | Salehi, Alireza | Rezaeizadeh, Hossein | Zarshenas, Mohammad M. | Nimrouzi, Majid | Fox, Kealoha | Hughes, John | Kostanjsek, Nenad | Espinosa, Stéphane | Lewith, George | Fisher, Peter | Latif, Abdul | Lefeber, Donald | Paske, William | Öztürk, Ali Ö. | Öztürk, Gizemnur | Boers, Inge | Tissing, Wim | Naafs, Marianne | Busch, Martine | Jong, Miek | Daneshfard, Babak | Sanaye, Mohammad R. | Dräger, Kilian | Fisher, Peter | Kreitzer, Mary J. | Evans, Roni | Leininger, Brent | Shafto, Kate | Breen, Jenny | Sanaye, Mohammad R. | Daneshfard, Babak | Simões-Wüst, Ana P. | Moltó-Puigmartí, Carolina | van Dongen, Martien | Dagnelie, Pieter | Thijs, Carel | White, Shelley | Wiesener, Solveig | Salamonsen, Anita | Stub, Trine | Fønnebø, Vinjar | Abanades, Sergio | Blanco, Mar | Masllorens, Laia | Sala, Roser | Al-Ahnoumy, Shafekah | Han, Dongwoon | He, Luzhu | Kim, Ha Yun | In Choi, Da | Alræk, Terje | Stub, Trine | Kristoffersen, Agnete | von Sceidt, Christel | Michalsen, Andreas | Bruset, Stig | Musial, Frauke | Anheyer, Dennis | Cramer, Holger | Lauche, Romy | Saha, Felix J. | Dobos, Gustav | Anheyer, Dennis | Haller, Heidemarie | Lauche, Romy | Dobos, Gustav | Cramer, Holger | Azizi, Hoda | Khadem, Nayereh | Hassanzadeh, Malihe | Estiri, Nazanin | Azizi, Hamideh | Tavassoli, Fatemeh | Lotfalizadeh, Marzieh | Zabihi, Reza | Esmaily, Habibollah | Azizi, Hoda | Shabestari, Mahmoud Mohammadzadeh | Paeizi, Reza | Azari, Masoumeh Alvandi | Bahrami-Taghanaki, Hamidreza | Zabihi, Reza | Azizi, Hamideh | Esmaily, Habibollah | Baars, Erik | De Bruin, Anja | Ponstein, Anne | Baccetti, Sonia | Di Stefano, Mariella | Rossi, Elio | Firenzuoli, Fabio | Segantini, Sergio | Monechi, Maria Valeria | Voller, Fabio | Barth, Jürgen | Kern, Alexandra | Lüthi, Sebastian | Witt, Claudia | Barth, Jürgen | Zieger, Anja | Otto, Fabius | Witt, Claudia | Beccia, Ariel | Dunlap, Corina | Courneene, Brendan | Bedregal, Paula | Passi, Alvaro | Rodríguez, Alfredo | Chang, Mayling | Gutiérrez, Soledad | Beissner, Florian | Beissner, Florian | Preibisch, Christine | Schweizer-Arau, Annemarie | Popovici, Roxana | Meissner, Karin | Beljanski, Sylvie | Belland, Laura | Rivera-Reyes, Laura | Hwang, Ula | Berger, Bettina | Sethe, Dominik | Hilgard, Dörte | Heusser, Peter | Bishop, Felicity | Al-Abbadey, Miznah | Bradbury, Katherine | Carnes, Dawn | Dimitrov, Borislav | Fawkes, Carol | Foster, Jo | MacPherson, Hugh | Roberts, Lisa | Yardley, Lucy | Lewith, George | Bishop, Felicity | Al-Abbadey, Miznah | Bradbury, Katherine | Carnes, Dawn | Dimitrov, Borislav | Fawkes, Carol | Foster, Jo | MacPherson, Hugh | Roberts, Lisa | Yardley, Lucy | Lewith, George | Bishop, Felicity | Holmes, Michelle | Lewith, George | Yardley, Lucy | Little, Paul | Cooper, Cyrus | Bogani, Patrizia | Maggini, Valentina | Gallo, Eugenia | Miceli, Elisangela | Biffi, Sauro | Mengoni, Alessio | Fani, Renato | Firenzuoli, Fabio | Brands-Guendling, Nadine | Guendling, Peter W. | Bronfort, Gert | Evans, Roni | Haas, Mitch | Leininger, Brent | Schulz, Craig | Bu, Xiangwei | Wang, J. | Fang, T. | Shen, Z. | He, Y. | Zhang, X. | Zhang, Zhengju | Wang, Dali | Meng, Fengxian | Büssing, Arndt | Baumann, Klaus | Frick, Eckhard | Jacobs, Christoph | Büssing, Arndt | Grünther, Ralph-Achim | Lötzke, Désirée | Büssing, Arndt | Jung, Sonny | Lötzke, Désirée | Recchia, Daniela R. | Robens, Sibylle | Ostermann, Thomas | Berger, Bettina | Stankewitz, Josephin | Kröz, Matthias | Jeitler, Mika | Kessler, Christian | Michalsen, Andreas | Cheon, Chunhoo | Jang, Bo H. | Ko, Seong G. | Huang, Ching W. | Sasaki, Yui | Ko, Youme | Cheshire, Anna | Ridge, Damien | Hughes, John | Peters, David | Panagioti, Maria | Simon, Chantal | Lewith, George | Cho, Hyun J. | Han, Dongwoon | Choi, Soo J. | Jung, Young S. | Im, Hyea B | Cooley, Kieran | Tummon-Simmons, Laura | Cotton, Sian | Luberto, Christina M. | Wasson, Rachel | Kraemer, Kristen | Sears, Richard | Hueber, Carly | Derk, Gwendolyn | Lill, JR | An, Ruopeng | Steinberg, Lois | Rodriguez, Lourdes Diaz | la Fuente, Francisca García-de | De la Vega, Miguel | Vargas-Román, Keyla | Fernández-Ruiz, Jonatan | Cantarero-Villanueva, Irene | Rodriguez, Lourdes Diaz | García-De la Fuente, Francisca | Jiménez-Guerrero, Fanny | Vargas-Román, Keyla | Fernández-Ruiz, Jonatan | Galiano-Castillo, Noelia | Diaz-Saez, Gualberto | Torres-Jimenez, José I. | Garcia-Gomez, Olga | Hortal-Muñoz, Luis | Diaz-Diez, Camino | Dicen, Demijon | Diezel, Helene | Adams, Jon | Steel, Amie | Wardle, Jon | Diezel, Helene | Steel, Amie | Frawley, Jane | Wardle, Jon | Broom, Alex | Adams, Jon | Dong, Fei | Yu, He | Liu, Tiegang | Ma, Xueyan | Yan, Liyi | Wan, Yuxiang | Zheng, Zian | Gu, Xiaohong | Dong, Fei | Yu, He | Wu, Liqun | Liu, Tiegang | Ma, Xueyan | Ma, Jiaju | Yan, Liyi | Wan, Yuxiang | Zheng, Zian | Zhen, Jianhua | Gu, Xiaohong | Dubois, Julie | Rodondi, Pierre-Yves | Edelhäuser, Friedrich | Schwartze, Sophia | Trapp, Barbara | Cysarz, Dirk
doi:10.1186/s12906-017-1782-4
PMCID: PMC5498855
6.  Providing online weight management in Primary Care: a mixed methods process evaluation of healthcare practitioners’ experiences of using and supporting patients using POWeR+ 
Background
An online weight management intervention (POWeR+) combined with a small amount of primary care healthcare practitioner support is effective in helping patients to lose weight, but little is known about how practitioners interact with the POWeR+ intervention or their experiences of providing support for patients using POWeR+. The aim of this study was to explore practitioners’ usage of POWeR+ and their experiences of providing support to patients using POWeR+.
Methods
Set within a randomised controlled trial of POWeR+, practitioners’ usage of POWeR+ was automatically captured and a qualitative process analysis was conducted employing semi-structured telephone interviews with practitioners who provided support to patients using POWeR+. The usage analysis captured how 54 practitioners used the POWeR+ intervention. Thirteen telephone interviews explored practitioners’ experiences of using POWeR+ and providing patients with face-to-face or remote (email and telephone) support. Interview data were analysed using inductive thematic analysis.
Results
Usage analysis indicated that almost all practitioners engaged with POWeR+. Pages which displayed patients’ progress and allowed practitioners to email patients were used the most. Practitioners found POWeR+ straightforward and easy to use. Some practitioners preferred providing support face-to-face, which they enjoyed more than remote support. A small number of nurses found providing non-directive support using the CARe approach (Congratulate, Ask, Remind) challenging, feeling it was the opposite of their normal approach. POWeR+ enabled practitioners to raise the topic of weight loss with patients, and POWeR+ was viewed as a superior alternative to existing weight management support which was limited in most practices. Still some practitioners found it difficult to fit providing support into their busy schedules.
Conclusions
Overall, practitioners engaged well with POWeR+ and perceived providing patients with support whilst using POWeR+ as acceptable and feasible. CARe provides a potentially useful model for how practitioners can combine human and digital support in a cost-effective way, which could be useful for the management of other conditions. Some potential barriers to implementation were identified, which allowed modification of POWeR+. The findings suggest that implementing this cost-effective online weight management intervention in Primary Care would be feasible and acceptable to practitioners.
Trial registration
ClinicalTrial.gov, ISRCTN21244703
doi:10.1186/s13012-017-0596-6
PMCID: PMC5445406  PMID: 28545538
Obesity; Mixed methods; Process analysis; Healthcare practitioners; Weight loss; Digital intervention; E-health
7.  ‘You feel like your whole world is caving in’: A qualitative study of primary care patients’ conceptualisations of emotional distress 
Health (London, England : 1997)  2016;21(3):295-315.
General practitioners are tasked with determining the nature of patients’ emotional distress and providing appropriate care. For patients whose symptoms appear to fall near the ‘boundaries’ of psychiatric disorder, this can be difficult with important implications for treatment. There is a lack of qualitative research among patients with symptoms severe enough to warrant consultation, but where general practitioners have refrained from diagnosis. We aimed to explore how patients in this potentially large group conceptualise their symptoms and consequently investigate lay understandings of complex distinctions between emotional distress and psychiatric disorder. Interviews were conducted with 20 primary care patients whom general practitioners had identified as experiencing emotional distress, but had not diagnosed with major depressive disorder. Participants described severe emotional experiences with substantial impact on their lives. The term ‘depression’ was used in many different ways; however, despite severity, they often considered their emotional experience to be different to their perceived notions of ‘actual’ depression or mental illness. Where anxiety was mentioned, use appeared to refer to an underlying generalised state. Participants drew on complex, sometimes fluid and often theoretically coherent conceptualisations of their emotional distress, as related to, but distinct from, mental disorder. These conceptualisations differ from those frequently drawn on in research and treatment guidelines, compounding the difficulty for general practitioners. Developing models of psychological symptoms that draw on patient experience and integrate psychological/psychiatric theory may help patients understand the nature of their experience and, critically, provide the basis for a broader range of primary care interventions.
doi:10.1177/1363459316674786
PMCID: PMC5439536  PMID: 28177273
depression; emotional distress; mental disorder; primary care; qualitative
8.  Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough 
BMJ Open  2017;7(5):e014506.
Objective
To investigate recruitment and retention, data collection methods and the acceptability of a ‘within-consultation’ complex intervention designed to reduce antibiotic prescribing.
Design
Primary care feasibility cluster randomised controlled trial.
Setting
32 general practices in South West England recruiting children from October 2014 to April 2015.
Participants
Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI).
Intervention
A web-based clinician-focussed clinical rule to predict risk of future hospitalisation and a printed leaflet with individualised child health information for carers, safety-netting advice and a treatment decision record.
Controls
Usual practice, with clinicians recording data on symptoms, signs and treatment decisions.
Results
Of 542 children invited, 501 (92.4%) consented to participate, a month ahead of schedule. Antibiotic prescribing data were collected for all children, follow-up data for 495 (98.8%) and the National Health Service resource use data for 494 (98.6%). The overall antibiotic prescribing rates for children’s RTIs were 25% and 15.8% (p=0.018) in intervention and control groups, respectively. We found evidence of postrandomisation differential recruitment: the number of children recruited to the intervention arm was higher (292 vs 209); over half were recruited by prescribing nurses compared with less than a third in the control arm; children in the intervention arm were younger (median age 2 vs 3 years controls, p=0.03) and appeared to be more unwell than those in the control arm with higher respiratory rates (p<0.0001), wheeze prevalence (p=0.007) and global illness severity scores assessed by carers (p=0.045) and clinicians (p=0.01). Interviews with clinicians confirmed preferential recruitment of less unwell children to the trial, more so in the control arm.
Conclusion
Differential recruitment may explain the paradoxical antibiotic prescribing rates. Future cluster level studies should consider designs which remove the need for individual consent postrandomisation and embed the intervention within electronic primary care records.
Trial registration number
ISRCTN 23547970
UKCRN study ID
16891
doi:10.1136/bmjopen-2016-014506
PMCID: PMC5623421  PMID: 28490554
Randomised controlled trial (RCT); Feasibility; Children; Respiratory tract infections (RTIs); Primary care; Cough; Antibiotics (or Anti-microbial agents)
9.  Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies 
Patient education and counseling  2016;100(4):616-635.
Objectives
To understand the experiences of patients and healthcare professionals (HCPs) using self-management digital interventions (DIs) for chronic physical health conditions.
Methods
A systematic search was conducted in 6 electronic databases. Qualitative studies describing users’ experiences of self-management DIs were included, and authors’ interpretations were synthesised using meta-ethnography.
Results
30 papers met the inclusion criteria, covering a range of DIs and chronic conditions, including hypertension, asthma and heart disease. The review found that patients monitoring their health felt reassured by the insight this provided, and perceived they had more meaningful consultations with the HCP. These benefits were elicited by simple tele-monitoring systems as well as multifaceted DIs. Patients appeared to feel more reliant on HCPs if they received regular feedback from the HCP. HCPs focused mainly on their improved clinical control, and some also appreciated patients’ increased understanding of their condition.
Conclusions
Patients using self-management DIs tend to feel well cared for and perceive that they adopt a more active role in consultations, whilst HCPs focus on the clinical benefits provided by DIs.
Practice implications
DIs can simultaneously support patient condition management, and HCPs’ control of patient health. Tele-monitoring physiological data can promote complex behaviour change amongst patients.
doi:10.1016/j.pec.2016.10.019
PMCID: PMC5380218  PMID: 28029572
Self-management; Qualitative; Digital; Interventions
10.  The Diagnosis of Urinary Tract Infection in Young Children (DUTY) Study Clinical Rule: Economic Evaluation 
Value in Health  2017;20(4):556-566.
Objective
To estimate the cost-effectiveness of a two-step clinical rule using symptoms, signs and dipstick testing to guide the diagnosis and antibiotic treatment of urinary tract infection (UTI) in acutely unwell young children presenting to primary care.
Methods
Decision analytic model synthesising data from a multicentre, prospective cohort study (DUTY) and the wider literature to estimate the short-term and lifetime costs and healthcare outcomes (symptomatic days, recurrent UTI, quality adjusted life years) of eight diagnostic strategies. We compared GP clinical judgement with three strategies based on a ‘coefficient score’ combining seven symptoms and signs independently associated with UTI and four strategies based on weighted scores according to the presence/absence of five symptoms and signs. We compared dipstick testing versus laboratory culture in children at intermediate risk of UTI.
Results
Sampling, culture and antibiotic costs were lowest in high-specificity DUTY strategies (£1.22 and £1.08) compared to clinical judgement (£1.99). These strategies also approximately halved urine sampling (4.8% versus 9.1% in clinical judgement) without reducing sensitivity (58.2% versus 56.4%). Outcomes were very similar across all diagnostic strategies. High-specificity DUTY strategies were more cost-effective than clinical judgement in the short- (iNMB = £0.78 and £0.84) and long-term (iNMB =£2.31 and £2.50). Dipstick tests had poorer cost-effectiveness than laboratory culture in children at intermediate risk of UTI (iNMB = £-1.41).
Conclusions
Compared to GPs’ clinical judgement, high specificity clinical rules from the DUTY study could substantially reduce urine sampling, achieving lower costs and equivalent patient outcomes. Dipstick testing children for UTI is not cost-effective.
doi:10.1016/j.jval.2017.01.003
PMCID: PMC5406157  PMID: 28407997
antibacterial agents; diagnosis; economics; medical; pediatrics; urinary tract infections
11.  Determinants of initiation, implementation, and discontinuation of amoxicillin by adults with acute cough in primary care 
Aim
To investigate the determinants of adherence to amoxicillin in patients with acute lower respiratory tract infection.
Materials and methods
Three European data sets were used. Adherence data were collected using self-reported diaries. Candidate determinants included factors relating to patient, condition, therapy, health care system/provider, and the study in which the patient participated. Logistic and Cox regression models were used to investigate the determinants of initiation, implementation, and discontinuation of amoxicillin.
Results
Although initiation differed across samples, implementation and discontinuation were similar. Determinants of initiation were days waited before consulting, duration of prescription, and being in a country where a doctor-issued sick certificate is required for being off work for <7 days. Implementation was higher for older participants or those with abnormal auscultation. Implementation was lower for those prescribed longer courses of amoxicillin (≥8 days). Time from initiation to discontinuation was longer for longer prescriptions and shorter for those from countries where single-handed practices were widespread.
Conclusion
Nonadherence to amoxicillin was largely driven by noninitiation. Differing sets of determinants were found for initiation, implementation, and discontinuation. There is a need to further understand the reasons for these determinants, the impact of poor adherence to antibiotics on outcomes, and to develop interventions to improve antibiotic use when prescribed.
doi:10.2147/PPA.S119256
PMCID: PMC5359137
adherence; antibiotics; general practice; determinants
12.  Intervention planning for a digital intervention for self-management of hypertension: a theory-, evidence- and person-based approach 
Background
This paper describes the intervention planning process for the Home and Online Management and Evaluation of Blood Pressure (HOME BP), a digital intervention to promote hypertension self-management. It illustrates how a Person-Based Approach can be integrated with theory- and evidence-based approaches. The Person-Based Approach to intervention development emphasises the use of qualitative research to ensure that the intervention is acceptable, persuasive, engaging and easy to implement.
Methods
Our intervention planning process comprised two parallel, integrated work streams, which combined theory-, evidence- and person-based elements. The first work stream involved collating evidence from a mixed methods feasibility study, a systematic review and a synthesis of qualitative research. This evidence was analysed to identify likely barriers and facilitators to uptake and implementation as well as design features that should be incorporated in the HOME BP intervention. The second work stream used three complementary approaches to theoretical modelling: developing brief guiding principles for intervention design, causal modelling to map behaviour change techniques in the intervention onto the Behaviour Change Wheel and Normalisation Process Theory frameworks, and developing a logic model.
Results
The different elements of our integrated approach to intervention planning yielded important, complementary insights into how to design the intervention to maximise acceptability and ease of implementation by both patients and health professionals. From the primary and secondary evidence, we identified key barriers to overcome (such as patient and health professional concerns about side effects of escalating medication) and effective intervention ingredients (such as providing in-person support for making healthy behaviour changes). Our guiding principles highlighted unique design features that could address these issues (such as online reassurance and procedures for managing concerns). Causal modelling ensured that all relevant behavioural determinants had been addressed, and provided a complete description of the intervention. Our logic model linked the hypothesised mechanisms of action of our intervention to existing psychological theory.
Conclusion
Our integrated approach to intervention development, combining theory-, evidence- and person-based approaches, increased the clarity, comprehensiveness and confidence of our theoretical modelling and enabled us to ground our intervention in an in-depth understanding of the barriers and facilitators most relevant to this specific intervention and user population.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-017-0553-4) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-017-0553-4
PMCID: PMC5324312  PMID: 28231840
Intervention planning; Theoretical modelling; Methodological study; Hypertension; Blood pressure; Self-monitoring; Self-management
13.  Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study 
PLoS ONE  2017;12(2):e0171113.
Objectives
To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory.
Population and methods
We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads.
Results
251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples.
Conclusions
The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children.
doi:10.1371/journal.pone.0171113
PMCID: PMC5310769  PMID: 28199403
14.  Effects on Engagement and Health Literacy Outcomes of Web-Based Materials Promoting Physical Activity in People With Diabetes: An International Randomized Trial 
Background
Developing accessible Web-based materials to support diabetes self-management in people with lower levels of health literacy is a continuing challenge.
Objective
The objective of this international study was to develop a Web-based intervention promoting physical activity among people with type 2 diabetes to determine whether audiovisual presentation and interactivity (quizzes, planners, tailoring) could help to overcome the digital divide by making digital interventions accessible and effective for people with all levels of health literacy. This study also aimed to determine whether these materials can improve health literacy outcomes for people with lower levels of health literacy and also be effective for people with higher levels of health literacy.
Methods
To assess the impact of interactivity and audiovisual features on usage, engagement, and health literacy outcomes, we designed two versions of a Web-based intervention (one interactive and one plain-text version of the same content) to promote physical activity in people with type 2 diabetes. We randomly assigned participants from the United Kingdom, Austria, Germany, Ireland, and Taiwan to either an interactive or plain-text version of the intervention in English, German, or Mandarin. Intervention usage was objectively recorded by the intervention software. Self-report measures were taken at baseline and follow-up (immediately after participants viewed the intervention) and included measures of health literacy, engagement (website satisfaction and willingness to recommend the intervention to others), and health literacy outcomes (diabetes knowledge, enablement, attitude, perceived behavioral control, and intention to undertake physical activity).
Results
In total, 1041 people took part in this study. Of the 1005 who completed health literacy information, 268 (26.67%) had intermediate or low levels of health literacy. The interactive intervention overall did not produce better outcomes than did the plain-text version. Participants in the plain-text intervention group looked at significantly more sections of the intervention (mean difference –0.47, 95% CI –0.64 to –0.30, P<.001), but this did not lead to better outcomes. Health literacy outcomes, including attitudes and intentions to engage in physical activity, significantly improved following the intervention for participants in both intervention groups. These improvements were similar across higher and lower health literacy levels and in all countries. Participants in the interactive intervention group had acquired more diabetes knowledge (mean difference 0.80, 95% CI 0.65-0.94, P<.001). Participants from both groups reported high levels of website satisfaction and would recommend the website to others.
Conclusions
Following established practice for simple, clear design and presentation and using a person-based approach to intervention development, with in-depth iterative feedback from users, may be more important than interactivity and audiovisual presentations when developing accessible digital health interventions to improve health literacy outcomes.
ClinicalTrial
International Standard Randomized Controlled Trial Number (ISRCTN): 43587048; http://www.isrctn.com/ISRCTN43587048. (Archived by WebCite at http://www.webcitation.org/6nGhaP9bv)
doi:10.2196/jmir.6601
PMCID: PMC5294369  PMID: 28115299
health literacy; digital intervention; diabetes; quantitative trial; physical activity
15.  Predicting the presence of bacterial pathogens in the airways of primary care patients with acute cough 
BACKGROUND:
Bacterial testing of all patients who present with acute cough is not feasible in primary care. Furthermore, the extent to which easily obtainable clinical information predicts bacterial infection is unknown. We evaluated the diagnostic value of clinical examination and testing for C-reactive protein and procalcitonin for bacterial lower respiratory tract infection.
METHODS:
Through a European diagnostic study, we recruited 3104 adults with acute cough (≤ 28 days) in primary care settings. All of the patients underwent clinical examination, measurement of C-reactive protein and procalcitonin in blood, and chest radiography. Bacterial infection was determined by conventional culture, polymerase chain reaction and serology, and positive results were defined by the presence of Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Bordetella pertussis or Legionella pneumophila. Using multivariable regression analysis, we examined the association of diagnostic variables with the presence of bacterial infection.
RESULTS:
Overall, 539 patients (17%) had bacterial lower respiratory tract infection, and 38 (1%) had bacterial pneumonia. The only item with diagnostic value for lower respiratory tract infection was discoloured sputum (area under the receiver operating characteristic [ROC] curve 0.56, 95% confidence interval [CI] 0.54–0.59). Adding C-reactive protein above 30 mg/L increased the area under the ROC curve to 0.62 (95% CI 0.59–0.65). For bacterial pneumonia, comorbidity, fever and crackles on auscultation had diagnostic value (area under ROC curve 0.68, 95% CI 0.58–0.77). Adding C-reactive protein above 30 mg/L increased the area under the ROC curve to 0.79 (95% CI 0.71–0.87). Procalcitonin did not add diagnostic information for any bacterial lower respiratory tract infection, including bacterial pneumonia.
INTERPRETATION:
In adults presenting with acute lower respiratory tract infection, signs, symptoms and C-reactive protein showed diagnostic value for a bacterial cause. However, the ability of these diagnostic indicators to exclude a bacterial cause was limited. Procalcitonin added no clinically relevant information.
doi:10.1503/cmaj.151364
PMCID: PMC5235925  PMID: 27777252
16.  Screening for Atrial Fibrillation using Economical and accurate TechnologY (SAFETY)—a pilot study 
BMJ Open  2017;7(1):e013535.
Introduction
Atrial fibrillation (AF) is a cause of stroke and a marker of atherosclerosis and of all patients with stroke, around 17% have AF. The screening and treatment of AF could prevent about 12% of all strokes. Several relatively low-cost devices with good accuracy now exist which can detect AF including WatchBP and AliveCor. However, they can only measure the ECG or pulse over short time periods. Inexpensive devices such as heart rate monitors, which are widely available, can measure heart rate for prolonged periods and may have potential in screening for AF. This study aims to determine the accuracy of AliveCor and WatchBP along with a bespoke algorithm using a heart rate monitor belt (Polar H7) and a wearable RR interval recorder (Firstbeat Bodyguard 2) for detecting AF during a single screening visit in primary care patients.
Methods/analysis
A multicentre case–control diagnostic study comparing the four different devices for the detection of AF with a reference standard consisting of a 12-lead ECG in GP surgeries across Hampshire, UK. We aim to recruit 92 participants with AF and 329 without AF aged 65 years and over. We will ask participants to rate comfort and overall impression for each device. We will collect qualitative data from participants capturing their experience of using wearable devices in order to evaluate acceptability. We will collect data from GPs to determine their views on AF screening.
Ethics and dissemination
This protocol was approved by the London—City & East Research Ethics Committee in June 2016. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and the Atrial Fibrillation Association, UK.
Trial registration number
ISRCTN17495003, Pre-results.
doi:10.1136/bmjopen-2016-013535
PMCID: PMC5253592  PMID: 28087552
17.  Understanding how primary care practitioners perceive an online intervention for the management of hypertension 
Background
In order to achieve successful implementation an intervention needs to be acceptable and feasible to its users and must overcome barriers to behaviour change. The Person-Based Approach can help intervention developers to improve their interventions to ensure more successful implementation. This study provides an example of using the Person-Based Approach to refine a digital intervention for hypertension (HOME BP).
Methods
Our Person-Based Approach involved conducting qualitative focus groups with practice staff to explore their perceptions of HOME BP and to identify any potential barriers to implementation of the HOME BP procedures. We took an iterative approach moving between data collection, analysis and modifications to the HOME BP intervention, followed by further data collection. The data was analysed using thematic analysis.
Results
Many aspects of HOME BP appeared to be acceptable, persuasive and feasible to implement. Practitioners perceived benefits in using HOME BP, including that it could empower patients to self-manage their health, potentially overcome clinical inertia around prescribing medication and save both the patient and practitioner time. However, practitioners also had some concerns. Some practitioners were concerned about the accuracy of patients’ home blood pressure readings, or the potential for home monitoring to cause patients anxiety and therefore increase consultations. Some GPs lacked confidence in choosing multiple medication changes, or had concerns about unanticipated drug interactions. A few nurses were concerned that the model of patient support they were asked to provide was not consistent with their perceived role. Modifications were made to the intervention based on this feedback, which appeared to help overcome practitioners’ concerns and improve the acceptability and feasibility of the intervention.
Conclusions
This paper provides a detailed example of using the Person-Based Approach to refine HOME BP, demonstrating how we improved the acceptability and feasibility of HOME BP based on feedback from practice staff. This demonstration may be useful to others developing digital interventions.
doi:10.1186/s12911-016-0397-x
PMCID: PMC5223423  PMID: 28069041
Person-based approach; Qualitative research; Intervention development; Hypertension
18.  Predicting adherence to acupuncture appointments for low back pain: a prospective observational study 
Background
Acupuncture is a popular form of complementary and alternative medicine (CAM), but it is not clear why patients do (or do not) follow acupuncturists’ treatment recommendations. This study aimed to investigate theoretically-derived predictors of adherence to acupuncture.
Methods
In a prospective study, adults receiving acupuncture for low back pain completed validated questionnaires at baseline, 2 weeks, 3 months, and 6 months. Patients and acupuncturists reported attendance. Logistic regression tested whether illness perceptions, treatment beliefs, and treatment appraisals measured at 2 weeks predicted attendance at all recommended acupuncture appointments.
Results
Three hundred twenty-four people participated (aged 18–89 years, M = 55.9, SD = 14.4; 70% female). 165 (51%) attended all recommended acupuncture appointments. Adherence was predicted by appraising acupuncture as credible, appraising the acupuncturist positively, appraising practicalities of treatment positively, and holding pro-acupuncture treatment beliefs. A multivariable logistic regression model including demographic, clinical, and psychological predictors, fit the data well (χ 2 (21) = 52.723, p < .001), explained 20% of the variance, and correctly classified 65.4% of participants as adherent/non-adherent.
Conclusions
The results partially support the dynamic extended common-sense model for CAM use. As hypothesised, attending all recommended acupuncture appointments was predicted by illness perceptions, treatment beliefs, and treatment appraisals. However, experiencing early changes in symptoms did not predict attendance. Acupuncturists could make small changes to consultations and service organisation to encourage attendance at recommended appointments and thus potentially improve patient outcomes.
doi:10.1186/s12906-016-1499-9
PMCID: PMC5209924  PMID: 28049527
Acupuncture; Adherence; Back pain; Health knowledge, Attitudes, Practice; Illness perceptions; Treatment beliefs
19.  Antibiotic prescription strategies and adverse outcome for uncomplicated lower respiratory tract infections: prospective cough complication cohort (3C) study 
The BMJ  2017;357:j2148.
Objective To assess the impact on adverse outcomes of different antibiotic prescribing strategies for lower respiratory tract infections in people aged 16 years or more.
Design Prospective cohort study.
Setting UK general practice.
Participants 28 883 patients with lower respiratory tract infection; symptoms, signs, and antibiotic prescribing strategies were recorded at the index consultation.
Main outcome measures The main outcomes were reconsultation with symptoms of lower respiratory tract infection in the 30 days after the index consultation, hospital admission, or death. Multivariable analysis controlled for an extensive list of variables related to the propensity to prescribe antibiotics and for clustering by doctor.
Results Of the 28 883 participants, 104 (0.4%) were referred to hospital for radiographic investigation or admission, or both on the day of the index consultation, or were admitted with cancer. Of the remaining 28 779, subsequent hospital admission or death occurred in 26/7332 (0.3%) after no antibiotic prescription, 156/17 628 (0.9%) after prescription for immediate antibiotics, and 14/3819 (0.4%) after a prescription for delayed antibiotics. Multivariable analysis documented no reduction in hospital admission and death after immediate antibiotics (multivariable risk ratio 1.06, 95% confidence interval 0.63 to 1.81, P=0.84) and a non-significant reduction with delayed antibiotics (0.81, 0.41 to 1.64, P=0.61). Reconsultation for new, worsening, or non-resolving symptoms was common (1443/7332 (19.7%), 4455/17 628 (25.3%), and 538/3819 (14.1%), respectively) and was significantly reduced by delayed antibiotics (multivariable risk ratio 0.64, 0.57 to 0.72, P<0.001) but not by immediate antibiotics (0.98, 0.90 to 1.07, P=0.66).
Conclusion Prescribing immediate antibiotics may not reduce subsequent hospital admission or death for young people and adults with uncomplicated lower respiratory tract infection, and such events are uncommon. If clinicians are considering antibiotics, a delayed prescription may be preferable since it is associated with a reduced number of reconsultations for worsening illness.
doi:10.1136/bmj.j2148
PMCID: PMC5439222  PMID: 28533265
20.  Developing an Unguided Internet-Delivered Intervention for Emotional Distress in Primary Care Patients: Applying Common Factor and Person-Based Approaches 
JMIR Mental Health  2016;3(4):e53.
Background
Developing effective, unguided Internet interventions for mental health represents a challenge. Without structured human guidance, engagement with these interventions is often limited and the effectiveness reduced. If their effectiveness can be increased, they have great potential for broad, low-cost dissemination. Improving unguided Internet interventions for mental health requires a renewed focus on the proposed underlying mechanisms of symptom improvement and the involvement of target users from the outset.
Objective
The aim of our study was to develop an unguided e-mental health intervention for distress in primary care patients, drawing on meta-theory of psychotherapeutic change and utilizing the person-based approach (PBA) to guide iterative qualitative piloting with patients.
Methods
Common factors meta-theory informed the selection and structure of therapeutic content, enabling flexibility whilst retaining the proposed necessary ingredients for effectiveness. A logic model was designed outlining intervention components and proposed mechanisms underlying improvement. The PBA provided a framework for systematically incorporating target-user perspective into the intervention development. Primary care patients (N=20) who had consulted with emotional distress in the last 12 months took part in exploratory qualitative interviews, and a subsample (n=13) undertook think-aloud interviews with a prototype of the intervention.
Results
A flexible intervention was developed, to be used as and when patients need, diverting from a more traditional, linear approach. Based on the in-depth qualitative findings, disorder terms such as “depression” were avoided, and discussions of psychological symptoms were placed in the context of stressful life events. Think-aloud interviews showed that patients were positive about the design and structure of the intervention. On the basis of patient feedback, modifications were made to increase immediate access to all therapeutic techniques.
Conclusions
Detailing theoretical assumptions underlying Internet interventions for mental health, and integrating this approach with systematic in-depth qualitative research with target patients is important. These strategies may provide novel ways for addressing the challenges of unguided delivery. The resulting intervention, Healthy Paths, will be evaluated in primary care-based randomized controlled trials, and deployed as a massive open online intervention (MOOI).
doi:10.2196/mental.5845
PMCID: PMC5209611  PMID: 27998878
Internet; unguided; distress; person-based approach
21.  Antibiotic prescribing in patients with self-reported sore throat 
Objectives: To investigate the predictors of general practitioner (GP) consultation and antibiotic use in those developing sore throat.
Methods: We conducted a prospective population-based cohort study on 4461 participants in two rounds (2010–11) from 1897 households.
Results: Participants reported 2193 sore throat illnesses, giving a community sore throat incidence of 1.57/ person-year. 13% of sore throat illnesses led to a GP consultation and 56% of these consultations led to antibiotic use. Participants most likely to have sore throats included women and children (e.g. school compared with retirement age); adjusted incidence rate ratio (aIRR) of 1.33 and 1.52, respectively. Participants with sore throat were more likely to consult their GP if they were preschool compared with retirement age [adjusted OR (aOR) 3.22], had more days of sore throat (aOR 1.11), reported more severe pain (aOR 4.24) or reported fever (aOR 3.82). Antibiotics were more often used by chronically ill individuals (aOR 1.78), those reporting severe pain (aOR 4.14), those reporting fever (aOR 2.58) or children with earache (aOR 1.85). Among those who consulted, males and adults who reported feeling anxious were more likely to use antibiotics; aOR 1.87 and 5.36, respectively.
Conclusions: Only 1 in 10 people who have a sore throat see a doctor and more than half of those attending get antibiotics. Further efforts to curb antibiotic use should focus on reducing initial GP consultations through public information promoting safe self-management, targeted at groups identified above as most likely to attend with sore throats.
doi:10.1093/jac/dkw497
PMCID: PMC5400092  PMID: 27999063
22.  Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial 
BMJ Open  2016;6(11):e012684.
Introduction
Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care.
Methods and analysis
The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence.
Ethics and dissemination
This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension.
Trial registration number
ISRCTN13790648; pre-results.
doi:10.1136/bmjopen-2016-012684
PMCID: PMC5129001  PMID: 27821598
PRIMARY CARE
23.  Development and internal validation of a clinical rule to improve antibiotic use in children presenting to primary care with acute respiratory tract infection and cough: a prognostic cohort study 
The Lancet. Respiratory Medicine  2016;4(11):902-910.
Summary
Background
Antimicrobial resistance is a serious threat to public health, with most antibiotics prescribed in primary care. General practitioners (GPs) report defensive antibiotic prescribing to mitigate perceived risk of future hospital admission in children with respiratory tract infections. We developed a clinical rule aimed to reduce clinical uncertainty by stratifying risk of future hospital admission.
Methods
8394 children aged between 3 months and 16 years presenting with acute cough (for ≤28 days) and respiratory tract infection were recruited to a prognostic cohort study from 247 general practitioner practices in England. Exposure variables included demographic characteristics, parent-reported symptoms, and physical examination signs. The outcome was hospital admission for respiratory tract infection within 30 days, collected using a structured, blinded review of medical records.
Findings
8394 (100%) children were included in the analysis, with 78 (0·9%, 95% CI 0·7%–1·2%) admitted to hospital: 15 (19%) were admitted on the day of recruitment (day 1), 33 (42%) on days 2–7; and 30 (39%) on days 8–30. Seven characteristics were independently associated (p<0·01) with hospital admission: age <2 years, current asthma, illness duration of 3 days or less, parent-reported moderate or severe vomiting in the previous 24 h, parent-reported severe fever in the previous 24 h or a body temperature of 37·8°C or more at presentation, clinician-reported intercostal or subcostal recession, and clinician-reported wheeze on auscultation. The area under the receiver operating characteristic (AUROC) curve for the coefficient-based clinical rule was 0·82 (95% CI 0·77–0·87, bootstrap validated 0·81). Assigning one point per characteristic, a points-based clinical rule consisting of short illness, temperature, age, recession, wheeze, asthma, and vomiting (mnemonic STARWAVe; AUROC 0·81, 0·76–0·85) distinguished three hospital admission risk strata: very low (0·3%, 0·2–0·4%) with 1 point or less, normal (1·5%, 1·0–1·9%) with 2 or 3 points, and high (11·8%, 7·3–16·2%) with 4 points or more.
Interpretation
Clinical characteristics can distinguish children at very low, normal, and high risk of future hospital admission for respiratory tract infection and could be used to reduce antibiotic prescriptions in primary care for children at very low risk.
Funding
National Institute for Health Research (NIHR).
doi:10.1016/S2213-2600(16)30223-5
PMCID: PMC5080970  PMID: 27594440
24.  Family Practitioners’ Advice about Taking Time Off Work for Lower Respiratory Tract Infections: A Prospective Study in Twelve European Primary Care Networks 
PLoS ONE  2016;11(10):e0164779.
Background
Acute cough and lower respiratory tract infections (LRTIs) are one of the most important causes of lost working hours.
Aim
to explore variation and predictors in family practitioners (FPs) advice to patients with LRTIs about taking time off work in different European countries.
Methods
Prospective observational study in primary care networks in 12 countries, with multilevel mixed-effects binomial logistic regression.
Results
324 FPs recruited 1616 employed adults who presented to primary care with LRTIs. The proportion of patients advised to take time off work varied from 7.6% in the Netherlands to 89.2% in Slovakia, and of these, 88.2% overall were advised to stay off work for seven days or less. None of Finnish or Dutch patients were advised to take more than 7 days off, in contrast to 35.5% of Polish and 27.0% of Slovak patients. The strongest predictors of FPs’ advice about time off work were: patient symptoms interfering with normal activities (OR 4.43; P<0.001), fever (2.49; P<0.001), patients feeling generally unwell (2.21; P<0.001), antibiotic prescribing (1.51; P = 0.025) and auscultation abnormality (1.50; P = 0.029). Advice to take time off was not associated with patient reported recovery.
Conclusions
There is large variation in FPs’ advice given to patients with LRTIs in Europe about taking time off work, which is not explained by differences in patients’ reported illness duration, but might be explained by differences in regulations around certification and sick pay. Evidence based guidance for advising patients about taking time off work for this common condition is needed.
doi:10.1371/journal.pone.0164779
PMCID: PMC5070783  PMID: 27760225
25.  Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial 
Background:
Systematic reviews support nasal saline irrigation for chronic or recurrent sinus symptoms, but trials have been small and few in primary care settings. Steam inhalation has also been proposed, but supporting evidence is lacking. We investigated whether brief pragmatic interventions to encourage use of nasal irrigation or steam inhalation would be effective in relieving sinus symptoms.
Methods:
We conducted a pragmatic randomized controlled trial involving adults (age 18–65 yr) from 72 primary care practices in the United Kingdom who had a history of chronic or recurrent sinusitis and reported a “moderate to severe” impact of sinus symptoms on their quality of life. Participants were recruited between Feb. 11, 2009, and June 30, 2014, and randomly assigned to 1 of 4 advice strategies: usual care, daily nasal saline irrigation supported by a demonstration video, daily steam inhalation, or combined treatment with both interventions. The primary outcome measure was the Rhinosinusitis Disability Index (RSDI). Patients were followed up at 3 and 6 months. We imputed missing data using multiple imputation methods.
Results:
Of the 961 patients who consented, 871 returned baseline questionnaires (210 usual care, 219 nasal irrigation, 232 steam inhalation and 210 combined treatment). A total of 671 (77.0%) of the 871 participants reported RSDI scores at 3 months. Patients’ RSDI scores improved more with nasal irrigation than without nasal irrigation by 3 months (crude change −7.42 v. −5.23; estimated adjusted mean difference between groups −2.51, 95% confidence interval −4.65 to −0.37). By 6 months, significantly more patients maintained a 10-point clinically important improvement in the RSDI score with nasal irrigation (44.1% v. 36.6%); fewer used over-the-counter medications (59.4% v. 68.0%) or intended to consult a doctor in future episodes. Steam inhalation reduced headache but had no significant effect on other outcomes. The proportion of participants who had adverse effects was the same in both intervention groups.
Interpretation:
Advice to use steam inhalation for chronic or recurrent sinus symptoms in primary care was not effective. A similar strategy to use nasal irrigation was less effective than prior evidence suggested, but it provided some symptomatic benefit. Trial registration: ISRCTN, no. 88204146.
doi:10.1503/cmaj.160362
PMCID: PMC5026511  PMID: 27431306

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